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Federal Register The Regulatory Plan

Vol. 71, No. 237

Monday, December 11, 2006


Federal regulation is a fundamental instrument of national policy. It is

one of the three major tools — in addition to spending and taxing —
used to implement policy. It is used to advance numerous public objectives,
including homeland security, environmental protection, educational quality,
food safety, transportation safety, health care quality, equal employment
opportunity, energy security, immigration control, and consumer protection.
The Office of Management and Budget’s (OMB) Office of Information and
Regulatory Affairs (OIRA) is responsible for overseeing and coordinating
the Federal Government’s regulatory policies.

The Regulatory Plan is published as part of the fall edition of the Unified
Agenda of Federal Regulatory and Deregulatory Actions, and serves as a
statement of the Administration’s regulatory and deregulatory policies and
priorities. The purpose of the Plan is to make the regulatory process more
accessible to the public and to ensure that the planning and coordination
necessary for a well-functioning regulatory process occurs. The Plan identifies
regulatory priorities and contains information about the most significant
regulatory actions that agencies expect to undertake in the coming year.
An accessible regulatory process enables citizen centered service, which
is a vital part of the President’s Management Agenda.

Federal Regulatory Policy

The Bush Administration supports Federal regulations that are sensible and
based on sound science, economics, and the law. Accordingly, the Adminis-
tration is striving for a regulatory process that adopts new rules when
markets fail to serve the public interest, simplifies and modifies existing
rules to make them more effective or less costly or less intrusive, and
rescinds outmoded rules whose benefits do not justify their costs. In pursuing
this agenda, OIRA has adopted an approach based on the principles of
regulatory analysis and policy espoused in Executive Order 12866, signed
by President Clinton in 1993.

Effective regulatory policy is not uniformly pro-regulation or anti-regulation.

It begins with the authority granted under the law. Within the discretion
available to the regulating agency by its statutory authority, agencies apply
a number of principles articulated in Executive Order 12866, as well as
other applicable Executive orders, in order to design regulations that achieve
their ends in the most efficient way. This means bringing to bear on the
policy problem sound economic principles, the highest quality information,
and the best possible science. This is not always an easy task, as sometimes
economic and scientific information may point in very different directions,
and therefore designing regulations does not mean just the rote application
of quantified data to reach policy decisions. In making regulatory decisions,
we expect agencies to consider not only benefit and cost items that can
be quantified and expressed in monetary units, but also other attributes
and factors that cannot be integrated readily in a benefit-cost framework,
such as fairness and privacy. However, effective regulation is the result

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of the careful use of all available high-quality data, and the application
of broad principles established by the President.

In pursuing this goal of establishing an effective, results-oriented regulatory

system, the Bush Administration has increased the level of public involve-
ment and transparency in its review and clearance of new and existing

For new rulemakings and programs, OIRA has enhanced the transparency
of OMB’s regulatory review process. OIRA’s website now enables the public
to find which rules are formally under review at OMB and which rules
have recently been cleared or have been returned to agencies for reconsider-
ation. OIRA has also increased the amount of information available on
its website. In addition to information on meetings and correspondence,
OIRA makes available communications from the OIRA Administrator to
agencies, including ‘‘prompt letters,’’ ‘‘return letters,’’ and ‘‘post clearance
letters,’’ as well as the Administrator’s memorandum to the President’s Man-
agement Council (September 20, 2001) on presidential review of agency
rulemaking by OIRA.

For existing rulemakings, OIRA has initiated a modest series of calls for
reform nominations in 2001, 2002, and 2004. In the draft 2001 annual
Report to Congress on the Costs and Benefits of Federal Regulation, OMB
asked for suggestions from the public about specific regulations that should
be modified in order to increase net benefits to the public. We received
suggestions regarding 71 regulations, 23 of which OMB designated as high
priorities. After a similar call for reforms in the 2002 draft Report, OMB
received recommendations on 316 distinct rules, guidance documents, and
paperwork requirements from over 1,700 commenters. Many of the nomina-
tions involved rules and guidance documents that were recently issued
or already under review by the agencies, or involved independent agency
rules or guidance documents. OMB determined that the remaining 122 rules
and 34 guidance documents were not under active review, and referred
them to the agencies for their evaluation as possible reforms. Finally, in
the 2004 draft Report, OMB requested public nominations of promising
regulatory reforms relevant to the manufacturing sector. In particular, com-
menters were asked to suggest specific reforms to rules, guidance documents,
or paperwork requirements that would improve manufacturing regulation
by reducing unnecessary costs, increasing effectiveness, enhancing competi-
tiveness, reducing uncertainty, and increasing flexibility. In response to the
solicitation, OMB received 189 distinct reform nominations from 41 com-
menters. Of these, Federal agencies and OMB have determined that 76
of the 189 nominations have potential merit and justify further action. For
further information, all of these Reports are available on OIRA’s website

The Bush Administration has also moved aggressively to establish basic

quality performance goals for all information disseminated by Federal agen-
cies, including information disseminated in support of proposed and final
regulations. The Federal agencies issued guidelines on October 1, 2002 under
the Information Quality Act to ensure the ‘‘quality, objectivity, utility, and
integrity’’ of all information disseminated by Federal agencies. Under these
guidelines, Federal agencies are taking appropriate steps to incorporate the
information quality performance standards into agency information dissemi-
nation practices, and developing pre-dissemination review procedures to
substantiate the quality of information before it is disseminated. Under the
agency information quality guidelines, ‘‘affected persons’’ can request that
the agencies correct information if they believe that scientific, technical,
economic, statistical or other information disseminated does not meet the
agency and OMB standards. If the requestor is dissatisfied with the initial

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72727

agency response to a correction request, an appeal opportunity is provided

by the agencies. With the implementation of these guidelines, agencies are
now aware that ensuring the high quality of government information dissemi-
nations is a high priority of the Administration. Further information on
OIRA’s activities implementing the Information Quality Act is available on
OIRA’s website at

As part of its efforts to improve the quality, objectivity, utility, and integrity
of information disseminated by the Federal agencies, on December 16, 2004,
OMB issued a Final Information Quality Bulletin for Peer Review. This
Bulletin establishes government-wide guidance aimed at enhancing the prac-
tice of peer review of government science documents. The Bulletin describes
minimum standards for when peer review is required and how intensive
the peer review should be for different information. The Bulletin requires
the most rigorous form of peer review for highly influential scientific assess-
ments. Further information on peer review is available on OIRA’s website

In addition to increasing the level of public involvement and transparency

in its review of regulations, the Bush Administration has sought to enhance
the role of analysis in the development of effective regulations. On September
17, 2003, OMB issued revised guidance to agencies on regulatory analysis.1
Key features of the revised guidance include more emphasis on cost-effective-
ness, more careful evaluation of qualitative and intangible values, and a
greater emphasis on considering the uncertainty inherent in estimates of
impact. OIRA was very interested in updating the guidance in light of
these and other innovations now commonplace in the research community.
The 2006 Regulatory Plan continues OIRA’s effort to ensure coordination
across Federal agencies in pursuing analytically sound regulatory policies.

The Administration’s 2006 Regulatory Priorities

With regard to Federal regulation, the Bush Administration’s objective is

quality, not quantity. Those rules that are adopted promise to be more
effective, less intrusive, and more cost-effective in achieving national objec-
tives while demonstrating greater durability in the face of political and
legal attack. The Regulatory Plan is integral to enhancing the quality of
Federal regulations, and OMB seeks to ensure that the public is provided
with the information needed to understand and comment on the Federal
regulatory agenda. Accordingly, the 2006 Regulatory Plan highlights the
following themes:
• Regulations that are particularly good examples of the Administration’s
‘‘smart’’ regulation agenda to streamline regulations and reporting re-
quirements, which is a key part of the President’s economic plan.
• Regulations that are of particular concern to small businesses.

1 See Circular A-4, ‘‘Regulatory Analysis,’’ published as part of OMB’s 2003
Report to Congress on the Costs and Benefits of Federal Regulations. The
report is available on OMB’s website at

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• Regulations that respond to public nominations submitted to OMB in

2001 or 2002.
• Regulations that address 2004 nominations for promising regulatory re-
forms in the manufacturing sector.


Smarter regulatory policies, created through public participation, trans-

parency, and cooperation across Federal agencies, are a key Administration
objective. The following department and agency plans provide further infor-
mation on regulatory priorities. All agencies’ plans are a reflection of the
Administration’s Federal Regulatory Policy objectives, which aim at imple-
menting an effective and results-oriented regulatory system.

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72729

Sequence Title Identifier Rulemaking Stage
Number Number

1 Procurement of Commodities for Foreign Donation 0560–AH40 Final Rule Stage

2 Animal Welfare; Regulations and Standards for Birds 0579–AC02 Proposed Rule
3 Importation of Plants for Planting; Establishing a New Category of Plants for Planting Not
Authorized for Importation Pending Risk Assessment 0579–AC03 Proposed Rule
4 Revision of Fruits and Vegetables Import Regulations 0579–AB80 Final Rule Stage
5 Phytophthora Ramorum; Quarantine and Regulations 0579–AB82 Final Rule Stage
6 Special Nutrition Programs: Fluid Milk Substitutions 0584–AD58 Proposed Rule
7 Child and Adult Care Food Program: Improving Management and Program Integrity 0584–AC24 Final Rule Stage
8 FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment
Act of 2002 0584–AD30 Final Rule Stage
9 Quality Control Provisions of Title IV of Public Law 107-171 0584–AD31 Final Rule Stage
10 Direct Certification of Children in Food Stamp Households and Certification of Homeless,
Migrant and Runaway Children for Free Meals in the NSLP, SBP, and SMP 0584–AD60 Final Rule Stage
11 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): WIC
Vendor Cost Containment 0584–AD71 Final Rule Stage
12 Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revi-
sions in the WIC Food Packages 0584–AD77 Final Rule Stage
13 Egg Products Inspection Regulations 0583–AC58 Proposed Rule
14 Performance Standards for the Production of Processed Meat and Poultry Products;
Control of Listeria Monocytogenes in Ready-to-Eat Meat and Poultry Products 0583–AC46 Final Rule Stage
15 Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poul-
try Products 0583–AC60 Final Rule Stage
16 Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for
the Disposition of Non-Ambulatory Disabled Cattle 0583–AC88 Final Rule Stage
17 Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery Sys-
tems 0583–AD00 Final Rule Stage
18 Prohibition on the Use of Air-Injection Stunners for the Slaughter of Cattle 0583–AD03 Final Rule Stage
19 Availability of Lists of Retail Consignees During Meat or Poultry Product Recalls 0583–AD10 Final Rule Stage
20 Forest Service National Environmental Policy Act Procedures 0596–AC49 Proposed Rule
21 National Forest System Land Management Planning Categorical Exclusion (Final Direc-
tive, Forest Service Handbook 1909.15, Chapter 30) 0596–AB86 Final Rule Stage
22 National Forest System Land Management Planning Directive (Final Directive, Forest
Service Handbook 1909.12, Chapter 70-Wilderness Evaluation) 0596–AC57 Final Rule Stage

Sequence Title Identifier Rulemaking Stage
Number Number

23 Right Whale Ship Strike Reduction 0648–AS36 Final Rule Stage

24 Implement and Administer a Coupon Program for Digital-to-Analog Converter Boxes 0660–AA16 Final Rule Stage

Sequence Title Identifier Rulemaking Stage
Number Number

25 TRICARE Outpatient Prospective Payment System (OPPS) 0720–AB03 Final Rule Stage
26 TRICARE; Certain Survivors of Deceased Active Duty Members; and Adoption Inter-
mediaries 0720–AB04 Final Rule Stage
27 Expand Eligibility of Selected Reserve Members Under the TRICARE Program 0720–AB05 Final Rule Stage

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Sequence Title Identifier Rulemaking Stage
Number Number

28 Energy Conservation Standards for Residential Electric and Gas Ranges and Ovens and
Microwave Ovens, Dishwashers, Dehumidifiers, and Commercial Clothes Washers 1904–AB49 Prerule Stage
29 Energy Efficiency Standards for Commercial Refrigeration Equipment 1904–AB59 Prerule Stage
30 Energy Efficiency Standards for Residential Furnaces and Boilers 1904–AA78 Proposed Rule
31 Energy Efficiency Standards for Electric Distribution Transformers 1904–AB08 Final Rule Stage
32 Energy Efficiency Standards for Ceiling Fan Light Kits 1904–AB61 Final Rule Stage
33 Loan Guarantees for Projects That Employ Innovative Technologies 1901–AB21 Proposed Rule
34 Radiation Protection of the Public and the Environment 1901–AA38 Final Rule Stage


Sequence Title Identifier Rulemaking Stage
Number Number

35 Control of Communicable Diseases, Interstate and Foreign Quarantine 0920–AA12 Final Rule Stage
36 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 0910–AC52 Proposed Rule
37 Content and Format of Labeling for Human Prescription Drugs and Biologics; Require-
ments for Pregnancy and Lactation Labeling 0910–AF11 Proposed Rule
38 Expanded Access to Investigational Drugs for Treatment Use 0910–AF14 Proposed Rule
39 Label Requirement for Food That Has Been Refused Admission Into the United States 0910–AF61 Proposed Rule
40 Medical Device Reporting; Electronic Submission Requirements 0910–AF86 Proposed Rule
41 Electronic Registration and Listing for Devices 0910–AF88 Proposed Rule
42 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary In-
gredients and Dietary Supplements 0910–AB88 Final Rule Stage
43 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Pre-
paredness and Response Act of 2002 0910–AC41 Final Rule Stage
44 Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment
Rate Updates (CMS-1529-P) 0938–AO30 Proposed Rule
45 Standards for E-Prescribing Under Medicare Part D (CMS-0016-P) 0938–AO66 Proposed Rule
46 Changes to the Hospital Inpatient Prospective Payment Systems and FY 2008 Rates
(CMS-1533-P) 0938–AO70 Proposed Rule
47 Revisions to the Medicare Advantage and Part D Prescription Drug Contract Confiden-
tiality and Disclosure, Determinations, Appeals, and Intermediate Sanctions Processes
(CMS-4124-P) 0938–AO78 Proposed Rule
48 Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,
Orthotics, and Supplies (CMS-1270-F) 0938–AN14 Final Rule Stage


Sequence Title Identifier Rulemaking Stage
Number Number

49 Minimum Standards for Driver’s Licenses and Identification Cards Acceptable to Federal
Agencies for Official Purposes 1601–AA37 Proposed Rule
50 United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT),
Enrollment of Additional Aliens in US-VISIT 1601–AA35 Final Rule Stage
51 Chemical Security Anti-terrorism Standards 1601–AA41 Final Rule Stage

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Sequence Title Identifier Rulemaking Stage
Number Number

52 Special Immigrant and Nonimmigrant Religious Workers 1615–AA16 Proposed Rule

53 Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant
Status 1615–AA60 Final Rule Stage
54 New Classification for Victims of Certain Criminal Activity; Eligibility for the U Non-
immigrant Status 1615–AA67 Final Rule Stage
55 Removal of Standardized Request for Evidence Processing Timeframe 1615–AB13 Final Rule Stage
56 Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification
System (USCG-2005-21869) 1625–AA99 Proposed Rule
57 Passenger Manifest for Commercial Aircraft Arriving In and Departing From the United
States; Passengers and Crew Manifests for Commercial Vessels Departing From the
United States 1651–AA62 Final Rule Stage


Sequence Title Identifier Rulemaking Stage
Number Number

58 Permanent Foundations for Manufactured Housing (FR-5075) 2502–AI45 Proposed Rule

59 Capital Fund Program (FR-4880) 2577–AC50 Proposed Rule
60 Revisions to the Public Housing Assessment System (PHAS) (FR-5094) 2577–AC68 Proposed Rule


Sequence Title Identifier Rulemaking Stage
Number Number

61 Valuation of Oil From Indian Leases 1010–AD00 Final Rule Stage

62 Placement of Excess Spoil 1029–AC04 Proposed Rule
63 Oil Shale Leasing and Operations 1004–AD90 Proposed Rule

Sequence Title Identifier Rulemaking Stage
Number Number

64 Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial

Facilities 1190–AA44 Proposed Rule
65 Nondiscrimination on the Basis of Disability in State and Local Government Services 1190–AA46 Proposed Rule

Sequence Title Identifier Rulemaking Stage
Number Number

66 Family and Medical Leave Act of 1993; Conform to the Supreme Court’s Ragsdale Deci-
sion 1215–AB35 Prerule Stage
67 Alternative Trade Adjustment Assistance Benefits; Amendment of Regulations 1205–AB40 Proposed Rule

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Sequence Title Identifier Rulemaking Stage
Number Number

68 Revision of the Department of Labor Regulations for Petitions and Determinations of Eli-
gibility to Apply for Trade Adjustment Assistance for Workers 1205–AB44 Proposed Rule
69 Revision to the Department of Labor Benefit Regulations for Trade Adjustment Assist-
ance for Workers Under the Trade Act of 1974, as Amended 1205–AB32 Final Rule Stage
70 Labor Certification for the Permanent Employment of Aliens in the United States; Reduc-
ing the Incentives and Opportunities for Fraud and Abuse and Enhancing Program In-
tegrity 1205–AB42 Final Rule Stage
71 Amendment of Regulation Relating to Definition of Plan Assets—Participant Contribu-
tions 1210–AB02 Proposed Rule
72 Regulations Implementing the Health Care Access, Portability, and Renewability Provi-
sions of the Health Insurance Portability and Accountability Act of 1996 1210–AA54 Final Rule Stage
73 Prohibiting Discrimination Against Participants and Beneficiaries Based on Health Status 1210–AA77 Final Rule Stage
74 Section 404 Regulation—Default Investment Alternatives Under Participant Directed Indi-
vidual Account Plans 1210–AB10 Final Rule Stage
75 Personal Continuous Dust Monitors 1219–AB48 Prerule Stage
76 Sealing of Abandoned Areas 1219–AB52 Proposed Rule
77 Mine Rescue Teams 1219–AB53 Proposed Rule
78 Diesel Particulate Matter: Conversion Factor from Total Carbon to Elemental Carbon 1219–AB55 Proposed Rule
79 Asbestos Exposure Limit 1219–AB24 Final Rule Stage
80 Emergency Mine Evacuation 1219–AB46 Final Rule Stage
81 Criteria and Procedures for Proposed Assessment of Civil Penalties 1219–AB51 Final Rule Stage
82 Occupational Exposure to Crystalline Silica 1218–AB70 Prerule Stage
83 Hazard Communication 1218–AC20 Prerule Stage
84 Cranes and Derricks 1218–AC01 Proposed Rule

Sequence Title Identifier Rulemaking Stage
Number Number

85 Commuter Operations in Very Light Jets (VLJS) 2120–AI84 Proposed Rule

86 Aging Aircraft Program (Widespread Fatigue Damage) 2120–AI05 Final Rule Stage
87 Transport Airplane Fuel Tank Flammability Reduction 2120–AI23 Final Rule Stage
88 Medical Certification Requirements as Part of the Commercial Driver’s License 2126–AA10 Proposed Rule
89 Unified Registration System 2126–AA22 Proposed Rule
90 National Registry of Certified Medical Examiners 2126–AA97 Proposed Rule
91 Roof Crush Resistance 2127–AG51 Final Rule Stage
92 Side Impact Protection Upgrade—FMVSS No. 214 2127–AJ10 Final Rule Stage
93 Reduced Stopping Distance Requirements for Truck Tractors 2127–AJ37 Final Rule Stage
94 Electronic Stability Control (ESC) 2127–AJ77 Final Rule Stage


Sequence Title Identifier Rulemaking Stage
Number Number

95 Implementation of a Revised Basel Capital Accord (Basel II) 1557–AC91 Proposed Rule

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Sequence Title Identifier Rulemaking Stage
Number Number

96 Risk-Based Capital Guidelines; Capital Adequacy Guidelines; Capital Maintenance: Do-

mestic Capital Modifications (Basel IA) 1557–AC95 Proposed Rule
97 Implementation of a Revised Basel Capital Accord (Basel II) 1550–AB56 Proposed Rule


Sequence Title Identifier Rulemaking Stage
Number Number

98 Endocrine Disrupter Screening Program (EDSP); Implementing the Screening and Test-
ing Phase 2070–AD61 Prerule Stage
99 Standards for the Management of Coal Combustion Wastes Generated by Commercial
Electric Power Producers 2050–AE81 Prerule Stage
100 Review of the National Ambient Air Quality Standards for Carbon Monoxide 2060–AI43 Proposed Rule
101 Control of Emissions From New Locomotives and New Marine Diesel Engines Less
Than 30 Liters per Cylinder 2060–AM06 Proposed Rule
102 Control of Emissions From Nonroad Spark-Ignition Engines and Equipment 2060–AM34 Proposed Rule
103 Implementing Periodic Monitoring in Federal and State Operating Permit Programs 2060–AN00 Proposed Rule
104 Review of the National Ambient Air Quality Standards for Ozone 2060–AN24 Proposed Rule
105 Prevention of Significant Deterioration, Nonattainment New Source Review, and New
Source Performance Standards: Emissions Test for Electric Generating Units 2060–AN28 Proposed Rule
106 Review of the National Ambient Air Quality Standards for Lead 2060–AN83 Proposed Rule
107 Test Rule; Testing of Certain High Production Volume (HPV) Chemicals 2070–AD16 Proposed Rule
108 Pesticides; Competency Standards for Occupational Users 2070–AJ20 Proposed Rule
109 Pesticides; Agricultural Worker Protection Standard Revisions 2070–AJ22 Proposed Rule
110 Pesticide Agricultural Container Recycling Program 2070–AJ29 Proposed Rule
111 Revisions to the Spill Prevention, Control, and Countermeasure (SPCC) Rule, 40 CFR
Part 112 2050–AG16 Proposed Rule
112 Expanding the Comparable Fuels Exclusion under RCRA 2050–AG24 Proposed Rule
113 Definition of Solid Wastes Revisions 2050–AG31 Proposed Rule
114 NESHAP: Hazardous Organic NESHAP (HON) Residual Risk Standards 2060–AK14 Final Rule Stage
115 NESHAP: Halogenated Solvent Cleaning—Residual Risk Standards 2060–AK22 Final Rule Stage
116 Control of Hazardous Air Pollutants From Mobile Sources 2060–AK70 Final Rule Stage
117 Clean Air Fine Particle Implementation Rule 2060–AK74 Final Rule Stage
118 Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review
(NSR): Debottlenecking, Aggregation and Project Netting 2060–AL75 Final Rule Stage
119 Fuel Economy Labeling of Motor Vehicles: Revisions to Improve Calculation of Fuel
Economy Estimates 2060–AN14 Final Rule Stage
120 Amendment of the Standards for Radioactive Waste Disposal in Yucca Mountain, Ne-
vada 2060–AN15 Final Rule Stage
121 Renewable Fuels Standard Rule 2060–AN76 Final Rule Stage
122 Final Rule for Implementation of the New Source Review (NSR) Program for PM2.5 2060–AN86 Final Rule Stage
123 Pesticides; Data Requirements for Conventional Chemicals 2070–AC12 Final Rule Stage
124 Lead-Based Paint Activities; Amendments for Renovation, Repair, and Painting 2070–AC83 Final Rule Stage
125 Pesticides; Data Requirements for Biochemical and Microbial Products 2070–AD51 Final Rule Stage

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Sequence Title Identifier Rulemaking Stage
Number Number

126 Notification of Chemical Exports under TSCA Section 12(b) 2070–AJ01 Final Rule Stage
127 Testing Agreement for Perfluorooctanoic Acid (PFOA) 2070–AJ06 Final Rule Stage
128 Hazardous Waste Manifest Revisions-Standards and Procedures for Electronic Manifests 2050–AG20 Final Rule Stage
129 Oil Pollution Prevention; Spill Prevention, Control, and Countermeasure (SPCC) Require-
ments—Amendments 2050–AG23 Final Rule Stage
130 National Pollutant Discharge Elimination System Permit Requirements for Peak Wet
Weather Discharges from Publicly Owned Treatment Work Treatment Plants Serving
Sanitary Sewer Collection Systems Policy 2040–AD87 Final Rule Stage
131 Concentrated Animal Feeding Operation Rule 2040–AE80 Final Rule Stage
132 Water Transfers Rule 2040–AE86 Final Rule Stage
133 Implementation Guidance for Mercury Water Quality Criteria 2040–AE87 Final Rule Stage
134 Toxics Release Inventory Reporting Burden Reduction Rule 2025–AA14 Final Rule Stage


Sequence Title Identifier Rulemaking Stage
Number Number

134A Coordination of Retired Health Benefits With Medicare and State Health Benefits 3046–AA72 Final Rule Stage


Sequence Title Identifier Rulemaking Stage
Number Number

135 Federal Records Management 3095–AB16 Proposed Rule



Sequence Title Identifier Rulemaking Stage
Number Number

136 Small Business Lending Company and Lender Oversight Regulations 3245–AE14 Proposed Rule
137 Size for Purposes of Long Term Contracts; Small Business Size Regulations; 8(a) Busi-
ness Development/Small Disadvantaged Business Status Determinations 3245–AF06 Final Rule Stage


Sequence Title Identifier Rulemaking Stage
Number Number

138 Revised Medical Criteria for Evaluating Mental Disorders (886P) 0960–AF69 Proposed Rule
139 Additional Insured Status Requirements for Certain Alien Workers (2882P) 0960–AG22 Proposed Rule
140 Consultative Examination - Annual Onsite Review by DDSs (3338P) 0960–AG41 Proposed Rule
141 Revised Medical Criteria for Evaluating Impairments of the Digestive System (800F) 0960–AF28 Final Rule Stage
142 Revised Medical Criteria for Evaluating Immune System Disorders (804F) 0960–AF33 Final Rule Stage
143 Mandatory Exclusion of Health Care Providers and Representatives From Participating in
Programs Administered by SSA, Including Representative Payment (954F) 0960–AF85 Final Rule Stage
144 Amendments to the Ticket to Work and Self-Sufficiency Program (967F) 0960–AF89 Final Rule Stage
145 Age as a Factor in Evaluating Disability (3183F) 0960–AG29 Final Rule Stage

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Sequence Title Identifier Rulemaking Stage
Number Number

146 Flammability Standard for Upholstered Furniture 3041–AB35 Proposed Rule



Sequence Title Identifier Rulemaking Stage
Number Number

147 Technical Amendments to the Minimum Internal Control Standards 3141–AA27 Final Rule Stage
148 Technical Standards for Gaming Machines and Gaming Systems 3141–AA29 Final Rule Stage
149 Game Classification Standards 3141–AA31 Final Rule Stage

[FR Doc. 06–8765 Filed 12–08–06; 8:45 am]


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DEPARTMENT OF AGRICULTURE Service land by developing leases and The diversity in purpose and outreach
(USDA) expedited reviews of permits. If of USDA programs contributes
accomplished, the use of oil or natural significantly to USDA being near the top
Statement of Regulatory Priorities gas could be used in accelerating the of the list of departments that produce
USDA’s regulations cover a broad completion of projects while the largest number of regulations
range of issues. Within the rulemaking maintaining the safety of public annually. These regulations range from
process is the department-wide effort to health, environment and working to nutrition standards for the school lunch
reduce burden on participants and reduce dependence on foreign oil. program, to natural resource and
program administrators alike by • USDA will continue to promote environmental measures governing
focusing on improving program economic opportunities for national forest usage and soil
outcomes, and particularly on achieving agriculture and rural communities conservation, to emergency producer
the performance measures specified in through its Federal Biobased Product assistance as a result of natural
the USDA and agency Strategic Plans. Preferred Procurement Program disasters, to regulations protecting
Significant focus is being placed on (FB4P). The Department will continue American agribusiness (the largest
efficiencies that can be achieved to designate groups of biobased dollar value contributor to exports) from
through eGov activities, the migration to products to receive procurement the ravages of domestic or foreign plant
efficient electronic services and preference from Federal agencies and or animal pestilence, and they extend
capabilities, and the implementation of contractors. In addition, USDA from farm to supermarket to ensure the
focused, efficient information intends to publish rules establishing safety, quality, and availability of the
collections necessary to support the Voluntary Labeling Program for Nation’s food supply.
effective program management. biobased products. Many regulations function in a
Important areas of activity include the dynamic environment, which requires
following: Reducing Paperwork Burden on their periodic modification. The factors
• USDA will continue regulatory work Customers determining various entitlement,
to protect the health and value of U.S. eligibility, and administrative criteria
USDA has made substantial progress often change from year to year.
agricultural and natural resources
in implementing the goal of the Therefore, many significant regulations
while facilitating trade flows. This
Paperwork Reduction Act of 1995 to must be revised annually to reflect
includes amending regulations related
reduce the burden of information changes in economic and market
to the importation of fruits and
collection on the public. To meet the benchmarks.
vegetables, nursery products, and
requirements of the Government
animals and animal products, and Almost all legislation that affects
Paperwork Elimination Act (GPEA) and
continuing work related to regulation USDA programs has accompanying
the E-Government Act, agencies across
of plant and animal biotechnologies. regulatory needs, often with a
USDA are providing electronic
In addition, USDA will propose significant impact. The Farm Security
alternatives to their traditionally paper-
specific standards for the humane and Rural Investment Act of 2002,
based customer transactions. As a result,
handling, care, treatment, and Public Law 107-171; the Child Nutrition
producers increasingly have the option
transportation of birds under the and WIC Reauthorization Act of 2004,
to electronically file forms and all other
Animal Welfare Act. Public Law 108-265; and the
documentation online. To facilitate the
• In the area of food safety, USDA will expansion of electronic government, Agricultural Risk Protection Act of
continue to develop science-based USDA implemented an electronic 2000, Public Law 106-224, affect most
regulations that improve the safety of authentication capability that allows agencies of USDA resulting in the
meat, poultry, and egg products in the customers to ‘‘sign-on’’ once and modification, addition, or deletion of
least burdensome and most cost- conduct business with all USDA many programs. These statutes set in
effective manner. In May 2006, an agencies. Supporting these efforts are motion rulemakings that provide for
enhanced small business outreach ongoing analyses to identify and improvements in market loss and
program was established. The agency eliminate redundant data collections conservation assistance, crop and
will collaborate in this initiative with and streamline collection instructions. livestock disease and pest protection,
other USDA agencies and cooperating The end result of implementing these marketing enhancements, pollution
State partners. Regulations will be initiatives is better service to our control, research and development for
revised to address emerging food customers enabling them to choose biomass, and refinements to the
safety challenges, streamlined to when and where to conduct business nutrition assistance programs to help
remove excessively prescriptive with USDA. ensure the best practical outcomes for
regulations, and updated to be made beneficiaries and the taxpayer.
consistent with hazard analysis and The Role of Regulations Major Regulatory Priorities
critical control point principles.
The programs of USDA are diverse This document represents summary
• As changes are made for the nutrition and far reaching, as are the regulations information on prospective significant
assistance programs, USDA will work that attend their delivery. Regulations regulations as called for in Executive
to foster actions that will help codify how USDA will conduct its Order 12866. The following agencies are
improve diets, and particularly to business, including the specifics of represented in this regulatory plan,
prevent and reduce overweight and access to, and eligibility for, USDA along with a summary of their mission
obesity. In 2007, FNS will continue to programs. Regulations also specify the and key regulatory priorities for 2007:
promote nutritional knowledge and responsibilities of State and local
education while minimizing governments, private industry, Food and Nutrition Service
participant and vender fraud. businesses, and individuals that are Mission: FNS increases food security
• USDA has a priority to improve necessary to comply with their and reduces hunger in partnership with
access to natural resources of Forest provisions. cooperating organizations by providing

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72737

children and low-income people access monitoring at the State and institution reform nomination to OMB. FSIS has
to food, a healthful diet, and nutrition levels. For example, the proposed Food carefully reviewed its economic analysis
education in a manner that supports Stamp Program Disqualified Recipient of the interim rule in response to this
American agriculture and inspires Reporting and Computer Matching rule recommendation and is planning to
public confidence. would require State agencies at adjust provisions of the rule to reduce
Priorities: In addition to responding certification and periodically thereafter the information collection burden on
to provisions of legislation authorizing to match persons in households small businesses. FSIS also is planning
and modifying Federal nutrition applying for benefits against several further action with respect to other
assistance programs, FNS’ 2006 databases to ensure prisoners, deceased, elements of the 2001 proposal, based on
regulatory plan supports USDA’s and other disqualified individuals are quantitative risk assessments of target
Strategic Goal 5, ‘‘Improve the Nation’s not receiving food stamp benefits. FNS pathogens in processed products.
Nutrition and Health,’’ and its three will also publish rules implementing FSIS plans to propose amending the
related objectives: several changes to the Food Stamp poultry products inspection regulations
Quality Control system, and related by replacing, with a performance
Improve Access to Nutritious Food. performance incentives for States,
This objective represents FNS’ efforts to standard, the requirement for ready-to-
required by P. L. 107-171, and propose cook poultry products to be chilled to
improve nutrition by providing access rules to correct and clarify provisions of
to program benefits (Food Stamps, WIC, 40(deg) F or below within certain time
the July 6, 2000, final regulation on limits according to the weight of the
and school meals) and distributing State recipient claims.
administrative funds to support program dressed carcasses. Under the
operations. To advance this objective, Food Safety and Inspection Service performance standard, poultry
FNS plans to finalize rules establishments would have to carry out
Mission: The Food Safety and slaughtering, dressing, and chilling
implementing provisions of the Farm Inspection Service (FSIS) is responsible
Security and Rural Investment Act of operations in a manner that ensures no
for ensuring that meat, poultry, and egg significant growth of pathogens, as
2002 (P.L. 107-171) to simplify program products in commerce are wholesome,
administration, support work, and demonstrated by control of the
not adulterated, and properly marked, pathogens or indicator organisms. The
improve access to benefits in the Food labeled, and packaged.
Stamp Program. The Agency will also existing time/temperature chilling
issue rules implementing provisions of Priorities: FSIS is committed to regulations would remain available for
the Child Nutrition and WIC developing and issuing science-based use by establishments as a ‘‘safe harbor’’
Reauthorization Act of 2004 (P.L. 108- regulations intended to ensure that for compliance with the new standard.
265) to ensure access to the Child meat, poultry, and egg products are Bovine Spongiform Encephalopathy
Nutrition Programs for low-income wholesome and not adulterated or (BSE): In January 2004, FSIS published
children receiving Food Stamps through misbranded. FSIS continues to review three interim final rules to prevent the
direct certification, and to establish its existing authorities and regulations agent of BSE from entering the human
automatic eligibility for homeless to streamline excessively prescriptive food supply. FSIS took this action in
children. regulations, to revise or remove response to the confirmation of BSE in
regulations that are inconsistent with a cow in Washington State that had
Promote Healthier Eating Habits and the Agency’s hazard analysis and
Lifestyles. This objective represents been imported from Canada. In
critical control point regulations, and to addition, FSIS issued a Federal Register
FNS’ efforts to improve nutrition ensure that it can address emerging food
knowledge and behavior through Notice in January 2004 that announced
safety challenges. FSIS’ 2006 regulatory that the Agency would no longer pass
nutrition education and breastfeeding
plan supports USDA’s Strategic Goal 5, and apply the mark of inspection to
promotion, and to ensure that program
‘‘Enhance Protection and Safety of the carcasses and parts of cattle selected for
benefits meet the appropriate nutrition
Nation’s Agriculture and Food Supply,’’ BSE testing by APHIS until the sample
standards to effectively improve
and the related objective to reduce the is determined to be negative. FSIS has
nutrition for program participants. In
incidence of food borne illnesses related been evaluating the comments received
support of this objective, FNS plans to
to meat, poultry, and egg products in the in response to the interim final rules to
propose a rule revising requirements
U.S. determine whether to implement
that allow schools to substitute
nutritionally-equivalent non-dairy Following are some of the Agency’s additional measures to prevent human
beverages for fluid milk at the request of recent and planned initiatives: exposure to the BSE agent.
a recipient’s parent. FNS will also Expand the Use of Performance Expand the Use of Hazard Analysis
propose changes to improve food Standards: In February 2001, FSIS and Critical Control Point (HACCP)
packages in the WIC program to reflect proposed a rule to establish food safety Systems: FSIS also is planning to
current dietary guidance, based on performance standards for all processed propose requirements for federally
recommendations made by an Institute ready-to-eat (RTE) meat and poultry inspected egg product plants to develop
of Medicine expert panel. products and for partially heat-treated and implement HACCP systems and
Improve Nutrition Assistance meat and poultry products that are not sanitation standard operating
Program Management and Customer ready-to-eat. The proposal also procedures. The Agency will be
Service. This objective represents FNS’ contained provisions addressing post- proposing pathogen reduction
ongoing commitment to maximize the lethality contamination of RTE products performance standards for egg products.
accuracy of benefits issued, maximize with Listeria monocytogenes. In June Further, the Agency will be proposing to
the efficiency and effectiveness of 2003, FSIS published an interim final remove requirements for FSIS approval
program operations, and minimize rule requiring establishments to prevent of egg-product plant drawings,
participant and vendor fraud. In support L. monocytogenes contamination of RTE specifications, and equipment before
of this objective, FNS plans to finalize products. The Agency is evaluating the their use, and to end the system for pre-
rules in the Food Stamp Program (FSP) effectiveness of this interim rule, which marketing approval of labeling for egg
to improve program operations and in 2004 was the subject of a regulatory products.

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72738 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Improve Consumer Information: FSIS specific needs and provide joint training Agricultural Marketing Service
has proposed requirements for the sessions for small and very small plants Mission: The Agricultural Marketing
nutrition labeling of ground or chopped and FSIS employees. Service (AMS) provides marketing
meat and poultry products and single- services to producers, manufacturers,
ingredient products. This proposed rule Animal and Plant Health Inspection distributors, importers, exporters, and
would require nutrition labeling, on the Service consumers of food products. The AMS
label or at the point-of-purchase, for the also manages the Government’s food
major cuts of single-ingredient, raw Mission: A major part of the mission
of the Animal and Plant Health purchases, supervises food quality
products and would require nutrition grading, maintains food quality
information on the label of ground or Inspection Service (APHIS) is to protect
the health and value of American standards, and supervises the Federal
chopped products. Completing this research and promotion programs.
rulemaking would respond to a agricultural and natural resources.
regulatory reform recommendation APHIS conducts programs to prevent Priorities: AMS’ priorities are to
made to OMB in 2002. the introduction of exotic pests and support Strategic Goal 2, ‘‘Enhance the
diseases into the United States and Competitiveness and Sustainability of
FSIS proposed March 7, 2006, to conducts surveillance, monitoring, Rural and Farm Economies,’’ by
amend the Federal meat and poultry control, and eradication programs for expanding domestic market
product regulations to provide that the pests and diseases in this country. opportunities for agricultural producers.
Agency would make available to These activities enhance agricultural In response to concerns raised by Fruit
individual consumers lists of the retail productivity and competitiveness and and Vegetable industry members that
consignees of meat and poultry products produce sellers may lose their status as
contribute to the national economy and
that a federally inspected meat or trust creditors when using electronic
the public health. APHIS also conducts
poultry products establishment has invoicing systems, the Agricultural
programs to ensure the humane
voluntarily recalled. FSIS believes that Marketing Service issued an advance
handling, care, treatment, and
this information will be of value to notice of proposed rulemaking (ANPR)
transportation of animals under the
consumers and the industry in under the Perishable Agricultural
Animal Welfare Act.
clarifying which products should be Commodities Act (PACA) soliciting
removed from commerce and form Priorities: APHIS is continuing work comments from the public, including
consumers’ possession because the that will result in a revision of its buyers and sellers of fruits and
products may be adulterated or regulations concerning the introduction vegetables. The ANPR was published on
misbranded. of organisms and products altered or January 30, 2006, and the comment
Small business implications: The produced through genetic engineering. period ended March 16, 2006. The
great majority of businesses regulated by This work consists of two parts. The agency expects to proceed to rulemaking
FSIS are small businesses. With the first is to amend the existing plant- in the near future. The PACA
possible exception of the poultry related regulations to reflect new established a code of fair trading
chilling proposal, the regulations listed consolidated authorities under the Plant practices in the marketing of fresh and
above substantially affect small Protection Act and to address new frozen fruits and vegetables in interstate
businesses. FSIS recognizes the technological trends. The second is to and foreign commerce. The law imposes
difficulties faced by many small and develop a regulatory framework for a statutory trust on the assets, including
very small establishments in complying transgenic animals. These regulatory inventory and receivables, of a licensee
with necessary, science-based food changes are needed to address risks to or firms operating subject to the PACA.
safety requirements and in assuming the plant and animal health. APHIS also The PACA provides that PACA
associated technical and financial plans to complete rulemaking to licensees may preserve their trust rights
burdens. FSIS attempts to reduce the streamline the process for approving by including specified language on
burdens of its regulations on small new fruits and vegetables for billing or invoicing statements. In 1997,
business by providing alternative dates importation, and to propose changes to the PACA regulations were amended to
of compliance, furnishing detailed the regulations for importing nursery state that electronic transmissions are
compliance guidance material, and stock that will enhance our ability to considered ‘‘ordinary and usual billing
conducting outreach programs to small protect plant health. The Agency is also and invoicing statements.’’ A number of
and very small establishments. continuing to work on amending its produce sellers have voiced concerns
In May 2006, FSIS announced an regulations concerning bovine that their PACA trust rights may not be
enhanced small business outreach spongiform encephalopathy (BSE) to preserved when invoicing
program that will ensure critical provide for the importation of certain electronically. Additional concerns have
training, access to food safety experts, animals and products that present low been expressed that notice to sellers
and information resources that are risk. using the alternate method of trust
available in a form that is uniform, notice (i.e., separate trust notice letter)
With regard to animal welfare, APHIS is not being accepted by some buyers
easily comprehended, and consistent. plans to propose specific standards for
The Agency will collaborate in this who require their suppliers to invoice
the humane handling, care, treatment, electronically. Others in the industry
initiative with other USDA Agencies and transportation of birds covered
and cooperating State partners. For have expressed concern about being
under the Animal Welfare Act. charged a fee by the buyer to accept the
example, FSIS will make plant owners
and operators aware of loan programs, APHIS’ 2006 regulatory plan supports notice to preserve their trust benefits if
available through USDA’s Rural USDA’s Strategic Goal 4, ‘‘Enhance they send a paper invoice or separate
Business and Cooperative programs, to Protection and Safety of the Nation’s trust notice.
help them in upgrading their facilities. Agriculture and Food Supply, ’’ and the The Agricultural Marketing Service
FSIS employees will be meeting related objective to reduce the number (AMS) administers the National Organic
proactively with small and very small and severity of agricultural pest and Program (NOP) which is authorized by
plant operators to learn more about their disease outbreaks. the Organic Food Production Act of

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1990 (7 U.S.C. 6510 et seq.). Under the expect major initiatives for a new Farm technical assistance and scientific
NOP, AMS establishes national Bill to be proposed by this exchanges in support of international
standards for the production and Administration for the 2008 and forest and range conservation.
handling of organically produced subsequent crop years. FSA will Priorities: Forest Service’s regulatory
agricultural products. Since the develop and issue the necessary plan supports USDA Strategic Goal 6,
implementation of the NOP, some regulations and make program funds ‘‘Protect and Enhance the Nation’s
members of the public have advocated available to eligible clientele in as Natural Resource Base and
for a more explicit regulatory standard timely a manner as possible. As these Environment.’’ The agency’s priorities
on the relationship between livestock, and future changes required by for fall 2006 include publishing a
particularly dairy animals, and grazing Administration initiatives and new proposed regulation to revise 36 CFR
land. Appropriate access to pasture has legislation are made, the Agency’s focus Part 220 regarding the agency’s
been a topic of discussion in the organic will be to implement the changes in implementation of the National
community for many years, including such a way as to provide benefits while Environmental Policy Act (NEPA). The
by the National Organic Standards minimizing program complexity and proposed regulation would move
Board (NOSB). For these reasons, AMS regulatory burden for program existing agency NEPA procedures
published an Advance Notice of participants. Opportunities will be required by 40 CFR 1507.3 from the
Proposed Rulemaking (ANPR) on April taken to clarify, simplify, and reduce internal Forest Service Handbook
13, 2006, to give the public the confusion whenever possible. In 1909.15 to the Code of Federal
opportunity to comment on key issues addition, the Agency will continue to Regulations. Codifying agency NEPA
that have been raised during previous streamline its farm loan programs procedures would make it easier for the
rulemakings and National Organic operated under the Consolidated Farm Forest Service to revise internal agency
Standards Board deliberations regarding and Rural Development Act, as guidance.
access to pasture and temporary amended (Pub. L. 87-128).
The agency plans to publish two final
confinement based on an animal’s stage The Agency plans to publish a final directives to Forest Service
of production. The comment period rule to adopt new procedures to be used Environmental Policy and Procedures
closed on June 12. AMS intends to by the Commodity Credit Corporation Handbook 1909.15, chapter 30. The
publish a proposed rule this fall. (CCC) in the evaluation of bids in existing agency NEPA procedures
connection with the procurement of would be updated to allow the use of a
Farm Service Agency
commodities for foreign donation under categorical exclusion when a land
Mission: The mission of the Farm various food aid authorities. CCC is management plan is not making
Service Agency is to stabilize farm amending the existing regulations to decisions that will result in significant
income, help farmers conserve land and provide for the simultaneous review of impacts on the human environment and
water resources, provide credit to new commodity and ocean freight offers where no extraordinary circumstances
or disadvantaged farmers and ranchers, when evaluating lowest-landed cost exist that would prohibit the use of the
and help farm operations recover from options in connection with the categorical exclusion. Notice of the
the effects of disaster. procurement of commodities for foreign proposed categorical exclusion and
Priorities: FSA’s Regulatory Plan donation. Under the revised bid process, request for comment was published
supports USDA Strategic Goal 2, CCC can better control shipping costs, January 5, 2005 (70 FR 3).
‘‘Enhance the Competitiveness and take advantage of efficiencies in load
consolidation and ensure a more The second final directive to Forest
Sustainability of Rural and Farm Service Environmental Policy and
Economies,’’ and Strategic Goal 6, competitive commodity procurement
process. Program savings should result Procedures Handbook 1909.15, chapter
‘‘Protect and Enhance the Nation’s 30 applies to issuance of Surface Use
Natural Resource Base and from the ability to better position
procured commodities at domestic ports Plans of Operation for exploration or
Environment.’’ FSA’s immediate development of an oil and gas lease. The
priority is to finish implementation of based on actual shipping cost
comparisons. Program savings are also final directive will allow for expedited
the disaster assistance programs review of permits to accelerate the
expected as a result of greater head-to-
required by the 2006 Emergency completion of projects while
head competition for program freight
Appropriations Act (Pub. L. 109-148), maintaining safety, public health and
among U.S.-flagged carriers. These
and the Emergency Supplemental environmental protection. Notice of the
savings should allow for additional food
Appropriations Act for Defense, the proposed directive and request for
aid quantities to move to donation
Global War on Terror, and Hurricane comment was published December 13,
countries. This rule will enhance
Recovery of 2006. The disaster programs 2005 (70 FR 238).
bidding opportunities for potential
provide assistance to agricultural
vendors while allowing CCC to more Forest Service also plans to publish a
producers in areas that were affected by
efficiently acquire commodities. final directive to Forest Service National
the unusual number and severity of
Forest System Land Management
hurricanes in 2005. Forest Service Planning Handbook 1909.12, chapter 70,
A primary mission of FSA is to Mission: The mission of the Forest regarding wilderness evaluation. The
administer the commodity and Service is to sustain the health, final planning rule was published on
conservation programs provided by the productivity, and diversity of the January 5, 2005 (70 FR 1023), and an
Farm Security and Rural Investment Act Nation’s forests and rangelands to meet interim directive to chapter 70 regarding
of 2002 (2002 Act). Generally, these the needs of present and future wilderness evaluation was published on
programs are authorized by the 2002 Act generations. This includes protecting March 23, 2005 (70 FR 14637). The final
with respect to the 2002 through 2007 and managing National Forest System directive updates guidance for the
crop years. Accordingly, FSA envisions lands; providing technical and financial identification, inventory, evaluation,
no major changes in the last year of the assistance to States, communities, and and recommendation of areas within
regulations used to administer these private forest landowners; and National Forest System lands that
programs. However. the Agency does developing and providing scientific and satisfy the definition of wilderness

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72740 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

found in section 2(c) of the 1964 This action will modify the FRPP final provide for the simultaneous review of
Wilderness Act. rule to clarify the amount of commodity and ocean freight offers
construction and forested acres when evaluating lowest landed cost
Natural Resources Conservation Service
permitted on FRPP easements and options in connection with the
Mission: The Natural Resources identify the procedure in which the procurement of commodities.
Conservation Service (NRCS) mission is United States would invoke its
to provide leadership in a partnership contingent rights. Statement of Need:
effort to help people conserve, maintain, Under the revised bid process, CCC can
Interim Final Rule for the
and improve our natural resources and better control shipping costs, take
Confidentiality of Conservation Program
environment. advantage of efficiencies in load
Information: If a producer believed that
Priorities: NRCS’ priority for FY 2007 the proprietary information about their consolidation and ensure a more
will be to make final adjustments to land and the agricultural operation competitive commodity procurement
rules related to the conservation provided to NRCS for participation in a process. The ‘‘two-step’’ process was
provisions of the Farm Security and conservation program would become designed at a time when donation
Rural Investment Act of 2002 (the 2002 ‘‘public’’ and thus subject to disclosure commodities were shipped under ocean
Farm Bill), in response to public requirements under the Freedom of carrier tariffs that could be readily
comments and experience gained from Information Act, the producer might not identified. Despite the irrelevance of
the implementation of the programs. wish to participate in the voluntary published ocean tariffs and reliance on
These clarifications and modifications conservation programs. Therefore, negotiated shipping service contracts
will ensure efficient and responsive NRCS action to promulgate a rule is to today, the current ‘‘two-step’’
delivery of conservation programs to ensure that NRCS or anyone acting on procurement process remains tied by
landowners and land users and help its behalf does not unlawfully release regulation to the obsolete tariff system.
further the agency mission to help protected information. 7 CFR Part 1496.5 (b)(4) states as
people conserve, maintain, and improve follows: ‘‘Freight rates will be obtained
Final Rule for the Healthy Forest
our natural resources and the from published ocean tariffs to make
Reserve Program (HFRP): This action
environment. NRCS’ 2006 regulatory cost comparisons between various
implements HFRP — a voluntary
plan supports USDA’s Strategic Goal 6, steamship companies and coastal
program to restore and enhance forest
‘‘Protect and Enhance the Nation’s ranges.’’
ecosystems that promote the recovery of
Natural Resource Base and
threatened and endangered species, Without the changes that are being
Environment,’’ and the related
improve biodiversity, and enhance made to 7 CFR Part 1496 under this
objectives to protect and conserve
carbon sequestration. Land can be final rule, the Kansas City Commodity
natural resources that form the
enrolled through a 10-year cost-share Office (KCCO) would be forced to
foundation for healthy lands.
agreement and an easement contract. continue to operate the identified
NRCS remains committed to donation programs without reliable rate
compliance with the Government information. The current collection
Paperwork Elimination Act and the USDA—Farm Service Agency (FSA) process for non-binding rate indications
Freedom to E-File Act, which require is exceedingly cumbersome and time-
Government agencies in general and consuming. In addition, the rate
NRCS in particular to provide the public FINAL RULE STAGE indications obtained are generally not
the option of submitting information or representative of the rates under which
transacting business electronically to the procured products will be shipped.
the maximum extent possible. NRCS is 1. PROCUREMENT OF COMMODITIES The ‘‘two-step’’ process invites gaming
designing its program forms to allow the FOR FOREIGN DONATION and manipulation by participating
public to conduct business with NRCS ocean carriers. These problems render
electronically. the lowest-landed-cost criteria under
Other Significant which the program operates nearly
The NRCS plans to publish the
following rules during FY 2007: Legal Authority: meaningless. Without the ability to
determine accurate freight rates, KCCO
Interim Final Rule for the 7 USC 1431; 7 USC 1721; 15 USC 714b
cannot effectively manage these
Environmental Quality Incentives
CFR Citation: programs to maximize the quantity of
Programs (EQIP): This revision to the
7 CFR 1496 food products donated under them.
final rule is to: 1) consider public
comments about which resource Summary of Legal Basis:
Legal Deadline:
concerns should be given national
priority in the implementation of EQIP None 15 U.S.C. 714b(h) provides that CCC
in future years; 2) clarify the cost-share may contract for the use, in accordance
Abstract: with the usual customs of trade and
rates (actual versus average cost); and 3)
expansion of conservation practice This rule proposes new procedures to commerce, of plants and facilities for
definitions with varying payment be used by the Commodity Credit the physical handling, storage,
incentives for a single conservation Corporation (CCC) in the evaluation of processing, servicing, and
practice applied at different levels to bids in connection with the transportation of the agricultural
achieve additional environmental procurement of commodities for commodities subject to its control. The
benefits. donation overseas. This proposed rule Commodity Credit Corporation may sell
would enhance bidding opportunities any commodity owned or controlled by
The rulemaking for EQIP consists of for potential vendors while allowing the Corporation at any price that the
making minor changes to existing rules. CCC to more efficiently acquire Secretary determines will maximize
Final Rule for the Farmland and commodities. In general, CCC proposes returns to the Corporation, including
Ranchland Protection Program (FRPP): to amend the existing regulations to minimizing the handling and

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transportation costs in making delivery Government Levels Affected: Summary of Legal Basis:
of the commodity. The Animal Welfare Act (AWA)
Alternatives: authorizes the Secretary of Agriculture
Agency Contact: to promulgate standards and other
CCC has the alternative of maintaining requirements governing the humane
the current ‘‘two-step’’ process used to Phillip Elder
Agricultural Economist handling, care, treatment, and
procure and ship agricultural transportation of certain animals by
commodities. Department of Agriculture
Farm Service Agency dealers, research facilities, exhibitors,
Anticipated Cost and Benefits: 1400 Independence Avenue SW operators of auction sales, and carriers
Washington, DC 20250 and immediate handlers. Animals
Program savings should result from the covered by the AWA include birds that
ability to better position procured Phone: 202 690–8104
Fax: 202 720–5233 are not bred for use in research.
commodities at domestic ports based
on actual shipping cost comparisons. Email: Alternatives:
Program savings are also expected as RIN: 0560–AH40 To be identified.
a result of greater head-to-head
competition for program freight among Anticipated Cost and Benefits:
U.S.-flagged carriers. These savings USDA—Animal and Plant Health
To be determined.
should allow for additional food aid Inspection Service (APHIS)
quantities to move to donation Risks:
countries. This rule will enhance Not applicable.
bidding opportunities for potential PROPOSED RULE STAGE
vendors while allowing CCC to more
efficiently acquire commodities. Action Date FR Cite
Risks: AND STANDARDS FOR BIRDS NPRM Comment 11/00/07
The magnitude of the savings or losses Period End
from lower expected freight revenue
Regulatory Flexibility Analysis
will be driven by the behavior of Other Significant
carriers as they adjust to the new
process. Such costs are difficult to Legal Authority: Yes
quantify given the impossibility of 7 USC 2131 to 2159 Small Entities Affected:
predicting ocean carrier bidding
behavior under the ‘‘one-step’’ system. CFR Citation: Businesses
Larger trends in program shipments 9 CFR 1 to 3 Government Levels Affected:
and costs are expected to continue
when the ‘‘one-step’’ freight bidding Legal Deadline: Undetermined
process is implemented. The existing Additional Information:
trends reflect issues of port capacity
Additional information about APHIS
and facilities, shipping trade and vessel Abstract: and its programs is available on the
availability, and the more general
APHIS intends to establish standards Internet at
availability of container and inland
freight equipment. The opportunity to for the humane handling, care, Agency Contact:
better consolidate loads should support treatment, and transportation of birds
other than birds bred for use in Jerry D. DePoyster
the continuation of these trends and, Senior Veterinary Medical Officer,
in doing so, lower freight costs for research.
Animal Care
program shipments. Statement of Need: Department of Agriculture
Timetable: The Farm Security and Rural Animal and Plant Health Inspection
Action Date FR Cite Investment Act of 2002 amended the Service
definition of animal in the Animal 4700 River Road, Unit 84
NPRM 12/16/05 70 FR 74717 Riverdale, MD 20737–1234
NPRM Comment 01/17/06
Welfare Act (AWA) by specifically
excluding birds, rats of the genus Phone: 301 734–7586
Period End
NPRM Comment 01/23/06 71 FR 3442 Rattus, and mice of the genus Mus, RIN: 0579–AC02
Period Extended bred for use in research. While the
Public Meeting 02/21/06 definition of animal in the regulations
Second NPRM 04/07/06 71 FR 17767 contained in 9 CFR part 1 has excluded
Second NPRM 05/08/06 rats of the genus Rattus and mice of 3. IMPORTATION OF PLANTS FOR
Comment Period the genus Mus bred for use in research, PLANTING; ESTABLISHING A NEW
End that definition has also excluded all CATEGORY OF PLANTS FOR
Final Action 01/00/07 birds (i.e., not just those birds bred for PLANTING NOT AUTHORIZED FOR
use in research). In line with this IMPORTATION PENDING RISK
Regulatory Flexibility Analysis change to the definition of animal in ASSESSMENT (RULEMAKING
Required: the AWA, APHIS intends to establish RESULTING FROM A SECTION 610
No standards in 9 CFR part 3 for the REVIEW)
humane handling, care, treatment, and
Small Entities Affected: transportation of birds other than those Priority:
No birds bred for use in research. Other Significant

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72742 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Legal Authority: the number of types of plants for via imported nursery stock are likely,
7 USC 450; 7 USC 7701 to 7772; 7 USC planting have increased dramatically in causing extensive damage to both
7781 to 7786; 21 USC 136 and 136a recent years, and there are several agricultural and natural plant resources.
problems associated with gathering data Timetable:
CFR Citation: on what plants for planting are being
7 CFR 319 imported and on the risks such Action Date FR Cite
importation presents. In addition, NPRM 02/00/07
Legal Deadline: quarantine pests that enter the United NPRM Comment 04/00/07
None States via the importation of plants for Period End
planting pose a particularly high risk
Abstract: Regulatory Flexibility Analysis
of becoming established within the
This action would establish a new United States. The current regulations Required:
category in the regulations governing need to be amended to better address No
the importation of nursery stock, also these risks.
known as plants for planting. This Government Levels Affected:
category would list taxa of plants for Summary of Legal Basis: None
planting whose importation is not The Secretary of Agriculture may
authorized pending risk assessment. In prohibit or restrict the importation or Additional Information:
order to determine whether to add a entry of any plant if the Secretary Additional information about APHIS
taxon of plants for planting to this determines that the prohibition or and its programs is available on the
category, we would review scientific restriction is necessary to prevent the Internet at
information other than a pest risk introduction into the United States of
assessment; the types of scientific Agency Contact:
a plant pest or noxious weed (7 U.S.C.
information we would review would be 7712). Arnold T. Tschanz
listed in the regulations. If scientific Senior Import Specialist, Commodity
information other than a pest risk Alternatives: Import Analysis & Operations, PPQ
assessment indicated that importation APHIS has identified two alternatives Department of Agriculture
of the taxon of plants for planting to the approach we are considering. Animal and Plant Health Inspection
posed a potential risk, we would then The first is to maintain the status quo; Service
publish an interim rule adding the this alternative was rejected because, 4700 River Road, Unit 141
taxon to the proposed category and given our limited resources and the Riverdale, MD 20737–1236
giving the public an opportunity to risks of pest introduction posed by the Phone: 301 734–5306
comment on the change. We would rapid increase in the importation of RIN: 0579–AC03
allow foreign governments to request plants for planting, we do not believe
that a pest risk assessment be that this approach would allow us to
conducted for a taxon whose address the potential risks posed by USDA—APHIS
importation is not authorized pending quarantine pests in a timely manner.
risk evaluation. After the pest risk The second is to prohibit the
assessment was completed, we would importation of all nursery stock FINAL RULE STAGE
conduct rulemaking to remove the pending risk evaluation, approval, and
taxon from the proposed category. We notice-and-comment rulemaking,
are also proposing to expand the scope similar to APHIS’s approach to 4. REVISION OF FRUITS AND
of the plants regulated in the plants for regulating imported fruits and VEGETABLES IMPORT REGULATIONS
planting regulations to include non- vegetables; this approach was rejected
vascular plants. These changes would because, in the absence of additional Priority:
allow us to react more quickly to resources for conducting risk evaluation Other Significant
evidence that a taxon of plants for and rulemaking, this approach would
planting may pose a pest risk while lead to a major interruption in Legal Authority:
ensuring that our actions are based on international trade and would have 7 USC 450; 7 USC 7701 to 7772; 7 USC
scientific evidence. significant economic effects on both 7781 to 7786; 7 USC 8311; 21 USC 136
U.S. importers and U.S. consumers of and 136a; 31 USC 9701
Statement of Need:
plants for planting.
APHIS typically relies on inspection at CFR Citation:
a Federal plant inspection station or Anticipated Cost and Benefits: 7 CFR 305; 7 CFR 319; 7 CFR 352
port of entry to mitigate the risks of In general, the costs associated with
pest introduction associated with the plant pests that are introduced into the Legal Deadline:
importation of plants for planting. United States via imported nursery None
Importation of plants for planting is stock are expected to increase in the
further restricted or prohibited only if absence of some action to revise the Abstract:
there is specific evidence that such nursery stock regulations to better This rule would revise and reorganize
importation could introduce a address pest risks. Specific costs and the regulations pertaining to the
quarantine pest into the United States. benefits will be determined. importation of fruits and vegetables to
Most of the taxa of plants for planting consolidate requirements of general
currently being imported have not been Risks: applicability and eliminate redundant
thoroughly studied to determine In the absence of some action to revise requirements, update terms and remove
whether their importation presents a the nursery stock regulations to allow outdated requirements and references,
risk of introducing a quarantine pest us to better address pest risks, update the regulations that apply to
into the United States. The volume and increased introductions of plant pests importations into territories under U.S.

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72743

administration, and make various notice-and-comment rulemaking, as we Regulatory Flexibility Analysis

editorial and nonsubstantive changes to have been doing since 1987. This Required:
regulations to make them easier to use. approach is unsatisfactory, because the Undetermined
The rule would also make substantive number of requests we receive from
changes to the regulations, including: foreign exporters and domestic Government Levels Affected:
(1) Establishing criteria within the importers to amend the regulations has None
regulations that, if met, would allow us been steadily increasing. Maintaining
to approve certain new fruits and the current process will make it Additional Information:
vegetables for importation into the difficult to keep pace with the volume Additional information about APHIS
United States and to acknowledge pest- of import requests. Therefore, this and its programs is available on the
free areas in foreign countries without alternative was rejected. We believe Internet at
undertaking rulemaking; (2) doing away that the new approach would enable
with the practice of listing specific us to be more responsive to the import Agency Contact:
commodities that may be imported requests of our trading partners while Donna L. West
subject to certain types of phytosanitary maintaining the transparency of our Senior Import Specialist, Commodity
measures; and (3) providing for the decision-making afforded by notice- Import Analysis and Operations, PPQ
issuance of special use permits for and-comment rulemaking. Department of Agriculture
fruits and vegetables. These changes are Animal and Plant Health Inspection
intended to simplify and expedite our Prior to 1987, APHIS authorized the
importation of a fruit or vegetable by Service
processes for approving certain new 4700 River Road, Unit 133
imports and pest-free areas while simply issuing a permit once the
Agency was satisfied that the relevant Riverdale, MD 20737–1231
continuing to allow for public Phone: 301 734–0627
participation in the processes. If criteria in the regulations had been met.
adopted, the rule would represent a Another alternative to this proposed RIN: 0579–AB80
significant structural revision of the rule would be to return to this method
fruits and vegetables import regulations of authorizing fruit and vegetable
and would establish a new process for importations. This approach is
approving certain new commodities for unsatisfactory, because it does not 5. PHYTOPHTHORA RAMORUM;
importation into the United States. It provide the opportunity for public QUARANTINE AND REGULATIONS
would not, however, allow the analysis of and comment on the science
associated with such imports. Priority:
importation of any specific new fruits
or vegetables, nor would it alter the Therefore, this alternative was rejected. Other Significant
conditions for importing currently We believe that the new approach
would enable us to be more responsive Legal Authority:
approved fruits or vegetables except as
specifically described in this document. to the import requests of our trading 7 USC 7701 to 7772; 7 USC 7781 to
partners while maintaining the 7786; sec 301.75–15 also issued under
Statement of Need: transparency of our decisionmaking sec 204, title II, PL 106–113, 113 Stat
The volume of requests for new imports afforded by notice-and-comment 1501A–293; secs 301.75–15 and
of fruits and vegetables has risen rulemaking. 301.75–16 also issued under sec 203,
sharply in recent years with expanding title II, PL 106–224, 114 Stat 400 (7
global trade. APHIS is seeking an Anticipated Cost and Benefits: USC 1421 note)
alternative process for certain new
There would be no new costs CFR Citation:
imports to expedite their evaluation
associated with this rule. Benefits could 7 CFR 301
and, where applicable, their approval.
include more timely action on import
Summary of Legal Basis: requests, which could also lead to Legal Deadline:
Under the Plant Protection Act of 2000, reciprocal action by trading partners as None
it is the responsibility of the Secretary they evaluate our export requests.
to facilitate . . . imports . . . in
Risks: This action will amend the
agricultural products and other
commodities that pose a risk of This action is administrative in nature Phytophthora ramorum regulations to
harboring plant pests or noxious weeds and poses no direct specific risks. If make the regulations consistent with a
in ways that will reduce, to the extent new import requests are evaluated Federal Order issued by APHIS in
practicable, as determined by the using the system proposed in this rule, December 2004 that established
Secretary, the risk of dissemination of each would be based on a unique risk restrictions on the interstate movement
plant pests or noxious weeds. This analysis. of nursery stock from nurseries in
proposed rule, if adopted, would nonquarantined counties in California,
expedite the process for approving Timetable: Oregon, and Washington. This action
certain new imports. will also update conditions for the
Action Date FR Cite
movement of regulated articles of
Alternatives: NPRM 04/27/06 71 FR 25010 nursery stock from quarantined areas,
One alternative to this proposed rule NPRM Comment 07/26/06 as well as restrict the interstate
would be to simply continue under Period End movement of all other nursery stock
APHIS’ current process of authorizing NPRM Comment 08/01/06 71 FR 43385 from nurseries in quarantined areas. We
the importation of fruits and vegetables. Period Reopened are also updating the list of plants
In this case, we would continue to list NPRM Comment 08/25/06 regulated because of P. ramorum and
all newly approved fruits and Period End the list of areas that are quarantined
vegetables in the regulations through Final Rule 03/00/07 for P. ramorum and making other

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72744 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

miscellaneous revisions to the trade in articles that may be infested, $1.2 billion. With new hosts being
regulations. These actions are necessary and (2) quarantine the entire states of consistently added to the list, and our
to prevent the spread of P. ramorum California, Oregon, and Washington knowledge of the pathogen’s pathways
to noninfested areas of the United and prohibit the interstate movement of increasing, this rulemaking is
States. We will continue to update the P. ramorum host articles to protect necessary, not only for protecting the
regulations through additional against the interstate spread of the nursery industry in the Pacific
rulemakings as new scientific pathogen. We rejected the first northwest, but also for protecting the
information on this pathogen becomes alternative because of insufficient nursery industry nationwide.
available. evidence about the presence of the
pathogen in eastern U.S. nurseries or Risks:
Statement of Need: forests. The lack of evidence of spread This rulemaking addresses risks
Since 1995, oaks and tanoaks have been despite the significant amount of trade associated with the interstate
dying in the coastal counties of in potentially infected material that has movement of articles that may spread
California. Since then, other types of already occurred is the reason we did P. ramorum to areas of the United
plants have been found to be infected not select the second alternative. Our States where the disease is not known
or associated with this disease, referred preferred action balances the need to to exist.
to as Sudden Oak Death (SOD), protect eastern forests and nurseries
ramorum leaf blight, ramorum dieback, with the goal of imposing only those
or in Federal regulations, as restrictions on trade that are necessary Action Date FR Cite
Phytophthora ramorum. P. ramorum to prevent the spread of the pathogen. Interim Final Rule 01/00/07
was first seen in 1995 in Mill Valley Anticipated Cost and Benefits: Interim Final Rule 03/00/07
(Marin County) on tanoak. Since that Comment Period
time, the disease has been confirmed The anticipated costs of this End
on various native hosts in 14 coastal rulemaking mirror those of the Federal
California counties (Marin, Santa Cruz, Order of 2004. Specifically, nurseries in Regulatory Flexibility Analysis
Sonoma, Napa, San Mateo, Monterey, regulated and quarantined areas will Required:
Santa Clara, Mendocino, Solano, have to meet certain criteria prior to Undetermined
Alameda, Contra Costa, Humboldt, engaging in the interstate trade of
nursery stock. Depending on the Government Levels Affected:
Lake, and San Francisco) and in Curry
County, Oregon. The pathogen has been location of the nursery, the Local, State
confirmed to infect 39 host plant taxa, classification of nursery stock
propagated within, and on the Additional Information:
and there are over 30 additional taxa
that are suspected to be hosts. In 2004, classification of articles to be shipped, Additional information about APHIS
the pathogen was detected in plants the nursery will have to undergo and its programs is available on the
shipped interstate from nonquarantined annual inspection; and/or inspection, Internet at
areas in California, Oregon, and sampling, and testing of individual
shipments in order to receive Agency Contact:
Washington. Given the uncertainty
associated with the spread of the certification for interstate shipment. Jonathan Jones
pathogen and its potential effects on Currently, USDA covers the costs of National Phytophthora Ramorum Program
eastern oak forests, APHIS is taking annual inspection during normal Manager, Pest Detection and Management
action to define the extent of the business hours; however, as with all Programs, PPQ
pathogen’s distribution in the United government subsidized programs, the Department of Agriculture
budget allowable may differ from year Animal and Plant Health Inspection
States and limit its artificial spread
to year. There are other intangible costs Service
beyond infected areas through
of rulemaking, such as the potential for 4700 River Road, Unit 160
quarantine and a public education
lost revenue while holding plants Riverdale, MD 20737
program. Completing this action is
during sampling and testing. Further, Phone: 301 734–8247
integral to having a scientifically sound
there have been some negative stigma
quarantine as the foundation of our RIN: 0579–AB82
associated with nursery stock from
regulated areas of Oregon and
Summary of Legal Basis: Washington state as a result of the P. USDA—Food and Nutrition Service
The Plant Protection Act (7 U.S.C. 7701 ramorum rulemaking and restrictions (FNS)
to 7773) authorizes the Secretary to on interstate movement, although it is
prohibit or restrict the movement in hard to quantify the effect of any
interstate commerce of any plant, plant perceived stigma. PROPOSED RULE STAGE
product, or other article if the Secretary Because knowledge of the P. ramorum
determines that the prohibition or pathogen and how it spreads is still in
restriction is necessary to prevent the its infancy, the benefits of proactively 6. SPECIAL NUTRITION PROGRAMS:
dissemination of a plant pest within the addressing the situation in hopes of FLUID MILK SUBSTITUTIONS
United States. preventing widespread infestation far
outweigh any costs associated with the Priority:
Alternatives: rulemaking. The total value of sales of Other Significant
The two most significant alternatives nursery stock reported in 2004 from
APHIS considered were to (1) eliminate operations with $100,000 or more in Legal Authority:
the Federal quarantine for P. ramorum sales in the United States was over $4.8 PL 108–265, sec 102
because of the likelihood that the billion. California, Oregon, and
pathogen has already spread to other Washington alone account for about 25 CFR Citation:
parts of the United States via interstate percent of that total, with sales of over 7 CFR 210; 7 CFR 220

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72745

Legal Deadline: beverage nutritionally equivalent to Federal program reviews and from
None milk. audits and investigations conducted by
the Office of Inspector General. This
Risks: rule revises: State agency criteria for
USDA must be diligent in making any approving and renewing institution
Currently, by regulation, schools must determinations of nutritional applications; program training and
make substitutions for fluid milk for equivalency to milk. other operating requirements for child
students with a disability when the care institutions and facilities; and
request is authorized by a licensed Timetable:
State- and institution-level monitoring
physician and may make substitutions Action Date FR Cite requirements. This rule also includes
for students with medical or other changes that are required by the
dietary needs if requested by NPRM 11/09/06 71 FR 65753
NPRM Comment 01/08/07 Healthy Meals for Healthy Americans
recognized medical authority. These Act of 1994 (Pub. L. 103-448), the
Period End
regulatory provisions were included in Personal Responsibility and Work
Final Action 01/00/08
Public Law 108-265 which amended Opportunities Reconciliation Act of
the Richard B. Russell National School Regulatory Flexibility Analysis 1996 (Pub. L. 104-193), and the William
Lunch Act. Public Law 108-265 also Required: F. Goodling Child Nutrition
amended the current law to allow Reauthorization Act of 1998 (Pub. L.
schools to substitute non-dairy 105-336).
beverages nutritionally equivalent (as Small Entities Affected:
established by the Secretary) to fluid The changes are designed to improve
Businesses, Governmental Jurisdictions program operations and monitoring at
milk for medical or other special
dietary needs at the request of a Government Levels Affected: the State and institution levels and,
parent/guardian. In response to Public where possible, to streamline and
Local, State simplify program requirements for State
Law 108-265, the National School
Lunch Program and School Breakfast Agency Contact: agencies and institutions. (95-024)
Program regulations will be revised to Sharon Ackerman Statement of Need:
add these provisions. (04-016) Agency Regulatory Officer In recent years, State and Federal
Statement of Need: Department of Agriculture program reviews have found numerous
Food and Nutrition Service cases of mismanagement, abuse, and in
The changes made to the Richard B. Room 918 some instances, fraud by child care
Russell National School Lunch Act 3101 Park Center Drive institutions and facilities in the CACFP.
concerning substitutions for fluid milk Alexandria, VA 22302 These reviews revealed weaknesses in
are intended to assist children with an Phone: 703 305–2246 management controls over program
intolerance to or a cultural or other Fax: 703 605–0220 operations and examples of regulatory
restriction concerning the consumption Email: noncompliance by institutions,
of milk. This regulation allows schools including failure to pay facilities or
to make substitutions at the request of RIN: 0584–AD58
failure to pay them in a timely manner;
a parent or guardian, which assists improper use of program funds for non-
families that are unable to obtain a USDA—FNS program expenditures; and improper
doctor’s statement. However, the meal reimbursements due to incorrect
Secretary must develop criteria to limit meal counts or to miscategorized or
the substitutions for milk to FINAL RULE STAGE incomplete income eligibility
nutritionally equivalent beverages. The statements. In addition, audits and
determination of nutritionally investigations conducted by the Office
equivalent beverages will require 7. CHILD AND ADULT CARE FOOD of Inspector General (OIG) have raised
careful research and consultation. PROGRAM: IMPROVING serious concerns regarding the
Summary of Legal Basis: MANAGEMENT AND PROGRAM adequacy of financial and
INTEGRITY administrative controls in CACFP.
These changes are being made in Based on its findings, OIG
response to provisions in Public Law Priority: recommended changes to CACFP
108-265. Other Significant review requirements and management
Alternatives: controls.
Legal Authority:
USDA will be working with other 42 USC 1766; PL 103–448; PL 104–193; Summary of Legal Basis:
Federal agencies to develop criteria for PL 105–336 Some of the changes proposed in the
nutritionally equivalent substitutes for rule are discretionary changes being
fluid milk as well as conducting CFR Citation: made in response to deficiencies found
research. USDA is issuing a proposed 7 CFR 226 in program reviews and OIG audits.
rule on this provision in order to solicit Other changes codify statutory changes
public comments prior to any final Legal Deadline: made by the Healthy Meals for Healthy
decisionmaking. None Americans Act of 1994 (Pub. L. 103-
448), the Personal Responsibility and
Anticipated Cost and Benefits: Abstract: Work Opportunities Reconciliation Act
Schools may incur additional costs in This rule amends the Child and Adult of 1996 (Pub. L. 104-193), and the
obtaining and offering substitute Care Food Program (CACFP) William F. Goodling Child Nutrition
beverages. However, children who regulations. The changes in this rule Reauthorization Act of 1998 (Pub. L.
cannot consume milk will now have a result from the findings of State and 105-336).

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72746 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Alternatives: Action Date FR Cite Farm Security and Rural Investment

Act of 2002.
In developing the proposal, the Agency Interim Final Rule 09/01/05
considered various alternatives to Comment Period Summary of Legal Basis:
minimize burden on State agencies and End
institutions while ensuring effective Final Action 09/00/07 The legal basis for this rule is Public
program operation. Key areas in which Law 107-171, the Farm Security and
alternatives were considered include Regulatory Flexibility Analysis Rural Investment Act of 2002.
State agency reviews of institutions and Required:
sponsoring organization oversight of No
day care homes. This final rule deals with changes
Small Entities Affected: required by Public Law 107-171, the
Anticipated Cost and Benefits: No Farm Security and Rural Investment
Act of 2002. The Department has
This rule contains changes designed to Government Levels Affected: limited discretion in implementing
improve management and financial provisions of that law. Most of the
integrity in the CACFP. When Local, State
provisions in this rule were effective
implemented, these changes would Federalism: October 1, 2002, and must be
affect all entities in CACFP, from USDA implemented by State agencies prior to
to participating children and children’s This action may have federalism
implications as defined in EO 13132. publication of this rule.
households. These changes will
primarily affect the procedures used by Agency Contact: Anticipated Cost and Benefits:
State agencies in reviewing applications
Sharon Ackerman The provisions of this rule simplify
submitted by, and monitoring the
Agency Regulatory Officer State administration of the Food Stamp
performance of, institutions which are
Department of Agriculture Program, increase eligibility for the
participating or wish to participate in
Food and Nutrition Service program among certain groups, increase
the CACFP. Those changes which
Room 918 access to the program among low-
would affect institutions and facilities
3101 Park Center Drive income families and individuals, and
will not, in the aggregate, have a
Alexandria, VA 22302 increase benefit levels. The provisions
significant economic impact.
Phone: 703 305–2246 of Public Law 107-171 implemented by
Data on CACFP integrity is limited, Fax: 703 605–0220 this rule have a 5-year cost of
despite numerous OIG reports on Email: approximately $1.9 billion.
individual institutions and facilities RIN: 0584–AC24
that have been deficient in CACFP Risks:
management. While program reviews The FSP provides nutrition assistance
and OIG reports clearly illustrate that USDA—FNS to millions of Americans nationwide—
there are weaknesses in parts of the working families, eligible non-citizens,
program regulations and that there have and elderly and disabled individuals.
been weaknesses in oversight, neither Many low-income families don’t earn
program reviews, OIG reports, nor any enough money and many elderly and
other data sources illustrate the disabled individuals don’t receive
prevalence and magnitude of CACFP Priority: enough in retirement or disability
fraud and abuse. This lack of benefits to meet all of their expenses
Economically Significant. Major under
information precludes USDA from and purchase healthy and nutritious
5 USC 801.
estimating the amount of money lost meals. The FSP serves a vital role in
due to fraud and abuse or the reduction Legal Authority: helping these families and individuals
in fraud and abuse the changes in this achieve and maintain self-sufficiency
PL 107–171, secs 4101 to 4109, 4114,
rule will realize. and purchase a nutritious diet. This
4115, and 4401
rule implements the certification and
Risks: CFR Citation: eligibility provisions of Public Law
Continuing to operate the CACFP under 7 CFR 273 107-171, the Farm Security and Rural
existing provisions of the regulations Investment Act of 2002. It simplifies
that do not sufficiently protect against Legal Deadline: State administration of the Food Stamp
fraud and abuse in CACFP puts the None Program, increases eligibility for the
program at significant risk. This rule program among certain groups,
includes changes designed to Abstract: increases access to the program among
strengthen current program regulations This rulemaking will amend Food low-income families and individuals,
to reduce the risk associated with the Stamp Program regulations to and increases benefit levels. The
program. implement 11 provisions of the Farm provisions of this rule increase benefits
Security and Rural Investment Act of by approximately $1.95 billion over 5
Timetable: years. When fully effective in FY 2006,
2002 that establish new eligibility and
Action Date FR Cite certification requirements for the the provisions of this rule will add
receipt of food stamps. (02-007) approximately 415,000 new
NPRM 09/12/00 65 FR 55103
NPRM Comment 12/11/00
Statement of Need:
Period End Timetable:
Interim Final Rule 09/01/04 69 FR 53502 The rule is needed to implement the
food stamp certification and eligibility Action Date FR Cite
Interim Final Rule 10/01/04
Effective provisions of Public Law 107-171, the NPRM 04/16/04 69 FR 20724

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72747

Action Date FR Cite 3) Timeframes for determining final Security and Rural Investment Act of
error rates; 2002. The Department has no discretion
NPRM Comment 06/15/04 in implementing the time frames for
Period End 4) The threshold for potential sanctions
and time period for sanctions; completing quality control reviews, the
Final Action 12/00/06
arbitration process, and determining the
Final Action Effective 02/00/07 5) The calculation of State error rates; final error rates; the threshold for
Regulatory Flexibility Analysis 6) The formula for determining States’ potential sanctions and the time period
Required: liability amounts; for the sanctions; the calculation for
No 7) Sanction notification and method of State error rates; the formula for
payment; and determining liability amounts; the
Small Entities Affected: sanction notification; method of
8) Corrective action plans. payment for liabilities; corrective action
The following provisions required by planning, and the elimination of
Government Levels Affected: Sections 4118 and 4119 and additional enhanced funding. These provisions
Federal, Local, State, Tribal policy and technical changes, and were effective for the fiscal year 2003
contained in the Proposed rule, are quality control review period and must
Agency Contact: implemented by this final rule: have been implemented by FNS and
Sharon Ackerman Legislative changes based on or State agencies during fiscal year 2003.
Agency Regulatory Officer required by Sections 4118 and 4119 This rule also deals in part with
Department of Agriculture discretionary changes to the quality
1) Eliminate enhanced funding; control system resulting from Public
Food and Nutrition Service
Room 918 2) Establish timeframes for completing Law 107-171. The provision addressing
3101 Park Center Drive individual quality control reviews; and results of appeals is required to be
Alexandria, VA 22302 3) Establish procedures for adjusting regulated by Public Law 107-171. The
Phone: 703 305–2246 liability determinations following remaining changes amend existing
Fax: 703 605–0220 appeal decisions. regulations and are required to make
Email: technical changes resulting from these
Policy and technical changes
RIN: 0584–AD30 changes or to update policy consistent
1) Require State agency QC reviewers with current requirements.
to attempt to complete review when a
USDA—FNS household refuses to cooperate; Anticipated Cost and Benefits:
9. QUALITY CONTROL PROVISIONS 2) Mandate FNS validation of negative The provisions of this rule are not
OF TITLE IV OF PUBLIC LAW 107–171 sample for purposes of high anticipated to have any impact on
performance bonuses; benefit levels or administrative costs.
3) Revise procedures for conducting
Other Significant negative case reviews; Risks:
Legal Authority: 4) Revise time frames for household The FSP provides nutrition assistance
7 USC 2011 to 2032; PL 107–171 penalties for refusal to cooperate with to millions of Americans nationwide.
State and Federal QC reviews; The quality control system measures
CFR Citation: 5) Revise procedures for QC reviews of the accuracy of States providing food
7 CFR 273; 7 CFR 275 demonstration and SSA processed stamp benefits to the program
cases; recipients. This rule is intended to
Legal Deadline: implement the quality control
None 6) Eliminate requirement to report provisions of Public Law 107-701, the
variances resulting from Federal Farm Security and Rural Investment
Abstract: information exchange systems (FIX) Act of 2002. It will significantly revise
This rule finalizes the Interim rule errors; the system for determining State agency
‘‘Non-Discretionary Quality Control 7) Eliminate references to integrated liabilities and sanctions for high
Provisions of Title IV of Public Law QC; and payment error rates.
107-171’’ (published October 16, 2003 8) Update definitions section to remove
at 68 FR 59519) and the Proposed rule Timetable:
out-dated definitions. (02-014)
‘‘Discretionary Quality Control Action Date FR Cite
Provisions of Title IV of Public Law Statement of Need:
Interim Final Rule 10/16/03 68 FR 59519
107-171’’ (published September 23, The rule is needed to implement the Interim Final Rule 12/15/03
2005 at 70 FR 55776). food stamp quality control provisions Effective
The following quality control (QC) of Public Law 107-171, the Farm Interim Final Rule 01/14/04
provisions required by Sections 4118 Security and Rural Investment Act of Comment Period
and 4119 of the Farm Security and 2002. End
Rural Investment Act of 2002 (Title IV Final Action 01/00/07
Summary of Legal Basis:
of Public Law 107-171) and contained
in the Interim rule are implemented by The legal basis for this rule is Public Regulatory Flexibility Analysis
this final rule: Law 107-171, the Farm Security and Required:
Rural Investment Act of 2002.
1) Timeframes for completing quality No
control reviews; Alternatives:
Government Levels Affected:
2) Timeframes for completing the This rule deals with changes required
arbitration process; by Public Law 107-171, the Farm Federal, Local, State

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72748 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Agency Contact: implement the statutory changes and USDA—FNS

Sharon Ackerman provide State agencies and local
educational agencies with the policies 11. SPECIAL SUPPLEMENTAL
Agency Regulatory Officer NUTRITION PROGRAM FOR WOMEN,
Department of Agriculture and procedures to conduct mandatory
and discretionary direct certification. INFANTS, AND CHILDREN (WIC): WIC
Food and Nutrition Service VENDOR COST CONTAINMENT
Room 918 Summary of Legal Basis:
3101 Park Center Drive Priority:
Alexandria, VA 22302 These changes are being made in Other Significant
Phone: 703 305–2246 response to provisions in Public Law
Fax: 703 605–0220 Legal Authority:
Email: 42 USC 1786
Related RIN: Merged with 0584–AD37 CFR Citation:
RIN: 0584–AD31 FNS will be working closely with State 7 CFR 246
agencies to implement the changes
made by this regulation and will be Legal Deadline:
USDA—FNS developing extensive guidance Final, Statutory, December 2005.
10. DIRECT CERTIFICATION OF materials in conjunction with our
cooperators. Abstract:
Anticipated Cost and Benefits: regulations to strengthen vendor cost
RUNAWAY CHILDREN FOR FREE containment. The rule incorporates into
This regulation will reduce paperwork,
MEALS IN THE NSLP, SBP, AND SMP program regulations new legislative
target benefits more precisely, and will
requirements that affect the selection,
improve program access of eligible
Priority: authorization, and reimbursement of
school children.
Other Significant retail vendors. These requirements are
Risks: contained in the Child Nutrition and
Legal Authority: WIC Reauthorization Act of 2004 (Pub.
PL 108–265, sec 104 This regulation may require L. 108-265), which was enacted on June
adjustments to existing computer 30, 2004. The rule reflects the statutory
CFR Citation: systems to more readily share provisions that require WIC State
7 CFR 245 information between schools, food agencies to implement a vendor peer
stamp offices, and other agencies. group system, competitive price
Legal Deadline: selection criteria, and allowable
None reimbursement levels in a manner that
Action Date FR Cite ensures that the WIC Program pays
Abstract: authorized vendors competitive prices
Interim Final Rule 02/00/07
In response to Public Law 108-265, Interim Final Rule 02/00/08 for supplemental foods. It also requires
which amended the Richard B. Russell Comment Period State agencies to ensure that vendors
National School Lunch Act, 7 CFR 245, End that derive more than 50 percent of
Determining Eligibility for Free and Final Action 02/00/09 their annual food sales revenue from
Reduced Price Meals and Free Milk in WIC food instruments do not result in
Schools, will be amended to establish Regulatory Flexibility Analysis higher food costs to the program than
categorical (automatic) eligibility for Required: do other vendors. The intent of these
free meals and free milk upon provisions is to maximize the number
documentation that a child is (1) Yes of women, infants, and children served
homeless as defined by the McKinney- with available Federal funding. (04-029)
Small Entities Affected:
Vento Homeless Assistance Act; (2) a
runaway served by grant programs Statement of Need:
Governmental Jurisdictions
under the Runaway and Homeless This action is needed to implement the
Youth Act; or (3) migratory as defined Government Levels Affected: vendor cost containment provisions of
in sec. 1309(2) of the Elementary and the Child Nutrition and WIC
Local, State Reauthorization Act of 2004, Public
Secondary Education Act. The rule also
requires phase-in of mandatory direct Agency Contact: Law 108-265. The rule requires WIC
certification for children who are State agencies to operate vendor
members of households receiving food Sharon Ackerman management systems that effectively
stamps and continues discretionary Agency Regulatory Officer contain food costs by ensuring that
direct certification for other Department of Agriculture prices paid for supplemental foods are
categorically eligible children. (04-018) Food and Nutrition Service competitive. The rule also responds to
Room 918 data which indicate that WIC food
Statement of Need: 3101 Park Center Drive expenditures increasingly include
The changes made to the Richard B. Alexandria, VA 22302 payments to a type of vendor whose
Russell National School Lunch Act Phone: 703 305–2246 prices are not governed by the market
concerning direct certification are Fax: 703 605–0220 forces that affect most retail grocers. As
intended to improve program access, Email: a result, the prices charged by these
reduce paperwork, and improve the Related RIN: Merged with 0584–AD62 vendors tend to be higher than those
accuracy of the delivery of free meal of other retail grocery stores
benefits. This regulation will RIN: 0584–AD60 participating in the program. To ensure

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72749

that the program pays competitive containment. In the interim, FNS Action Date FR Cite
prices, this rule codifies the new believes that the current rule will
statutory requirements for State substantially accomplish the goal of the Interim Final Rule 11/29/06
agencies to use in evaluating vendor Act of containing food costs and Comment Period
applicants’ prices during the vendor ensuring that above-50-percent vendors
Interim Final Rule 12/29/05
selection process and when paying do not result in higher costs to the WIC Effective
vendors for supplemental foods Program than regular vendors. Final Action 08/00/07
following authorization. Final Action Effective 09/00/07
Anticipated Cost and Benefits:
Summary of Legal Basis: Regulatory Flexibility Analysis
Costs: This rule places new
Section 203 of Public Law 108-265, requirements on State agencies; Required:
Child Nutrition and WIC therefore, the cost implications of this No
Reauthorization Act of 2004. rule relate primarily to administrative
burden for WIC State agencies. These Small Entities Affected:
cost implications are partially Businesses, Governmental Jurisdictions
This rule implements the vendor peer dependent on the current practices of
group provisions of the Child Nutrition State agencies relative to the Government Levels Affected:
and WIC Reauthorization Act of 2004, requirements of the rule. Detailed Federal, Local, State, Tribal
which FNS believes is an effective information regarding the cost
means of controlling WIC food costs. implications of this rule is contained URL For More Information:
While this Act mandates that States in the Regulatory Impact Analysis
establish peer groups, competitive price developed by FNS to accompany this
criteria, and allowable reimbursement rulemaking. Agency Contact:
levels, and states that these Sharon Ackerman
Benefits: The WIC Program will benefit
requirements must result in the Agency Regulatory Officer
from the provisions of this rule by
outcome of paying above-50-percent Department of Agriculture
reducing unnecessary food
vendors no more than regular vendors, Food and Nutrition Service
expenditures, thus increasing the
the rule does not specify particular Room 918
potential to serve more eligible women,
criteria for peer groups or acceptable 3101 Park Center Drive
infants, and children for the same cost.
methods of setting competitive price Alexandria, VA 22302
This rule should have the effect of
criteria and allowable reimbursement Phone: 703 305–2246
ensuring that payments to vendors,
levels. FNS considered mandating Fax: 703 605–0220
particularly vendors that derive more
specific means of developing peer Email:
than 50 percent of their annual food
groups, competitive price criteria, and
sales revenue from WIC food RIN: 0584–AD71
allowable reimbursement levels in
instruments, reflect competitive prices
order to ensure that the outcome of this
for WIC foods. The Regulatory Impact
legislation was achieved. USDA—FNS
Analysis prepared by FNS to
However, given States’ responsibility to accompany this rulemaking projects an 12. SPECIAL SUPPLEMENTAL
manage WIC as a discretionary grant estimated monthly cost savings of over NUTRITION PROGRAM FOR WOMEN,
program and the varying market $6.25 million. (Details of this projection INFANTS AND CHILDREN (WIC):
conditions in each State, FNS believes can be found in the complete REVISIONS IN THE WIC FOOD
that States need flexibility to develop Regulatory Impact Analysis.) PACKAGES
their own peer groups, competitive
price criteria, and allowable Risks: Priority:
reimbursement levels. At the October Because the vendor peer group Economically Significant. Major under
2004 meeting the FNS convened to gain provisions in the Child Nutrition and 5 USC 801.
input for this rule, States indicated that WIC Reauthorization Act of 2004 and
they needed the ability to design cost this rule provide for some flexibility in Legal Authority:
containment practices that would be implementation, and because there is 42 USC 1786
effective in their own markets and a wide degree of variation in food
would ensure participant access. In prices and current vendor cost CFR Citation:
addition, there is little information containment practices across State 7 CFR part 246
about the effectiveness of particular agencies, the impact of many of the
cost containment practices in the provisions of this rule is uncertain. Legal Deadline:
variety of markets represented by the Uncertainties include the Final, Statutory, November 2006, CN
89 WIC State agencies. Mandating more administrative burden State agencies and WIC Reauthorization Act of 2004
specific means of developing peer will incur and the savings that can be requires issuance of final rule within
groups, competitive price criteria, and realized nationally or in any State 18 months of release of IOM Report.
allowable reimbursement levels could agency. The major uncertainties for
have unintended negative consequences both administrative burden and Abstract:
for participant access, food costs and program savings are discussed in This proposed rule would revise
administrative burden. greater detail in the Regulatory Impact regulations governing the WIC food
As States gain experience and the Analysis. packages to change age specifications
results of their vendor cost containment Timetable: for assignment to infant feeding
practices become apparent, FNS may packages; establish infant formula
develop further regulations and Action Date FR Cite feeding or breastfeeding categories for
guidance to improve vendor cost Interim Final Rule 11/29/05 70 FR 71708 infants; revise the maximum monthly

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72750 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

allowances and minimum requirements address a variety of alternatives that are USDA—Food Safety and Inspection
for certain WIC foods; revise the considered in the proposed rulemaking. Service (FSIS)
substitution rates for certain WIC foods
and allow additional foods as Anticipated Cost and Benefits:
alternatives; add fruits and vegetables The IOM was charged by FNS to PROPOSED RULE STAGE
for WIC participants 6 months of age develop recommendations that were
and older and eliminate juice from cost-neutral. The regulatory impact
infants’ food packages; add whole analysis will provide a more detailed 13. EGG PRODUCTS INSPECTION
grains to food packages for children summary of specific costs/benefits REGULATIONS
and women and baby food meat for associated with the proposed revisions
fully breastfed infants 6 through 11 to the WIC Food Packages. Priority:
months of age; revise the purpose, Economically Significant. Major under
content, and requirements for Food Risks: 5 USC 801.
Package III; and address general The proposed rule has a 90-day
provisions that apply to all food Unfunded Mandates:
comment period, during which
packages. The revisions reflect interested parties may submit Undetermined
recommendations made by the Institute comments on any and all provisions Legal Authority:
of Medicine in its report, WIC Food contained in the rulemaking. Once the
Packages: Time for a Change, and comment period has expired, all 21 USC 1031 to 1056
certain other administrative revisions comments received will be carefully CFR Citation:
deemed necessary by the Department. considered in the development of the
These revisions would bring the WIC 9 CFR 590.570; 9 CFR 590.575; 9 CFR
final rule. Opportunities for training on
food packages in line with the 2005 590.146; 9 CFR 590.10; 9 CFR 590.411;
and discussion of the revised WIC food
Dietary Guidelines for Americans and 9 CFR 590.502; 9 CFR 590.504; 9 CFR
packages will be offered to State
current infant feeding practice 590.580; 9 CFR 591; . . .
agencies and other entities as
guidelines, better promote and support necessary. Legal Deadline:
the establishment of successful long-
Timetable: None
term breastfeeding, provide WIC
participants with a wider variety of Action Date FR Cite Abstract:
food, provide WIC State agencies with NPRM 08/07/06 71 FR 44784 The Food Safety and Inspection Service
greater flexibility in prescribing food NPRM Comment 11/06/06 (FSIS) is proposing to require egg
packages to accommodate participants Period End products plants and establishments that
with cultural food preferences, and Interim Final Rule 09/00/07 pasteurize shell eggs to develop and
serve all participants with certain Interim Final Rule 10/00/07 implement Hazard Analysis and
medical provisions under one food Effective Critical Control Points (HACCP)
package to facilitate efficient Interim Final Rule 10/00/09 systems and Sanitation Standard
management of medically fragile Comment Period Operating Procedures (SOPs). FSIS also
participants. (05-006) End is proposing pathogen reduction
Statement of Need: Regulatory Flexibility Analysis performance standards that would be
Required: applicable to egg products and
The revisions proposed in this pasteurized shell eggs. FSIS is
rulemaking reflect recommendations No proposing to amend the Federal egg
made by the Institute of Medicine products inspection regulations by
Small Entities Affected:
(IOM) in its report, WIC Food Packages: removing current requirements for prior
Time for a Change, and certain Businesses approval by FSIS of egg products plant
administrative revisions deemed drawings, specifications, and
Government Levels Affected:
necessary by the Department. The Child equipment prior to their use in official
Nutrition and WIC Reauthorization Act Local, State, Tribal plants. The Agency also plans to
of 2004, enacted on June 30, 2004, eliminate the prior label approval
requires the Department to issue a final URL For More Information:
system for egg products. This proposal
rule within 18 months (November will not encompass shell egg packers.
2006) of receiving the IOM’s report. In the near future, FSIS will initiate
URL For Public Comments:
non-regulatory outreach efforts for shell
Summary of Legal Basis: egg packers that will provide
The Child Nutrition and WIC information intended to help them to
Agency Contact:
Reauthorization Act of 2004, enacted safely process shell eggs intended for
on June 30, 2004, requires the Sharon Ackerman human consumption or further
Department to issue a final rule within Agency Regulatory Officer processing.
18 months of receiving the Institute of Department of Agriculture The actions being proposed are part of
Medicine’s report on revisions to the Food and Nutrition Service FSIS’ regulatory reform effort to
WIC food packages. This report was Room 918 improve FSIS’ egg products food safety
published and released to the public 3101 Park Center Drive regulations, better define the roles of
on April 27, 2005. Alexandria, VA 22302 Government and the regulated industry,
Phone: 703 305–2246 encourage innovations that will
Alternatives: Fax: 703 605–0220 improve food safety, remove
FNS is in the process of developing a Email: unnecessary regulatory burdens on
regulatory impact analysis that will RIN: 0584–AD77 inspected egg products plants, and

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72751

make the egg products regulations as number of factors. These costs include and qualitative benefits associated with
consistent as possible with the the required lethality, or level of each alternative.
Agency’s meat and poultry products pathogen reduction, and the cost of
regulations. FSIS is also taking these HACCP plan and sanitation SOP Human health benefits from this
actions in light of changing inspection development, implementation, and rulemaking are likely to be small
priorities and findings of Salmonella in associated employee training. The because of the low level of (chiefly
pasteurized egg products. pathogen reduction costs will depend post-processing) contamination of
on the amount of reduction sought and pasteurized egg products. In light of
Statement of Need: recent scientific studies that raise
on the classes of product, product
The actions being proposed are part of formulations, or processes. questions about the efficacy of current
FSIS’ regulatory reform effort to regulations, however, it is likely that
Relative enforcement costs to FSIS and
improve FSIS’ shell egg and egg measurable reductions will be achieved
Food and Drug Administration may
products food safety regulations, better in the risk of foodborne illness.
change because the two agencies share
define the roles of Government and the
responsibility for inspection and
regulated industry, encourage Risks:
oversight of the egg industry and a
innovations that will improve food
common farm-to-table approach for FSIS believes that this regulatory action
safety, remove unnecessary regulatory
shell egg and egg products food safety.
burdens on inspected egg products may result in a further reduction in the
Other Federal agencies and local
plants, and make the egg products risks associated with egg products. The
governments are not likely to be
regulations as consistent as possible development of a lethality-based
with the Agency’s meat and poultry pathogen reduction performance
products regulations. FSIS also is FSIS has cooperative agreements with standard for egg products, replacing
taking these actions in light of changing four States and the Commonwealth of command-and-control regulations, will
inspection priorities and recent Puerto Rico under which they provide remove unnecessary regulatory
findings of Salmonella in pasteurized inspection services to egg processing obstacles to, and provide incentives for,
egg products. plants under Federal jurisdiction. FSIS innovation to improve the safety of egg
reimburses the States for staffing costs
This proposal is directly related to products.
and expenses for full-time State
FSIS’ PR/HACCP initiative.
inspectors. HACCP implementation To assess the potential risk-reduction
Summary of Legal Basis: may result in a reduction of staffing impacts of this rulemaking on the
This proposed rule is authorized under resource requirements in the States and public, an intra-Agency group of
the Egg Products Inspection Act (21 a corresponding reduction of the scientific and technical experts is
U.S.C. 1031 to 1056). It is not the result Federal reimbursement. As a result, conducting a risk management analysis.
of any specific mandate by the some States may decide to stop The group has been charged with
Congress or a Federal court. providing inspection services and identifying the lethality requirement
convert to Federal inspection of egg
Alternatives: sufficient to ensure the safety of egg
products plants.
products and the alternative methods
A team of FSIS economists and food Egg and egg product inspection systems for implementing the requirement. FSIS
technologists is conducting a cost- of foreign countries wishing to export has developed new risk assessments for
benefit analysis to evaluate the eggs and egg products to the U.S. must SE in eggs and for Salmonella spp. in
potential economic impacts of several be equivalent to the U.S. system. FSIS liquid egg products to evaluate the risk
alternatives on the public, egg products will consult with these countries, as
industry, and FSIS. These alternatives associated with the regulatory
needed, if and when this proposal alternatives.
include: (1) Taking no regulatory becomes effective.
action; (2) requiring all inspected egg Timetable:
This proposal is not likely to have a
products plants to develop, adopt, and
significant impact on small entities. Action Date FR Cite
implement written sanitation SOPs and
The entities that would be directly
HACCP plans; and (3) converting to a NPRM 09/00/07
affected by this proposal would be the
lethality-based pathogen reduction
approximately 75 federally inspected
performance standard many of the Regulatory Flexibility Analysis
egg products plants, most of which are
current highly prescriptive egg products Required:
small businesses, according to Small
processing requirements. The team will
Business Administration criteria. If
consider the effects of a uniform, No
necessary, FSIS will develop
across-the-board standard for all egg
compliance guides to assist these small Small Entities Affected:
products; a performance standard based
firms in implementing the proposed
on the relative risk of different classes
requirements. Businesses, Governmental Jurisdictions
of egg products; and a performance
standard based on the relative risks to Potential benefits associated with this
public health of different production rulemaking include: Improvements in Government Levels Affected:
processes. human health due to pathogen
Federal, State
reduction; improved utilization of FSIS
Anticipated Cost and Benefits: inspection program resources; and cost Federalism:
FSIS is analyzing the potential costs of savings resulting from the flexibility of
this proposed rulemaking to industry, egg products plants in achieving a Undetermined
FSIS and other Federal agencies, State lethality-based pathogen reduction
and local governments, small entities, performance standard. Once specific
and foreign countries. The expected alternatives are identified, economic
costs to industry will depend on a analysis will identify the quantitative

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72752 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Agency Contact: standards will include and be Summary of Legal Basis:

Victoria Levine consistent with standards already in Under the Federal Meat Inspection Act
Program Analyst, Regulations and place for certain ready-to-eat meat and (21 U.S.C. 601 to 695) and the Poultry
Petitions Policy Staff poultry products. Product Inspection Act (21 U.S.C. 451
Department of Agriculture to 470), FSIS issues regulations
Statement of Need: governing the production of meat and
Food Safety and Inspection Service
1400 Independence Avenue SW The Food Safety and Inspection Service poultry products prepared for
Washington, DC 20250 (FSIS) has proposed to amend the distribution in commerce. The
Phone: 202 720–5627 Federal meat and poultry inspection regulations, along with FSIS inspection
Fax: 202 690–0486 regulations by establishing food safety programs, are designed to ensure that
Email: performance standards for all ready-to- meat and poultry products are safe, not
RIN: 0583–AC58 eat and all partially heat-treated meat adulterated, and properly marked,
and poultry products. The proposed labeled, and packaged.
performance standards set forth both Alternatives:
USDA—FSIS levels of pathogen reduction and limits
As an alternative to all of the proposed
on pathogen growth that official meat
requirements, FSIS considered taking
and poultry establishments must
FINAL RULE STAGE no action. As alternatives to the
achieve during their operations in order
proposed performance standard
to produce unadulterated products but
requirements, FSIS considered end-
allow the use of customized, plant-
14. PERFORMANCE STANDARDS FOR product testing and requiring ‘‘use-by’’
specific processing procedures. The
THE PRODUCTION OF PROCESSED date labeling on ready-to-eat products.
proposed performance standards apply
MEAT AND POULTRY PRODUCTS; to ready-to-eat meat and poultry Anticipated Cost and Benefits:
CONTROL OF LISTERIA products, categorized as follows: Dried Benefits are expected to result from
MONOCYTOGENES IN products (e.g., beef or poultry jerky); fewer contaminated products entering
READY–TO–EAT MEAT AND salt-cured products (e.g., country ham); commercial food distribution channels
POULTRY PRODUCTS fermented products (e.g., salami and as a result of improved sanitation and
Priority: Lebanon bologna); cooked and process controls and in-plant
otherwise processed products (e.g., beef verification. FSIS believes that the
Economically Significant. Major under and chicken burritos, corned beef,
5 USC 801. benefits of the rule would exceed the
pastrami, poultry rolls, and turkey total costs of implementing its
Legal Authority: franks); and thermally processed, provisions.
commercially sterile products (e.g.,
21 USC 451 et seq; 21 USC 601 et seq canned spaghetti with meat balls and The main provisions of the proposed
CFR Citation: canned corned beef hash). rule are: Lethality performance
standards for Salmonella and E. coli
9 CFR 301; 9 CFR 303; 9 CFR 317; 9 Although FSIS routinely samples and 0157:H7 and stabilization performance
CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR tests some ready-to-eat products for the standards for C. perfringens that firms
325; 9 CFR 331; 9 CFR 381; 9 CFR 417; presence of pathogens prior to must meet when producing RTE meat
9 CFR 430; 9 CFR 431 distribution, there are no specific and poultry products. Most of the costs
Legal Deadline: regulatory pathogen reduction of these requirements would be
requirements for most of these associated with one-time process
products. The proposed performance performance validation in the first year
Abstract: standards will help ensure the safety of implementation of the rule and with
FSIS has proposed to establish of these products; give establishments revision of HACCP plans. Benefits are
pathogen reduction performance the incentive and flexibility to adopt expected to result from the entry into
standards for all ready-to-eat (RTE) and innovative, science-based food safety commercial food distribution channels
partially heat-treated meat and poultry processing procedures and controls; of product with lower levels of
products, and measures, including and provide objective, measurable contamination resulting from improved
testing, to control Listeria standards that can be verified by in-plant process verification and
monocytogenes in RTE products. The Agency oversight. sanitation. Consequently, there will be
performance standards spell out the fewer cases of foodborne illness.
The proposal also contained provisions
objective level of pathogen reduction addressing Listeria monocytogenes in Risks:
that establishments must meet during RTE products. An Interim Final Rule None.
their operations in order to produce on this subject was published June 6,
safe products but allow the use of Timetable:
2003 (68 FR 34208).
customized, plant-specific processing Action Date FR Cite
procedures other than those prescribed FSIS also has proposed to eliminate its
NPRM 02/27/01 66 FR 12590
in the earlier regulations. With HACCP, regulations that require that both ready-
NPRM Comment 05/29/01
food safety performance standards give to-eat and not-ready-to-eat pork and Period End
establishments the incentive and products containing pork be treated to NPRM Comment 07/03/01 66 FR 35112
flexibility to adopt innovative, science- destroy trichinae (Trichinella spiralis). Period Extended
based food safety processing procedures These requirements are inconsistent NPRM Comment 09/10/01
and controls, while providing objective, with HACCP, and some will be Period End
measurable standards that can be unnecessary if FSIS makes final the Interim Final Rule 06/06/03 68 FR 34208
verified by Agency inspectional proposed performance standards for Interim Final Rule 10/06/03
oversight. This set of performance ready-to-eat meat and poultry products. Effective

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72753

Action Date FR Cite poultry products, unless an exemption (major cuts and non-major cuts) and all
applies. The requirements for ground or ground or chopped products; nutrition
Interim Final Rule 01/31/05 chopped products will be consistent labels required on all major cuts of
Comment Period
with those for multi-ingredient single-ingredient, raw products (but not
products. non-major cuts) and all ground or
NPRM Comment 03/24/05 70 FR 15017
Period Reopened FSIS also proposed to amend the chopped products; nutrition
NPRM Comment 05/09/05 nutrition labeling regulations to provide information at the point-of-purchase
Period End that when a ground or chopped product required for all single-ingredient, raw
Affirmation of Interim 02/00/07 does not meet the regulatory criteria to products (major and non-major cuts)
Final Rule be labeled ‘‘low fat,’’ a lean percentage and for all ground or chopped
Final Action 06/00/07 claim may be included on the label or products.
Regulatory Flexibility Analysis in labeling, as long as a statement of
Required: the fat percentage also is displayed on Anticipated Cost and Benefits:
the label or in labeling.
Yes Costs will include the equipment for
Statement of Need: making labels, labor, and materials
Small Entities Affected: used for labels for ground or chopped
The Agency will require that nutrition
Businesses information be provided for the major products. The cost of providing
cuts of single-ingredient, raw meat and nutrition labeling for the major cuts of
Government Levels Affected:
poultry products, either on their label single-ingredient, raw meat and poultry
Undetermined or at their point-of-purchase, because products should not be significant,
during the most recent surveys of because retail establishments would
Agency Contact:
retailers, the Agency did not find have the option of providing nutrition
Dr. Daniel L. Engeljohn significant participation in the information through point-of-purchase
Deputy Assistant Administrator, Office of voluntary nutrition labeling program for materials.
Policy, Program, and Employee single-ingredient, raw meat and poultry
Development products. Without nutrition Benefits of the nutrition labeling rule
Department of Agriculture information, FSIS has concluded that would result from consumers
Food Safety and Inspection Service the major cuts of single-ingredient, raw modifying their diets in response to
1400 Independence Avenue SW meat and poultry products would be new nutrition information concerning
Washington, DC 20250 misbranded. ground or chopped products and the
Phone: 202 205–0495 Because consumers cannot easily major cuts of single-ingredient, raw
Fax: 202 401–1760 estimate the level of fat in ground or products. Reductions in consumption
Email: chopped meat and poultry products of fat and cholesterol are associated
RIN: 0583–AC46 and because producers are able to with reduced incidence of cancer and
formulate precisely the fat content of coronary heart disease.
ground or chopped products, FSIS has
USDA—FSIS FSIS has concluded that the
concluded that ground or chopped
15. NUTRITION LABELING OF meat and poultry products that do not quantitative benefits will exceed the
SINGLE–INGREDIENT PRODUCTS bear nutrition information on their quantitative costs of the rule.
AND GROUND OR CHOPPED MEAT labels would also be misbranded.
AND POULTRY PRODUCTS Finally, FSIS will amend the nutrition
Priority: labeling regulations to provide that None.
when a ground or chopped product
Economically Significant. Major under does not meet the criteria to be labeled Timetable:
5 USC 801. ‘‘low fat,’’ a lean percentage claim may Action Date FR Cite
Legal Authority: be included on the product, as long as
a statement of the fat percentage is also NPRM 01/18/01 66 FR 4970
21 USC 601 et seq; 21 USC 451 et seq displayed on the label or in labeling. NPRM Comment 04/18/01
FSIS will include these provisions in Period End
CFR Citation:
the final nutrition labeling regulations Extension of 04/20/01 66 FR 20213
9 CFR 317; 9 CFR 381 because many consumers have become Comment Period
accustomed to this labeling on ground NPRM Comment 07/17/01
Legal Deadline: Period End
beef products and because this labeling
None provides a quick, simple, accurate Final Action 12/00/06
Abstract: means of comparing all ground or
chopped meat and poultry products. Regulatory Flexibility Analysis
FSIS has proposed to amend the Required:
Federal meat and poultry products Summary of Legal Basis:
inspection regulations to require This action is authorized under the No
nutrition labeling for the major cuts of Federal Meat Inspection Act (21 U.S.C.
single-ingredient, raw meat and poultry Small Entities Affected:
601 to 695) and the Poultry Products
products, either on their label or at Inspection Act (21 U.S.C. 451 to 470). Businesses
their point-of-purchase, unless an
exemption applies. FSIS also proposed Alternatives:
Government Levels Affected:
to require nutrition information on the No action; nutrition labels required on
label of ground or chopped meat and all single-ingredient, raw products None

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72754 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Agency Contact: prerequisite program. FSIS took this Alternatives:

Robert Post Ph.D. action in response to the diagnosis on As an alternative to the interim final
Director, Labeling and Consumer December 23, 2003, by the U.S. rule, FSIS considered taking no action.
Protection Staff Department of Agriculture of a positive FSIS rejected this option because, as
Department of Agriculture case of bovine spongiform previously mentioned, USDA policy in
Food Safety and Inspection Service encephalopathy (BSE) in an adult regard to BSE has been to be proactive
1400 Independence Avenue SW Holstein cow in the State of and preventive.
Washington, DC 20250 Washington. This action is intended to
minimize human exposure to materials Anticipated Cost and Benefits:
Phone: 202 205–0279
Email: that scientific studies have This interim final rule could result in
demonstrated as containing the BSE costs to the regulated industry. FSIS
RIN: 0583–AC60 agent in cattle infected with the expects to minimize the costs by
disease. Infectivity has never been targeting the regulations to apply to
USDA—FSIS demonstrated in the muscle tissue of those cattle whose materials are most
cattle experimentally or naturally likely to contain the BSE agent if the
16. PROHIBITION OF THE USE OF infected with BSE at any stage of the animal is infected with BSE. Banning
SPECIFIED RISK MATERIALS FOR disease. certain materials, such as brain and
HUMAN FOOD AND REQUIREMENTS spinal cord, for use as human food may
require additional staff and time to
NON–AMBULATORY DISABLED FSIS issued an interim final rule to remove such materials. Materials
CATTLE amend the meat inspection regulations prohibited for use as human food could
to add provisions to prevent meat and not be sold domestically or exported.
meat products that may contain the Companies may be required to find
Economically Significant. Major under BSE agent from entering commerce. new ways to handle and dispose of
5 USC 801. these materials, which would impose
BSE is a chronic, degenerative,
Legal Authority: neurological disorder of cattle. additional costs. Prohibiting the use of
Worldwide, there have been more than bovine vertebral column as a source
21 USC 601 et seq material in AMRS could result in a
185,000 cases since the disease was
CFR Citation: first diagnosed in 1986 in Great Britain. decrease in product yield and may
Recent laboratory and epidemiological require companies that use these
Not Yet Determined systems to produce boneless beef and
research indicate that there is a causal
Legal Deadline: association between BSE and variant beef products to find other uses for
Creutzfeldt-Jakob Disease (vCJD), a slow bovine vertebral column.
None Establishments whose equipment may
degenerative disease that affects the
Abstract: central nervous system of humans. Both have been contaminated with the BSE
BSE and vCJD are always fatal. agent may have costs associated with
On January 12, 2004, the Food Safety sanitation or disposal of plant
and Inspection Service (FSIS) issued an USDA policy in regard to BSE has been equipment.
interim final rule to amend the Federal to be proactive and preventive. The
meat inspection regulations to regulations: (1) Prohibit certain FSIS may incur costs to increase
designate the brain, skull, eyes, materials that have been shown to inspection and compliance activities to
trigeminal ganglia, spinal cord, contain the BSE agent in BSE-infected ensure that the measures taken to
vertebral column (excluding the cattle to be used for human food or prevent meat and meat food products
vertebrae of the tail, the transverse in the production of human food; (2) that may contain the BSE agent from
processes of the thoracic and lumbar prescribe handling, storage, and entering commerce are effective.
vertebrae, and the wings of the sacrum), transportation requirements for such Producers may receive lower prices
and dorsal root ganglia (DRG) of cattle materials; (3) prohibit slaughter from processors, and some of their
30 months of age and older, and the procedures that may cause potentially stock may be condemned outright. The
tonsils and distal ileum of the small infective tissues to migrate to edible price consumers pay for meat may rise
intestine of all cattle, as ‘‘specified risk tissues; (4) prescribe requirements for or fall depending on how the discovery
materials’’ (SRMs). The Agency the slaughtering and processing of of BSE in the U.S. affects consumer
declared that SRMs are inedible and cattle whose materials are most likely demand for beef.
prohibited their use for human food. to contain the BSE agent if the animal The main benefit of this proposed rule
In addition, as a result of the interim is infected with BSE; and (5) prescribe is the prevention of vCJD in the United
final rule, FSIS now requires that all requirements for the sanitation or States. There have been over 100
non-ambulatory disabled cattle disposal of plant equipment that may definite and probable cases of vCJD
presented for slaughter be condemned. be contaminated with the BSE agent. detected worldwide since the disease
The Agency also requires that federally was first identified in 1986 in the
inspected establishments that slaughter Summary of Legal Basis: United Kingdom. While vCJD is still
cattle and federally inspected Under the Federal Meat Inspection Act considered a rare condition, the extent
establishments that process the (21 U.S.C. 601 to 695), FSIS issues or occurrence of a vCJD epidemic in
carcasses or parts of cattle develop, regulations governing the production of the United Kingdom cannot be
implement, and maintain written meat and meat food products. The determined because of the long
procedures for the removal, segregation, regulations, along with FSIS inspection incubation period (up to 25 years).
and disposition of SRMs. programs, are designed to ensure that Thus, the interim final rule could have
Establishments must incorporate these meat food products are safe, not widespread public health benefits if it
procedures into their HACCP plans or adulterated, and properly marked, serves to prevent a vCJD epidemic from
in their Sanitation SOPs or other labeled, and packaged. developing in the U.S. Even if vCJD

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72755

remains a rare condition, this proposed Small Entities Affected: marrow as measured by the presence
rule will still have public health Businesses of calcium and iron in excess of the
benefits because of the severity of the requirements in the interim final rule.
symptoms associated with vCJD and the Government Levels Affected: This rule also requires that federally
fact that vCJD is always fatal. Undetermined inspected establishments that process
This interim final rule may benefit the cattle develop, implement, and
meat industry by helping to restore Agency Contact: maintain written procedures for the
confidence in the domestic meat Dr. Daniel L. Engeljohn removal, segregation, and disposition of
supply. This may limit losses to meat Deputy Assistant Administrator, Office of specified risk materials (SRMs),
slaughter and processing operations in Policy, Program, and Employee including non-complying products from
the long run. Development beef AMR systems. These procedures
Department of Agriculture are required to be incorporated into an
Risks: establishment’s HACCP plan, Sanitation
Food Safety and Inspection Service
Although vCJD is a rare condition, the 1400 Independence Avenue SW Standard Operation Procedures, or
symptoms are severe, and it is always Washington, DC 20250 other prerequisite program. FSIS took
fatal. This interim final rule is intended Phone: 202 205–0495 this action in response to the diagnosis
to reduce the risk of humans Fax: 202 401–1760 on December 23, 2003, by the
developing vCJD in the U.S. in the Email: Department of Agriculture of a positive
event BSE is detected in native cattle. case of BSE in an adult Holstein cow
RIN: 0583–AC88 in the State of Washington.
The measures implemented by FSIS are
intended to minimize human exposure
Statement of Need:
to materials from cattle that could USDA—FSIS
potentially contain the BSE agent. In FSIS issued an interim final rule in part
April 1998, USDA entered into a 17. MEAT PRODUCED BY ADVANCED to prevent human exposure to the BSE
cooperative agreement with Harvard MEAT/BONE SEPARATION agent by ensuring that AMR systems
University’s School of Public Health to MACHINERY AND MEAT RECOVERY are not a means of introducing CNS-
conduct a risk analysis to assess the SYSTEMS type tissue into product labeled as
potential pathways for entry into U.S. Priority: ‘‘meat.’’ In addition to the measures
cattle and the U.S. food supply, to related to BSE, FSIS is finalizing
evaluate existing regulations and Other Significant restrictions related to bone solids and
policies, and to identify any additional Legal Authority: bone marrow for livestock products.
measures that could be taken to protect This rule sets out the criteria that FSIS
human and animal health. FSIS used 21 USC 601 to 695 will use to ensure that AMR products
the findings of the risk assessment to CFR Citation: can be represented as ‘‘meat’’ and,
inform its decision to prohibit certain therefore, are not adulterated or
bovine materials for human food. 9 CFR 301.2; 9 CFR 318.24 (Revision); misbranded. Finally, the Agency is
9 CFR 320.1 requiring that federally inspected
Unlike bacterial and viral pathogens
that may be found in or on meat food Legal Deadline: establishments that process the
products, the BSE agent cannot be carcasses or parts of cattle develop,
destroyed by conventional methods, implement, and maintain written
such as cooking or irradiation. Also, Abstract: procedures for the removal, segregation,
although it is rare, vCJD, the human and disposition of specified risk
On January 12, 2004, the Food Safety
disease associated with exposure to the materials (SRMs), including
and Inspection Service (FSIS) issued an
BSE agent, is generally more severe noncomplying product from AMR
interim final rule to amend the Federal
than the human illnesses associated systems processing beef. A 2002 FSIS
meat inspection regulations. The rule
with exposure to bacterial and viral survey of establishments harvesting
is designed, in part, to prevent human
pathogens. Thus, additional measures AMR product derived from beef
exposure to the Bovine Spongiform
to reduce the risk of human exposure vertebrae or beef vertebrae mixed with
Encephalopathy (BSE) agent by
to the BSE agent are necessary to other types of beef bones indicated that
ensuring that Advanced Meat/Bone
protect public health. 35 percent of the final AMRs product
Separation Machinery and Meat
samples tested positive for spinal cord
Timetable: Recovery (AMR) systems are not a
or dorsal root ganglia.
means of introducing central nervous
Action Date FR Cite
system (CNS)-type tissue into product Summary of Legal Basis:
Interim Final Rule 01/12/04 69 FR 1862 labeled as ‘‘meat.’’ Meat may be derived
Interim Final Rule 05/07/04 by mechanically separating skeletal This action is authorized under the
Comment Period muscle tissue from the bones of Federal Meat Inspection Act (21 U.S.C.
End livestock, other than skulls or vertebral 601 to 695).
Interim Final Rule 07/07/05 70 FR 53043 column bones of cattle 30 months of
Amendment Alternatives:
age and older, using advances in
Interim Final Rule 10/07/05 No action.
Amendment mechanical meat/bone separation
Comment Period machinery; i.e., AMR systems. The
Anticipated Cost and Benefits:
End recovered meat product may not
Final Action 12/00/06 incorporate any brain, trigeminal The interim final rule was determined
ganglia, spinal cord, or dorsal root to be not economically significant, but
Regulatory Flexibility Analysis ganglia tissues. In addition, there must significant. The benefit of enforcing the
Required: be no more than a non-significant misbranding provisions will ensure that
Yes incorporation of bone solids or bone the product does not contain materials

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72756 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

not consistent with boneless, encephalopathy (BSE) conducted by the FSIS rejected the option of no
comminuted meat. Harvard Center for Risk Analysis rulemaking because the Agency
(referred to as the Harvard study) and determined that it does not address the
Risks: is part of a series of actions that the potential risk of human exposure to the
None USDA is taking to strengthen its BSE BSE agent presented by air-injection
Timetable: prevention programs. stunning.
Action Date FR Cite Statement of Need: Anticipated Cost and Benefits:
Interim Final Rule 01/12/04 69 FR 1874 FSIS is taking this action to address There are likely no anticipated costs
Interim Final Rule 05/07/04 the potential risk posed by stunning associated with this rule because FSIS
Comment Period devices that may force visible pieces is not aware of any establishments that
End of central nervous system (CNS) tissue, use air-injection stunning on cattle.
Final Action 09/00/07 known as macro-emboli, into the However, although the U.S. beef
circulatory system of stunned cattle. In slaughter industry no longer uses air-
Regulatory Flexibility Analysis
cattle in the end stages of bovine injection stunning devices, FSIS is
spongiform encephalopathy (BSE), CNS taking this action to prohibit any future
No tissue contains the highest levels of the use of these devices, to help facilitate
BSE agent. Thus, because CNS macro- exports of U.S. products, and to ensure
Small Entities Affected:
emboli can potentially become lodged the safety of imported beef products
Businesses in edible tissues, this action is into the United States.
Government Levels Affected: necessary to prevent potential human
exposure to the BSE agent.
None None
Summary of Legal Basis:
Agency Contact: Timetable:
FSIS’ authority to prohibit the use of
Dr. Daniel L. Engeljohn captive bolt stunning devices that inject Action Date FR Cite
Deputy Assistant Administrator, Office of air into the cranium of cattle derives Interim Final Rule 01/12/04 69 FR 1885
Policy, Program, and Employee from the Federal Meat Inspection Act Interim Final Rule 05/07/04
Development (21 U.S.C. 601(m), 621). Comment Period
Department of Agriculture End
Food Safety and Inspection Service Alternatives: Final Action 12/00/06
1400 Independence Avenue SW FSIS considered the alternative of
Washington, DC 20250 Regulatory Flexibility Analysis
establishing a performance standard Required:
Phone: 202 205–0495 that stunning equipment would be
Fax: 202 401–1760 required to meet to be used on cattle, No
Email: and the alternative of no rulemaking. Small Entities Affected:
Related RIN: Duplicate of 0583–AC51 Under the performance standard
option, the Agency would have Businesses
RIN: 0583–AD00
developed a CNS tissue emboli Government Levels Affected:
performance standard that stunners
USDA—FSIS would be required to meet to be Undetermined
permitted to be used on cattle. The
benefits of this option are that it is
more consistent with FSIS regulatory
SLAUGHTER OF CATTLE Deputy Assistant Administrator, Office of
policy than banning a specific
Priority: technology, and that it would prevent Policy, Program, and Employee
all methods of stunning that do not Development
Other Significant Department of Agriculture
comply with the performance standard
Legal Authority: from being used on cattle, not just air- Food Safety and Inspection Service
injection stunning. Thus, this option 1400 Independence Avenue SW
Federal Meat Inspection Act, 21 USC Washington, DC 20250
would prevent the need to regulate
601(m), 621 Phone: 202 205–0495
individual pieces of equipment.
CFR Citation: Fax: 202 401–1760
A potential problem with this option Email:
9 CFR 313 is that there are relatively few studies
on stunning methods and CNS tissue RIN: 0583–AD03
Legal Deadline: emboli. Thus, the Agency was
None concerned that if it were to establish USDA—FSIS
a CNS tissue emboli performance
Abstract: standard for cattle stunning devices at 19. AVAILABILITY OF LISTS OF
The Food Safety and Inspection Service this time, further studies could reveal RETAIL CONSIGNEES DURING MEAT
(FSIS) is amending the Federal meat that the performance standard selected OR POULTRY PRODUCT RECALLS
inspection regulations to prohibit the does not achieve the result intended by
use of penetrative captive bolt stunning the Agency. Therefore, FSIS decided to Priority:
devices that deliberately inject air into prohibit the use of the stunning method Other Significant
the cranial cavity of cattle. This that all available studies do conclude
rulemaking responds to the findings of result in CNS tissue macro-emboli, i.e., Legal Authority:
a risk assessment on bovine spongiform stunning that uses air-injection. 5 USC 301, 552

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72757

CFR Citation: information no longer has confidential Risks:

9 CFR 390 status. Currently, FSIS will not disclose FSIS believes that this regulatory action
distribution lists to the general public may result in a further reduction in the
Legal Deadline: or to States or other Federal risks associated with the consumption
None government agencies that have not of meat and poultry products.
provided to FSIS the written statement
Abstract: and commitment required by the Timetable:
The Food Safety and Inspection Service Agency’s Freedom of Information and Action Date FR Cite
(FSIS) has proposed to amend the public information regulations.
NPRM 03/07/06 71 FR 11326
federal meat and poultry products Consumer activists and States have NPRM Comment 06/11/06 71 FR 27211
inspection regulations to provide that increasingly demanded the public Period End
the Agency will make available to the release of information on where Final Action 05/00/07
public lists of the retail consignees of recalled meat and poultry products
meat and poultry products that have have been shipped. The States have Regulatory Flexibility Analysis
been voluntarily recalled by a federally requested this information be provided Required:
inspected meat or poultry products without the limitations imposed by No
establishment. FSIS has proposed this FSIS’s regulations. Consumer groups
action because it believes that making Small Entities Affected:
have claimed that the public needs this
this information available will be of information to fully protect itself. In No
significant value to consumers and the response to these requests, FSIS is
industry. It will clarify what products Government Levels Affected:
proposing to make available to the
should be removed from commerce and public the names of likely retail Undetermined
from consumers’ possession because consignees of recalled meat and poultry
there is reason to believe they are Agency Contact:
adulterated or misbranded. Mr. Philip Derfler
Summary of Legal Basis: Assistant Administrator, Office of Policy,
Statement of Need: Program, and Employee Development
This proposed rule is authorized under
The objective to be accomplished by 5 U.S.C. 301, Departmental regulations, Department of Agriculture
this regulatory action is to provide and 5 U.S.C. 552, Public information; Food Safety and Inspection Service
important information to consumers agency rules, opinions, orders, records, Room 350, Jamie L. Whitten Building
while ensuring the appropriate and proceedings. It is not the result of 1400 Independence Avenue SW
flexibility for FSIS to protect any specific mandate by the Congress Washington, DC 20250–3700
proprietary information. or a Federal court. Phone: 202 720–2709
While FSIS does not have mandatory Fax: 202 720–2025
recall authority under the Federal Meat Alternatives: Email:
Inspection Act (FMIA) (21 U.S.C. 601 FSIS has prepared a regulatory impact RIN: 0583–AD10
et seq.) or the Poultry Products analysis to evaluate the potential
Inspection Act (PPIA) (21 U.S.C. 451 economic impacts of several
et seq.), the Agency, to protect the alternatives on the public, the meat and USDA—Forest Service (FS)
public health, does ask establishments poultry industry, and FSIS. These
to voluntarily recall adulterated or alternatives include: (1) Including local
misbranded meat and poultry products. health departments as entities that PROPOSED RULE STAGE
FSIS verifies that such recalls are could receive recall distribution lists;
conducted expeditiously and (2) making available to the general
effectively. public recall distribution lists only in 20. ∑ FOREST SERVICE NATIONAL
response to a Freedom of Information ENVIRONMENTAL POLICY ACT
In 2002, FSIS promulgated regulations
request; and (3) making lists available PROCEDURES
defining the circumstances and criteria
under which it would share customer to State agencies with agreements with Priority:
lists with States and other Federal FSIS under 9 CFR 390.9.
Other Significant
agencies in connection with voluntary Anticipated Cost and Benefits:
meat and poultry product recalls. In Legal Authority:
short, FSIS will disclose product FSIS is analyzing the potential costs of
this proposed rulemaking. 40 CFR 1507.3
distribution lists that have been
obtained during voluntary recalls to This proposed rule would provide CFR Citation:
States and other Federal government information to consumers about meat 36 CFR 220
agencies to verify the removal of the and poultry products sold at retail
recalled product, provided that the establishments that are believed to be Legal Deadline:
State or Federal agency has provided: adulterated or misbranded and are None
(1) A written statement establishing its therefore subject to being recalled. The
authority to protect confidential consumption of such products may Abstract:
distribution lists from public cause food borne illness and other The Forest Service is proposing to
disclosure; and (2) a written adverse health consequences, including move existing agency NEPA procedures
commitment not to disclose any death. Providing information of this required by 40 CFR 1507.3 from Forest
information provided by FSIS without sort that is more accessible and likely Service Handbook 1909.15 to the CFR,
the written permission of the submitter to be used by the consumer will reduce add new procedures, and edit some
of the information or written the likelihood of food borne illnesses existing procedures. Presently, Forest
confirmation by FSIS that the and related consequences. Service procedures are combined with

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72758 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

agency guidance in FSH 1909.15 along would make it easier for the Forest USDA—FS
with quotations from the Council on Service to provide guidance through
Environmental Quality regulations. the agency directive system. General
Having agency NEPA procedures in guidance and internal processes would FINAL RULE STAGE
regulations, separate from guidance, reside in the FSH 1909.15 handbook
will make it easier for the Forest with references to both CEQ and Forest
Service to provide guidance through Service NEPA procedures set out in the 21. NATIONAL FOREST SYSTEM
the agency directive system. Agency CFR. This will make future revisions LAND MANAGEMENT PLANNING
internal processes will continue to to internal agency guidance more CATEGORICAL EXCLUSION (FINAL
reside in FSH 1909.15 with references responsive to new ideas and DIRECTIVE, FOREST SERVICE
to both CEQ and Forest Service NEPA information. Having the agency NEPA HANDBOOK 1909.15, CHAPTER 30)
procedures. procedures at the same level as the
CEQ regulations would also give them Priority:
Statement of Need:
equal status in court. Other Significant
The Forest Service is proposing to
move existing agency NEPA New procedures and revisions to Legal Authority:
procedures, required by the Council on existing procedures would further
16 USC et seq; 5 USC 301
Environmental Quality (CEQ) and define how the agency must comply
codified at 40 CFR 1507.3, from the with NEPA where the CEQ regulations CFR Citation:
internal Forest Service Environmental lack clarity, when additional CEQ 36 CFR 219, subpart A
Policy and Procedures Handbook (FSH) guidance has been issued, or when
1909.15 to the Code of Federal there are more efficient or applicable Legal Deadline:
Regulations. New procedures would be procedures appropriate to agency None
added and existing procedures would decision making. With more flexibility
be revised where clarity is needed to in how NEPA documents are prepared, Abstract:
incorporate CEQ guidance and align the NEPA process is expected to be The Forest Service requested comment
agency NEPA procedures with agency more efficient and responsive to on a proposed revision to its
decision processes. decision maker needs. procedures for implementing the
Presently, the Forest Service NEPA National Environmental Policy Act
procedures are combined with agency (NEPA) and Council on Environmental
guidance in FSH 1909.15 along with More NEPA procedural requirements Quality (CEQ) regulations. This revision
quotations from the CEQ regulations. could be added which would add to is being proposed at Forest Service
This handbook contains general the present processes. Also, given that Handbook 1909.15, chapter 30, which
guidance such as how to select an some of the proposed procedures describes categorical exclusions, that is,
interdisciplinary team, thereby would allow more flexibility and categories of actions that will not result
associating guidance with NEPA options to comply with NEPA, the in significant impacts on the human
procedures. Guidance and quotes from results could be a more complex set environment and which are therefore
the CEQ regulations are important to of regulations for the field to exempt from requirements to prepare
internal agency work, but bear little understand. further NEPA documentation absent
similarity to the agency procedures extraordinary circumstances. The
Timetable: proposal would add one such category
contemplated in the CEQ regulations
(40 CFR 1507.3(b)). Changes to agency Action Date FR Cite of actions to the agency’s NEPA
guidance in FSH 1909.15 currently NPRM 12/00/06
procedures for final approvals on
involve consultation with CEQ because proposals to develop, amend, or revise
the handbook does not differentiate Regulatory Flexibility Analysis land management plans that are
between NEPA guidance and Required: comprised of five components, which
‘‘procedures.’’ This makes it more are desired conditions, objectives,
No guidelines, suitability of areas, and
difficult to update simple guidance.
Small Entities Affected: special areas for a forest. This proposal
Summary of Legal Basis: was published in conjunction with the
The Council on Environmental Quality No final Forest Service planning
(CEQ) regulations (40 CFR 1507.3) regulations published January 5, 2005.
Government Levels Affected:
direct Federal agencies to develop Statement of Need:
NEPA procedures to supplement the None
CEQ regulations. The CEQ regulations On January 5, 2005, the Forest Service
require agencies to provide for public Agency Contact: published a final rule in the Federal
notice and comment and CEQ Register (70 FR 1023) revising Title 36,
Andria D. Weeks
consultation when developing and Code of Federal Regulations, Part 219,
Regulatory Analyst
revising agency NEPA procedures. Subpart A, ‘‘National Forest System
Department of Agriculture
Land Management Planning.’’ This final
Alternatives: Forest Service
rule substantially changed the type of
ATTN: ORMS, D&R Branch
A possible alternative would be to have decisions made in land management
1400 Independence Avenue SW
the CEQ revise its regulations or seek plans. These plans developed under
Washington, DC 20250–0003
legislative changes. this regulation are aspirational, and do
Phone: 202 205–3610
not result in significant impacts on the
Anticipated Cost and Benefits: Fax: 202 260–6539
human environment. Accordingly,
Codifying agency NEPA procedures in existing agency NEPA procedures need
regulation, separate from guidance, RIN: 0596–AC49 to be updated to allow the use of a

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72759

categorical exclusion when a land Risks: 14637) to Forest Service Manual 1330
management plan is not making The directive will help strengthen the (New Management Strategies; 1900
decisions that will result in significant Forest Service’s ability to respond (Planning; 1920 (Land and Resource
impacts on the human environment quickly and effectively to a variety of Management Planning; and 1909.12
and where no extraordinary changing issues, such as new scientific (Land and Resource Management
circumstances exist that would prohibit information, new listing of species, the Planning Handbook). These directives
the use of the categorical exclusion. effects of wildfire, and unforeseen plan provide the detailed direction to agency
implementation activities. It will help employees necessary to implement the
Summary of Legal Basis: provisions of the final land and
reduce the risk of a land management
The National Forest Management Act plan being outdated. resource management planning rule,
(NFMA) is the legal basis for National which was published on January 5,
Forest System Land Management Timetable: 2005 (70 FR 1023). On January 31, 2006
Planning. It requires ‘‘specifying Action Date FR Cite (71 FR 5124), all the chapters were
procedures to insure that land finalized except for FSH 1909.12,
NPRM 12/06/02 67 FR 72770
management plans are prepared in chapter 70-Wilderness Evaluation. Once
NPRM Comment 03/24/03 finalized, this chapter will provide
accordance with the National Period End
Environmental Policy Act [NEPA] of guidance for the identification,
Final Rule 01/05/05 70 FR 1023
1969, including, but not limited to, inventory, evaluation, and
Proposed Directive 01/05/05 70 FR 1062
direction on when and for what plans recommendation of areas within
Comment Period End 03/07/05
an environmental impact statement National Forest System lands that
Final Action 12/00/06
required under section 102(2)(C) of that satisfy the definition of wilderness
Act shall be prepared.’’ Notice of the Regulatory Flexibility Analysis found in section 2(c) of the 1964
proposed categorical exclusion and Required: Wilderness Act.
request for comment was published No Statement of Need:
January 5, 2005 (70 FR 1062).
Small Entities Affected: On January 5, 2005, the Forest Service
Alternatives: published a final rule in the Federal
The agency would continue using Register (70 FR 1023) revising Title 36,
environmental impact statements or Government Levels Affected: Code of Federal Regulations, Part 219,
environmental assessments for the None Subpart A, ‘‘National Forest System
development, amendment, or revision Land Management Planning.’’ To meet
Agency Contact: the new requirements, this directive
of land management plans.
Andria D. Weeks updates guidance for the identification,
Anticipated Cost and Benefits: Regulatory Analyst inventory, evaluation, and
A cost-benefit analysis was conducted Department of Agriculture recommendation of areas within
to compare the costs and benefits of Forest Service National Forest System lands that
implementing the final National Forest ATTN: ORMS, D&R Branch satisfy the definition of wilderness
System Land Management Planning 1400 Independence Avenue SW found in section 2(c) of the 1964
regulation to the baseline, 1982 Washington, DC 20250–0003 Wilderness Act.
planning rule. This analysis is posted Phone: 202 205–3610 Summary of Legal Basis:
at the Forest Service web site address Fax: 202 260–6539
The Wilderness Act of 1964 requires
(, Email:
identification of potential wilderness
along with other documents associated RIN: 0596–AB86 areas. The National Forest Management
with the final rule. A basic assumption
Act of 1976 requires ‘‘specifying
of the cost-benefit analysis is that the
USDA—FS guidelines for land management plans
planning rule would be carried out
developed to achieve the goals of the
using the planning categorical 22. ∑ NATIONAL FOREST SYSTEM Program which — (A) insure
exclusion. LAND MANAGEMENT PLANNING consideration of the economic and
Based on costs that can be quantified, DIRECTIVE (FINAL DIRECTIVE, environmental aspects of various
implementation of the final rule is FOREST SERVICE HANDBOOK systems of renewable resource
expected to have an estimated annual 1909.12, CHAPTER 70–WILDERNESS management, including the related
average cost savings of $4.6 million EVALUATION) systems of silviculture and protection
when compared to the 1982 planning of forest resources, to provide for
rule, and an estimated annual average Priority:
outdoor recreation (including
savings of $36.9 million when Other Significant wilderness), range, timber, watershed,
compared to estimates of Legal Authority: wildlife, and fish;....’’
implementation of the 2000 planning The National Forest System Land
rule. The final rule is expected to be 36 CFR 219
Management Planning regulation
less costly than the 2000 planning rule; CFR Citation: requires the development of planning
some of those saved costs are expected directives to set forth the legal
to be shifted to monitoring and None
authorities, objectives, policy,
evaluation. Legal Deadline: responsibilities, direction, and overall
The appropriate use of a categorical None guidance needed by Forest Service line
exclusion to meet NEPA requirements officers, agency employees, and others
will be a substantial savings over the Abstract: to use the rule. Notice of issuance of
cost of an environmental impact On March 23, 2005, the Forest Service the interim directive for Chapter 70 —
statement or environmental assessment. published 12 interim directives (70 FR Wilderness Evaluation and a request for

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72760 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

comment was published March 23, Based on costs that can be quantified, Timetable:
2005 (70 FR 14637) along with 11 other implementation of the final rule is Action Date FR Cite
interim directives. expected to have an estimated annual
average cost savings of $4.6 million Interim Final Directive 03/23/05 70 FR 14637
Alternatives: when compared to the 1982 planning Comment Period End 06/21/05
rule, and an estimated annual average Final Action 12/00/06
As an alternative to publishing the final savings of $36.9 million when
directive, the agency will use the Regulatory Flexibility Analysis
compared to estimates of Required:
interim directive until it expires on implementation of the 2000 planning
September 23, 2006. The interim rule. The final rule is expected to be No
directive could be extended for an less costly than the 2000 planning rule;
additional 18 months beyond Small Entities Affected:
some of those saved costs are expected
September 23, 2006. If the interim to be shifted to monitoring and No
directive is not issued in final, before evaluation.
expiration, the agency would operate Government Levels Affected:
under the previous outdated directive. Risks: None

Anticipated Cost and Benefits: The interim directive expires on March Agency Contact:
7, 2008. If it is not finalized, the Andria D. Weeks
A cost-benefit analysis was conducted directive will not be coordinated with Regulatory Analyst
to compare the costs and benefits of conceptual and terminology changes Department of Agriculture
implementing the final National Forest made in the other 11 planning Forest Service
System Land Management Planning directives for implementation of the ATTN: ORMS, D&R Branch
regulation to the baseline, 1982 2005 National Forest System Land 1400 Independence Avenue SW
planning rule. This analysis is posted Management Planning regulation. This Washington, DC 20250–0003
on the Forest Service web site address lack of coordination would cause Phone: 202 205–3610
(, public and employee confusion, Fax: 202 260–6539
along with other documents associated delaying the agency’s ability to respond Email:
with the final rule. A basic assumption quickly and effectively to land
of the cost-benefit analysis is that the management plan revision, changing Related RIN: Related to 0596–AC02
planning rule would be carried out issues, or unforeseen plan RIN: 0596–AC57
using updated directives. implementation activities. BILLING CODE 3410–90–S

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72761

DEPARTMENT OF COMMERCE (DOC) supporting the American people, now As the Nation looks to revitalize its
and in the future. We confront the industries and communities, the DOC
Statement of Regulatory and intersection of trade promotion, civilian works as a partner with private entities
Deregulatory Priorities technology, economic development, to build America with an eye on the
Enhancing long-term economic sustainable development, and economic future. Through technology, research
growth is a central focus of the analysis, and we want to provide and development, and innovation, we
President’s policies and priorities. The leadership in these areas for the Nation. are making sure America continues to
mission of the Department of Commerce We work to provide programs and prosper in the short-term, while also
is to promote job creation, economic services that serve our country’s helping industries prepare for long-term
growth, technological competitiveness, businesses, communities, and families, success.
sustainable development, and improved as initiated and supported by the The DOC’s considerable information
living standards for all Americans by President and the Congress. We are capacities help businesses understand
working in partnership with businesses, dedicated to making these programs and clearly where our national and world
universities, communities, and workers services as effective as possible, while economies are going and take advantage
to: ensuring that they are being delivered in of that knowledge by planning the road
• Build for the future and promote U.S. the most cost-effective ways. We seek to ahead. Armed with the Department’s
economic competitiveness in the function in close concert with other economic and demographic statistics,
global marketplace by strengthening agencies having complementary businesses can undertake the new
and safeguarding the Nation’s responsibilities so that our collective ventures, investments, and expansions
economic infrastructure; impact can be most powerful. We seek that make our economy grow.
to meet the needs of our customers
• Keep America competitive with quickly and efficiently, with programs, The DOC has instituted programs and
cutting-edge science and technology information, and services they require policies that lead to cutting-edge,
and an unrivaled information base; and deserve. competitive, and better paying jobs. We
and work every day to boost exports, to
As a permanent part of the Federal deregulate business, to help smaller
• Provide effective management and Government, but serving an manufacturers battle foreign
stewardship of our nation’s resources Administration and Congress that can competition, to advance the
and assets to ensure sustainable vary with election results, we seek to technologies critical to our future
economic opportunities. serve the unchanging needs of the prosperity, to invest in our
The DOC mission statement, Nation, according to the priorities of the communities, and to fuse economic and
containing our three strategic themes, President and the Congress. The environmental goals.
provides the vehicle for understanding President’s priorities for the Department
range from issues concerning the The DOC is American business’ surest
the Department’s aims, how they ally in job creation, serving as a vital
interlock, and how they are to be economy to the environment. For
example, the President directs the resource base, a tireless advocate, and
implemented through our programs. its Cabinet-level voice.
This statement was developed with the Department to promote electronic
intent that it serve as both a statement commerce activities; encourage open The Regulatory Plan directly tracks
of departmental philosophy and as the and free trade; represent American these policy and program priorities,
guiding force behind the Department’s business interests abroad; and assist only a few of which involve regulation
programs. small businesses to expand and create of the private sector by the Department.
jobs. We are able to address these
The importance that this mission priorities effectively by functioning in Responding to the Administration’s
statement and these strategic themes accordance with the legislation that Regulatory Philosophy and Principles
have for the Nation is amplified by the undergirds our programs and by The vast majority of the Department’s
vision they pursue for America’s working closely with the President and programs and activities do not involve
communities, businesses, and families. the committees in Congress, which have regulation. Of the Department’s 12
Commerce is the smallest Cabinet programmatic and financial oversight primary operating units, only the
agency, yet our presence is felt, and our for our programs. National Oceanic and Atmospheric
contributions are found, in every State. Administration (NOAA) and the
The DOC also promotes and expedites
The DOC touches Americans, daily, in American exports, helps nurture National Telecommunications and
many ways—we make possible the business contacts abroad, protects U.S. Information Administration (NTIA) plan
weather reports that all of us hear every firms from unfair foreign competition, actions that are considered the ‘‘most
morning; we facilitate the technology and makes how-to-export information important’’ significant preregulatory or
that all of us use in the workplace and accessible to small and mid-sized regulatory action for this Regulatory
in the home each day; we support the companies throughout the Nation, Plan year. During the next year, NOAA
development, gathering, and thereby ensuring that U.S. market plans to complete one action entitled
transmitting of information essential to opportunities span the globe. ‘‘Endangered Fish and Wildlife;
competitive business; we make possible The DOC encourages development in Implement Speed Restrictions to Reduce
the diversity of companies and goods every community, clearing the way for the Threat of Ship Collisions with North
found in America’s (and the world’s) private-sector growth by building and Atlantic Right Whales,’’ and NTIA plans
marketplace; and we support rebuilding economically deprived and to complete one action entitled
environmental and economic health for distressed communities. We promote ‘‘Implement and Administer a Coupon
the communities in which Americans minority entrepreneurship to establish Program for Digital-to-Analog Converter
live. businesses that frequently anchor Boxes. ’’ Further information on these
The DOC has a clear and powerful neighborhoods and create new job actions are provided below.
vision for itself, for its role in the opportunities. We work with the private Though not principally a regulatory
Federal Government, and for its roles sector to enhance competitive assets. agency, the DOC has long been a leader

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72762 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

in advocating and using market-oriented Recognizing that economic growth In the environmental stewardship
regulatory approaches in lieu of must go hand-in-hand with area, NOAA’s goals include: rebuilding
traditional command-and-control environmental stewardship, the U.S. fisheries by refocusing policies and
regulations when such approaches offer Department, through NOAA, conducts fishery management planning on
a better alternative. All regulations are programs designed to provide a better increased scientific information;
designed and implemented to maximize understanding of the connections increasing the populations of depleted,
societal benefits while placing the between environmental health, threatened, or endangered species of
smallest possible burden on those being economics, and national security. marine mammals by implementing
regulated. Commerce’s emphasis on ‘‘sustainable recovery plans that provide for their
fisheries’’ is saving fisheries and recovery while still allowing for
The DOC is also refocusing on its confronting short-term economic economic and recreational
regulatory mission by taking into dislocation, while boosting long-term opportunities; promoting healthy
account, among other things, the economic growth. The Department is coastal ecosystems by ensuring that
President’s regulatory principles. To the where business and environmental economic development is managed in
extent permitted by law, all interests intersect, and the classic ways that maintain biodiversity and
preregulatory and regulatory activities debate on the use of natural resources is long-term productivity for sustained
and decisions adhere to the transformed into a ‘‘win-win’’ situation use; and modernizing navigation and
Administration’s statement of regulatory for the environment and the economy. positioning services. In the
philosophy and principles, as set forth environmental assessment and
in section 1 of Executive Order 12866. Three of NOAA’s major components, prediction area, goals include:
Moreover, we have made bold and the National Marine Fisheries Services modernizing the National Weather
dramatic changes, never being satisfied (NMFS), the National Ocean Service Service; implementing reliable seasonal
with the status quo. We have (NOS), and the National Environmental and interannual climate forecasts to
emphasized, initiated, and expanded Satellite, Data, and Information Service guide economic planning; providing
programs that work in partnership with (NESDIS), exercise regulatory authority. science-based policy advice on options
the American people to secure the to deal with very long-term (decadal to
NMFS oversees the management and
Nation’s economic future. At the same centennial) changes in the environment;
conservation of the Nation’s marine
time we have downsized, cut and advancing and improving short-
fisheries, protects marine mammals, and
regulations, closed offices, and term warning and forecast services for
promotes economic development of the
eliminated programs and jobs that are the entire environment.
U.S. fishing industry. NOS assists the
not part of our core mission. The bottom
coastal states in their management of Magnuson-Stevens Act Rulemakings
line is that, after much thought and
land and ocean resources in their Magnuson-Stevens Fishery
debate, we have made many hard
coastal zones, including estuarine Conservation and Management Act
choices needed to make this Department
research reserves; manages the Nation’s (Magnuson-Stevens Act) rulemakings
‘‘state of the art.’’
national marine sanctuaries; monitors concern the conservation and
The Department has a long-standing marine pollution; and directs the management of fishery resources in the
policy to prohibit the issuance of any national program for deep-seabed U.S. 3-to-200-mile Exclusive Economic
regulation that discriminates on the minerals and ocean thermal energy. Zone (EEZ). Among the several hundred
basis of race, religion, gender, or any NESDIS administers the civilian rulemakings that NOAA plans to issue
other suspect category and requires that weather satellite program and licenses in the Regulatory Plan year, a number of
all regulations be written so as to be private organizations to operate the preregulatory and regulatory actions
understandable to those affected by commercial land-remote sensing will be significant. The exact number of
them. The Secretary also requires that satellite systems. such rulemakings is unknown, since
the Department afford the public the The Administration is committed to they are usually initiated by the actions
maximum possible opportunity to an environmental strategy that promotes of eight regional Fishery Management
participate in departmental sustainable economic development and Councils (FMCs) that are responsible for
rulemakings, even where public rejects the false choice between preparing fishery management plans
participation is not required by law. environmental goals and economic (FMPs) and FMP amendments, and for
growth. The intent is to have the drafting implementing regulations for
National Oceanic and Atmospheric each managed fishery. Once a
Administration Government’s economic decisions
guided by a comprehensive rulemaking is triggered by an FMC, the
The National Oceanic and understanding of the environment. The Magnuson-Stevens Act places stringent
Atmospheric Administration (NOAA) Department, through NOAA, has a deadlines upon NMFS by which it must
establishes and administers Federal unique role in promoting stewardship of exercise its rulemaking responsibilities.
policy for the conservation and the global environment through While most of these rulemakings will
management of the Nation’s oceanic, effective management of the Nation’s be minor, involving only the opening or
coastal, and atmospheric resources. It marine and coastal resources and in closing of a fishery under an existing
provides a variety of essential monitoring and predicting changes in FMP, one action is of particular
environmental services vital to public the Earth’s environment, thus linking significance and has been designated as
safety and to the Nation ’s economy, trade, development, and technology one of the most important regulatory
such as weather forecasts and storm with environmental issues. NOAA has actions undertaken by the Department.
warnings. It is a source of objective the primary Federal responsibility for This rule is entitled ‘‘Endangered Fish
information on the state of the providing sound scientific observations, and Wildlife; Implement Speed
environment. NOAA plays the lead role assessments, and forecasts of Restrictions to Reduce the Threat of
in achieving the departmental goal of environmental phenomena on which Ship Collisions with North Atlantic
promoting stewardship by providing resource management and other societal Right Whales.’’ In this rulemaking,
assessments of the global environment. decisions can be made. NOAA plans to implement a strategy to

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72763

reduce the known mortalities to North documentation, is submitted to NMFS Cold War has been a major
Atlantic right whales as a result of for review against the national standards accomplishment of BIS.
collisions with vessels, which account set forth in the Magnuson-Stevens Act, BIS is also responsible for:
for more confirmed right whale deaths in other provisions of the Act, and other
than any other human-related activity. applicable laws. The same process • Enforcing the export control and
The strategy addresses the lack of applies to amending an existing antiboycott provisions of the Export
recovery of the endangered North approved FMP. Administration Act (EAA), as well as
Atlantic right whale by reducing the other statutes such as the Fastener
The Magnuson-Stevens Act contains Quality Act. The EAA is enforced
likelihood and threat of ship strike ten national standards against which
mortalities to the species. NOAA has through a variety of administrative,
fishery management measures are civil, and criminal sanctions.
developed a framework of proposed, judged. NMFS has supplemented the
new operational measures for the standards with guidelines interpreting • Analyzing and protecting the defense
shipping industry as an element of this each standard, and has updated and industrial and technology base,
strategy, including consideration of added to those guidelines. One of the pursuant to the Defense Production
routing and speed restrictions. These national standards requires that Act and other laws. As the Defense
operational measures would be limited management measures, where Department increases its reliance on
to areas and times when North Atlantic practicable, minimize costs and avoid dual-use high technology goods as
right whales and ships overlap to reduce unnecessary duplication. Under the part of its cost-cutting efforts,
the likelihood of ship strikes to the guidelines, NMFS will not approve ensuring that we remain competitive
extent practicable. management measures submitted by an in those sectors and subsectors is
The Magnuson-Stevens Act, which is FMC unless the fishery is in need of critical to our national security.
the primary legal authority for Federal management. Together, the standards • Helping Ukraine, Kazakstan, Belarus,
regulation to conserve and manage and the guidelines correspond to many Russia, and other newly emerging
fishery resources, establishes eight of the Administration’s principles of countries develop effective export
regional FMCs, responsible for regulation as set forth in section 1(b) of control systems. The effectiveness of
preparing FMPs and FMP amendments. Executive Order 12866. One of the U.S. export controls can be severely
NMFS issues regulations to implement national standards establishes a undercut if ‘‘rogue states’’ or terrorists
FMPs and FMP amendments. FMPs qualitative equivalent to the Executive gain access to sensitive goods and
address a variety of fishery matters, Order’s ‘‘net benefits’’ requirement—one technology from other supplier
including depressed stocks, overfished of the focuses of the Administration’s countries.
stocks, gear conflicts, and foreign statement of regulatory philosophy as
stated in section 1(a) of the Executive • Working with former defense plants
fishing. One of the problems that FMPs in the Newly Independent States to
may address is preventing Order.
help make a successful transition to
overcapitalization (preventing excess Bureau of Industry and Security profitable and peaceful civilian
fishing capacity) of fisheries. This may endeavors. This involves helping
The Bureau of Industry and Security
be resolved by limiting access to those remove unnecessary obstacles to trade
(BIS) promotes U.S. national and
dependent on the fishery in the past and investment and identifying
economic security and foreign policy
and/or by allocating the resource opportunities for joint ventures with
interests by managing and enforcing the
through individual transferable quotas, U.S. companies.
Department’s security-related trade and
which can be sold on the open market
competitiveness programs. BIS plays a • Assisting U.S. defense enterprises to
to other participants or those wishing
key role in challenging issues involving meet the challenge of the reduction in
access. Quotas set on sound scientific
national security and nonproliferation, defense spending by converting to
information, whether as a total fishing
export growth, and high technology. civilian production and by developing
limit for a species in a fishery or as a
The Bureau’s continuing major export markets. This work assists in
share assigned to each vessel
challenge is combating the proliferation maintaining our defense industrial
participant, enable stressed stocks to
of weapons of mass destruction while base as well as preserving jobs for
rebuild. Other measures include
furthering the growth of U.S. exports, U.S. workers.
staggering fishing seasons or limiting
which are critical to maintaining our
gear types to avoid gear conflicts on the National Telecommunications and
leadership in an increasingly
fishing grounds, and establishing Information Administration
competitive global economy. BIS strives
seasonal and area closures to protect The National Telecommunications
to be the leading innovator in
fishery stocks. and Information Administration (NTIA)
transforming U.S. strategic trade policy
The FMCs provide a forum for public and programs to adapt to the changing is the President’s principal adviser on
debate and, using the best scientific world. telecommunications and information
information available, make the policy issues. The advent of the
judgments needed to determine Major Programs and Activities telecommunications and information
optimum yield on a fishery-by-fishery The Export Administration revolution is bringing dramatic growth
basis. Optional management measures Regulations (EAR) provide for export and change to the Nation’s economic,
are examined and selected in controls on dual-use goods and social, and political life, and as a result,
accordance with the national standards technology (primarily commercial goods NTIA’s fundamental mission is to
set forth in the Magnuson-Stevens Act. that have potential military promote market-based policies which
This process, including the selection of applications) not only to fight lower prices to consumers and
the preferred management measures, proliferation, but also to pursue other encourage innovation, while harnessing
constitutes the development, in national security, short supply, and the resources of the Federal Government
simplified form, of an FMP. The FMP, foreign policy goals (such as combating to support spectrum-based technologies
together with draft implementing terrorism). Simplifying and updating which enhance efficiency and
regulations and supporting these controls in light of the end of the productivity.

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72764 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Major Programs and Activities DOC—National Oceanic and are part of NMFS’ Ship Strike
Atmospheric Administration (NOAA) Reduction Strategy to help recover the
NTIA’s main role is to provide advice North Atlantic right whale.
to the President on telecommunications
and information policy issues. In this Summary of Legal Basis:
role, NTIA frequently works with other NOAA is proposing these regulations
Executive Branch agencies to develop pursuant to its rulemaking authority
and present the Administration’s 23. RIGHT WHALE SHIP STRIKE under Marine Mammal Protection Act
position on these issues. In addition to REDUCTION (MMPA) section 112(a) (16 U.S.C.
representing the Executive Branch in 1382(a)), and Endangered Species Act
both domestic and international Priority: (ESA) section 11(f) (16 U.S.C. 1540(f)).
telecommunications and information Economically Significant. Major under These proposed regulations also are
policy activities, NTIA also: 5 USC 801. consistent with the purpose of the ESA
‘‘to provide a program for the
• Manages the Federal use of spectrum; Legal Authority: conservation of [. . .] endangered
• Performs cutting-edge 16 USC 1361 species’’ and ‘‘the policy of Congress
telecommunications research and that all Federal departments and
CFR Citation: agencies shall seek to conserve
engineering, including resolving
50 CFR 224 endangered species [. . .] and shall
technical telecommunications issues
utilize their authorities in furtherance
for the Federal Government and Legal Deadline: of the purposes of [the ESA].’’ 16 U.S.C.
private sector; and 1531(b),(c).
• Administers infrastructure and public
Abstract: Alternatives:
telecommunications facilities grants.
These regulations would implement a NMFS identified five alternatives to the
During the next year, NTIA will be strategy to reduce the known action being proposed. Alternative 1 is
completing one action that rises to the mortalities to North Atlantic right No Action (Status Quo) in which NMFS
level of ‘‘most important’’ significant whales as a result of collisions with would continue to implement existing
preregulatory or regulatory action. This vessels, which account for more measures and programs, largely non-
rule is entitled ‘‘Implement and confirmed right whale deaths than any regulatory, to reduce the likelihood of
Administer a Coupon Program for other human-related activity. The mortality from ship strikes. Alternative
Digital-to-Analog Converter Boxes.’’ In strategy addresses the lack of recovery 2 includes all elements of Alternative
this action, NTIA would implement a of the endangered North Atlantic right 1 and involves use of Dynamically
digital-to-analog converter box coupon whale by reducing the likelihood and Managed Areas (DMA), which consists
program pursuant to section 3005 of the threat of ship strike mortalities to the of certain vessel speed restrictions
Deficit Reduction Act of 2005 (the species. The National Marine Fisheries applying only when and where right
‘‘Act’’). The Act, among other things, Service (NMFS) has developed a whale sightings occur. Alternative 3 is
framework of proposed, new vessel speed restrictions in designated
requires the Federal Communications
operational measures for the shipping areas. It includes all elements of
Commission (FCC) to require full-power
industry as an element of this strategy, Alternative 1 and implements large-
television stations to cease analog
including consideration of routing and scale speed restrictions throughout the
broadcasting by February 18, 2009. range of North Atlantic right whales.
Recognizing that consumers may wish speed restrictions. These operational
measures would be limited to areas and Alternative 4 is the use of designated
to continue receiving broadcast shipping routes. It includes all the
times when North Atlantic right whales
programming over the air using analog- elements of Alternative 1 and relies on
and ships overlap to reduce the
only televisions not connected to cable altering some current vessel patterns to
likelihood of ship strikes to the extent
or satellite service, the Act authorizes move vessels away from areas where
NTIA to create an assistance program to whales are known to congregate.
provide $40 coupons to consumers for Statement of Need: Alternative 5 is a combination that
use toward the purchase of digital-to- The National Oceanic and Atmospheric includes all elements of Alternatives 1
analog converter boxes. Through this Administration (NOAA) proposes to 4. Alternative 6 (the preferred
coupon program, NTIA will facilitate regulations to implement speed alternative and the approach that is the
public access to full-power broadcasting restrictions on vessels 65 ft (19.8m) or subject of the proposed rule) includes
program over the air using analog-only greater in overall length in certain a combination of operational measures
television sets. Without converter boxes, locations and at certain times of the (routing measures and speed
consumers with analog-only television year along the East Coast of the United restrictions). The principal difference
sets will be unable to view full-power States. These regulations are needed as between Alternatives 5 and 6 is that
television broadcasts unless they current efforts to reduce occurrence of Alternative 6 does not include large-
purchase digital television sets or North Atlantic right whale deaths and scale speed restrictions (as identified in
subscribe to cable or satellite service. serious injury from ship strikes have Alternative 3) but instead relies on
not been sufficient to alter the speed restrictions in much smaller
trajectory of this species toward Seasonally Managed Areas.
extinction. The purpose of these Anticipated Cost and Benefits:
proposed regulatory measures is to
reduce the likelihood of deaths and Benefits
serious injuries to endangered North The benefits of reducing the risk of
Atlantic right whales that result from right whale mortality caused by ship
collisions with ships. These measures strikes are expected to be considerable.

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Because ship strikes appear to be the in place. Assuming half of these calls The combined impacts to the high-
leading anthropogenic cause of right were in the southbound direction and speed and regular-speed passenger
whale mortalities, adopting measures to that the typical vessel made calls at ferries bring the total estimated
reduce the incidences of ship strikes three U.S. East Coast ports per service, economic impacts to $5.6 million.
will aid in the recovery of this highly there would be about 615 southbound Whale watching vessels:
endangered species. However, monetary vessels that are likely to route outside
estimates of these benefits are currently of the seasonal speed restricted areas Under the proposed action, speed
unavailable; therefore, the discussion of rather than proceed through the restrictions for Cape Cod Bay are
these benefits specific to right whales restricted areas at a lower speed. Based implemented from January 1 through
is descriptive. The full range of values on an increase in routing of 80 nautical May 15. Hence, the peak summer whale
of right whale recovery includes use miles and an average operating speed watching season would not be affected
values and nonuse values. Use values of 20 knots, the containership would for high-speed or regular speed vessels.
include those values associated with have increased sailing time of 4 hours. Similarly, the speed restrictions for the
whale watching trips, or other viewing Using an average hourly operating cost Off Race Point area are proposed for
opportunities. Nonuse values include at sea of $1,000, the estimated March through April would not impact
those values placed on knowing that economic impact for each southbound the whale watching season.
right whales remain for future vessel would be $4,000. For 2003 and Accordingly, the economic impact due
generations (bequest value) and values 2004, the additional economic impact to DMAs under the proposed action is
placed on knowing that right whales for containerships for coastwise an estimated $0.9 million.
will continue to survive (existence shipping under Alternative 6 was Indirect Economic Impacts of Port
value). The proposed action would be estimated at $2.5 million. Diversions
highly beneficial to the recovery of the Commercial fishing vessels: Under the proposed action, speed
right whale population as it also is Using 2003 data, the estimated impact restrictions for both Off Race Point area
designed to address the various ship at 10 knots on commercial fishing and the Great South Channel in the
strike scenarios that might occur. vessels due to the proposed action is Northeast are in effect during the
Estimated Direct Economic Impact estimated to be $686,000 for the month of April causing many ships to
Shipping Industry: Northeast Region and $348,000 for the route around this large area during that
Southeast Region. The combined time. The diversion is assumed at 10
Direct annual economic impact to Northeast and Southeast regional percent for containerships and ro-ro
commercial shipping is estimated at economic impact of slightly more than cargo ships during the restricted period.
$49.4 million at the 10 knot speed $1 million is approximately two-tenths For port areas in Block Island Sound,
restriction. The following port areas of one percent of the U.S. East Coast two percent of containerships and ro-
may expect the greatest impact: New commercial fishery landings of $628.2 ro cargo ships are assumed to divert
York/New Jersey ($11.2 million), million in 2003. to other port areas to avoid speed
Hampton Roads, VA ($7.5 million), restricted areas. For the affected Mid-
Savannah, GA ($5.3 million) and Charter fishing vessels:
Atlantic ports, 0.5 percent of restricted
Charleston, SC ($5.2 million). It is estimated that annual economic
period containership and ro-ro cargo
impact of a speed restriction of 10
Multi-port calls: ship vessel calls are assumed to divert
knots for these vessels over 30 nautical
The speed restriction component of the to other port areas.
miles for the proposed action would be
proposed action leads to additional approximately $1.2 million. This Additional diversions away from the
impacts to vessels coming into at least calculation assumes 40 headboat port area of Providence may also occur
two restricted ports. The 2004 vessel vessels with 60 roundtrips per year and under the proposed action. This port
arrival database indicates that the total an hourly steaming operating cost of area has speed restrictions in effect for
number of multi-port string restricted $200. 181 days as compared to 61 days for
arrivals to be 5,147. The additional the port area of Boston. Therefore, 15
Passenger ferries:
direct economic impact of multi-port percent of the containership and ro-ro
strings on the shipping industry due to Under the proposed action, speed cargo ship restricted period calls at
the 10 knot speed restriction in 2004 restrictions for Cape Cod Bay are Providence are assumed to divert to the
is estimated at $5.8 million. implemented from January 1 through nearby port area of Boston.
May 15. As such, the fast ferry service
Rerouting of Southbound Coastwise from Boston to Provincetown would NMFS anticipates that the use of
Shipping: remain in operation. Speed restrictions recommended routes into the
The proposed speed restrictions in the for Block Island Sound would be from Southeastern Region ports of Brunswick
Mid-Atlantic region would be November 1 through April 30. and Fernandina are likely to result in
implemented for a 30 nautical mile However, the speed restricted area for a diversion of two percent of
buffer zone radiating out from each port Block Island Sound under the proposed containerships and ro-ro cargo ships
area. Hence, the additional distance action would not extend to the from these ports to Savannah. As a
incurred by southbound vessels would shoreline and hence would not impact result of these diversions, NMFS
be 80 nautical miles (20 nautical miles fast ferry operations. DMAs would also anticipates additional delays relative to
per arrival and departure at be implemented under the proposed Savannah. Finally, 30 percent of the
intermediate port calls). The 2003 action. The estimated economic impact restricted period cruise vessel calls at
vessel traffic database indicated that for fast ferry service under the Jacksonville are assumed to divert to
3,688 containerships and ro-ro cargo proposed action due to the presence of Port Canaveral as that port is not
ships would have traveled through DMAs is $2.6 million. For regular affected by speed restrictions or the use
speed restricted U.S. East Coast port ferries, the economic impact due to the of recommended routes.
areas ranging from Baltimore through proposed action is estimated to be $3.0 The indirect economic impact of port
Port Canaveral had the restrictions been million for 10 knots speed restrictions. diversions is estimated to be $49.7

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72766 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

million for the 10 knot speed Public Compliance Cost: using analog-only televisions not
restriction. The largest negative indirect Initial Cost: $0 connected to cable or satellite service,
impacts are generated in the port areas Yearly Recurring Cost: $116,000,000 the Act authorizes NTIA to create an
of New York/New Jersey ($21.2 Base Year for Dollar Estimates: 2005 assistance program to provide $40
million), Jacksonville, FL ($15.5 coupons to consumers for use toward
million) and Hampton Roads, VA URL For More Information: the purchase of digital-to-analog
($12.4 million). The following port converter boxes. Without converter
areas are expected to experience a boxes, consumers with analog-only
positive indirect economic impact: Port Agency Contact: television sets will be unable to view
Canaveral, FL ($2.2 million) and James H. Lecky full-power television broadcasts unless
Savannah, GA ($1.7 million). Director, Office of Protected Resources they purchase digital television sets or
Risks: Department of Commerce subscribe to cable or satellite service.
National Oceanic and Atmospheric Statement of Need:
The risk associated with not pursuing
the proposed rulemaking is allowing This action is necessary to provide
the continued decline in the population 1315 East–West Highway
Silver Spring, MD 20910 guidance for the digital-to-analog
of North Atlantic right whales. The converter box coupon program.
North Atlantic right whale is in danger Phone: 301 713–2332
Converter boxes are necessary for
of extinction: some estimates have it on consumers who wish to continue
Peter Robbins
a trajectory of going extinct within 200 receiving full-power broadcast
Attorney Advisor
years if serious injury and death from programming over the air using analog-
Department of Commerce
certain human activities is not abated. only television sets after February 18,
14th & Constitution Ave. NW.
NMFS conducts consultations under 2009—the date that the law requires
Washington, DC 20230
Section 7 of the Endangered Species full-power television stations to cease
Phone: 202 482–0846
Act (ESA) with other agencies with analog broadcasting. With respect to
regard to activities undertaken or consumers, this action provides
permitted by those agencies that may RIN: 0648–AS36 eligibility requirements, application
adversely affect North Atlantic right procedures, and guidance on the use,
whales. NMFS routinely concludes that DOC—National Telecommunications value, and restrictions of the coupons.
those activities, and the cumulative and Information Administration (NTIA) This action also provides specifications
effect of other pressures on the on eligible converter boxes that will
population, will jeopardize the assist manufacturers in developing
continued existence of the species in converter boxes. Finally, this action
all or part of its range. The proposed provides guidance and sets for the
regulations are expected to reduce or rights and responsibilities of retailers.
eliminate the threat of right whale
deaths from collisions with ships, and, 24. ∑ IMPLEMENT AND ADMINISTER A Summary of Legal Basis:
as a result, provide relief from a key COUPON PROGRAM FOR
Section 3005 of the Deficit Reduction
threat to the species. NMFS is required DIGITAL–TO–ANALOG CONVERTER
Act of 2005 directs NTIA to implement
under the ESA to take steps to recover BOXES
and administer a program through
the species. By failing to take adequate Priority: which eligible U.S. households may
steps, including those identified in the obtain a maximum of two coupons of
Economically Significant. Major under
rulemaking, NMFS would fail to meet $40 each to be applied toward the
5 USC 801.
its legal requirements under the ESA. purchase of a digital-to-analog
Timetable: Legal Authority: converter box. See title III of the Deficit
PL 109–171 Reduction Act of 2005, Pub. L. 109-171,
Action Date FR Cite
120 Stat. 4, 21 (Feb. 8, 2006).
ANPRM 06/01/04 69 FR 30857 CFR Citation:
ANPRM Comment 07/09/04 69 FR 41446 Alternatives:
47 CFR 301
Period Extended NTIA considered various ways to
ANPRM Comment 09/13/04 69 FR 55135 Legal Deadline: implement the program. NTIA
Period Extended None proposed that eligible households will
NPRM 06/26/06 71 FR 36299 be only those that receive over-the-air
NPRM Comment 08/25/06 Abstract: broadcasts, and that coupons will be
Period End Pursuant to the Digital Television distributed on a first-come, first-served
Comment Period 08/14/06 71 FR 46440 Transition and Public Safety Act of basis. An alternative for which the
2005 (the Act), the National agency sought public comment through
Comment Period End 10/05/06
Telecommunications and Information the proposed rule was whether other
Final Action 12/00/06
Administration (NTIA) proposes to eligibility factors, such as a means test,
Regulatory Flexibility Analysis implement a digital-to-analog converter should be used. NTIA also considered
Required: box coupon program. The Act, among various formats for the actual coupon.
No other things, requires the Federal In its proposed rule NTIA proposed a
Communications Commission (FCC) to paper coupon but requested comment
Small Entities Affected: require full-power television stations to on an electronic coupon card. NTIA
Businesses cease analog broadcasting by February proposed options for addressing the
18, 2009. Recognizing that consumers expiration requirement. In its proposed
Government Levels Affected: may wish to continue receiving rule, NTIA proposed that the expiration
Federal broadcast programming over the air date will be three months after the

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coupon’s issuance date, which would converter box that is certified, and manufacturers to build the converter
be the date upon which the coupon is consumer knowledge. boxes. The Act states that consumers
placed in the U.S. mail. NTIA also This program, if implemented, would must be able to apply for coupons
requested comment on an alternative to also require retailers to have systems between January 1, 2008, and March
the definition of the issuance date, in place that can be easily audited as 31, 2009. The agency has been
which would be the date upon which well as systems that have the ability informed that the specifications for the
a consumer receives a coupon. Finally, to prevent fraud and abuse in the converter box, as directed in the final
NTIA proposed to require coupon program. We assume that most rule, must be available at least one year
manufacturers to self-certify that the businesses would have systems in place in advance. To the extent that the final
converter boxes meet the standards that can be easily audited, and rule is not issued by January 2007,
outlined in the proposed rule. therefore, we do not anticipate that converter boxes may not be available
However, it requested comment on businesses will have to assume a cost when the statutory application period
whether there are existing industry or to purchase a new system for the begins.
government organizations engaged in coupon program. Retailers must also
activities that can help speed the Timetable:
have systems in place that have the
development of testing/certification ability to prevent fraud and abuse in Action Date FR Cite
processes within the allowed time the coupon program. We assume that NPRM 07/25/06 71 FR 42067
frame of this program. most retailers are familiar with and Final Action 01/00/07
Anticipated Cost and Benefits: accept coupons for merchandise, and
that they have in place systems to Regulatory Flexibility Analysis
The Act authorizes $1.5 billion to
prevent fraud. The nature of this Required:
operate the coupon program. The Act,
coupon program, however, may require
however, is part of the Deficit Yes
participating retailers to assume
Reduction Act of 2005 which the
additional costs associated with Small Entities Affected:
Congressional Budget Office predicts
preventing fraud. These costs cannot be
will reduce direct spending by about
estimated at this point in the Businesses
$39 billion over the 2006 to 2010
rulemaking process. There may be costs
period and by about $99 billion over Government Levels Affected:
associated in complying with an audit.
the 2006 to 2015 period. The direct
These costs would most likely be None
costs to eligible households as a result
calculated in terms of employee hourly
of this rule is certainly less than if the
rates. The associated costs depend on Additional Information:
coupon program was not instituted.
the nature and extent of an audit.
Estimates of the cost of the converter This action would establish the
box range between $50 and $70. Using There are also costs associated with eligibility criteria, application process,
the $40 coupon, consumers can then handling coupons, that is, accepting the coupon value and use restrictions, and
expect to pay between $10 and $30 for coupons, submitting the coupons for manufacturer and retailer certification
each converter box purchased. Without redemption, and retaining hard copies process. To implement this program,
the coupons, consumers would have to of the coupons. Again, these associated the Act authorizes NTIA to use up to
pay the full retail price of the converter costs depend on a number of factors $990 million to fund the program,
box, or purchase a digital television. such as the particular systems that including $100 million for program
This program, if implemented, imposes retailers currently have in place, as administration. NTIA is also authorized
certain requirements if retailers and well as which of these costs can be to expend up to $1.5 billion for the
manufacturers decide to participate in absorbed within existing procedures program, including $160 million for
the coupon program. Besides the time that the retailer has in place. administration, upon a 60-day notice
that it takes to submit a certification Although there may be costs associated and certification to the Committee on
form to NTIA, there will be actual costs with accepting the coupons and selling Energy and Commerce of the House of
associated with meeting compliance the converter boxes, the coupon Representatives and the Committee on
requirements. These costs, however, are program does not restrict the retailer Commerce, Science, and Transportation
difficult to quantify because of many in pricing the converter box. of the Senate that the $990 million is
varying factors. However, NTIA Manufacturers and retailers may insufficient to fulfill coupon requests
anticipates that the costs would be consider these associated costs and for eligible U.S. households.
minimal because retailers and establish the wholesale and retail price
manufacturers may already have the of the converter boxes to recoup any Agency Contact:
ability to meet the requirements associated costs. In fact, the coupon Milton Brown
associated with participation in this program anticipates that there will be Deputy Chief Counsel
program. For example, retailers would a co-pay element to the purchase price. Department of Commerce
have to ensure that employees are Thus, to the extent that a small retailer National Telecommunications and
capable of educating customers about or manufacturer incurs costs as a result Information Administration
the necessity for and installation of of this program, those costs can be 14th & Pennsylvania Avenue, NW.
converter boxes. The costs for this recouped through the retail or Washington, DC 20230
compliance would be calculated by the wholesale price, which the retailer and Phone: 202 482–1816
number of hours it would take to train manufacturer are at liberty to choose. Fax: 202 501–8013
employees. The estimate would depend Email:
on a number of factors such as the Risks:
existing sales force’s expertise, number One risk is that the final rule will not RIN: 0660–AA16
of employees, salary levels, type of be promulgated in time for the BILLING CODE 3510–BW–S

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72768 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

DEPARTMENT OF DEFENSE (DOD) Coordination Conflicting Regulations

Interagency Since DoD seldom issues significant
Statement of Regulatory Priorities regulations, the probability of
DoD annually receives regulatory developing conflicting regulations is
Background plans from those agencies that influence low. Conversely, DoD is affected to a
the operation of the Department through great degree by the regulating agencies.
The Department of Defense (DoD) is the issuance of regulations. A system for From that perspective, DoD is in a
the largest Federal department, coordinating the review process is in position to advise the regulatory
consisting of 3 military departments place, regulations are reviewed, and agencies of conflicts that appear to exist
(Army, Navy, and Air Force), 9 unified comments are forwarded to the Office of using the coordination processes that
combatant commands, 17 Defense Management and Budget. The system is exist in the DoD and other Federal
agencies, and 11 DoD field activities. It working in the Department, and the agency regulatory programs. It is a
has over 1,380,000 military personnel feedback from the Defense components priority in the Department to
and 676,000 civilians assigned as of is most encouraging, since they are able communicate with other agencies and
June 30, 2006, and over 200 large and to see and comment on regulations from the affected public to identify and
medium installations in the continental the other agencies before they are proactively pursue regulatory problems
United States, U. S. territories, and required to comply with them. The that occur as a result of conflicting
foreign countries. The overall size, coordination process in DoD continues regulations both within and outside the
composition, and dispersion of the to work as outlined in Executive Order Department.
Department of Defense, coupled with an 12866.
innovative regulatory program, presents Alternatives
a challenge to the management of the Internal DoD will identify feasible alternatives
Defense regulatory efforts under Through regulatory program points of that will obtain the desired regulatory
Executive Order 12866 ‘‘Regulatory contact in the Department, we have objectives. Where possible, the
Planning and Review’’ of September 30, established a system that provides Department encourages the use of
1993. information from the Administrator of incentives to include financial, quality
the Office of Information and Regulatory of life, and others to achieve the desired
Because of its diversified nature, DoD Affairs (OIRA) to the personnel regulatory results.
is affected by the regulations issued by responsible for the development and
regulatory agencies such as the Risk Assessment
implementation of DoD regulations.
Departments of Energy, Health and Conversely, the system can provide Assessing and managing risk is a high
Human Services, Housing and Urban feedback from DoD regulatory personnel priority in the DoD regulatory program.
Development, Labor, Transportation, to the Administrator, OIRA. DoD The Department is committed to risk
and the Environmental Protection continues to refine its internal prioritization and an ‘‘anticipatory’’
Agency. In order to develop the best procedures, and this ongoing effort to approach to regulatory planning, which
possible regulations that embody the improve coordination and focuses attention on the identification of
principles and objectives embedded in communication practices is well future risk. Predicting future regulatory
Executive Order 12866, there must be received and supported within the risk is exceedingly difficult due to rapid
coordination of proposed regulations Department. introduction of new technologies, side
among the regulating agencies and the effects of Government intervention, and
affected Defense components. Overall Priorities changing societal concerns. These
Coordinating the proposed regulations difficulties can be mitigated to a
The Department of Defense needs to manageable degree through the
in advance throughout an organization function at a reasonable cost, while
as large as DoD is straightforward, yet a incorporation of risk prioritization and
ensuring that it does not impose anticipatory regulatory planning into
formidable undertaking. ineffective and unnecessarily DoD’s decisionmaking process, which
DoD is not a regulatory agency but burdensome regulations on the public. results in an improved regulatory
occasionally issues regulations that have The rulemaking process should be process and increases the customer’s
an affect on the public. These responsive, efficient, cost-effective, and understanding of risk.
regulations, while small in number both fair and perceived as fair. This is
being done in the Department while it Cost-Effectiveness
compared to the regulating agencies, can
be significant as defined in Executive must react to the contradictory One of the highest priority objectives
Order 12866. In addition, some of DoD’s pressures of providing more services of DoD is to obtain the desired
regulations may affect the regulatory with fewer resources. The Department regulatory objective by the most cost-
agencies. DoD, as an integral part of its of Defense, as a matter of overall priority effective method available. This may or
program, not only receives coordinating for its regulatory program, adheres to may not be through the regulatory
actions from the regulating agencies, but the general principles set forth in process. When a regulation is required,
coordinates with the agencies that are Executive Order 12866 as amplified DoD considers incentives for innovation
affected by its regulations as well. below. to achieve desired results, consistency
in the application of the regulation,
The regulatory program within DoD Problem Identification
predictability of the activity outcome
fully incorporates the provisions of the Congress typically passes legislation (achieving the expected results), and the
President’s priorities and objectives to authorize or require an agency to costs for regulation development,
under Executive Order 12866. issue regulations and often is quite enforcement, and compliance. These
Promulgating and implementing the specific about the problem identified for will include costs to the public,
regulatory program throughout DoD correction. Therefore, DoD does not Government, and regulated entities,
presents a unique challenge to the generally initiate regulations as a part of using the best available data or
management of our regulatory efforts. its mission. parametric analysis methods, in the

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72769

cost-benefit analysis and the Historically, this has included such Department of Defense to impose upon
decisionmaking process. activities as receiving comments from the public the smallest burden viable, as
the public, holding hearings, and infrequently as possible, and for no
Cost-Benefit conducting focus groups. This reaching longer than absolutely necessary.
Conducting cost-benefit analyses on out to organizations and individuals
regulation alternatives is a priority in that are affected by or involved in a Plain Language
the Department of Defense so as to particular regulatory action remains a Ensuring that regulations are simple
ensure that the potential benefits to significant regulatory priority of the and easy to understand is a high
society outweigh the costs. Evaluations Department and, we feel, results in regulatory priority in the Department of
of these alternatives are done much better regulations. Defense. All too often, the regulations
quantitatively or qualitatively or both, The Department is actively engaged in are complicated, difficult to understand,
depending on the nature of the problem addressing the requirements of the and subject to misinterpretation, all of
being solved and the type of information Government Paperwork Elimination Act which can result in the costly process of
and data available on the subject. DoD (GPEA) in implementing electronic litigation. The objective in the
is committed to considering the most government and in achieving IT development of regulations is to write
important alternative approaches to the accessibility for individuals with them in clear, concise language that is
problem being solved and providing the disabilities. This is consistent with the simple and easy to understand.
reasoning for selecting the proposed Administration’s strategy of advancing DoD recognizes that it has a
regulatory change over the other E-government as expressed in ‘‘The responsibility for drafting clearly
alternatives. President’s Management Agenda.’’ The written rules that are reader-oriented
Information-Based Decisions Department is actively participating in and easily understood. Rules will be
the eRulemaking Initiative to implement written for the customer using natural
The Defense Department uses the a governmentwide docket management expressions and simple words. Stilted
latest technology to provide access to system that will provide the framework jargon and complex construction will be
the most current technical, scientific, for wider citizen input and improve avoided. Clearly written rules will tell
and demographic information in a regulatory policies and outcomes by our customers what to do and how to do
timely manner through the worldwide cultivating public participation in it. DoD is committed to a more
communications capabilities that are Federal decisionmaking. customer-oriented approach and uses
available on the Internet. Realizing that plain language rules thereby improving
increased public participation in the Coordination
compliance and reducing litigation.
rulemaking process improves the DoD has enthusiastically embraced
quality and acceptability of regulations, the coordination process between and In summary, the rulemaking process
DoD is committed to exploring the use among other Federal agencies in the in DoD should produce a rule that:
of information technology (IT) in rule development of new and revised Addresses an identifiable problem,
development and implementation. IT regulations. Annually, DoD receives implements the law, incorporates the
provides the public with easier and regulatory plans from key regulatory President’s policies defined in
more meaningful access to the agencies and has established a Executive Order 12866, is in the public
processing of regulations. Furthermore, systematic approach to providing the interest, is consistent with other rules
the Department endeavors to increase plans to the appropriate policy officials and policies, is based on the best
the use of automation in the Notice and within the Department. Feedback from information available, is rationally
Comment rulemaking process in an the DoD components indicates that this justified, is cost-effective, can actually
effort to reduce time pressures and communication among the Federal be implemented, is acceptable and
increase public access in the regulatory agencies is a major step forward in enforceable, is easily understood, and
process. Notable progress has been improving regulations and the stays in effect only as long as is
made in the Defense acquisition regulatory process, as well as in necessary. Moreover, the proposed rule
regulations area toward achieving the improving Government operations. or the elimination of a rule should
Administration’s E-government simply make sense.
Minimize Burden
initiative of making it simpler for Rulemakings That Support the
citizens to receive high-quality service In the regulatory process, there are
Administration’s Regulation Agenda to
from the Federal Government, inform more complaints concerning burden
Streamline Regulations and Reporting
citizens, and allow access to the than anything else. In DoD, much of the
development of rules. burden is in the acquisition area. Over
the years, acquisition regulations have The Department will:
Performance-Based Regulations grown and become burdensome Consolidate all of the existing
Where appropriate, DoD is principally because of legislative action. emergency procurement authorities into
incorporating performance-based But, in coordination with Congress, the Part 18 of the FAR and Part 218 of the
standards that allow the regulated Office of Federal Procurement Policy, DFARS;
parties to achieve the regulatory and the public, DoD is initiating
objective in the most cost-effective significant reforms in acquisition so as Direct use of electronic subcontracting
manner. to effect major reductions in the and reporting system for both the
regulatory burden on personnel in summary and individual subcontract
Outreach Initiatives Government and the private sector. DoD reporting, in conjunction with and as
DoD endeavors to obtain the views of has implemented a multi-year strategy part of the integration with FPDS;
appropriate State, local, and tribal for reducing the paperwork burden Rewrite the rules on Government
officials and the public in implementing imposed on the public. This plan shows property to organize and streamline
measures to enhance public awareness that DoD has met and will exceed the management of Government property.
and participation both in developing goals set forth in the Paperwork Emphasize contractor accountability
and implementing regulatory efforts. Reduction Act. It is the goal of the while reducing contract clauses and

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72770 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

reporting requirements. Allow Report to Congress on the Costs and modifying those concepts to improve
contractors to provide item unique Benefits of Regulations and Unfunded compensatory mitigation
identification (IUID) data electronically Mandates on State, Local, and Tribal decisionmaking and processes. The
in the IUID Registry for all DoD personal Entities, Stimulating Smarter proposed rule takes a watershed
property in possession of the contractor, Regulation: 2002 Report to Congress on approach to compensatory mitigation
rather than annual reporting; the Costs and Benefits of Regulations for permitted impacts to wetlands,
Simplify and clarify the coverage of and Unfunded Mandates on State, streams, and other aquatic resources.
multi-year acquisitions; Local, and Tribal Entities, and Progress Although the statute refers only to
in Regulatory Reform: 2004 Report to wetlands, the proposed rule is broader
Provide simplified criteria for the Congress on the Costs and Benefits of
release of supplies by the contractor in scope, and addresses compensatory
Federal Regulations and Unfunded mitigation requirements for impacts to
based on complexity and criticality; Mandates on State, Local, and Tribal other aquatic resources, such as streams,
Finalize the rewrite of FAR Part 27, Entities.
in addition to wetlands. Comments
Patents, Data and Copyrights, to clarify,
Specific Priorities received in response to the proposed
streamline, and update guidance and
clauses on patents, data, and copyrights. For this regulatory plan, there are four rule are being evaluated, and a final rule
Transform the DFARS regulations on specific DoD priorities, all of which will be prepared.
patents, data and copyrights to clarify reflect the established regulatory
principles. In those areas where Army Regulatory Program’s Compliance
and simplify, dramatically reducing the
amount of regulatory text and the rulemaking or participation in the with the National Historic Preservation
number of required clauses; regulatory process is required, DoD has Act
studied and developed policy and
Implement DFARS transformation In 1990, the Army Corps of Engineers
regulations that incorporate the
proposals relating to the Material published as appendix C of 33 CFR part
provisions of the President’s priorities
Inspection and Receiving Report, 325, a rule that governs compliance
and objectives under the Executive
acquisition planning, transportation, with the National Historic Preservation
contract pricing and cost accounting Act (NHPA) for the Army’s Regulatory
standards, and protests, disputes, and DoD has focused its regulatory Program. Over the years, there have
appeals; and resources on the most serious been substantial changes in policy, and
environmental, health, and safety risks. the NHPA was amended in 1992,
Delete obsolete restrictions on the
Perhaps most significant is that each of leading to the publication in December
acquisition of PAN Carbon Fiber.
the priorities described below
2000 of new implementing regulations
Regulations of Particular Interest to promulgates regulations to offset the
at 36 CFR part 800, issued by the
Small Business resource impacts of Federal decisions
Advisory Council on Historic
Of interest to small businesses are on the public or to improve the quality
of public life, such as those regulations Preservation. Those regulations were
regulations to: amended on July 6, 2004. The Advisory
concerning civil functions of the U.S.
Permit subcontracts awarded to Army Corps of Engineers, acquisition, Council on Historic Preservation’s
certain Alaska Native Corporations to be installations and the environment, and regulations allow Federal agencies to
counted toward a contractor’s goal for health affairs. utilize alternate procedures in lieu of
subcontracting with Small Business and the regulations at 36 CFR part 800. To
Small Disadvantaged Business concerns U.S. Army Corps of Engineers, solicit public comment on the
and subcontracts to Indian tribes to be Directorate of Civil Works appropriate mechanism for revising the
counted toward a contractor’s goal for Compensatory Mitigation in the Army Army Regulatory Program’s process for
subcontracting with small business Regulatory Program considering effects to historic properties
concerns, regardless of size, in resulting from activities authorized by
Section 314 of the National Defense
accordance with section 702 of Pub. L. DA permits, the Army Corps of
Authorization Act for Fiscal Year 2004
107-117, as amended by section 3003 of Engineers published an Advance Notice
(Public Law 108-136) requires the
Pub. L. 107-206; of Proposed Rulemaking (ANPRM) to
Secretary of the Army, acting through
Amend the FAR to address changes in the Chief of Engineers, to issue obtain the views of interested parties.
the Small Business Administration regulations that establish performance After reviewing the comments received
regulations to implement changes in the standards and criteria for the use of in response to the ANPRM, the Army
HUBZone Program; and compensatory mitigation for wetland Corps of Engineers held facilitated
Implement DFARS transformation functions lost as a result of activities stakeholder meetings to determine the
proposals relating to small business authorized by Department of the Army best course of action for revising its
programs. (DA) permits. The statute also requires procedures to comply with the
the regulation to contain provisions for requirements of Section 106 of the
Suggestions From the Public for the application of equivalent standards National Historic Preservation Act. The
Reform—Status of DoD Items and criteria to each type of Corps plans on holding additional focus
Rulemaking Actions in Response to compensatory mitigation. group meetings facilitated by our eight
Public Nominations The proposed rule was published for division offices to gather input from
The Army Corps of Engineers has not public comment on March 28, 2006 (71 federally recognized tribes on their
undertaken any rulemaking actions in FR 15520). The comment period expired recommendations concerning how
response to the public nominations on June 30, 2006 (71 FR 29604). The government-to-government consultation
submitted to the Office of Management proposed regulation was developed by could occur. Also, our division offices
and Budget in 2001, 2002, or 2004. considering concepts in current Federal will solicit information on topics that
Those nominations were discussed in compensatory mitigation guidance any new alternative procedure should
Making Sense of Regulation: 2001 documents, and updating and address.

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Defense Procurement and Acquisition Robert T. Stafford Disaster Relief and Department proposed and requested
The Department continues its efforts Emergency Assistance Act, in order to public comments on regulations
to reengineer its acquisition system to implement the Local Community regarding the characteristics,
achieve its vision of an acquisition Recovery Act of 2006. composition, funding, and
system that is recognized as being the • Prohibit trafficking in persons by establishment of RABs. These
smartest, most efficient, most responsive contractors, contractor employees, regulations were not finalized.
buyer of best value goods and services, and subcontractors. As a consequence of litigation in
which meet the warfighter’s needs from • Address contractor notification
2001, the Department substantially
a globally competitive base. To achieve requirements associated with
revised the regulations and shared a
this vision, the Department will focus in deficient processes or defective parts
draft rule with RAB community
the acquisition regulations during this related to aviation critical safety
members as part of the Department’s
next year on implementing and items.
outreach to affected members of the
institutionalizing initiatives that may public. On March 26, 2003, OMB
include additional changes to existing • Phase in DFARS requirements for reviewed the draft proposed rule and
and recently modified regulations to contractors to affix radio frequency agreed that it is not a ‘‘significant
ensure that we are achieving the identification (RFID) tags to the regulatory action’’ under EO 12866. The
outcomes we desire (continuous process exterior packaging of items delivered Department published the proposed rule
improvement). under DoD contracts, adding in the Federal Register on January 28,
additional commodities and ship-to 2005. The proposed rule addressed
The Department of Defense
locations. This practice will improve scope, characteristics, composition,
continuously reviews the Defense
visibility of DoD assets in the supply funding, establishment, operation and
Federal Acquisition Regulation
chain, increase the accuracy of adjournment. The public comment
Supplement (DFARS) and continues to
shipment and receipt data, and reduce period ended on March 29, 2005. The
lead Government efforts to:
the amount of time it takes to deliver Department received a total of 219
• Improve the DFARS to enhance the material to the warfighter. comments from 29 individuals and
efficiency and effectiveness of the organizations.
• Improve debt collection by evaluating
acquisition process, while allowing
existing FAR controls and procedures The Department published final
the acquisition workforce flexibility to
for ensuring contract debts are regulations governing the establishment
innovate. The DFARS contains only
identified and recovered in a timely and administration of Restoration
requirements of law, DoD-wide
manner, properly accounted for in Advisory Boards in the Federal Register
policies, delegations of FAR
each agencies’ books and records, and on May 12, 2006 (71 FR 27610-27621).
authorities, deviations from FAR
properly coordinated with the Corrections were published in the
requirements, and
appropriate Government officials. Federal Register on May 30, 2006 (71
policies/procedures that have a
significant impact on contractors, Defense Installations and the FR 30719) and July 28, 2006 (71 FR
offerors, and/or the public. Environment 42756-42757).
Munitions Response Site Prioritization
• Revise the uniform treatment of The Department is committed to
reducing the total ownership costs of Protocol
contractor personnel who are
authorized to accompany the U.S. the military infrastructure while Section 2710(b)(1) of Title 10, United
Armed Forces deployed outside the providing the Nation with military States Code, directed the Secretary of
United States in contingency installations that efficiently support the Defense to develop a protocol for
operations, humanitarian or warfighter in: Achieving military prioritizing response actions for each
peacekeeping operations, other dominance, ensuring superior living defense site known or suspected to
military operations, or training and working conditions, and enhancing contain unexploded ordnance,
exercises designated by the combatant the safety of the force and the quality of discarded military munitions, or
commander, to implement the new the environment. DoD has focused its munitions constituents. Following
DoD Instruction, and require training regulatory priorities on explosives required consultations with State and
for contractor personnel who interact safety, human health, and the tribal representatives, the Department
with detainees. Implement the DoD environment. These regulations provide published the proposed rule for public
Law of War Program, requiring means for the Department to provide review and comment on August 22,
contractors to report violations. information about restoration activities 2003. The Department reviewed
at Federal facilities and to take public comments received during the public
• Coordinate with the Department of
advice on the restoration activities. comment period, which ended on
State to finalize a FAR rule to address
November 19, 2003, and revised the rule
uniform treatment of other contractor Restoration Advisory Boards
accordingly. The most significant
personnel who are performing outside The requirement for the establishment change pertained to the module that
the United States in a theater of of Restoration Advisory Board (RABs) is evaluates health hazards associated with
operations during contingency grounded in Section 324(a) of Public munitions constituents and other
operations; humanitarian or Law 104-106, which requires the chemical constituents. The Department
peacekeeping operations; other Secretary of Defense to ‘‘prescribe published the final rule in the Federal
military operations; or military regulations regarding the establishment, Register on October 5, 2005 (70 FR
exercises designated by the combatant characteristics, composition, and 58016-58054).
commander; or at a diplomatic or funding of restoration advisory boards.’’
consular mission, when designated by Section 324(a) also stated that DoD’s Health Affairs, Department of Defense
the chief of mission. issuance of regulations shall not be a The Department of Defense is able to
• Finalize the FAR rule that authorizes precondition to the establishment of meet its dual mission of wartime
set-asides for awards based on RABs (amended Title 10 Section readiness and peacetime health care by
specific geographic areas under the 2705(d)(2)(B)). In August 1996, the operating an extensive network of

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72772 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

medical treatment facilities. This while at the same time eliminating amounts), there will be some significant
network includes DoD’s own military any undue financial burden to deviations required to accommodate the
treatment facilities supplemented by TRICARE Prime, Extra and Standard uniqueness of the TRICARE program.
civilian healthcare providers, facilities, beneficiary populations. The These deviations have been designed to
and services under contract to DoD economic impact of this rule is accommodate existing TRICARE benefit
through the TRICARE program. estimated to be less than $100 structure and claims processing
TRICARE is a major health care program million. It is anticipated that the final procedures implemented under the
designed to improve the management rule will be published by April 1, TRICARE Next Generation Contracts (T-
and integration of DoD’s health care 2007. It is anticipated that an interim NEX) while at the same time
delivery system. The program’s goal is final rule will be required to be eliminating any undue financial burden
to increase access to health care promulgated in order to implement a to TRICARE Prime, Extra and Standard
services, improve health care quality, provision of the National Defense beneficiary populations.
and control health care costs. Authorization Act for FY07 to expand
the TRICARE Reserve Select program Statement of Need:
The TRICARE Management Activity
plans to submit the following rules: to allow all members of the Selected The interim final rule is necessary to
Reserve to purchase their health care meet the standing Congressional
• Interim Final Rule concerning Certain through the Military Health System at mandate to adopt Medicare
Survivors of Deceased Active Duty the same low cost, regardless of the institutional payment methodologies
Members and Adoption member’s duty status. The economic whenever practicable.
Intermediaries: The rule addresses
impact of this rule is estimated to be
two provisions of the National Summary of Legal Basis:
less than $100 million. It is
Defense Authorization Act for Fiscal Congress established enabling
anticipated that the interim final rule
Year 2006 (NDAA-06), Pub. L. 109- legislation under section 707 of the
will be published by June 1, 2007.
163. Section 715 of the NDAA-06 National Defense Authorization Act of
extends the time frame that certain Fiscal Year 2002 (NDAA-02), Pub. L.
dependents of Active Duty Service DOD—Office of Assistant Secretary 107-107 (December 28, 2001) changing
Members (ADSM) who die while on for Health Affairs (DODOASHA) the statutory authorization in 10 U.S.C.
active duty for more than 30 days 1079(j)(2) that TRICARE payment
shall receive TRICARE medical methods for institutional care be
benefits at active duty dependent FINAL RULE STAGE determined to the extent practicable, in
payment rates. Second, Section 592 accordance with the same
modifies the requirement for
reimbursement rules used by Medicare.
intermediaries who provide adoption 25. ∑ TRICARE OUTPATIENT
placements. The economic impact of PROSPECTIVE PAYMENT SYSTEM Alternatives:
this rule is estimated to be less than (OPPS) The interim final rule implements
$100 million. It is anticipated that the statutorily required provisions for
final rule will be published by May 1, Priority:
adoption and implementation of
2007. Other Significant Medicare institutional reimbursement
• Interim Final Rule on TRICARE systems which are consistent with well
Outpatient Prospective Payment Legal Authority:
established Congressional objectives.
System (OPPS): The rule implements 10 USC Ch 55; 5 USC 301; 10 USC No other alternatives are applicable.
a prospective payment system for 1079(j)(2)
hospital outpatient services similar to Anticipated Cost and Benefits:
that furnished to Medicare CFR Citation:
It is projected that implementation of
beneficiaries, as set forth in section 32 CFR 199 this rule will result in a health care
1833(t) of the Social Security Act. The dollar savings of $50 to $70 million per
rule also recognizes applicable Legal Deadline:
year with an estimated initial startup
statutory requirements and changes None cost of $4 to $6 million and recurring
arising from Medicare’s continuing administrative costs of approximately
experience with its system, including Abstract:
$1 million per year.
certain related provisions of the The interim final rule implements a
Medicare Prescription Drug, prospective payment system for Risks:
Improvement, and Modernization Act hospital outpatient services similar to The interim final rule implements
of 2003. While TRICARE intends to that furnished to Medicare statutorily required provisions for
remain as true as possible to beneficiaries, as set forth in section adoption and implementation of
Medicare’s basic OPPS methodology 1833(t) of the Social Security Act. The Medicare institutional reimbursement
(i.e., adoption and updating of the rule also recognizes applicable statutory systems which are consistent with well
Medicare data elements used in requirements and changes arising from established Congressional objectives.
calculating the prospective payment Medicare’s continuing experience with No risk to the public is applicable.
amounts), there will be some its system, including certain related Timetable:
significant deviations required to provisions of the Medicare Prescription
accommodate the uniqueness of the Drug, Improvement, and Modernization Action Date FR Cite
TRICARE program. These deviations Act of 2003. While TRICARE intends Interim Final Rule 12/00/06
have been designed to accommodate to remain as true as possible to Interim Final Rule 02/00/07
existing TRICARE benefit structure Medicare’s basic OPPS methodology Comment Period
and claims processing procedures (i.e., adoption and updating of the End
implemented under the TRICARE Medicare data elements used in Final Action 04/00/07
Next Generation Contracts (T-NEX) calculating the prospective payment Final Action Effective 06/00/07

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Regulatory Flexibility Analysis Anticipated Cost and Benefits: CFR Citation:

Required: 32 CFR 199
Estimated costs for FY07 (includes
Yes retroactive years to 2001). Health care Legal Deadline:
costs $533,000 and administrative costs
Small Entities Affected: Final, Statutory, October 1, 2007,
of $774,000 (which includes total
Businesses startup costs of $300,000). The benefit NDAA for FY07.
of this rule is that surviving children Abstract:
Government Levels Affected:
of ADSMs whose death occurs on or
Federal The proposal would expand the
after October 7, 2001, will receive
recently enacted Reserve health care
TRICARE benefits at the AD family
Agency Contact: benefit for Reservists (called TRICARE
member rate for the duration of their
David E. Bennett Reserve Select) to allow all members
TRICARE eligibility.
Department of Defense of the Selected Reserve to purchase
Office of Assistant Secretary for Health Risks: their health care through the Military
Affairs Health System at the same low cost,
This rule implements a statutory regardless of the member’s duty status.
1200 Defense Pentagon provision to extend the time frame that
Washington, DC 20301 Only members who are eligible for the
surviving children of deceased ADSM Federal Health Benefits program would
Phone: 303 676–3494 whose death occurred on or after
Email: be excluded from this benefit.
October 7, 2001, can receive TRICARE Participating Reserve Component
RIN: 0720–AB03 at active duty family member rates. Not members would be required to pay a
implementing this statutory provision monthly premium of 28 percent of the
creates additional out-of-pocket costs cost of care for the TRICARE Reserve
DOD—DODOASHA for surviving children. Select plan and would be subject to the
26. ∑ TRICARE; CERTAIN SURVIVORS Timetable: same deductibles, copayments and
OF DECEASED ACTIVE DUTY other non-premium payments
Action Date FR Cite
MEMBERS; AND ADOPTION applicable to dependents of active duty
INTERMEDIARIES Interim Final Rule 12/00/06 members who selected the same
Interim Final Rule 02/00/07 TRICARE option.
Priority: Comment Period
Other Significant End Statement of Need:
Interim Final Rule 10/07/01 The Department of Defense (DoD)
Legal Authority: Effective interim final rule identifies a process
10 USC Ch 55; 5 USC 301; PL 109–163 Final Action 05/00/07 to comply with the Congressional
Final Action Effective 06/00/07 mandate that all members of the
CFR Citation: Selected Reserve may be able to
Regulatory Flexibility Analysis
32 CFR 199 Required: purchase their health care through the
Military Health System, regardless of
Legal Deadline: No the member’s duty status.
Final, Statutory, October 7, 2001,
Small Entities Affected: Summary of Legal Basis:
Public Law 109–163.
No This regulation is proposed under the
Abstract: authorities the National Defense
The interim final addresses two Government Levels Affected: Authorization Act for Fiscal Year 2007.
provisions of the NDAA-FY06, Pub. L. Federal Alternatives:
109-163. Section 715 of the NDAA-
FY06 extends the time frame that Agency Contact: The interim final rule complies with
certain dependents of Active Duty Ann N. Fazzini the Congressional mandate. No other
Service Members (ADSM) who die Department of Defense alternatives are applicable.
while on active duty for more than 30 Office of Assistant Secretary for Health Anticipated Cost and Benefits:
days shall receive TRICARE medical Affairs
benefits at active duty dependent It is estimated that implementing the
1200 Defense Pentagon
payment rates. Second, Section 592 rule equates to national incremental
Washington, DC 20301
modifies the requirement for costs totaling less than $100 million per
Phone: 303 676–3803
intermediaries who provide adoption year.
placements. RIN: 0720–AB04 Benefits include: Access to health care
for all Reservists, regardless of the
Statement of Need: member’s duty status; however, at this
This rule is necessary to comply with time, the effect on readiness,
the statutory requirement. 27. ∑ EXPAND ELIGIBILITY OF recruitment, and retention are not
This rule is required by the NDAA- Priority:
FY06, Pub L 109-163. The degree of risk to the public is low.
Other Significant Timetable:
This rule is statutory. No other Legal Authority: Action Date FR Cite
alternative is applicable. 10 USC Ch 55; 5 USC 301 Interim Final Rule 06/00/07

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72774 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Action Date FR Cite Small Entities Affected: Agency Contact:

Interim Final Rule 08/00/07 No Jody Donehoo
Comment Period Department of Defense
End Government Levels Affected: Office of Assistant Secretary for Health
Final Action 09/00/07 Affairs
Final Action Effective 10/00/07 Federal Defense Pentagon
Washington, DC 20301
Regulatory Flexibility Analysis Phone: 703 681–0039
Required: RIN: 0720–AB05

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DEPARTMENT OF EDUCATION (ED) level. The President has called evidence yearly progress (AYP), subject to a cap
of poor performance by America’s high of one percent of the number of students
Statement of Regulatory and schools ‘‘a warning and a call to action.’’ in a school district or State.
Deregulatory Priorities The Administration’s response is a We are also working on developing
General comprehensive proposal that builds on final regulations that would provide
the stronger accountability of No Child further flexibility by permitting a State
We support States, local communities, Left Behind to improve the quality of
institutions of higher education, and to develop modified achievement
secondary education and ensure that standards and assessments for some
others in improving education every student not only graduates from
Nationwide. Our roles include students with disabilities who are not
high school, but, also, graduates included in the regulations that apply to
providing leadership and financial prepared to enter college or the
assistance for education to agencies, students with the most significant
workforce with the skills to succeed. cognitive disabilities.
institutions, and individuals in This initiative includes creation of
situations in which there is a national Finally, we have published final
several new programs and significant
interest; such as ensuring that all regulations to permit a State to: (1)
funding increases for existing programs
students reach grade level standards in exempt LEP students new to schools in
that can have a major impact on
reading/language arts and mathematics; the United States from one
secondary education. The actual
monitoring and enforcing Federal civil administration of the State’s
appropriations will depend on
rights laws in programs and activities reading/language arts assessment,
congressional action. The
that receive Federal financial assistance; provided the student takes an English
appropriations may, in turn, result in
and supporting research, evaluation, language proficiency assessment; and
additional regulatory activities by the
and dissemination of findings to (2) include, for up to two years, former
Department. LEP students in the LEP subgroup when
improve the quality of education.
No Child Left Behind making determinations of AYP.
We administer programs that touch
nearly every American at one point in The No Child Left Behind Act of We are continuing to focus on helping
their lives—nearly 54 million students 2001, which reauthorized the States place a highly qualified teacher in
attending 93,000 elementary and Elementary and Secondary Education every classroom; identifying schools
secondary schools in approximately Act of 1965, increases accountability for and districts in need of improvement
15,000 public school districts and States, school districts, and schools; and making sure they are getting the
almost 22 million postsecondary provides greater choice for parents and assistance they need to get back on
students. students, particularly those attending track; expanding the opportunities for
low-performing schools; provides more eligible students to receive tutoring and
We have forged effective partnerships
flexibility for States and local other supplemental educational
with customers and others to develop services; and helping districts create
policies, regulations, guidance, educational agencies in the use of
Federal education dollars; and places a capacity in order to make public school
technical assistance, and approaches to choice available to all eligible students
compliance. We have a record of stronger emphasis on using
scientifically based research to guide who wish to change schools.
successful communication and shared
policy development with affected instruction, especially in reading for our We have recently peer-reviewed
persons and groups, including parents, youngest children. evidence of each State’s standards and
students, and educators; State, local, Each State (including Puerto Rico and aligned assessment systems that
and tribal governments; neighborhood the District of Columbia) has submitted implement No Child Left Behind’s
groups, schools, colleges, rehabilitation an accountability plan, which the requirements for annual testing in
service providers, professional Department approved. Each State has reading/language arts and mathematics
associations, advocacy organizations, used its respective plan to hold schools in grades 3 through 8 and once in high
businesses, and labor organizations. and school districts accountable since school. These new reading/language arts
2002-03 for the academic achievement and mathematics standards and
In particular, we continue to seek assessments had to be in place by the
greater and more useful customer of all their students, including students
end of the 2005-06 school year.
participation in our rulemaking in specific subgroups such as students
activities through the use of consensual with disabilities and limited English Regulatory and Deregulatory Priorities
rulemaking and new technology. If we proficient (LEP) students. Beginning for the Next Year
determine that the development of with the 2005-06 school year, each State The Individuals with Disabilities
regulations is necessary, we seek assessed students in each of grades 3 Education Improvement Act of 2004
customer participation at all stages in through 8 and high school and used (Pub. L. 108-446) made substantial
the rulemaking process. We invite the those results for school and district changes to the Individuals with
public to submit comments on all accountability. Disabilities Education Act (IDEA). In
proposed regulations through the With respect to students with addition to recently published final
Internet or by regular mail. disabilities and LEP students, in regulations designed to improve
We are continuing our efforts to particular, the Department has initiated implementation of the education of
streamline information collections, regulatory actions to address unique children with disabilities program
reduce burden on information providers issues in the implementation of No (including preschool services) under
involved in our programs, and make Child Left Behind. Our current part B, we plan to issue in 2007 a notice
information maintained by us easily regulations permit a State to: (1) develop of proposed rulemaking that would
available to the public. alternate achievement standards for address issues in part B that were not
students with the most significant covered by those final regulations. Also,
Initiatives cognitive disabilities; and (2) include in early 2007 we expect to issue
Among our initiatives is bringing No those students’ proficient and advanced proposed regulations to implement
Child Left Behind to the high school scores in determinations of adequate changes to the part C program—the

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early intervention program for infants statutory framework of the HEA, the administration of programs under both
and toddlers with disabilities. negotiated rulemaking process could be statutes.
On July 3, 2006, we published interim used to address the recommendations of During the coming year other
final regulations, with a request for the Commission for changes that could regulations may be necessitated by
comments, and on November 1, 2006, reduce regulatory burden; improve the legislation or programmatic experience.
we published final regulations administration of the Department’s In developing and promulgating any
implementing the Academic programs authorized by title IV of the additional regulations we will be guided
Competitiveness Grant (ACG) and HEA, including the Federal student aid by the following Principles for
National Science and Mathematics programs; and improve the quality of Regulating:
Access to Retain Talent Grant (National information on cost, price, and student
SMART Grant) programs. These outcomes available to students and their Principles for Regulating
regulations and amendments to families.
Our Principles for Regulating
regulations governing other higher We expect that the negotiated determine when and how we will
education programs were needed to rulemaking process will address other regulate. Through consistent application
implement provisions of the HEA, as regulatory issues, including issues of the following principles, we have
amended by the Higher Education raised by the public during the regional eliminated unnecessary regulations and
Reconciliation Act of 2005 (HERA), hearings; issues resulting from changes identified situations in which major
enacted on February 8, 2006. made, other than those relating to the programs could be implemented
The regulations specify the eligibility ACG and National SMART Grant without any regulations or with only
requirements for a student to apply for programs, by the HERA; and items that limited regulations.
and receive an award under these have been identified by the Department
We will regulate only if regulating
programs. The regulations also identify as needed to improve program
improves the quality and equality of
the roles of institutions of higher administration and accountability.
services to our customers, learners of all
education, State educational agencies, ages. We will regulate only if absolutely
Other Potential Regulatory Activities
and local educational agencies in necessary and then in the most flexible,
administering the programs. Recent reauthorization of the Carl D.
most equitable, and least burdensome
The interim final regulations are Perkins Vocational and Technical
way possible.
effective for the 2006-07 award year. Education Act of 1998 might result in
regulatory activities by the Department. When regulating, we consider:
The final regulations, which amend the
interim final regulations, are effective The reauthorization made changes • Whether regulations are essential to
for the 2007-08 award year. designed to improve the State grant and promote quality and equality of
other programs providing assistance opportunity in education.
In addition, we published on August under this statute and to help States and
9, 2006, interim final regulations, with local communities strengthen career and • Whether a demonstrated problem
a request for comments, and on technical education and improve cannot be resolved without
November 1, 2006, we published final educational opportunities for career and regulation.
regulations amending various technical education students. In • Whether regulations are necessary to
regulations for Federal student aid working with Congress on the provide a legally binding
programs authorized under title IV of reauthorization, the Administration has interpretation to resolve ambiguity.
the HEA. These regulations implement emphasized student achievement,
changes to the HEA resulting from the particularly the academic achievement • Whether entities or situations to be
HERA and reflect provisions of the of career and technical education regulated are so diverse that a uniform
HERA that affect students, borrowers, students, and increasing accountability approach does more harm than good.
and program participants. and program quality. How to regulate:
On August 18, the Department Congress also is considering • Regulate no more than necessary.
announced in the Federal Register our legislation to reauthorize the Adult
intent to conduct negotiated rulemaking • Minimize burden and promote
Education and Family Literacy Act multiple approaches to meeting
under title IV of the Higher Education (AEFLA) (title II of the Workforce
Act. As we indicated when we statutory requirements.
Investment Act of 1998)—including the
announced the interim final regulations National Institute for Literacy—and the • Encourage federally funded activities
on July 3, we intend to develop Rehabilitation Act of 1973. The to be integrated with State and local
proposed regulations for the new ACG Administration is working with reform activities.
and National SMART Grant programs Congress to ensure that any changes to • Ensure that benefits justify costs of
for the third and subsequent years of these laws improve and streamline the regulation.
implementation of these programs (that State grant and other programs
is, beginning July 1, 2008). providing assistance for adult basic • Establish performance objectives
We also intend to consider the education under the AEFLA and for rather than specify compliance
recommendations of the Secretary’s vocational rehabilitation and behavior.
Commission on the Future of Higher independent living services for persons • Encourage flexibility so institutional
Education. The Commission released its with disabilities under the forces and incentives achieve desired
report on September 19, 2006. To the Rehabilitation Act of 1973, and that they results.
extent possible within the existing provide greater accountability in the BILLING CODE 4000–01–S

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DEPARTMENT OF ENERGY (DOE) industrial equipment. In addition, on also be found in the Department’s
July 25, 2006, DOE published a Notice Regulatory Agenda, which appears
Statement of Regulatory and of Proposed Rulemaking (NOPR) to elsewhere in this issue of the Federal
Deregulatory Priorities provide for new Federal energy Register.
The Department of Energy efficiency and water conservation test
procedures, and related definitions, for Nuclear Safety Regulations
(Department or DOE) makes vital
contributions to the Nation’s welfare certain consumer products and certain The Department is committed to
through its activities focused on commercial and industrial equipment openness and public participation as it
improving national security, energy under EPACT 2005. Consistent with addresses one of its greatest
supply, energy efficiency, EPACT 2005, the Department intends to challenges—managing the environment,
environmental remediation, and energy continue its work on adoption of health, and safety risks posed by its
research. The Department’s mission is amended energy efficiency standards for nuclear activities. A key element in the
to: residential furnaces and boilers and on management of these risks is to establish
new standards for electric distribution the Department’s expectations and
• Promote dependable, affordable and transformers. requirements relative to nuclear safety
environmentally sound production and to hold its contractors accountable
and distribution of energy; On January 31, 2006, the Department
released a schedule for setting new for safety performance. The 1988 Price-
• Foster energy efficiency and appliance efficiency standards that will Anderson Amendments Act revisions to
conservation; save American consumers billions of the Atomic Energy Act of 1954 (AEA)
provide for the imposition of civil and
• Provide responsible stewardship of dollars in energy costs. The five-year
plan outlines how DOE will address the criminal penalties for violations of DOE
the Nation’s nuclear weapons;
appliance standards rulemaking backlog nuclear safety requirements. As a result,
• Clean up the Department’s sites and and meet the statutory requirements new nuclear safety requirements were
facilities, which include sites dating established in the EPCA and EPACT initiated with the publication of four
back to the Manhattan Project; 2005. The statutes require DOE to set notices of proposed rulemaking for
• Lead in the physical sciences and appliance efficiency standards at levels review and comment in 1991. The
advance the biological, environmental that achieve the maximum improvement Department’s nuclear safety procedural
and computational sciences; and in energy efficiency that is regulations (10 CFR part 820) were
technologically feasible and published as a final rule in 1993. The
• Provide premier instruments of Department’s substantive nuclear safety
economically justified. Standards
science for the Nation’s research requirements (10 CFR parts 830 and
already in place for residential products
enterprise. 835) were finalized in 2001 and 1998,
are expected to save consumers nearly
The Department’s regulatory activities $93 billion by 2020, and to save enough respectively. In February 2006, the
are essential to achieving its critical energy to operate all U.S. homes for Department issued a final rule adding a
mission and to implementing major approximately two years. new part, 10 CFR 851, Worker Safety
initiatives of the President’s National and Health, that established basic
The five-year plan, which was
Energy Policy. Among other things, the requirements to ensure workers are
developed considering the public
Regulatory Plan and the Unified Agenda protected from safety and health
comments received on the appliance
contain the rulemakings the Department hazards at DOE facilities. The remaining
standards program, provides for the
will be engaged in during the coming action, 10 CFR part 834, Radiation
issuance of one rulemaking for each of
year to implement provisions of the Protection of the Public and the
the 18 products in the backlog. The plan
Energy Policy Act of 2005 (EPACT Environment, is scheduled for
also provides for setting appliance
2005). The Regulatory Plan and Unified completion in 2008.
standards for products required under
Agenda also reflect the Department’s
EPACT 2005. The Department is Loan Guarantees
continuing commitment to cut costs,
aggressively implementing process Title XVII of the Energy Policy Act of
reduce regulatory burden, and increase
improvements to speed up the 2005 (42 U.S.C. 16511-16514) authorizes
responsiveness to the public.
development and issuance of appliance the Secretary of Energy to issue loan
Energy Efficiency Program for standards rules. guarantees for energy related projects
Consumer Products and Commercial The overall plan for implementing the that ‘‘avoid, reduce, or sequester air
Equipment schedule is contained in the Report to pollutants or anthropogenic emissions
The Energy Policy Act of 2005, Congress under section 141 of EPACT of greenhouse gases; and employ new or
enacted on August 8, 2005, had a 2005, which was released January 31, significantly improved technologies as
significant impact on the Department’s 2006. The report and schedule is posted compared to commercial technologies in
priorities for its rulemaking activities at: service in the United States at the time
related to energy efficiency standards, the guarantee is issued.’’ By reducing
test procedures, and determinations. appliancelstandards/ the financial risk of these innovative
EPACT 2005 not only added new 2006lschedulelsetting.html. The technologies, DOE hopes to facilitate
products to those already covered by the report identifies all products for which their advancement to market. DOE
Energy Policy and Conservation Act DOE has missed the deadlines believes that accelerated commercial
(EPCA), but it also affects ongoing established in EPCA (42 U.S.C. § 6291 use of new or improved technologies
rulemakings. On October 18, 2005, DOE et seq.). It also describes the reasons for will help to sustain economic growth,
published a technical amendment to such delays and the Secretary’s plan for yield environmental benefits, and
place in the Code of Federal Regulations expeditiously prescribing new or produce a more stable and secure energy
the energy conservation standards, and amended standards. The first semi- supply. DOE is committed to openness
related definitions, that Congress annual update to the report was released and public participation as it develops
prescribed in EPACT 2005 for certain August 10, 2006. Information and rules and criteria for loan guarantees
consumer products and commercial and timetables concerning these actions can and promptly will be taking action to

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72778 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

promulgate such rules. The Department Timetable: technologically feasible and

intends to publish a notice of proposed Action Date FR Cite
economically justified.
rulemaking in December 2006.
ANPRM 08/00/07 Summary of Legal Basis:
NPRM 07/00/08 The EPACT 2005 amendments to EPCA
DOE—Energy Efficiency and Final Action 03/00/09 authorize DOE to establish energy
Renewable Energy (EE) conservation standards for commercial
Regulatory Flexibility Analysis
refrigeration equipment.
PRERULE STAGE Undetermined Alternatives:
EPCA, as amended, requires DOE to
Government Levels Affected: conduct rulemaking to review
28. ENERGY CONSERVATION Local, State standards and to revise standards to
STANDARDS FOR RESIDENTIAL achieve the maximum improvement in
ELECTRIC AND GAS RANGES AND energy efficiency that the Secretary
OVENS AND MICROWAVE OVENS, Undetermined determines is technically feasible and
DISHWASHERS, DEHUMIDIFIERS, Additional Information: economically justified. In making this
AND COMMERCIAL CLOTHES determination, DOE conducts a
WASHERS Merged dishwashers from RIN 1904- thorough analysis of alternative
AA89 and added residential standard levels, based on criteria
Priority: dehumidifiers and commercial clothes specified by statute.
Economically Significant. Major under washers.
5 USC 801. Agency Contact: Action Date FR Cite
Unfunded Mandates: Bryan Berringer, EE–2J ANPRM 07/00/07
Undetermined Office of Building Technologies Program NPRM 05/00/08
Department of Energy Final Action 01/01/09
Legal Authority: Energy Efficiency and Renewable Energy
42 USC 6295(g) to (h)(cc); 42 USC 1000 Independence Avenue SW. Regulatory Flexibility Analysis
6313(e) Washington, DC 20585 Required:
Phone: 202 586–0371 Undetermined
CFR Citation:
Fax: 202 586–4617
10 CFR 430 Email: Government Levels Affected:
Legal Deadline: Related RIN: Merged with 1904–AA89 None
Final, Statutory, January 1, 1997. RIN: 1904–AB49 Agency Contact:
Abstract: Charles Llenza, EE–2J
DOE—EE Office of Building Technologies Program
The Department is committed to Department of Energy
becoming current on all energy 29. ENERGY EFFICIENCY Energy Efficiency and Renewable Energy
standards rulemakings, including the STANDARDS FOR COMMERCIAL 1000 Independence Avenue SW.
current standards for residential electric REFRIGERATION EQUIPMENT Washington, DC 20585
and gas ranges and ovens, microwave Phone: 202 586–2192
ovens, dishwashers, dehumidifiers, and Priority:
commercial clothes washers. The Economically Significant. Major under
EPACT 2005 amendments to EPCA, RIN: 1904–AB59
5 USC 801.
established initial energy efficiency
standard level for commercial clothes Legal Authority:
washers. 42 USC 6313(c)
Statement of Need: CFR Citation:
The Department may determine that 10 CFR 431
separate rulemakings may be warranted
for some of these individual products Legal Deadline:
or equipment. Final, Statutory, January 1, 2009.
Alternatives: Abstract: FURNACES AND BOILERS
EPCA, as amended, requires DOE to The EPACT 2005 amendments to EPCA Priority:
conduct rulemaking to review require that standards be established for Economically Significant. Major under
standards and to revise standards to ice cream freezers; self-contained 5 USC 801.
achieve the maximum improvement in commercial refrigerators, freezers, and
energy efficiency that the Secretary refrigerator-freezers without doors; and Legal Authority:
determines is technically feasible and remote-condensing commercial 42 USC 6295(f)
economically justified. In making this refrigerators, freezers, and refrigerator-
determination, DOE conducts a freezers. CFR Citation:
thorough analysis of alternative 10 CFR 430
standard levels, including the existing Statement of Need:
standard, based on criteria specified in EPCA, as amended, requires that DOE Legal Deadline:
the statute. set energy efficiency standards that are Final, Statutory, January 1, 1994.

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72779

Abstract: with a national financial impact on the CFR Citation:

The Energy Policy and Conservation consumer in terms of national Net 10 CFR 431
Act (EPCA), as amended, establishes Present Value (NPV) ranging from $0.1
to $3.2 billion. (69 FR 45420) Legal Deadline:
initial energy efficiency standard levels
for most types of major residential Risks: Final, Statutory, October 24, 1996.
appliances and generally requires DOE At higher efficiency levels, consumers Abstract:
to undertake two subsequent risk unintended condensation of flue
rulemakings, at specified times, to Prior to enactment of EPACT 2005, the
gases, whereas, without changes to the Energy Policy and Conservation Act, as
determine whether the extant standard existing furnace and boiler standards,
for a covered product should be amended, (EPCA) did not establish
energy use and energy costs for energy efficiency standards for electric
amended. consumers will continue to increase. distribution transformers. EPCA
This is the initial review of the Enhancing appliance energy efficiency directed DOE to determine whether
statutory standards for residential also reduces atmospheric emissions standards for electric distribution
furnaces and boilers. such as CO2 and NOx. Establishing transformers were warranted. However,
standards that are too stringent could as a result of amendments adopted in
Statement of Need:
result in excessive increases in the cost EPACT 2005, Public Law No. 109-58,
Experience has shown that the choice of the product and possible reductions section 135(c)(4), EPCA now contains
of residential appliances and in product utility. It might also place standards for low voltage dry-type
commercial equipment being purchased an undue burden on manufacturers that electric distribution transformers, but
by both builders and building owners could result in loss of jobs or other not other types of distribution
is generally based on the initial cost adverse economic impacts. transformers. This rulemaking will
rather than on life-cycle costs. Thus, Timetable: determine whether it is appropriate to
the law requires minimum energy establish standards for these other types
efficiency standards for appliances to Action Date FR Cite
of electric distribution transformers.
eliminate inefficient appliances and ANPRM 09/08/93 58 FR 47326
equipment from the market. ANPRM 07/29/04 69 FR 45419 Statement of Need:
Summary of Legal Basis:
ANPRM Comment 11/10/04 Experience has shown that the choice
Period End of residential appliances and
EPCA establishes initial energy NPRM 10/06/06 71 FR 59204 commercial equipment being purchased
efficiency standard levels for most NPRM Comment 01/15/07 by both builders and building owners
types of major residential appliances Period End is generally based on the initial cost
and certain commercial equipment. Final Action 09/00/07 rather than on life-cycle cost. Thus, the
EPCA generally requires DOE to Regulatory Flexibility Analysis law requires minimum energy
undertake rulemakings, at specified Required: efficiency standards for appliances to
times, to determine whether the eliminate inefficient appliances and
standard for a covered product should No
equipment from the market.
be made more stringent. EPACT 2005 Government Levels Affected:
amended EPCA to authorize the Summary of Legal Basis:
Local, State
Department to set standards for EPCA authorizes the Department to
electricity used in furnaces to circulate Agency Contact: establish energy conservation standards
air through duct work. Section 135(c). Mohammed Kahn EE-2J for various consumer products and
Department of Energy commercial and industrial equipment,
Energy Efficiency and Renewable Energy including distribution transformers, if
The statute requires the Department to Office of Building Technologies Program DOE determines that energy
conduct rulemakings to review 1000 Independence Avenue SW. conservation standards would be
standards and to revise standards to Washington, DC 20585 technologically feasible and
achieve the maximum improvement in Phone: 202 586–7892 economically justified, and would
energy efficiency that the Secretary Email: result in significant energy savings.
determines is technologically feasible Title III of EPCA sets forth a variety
and economically justified. In making RIN: 1904-AA78
of provisions designed to improve
this determination, the Department energy efficiency. Part C of title III, 42
conducts a thorough analysis of the DOE—EE U.S.C. 6311 to 6317, establishes a
alternative standard levels, including program for ‘‘Certain Industrial
the existing standard, based on criteria Equipment,’’ similar to the one for
specified by statute. FINAL RULE STAGE consumer products in part B, and
includes distribution transformers.
Anticipated Cost and Benefits:
Since EPACT 2005, Public Law No.
The specific costs and benefits for this 31. ENERGY EFFICIENCY 109-58, section 135(c), establishes
rulemaking have not been established STANDARDS FOR ELECTRIC energy conservation standards for one
because the final standard levels have DISTRIBUTION TRANSFORMERS group of transformers, low-voltage, dry-
not been determined. Nevertheless, type distribution transformers, that
existing analysis from the Advance Priority: category will no longer be covered by
Notice of Proposed Rulemaking for Economically Significant. Major under this rulemaking.
energy conservation standards for 5 USC 801.
furnace and boilers projects saving Alternatives:
between 0.28 and 9.29 quadrillion Legal Authority: The statute requires DOE to conduct
BTUs of energy from 2012 to 2035, 42 USC 6317(a)(2) rulemakings to review standards and to

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72780 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

revise standards to achieve the Agency Contact: DOE does not complete the required
maximum improvement in energy Antonio Bouza, EE–2J rulemaking by January 1, 2007, energy
efficiency that the Secretary determines Department of Energy efficiency levels specified in the statute
is technologically feasible and Energy Efficiency and Renewable Energy go into effect for covered products
economically justified. In making this 1000 Independence Avenue SW. manufactured after January 1, 2009.
determination, the Department Washington, DC 20585 Timetable:
conducts a thorough analysis of Phone: 202 586–4563 Action Date FR Cite
alternative standard levels, including Fax: 202 586–4617
the existing standard, based on criteria Email: Legislative Date for 01/00/07
specified by statute. Final Rule
RIN: 1904–AB08 Standards Effective 01/01/09
Anticipated Cost and Benefits: Date (for products
manufactured after
DOE—EE 01/01/2009)
The specific costs and benefits for this
rulemaking have not been established 32. ENERGY EFFICIENCY Regulatory Flexibility Analysis
because the final standard levels have STANDARDS FOR CEILING FAN Required:
not been determined. Nevertheless, LIGHT KITS
existing analysis from the Notice of Priority:
Proposed Rulemaking, 71 FR 44356, for Government Levels Affected:
energy conservation standards for Economically Significant. Major under
5 USC 801. None
distribution transformers projects
savings of 2.4 quadrillion BTUs of Additional Information:
Legal Authority:
energy from 2010 to 2038, with a DOE will not complete the required
42 USC 6295(ff)(4)
national financial impact on the rulemaking by January 1, 2007. Thus,
consumer in terms of national Net CFR Citation: the statutory standards specified in 42
Present Value (NPV) up to 2.5 billion U.S.C. 6295 (ff)(4)(C) will go into effect
10 CFR 430
dollars. for products manufactured after January
Legal Deadline: 1, 2009.
Risks: Final, Statutory, January 1, 2007. Agency Contact:
At higher efficiency levels, the limited Abstract: Linda Graves, EE–2J
availability of some core steels is an Office of Building Technologies Program
The EPACT 2005 amendments to EPCA
important issue. Other issues that pose Department of Energy
require that DOE establish standards for
some risks include significant capital Energy Efficiency and Renewable Energy
ceiling fan light kits (other than those
investment requirements, core 1000 Independence Avenue SW.
with prescribed standards in EPACT
processing equipment, retooling, and Washington, DC 20585
2005) by January 1, 2007. If DOE does
R&D. Establishing standards that are too Phone: 202 586–1851
not meet this deadline, EPACT 2005
stringent could result in excessive Email:
specifies that the energy consumption
increases in the cost of the product, levels in 42 U.S.C. 6295 (ff)(4)(C) go RIN: 1904–AB61
with possible reductions in product into effect for products manufactured
utility (larger/bulkier/heavier after January 1, 2009. DOE—Departmental and Others
transformers), with additional pressure
Statement of Need: (ENDEP)
on some manufacturers to move
production out of the U.S. and a EPCA, as amended, require DOE to set
possible risk that some small appliance efficiency standards at
manufacturers would exit. technologically feasible and
economically justified levels.
Summary of Legal Basis: 33. ∑ LOAN GUARANTEES FOR
The EPACT 2005 amendments to EPCA
Determination Notice 10/22/97 62 FR 54809 authorize DOE to establish energy INNOVATIVE TECHNOLOGIES
ANPRM 07/29/04 69 FR 45375 conservation standards for ceiling fan Priority:
ANPRM Comment 11/09/04 light kits.
Period End Economically Significant. Major under
Alternatives: 5 USC 801.
NPRM 08/04/06 71 FR 44356
NPRM Comment 10/13/06 The statute requires DOE to conduct Legal Authority:
Period End rulemaking to review standards and to 42 USC 16511; 42 USC 16514
Final Action 09/00/07 revise standards to achieve the
maximum improvement in energy CFR Citation:
Regulatory Flexibility Analysis efficiency that the Secretary determines Not Yet Determined
Required: is technologically feasible and
economically justified. In making this Legal Deadline:
Undetermined determination, DOE conducts a None
thorough analysis of alternative
Government Levels Affected: standard levels, including the existing Abstract:
None standard, based on criteria specified by Title XVII of the Energy Policy Act of
statute. Pursuant to EPACT 2005, if 2005 authorizes the Secretary of

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72781

Energy, after consultation with the DOE—ENDEP Alternatives:

Secretary of the Treasury, to make loan
guarantees for projects that ‘‘avoid, The Department could continue to
reduce, or sequester air pollutants or FINAL RULE STAGE impose nuclear safety requirements
anthropogenic emissions of greenhouse through directives made applicable to
gases; and employ new or significantly DOE contractors through the terms of
improved technologies as compared to 34. RADIATION PROTECTION OF THE their contracts.
commercial technologies in service in PUBLIC AND THE ENVIRONMENT
Anticipated Cost and Benefits:
the United States at the time the Priority:
guarantee is issued.’’ Following The incremental costs of the proposed
publication of guidelines to govern an Other Significant rules should be minimal because
initial solicitation of projects seeking Legal Authority: contractors are currently bound by
Federal loan guarantees in August comparable contractual obligations.
42 USC 2201; 42 USC 7191
2006, this proposed rulemaking will Full compliance by contractors with
establish policies and procedures CFR Citation: nuclear safety standards will result in
applicable to all subsequent 10 CFR 834 substantial societal benefits.
solicitations for project proposals. The
default and audit provisions of the Legal Deadline: Risks:
proposed rulemaking, however, will be None
applicable to all solicitations. This rulemaking should reduce the risk
Abstract: of nuclear safety problems by clarifying
Statement of Need: This action would add a new 10 CFR safety requirements applicable to DOE
834 to DOE’s regulations establishing a contractors and improving compliance.
A principal purpose of the loan body of rules setting forth the basic
guarantee program is to encourage early Timetable:
requirements for ensuring radiation
commercial use in the United States of protection of the public and Action Date FR Cite
new or significantly improved environment in connection with DOE
technologies in energy projects. By NPRM 03/25/93 58 FR 16268
nuclear activities. These requirements
facilitating the employment of such Second NPRM 08/31/95 60 FR 45381
stem from the Department’s ongoing
technologies, we can meet the principal effort to strengthen the protection of Second NPRM 10/02/95
energy challenges of enhancing energy Comment Period
health, safety, and the environment End
security, repairing and modernizing our from the nuclear and chemical hazards
Integrate New EPA 12/00/06
energy infrastructure, promoting energy posed by these DOE activities. Major Guidance
conservation, and increasing our energy elements of the proposal include a dose
Final Action 10/00/08
supplies in ways that protect and limitation system for protection of the
improve the environment. public; requirements for application Regulatory Flexibility Analysis
optimization (As Low As is Reasonably Required:
Timetable: Achievable, ALARA) process;
Action Date FR Cite requirements for liquid discharges; No
reporting and monitoring requirements;
NPRM 12/00/06 and residual radioactive material Government Levels Affected:
Final Action 10/00/07 requirements.
Regulatory Flexibility Analysis Statement of Need:
Required: The purpose of this rule is to ensure Additional Information:
that the Department’s obligation to
No The Environmental Protection Agency
protect health and safety is fulfilled
(EPA) is considering revising the
and to provide, if needed, a basis for
Government Levels Affected: the imposition of civil and criminal Federal Guidance for Radiation
penalties consistent with the Price- Protection of the Public. This
None Presidential-level guidance would
Anderson Amendments Act of 1988.
This action is consistent with the refine the radiation protection and dose
Agency Contact:
Department’s commitment to the limitation framework for the public,
Warren Belmar issuance of nuclear safety requirements and may include numerical Radiation
Deputy General Counsel for Energy Policy using notice and comment rulemaking. Protection Goals (i.e., dose limits).
Department of Energy Because it is DOE’s preference to be
1000 Independence Avenue, SW. Summary of Legal Basis: consistent with Federal radiation
Washington, DC 20585 Under the Atomic Energy Act of 1954, protection policy, the Department is
Phone: 202 586–6758 as amended, the Department of Energy adjusting the schedule for part 834 in
Email: has the authority to regulate activities anticipation of revised Federal
at facilities under its jurisdiction. The Guidance and will issue the rule
RIN: 1901–AB21 Department is committed to honoring following EPA action on the guidance.
its obligation to ensure the health and This will allow DOE to be consistent
safety of the public and workers with the most current Presidential-level
affected by its operations and the guidance upon its release.
protection of the environs around its

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72782 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Agency Contact:
Andrew Wallo III
Director, Office of Air, Water and
Radiation Protection, Policy and
Department of Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586–4996
Fax: 202 586–3915
RIN: 1901–AA38

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72783

DEPARTMENT OF HEALTH AND methodology for setting payment HHS—Centers for Disease Control and
HUMAN SERVICES (HHS) amounts for durable medical Prevention (CDC)
equipment; and
Statement of Regulatory Priorities
• final rules for hospital inpatient
The Department of Health and Human services for fiscal year 2008 and for FINAL RULE STAGE
Services (HHS) conducts a broad range long-term-care hospital services for
of programs mandated by Congress to rate year 2008.
protect and promote the health and 35. CONTROL OF COMMUNICABLE
well-being of all Americans, focused Medicare Part D DISEASES, INTERSTATE AND
especially on those least able to help The Secretary believes that every FOREIGN QUARANTINE
themselves. HHS responsibilities senior must have access to affordable
include: Medicare, Medicaid, support prescription drugs, and that a reinforced Priority:
for public health preparedness, regulatory framework for implementing Economically Significant. Major under
biomedical research, substance abuse the Medicare prescription drug benefit 5 USC 801.
and mental health treatment, assurance can further connect beneficiaries with
the Part D program. The Plan Unfunded Mandates:
of safe and effective drugs and other
medical products, food safety, financial accordingly includes a proposal to This action may affect the private
assistance to low income families, Head clarify current provisions affecting Part sector under PL 104-4.
Start, services to older Americans, and D Prescription Drug Plan sponsors and
Legal Authority:
direct health services delivery. Medicare Advantage organizations, and
the above-cited proposal for the Not Yet Determined
Since assuming the leadership of
HHS, Secretary Michael O. Leavitt has adoption of final standards for the CFR Citation:
consistently sought to make transparent electronic transmission of basic
prescription-drug data. 42 CFR 70; 42 CFR 71
his approach to overseeing the
Department’s programs, through his use Disease Prevention Legal Deadline:
of a 500-Day Plan and a recent statement Also included among the Secretary’s None
of his nine major priorities. The 500-Day priorities is an emphasis on disease
Plan and the statement of priorities are Abstract:
prevention and the need for individual
available for public review at responsibility for personal wellness. By statute, the Secretary of Health and Three actions in the Plan reflect this Human Services has broad authority to
secretaryspage.html. The regulatory concern: prevent introduction, transmission, and
actions noted below reflect this policy spread of communicable diseases from
framework. • a final rule establishing good foreign countries into the United States
manufacturing practices for the and from one State or possession into
Health Information Technology dietary-supplement products favored another. Quarantine regulations are
The Secretary’s strategy for promoting by many Americans; divided into two parts: Part 71 dealing
improvements in the Nation’s health • a proposal to modify prescription with foreign arrivals and part 70
sector stresses maximum use of drug labeling so that health care dealing with interstate matters. The
electronic information technology. The providers may better understand and Secretary has delegated the authority to
FY 2007 Regulatory Plan accordingly communicate to their patients the prevent the introduction of diseases
includes a notice of proposed risks and benefits associated with the from foreign countries to the Director,
rulemaking to require that clinical study use of prescribed medicines during CDC. CDC maintains quarantine
data be provided to the Food and Drug pregnancy and lactation, and stations at eight major airports with
Administration (FDA) in electronic quarantine inspectors who respond to
format, using standard data structures, • a proposal to amend existing
regulations governing investigational reports of diseases from carriers.
terminology, and code sets. The change According to the statutory scheme, the
would further increase the efficiency of new drugs — the rule would delineate
new avenues of access for patients to President determines through Executive
the agency’s review processes, speeding order which diseases may subject
up the availability of new therapies. obtain investigational drugs for
treatment use. individuals to quarantine. The current
Additionally, the Plan includes: disease list, which was last updated in
proposed actions to require medical- Food Safety April 2005, includes cholera,
device firms to register electronically diphtheria, tuberculosis, plague,
The Secretary’s 500-Day Plan also
with the FDA, as well as to report post- smallpox, yellow fever, viral
embraces the need to secure the
marketing information to the agency hemorrhagic fevers, and Severe Acute
homeland. The Regulatory Plan thus
electronically; and a proposal for the Respiratory Syndrome (SARS) and
adoption of final standards for the influenza caused by novel or
electronic transmission of basic • a proposal to require owners or reemergent influenza virus that are
prescription-drug data. consignees to label imported food that causing, or have the potential to cause,
has previously been refused entry into a pandemic.
Medicare Modernization the United States. This action would
The Secretary’s statement of priorities prevent the introduction of unsafe Statement of Need:
includes a focus on Medicare food and facilitate the examination of The quarantine of persons believed to
modernization. The Regulatory Plan, imported food; and be infected with communicable
accordingly, highlights: • a final rule completing the rulemaking diseases is a long-term prevention
• a proposal to institute competitive process requiring that the FDA be measure that has been used effectively
bidding procedures to improve the notified prior to the entry of imported to contain the spread of disease. As
effectiveness of Medicare’s current food into the United States. diseases evolve due to natural

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72784 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

occurrences or man-made events, it is Anticipated Cost and Benefits: Legal Authority:

important to ensure that prevention 21 USC 355; 21 USC 371; 42 USC 262
The primary cost impact of the
procedures reflect new threats and proposed rule would be the collection
uniform ways to contain them. Recent CFR Citation:
and maintenance of crew and passenger
experiences with emerging infectious manifest data by air and water carriers 21 CFR 314.50; 21 CFR 601.12; 21 CFR
diseases such as West Nile Virus, that are likely to modify computer 314.94; 21 CFR 314.96
SARS, and monkeypox have illustrated systems and collect passenger
the rapidity with which disease may Legal Deadline:
information to come into compliance.
spread throughout the world, and the None
The benefits of the rule would be
impact communicable diseases, when measured in terms of the number of Abstract:
left unchecked, may have on the global deaths and illnesses prevented by rapid
economy. Stopping an outbreak — The Food and Drug Administration is
intervention. When the costs and proposing to amend the regulations
whether it is naturally occurring or benefits of the rule are considered over
intentionally caused — requires the use governing the format in which clinical
a 20-year period benefits clearly study data and bioequivalence data are
of the most rapid and effective public outweigh costs.
health tools available. One of those required to be submitted for new drug
tools is quarantine — restricting the Risks: applications (NDAs), biological license
movement of persons exposed to applications (BLAs), and abbreviated
Failure to move forward with this new drug applications (ANDAs). The
infection to prevent them from rulemaking would hinder the Nation’s
infecting others, including family proposal would revise our regulations
ability to use the most rapid and to require that data submitted for
members, friends, and neighbors. effective public health tools available NDAs, BLAs, and ANDAs, and their
Quarantine of exposed persons may be when responding to public health supplements and amendments be
the best initial way to prevent the emergencies and disease threats. provided in an electronic format that
uncontrolled spread of highly
Timetable: FDA can process, review, and archive.
dangerous biologic agents — especially
The proposal would also require the
when combined with other health Action Date FR Cite use of standardized data structure,
strategies such as vaccination, terminology, and code sets contained in
prophylactic drug treatment, patient NPRM 11/30/05 70 FR 71892
Final Action 08/00/07 current FDA guidance (the Study Data
isolation, and other appropriate Tabulation Model (SDTM) developed
infection control measures. Regulatory Flexibility Analysis by the Clinical Data Interchange
Required: Standards Consortium) to allow for
Summary of Legal Basis: more efficient and comprehensive data
These regulations would be proposed review.
under the authority of 25 U.S.C. 198, Small Entities Affected: Statement of Need:
231, 2001; 42 U.S.C. 243, 264 to 271. Businesses Before a drug is approved for
In addition, section 361(b) of the Public
Government Levels Affected: marketing, FDA must determine that
Health Service Act (42 U.S.C. 264(b))
the drug is safe and effective for its
authorizes the ‘‘apprehension, None intended use. This determination is
detention, or conditional release’’ of based in part on clinical study data and
persons to prevent the introduction, Agency Contact: bioequivalence data that are submitted
transmission, and spread of specified Ram Koppaka M.D., Ph.D as part of the marketing application.
communicable diseases from foreign Department of Health and Human Study data submitted to FDA in
countries into the United States and Services electronic format have generally been
from one State or possession into Centers for Disease Control and more efficient to process and review.
another. Among other public health Prevention
powers, the lawful ability to inspect FDA’s proposed rule would require the
MS–E–03 submission of study data in a
property, to medically examine and 1600 Clifton Road
monitor persons, and to detain or standardized electronic format, and it
Atlanta, GA 30333 provides that the specific format will
quarantine exists in current regulations. Phone: 404 498–2308
Acknowledging the critical importance be announced in FDA guidance.
of protecting the public’s health, long- RIN: 0920–AA12 Electronic submission of study data
standing court decisions uphold the would improve patient safety and
ability of Congress and State enhance health care delivery by
HHS—Food and Drug Administration enabling FDA to process, review, and
legislatures to enact quarantine and (FDA)
other public health laws, and to have archive data more efficiently.
them executed by public health Standardization would also enhance
officials. the ability to share study data and
PROPOSED RULE STAGE communicate results. Investigators and
Alternatives: industry would benefit from the use of
standards throughout the lifecycle of a
These regulations are necessary to 36. ELECTRONIC SUBMISSION OF study—in data collection, reporting,
ensure that HHS has the tools it needs DATA FROM STUDIES EVALUATING and analysis. The proposal would work
to respond to public health emergencies HUMAN DRUGS AND BIOLOGICS in concert with ongoing agency and
and disease threats. Any less stringent national initiatives to support increased
alternatives would prevent the use of electronic technology as a means
Department from the most effective Other Significant. Major status under 5 to improve patient safety and enhance
possible pursuit of this objective. USC 801 is undetermined. health care delivery.

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72785

Summary of Legal Basis: Risks: Statement of Need:

Our legal authority to amend our None. Under FDA’s current regulations,
regulations governing the submission labeling concerning the use of
and format of clinical study data and Timetable: prescription drugs in pregnancy uses
bioequivalence data for human drugs Action Date FR Cite letter categories (A, B, C, D, X) to
and biologics derives from sections 505 NPRM 03/00/07 characterize the risk to the fetus of
and 701 of the act (U.S.C. 355 and 371) using the drug during pregnancy.
and section 351 of the Public Health Regulatory Flexibility Analysis Dissatisfaction with the category system
Service Act (42 U.S.C. 262). Required: has been expressed by health care
providers, medical organizations,
Alternatives: Yes experts in the study of birth defects,
FDA considered issuing a guidance Small Entities Affected: women’s health researchers, and
document outlining the electronic women of childbearing age. These
submission and the standardization of Businesses stakeholders have expressed the view
study data, but not requiring electronic that the current categories are confusing
submission of the data in the Government Levels Affected:
and overly simplistic and thus are not
standardized format. This alternative None adequate to communicate risks
was rejected because the agency would effectively. One of the deficiencies of
not fully benefit from standardization Agency Contact: the category system is that drugs may
until it became the industry standard, Martha Nguyen be assigned to the same category when
which could take up to 20 years. Regulatory Counsel the severity, incidence, and types of
We also considered a number of Department of Health and Human risk are quite different.
different implementation scenarios, Services Stakeholders consulted through a
from shorter to longer time-periods. Food and Drug Administration public hearing, several focus groups,
The two-year time-period was selected Center for Drug Evaluation and Research and several advisory committees have
because the agency believes it would Office of Regulatory Policy recommended that FDA replace the
provide ample time for applicants to 5515 Security Lane, Suite 1101 (HFD–7) category system with a concise
comply without too long a delay in the Rockville, MD 20852 narrative summarizing a product’s risks
effective date. A longer time-period Phone: 301 594–2041 to pregnant women and to women of
would delay the benefit from the Fax: 301–827–5562 childbearing age. It has also been
increased efficiencies, such as Email: strongly recommended that pregnancy
standardization of review tools across RIN: 0910–AC52 labeling address the situation where a
applications, and the incremental cost woman has taken drugs before she
saving to industry would be small. realizes she is pregnant. The labeling
HHS—FDA that would be required under the
Anticipated Cost and Benefits:
37. CONTENT AND FORMAT OF proposed rule would be responsive to
Approximately 70 percent of study data the concerns discussed above, and
for NDAs and ANDAs are already LABELING FOR HUMAN
PRESCRIPTION DRUGS AND others that have been expressed by
submitted to FDA in electronic format critics of the current category system.
consistent with our current guidance on BIOLOGICS; REQUIREMENTS FOR
electronic submission of data. The PREGNANCY AND LACTATION Summary of Legal Basis:
other 30 percent is either submitted on LABELING
FDA has broad authority under sections
paper or in non-standardized electronic Priority: 201, 301, 501, 502, 503, 505, and 701
format. FDA estimates that the costs to of the Federal Food, Drug, and
industry resulting from the proposal Other Significant
Cosmetic Act (the Act) (21 U.S.C. 321,
would include some one-time costs and Legal Authority: 331, 351,352, 353, 355, and 371) and
possibly some annual recurring costs. section 351 of the Public Health Service
One-time costs would include, among 21 USC 321; 21 USC 331; 21 USC 351 Act (42 U.S.C. 262) to help ensure that
other things, the cost of converting data to 353; 21 USC 355; 21 USC 358; 21 prescription drugs (including biological
to standard structures, terminology, and USC 360; 21 USC 360b; 21 USC 360gg products that are regulated as drugs)
cost sets (i.e., purchase of software to to 360ss; 21 USC 371; 21 USC 374; 21 are safe and effective for their intended
convert data); the cost of submitting USC 379e; 42 USC 216; 42 USC 241; uses. A major part of FDA’s efforts
electronic data (i.e., purchase of file 42 USC 262; 42 USC 264 concerning the safe and effective use
transfer programs); and the cost of of drug products involves review,
installing and validating the software CFR Citation:
approval, and monitoring of drug
and training personnel. Additional 21 CFR 201.56; 21 CFR 201.57; 21 CFR labeling. Under section 502(f)(1) of the
annual recurring costs may result from 201.80 Act, a drug is misbranded unless its
software purchases and licensing labeling bears ‘‘adequate directions for
agreements for use of proprietary Legal Deadline:
use’’ or it is exempted from this
terminologies. None requirement by regulation. Under
The proposal could result in many section 201.100 (21 CFR 201.100), a
long-term benefits for industry, prescription drug is exempted from the
including improved patient safety To amend the regulations governing the requirement in section 502(f)(1) of the
through faster, more efficient, format and content of labeling for Act only if, among other things, it
comprehensive, and accurate data human prescription drugs and contains the information required and
review; enhanced communication biological products (21 CFR 201.56, in the format specified by sections
among sponsors and clinicians. 201.57, and 201.80). 201.56 and 201.57.

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72786 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Under section 502(a) of the Act, a drug knew they were pregnant. Such Statement of Need:
product is misbranded if its labeling is information may often be reassuring to The Food and Drug Administration
false or misleading in any particular. women and their health care providers. Modernization Act of 1997
Under section 505(d) and 505(e) of the (Modernization Act) amended the
Act, FDA must refuse to approve an Federal Food, Drug, and Cosmetic Act
application or may withdraw approval None. (the Act) to include specific provisions
of an application if the labeling for the Timetable: concerning expanded access to
drug is false or misleading in any investigational drugs for treatment use.
particular. Section 201(n) of the Act Action Date FR Cite
In particular, section 561(b) of the Act
provides that in determining whether NPRM 03/00/07 permits any person, acting through a
the labeling of a drug is misleading, licensed physician, to request access to
there shall be taken into account not Regulatory Flexibility Analysis
Required: an investigational drug to diagnose,
only representations or suggestions monitor, or treat a serious disease or
made in the labeling, but also the Undetermined condition provided that a number of
extent to which the labeling fails to conditions are met. The proposed rule
Small Entities Affected:
reveal facts that are material in light is needed to incorporate into FDA’s
of such representations or material with Businesses regulations this and other provisions of
respect to consequences which may Government Levels Affected: the Modernization Act concerning
result from use of the drug product access to investigational drugs.
under the conditions of use prescribed None
In addition, by this proposed rule, the
in the labeling or under customary Agency Contact: Agency seeks to increase awareness and
conditions of use.
Christine F. Rogers knowledge of expanded access
These statutory provisions, combined Regulatory Counsel programs and the procedures for
with section 701(a) of the Act and Department of Health and Human obtaining investigational drugs for
section 351 of the Public Health Service Services treatment use. The proposed rule
Act, clearly authorize FDA to publish Food and Drug Administration would assist in achieving this goal by
a proposed rule designed to help Center for Drug Evaluation and Research describing in detail the criteria,
ensure that practitioners prescribing 5515 Security Lane submission requirements, and
drugs (including biological products) to Rockville, MD 20852 safeguards applicable to different types
pregnant women and women of Phone: 301 594–2041 of treatment uses.
childbearing age would receive Fax: 301 827–5562 Summary of Legal Basis:
information essential to the safe and Email:
effective use of these drugs. FDA has the authority to impose
RIN: 0910–AF11 requirements concerning the treatment
Alternatives: use of investigational drugs under
The alternatives to the proposal include HHS—FDA various sections of the Act, including
not amending our existing regulation sections 505(i), 561, and 701(a) (21
governing the format and content of 38. EXPANDED ACCESS TO U.S.C. 355(i), 360bbb, and 371(a)).
labeling for human prescription drugs INVESTIGATIONAL DRUGS FOR Section 505(i) of the Act directs the
and biological products. This TREATMENT USE Secretary to promulgate regulations
alternative is inconsistent with Priority: exempting from the operation of the
widespread stakeholder dissatisfaction new drug approval requirements drugs
with the pregnancy labeling provided Other Significant intended solely for investigational use
pursuant to the current regulation. Legal Authority: by experts qualified by scientific
training and expertise to investigate the
Anticipated Cost and Benefits: 21 USC 355; 21 USC 360bbb; 21 USC safety and effectiveness of drugs. The
The proposed rule would impose one- 371; 42 USC 262 proposed rule explains procedures and
time costs for firms to modify drug CFR Citation: criteria for obtaining FDA authorization
product labeling. The extent of these for treatment uses of investigational
modifications would depend on 21 CFR 312.42; 21 CFR 312.300; 21
whether a product’s labeling is affected CFR 312.305; 21 CFR 312.310; 21 CFR
312.315; 21 CFR 312.320 The Modernization Act provides
by the physician labeling final rule significant additional authority for this
(PLR) and on the scope of the Legal Deadline: proposed rule. Section 561(a) states that
implementation. the Secretary may, under appropriate
The revised format and the information conditions determined by the Secretary,
provided in the labeling would make Abstract: authorize the shipment of
it easier for health care providers to To amend the regulations governing investigational drugs for the diagnosis,
understand the risks and benefits of investigational new drugs to describe monitoring, or treatment of a serious
drug use during pregnancy and the ways patients may obtain disease or condition in emergency
lactation. A better understanding of investigational drugs for treatment use situations. Section 561(b) allows any
risks and benefits would help women under expanded access programs. Such person, acting through a physician
and their healthcare providers make use of investigational drugs would be licensed in accordance with State law,
informed decisions about whether or available to: (1) Individual patients, to request from a manufacturer or
not to use drugs during pregnancy and including in emergencies; (2) distributor an investigational drug for
lactation. Labeling under the rule intermediate size patient populations; the diagnosis, monitoring, or treatment
would also provide information geared and (3) larger populations under a of a serious disease or condition if
to women who took drugs before they treatment protocol or treatment IND. certain conditions are met. Section

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72787

561(c) closely tracks existing FDA’s settings. In particular, the clarification food that is refused entry into the
existing regulation at 21 CFR 312.34 of eligibility criteria and submission United States. The label would read,
providing for treatment use by large requirements would enhance patient ’’UNITED STATES: REFUSED ENTRY.’’
patient populations under a treatment access by easing the administrative The proposal would describe the label’s
protocol or treatment IND if a number burdens on individual physicians characteristics (such as its size) and
of conditions are met. seeking investigational drugs for their processes for verifying that the label
Section 701(a) provides the Secretary patients and on sponsors who make has been affixed properly. We are
with the general authority to investigational drugs available for taking this action to prevent the
promulgate regulations for the efficient treatment use. introduction of unsafe food into the
enforcement of the Act. By clarifying United States, to facilitate the
Risks: examination of imported food, and to
the criteria and procedures relating to
treatment use of investigational The agency foresees no risks associated implement section 308 of the Public
products, this proposed rule is with the proposed rule. Health Security and Bioterrorism
expected to aid in the efficient Timetable: Preparedness and Response Act of 2002
enforcement of the Act. (the Bioterrorism Act) (Pub. L. 107-
Action Date FR Cite 188).
Alternatives: NPRM 12/00/06
Statement of Need:
One alternative to the proposed rule
that FDA considered was not to Regulatory Flexibility Analysis In 1998, the General Accounting Office
propose regulations implementing the Required: issued a report titled, ‘‘Food Safety:
expanded access provisions of the Yes Federal Efforts to Ensure the Safety of
Modernization Act. However, the Imported Foods Are Inconsistent and
Agency believes that implementing Small Entities Affected: Unreliable.’’ The report stated that
regulations would further improve the Organizations some food importers evade import
availability of investigational drugs for controls and are able to introduce
treatment use by providing clear Government Levels Affected: contaminated, adulterated, or unsafe
direction to sponsors, patients, and None food into the United States even after
licensed physicians about the criteria FDA refused to admit the food and the
for authorizing treatment use and what Agency Contact: Customs Service ordered the food to be
information must be submitted to FDA. Christine F. Rogers reexported or destroyed.
Another alternative FDA considered Regulatory Counsel Additionally, in 1998, the Senate
was to propose a regulation describing Department of Health and Human Permanent Subcommittee on
only individual patient and large scale Services Investigations conducted hearings on
expanded access criteria. However, the Food and Drug Administration the safety of food imports. The
Agency concluded that it would be Center for Drug Evaluation and Research subcommittee heard testimony about
preferable to have a third category of 5515 Security Lane reimporting refused foods through
expanded access for intermediate size Rockville, MD 20852 another port (a practice known as ‘‘port
patient populations. Phone: 301 594–2041 shopping’’). On July 3, 1999, then-
Fax: 301 827–5562 President Clinton issued a
Anticipated Cost and Benefits: Email: memorandum to the Secretary of Health
FDA expects that the total one-time RIN: 0910–AF14 and Human Services and the Secretary
costs of the proposed rule will be of the Treasury directing them, in part,
negligible. The Agency expects that the to take all actions available to ‘‘prohibit
annual and annualized costs of the HHS—FDA the reimportation of food that has been
proposed rule will range from a low 39. LABEL REQUIREMENT FOR FOOD previously refused admission and has
of about $130,000 to $260,000 in the THAT HAS BEEN REFUSED not been brought into compliance with
first year following publication of any ADMISSION INTO THE UNITED United States laws and regulations’’ by
final rule based on this proposal, to a STATES requiring the marking of shipping
high of about $350,000 to $690,000 in containers and/or papers of imported
the 4th and 5th years. These estimates Priority: food that is refused admission for safety
suggest that total annual and Other Significant reasons.
annualized costs for the proposed rule Consequently, on January 22, 2001,
would be between $1.4 million and Legal Authority: FDA and the Department of the
$2.7 million for the 5-year period 15 USC 1453 to 1455 ; 21 USC 321; Treasury jointly issued a proposed rule
following implementation of any final 21 USC 342; 21 USC 343; 21 USC 371; (66 FR 6502) that would require that
rule based on this proposal. The 21 USC 374; 21 USC 381; 42 USC 216; imported food that has been refused
Agency also expects that the estimated 42 USC 264 admission for safety reasons be marked
incremental cost burdens associated as ‘‘UNITED STATES: REFUSED
with this proposed rule are likely to CFR Citation: ENTRY.’’ The mark would make it
be widely dispersed among affected 21 CFR 1.98 easier to detect previously refused food
entities. and reduce, if not eliminate, ‘‘port
The benefits of the proposed rule are Legal Deadline: shopping.’’ However, on June 12, 2002,
expected to result from improved None before FDA and Treasury could
patient access to investigational drugs prescribe a final rule, the Bioterrorism
generally and from treatment use being Abstract: Act became law. Section 308(a) of the
made available for a broader variety of The proposed rule would require Bioterrorism Act created a new section
disease conditions and treatment owners or consignees to label imported 801(n) of the Federal Food, Drug, and

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72788 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Cosmetic Act (the act) to clarify FDA’s Additionally, section 301 of the Public food. The Agency is unable to quantify
authority to require the owner or Health Service Act (PHS act) authorizes the amount of illegal importation of
consignee of a food that had been FDA to ‘‘render assistance’’ to previously refused foods, so it cannot
refused admission into the United appropriate health authorities in the accurately predict the value of reduced
States to ‘‘affix to the container of the conduct of or to promote coordination illnesses and injury.
food a label that clearly and of research, investigations, experiments,
conspicuously bears the statement: demonstrations, and studies relating to Risks:
‘UNITED STATES: REFUSED ENTRY’.’’ the causes, diagnosis, treatment, There is a possible risk previously
Although section 308(c) of the control, and prevention of disease. refused, unpackaged food (such as
Bioterrorism Act stated that ’’nothing in Section 361 of the PHS act authorizes loose grain in a railroad car) would be
this section shall be construed to limit FDA to issue regulations to prevent the able to enter the United States because
the authority of the Secretary of Health introduction, transmission, or spread of the food itself cannot be labeled,
and Human Services or the Secretary communicable diseases into the United although the proposed rule would
of the Treasury to require the marking States. Affixing a label to refused food require the importer or consignee to
of refused articles of food under any products will help foreign health affix a label on papers accompanying
other provision of law,‘‘ the new officials determine whether to take the product.
statutory provision differed from the regulatory action against a particular Timetable:
January 22, 2001, proposed rule and product. It would also alert foreign
prompted FDA to withdraw the officials to previously refused food and Action Date FR Cite
proposal on August 21, 2002 (67 FR help prevent the introduction, NPRM 04/00/07
54138). transmission, or spread of
communicable diseases into the United Regulatory Flexibility Analysis
The new proposal would describe the Required:
States by making it more difficult for
label requirements for imported food
unsafe food to reenter the United Yes
that has been refused admission into
the United States. Small Entities Affected:
Summary of Legal Basis: Businesses
FDA considered exempting small
Section 801(a) of the act authorizes businesses from the rule, but, because Government Levels Affected:
FDA to refuse to admit imported food most importers and consignees would Undetermined
if the food has been manufactured, qualify as small businesses, this would
processed, or packed under insanitary negate the rule’s purpose. Agency Contact:
conditions, is forbidden or restricted in
The agency also considered ordering Philip L. Chao
sale in the country in which it was
the destruction of all refused food Senior Policy Analyst
produced, or is adulterated or
imports, but this would not be feasible Department of Health and Human
misbranded. Additionally, as explained
because it would divert Federal Services
earlier, section 801(n) of the act gives
resources to supervising or otherwise Food and Drug Administration
FDA express authority to require the
ensuring that the refused food imports Office of Policy and Planning (HF–23)
owner or consignee of a food that had
are stored until they can be destroyed 5600 Fishers Lane, Room 14C–17
been refused admission into the United
and that they are destroyed. Rockville, MD 20857
States to ‘‘affix to the container of the
FDA also rejected affixing the label on Phone: 301 827–0587
food a label that clearly and
some, but not all, imported food Fax: 301 827–4774
conspicuously bears the statement:
refused entry for safety reasons. While Email:
this alternative would be less costly, it RIN: 0910–AF61
Sections 402 and 403 of the act would also be less efficient because
describe when a food is adulterated or some refused food imports would be
misbranded respectively. Section 701(a) able to reenter the United States and HHS—FDA
of the act authorizes FDA to issue because a previously-refused, but 40. ∑ MEDICAL DEVICE REPORTING;
regulations for the efficient enforcement unlabeled, food would be difficult to ELECTRONIC SUBMISSION
of the Act, while section 701(b) of the detect compared to a previously-refused REQUIREMENTS
act authorizes FDA and the Department and labeled food. This alternative
of the Treasury to jointly prescribe would also result in arguments as to Priority:
regulations for the efficient enforcement the criteria to be applied and whether Other Significant
of section 801 of the act. a particular food should be labeled.
The proposed rule is within FDA’s Legal Authority:
Anticipated Cost and Benefits:
authority at sections 402, 403, 701, and 21 USC 352; 21 USC 360; 21 USC 360i;
801 of the act. In general, unsafe food Importers and consignees would bear 21 USC 360j; 21 USC 371; 21 USC 374
is often adulterated under section 402 the costs associated with affixing the
of the act, and may also be misbranded label to refused food imports. The CFR Citation:
under section 403 of the act if the food rule’s costs would, therefore, consist of 21 CFR 803
purports to meet a particular definition, labor costs (to affix the mark) and
standard of identity, or standard of equipment costs (the label equipment Legal Deadline:
quality. Labeling refused foods will used). FDA will estimate these costs in None
make it easier for FDA to refuse to the proposed rule.
admit previously-refused, adulterated The rule’s principal benefit would be Abstract:
or misbranded food imports into the a reduction in the number of illnesses The Food and Drug Administration
United States. and injuries caused by unsafe imported (FDA) is proposing to amend its

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postmarket medical device reporting Risks: that do not have access to the web,
regulations to require that reports None FDA would offer an avenue by which
submitted to the agency by persons they can register, list, and update
subject to mandatory reporting Timetable: information with a paper submission.
requirements be transmitted Action Date FR Cite
electronically in a form that FDA can Statement of Need:
NPRM 03/00/07
process, review, and archive. FDA is FDA is proposing to amend the medical
taking this action to improve the Regulatory Flexibility Analysis device establishment registration and
agency’s systems for collecting and Required: listing requirements under 21 CFR part
analyzing postmarketing safety reports. 807 to reflect the new requirements in
The proposed change would help the section 321 of the Public Health
agency to more quickly review safety Government Levels Affected: Security and Bioterrorism Preparedness
reports and identify emerging public Undetermined and Response Act of 2002 (BT Act) and
health issues. Section 207 of the Medical Device User
Federalism: Fee and Modernization Act of 2002
Statement of Need:
Undetermined (MDUFMA). This proposed rule would
The proposed rule would require user improve FDA’s device establishment
facilities and medical device Agency Contact: and registration and listing system and
manufacturers and importers to send utilize the latest technology in the
Myrna Hanna
medical device adverse event reports collection of this information.
Regulations Staff
electronically instead of using a paper
Department of Health and Human Summary of Legal Basis:
form. FDA is taking this action to
improve its adverse event reporting The statutory basis for our authority
Food and Drug Administration
program by enabling it to more quickly includes sections 510(a) through (j),
Center for Devices and Radiological
receive and process these reports. 510(p), 701, 801, and 903 of the Federal
Summary of Legal Basis: HFZ–215 Food, Drug, and Cosmetic Act.
1350 Piccard Drive, PI50 RM150F Alternatives:
The agency has legal authority under
Rockville, MD 20850
section 519 of the Federal Food, Drug, The alternatives to this rulemaking
Phone: 240 276–2347
and Cosmetic Act to require adverse include not updating the registration
Fax: 240 276–2352
event reports. The proposed rule would and listing regulations and not
require manufacturers, importers, and requiring the electronic submission of
user facilities to change their RIN: 0910–AF86
registration and listing information.
procedures to send reports of medical Because of the new statutory
device adverse events to FDA requirements, and the advances in data
electronically instead of using a hard collection and transmission technology,
copy form. 41. ∑ ELECTRONIC REGISTRATION FDA believes this rulemaking is the
AND LISTING FOR DEVICES preferable alternative to the paper
Priority: system currently in place.
The alternatives to this rulemaking
include not updating the medical Other Significant Anticipated Cost and Benefits:
device reporting requirements and not
requiring electronic submission of this Legal Authority: The agency believes that there may be
information. For over 20 years, medical some one-time costs associated with the
PL 107–188, sec 321; 21 USC 360(p)
device manufacturers, importers, and rulemaking, which involve resource
user facilities have sent adverse event CFR Citation: costs of familiarizing users with the
reports to FDA on paper forms. electronic system. Recurring costs
21 CFR 807
Processing paper forms is a time related to submission of the
consuming and expensive process. FDA Legal Deadline: information by domestic firms would
believes this rulemaking is the None probably remain the same or decrease
preferable alternative. because a paper submission and
Abstract: postage is not required. There might be
Anticipated Cost and Benefits: FDA is proposing to amend the medical some increase in the financial burden
FDA estimates that over 80 percent of device establishment registration and on foreign firms since they will have
the adverse event reports it receives listing requirements under 21 CFR 807 to supply additional registration
come directly from the reporter’s to reflect the new requirements in information as required by Section 321
computer databases. Computer section 321 of the Public Health of the BT Act.
applications are available that would Security and Bioterrorism Preparedness Risks:
take the information from the corporate and Response Act of 2002 and 21 USC
database and produce an electronic file 360(p). This proposed rule would None
that can be sent to the FDA. Once require domestic and foreign device Timetable:
reporters have developed the electronic establishments to submit registration
Action Date FR Cite
reporting capability, they would save and listing data electronically via the
significant mailing and adminstrative Internet using FDA’s Unified NPRM 02/00/07
processing costs. FDA is developing an Registration and Listing System. This
electronic system for reporters who do proposed rule would convert the Regulatory Flexibility Analysis
not have the capability to produce the registration and listing process to a Required:
required electronic file. paperless process. For those companies No

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72790 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Small Entities Affected: such dietary ingredients or dietary monitoring and controls, testing, and
Businesses supplements. FDA also proposed to written records. The benefits of the
require manufacturers to evaluate the proposed regulation are to improve
Government Levels Affected: identity, purity, quality, strength, and both product safety and quality. We
None composition of their dietary ingredients estimate that the proposed regulation
and dietary supplements. The proposed will reduce the number of sporadic
Agency Contact: rule also responds to concerns that human illnesses and rare catastrophic
Myrna Hanna such regulations are necessary to illnesses from contaminated products.
Regulations Staff ensure that consumers are provided The current quality of these products
Department of Health and Human with dietary supplement products is highly variable, and consumers lack
Services which have not been adulterated as a information about the potential hazards
Food and Drug Administration result of manufacturing, packing, or and variable quality of these products.
Center for Devices and Radiological holding, e.g., which have the identity The product quality benefits occur
Health and provide the quantity of dietary because there will be fewer product
HFZ–215 ingredients declared in labeling. recalls and more uniform products will
1350 Piccard Drive, PI50 RM150F reduce consumer search for preferred
Statement of Need: quality products. The proposed rule
Rockville, MD 20850
Phone: 240 276–2347 FDA intends to publish a final rule to will have a significant impact on a
Fax: 240 276–2352 establish CGMP for dietary substantial number of small businesses,
Email: supplements and dietary ingredients for so it will be significant under the
several reasons. First, FDA is concerned Regulatory Flexibility Act. We
RIN: 0910–AF88 that some firms may not be taking anticipate that small businesses will
appropriate steps during the bear a proportionately larger cost than
HHS—FDA manufacture of dietary supplements large businesses.
and dietary ingredients to ensure that
products are not adulterated as a result
FINAL RULE STAGE of manufacturing, packing, or holding. Any potential for consumers to be
There have been cases of misidentified provided adulterated (e.g.,
ingredients harming consumers using contaminated with industrial
dietary supplements. FDA is also aware chemicals, pesticides, microbial
of products that contain potentially pathogens, or dangerous misidentified
harmful contaminants because of ingredients or toxic components of
apparently inadequate manufacturing ingredients) products must be
controls and quality control procedures. considered a very serious risk because
The Agency believes that a system of of the possibility that such
Priority: CGMPs is the most effective and contamination could be widespread,
Economically Significant. Major under efficient way to ensure that these affecting whole segments of the
5 USC 801. products will not be adulterated during population, causing some severe long-
manufacturing, packing, or holding. term effects and even loss of life.
Unfunded Mandates: Dietary supplements are used by a large
Summary of Legal Basis: segment of the American public.
This action may affect the private
sector under PL 104-4. If CGMP regulations were adopted by Moreover, they are often used by
FDA, failure to manufacture, pack, or segments of the population that are
Legal Authority: hold dietary supplements or dietary particularly vulnerable to adulterated
21 USC 321; 21 USC 342; 21 USC 343; ingredients under CGMP regulations products, such as the elderly, young
21 USC 348; 21 USC 371; 21 USC 374; would render the dietary supplement children, pregnant and nursing women,
21 USC 381; 21 USC 393; 42 USC 264 or dietary ingredients adulterated under and persons who may have serious
section 402(g) of the Act. illnesses or are taking medications that
CFR Citation: may adversely interact with dietary
Alternatives: supplements. FDA has adopted or
21 CFR 111
The two principal alternatives to proposed manufacturing controls for a
Legal Deadline: comprehensive CGMPs are end product number of foods and commodities that
None testing and Hazard Analysis Critical present potential health hazards to
Control Points (HACCP). The Agency consumers if not processed properly,
Abstract: asked whether different approaches including seafood, juice products, and
The Food and Drug Administration may be better able to address the needs fruits and vegetables, and it is
proposed in the Federal Register of of the broad spectrum of firms that appropriate that FDA consider whether
March 13, 2003 (68 FR 12158), current conduct one or more distinct manufacturing controls are necessary to
good manufacturing practice (CGMP) operations, such as the manufacture of assure consumers that dietary
regulations for dietary ingredients and finished products, or solely the supplements are not adulterated during
dietary supplements. The proposed rule distribution and sale of finished the manufacturing, packing, or holding
was published to establish the products at the wholesale or retail process.
minimum CGMPs necessary to ensure level. Timetable:
that, if firms engage in activities related
to manufacturing, packaging, or holding Anticipated Cost and Benefits: Action Date FR Cite
dietary ingredients or dietary The costs of the regulation will include ANPRM 02/06/97 62 FR 5700
supplements, they do so in a manner the value of resources devoted to ANPRM Comment 06/06/97
that will not adulterate and misbrand increased sanitation, process Period End

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72791

Action Date FR Cite Abstract: Summary of Legal Basis:

NPRM 03/13/03 68 FR 12157 This rulemaking is one of a number of Section 307 of the Bioterrorism Act
NPRM Comment 08/11/03 actions being taken to improve FDA’s amended the act by adding section
Period End ability to respond to threats of 801(m), which authorizes the Secretary
Final Action 12/00/06 bioterrorism. Section 801(m) of the through FDA to establish by regulation
Federal Food, Drug, and Cosmetic Act requirements for the notification to
Regulatory Flexibility Analysis (the act), which was added by section FDA prior to the entry of imported
Required: 307 of the Public Health Security and food. In addition, section 307 of the
Yes Bioterrorism Preparedness and Bioterrorism Act also amends section
Response Act of 2002 (the Bioterrorism 301 of the act by making the offering
Small Entities Affected: Act), requires notification to FDA prior of a food for import or the importing
Businesses to the entry of imported food. The of a food without prior notification, as
required prior notice would provide the required by the new regulations, a
Government Levels Affected: identity of the article of food; the prohibited act.
Undetermined manufacturer; the shipper; the grower,
if known at the time of notification; the
Federalism: An alternative is to leave the IFR in
originating country; the shipping
Undetermined country; and the anticipated port of place and not to issue a final rule.
entry. The regulation identifies the However, we received numerous
Agency Contact:
parties responsible for providing the comments in response to the IFR that
Linda Kahl notice and explains the information require a response. Finalizing this rule
Senior Policy Analyst that the prior notice is required to will assist industry and the public in
Department of Health and Human contain, the method of submission of better understanding and complying
Services the notice, and the minimum and with the prior notice requirements.
Food and Drug Administration maximum period of advance notice
Center for Food Safety and Applied Anticipated Cost and Benefits:
required. Section 307 also states that
Nutrition if FDA does not receive prior notice The final rule will amend the interim
5100 Paint Branch Parkway or receives inadequate prior notice, the final rule already in place. We do not
HFS–024 imported food shall be refused expect the changes from the interim
College Park, MD 20740 admission and held at the port of entry final rule to be economically
Phone: 301 436–1209 until proper notice is provided. significant.
Fax: 301 436–2964 This final rule will require that FDA
Email: Section 307 authorizes the Secretary,
through FDA, to promulgate final be notified prior to the arrival of the
RIN: 0910–AB88 regulations by December 12, 2003. FDA food.
and the Bureau of Customs and Border Having prior notice of imported food
HHS—FDA Protection (CBP) issued an interim final will help deter deliberate and
rule (IFR) on October 10, 2003 (68 FR accidental contamination of food
43. PRIOR NOTICE OF IMPORTED 58974). The IFR originally provided a shipments. Knowledge of when, where,
FOOD UNDER THE PUBLIC HEALTH 75-day comment period to ensure that and how imported food will enter the
SECURITY AND BIOTERRORISM those that comment on the IFR have United States will help mitigate the
PREPAREDNESS AND RESPONSE the benefit of our outreach and effects of any potential food
ACT OF 2002 educational efforts and have the contamination issues.
experience with the systems,
Priority: Risks:
timeframes, and data elements. We
Other Significant reopened the comment period for an Regulations implementing legislation to
Legal Authority: additional 90 days in April through protect the health of citizens against
July 2004 to allow for additional bioterrorism and other public health
PL 107–188, sec 307 comment on the industry’s experience threats would advance the
CFR Citation: with the prior notice system, and development, organization and
comment on the Joint FDA-CBP Plan enhancement of public health
21 CFR 1.276 et seq for Increasing Integration and Assessing prevention systems and tools. The
Legal Deadline: the Coordination of Prior Notice magnitude of the risks addressed by
Timeframes. The final rule currently is such systems and tools is at least as
Final, Statutory, December 12, 2003. under development, and it will confirm great as the other risk reduction efforts
The Public Health Security and or amend the IFR, as appropriate. This within HHS’ jurisdiction. These
Bioterrorism Preparedness and final rule is not expected to have a regulations will improve the FDA’s
Response Act of 2002, section 307, significant impact on a substantial ability to address bioterrorism events
directs the Secretary, through FDA, to number of small entities. and public-health threats associated
issue final regulations establishing prior with imported food.
notice requirements for all imported Statement of Need:
food by December 12, 2003. If FDA fails This final rule is needed to complete
to issue final regulations by this date, the rulemaking process to implement Action Date FR Cite
the statute is self-executing on this section 307 of the Bioterrorism Act. NPRM 02/03/03 68 FR 5428
date, and requires FDA to receive prior The proposed rule was published on Interim Final Rule 10/10/03 68 FR 58974
notice of not less than eight hours, nor February 3, 2003 (68 FR 5428) and the Interim Final Rule 04/14/04 69 FR 19763
more than five days until final interim final rule on October 10, 2003 Comment Period
regulations are issued. (68 FR 58974). Reopened

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72792 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Action Date FR Cite amounts for Medicare long-term care HHS—CMS

hospitals and also presents proposed
Interim Final Rule 07/13/04 changes in long-term care policy. The 45. ∑ STANDARDS FOR
Comment Period
Rate Year (RY) 2008 proposed and final E–PRESCRIBING UNDER MEDICARE
Reopened End PART D (CMS–0016–P)
rules must be published by May 1,
Final Rule 05/00/07
2007 to be effective July 1, 2007. Under Priority:
Regulatory Flexibility Analysis the Long-Term Care Hospitals
Economically Significant. Major status
Required: Prospective Payment System (LTCH
under 5 USC 801 is undetermined.
No PPS), LTCHs are paid for each
discharge based on the standard Unfunded Mandates:
Small Entities Affected: Federal rate, adjusted to reflect the This action may affect State, local or
Businesses resource utilization, as well as other tribal governments and the private
facility-level and case-level sector.
Government Levels Affected: adjustments. In addition to the update
Federal to the standard Federal rate, several of Legal Authority:
the other facility-level and case-level 42 USC 1395
Agency Contact:
adjustments that affect LTCH PPS
May Nelson payments are updated or refined in the CFR Citation:
Regulatory Counsel annual LTCH PPS proposed and final 42 CFR 423
Department of Health and Human rules.
Services Legal Deadline:
Food and Drug Administration Summary of Legal Basis: Final, Statutory, April 1, 2008.
Center for Food Safety and Applied
Medicare was granted the legal Abstract:
authority for payment to LTCHs under
5100 Paint Branch Parkway This rule proposes standards for
PL 106-113, section 123, and PL 106-
College Park, MD 20740 electronic prescribing (e-prescribing)
554, section 307(b).
Phone: 301 436–1722 under Medicare Part D. This rule would
Fax: 301 436–2637 Alternatives: require Medicare Part D and Medicare
Email: Advantage plans to support electronic
None. This is a statutory requirement.
RIN: 0910–AC41 transmission of basic prescription data
Anticipated Cost and Benefits: to and from doctors and pharmacies
and to adopt final standards for e-
HHS—Centers for Medicare & We project expenditures of prescribing as required by section 101
Medicaid Services (CMS) approximately $5.4 billion in RY 2007. of the MMA.
Risks: Statement of Need:
PROPOSED RULE STAGE If this regulation is not published This rule would implement section 101
timely, Medicare payments for of the MMA which includes the
inpatient hospitals services provided at requirement that the Secretary
44. PROSPECTIVE PAYMENT SYSTEM LTCHs may not be paid appropriately. promulgate final uniform standards for
FOR LONG–TERM CARE HOSPITALS the electronic transmission of
RY 2008: ANNUAL PAYMENT RATE Timetable: prescriptions and certain other
UPDATES (CMS–1529–P) Action Date FR Cite information for covered Part D drugs
Priority: NPRM 01/00/07
prescribed for Part D eligible
Economically Significant. Major under
5 USC 801. Regulatory Flexibility Analysis Summary of Legal Basis:
Legal Authority: Section 101 of the MMA requires that
Yes the Secretary promulgate final uniform
PL 106–113 sec 123 ; PL 106–554 sec
Small Entities Affected: standards for the electronic
transmission of prescriptions and
CFR Citation: Businesses certain other information for covered
42 CFR 412 Part D drugs prescribed for Part D
Government Levels Affected: eligible individuals by no later than
Legal Deadline: None 4/1/2008.
Final, Statutory, July 1, 2007. Alternatives:
Agency Contact:
Abstract: This is a statutory requirement.
Linda McKenna
This rule proposes the annual payment Health Insurance Specialist Anticipated Cost and Benefits:
rate update for the 2008 prospective Department of Health and Human
payment system for Medicare long-term All Medicare drug plans would be
care hospitals and also presents required to implement the standards.
Centers for Medicare & Medicaid Services
proposed changes or revisions on LTCH We expect that the standards would
7500 Security Boulevard
PPS policy for public comment. include transactions for communicating
Baltimore, MD 21244
medication history and formulary
Statement of Need: Phone: 410 786–4537
information to prescribes, which would
The statute requires that we annually result in fewer adverse drug events and
update the annual payment rate RIN: 0938–AO30 increased formulary compliance.

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Risks: followed by a final rule, on the acute HHS—CMS

If this regulation is not published care hospital inpatient prospective
payment systems (IPPS) annual updates 47. ∑ REVISIONS TO THE MEDICARE
timely, plans may not be aware of the ADVANTAGE AND PART D
uniform standards. to the payment rates and related
hospital inpatient policy changes under PRESCRIPTION DRUG CONTRACT
Timetable: the Medicare program. Medicare pays CONFIDENTIALITY AND DISCLOSURE,
Action Date FR Cite for acute care hospital inpatient DETERMINATIONS, APPEALS, AND
services under a prospective payment INTERMEDIATE SANCTIONS
NPRM 06/00/07 PROCESSES (CMS–4124–P)
system (IPPS) in which payment is
Regulatory Flexibility Analysis made at a predetermined rate for the Priority:
Required: operating and capital-related costs
Other Significant
No associated with each hospital discharge.
Payment rates for IPPS hospitals and Legal Authority:
Small Entities Affected: the payment limits for hospitals 42 USC 1302; 42 USC 1395(hh); 42
Businesses excluded from IPPS are updated each USC 1395(w–101) to 1395(w–152)
year to take into account changes in
Government Levels Affected: the cost of goods and services used by CFR Citation:
State hospitals, as well as other factors. 42 CFR 401.134, 42 CFR 422.506, 42
Federalism: CFR 422.50; 42 CFR 423.509, 42 CFR
Summary of Legal Basis:
422.644 to 658, 42 CFR; 42 CFR
This action may have federalism Section 1886(d) of the Social Security 422.660 to 664; 42 CFR 423.650 to 652
implications as defined in EO 13132. Act establishes payment for inpatient
hospital services. The statute requires Legal Deadline:
Agency Contact:
that a proposed rule be published by None
Denise Buenning 4/1/07. It also requires that the final
Senior Advisor Abstract:
rule be published by 8/1/07.
Department of Health and Human This proposed rule would clarify and
Services Alternatives: modify the Medicare Advantage (MA)
Centers for Medicare & Medicaid Services program provisions relating to
None. This is a statutory requirement.
S2–26–17 disclosure of information, and contract
7500 Security Blvd Anticipated Cost and Benefits: determinations by MA Organizations
Baltimore, MD 21244 and Part D Prescription Drug Plan
Phone: 410 786–6711 We project the payment rate updates
sponsors. This proposed rule would
Email: to hospitals would increase by over
also revise requirements concerning the
$3.4 billion from FY 2007 to FY 2008.
RIN: 0938–AO66 reconsideration of determinations and
Risks: clarifies the schedule for MA
organizations and Part D plan sponsors
HHS—CMS If this regulation is not published to complete corrective action plans. In
timely, hospital inpatient services will addition, it would clarify the
46. ∑ CHANGES TO THE HOSPITAL not be paid appropriately.
INPATIENT PROSPECTIVE PAYMENT intermediate sanction and civil money
SYSTEMS AND FY 2008 RATES Timetable: penalty (CMP) provisions relating to
(CMS–1533–P) MA Organizations and Medicare Part D
Action Date FR Cite
Prescription Drug Plan sponsors.
Priority: NPRM 04/00/07
Statement of Need:
Other Significant. Major under 5 USC Regulatory Flexibility Analysis
801. With the increase from 160 Managed
Required: Care Organizations (MCOs) to over 500
Legal Authority: Yes in 2006, CMS needs to strengthen both
Sec 1888(d) of the Social Security Act its methodology and available tools to
Small Entities Affected: oversee this extremely augmented
CFR Citation: program. In an effort to strengthen the
42 CFR 412 Agency’s compliance oversight, this
Government Levels Affected: rule would ensure effective
Legal Deadline:
Federal management and enforcement of
NPRM, Statutory, April 1, 2007. program objectives.
Final, Statutory, August 1, 2007. Agency Contact:
Summary of Legal Basis:
Abstract: Marc Hartstein
This proposed rule would clarify and
Acting Deputy Director
This rule proposes to revise the modify provisions relating to disclosure
Department of Health and Human
Medicare hospital inpatient prospective of information, and contract
payment systems (IPPS) for operating determinations of Medicare Advantage
Centers for Medicare & Medicaid Services
and capital-related costs to implement (MA) Organizations and Part D
Mail Stop C4–25–11
changes arising from our continuing Prescription Drug Plan sponsors. It also
7500 Security Boulevard
experience with these systems would revise requirements concerning
Baltimore, MD 21244–1850
the reconsideration of such
Statement of Need: Phone: 410 786–4548
determinations and to clarify the
The statute requires by law that we schedule for MA organizations and Part
publish each year a proposed rule, RIN: 0938–AO70 D plan sponsors to complete corrective

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72794 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

action plans. In addition, it would HHS—CMS Summary of Legal Basis:

clarify the intermediate sanction and
Section 1847 of the Social Security Act
civil money penalty provisions relating
(the Act) requires the Secretary to
to MA Organizations and Part D FINAL RULE STAGE establish and implement competitive
Prescription Drug Plan sponsors.
acquisition programs for certain items
Alternatives: of DMEPOS. Section 1847(a)(1)(B) of
48. COMPETITIVE ACQUISITION FOR the Act requires phased-in
None. Given the fact that CMS’ CERTAIN DURABLE MEDICAL
compliance authorities are vested in implementation so that competition
EQUIPMENT (DME), PROSTHETICS, under the programs occurs in 10 of the
Federal regulations, we do not see ORTHOTICS, AND SUPPLIES
viable legal alternatives to revising MSAs in 2007, 80 of the largest MSAs
(CMS–1270–F) in 2009, and additional areas after
existing Federal regulations to
accomplish stated goals. 2009.
Anticipated Cost and Benefits: Other Significant. Major under 5 USC Alternatives:
We do not estimate any costs to the 801. None. This is a statutory requirement.
Government associated with
promulgating and implementing this Legal Authority: Anticipated Cost and Benefits:
regulation. There is the potential for PL 108–173, MMA; Deficit Reduction The projected annual Medicare program
increased costs to Medicare managed Act of 2005, PL 109–171, sec 5101 savings from DMEPOS competitive
care organizations as they change bidding over the first 4 years of the
existing compliance infrastructures to CFR Citation: program are estimated to be
accommodate these revised rules. This approximately $110 million the first
42 CFR 414.1; 42 CFR 424.1; 42 CFR
rule will benefit CMS in that it will year and increasing to over $1.2 billion
strengthen the Agency’s compliance 424.57
by the fourth year.
authorities and in so doing, benefit Legal Deadline:
Medicare beneficiaries who will have Risks:
greater confidence that Medicare Final, Statutory, December 31, 2007.
If this regulation is not published
managed care organizations comply timely, we will be unable to meet the
with Federal Medicare program Abstract:
statutory implementation schedule and
requirements. Section 302 of the Medicare receive the anticipated savings.
Risks: Modernization Act establishes DME
competitive bidding. National Timetable:
If this regulation is not finalized, competitive bidding will provide a Action Date FR Cite
program objectives may not be program for using market forces to set
effectively managed and enforced. NPRM 05/01/06 71 FR 25654
Medicare payment amounts. This will
Final Action 03/00/07
Timetable: create incentives for suppliers to
Action Date FR Cite provide quality items and services Regulatory Flexibility Analysis
while at the same time providing Required:
NPRM 12/00/06 Medicare with reasonable prices for
payment. This rule also incorporates Yes
Regulatory Flexibility Analysis
Required: provisions from section 5105 of the Small Entities Affected:
DRA of 2005, which concerns
No Businesses, Governmental Jurisdictions,
beneficiary ownership of certain DMEs.
Small Entities Affected: Organizations
Statement of Need:
No Government Levels Affected:
The statute requires that we establish
Government Levels Affected: Federal, State
and implement a new competitive
State bidding program for certain Durable Agency Contact:
Medical Equipment, Prosthetics,
Agency Contact: Ralph Goldberg
Orthotics, and Supplies (DMEPOS)
Kevin Stansbury items in the Medicare program. This Health Insurance Specialist
Health Insurance Specialist program changes the way that Medicare Department of Health and Human
Department of Health and Human pays for these items under Part B of Services
Services the Medicare program by utilizing bids Centers for Medicare & Medicaid Services
Centers for Medicare & Medicaid Services submitted by DMEPOS suppliers to Mailstop C5–08–27
C4–23–07 establish payment amounts. The final 7500 Security Boulevard
7500 Security Blvd rule must be published timely to ensure Baltimore, MD 21244–1850
Baltimore, MD 21244 that competition under the Medicare Phone: 410 786–4870
Phone: 410 786–2570 DMEPOS competitive bidding program Email:
Email: begins in 10 of the largest metropolitan RIN: 0938–AN14
RIN: 0938–AO78 statistical areas (MSAs) in 2007. BILLING CODE 4150–24–S

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72795

DEPARTMENT OF HOMELAND to ensure that the Department’s policies, Office of the Secretary of Homeland
SECURITY (DHS) operations, and structures are aligned in Security that are sponsored by the
the best way to address the potential Department’s major divisions or
Statement of Regulatory Priorities threats that face our nation. The directorates, including the Office of
The Department of Homeland Secretary’s six-point agenda is intended Information Analysis, DHS’s Office of
Security (DHS or the Department) was to: Policy and the US-VISIT program.
created in 2003 pursuant to the • Increase overall preparedness, Additionally, several DHS components
Homeland Security Act of 2002, Public particularly for catastrophic events; are authorized to promulgate
Law 107-296. DHS is comprised of 22 regulations. Those components include,
• Create better transportation security but are not limited to: the United States
Federal agencies brought together for
systems to move people and cargo Coast Guard, United States Citizenship
the common mission of preventing
more securely and efficiently; and Immigration Services, the Bureau of
terrorist attacks in the United States,
reducing the vulnerability of the United • Strengthen border security and Customs and Border Protection, the
States to terrorist attacks, and interior enforcement and reform Transportation Security Administration,
minimizing damage and assisting in immigration processes; and the Bureau of Immigration and
recovery from acts of terrorism, natural Customs Enforcement. The Fall 2006
• Enhance information sharing with our
disasters, or other emergencies that partners; Regulatory Plans for the Office of the
might occur in the United States. The Secretary and those DHS regulatory
Department’s Strategic Plan governs the • Improve DHS financial management, components with submissions for the
development of DHS’ strategies, human resource development, 2006 Plan are discussed below.
programs and projects, and ultimately is procurement and information
reflected in the Department’s budget technology; and Office of the Secretary
and regulatory agenda. DHS’ Strategic • Realign the DHS organization to During fiscal year 2007, DHS will be
Plan is posted on the Department’s Web maximize mission performance.
site: initiating a rulemaking action to
The regulations summarized in the establish minimum standards for State-
Department’s Fall Regulatory Program issued driver’s licenses and
DHSlStratPlanl FINALlspread.pdf.
and in the Unified Agenda support the identification cards that Federal
DHS’ Strategic Goals are: Department’s Strategic Goals and the agencies would accept for official
AWARENESS —Identify and Secretary’s six-point agenda and will purposes as required under the REAL ID
understand threats, assess improve the Department’s ability to Act of 2005.1 The REAL ID Act, effective
vulnerabilities, determine potential accomplish its primary missions. May 18, 2008, prohibits Federal
impacts, and disseminate timely DHS strives for organizational agencies from accepting a driver’s
information to our homeland security excellence and uses a centralized and license or personal identification card
partners and the American public. unified approach in managing its (license) for an ‘‘official purpose’’ unless
PREVENTION —Detect, deter, and regulatory resources. The Department’s it has been issued by a State that has
mitigate threats to our homeland. regulatory program, including the certified to, and been determined by
Unified Regulatory Agenda and DHS to meet, the requirements of the
PROTECTION —Safeguard our people Regulatory Plan, is managed by the Act. The Act sets forth minimum
and their freedoms, critical Office of the General Counsel. In document requirements, minimum
infrastructure, property, and the addition, DHS senior leadership reviews issuance standards, and other
economy of our Nation from acts of each significant regulatory project to requirements, including the following:
terrorism, natural disasters, or other ensure that the project fosters and
emergencies. • Information and features that must
supports the Department’s Strategic appear on the face of the license, and
RESPONSE —Lead, manage, and Goals. inclusion of a common machine
coordinate the national response to acts DHS also is committed to ensuring readable portion of a driver’s license
of terrorism, natural disasters, or other that all of its regulatory initiatives are or identification card;
emergencies. aligned with its guiding principles to
protect civil rights and civil liberties, • Presentation and verification of
RECOVERY —Lead national, state, information an applicant must
local, and private sector efforts to integrate our actions, build coalitions
and partnerships, develop human provide before a license may be
restore services and rebuild issued, including evidence that the
communities after acts of terrorism, resources, innovate and be accountable
to the American public. The Department applicant is a U.S. citizen or has
natural disasters, or other emergencies. lawful status in the United States;
values public involvement in the
SERVICE —Serve the public effectively development of its Regulatory Plan, • Physical security of locations where
by facilitating lawful trade, travel, and Unified Agenda and regulations, and licenses are produced, the security of
immigration. takes particular concern with the impact document materials and papers from
ORGANIZATIONAL EXCELLENCE its rules have on small businesses. DHS which licenses are produced, and the
—Value our most important resource, and each of its components continue to background check of certain
our people. Create a culture that emphasize the use of plain language in employees involved in the
promotes a common identity, our notices and rulemaking documents manufacture and production of
innovation, mutual respect, to promote better understanding of licenses; and
accountability, and teamwork to achieve regulations and increased public
efficiency, effectiveness, and participation in the Department’s 1 Division B—REAL ID Act of 2005, the

operational synergies. rulemakings. Emergency Supplemental Appropriations Act for

Defense, the Global War on Terror, and Tsunami
In 2005, the Secretary of Homeland The Fall 2006 Regulatory Plan for Relief, 2005, Pub. L. 109-13, 119 Stat. 231, 302
Security announced a six-point agenda DHS includes regulations issued by the (2005) (codified at 49 U.S.C. 30301 note).

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72796 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

• Physical security of the licenses to aliens that will be subject to US-VISIT would expand the applicability of these
prevent tampering, counterfeiting, requirements to eventually encompass requirements to better enable the Coast
and duplication of the documents for all aliens, with certain limited Guard to correlate vessel AIS data with
a fraudulent purpose. exceptions. This regulatory program NOAD data, enhance our ability to
DHS is issuing this rule in supports the Department’s Strategic identify and track vessels, detect
consultation with the Department of Goals of awareness, prevention, and anomalies, improve navigation safety,
Transportation, other representatives of protection by securing our borders and heighten our overall maritime
the Federal Government, and against terrorists who intend to harm domain awareness and security. This
representatives from many States, as the United States. rulemaking would expand the
required under the Act. United States Coast Guard applicability of NOADs to include all
foreign commercial vessels, regardless
The Department also will be issuing The United States Coast Guard (Coast of tonnage, and all U.S. commercial
regulations to establish security Guard) is a military, multi-mission, and vessels arriving from a foreign port or
requirements for chemical facilities. maritime agency. Our statutory place. This rulemaking supports the
Section 550 of the Homeland Security responsibilities include ensuring marine Commandant’s strategic goals of
Appropriations Act of 2007 (October 4, safety and security, preserving maritime maritime safety and maritime security.
2006), directs the Department of mobility, protecting the marine
Homeland Security to issue interim environment, enforcing U.S. laws and The Coast Guard has supported the e-
final regulations no later than six international treaties, and performing rulemaking initiative and, starting on
months after the date of enactment, search and rescue. The Coast Guard the day of the first Federal Register
establishing risk-based performance supports the Department’s overarching publication in a rulemaking project, the
standards for the security of chemical goal of mobilizing and organizing our public can submit comments
facilities and requiring vulnerability nation to secure the homeland from electronically and view Agency
assessments and the development and terrorist attacks, natural disasters, and documents and public comments on the
implementation of site security plans for other emergencies. In performing its Department of Transportation’s
chemical facilities. These regulations duties, the Coast Guard has established Document Management System, which
will apply to chemical facilities that five strategic goals — maritime safety, is available online at
present high levels of security risk, as protection of natural resources, The Coast Guard endeavors to reduce
determined by the Secretary of maritime security, maritime mobility the paperwork burden it places on the
Homeland Security. DHS will be issuing and national defense. The rulemaking public and strives to issue only
an interim final rule in early 2007 to projects identified for the Coast Guard necessary regulations that are tailored to
comply with the requirements of section in the Unified Agenda, and the rule impose the least burden on society.
550 of the Homeland Security appearing in the Fall 2006 Regulatory
Appropriations Act of 2007. U.S. Citizenship and Immigration
Plan below, support these strategic goals Services
DHS recently finalized the final rule and reflect our regulatory policies.
on Procedures for Handling Critical Further, although the Coast Guard has The mission of the U.S. Citizenship
Infrastructure Information (CII). This placed an emphasis on maritime and Immigration Services (USCIS) is to
rule establishes uniform procedures for security and national defense since protect national security while
the receipt, care, and storage of CII September 11, 2001, our emphasis on conveying our Nation’s privileges of
voluntarily submitted to the Federal these vital issues has not prevented the freedom and citizenship through the
Government. The procedures apply to Coast Guard from carrying out its other rule of law. The three strategic priorities
all Federal agencies that receive, care important regulatory responsibilities. of USCIS are national security, customer
for, or store CII voluntarily submitted to The Coast Guard has issued many rules service and organizational excellence.
the Federal Government. This rule that are not security-related as indicated USCIS’ key regulatory initiatives for the
supports the Department’s Strategic by the wide range of topics covered in 2007 President’s Agenda are aligned
Goals of awareness, prevention, its 54 rulemaking projects in this with these strategic priorities and our
protection, and response by identifying Unified Agenda. mission. Key regulations focus on
and assessing the vulnerability of ‘‘Vessel Requirements for Notices of withholding adjudication in security
critical infrastructure and key assets. Arrival and Departure (NOAD), and sensitive cases, replacing non-secure
Automatic Identification System (AIS)’’ identity cards, increasing flexibility in
During fiscal year 2007, the Office of
is a regulatory action of particular filing options to improve customer
the Secretary expects to expand the
importance to the Coast Guard in the service and securing appropriate fees to
scope of the United States Visitor and
Department’s Fall 2006 Regulatory Plan. ensure the soundness of our
Immigrant Status Indicator Technology
Currently, the Coast Guard does not organization.
(US-VISIT) program. US-VISIT is an
integrated, automated entry-exit system have a mechanism to capture vessel, These key initiatives directly advance
that records the arrival and departure of crew, passenger, or specific cargo the President’s policies and priorities,
aliens; verifies aliens’ identities, and information on vessels less than or the mission and the core values of the
authenticates aliens’ travel documents equal to 300 gross tons intending to Department of Homeland Security and
through comparison of biometric arrive at or depart from U.S. ports DHS Objectives 2.6, 6.2, 7.2 and 7.7.
identifiers. The goals of the US-VISIT unless they are arriving with certain USCIS seeks to welcome lawful
program are to enhance the security of dangerous cargo or are arriving at a port immigrants while preventing
United States citizens and visitors to the or place within the 7th Coast Guard exploitation of the immigration system
United States, facilitate legitimate travel District (primarily Florida and and we seek to create and maintain a
and trade, ensure the integrity of the surrounding waters). To remedy this high-performing, integrated, public
United States immigration system, and situation, the Coast Guard plans to issue service organization. As a nation of
protect the privacy of visitors to the ‘‘Vessel Requirements for Notices of immigrants, the United States has a
United States. For fiscal year 2007, DHS Arrival and Departure, and Automatic strong commitment to welcoming those
plans to further expand the classes of Identification System,’’ a rule that individuals who seek entry through our

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legal immigration system, and also to required background and security and Violence Protection Act of 2000 and
assisting those in need of humanitarian checks are completed and resolved to other related legislation. It will establish
protection against harm. the satisfaction of the Secretary of procedures for application and issuance
Based on a comprehensive review of Homeland Security or his delegate. The of U nonimmigrant status for victims of
the USCIS planned regulatory agenda, rule also modifies the regulations certain statutorily enumerated crimes.
several rulemakings will be governing the adjudication of Similarly, the ‘‘Adjustment of Status to
promulgated to directly support the naturalization applications to ensure Lawful Permanent Resident for Aliens
aforementioned core priorities as that background and security checks are in T and U Nonimmigrant Status’’ rule
delineated below. completed before an alien may be will implement provisions created by
naturalized. the Victims of Trafficking and Violence
National Security Protection Act of 2000 (VTVPA) that
Customer Service
USCIS has an essential role in allow for the adjustment of status to
supporting DHS’s Strategic Goal to USCIS strives to provide efficient, lawful permanent resident for aliens
ensure the security and integrity of the courteous, accurate and responsive who have completed three years in
immigration system by making certain services to those who seek and qualify lawful T or U nonimmigrant status.
that immigrants and nonimmigrants for admission into our country as well
as providing seamless, transparent and USCIS also plans to initiate a
comply with the laws and security
dedicated customer support services rulemaking action, ‘‘Petition to Classify
mandates to prevent those who seek to
within the agency. To improve our Alien as Immediate Relative of a U.S.
exploit our immigration benefits or
customer service goals, USCIS is Citizen or as a Preference Immigrant;
engage in illegal activities from
pursuing regulatory initiatives that will Self-Petitioning for Certain Battered or
obtaining lawful status in this country.
make immigration procedures Abused Alien Spouses and Children,’’
To further our national security
consistent with new laws, improve to implement provisions of the Battered
objectives, USCIS is pursuing regulatory
interpretive services, standardize Immigrant Women Protection Act of
initiatives that will disallow the
adjudication and filing procedures, and 2000 and the Violence Against Women
granting of immigration benefits while
modernize application processing to and Department of Justice
an applicant has an ongoing
investigation. These regulatory facilitate effective data collection and Reauthorization Act of 2005. Those
initiatives include the following: reporting. provisions amend the Immigration and
These regulatory initiatives include: Naturalization Act provisions that allow
USCIS plans to issue a rule, ‘‘Special battered spouses, children and parents
Immigrant and Nonimmigrant Religious USCIS final rule ‘‘Removal of the of U.S. citizens and lawful permanent
Workers,’’ proposing to amend its Standardized Request for Evidence residents to petition for immigrant
regulations regarding the special Processing Timeframe,’’ which amends classification without the assistance or
immigrant and nonimmigrant religious USCIS regulations to allow USCIS to set consent of the abuser.
worker visa classifications. This rule flexible times for requesting evidence
addresses concerns about the integrity based on the types and complexity of USCIS also is restructuring its entire
of the religious worker program by applications or petitions. This rule will business processes to implement new
proposing a petition requirement for remove the absolute requirement for, procedures for the filing, processing,
religious organizations seeking to and the fixed regulatory time limitations and adjudication of all benefit
classify an alien as an immigrant or on responses to, requests for evidence applications and petitions. USCIS is
nonimmigrant religious worker. This and notices of intent to deny. These moving toward complete electronic
rule also proposes including an on-site changes will enable USCIS to set an filing and adjudication of benefits to
inspection for religious organizations to appropriate deadline for responding to a streamline processing, modernize
ensure the legitimacy of petitioner request for evidence (RFE) or notice of adjudications, and facilitate efficient
organizations and employment offers intent to deny (NOID), specific to the and effective data collection and
made by such organizations. USCIS is type of case, benefit category, or reporting.
proposing to establish a fee, in addition classification, and thus improve the USCIS will be issuing a rulemaking
to the standard fee required for special process of adjudication of applications action ‘‘New Electronic Account,
immigrant or nonimmigrant visa and petitions by reducing the time a Adjudication, and Reporting System;
petitions, to cover the cost of the on-site case is held awaiting evidence, and by New Procedures for Filing and
inspections. reducing average case processing time. Processing of Fiscal Year 2007 H-1B
This rule also would clarify several This rule will result in improved Petitions Subject to Annual Cap’’ as part
substantive and procedural issues that efficiency in the USCIS adjudication of this business restructuring process.
have arisen since the religious worker process.
category was created. This rule proposes USCIS also plans to issue a rule, Overall Excellence
new definitions that describe more ‘‘Implementation of Amendments USCIS seeks to optimize mission
clearly the regulatory requirements, as Affecting Petitions for Employment performance by consolidating and
well as add specific evidentiary Creation Aliens EB-5,’’ to amend its integrating roles and responsibilities,
requirements for petitioning employers regulations to implement changes made and creating better operating processes
and prospective religious workers. by the 21st Century Department of and procedures while using the latest
USCIS also is issuing an interim rule Justice Appropriations Authorization technology. To achieve these goals,
‘‘Withholding of Adjudication of Act of 2001 (the Act). This legislation USCIS is pursuing regulatory initiatives
Petitions and Applications for made various changes to the EB-5 Alien that will adjust fees for certain
Immigration and Naturalization Benefits Entrepreneur immigrant classification. applications in order to guarantee
(Abeyance),’’ to amend USCIS The ‘‘New ‘U’ Nonimmigrant sufficient funding to process incoming
regulations to allow the adjudication of Classification for Victims of Certain applications/petitions and provide
a petition or application to be withheld Criminal Activity’’ rule will implement biometric services while ensuring
until any pending investigations or provisions of the Victims of Trafficking national security, enhancing customer

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72798 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

service, and maintaining standard Nation’s borders, both at and between and crewmembers and would facilitate
processing times. the ports of entry and at official the effective enforcement of the
The proposed rule ‘‘Adjustment of the crossings into the United States. CBP customs, immigration and
Immigration Benefit Application / must accomplish its border security and transportation security laws. CBP plans
Petition and Biometric Fee Schedule’’ enforcement mission without stifling to issue the final rule in fiscal year 2007.
proposes to adjust the immigration the flow of legitimate trade and travel. Also during fiscal year 2007, CBP
benefit application and petition fees of The primary mission of CBP is its plans to enhance homeland security
the Immigration Examinations Fee homeland security mission, that is, to further by issuing the following
Account (IEFA), and the biometric fee prevent terrorists and terrorist weapons regulatory actions:
for applicants/petitioners who apply for from entering the United States. An
important aspect of this priority mission CBP is working with the State
certain immigration benefits for the Department on a joint rulemaking
fiscal year FY 2008 and FY 2009 involves improving security at our
initiative (‘‘Documents Required for
biennial period. Fees collected from borders and ports of entry, but it also
Travel in the Western Hemisphere’’)
persons filing these benefits are means extending our zone of security
under section 7209 of the IRTPA, as
deposited into the IEFA and used to beyond our physical borders.
amended by section 546 of the
fund the full cost of processing CBP also is responsible for Department of Homeland Security
immigration benefit administering laws concerning the Appropriations Act of 2007, which
applications/petitions, biometric importation into the United States of provides that travelers (including U.S.
services, associated support services, goods, and enforcing the laws citizens) may enter the United States
and the cost of providing similar concerning the entry of persons into the only with passports or such alternatives
services to asylum and refugee United States. This includes regulating as the Secretary of Homeland Security
applicants and other immigrants, at no and facilitating international trade; may designate as satisfactorily
charge. collecting import duties; enforcing U.S. establishing identity and citizenship. In
‘‘Adjustment of the Premium trade, immigration and other laws of the the future, as a result of the
Processing Fee for Inflation’’ proposes to United States at our borders; inspecting implementation of the statute, as
adjust the premium processing fee for imports; overseeing the activities of amended, travel to the United States by
employment-based petitions and persons and businesses engaged in United States citizens and others from
applications according to the Consumer importing; enforcing the laws Western Hemisphere countries,
Price Index (CPI). USCIS uses this fee to concerning smuggling and trafficking in including Canada and Mexico, will
provide certain premium-processing contraband; apprehending individuals require a passport or acceptable
services to business customers, and to attempting to enter the United States alternative documents in circumstances
make infrastructure improvements in illegally; protecting our agriculture and where travel was previously permitted
the adjudications and customer-service economic interests from harmful pests without such documents. DHS and the
processes. and diseases; servicing all people, State Department jointly issued an
USCIS also plans to issue a rule, vehicles and cargo entering the United advance notice of proposed rulemaking
‘‘Adding a Filing Fee for Re-registration States; maintaining export controls; and on September 1, 2005, to announce the
and Extension of Temporary Protected protecting American businesses from travel initiative and to solicit public
Status,’’ proposing to require each TPS theft of their intellectual property. comments on the implementation of
initial registrant, re-registrant, or In carrying out its priority mission, these requirements. On August 11, 2006,
applicant for extension of temporary CBP’s goal is to facilitate the processing DHS and the State Department
treatment benefits to submit a filing fee of legitimate trade and people efficiently published a joint notice of proposed
or a fee waiver request with their Form rulemaking announcing proposed travel
without compromising security. During
I-821, Application for Temporary document requirements for air and sea
the past fiscal year, consistent with its
Protected Status. travel. CBP anticipates issuing a final
primary mission of homeland security,
rule for air travel in early fiscal year
Customs and Border Protection CBP issued a rule, ‘‘Passenger Manifests
2007 and a separate rulemaking action
for Commercial Aircraft Arriving in and
Under section 403(1) of the Homeland to implement the travel document
Departing from the United States,’’
Security Act (HSA), the former U.S. requirements at sea ad land border ports
proposing to require transmission of
Customs Service, including functions of of entry throughout the fiscal year.
manifest information for arriving and
the Secretary of the Treasury relating departing passengers and for departing All the rules discussed above foster
thereto, transferred to the Secretary of vessel passengers and crewmembers at DHS’ Strategic Goals of awareness and
Homeland Security. As part of the an earlier point in time than is now prevention.
initial organization of DHS, the Customs required. This proposed regulation is In addition to its plans to continue
Service inspection and trade functions consistent with the legislative mandate issuing regulations to enhance border
were combined with the immigration of the Intelligence Reform and security, CBP, during fiscal year 2007,
and agricultural inspection functions Terrorism Prevention Act of 2004 expects to continue to issue regulatory
and the Border Patrol and transferred (IRTPA) to perform vetting of passenger documents that will facilitate legitimate
into the Bureau of Customs and Border or crew information prior to the trade and implement trade benefit
Protection (CBP). It is noted that certain departure of an aircraft or vessel. In programs. Discussion of CBP regulations
regulatory authority of the United States addition, submission of this manifest regarding the customs revenue function
Customs Service relating to customs information at an earlier point in time is contained in the regulatory plan of
revenue functions was retained by the to CBP is a necessary component of the the Department of the Treasury.
Department of the Treasury (see the nation’s continuing program of ensuring
Department of the Treasury Regulatory aviation and vessel safety and protecting Immigration and Customs Enforcement
Plan). national security. The new requirement The mission of the Bureau of
CBP is the federal agency principally also would assist in the efficient Immigration and Customs Enforcement
responsible for the security of our inspection and control of passengers (ICE) is to prevent acts of terrorism by

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targeting the people, money, and that the employee is an alien who is not would augment regulations issued by
materials that support terrorist and authorized to work in the United States the Department of Transportation.
criminal activities. Established to and is using a SSN that is false or was
combat the criminal and national assigned to someone else. In addition to TSA will also continue testing and
security threats emergent in a post 9/11 the SSA ‘‘no-match letters,’’ ICE sends begin implementation of the Secure
environment, ICE combines a new similar letters after it has inspected an Flight program, in accordance with Sec.
investigative approach with new employer’s I-9 Forms and 4012(a)(1) of the Intelligence Reform
resources to provide unparalleled unsuccessfully attempted to confirm, in and Terrorism Prevention Act of 2004
investigation, interdiction and security agency records, that an immigration (IRTPA) (Pub. L. 108-458, 118 Stat.
services to the public and our law status document or employment 3638, 3714, Dec. 17, 2004). Through
enforcement partners in the federal and authorization document presented or rulemaking, TSA will begin to assume
local sectors. referenced by an employee was assigned from aircraft operators the function of
During fiscal year 2007, ICE will be to that person. The amended rule will comparing passenger information to the
pursuing rulemaking actions to clarify whether an employer will be consolidated and integrated watch list
implement major components of the found to have constructive knowledge maintained by the Federal Government.
President’s and Department’s strategic of the false SSN. This regulatory
goals. ICE will continue to promulgate initiative promotes the Department’s In addition, TSA will continue to
regulations as necessary to improve Secure Border Initiative. facilitate the development of the
control of the reporting requirements for Transportation Security Administration Registered Traveler (RT) program
over 500,000 international students through a new pilot program and
attending colleges and universities in The Transportation Security rulemaking to establish the final
the United States and a similar number Administration’s (TSA’s) mission is to program. The Registered Traveler
of exchange visitors entering the United protect the nation’s transportation program is expected to afford expedited
States through regulatory amendments systems by ensuring the freedom of
security screening for passengers who
to the Student Exchange Visitor movement for people and commerce. As
have voluntarily submitted background
Information System (SEVIS) and we work to meet the immediate needs
information and biometric data, such as
Student Exchange Visitor Program of the transportation sector, we continue
to develop and implement the strategies, fingerprints or an iris scan, and have
(SEVP). These actions will foster the successfully undergone a security threat
Department’s strategic goals of through its people, processes, and
technology, which enable us to perform assessment. Major components of the
awareness and prevention. RT program will be implemented by the
our daily activities while ultimately
In an effort to facilitate ICE’s ability to preparing us for the future. private sector in accordance with TSA-
carry out its legal obligation to remove issued standards. TSA will conduct the
aliens who have been issued a final In fiscal year 2007, TSA will promote
security threat assessments on
order of removal, ICE is working to DHS’ Strategic Goals of awareness,
individuals who wish to become RT
promulgate a joint final rule with the prevention, protection, response, and
service by emphasizing regulatory members. In the next fiscal year, TSA
Department of Justice establishing that plans to issue an NPRM proposing the
aliens who are not already in ICE efforts that allow TSA to better identify,
detect, and protect against threats to the program’s process and eligibility
custody at the time they become subject requirements.
to a final order of removal, deportation domestic transportation system, while
or exclusion, have an affirmative facilitating the efficient movement of TSA will also propose to amend the
obligation to surrender themselves to transportation workers, cargo, and the
current aviation security rules
ICE after an order of removal becomes traveling public.
applicable to foreign air carriers to make
final. The rule limits the exercise of In furtherance of this goal, TSA and them more consistent with the rules
discretion in the consideration of the U.S. Coast Guard will issue a joint applicable to domestic air carriers and
applications for discretionary forms of Final Rule to begin implementation of to add a new 49 CFR part 1554
relief within the authority of the the Transportation Worker regulation to improve the security of
Secretary of Homeland Security and the Identification Credential (TWIC) domestic and foreign aircraft repair
Attorney General with respect to aliens program, which will allow TSA to stations, as required by Sec. 611(b)(1) of
who have failed to surrender to ICE as perform security threat assessments and
Vision 100 Century of Aviation
required by the rule. This regulatory issue biometric credentials to
Reauthorization Act (Pub. L. 108-176,
initiative promotes the Department’s individuals requiring unescorted access
117 Stat. 2490, 2571, Dec. 12, 2003).
strategic goals of awareness and to secure areas of maritime
prevention. transportation facilities and vessels. The
DHS Regulatory Plan for Fiscal Year
In an effort to provide guidance to objective of the TWIC program is to
employers on employing legally reduce the threat of terrorism by
authorized workers, ICE also will preventing unauthorized persons from A more detailed description of the
promulgate a final rule to reconcile gaining access to secure areas. priority regulations that comprise DHS’
millions of earnings reports (W-2 Forms) In addition, TSA plans to issue a Fall 2006 Regulatory Plan follows.
in which the name and social security Notice of Proposed Rulemaking (NPRM)
number (SSN) of the employee do not that would propose security
match Social Security Administration requirements for rail transportation.
(SSA) records. In some of these cases, This rulemaking would enhance
SSA sends a letter that informs the security in the rail transportation mode
employer of this fact. The letter is by proposing requirements on freight
commonly referred to as a ‘‘no-match and passenger railroads and on facilities
letter.’’ There are many causes for such with rail connections that ship certain
a no-match, but one common cause is hazardous materials. The rulemaking

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72800 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

DHS—Office of the Secretary (OS) unless it has been issued by a State DHS—OS
that has certified to, and been
determined by DHS to meet, the
PROPOSED RULE STAGE requirements of the Act. The Act sets FINAL RULE STAGE
forth minimum document
requirements, minimum issuance
49. ∑ MINIMUM STANDARDS FOR standards, and other requirements, 50. UNITED STATES VISITOR AND
• Information and features that must
appear on the face of the license, and
inclusion of a common machine
Priority: readable portion of a driver’s license Priority:
Economically Significant. Major under or identification card; Other Significant. Major under 5 USC
5 USC 801. • Presentation and verification of 801.
Unfunded Mandates: information an applicant must provide Legal Authority:
before a license may be issued,
Undetermined including evidence that the applicant PL 106–215, sec 2(a), 114 Stat 337 (June
is a U.S. citizen or has lawful status 15, 2000); PL 106–396, sec 205, 114
Legal Authority: Stat 1637, 1641 (October 30, 2000); PL
in the United States;
Division B—REAL ID Act of 2005; The 107–56, sec 114, 115 Stat 271, 553
Emergency Supplemental • Physical security of locations where (October 26, 2001); PL 107–173, sec
Appropriations Act for Defense; The licenses are produced, the security of 302, 116 Stat 543, 552 (May 14, 2002)
Global War on Terror and Tsunami document materials and papers from
Relief, 2005; PL 109–13, 119 Stat 231, CFR Citation:
which licenses are produced, and the
302 (May 11, 2005) (codified at 49 USC background check of certain employees 8 CFR 215.8; 8 CFR 235.1
30301 note) involved in the manufacture and Legal Deadline:
CFR Citation: production of licenses and;
6 CFR 37, et seq (New) • Physical security of the licenses to
prevent tampering, counterfeiting, and
Legal Deadline: duplication of the documents for a In 2003, the Department of Homeland
Final, Statutory, May 11, 2008. fraudulent purpose. Security established the United States
Visitor and Immigrant Status
Abstract: DHS is issuing this rule in consultation Technology Program (US-VISIT), whose
This regulation is designed to with the Department of Transportation, objective is to create and maintain an
implement the REAL ID ACT. The Act other representatives of the Federal integrated, automated entry-exit system
prohibits Federal agencies from government, and representatives from that records the arrival and departure
accepting a driver’s license or personal many States, as required under the Act. of aliens, verifies their identities, and
identification card (license) for an authenticates their travel documents
‘‘official purpose’’ unless it has been Timetable:
through comparison of biometric
issued by a State that has certified to, Action Date FR Cite identifiers. The goals of the US-VISIT
and been determined by DHS to meet, NPRM 03/00/07 program are to enhance the security of
the requirements of the Act. The Act United States citizens and visitors to
sets forth minimum document Regulatory Flexibility Analysis the United States, facilitate legitimate
requirements, minimum issuance Required: travel and trade, ensure the integrity of
standards, and other requirements, the United States immigration system,
including: information and security Yes and protect the privacy of visitors to
features that must be incorporated into the United States. In its early stages,
each card; the information that must be Small Entities Affected: US-VISIT applied only to
provided by an applicant to establish nonimmigrants with visas and to those
identity and immigration status before Governmental Jurisdictions who did not require a visa as they were
a card can be issued; physical security entering under the Visa Waiver
standards for locations where licenses Government Levels Affected:
Program. This rule would amend DHS
are produced. Federal, Local, State regulations to provide that all aliens,
including lawful Permanent Residents,
Statement of Need:
Federalism: may be enrolled into US-VISIT, with
DHS will be initiating a rulemaking very few exceptions, such as diplomats
action to establish minimum standards Undetermined and Canadian visitors.
for State-issued driver’s licenses and
identification cards that Federal Agency Contact: Statement of Need:
agencies would accept for official Darrell Williams On July 27, 2006, DHS published a
purposes as required under the REAL Department of Homeland Security proposed rule in the Federal Register
ID Act of 2005. The REAL ID Act Office of the Secretary that outlined DHS’ plan to begin
prohibits Federal agencies, effective Washington, DC 20528 enrolling additional groups of aliens
May 18, 2008, from accepting a driver’s Phone: 202 282–8000 into the US-VISIT biometric screening
license or personal identification card protocol. (US-VISIT is an integrated,
(license) for an ‘‘official purpose’’ RIN: 1601–AA37 automated entry-exit system that

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72801

records the arrival and departure of Agency Contact: Statement of Need:

aliens, verifies aliens’ identities, and Michael Hardin Voluntary security programs have
authenticates aliens’ travel documents Senior Policy Advisor, US–VISIT resulted in significant capital
through the comparison of biometric Department of Homeland Security investments and implementation of
identifiers.) The expansion of US-VISIT 18th Floor responsible security measures by many
biometric screening to these additional 1616 N. Fort Myer Drive companies in the chemical industry.
groups is needed in order to verify the Arlington, VA 22209 The Secretary of Homeland Security,
identity and authenticity of aliens Phone: 202 298–5200 however, has concluded that voluntary
presenting United States issued travel Fax: 202 298–5201 efforts alone cannot provide sufficient
documents upon an application for Email: security for the chemical sector.
admission. The expansion is consistent
with the implementation of the US- RIN: 1601–AA35 Summary of Legal Basis:
VISIT program to date, which has taken This interim rule implements the
an incremental, phased-in approach to DHS—OS requirements of section 550 of the
the biometric screening of aliens Homeland Security Appropriation Act
applying for admission to and exiting 51. ∑ CHEMICAL SECURITY of 2007.
from the United States. This expansion ANTI–TERRORISM STANDARDS
will encompass the majority of aliens Anticipated Cost and Benefits:
to-date not undergoing biometric Priority:
The Department is developing a cost
screening by the US-VISIT program, Other Significant. Major under 5 USC benefit analysis that will be published
with the exception of Canadian citizens 801. with the interim rules.
entering the United States as either B-
1 visitors for business or B-2 visitors Unfunded Mandates: Timetable:
for pleasure. Undetermined Action Date FR Cite
Summary of Legal Basis: Legal Authority: Interim Final Rule 04/00/07
While the establishment of the US- Section 550 of the Homeland Security Regulatory Flexibility Analysis
VISIT program is found in the Appropriations Act of 2007, Pub. L. No. Required:
provisions of several public laws, the 109–295, § 550 (Oct. 4, 2006) Undetermined
abstracts of which have been discussed
in several rulemakings (See 69 FR CFR Citation: Government Levels Affected:
53318, for example) the authority for 6 CFR 27 Undetermined
the expansion of the program to
additional alien groups may be found Legal Deadline: Federalism:
in section 302(b)(2) of the Enhanced Other, Statutory, April 4, 2007, Section Undetermined
Border Security and Visa Entry Reform 550 of the Homeland Security
Act of 2002, Public Law 107-173, 116 Appropriations Act of 2005. Agency Contact:
Stat. 543, 552 (May 14, 2002). This
Section 550 of the Homeland Security Dennis Deziel
section of law requires the United
Appropriations Act of 2005 directs DHS Deputy Director, Chemical and Nuclear
States to install at all ports of entry
to issue interim rules no later than 6 Preparedness and Protection Division
equipment and software that allows for
months after the effective date of the Department of Homeland Security
the biometric comparison and
Act. The Act became effective on Washington, DC 20528
authentication of all United States visas
October 4, 2006 and so the statutory Phone: 703 605–1213
and all machine-readable, tamper-
resistant travel and entry documents deadline for issuance of the interim RIN: 1601–AA41
that are issued to aliens. The rules under this provision is April 4,
installation of the needed equipment 2007.
DHS—U.S. Citizenship and
and software is complete. Abstract: Immigration Services (USCIS)
Timetable: Section 550 of the Homeland Security
Action Date FR Cite Appropriations Act of 2007 provided
the Department of Homeland Security PROPOSED RULE STAGE
Proposed Rule 07/27/06 71 FR 42605 with authority to promulgate ‘‘interim
Comment Period End 08/28/06 final regulations’’ for the security of
Final Rule 06/00/07 certain chemical facilities in the United 52. SPECIAL IMMIGRANT AND
Regulatory Flexibility Analysis States. See Pub. L. No. 109-295, § 550 NONIMMIGRANT RELIGIOUS
Required: (Oct. 4, 2006). In accordance with WORKERS
section 550, these regulations will
No establish risk-based performance Priority:
Small Entities Affected: standards and require vulnerability Other Significant
assessments and the development and
No implementation of site security plans. Legal Authority:
DHS currently plans to issue an 8 USC 1101; 8 USC 1103; 8 USC 1151;
Government Levels Affected:
advanced notice of rulemaking seeking 8 USC 1153; 8 USC 1154; 8 USC 1182;
None comment both on practical and policy 8 USC 1186a; 8 USC 1255; 8 CFR 2
issues integral to the development of
Additional Information: a chemical facility security program. CFR Citation:
Transferred from RIN 1650-AA06. The interim rule will follow. 8 CFR 204

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72802 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

Legal Deadline: Summary of Legal Basis: DHS—USCIS

None While this action revises the
Abstract: regulations to reflect Congressional FINAL RULE STAGE
This rule proposes to amend U.S. extension of this program, this action
Citizenship and Immigration Services is not required in order to give effect
(USCIS) regulations regarding the to that extension. 53. ADJUSTMENT OF STATUS TO
special immigrant and nonimmigrant LAWFUL PERMANENT RESIDENT
religious worker visa classifications. FOR ALIENS IN T AND U
This rule addresses concerns about the None because the Department has NONIMMIGRANT STATUS
integrity of the religious worker agreed to implement the Priority:
program by proposing a petition recommendations contained in the
requirement for religious organizations aforementioned GAO report. Also the Other Significant
seeking to classify an alien as an risk section below provides further Legal Authority:
immigrant or nonimmigrant religious reasons why there are no alternatives.
worker. This rule also proposes 5 USC 552; 5 USC 552a; 8 USC 1101
including an on-site inspection for to 1104; 8 USC 1182; 8 USC 1184; 8
Anticipated Cost and Benefits:
religious organizations to ensure the USC 1187; 8 USC 1201; 8 USC 1224;
legitimacy of petitioner organizations A detailed cost benefit analysis will be 8 USC 1225; 8 USC 1226; 8 USC 1227;
and employment offers made by such included in the regulatory analysis in 8 USC 1252; 8 USC 1252a; 8 USC 1255;
organizations. USCIS is proposing to the proposed rule. 22 USC 7101; 22 USC 7105; . . .
establish a fee, in addition to the CFR Citation:
standard fee required for special Risks:
immigrant or nonimmigrant visa 8 CFR 204; 8 CFR 214; 8 CFR 245
petitions, to cover the cost of the on- Failure to promulgate this rule change Legal Deadline:
site inspections. leaves the religious worker program
vulnerable to fraud and compromises Other, Statutory, January 5, 2006,
This rule would also clarify several DHS and USCIS national security goals. Regulations need to be promulgated by
substantive and procedural issues that July 5, 2006.
have arisen since the religious worker Timetable:
category was created. This rule Abstract:
Action Date FR Cite
proposes new definitions that describe This rule sets forth measures by which
more clearly the regulatory NPRM (CIS No. 01/00/07 certain victims of severe forms of
requirements, as well as add specific 1436–94) trafficking who have been granted T
evidentiary requirements for petitioning NPRM Comment 03/00/07 nonimmigrant status and victims of
employers and prospective religious Period End certain criminal activity who have been
workers. granted U nonimmigrant status may
Regulatory Flexibility Analysis apply for adjustment to permanent
Finally, this rule also proposes to
Required: resident status in accordance with
amend how USCIS regulations
reference the sunset date, the statutory Public Law 106-386, Victims of
deadline by which special immigrant Trafficking and Violence Protection Act
religious workers, other than ministers, of 2000, and Public Law 109-162,
Small Entities Affected:
must immigrate or adjust status to Violence Against Women and
permanent residence, so that regular No Department of Justice Reauthorization
updates to the regulations are not Act of 2005.
required each time Congress extends Government Levels Affected: Statement of Need:
the sunset date.
None This rule is necessary to establish how
Statement of Need: an eligible alien with T nonimmigrant
Additional Information: status can adjust his or her status to
This rule is needed to implement the
recommendations contained in the that of lawful permanent resident.
CIS No. 1436-94 Those with T nonimmigrant status are
GAO report Issues Concerning the
Religious Worker Visa Program, Report Transferred from RIN 1115-AF12 eligible to be granted lawful permanent
GAO/NSIAD-99-67 (March 26, 1999). residency if they can demonstrate they
Finally, USCIS wishes to make the Agency Contact: have complied with any reasonable
nonimmigrant religious worker request for assistance in the
Efren Hernandez investigation or prosecution of acts of
regulations consistent with the rules Chief, Business and Trade Branch
governing the immigrant religious trafficking or that they will face
Department of Homeland Security extreme hardship involving unusual
worker category to the extent possible, U.S. Citizenship and Immigration
and this rule is necessary to achieve and severe harm if they were removed
Services from the United States.
that objective. Service Center Operations
The changes proposed in this rule, if 2nd Floor Summary of Legal Basis:
implemented, would decrease the 20 Massachusetts Avenue NW. Public Law 106-386, Victims of
opportunity for fraud in the religious Washington, DC 20529 Trafficking and Violence Protection Act
worker program. Moreover, this Phone: 202 272–8411 of 2000.
rulemaking will further enhance the Email:
Department’s efforts in deterring fraud Alternatives:
and domestic security. RIN: 1615–AA16 None.

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72803

Anticipated Cost and Benefits: Government Levels Affected: to assist in the petitioning process.
While there is no precise formula for None Eligible victims will be allowed to
determining anticipated costs, there remain in the United States.
will be additional costs for adjudicating Additional Information:
Statement of Need:
applications and investigating cases CIS No. 2134-01
deemed fraudulent. There may be This rule is necessary to establish the
Transferred from RIN 1115-AG21 procedure for an eligible alien to obtain
applications that will not be approved
for a variety of reasons, including Agency Contact: temporary immigration benefits as a
failure to meet basic adjustment of victim of certain qualifying criminal
Pearl Chang activity while providing assistance to
status requirements. All applications Chief
will be reviewed and some will require law enforcement officials at the
Department of Homeland Security Federal, State, and local levels
extensive investigation both here and U.S. Citizenship and Immigration
abroad to determine whether the investigating and prosecuting these
Services crimes.
applicant has complied with any Regulations and Product Management
reasonable request for assistance in the Summary of Legal Basis:
investigation and prosecution of the
3rd Floor Public Law 106-386, Victims of
acts of trafficking.
111 Massachusetts Avenue NW. Trafficking and Violence Protection Act
The anticipated benefits of these Washington, DC 20529 of 2000; Public Law 109-162, Violence
expenditures include: Continued Phone: 202 272–8350 Against Women and Department of
assistance to trafficked victims and Email: Justice Reauthorization Act.
their families, increased investigation
and prosecution of traffickers in RIN: 1615–AA60 Alternatives:
persons, and the elimination of abuses None.
caused by trafficking activities. DHS—USCIS
Benefits that may be attributed to the Anticipated Cost and Benefits:
implementation of this rule are While there is no precise formula for
expected to be: determining anticipated costs, there
—an increase in the number of cases have been and will be additional costs
brought forward for investigation for adjudicating benefits and
and/or prosecution; Priority: investigating claims, particularly those
Other Significant deemed fraudulent. Also, there are
—heightened awareness of trafficking- training costs for DHS staff. The U
in-persons issues by the law Legal Authority: nonimmigrant classification allows
enforcement community; and victims of certain qualifying criminal
5 USC 552; 5 USC 552a; 8 USC 1101;
—enhanced ability to develop and work 8 USC 1101 note; 8 USC 1102; . . . activity to remain in the United States
cases in trafficking in persons cross- past the time of their assistance to law
organizationally and multi- CFR Citation: enforcement if their presence in the
jurisdictionally which may begin to 8 CFR 103; 8 CFR 204; 8 CFR 212; 8 United States is justified on
influence changes in trafficking CFR 214; 8 CFR 299 humanitarian grounds, to ensure family
patterns. unity, or is otherwise in the public
Legal Deadline: interest.
Other, Statutory, January 5, 2006, There may be applications that will not
Risks associated with the Regulations need to be promulgated by be approved for a variety of reasons,
implementation of the congressionally July 5, 2006. including failure to meet the basic U
mandated new nonimmigrant
Public Law 109-162, Violence Against nonimmigrant status eligibility
classification include:
Women and Department of Justice requirements. All applications will be
—increased workload for adjudicators reviewed and some will require
Reauthorization Act of 2005.
which may impact overall efficiency investigation to determine whether they
and productivity; and Abstract: are fraudulent.
—increases in fraudulent This rule sets forth application The anticipated benefits of these
applications/claims of such requirements for a new nonimmigrant expenditures include: Assistance to
victimization in order to obtain lawful status. The U classification is for non- victims of criminal activity and their
permanent residence. U.S. Citizen/Lawful Permanent families, and an increase in the number
Timetable: Resident victims of certain crimes who of cases brought forward for
cooperate with an investigation or investigation and prosecution (and
Action Date FR Cite
prosecution of those crimes. There is possible deportation) of the perpetrators
Interim Final Rule 04/00/07 a limit of 10,000 principals per year. of the criminal activity.
Interim Final Rule 06/00/07
Comment Period
This rule establishes the procedures to Risks:
End be followed in order to petition for the
U nonimmigrant classifications. Risks associated with the
Regulatory Flexibility Analysis Specifically, the rule addresses: The implementation of the congressionally
Required: essential elements that must be mandated new nonimmigrant
demonstrated to receive the classification include:
nonimmigrant classification; procedures —increased workload for adjudicators
Small Entities Affected: that must be followed to make an and investigators, which may impact
No application; and evidentiary guidance overall efficiency and productivity; and

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72804 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

—increases in fraudulent Evidence (RFE) or Notice of Intent to requirement that USCIS issue an RFE
applications/claims of such Deny (NOID). These changes will for initial evidence. Instead, USCIS, in
victimization in order to obtain U enable USCIS to set an appropriate its discretion, may deny a petition or
nonimmigrant status. deadline for responding to an RFE or application when required initial
Timetable: NOID, specific to the type of case, evidence is missing. If an applicant or
benefit category, or classification, and petitioner fails to submit the required
Action Date FR Cite thus improve the process of initial evidence, and USCIS decides to
Interim Final Rule 01/00/07 adjudication of applications and deny the application or petition rather
Interim Final Rule 02/00/07 petitions by reducing the time a case than issue an RFE, the applicant or
Comment Period is held awaiting evidence, and by petitioner may file a motion to reopen,
End reducing average case processing time. with fee, as provided under 8 CFR
This rule will result in improved 103.5 or file a new application or
Regulatory Flexibility Analysis efficiency in the USCIS adjudication petition. The applicant or petitioner
Required: process. may also file an appeal of the denial
No In addition, this rule includes certain if other regulatory or statutory authority
Small Entities Affected: organizational changes necessitated by exists for such appeal.
the implementation of the Homeland
No Summary of Legal Basis:
Security Act of 2002, Public Law 107-
Government Levels Affected: 296. This rule also removes obsolete This action is not required by court
regulatory language related to the order or statute.
Federal, Local, State Replenishment Agricultural Worker
Additional Information: (RAW) program under section 210A of Alternatives:
the Immigration and Nationality Act The alternative is not promulgating a
Transferred from RIN 1115-AG39
(Act), which was repealed by section final rule and maintaining the
Agency Contact: 219(ee)(1) of the Immigration and mandatory 12-week response period.
Technical Corrections Act of 1994, This would further exacerbate the
Pearl Chang
Public Law 103-416. The rule further current backlogged adjudication process
removes references to the use of by impeding timely approval of
Department of Homeland Security
qualified designated entities for filing applications and petitions.
U.S. Citizenship and Immigration of applications for adjustment of status
Services in the Seasonal Agricultural Workers Anticipated Cost and Benefits:
Regulations and Product Management (SAW) and legalization programs under
Division The Department of Homeland Security
section 210 and 245A of the Act. By
3rd Floor has assessed both the costs and benefits
including the organizational changes,
111 Massachusetts Avenue NW. of this rule as required by Executive
the rule will also assist the public in
Washington, DC 20529 understanding the delegation of Order 12866, section 1(b)(6) and has
Phone: 202 272–8350 authority for adjudicating cases. concluded that there are minimal costs
Email: to the Department associated with
Statement of Need: instructing adjudicators about the
RIN: 1615–AA67
In adjudicating an application or options for dealing with inadequate
petition for benefits, USCIS often issues information. There are benefits to both
DHS—USCIS a Request for Evidence (RFE). This USCIS and the public. USCIS will
request may address documentary or reduce the number of RFEs and NOIDs
55. REMOVAL OF STANDARDIZED and the cycle time for responses to
REQUEST FOR EVIDENCE evidentiary deficiencies in the case.
Under current regulations, there are such notices, potentially reducing the
PROCESSING TIMEFRAME pending backlog of cases. The public
certain situations in which USCIS must
Priority: issue an RFE, and in all cases in which will receive fewer and more specific
an RFE is issued, USCIS must provide RFE or NOID notices and benefit from
Other Significant
a standard 12-week response time. faster approval of applications and
Legal Authority: USCIS will replace the current 12-week petitions.
8 USC 1103 response period reflected in 8 CFR
103.2(b)(8) with a more flexible
CFR Citation: approach, setting response periods While there are no major risks
8 CFR 103 based on various factors such as the associated with not promulgating this
type of benefit sought; the type of rule, the current process of RFE
Legal Deadline: application or petition filed; the type issuance sometimes slows the
NPRM, Statutory, September 1, 2003, of evidence needed for adjudication; adjudication process. Some RFEs are
NPRM Comment Period Ends January the source and availability of simple enough to require resubmission
31, 2005. documentation (both foreign and within a few weeks; others may require
domestic); etc. USCIS will remove most more time. A fixed, standard response
Abstract: provisions that require issuance of an time does not make the most efficient
This rule proposes to amend RFE or Notice of Intent to Deny (NOID) use of adjudicative resources. In
Department of Homeland Security in order to allow USCIS greater addition, there are circumstances in
regulations by removing the absolute flexibility in deciding cases based on which USCIS is required by regulation
requirement for, and the fixed the information received, including to issue an RFE, even though it is
regulatory time limitations on initial evidence and other relevant apparent from the record that the
responses to a U.S. Citizenship and materials.This rule amends 8 CFR application or petition must be denied.
Immigration Services issued Request for 103.2(b)(8) by removing the mandatory This forces the USCIS to focus time and

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resources on RFEs in cases that are Departure (NOAD) and Automatic beyond what we propose in this
clearly not of merit. Identification System (AIS) rulemaking; and that it was best to
Timetable: requirements. These expanded combine additional NOAD expansion
requirements would better enable the with future AIS expansion.
Action Date FR Cite Coast Guard to correlate vessel AIS data Although not in conjunction with a
NPRM 11/30/04 69 FR 69549 with NOAD data, enhance our ability proposed rule, the Coast Guard sought
NPRM Comment 01/31/05 to identify and track vessels, detect comment regarding expansion of AIS
Period End anomalies, improve navigation safety, carriage to other waters and other
Final Action 02/00/07 and heighten our overall maritime vessels not subject to the current
domain awareness. requirements (68 FR 39355-56, and
Regulatory Flexibility Analysis
Required: The NOAD portion of this rulemaking 39370, July 1, 2003; USCG 2003-14878).
would expand the applicability of the Those comments were reviewed and
No NOAD regulations by changing the considered in drafting this rule and
Small Entities Affected: minimum size of vessels covered below will become part of this docket.
the current 300 gross tons, require that
No To fulfill our agency obligations, the
a notice of departure be submitted for
Coast Guard needs to receive AIS
Government Levels Affected: all vessels required to submit a notice
reports and NOADs from vessels
None of arrival, and mandate electronic
identified in this rulemaking that
submission of NOAD notices to the
Additional Information: currently are not required to provide
National Vessel Movement Center.
this information. Policy or other non-
CIS No. 2287-03 Statement of Need: binding statements by the Coast Guard
Agency Contact: We do not have a current mechanism addressed to the owners of these
in place to capture vessel, crew, vessels would not produce the
Pearl Chang information required to sufficiently
Chief passenger, or specific cargo information
on vessels less than or equal to 300 enhance our MDA to produce the
Department of Homeland Security information required to fulfill our
U.S. Citizenship and Immigration gross tons (GT) intending to arrive at
or depart from U.S. ports unless they Agency obligations.
Regulations and Product Management are arriving with certain dangerous Anticipated Cost and Benefits:
Division cargo (CDC) or are arriving at a port
in the 7th Coast Guard District. The We expect vessel owners to incur costs
3rd Floor from the additional NOA requirements
111 Massachusetts Avenue NW. lack of NOA information on this large
and diverse population of vessels in order to comply with the mandatory
Washington, DC 20529 requirement of submitting notices by
Phone: 202 272–8350 represents a substantial gap in our
maritime domain awareness (MDA). We utilizing the Coast Guard’s electronic
Email: Notice of Arrival and Departure
can minimize this gap and enhance
RIN: 1615–AB13 MDA by expanding the applicability of (eNOAD) system.
the NOAD regulation beyond vessels Currently, vessels greater than 300
DHS—U.S. Coast Guard (USCG) greater than 300 GT, cover all foreign gross tons, foreign commercial and
commercial vessels and all U.S. recreational vessels less than 300 gross
commercial vessels coming from a tons entering the 7th Coast Guard
PROPOSED RULE STAGE foreign port; and enhance maritime District, and all vessels carrying certain
domain awareness by tracking them dangerous cargoes (CDCs) are required
(and others) with AIS. There is no to submit NOAs.
56. VESSEL REQUIREMENTS FOR current Coast Guard requirement for This rulemaking will expand the
NOTICES OF ARRIVAL AND vessels to submit notification of applicability of NOADs to include all
DEPARTURE, AND AUTOMATIC departure information. This information foreign commercial vessels, regardless
IDENTIFICATION SYSTEM is necessary in order to expand our of tonnage, and all U.S. commercial
(USCG–2005–21869) MDA. vessels arriving from a foreign port.
Priority: Summary of Legal Basis: From the Coast Guard’s database, we
This rulemaking is based on believe that we have an accurate
Other Significant. Major status under 5 estimate of the number of vessels
USC 801 is undetermined. Congressional authority provided in the
Ports and Waterways Safety Act and greater than 300 gross tons submitting
Legal Authority: the Maritime Transportation Security NOAs and the approximate number of
33 USC 1223, 1225, 1231; 46 USC 3716, Act of 2002. voyages they make. These vessels are
8502 and Chapter 701; sec 102 of PL currently required to submit NOAs and
Alternatives: will be required to submit NOAs/NODs
Our goal is to increase MDA and to through a mandatory submission
CFR Citation: identify anomalies by correlating vessel method. Approximately 20,000 vessels
33 CFR 160; 33 CFR 161; 33 CFR 164 AIS data with NOAD data. NOAD and greater than 300 gross tons, with
AIS information from a greater number foreign vessels comprising nearly
Legal Deadline: of vessels would provide even greater 17,000 of this amount, and U.S. vessels
None MDA than the proposed rule. We comprising the balance, are currently
considered expanding NOAD and AIS affected. We, however cannot at this
Abstract: to even more vessels, but we time provide an estimate of the number
This rulemaking would expand the determined we needed additional of vessels less than 300 gross tons that
applicability for Notice of Arrival and legislative authority to expand AIS will be affected by this rulemaking or

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72806 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

the number of U.S. vessels coming from Agency Contact: and crew on departing vessels prior to
a foreign port since these vessels are LTJG Julie Miller the departure of the vessels or aircraft.
not required to report nor do we have Project Manager, Office of Vessel Statement of Need:
an effective means to capture this Activities, Foreign and Offshore Vessel
information. We will determine the Current Advance Passenger Information
Activities Div. (G–PCV–2)
affected population and include that System (APIS) regulations require air
Department of Homeland Security
information in the detailed regulatory carriers to electronically transmit
U.S. Coast Guard
analysis. passenger arrival manifests to Customs
2100 Second Street SW.
and Border Protection (CBP) no later
Washington, DC 20593
We anticipate unquantified benefits than 15 minutes after the departure of
Phone: 202 372–1244
will be associated with both portions the aircraft from any place outside the
of this rulemaking. We anticipate that Jorge Arroyo United States and passenger departure
quantified benefits derived from marine Project Manager, Office of Navigation manifests no later than 15 minutes
casualty cases will be associated with Systems (G–PWN) prior to departure of the aircraft from
the AIS portion of this rulemaking. A Department of Homeland Security the United States. Manifests for crew
detailed benefit analysis will be U.S. Coast Guard members on passenger and all-cargo
included in the regulatory analysis. 2100 Second Street SW. flights and non-crew members on all-
Washington, DC 20593–0001 cargo flights must be electronically
Risks: Phone: 202 372–1563 transmitted to CBP no later than 60
minutes prior to the departure of any
Considering the economic utility of RIN: 1625–AA99 covered flight to, continuing within, or
U.S. ports, waterways, and coastal overflying the United States (19 CFR
approaches, it is clear that a terrorist DHS—Bureau of Customs and Border 122.49b(b)(2)) and no later than 60
incident against our U.S. Maritime Protection (BCBP) minutes prior to the departure of any
Transportation System (MTS) would covered flight from the United States.
have a disastrous impact on global The current regulations require vessel
shipping, international trade, and the FINAL RULE STAGE carriers to electronically transmit
world economy. By improving the arrival passenger and crew member
ability of the Coast Guard both to manifests at least 24 hours and up to
identify potential terrorists coming to 96 hours prior to the vessel’s entry at
the United States while their vessel is a U.S. port or place of destination,
far at sea and to coordinate appropriate depending on the length of the voyage.
Also, a vessel carrier must
responses and intercepts before the UNITED STATES; PASSENGERS AND
electronically transmit passenger and
vessel reaches a U.S. port, this CREW MANIFESTS FOR
crew member departure manifests to
rulemaking would contribute COMMERCIAL VESSELS DEPARTING
CBP no later than 15 minutes prior to
significantly to the expansion of MDA, FROM THE UNITED STATES
the vessel’s departure from the United
and consequently is instrumental in States. These regulations serve to
addressing the threat posed by terrorist provide the nation, the carrier
actions against the MTS. Economically Significant. Major under industries, and the international
5 USC 801. traveling public, additional security
Unfunded Mandates: from the threat of terrorism and
Action Date FR Cite enhance CBP’s ability to carry out its
This action may affect the private border enforcement mission.
NPRM 02/00/07 sector under PL 104-4.
The Intelligence Reform and Terrorism
Regulatory Flexibility Analysis Legal Authority: Prevention Act of 2004 (IRTPA)
Required: 5 USC 301; 19 USC 58b; 19 USC 66; requires DHS to issue regulations and
19 USC 1431; 19 USC 1433; 19 USC procedures to allow for pre-departure
Undetermined vetting of passengers onboard aircraft
1434; 19 USC 1436; 19 USC 1448; 19
USC 1459; 19 USC 1590; 19 USC 1594; arriving in and departing from the
Government Levels Affected: United States and of passengers and
19 USC 1623; 19 USC 1624; 19 USC
None 1644; 19 USC 1644a; 19 USC 2071 note; crew onboard vessels arriving in and
46 USC app 3; 46 USC 91; . . . departing from the United States. This
Additional Information: rulemaking is designed to implement
CFR Citation: these important IRTPA requirements
With regard to the legal deadline, we 19 CFR 4; 19 CFR 122 and to further enhance national
have indicated in past notices and security and the security of the air and
rulemaking documents, and it remains Legal Deadline: vessel travel industries in accordance
the case, that we have worked to None with the Aviation and Transportation
coordinate implementation of AIS Security Act (ATSA) and Enhanced
MTSA requirements with the Abstract: Border Security and Visa Entry Reform
development of our ability to take Amendment of parts 4 and 122 of the Act of 2002 (EBSA), both of which
advantage of AIS data (68 FR 39355- Customs and Border Protection formed the statutory basis for the APIS
56 and 39370, July 1, 2003). regulations to require the electronic regulations.
transmission of manifest information This proposed rule would require
relating to passengers on arriving and transmission of, as appropriate,
departing aircraft and for passengers passenger and/or crew member

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information early enough in the process carriers, this alternative would not transmit that data, as an entire
to prevent a high-risk passenger from provide enough of a window for CBP passenger and crew manifest, to CBP
boarding an aircraft and to prevent the to respond to a hit on the watch lists. at least 60 minutes prior to departure
departure of a vessel with such a (3) A 60-minute transmission of the aircraft. CBP estimates that this
passenger or crew member onboard. requirement only during periods of will result in 2 percent of passengers
CBP’s purpose in proposing this change heightened threat conditions—this rule on large carriers and 0.25 percent of
is to place itself in a better position would require carriers to submit passengers on small carriers missing
to: (1) Fully vet passenger and crew manifest data 60 minutes prior to connecting flights and needing to be
member information with sufficient rerouted, with an average delay of 4
departure only during periods of
time to effectively secure the aircraft hours. Additionally, we estimate that
heightened threat conditions. This
or vessel, including time to coordinate 15 percent of passengers will need to
alternative would probably cause a
with carrier personnel and domestic or arrive at the airport an average of 15
great deal of disruption due to the
foreign government authorities in order minutes earlier in order to make their
unanticipated need to provide
to take appropriate action warranted by flights. For the low end of the range
information earlier at irregular
the threat; (2) identify high-risk (under the AQQ procedure), we assume
intervals. Additionally, the threat of
passengers and prevent them from that all large air carriers will implement
terrorism is continuous, and specific
boarding aircraft bound for or departing AQQ to transmit information on
threat information on flights may not
from the United States; and (3) identify individual passengers as each checks
emerge. Thus, the risks would not in. CBP estimates that this will
high-risk passengers and crew members likely be diminished sufficiently to
to prevent the departure of vessels from significantly drive down even further
justify the costs. Finally, an alternating the percentage of passengers requiring
the United States with a high-risk system of manifest transmission timing
passenger or crew member onboard. rerouting on large carriers to 0.5
would likely affect carrier performance, percent. Travelers will not need to
Achieving these goals would permit with performance ratings suffering
CBP to more effectively prevent an modify their behavior to arrive at the
during the infrequent, non-routine airport earlier. The percentage on small
identified high-risk traveler from elevations in threat level, the more
becoming a threat to passengers, crew, carriers remains 0.25 percent because
critical period. we assume that small carriers will not
aircraft, vessels, or the public and
would ensure that the electronic data (4) A 120-minute transmission implement AQQ; rather, they will
transmission and screening process requirement—this rule would require continue to submit manifests at least
required under CBP regulations carriers to submit manifests 120 60 minutes prior to departure through
comports with the purposes of ATSA, minutes prior to departure. The costs eAPIS, CBP’s web-based application for
EBSA, and IRTPA. would be higher than under the small carriers. Thus, costs for small air
proposed rule because originating carriers are the same regardless of the
Summary of Legal Basis: passengers, not just connecting regulatory option considered. The
The APIS program is based on passengers, would now be affected. present value (PV) costs of the
Congressional authority provided in the High-risk passengers would be rulemaking are estimated to range from
Aviation and Transportation Security prevented from boarding aircraft. CBP $612 million to $1.9 billion over the
Act (ATSA) and Enhanced Border would be able to more easily coordinate next 10 years (2006-2015, 2005 dollars,
Security and Visa Entry Reform Act of and plan a response to a hit on the 7 percent discount rate).
2002 (EBSA). The amendments made watch lists well before the boarding We estimate four categories of benefits,
by this rulemaking are based on process began. This alternative would or costs that could be avoided, under
Congressional authority provided in the be quite disruptive because even the APIS 60 procedure: (1) Costs for
Intelligence Reform and Terrorism though passengers and carriers would conducting interviews with identified
Prevention Act of 2004 (IRTPA). have the predictability of a pre- high-risk individuals upon arrival in
determined transmission time, the United States; (2) costs for
Alternatives: passenger check-in at the original deporting a percentage of these
CBP considered a number of regulatory departure airport would be greatly individuals; (3) costs of delaying a
alternatives to the proposed rule. affected. high-risk aircraft at an airport; and (4)
costs of rerouting aircraft if high-risk
(1) Do not promulgate any further Anticipated Cost and Benefits:
individuals are identified after takeoff.
manifest transmission requirements (No We expect that air carriers and air Monetizing the benefits of avoiding an
Action)—the baseline case where passengers will be the parties primarily actual terrorist incident has proven
carriers would continue to submit APIS affected by the proposed rule. For APIS difficult because the damages caused by
manifests for arriving aircraft 60, costs will be driven by the number terrorism are a function of where the
passengers 15 minutes after departure of air travelers that will need to arrive attack takes place, the nature of the
and, for departing aircraft passengers, at their originating airports earlier and attack, the number of people affected,
15 minutes prior to departure. This the number of air travelers who miss the casualty rates, the psychological
alternative is inconsistent with the connecting flights and require rerouting impacts of the attack, and, perhaps
protective security objectives of ATSA, as a result. For APIS Quick Query most importantly, the ‘‘ripple effects’’
EBSA, and IRTPA. (AQQ), costs will be driven by as damages permeate throughout our
(2) A pre-departure transmission implementation expenses, data society and economy far beyond the
requirement—this would require transmission costs, and a small number initial target. The average recurring
carriers to submit manifests earlier than of air travelers who miss connecting benefits of the proposed rule are an
is required under the status quo flights. For the high end of the range estimated $15 million per year. This is
requirements for flights to and from the (i.e., under the APIS 60 procedure), in addition to the non-quantified
United States. Transmission of manifest CBP anticipates that passengers will security benefits, which are the primary
information would be made at least 30 provide APIS data upon check-in for impetus for this rule. Over the 10-year
minutes prior to departure. For large their flights and that all carriers will period of analysis, PV benefits are an

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72808 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

estimated $105 million at a 7 percent Risks: Regulatory Flexibility Analysis

discount rate ($128 million at a 3 Required:
percent discount rate). Promulgation of this rule would
increase CBP’s ability to effectively No
Given the quantified costs and benefits prevent an identified high-risk traveler
of the proposed rule, we can determine from becoming a threat to passengers, Government Levels Affected:
how much non-quantified security crew, aircraft, vessels, or the public.
benefits would have to be for this rule Failure to do so would compromise None
to be cost-beneficial. The 10-year costs
DHS and CBP’s national security goals
range from $612 million to $1.9 billion, Agency Contact:
by not providing CBP with a valuable
and the benefits are an estimated $103
tool in securing the international Charles Perez
million (all at the 7 percent discount
transportation system. Program Manager, Office of Field
rate). Thus, the non-quantified security
benefits would have to be $509 million Operations
to $1.8 billion over the 10-year period Department of Homeland Security
in order for this proposed rule to be Action Date FR Cite Bureau of Customs and Border Protection
cost-beneficial. In one hypothetical NPRM 07/14/06 71 FR 40035 1300 Pennsylvania Avenue NW.
security scenario involving only one NPRM Comment 08/14/06 Washington, DC 20229
aircraft and the people aboard, Period End Phone: 202 344–1983
estimated costs of an incident could Other/NPRM 08/02/06 71 FR 43681
exceed $790 million. This rule may not Comment Period Related RIN: Related to 1651–AA37
prevent such an incident, but if it did, Extended
the value of preventing such a limited NPRM Comment 10/12/06
RIN: 1651–AA62
incident would outweigh the costs at Period End BILLING CODE 4410–10–S

the low end of the range. Final Action 02/00/07

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72809

DEPARTMENT OF HOUSING AND opportunities are administered by FHA. provides capital funds to maintain this
URBAN DEVELOPMENT (HUD) By insuring mortgage loans, FHA allows asset. Capital funds are intended to
lenders to offer lower down payments cover modernization of public housing,
Statement of Regulatory Priorities than would otherwise be available, low as well as the costs of normal wear and
The Department of Housing and closing costs, and easy credit qualifying. tear. Through the use of capital funds,
Urban Development (HUD), as the One way that HUD will expand public housing agencies (PHAs) are able
nation’s housing agency, is committed homeownership opportunities in to undertake activities to modernize
to increasing homeownership, FY2007 is to make it easier for FHA to units, renovate properties, improve the
particularly among minorities; creating serve purchasers of affordable housing, safety and security of public housing,
affordable housing opportunities for such as manufactured homes. FHA and make public housing accessible to
low-income Americans; and supporting would eliminate a feature of its persons with disabilities. HUD’s goal is
the homeless, elderly, people with Manufactured Housing program that to ensure that PHAs can address their
disabilities, and people living with contain prescriptive requirements most serious capital issues when the
AIDS. HUD is also committed to pertaining to permanent foundations need arises in order to avoid more costly
promoting economic and community that do not provide for flexibility of and extensive renovations after need
development, and enforcing the nation’s design. The proposed amendment accrues for several years.
fair housing laws. would promote affordable housing and To accomplish these goals, HUD will
Each year, through its programs and the uniform quality and safety of focus on improving the management
initiatives, HUD enables millions of manufactured homes. accountability and physical conditions
individuals and families, including Regulatory Action: Permanent of public and assisted housing through
increasing numbers of minorities, to Foundations For Manufactured Housing the following regulations.
become homeowners or to obtain safe, Regulatory Action: Capital Fund
decent, and affordable rental housing. This proposed rule would amend
HUD’s regulations governing Program
HUD helps communities improve
manufactured homes erected on a Section 519 of the Quality Housing
economic conditions and infrastructure
permanent foundation that are to be the and Work Responsibility Act amended
in distressed areas, thereby making
security for a Title II FHA-insured section 9 of the United States Housing
these communities more livable. HUD
mortgage. In addition, this proposed Act of 1937 (1937 Act) by providing for
increases public awareness of fair
rule would amend HUD’s regulations a Capital Fund that would make
housing laws, and it is through this
governing manufactured homes erected assistance available to PHAs to carry out
awareness, coupled with enforcement of
on a permanent foundation that are to capital and management improvement
fair housing laws, that HUD reduces
be security for a Title I FHA- insured activities. The regulations implementing
incidents of housing discrimination.
mortgage. Current regulations contain the new Capital Fund formula were
Each year, HUD also continues to
prescriptive requirements pertaining to promulgated in 2000. This proposed
strengthen its partnerships with other
permanent foundations that do not rule would establish the full regulatory
federal agencies, state and local
provide for flexibility of design. HUD framework for the Capital Fund
governments, and private sector
proposes to remove these requirements Program. The Capital Fund Program
organizations, including for-profit,
for both existing and newly constructed addresses the capital and management
nonprofit, faith-based, and community-
manufactured homes by instead improvement needs of PHAs and
based organizations. These partnerships
deferring to the requirements replaces the Comprehensive Grant
help HUD advance its mission to
established by the Model Manufactured Program and the Comprehensive
increase homeownership, support
Home Installation Standards (Model Improvement Assistance Program. The
community development, and increase
Installation Standards). A separate rule proposed rule would complement the
access to affordable housing free from
would establish the minimum final rule that ensures the effective and
acceptable standards nationwide for the timely obligation and expenditure of
HUD’s three programmatic strategic installation and set-up of manufactured funds under the Public Housing Capital
goals, embodied in HUD’s mission homes. Fund Program.
statement — increasing
Priority: Improving the Quality of While HUD provides assistance that
homeownership, promoting access to
Public and Assisted Housing helps to ensure that PHAs can address
decent affordable housing, and
their most serious capital issues, HUD
strengthening communities, form the Promoting decent affordable housing holds PHAs accountable for providing
foundation each fiscal year for the is a central part of HUD’s mission. To safe and decent housing, and protecting
majority of HUD’s proposals for new or this end, HUD seeks to improve the the federal investment in their
revised regulatory programs and quality of the housing opportunities properties. HUD does this by measuring
initiatives, and that is true for Fiscal provided to families in public and the performance of PHAs and using this
Year (FY) 2007. assisted housing. Public housing is an information to assist those PHAs that
The regulatory plan for HUD for FY important asset in which the federal need improvement and holding those
2007 highlights certain significant government has invested for more than that do not improve accountable. HUD
regulatory policy proposals that are 7 decades. Throughout America, public is committed to ensuring that PHAs
designed to advance HUD’s mission. housing provides homes for millions of perform effectively, particularly as they
Americans who have serious housing move to project-based funding.
Priority: Increasing Homeownership needs due to age, income, or disability.
Opening doors to homeownership has For many very low-income families and Regulatory Action: Public Housing
been a core aspect of HUD’s mission individuals, public housing represents Assessment System (PHAS) Revision
stemming from the 1930s, when the line between decent shelter and This proposed rule would revise the
Congress created the Federal Housing homelessness. To ensure that those of PHAS regulation at 24 CFR part 902 to
Administration (FHA). HUD’s primary lesser means are well-housed in decent, provide additional information, revise
programs for offering homeownership safe, and viable communities, HUD certain procedures, and establish other

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72810 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

procedures for the assessment of the acceptable standards nationwide for the will be codified at 24 CFR part 3285.
physical condition, financial condition, installation and set-up of manufactured This rule would increase flexibility of
management operations, resident homes.) This rule will not supplant the design, resulting in reduced cost to
services, and resident satisfaction. The current installation requirements builders and consumers. Such a change
rule would provide assessments of entirely, but will permit them to be would also serve to protect the health
PHAs on a project level rather than on used in cases of FHA refinance and safety of occupants of
an entity-wide basis for all four of the transactions for any existing manufactured homes and FHA’s
PHAS indicators and would assess the manufactured home that is currently interest in the property. Overall, this
management of PHA properties security for an FHA-insured loan and change would promote affordable
according to an asset management which met FHA requirements at the housing and conform FHA’s installation
model, consistent with the management time of the original endorsement. The requirements to nationwide minimum
norms in multifamily, including project- rule would also amend HUD’s standards. Further, manufactured
based budgeting, and project-based regulations governing manufactured homes that already securitize FHA-
accounting. The purpose of the PHAS is homes erected on a permanent insured loans would not be affected by
to function as a management tool that foundation that are to be security for the regulatory change, and, therefore,
effectively and fairly measures a PHA’s a title I FHA-insured mortgage. The would bear no compliance costs.
performance based on standards that are proposed rule would promote
uniform and verifiable. affordable housing and the uniform Risks:
quality and safety of manufactured This rule poses no threat to public
The Priority Regulations That Comprise homes. safety, health, or the environment.
HUD’s FY 2007 Regulatory Plan
Statement of Need: Timetable:
A more detailed description of the
priority regulations that comprise The current regulations governing Action Date FR Cite
HUD’s FY 2007 Regulatory Plan follows. permanent foundations for NPRM 02/00/07
manufactured housing may be too
prescriptive in that they do not allow Regulatory Flexibility Analysis
HUD—Office of Housing (OH) for flexibility of design. This rule is Required:
also necessary to avoid HUD having No
two inconsistent foundation standards
PROPOSED RULE STAGE for the installation of manufactured Small Entities Affected:
homes. The Manufactured Housing No
Improvements Act of 2000 amended the
58. ∑ PERMANENT FOUNDATIONS National Manufactured Housing Government Levels Affected:
FOR MANUFACTURED HOUSING Construction and Safety Act of 1974 None
(FR–5075) (the Act) by establishing new
Agency Contact:
Priority: requirements pertaining to the
installation of manufactured homes. Joyce Richardson
Other Significant Among the requirements was a Director, Home Valuation Policy Division
provision that HUD must promulgate Department of Housing and Urban
Legal Authority:
Model Manufactured Installation Development
12 USC 1703; 42 USC 3535(d); 42 USC Standards. FHA regulations need to be Office of Housing
5301 to 5320 modified to reflect the new installation Washington, DC
compliance standards under the Act for Phone: 202 708–2121
CFR Citation:
manufactured homes that are to be RIN: 2502–AI45
24 CFR 201; 24 CFR 203 security for title I and title II FHA-
Legal Deadline: insured mortgages.
HUD—Office of Public and Indian
None Summary of Legal Basis: Housing (PIH)
The National Housing Act at 12 U.S.C.
1703 authorizes the Secretary to insure
This rule would amend HUD’s approved lenders against losses PROPOSED RULE STAGE
regulations governing manufactured sustained as a result of borrower
homes erected on a permanent default on, among other things,
foundation that are to be the security manufactured home loans. 59. CAPITAL FUND PROGRAM
for a title II Federal Housing (FR–4880)
Administration (FHA) insured Alternatives:
mortgage. The current regulations The changes made by this proposed Priority:
contain prescriptive requirements rule would modify an existing Other Significant
pertaining to permanent foundations regulatory requirement and, therefore,
that do not provide for flexibility of must also be promulgated through Legal Authority:
design. HUD proposes to remove these regulation. 42 USC 1437g; 42 USC 1437z–7; 42
requirements for both existing and new USC 3535(d)
construction manufactured homes and Anticipated Cost and Benefits:
instead defer to the requirements This rule would require that the CFR Citation:
established by the Model Manufactured Minimum Property Standards 24 CFR 905
Home Installation Standards (Model applicable to the installation of
Installation Standards). (A separate rule manufactured homes meet or exceed Legal Deadline:
would establish the minimum the Model Installation Standards, as None

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72811

Abstract: manage their physical assets, would new formula for distributing operating
This rule will implement the new provide increased benefits to the PHAs. subsidies to PHAs and to establish
Capital Fund Program for the capital Likewise, uniform program requirements for PHAs to convert to
and management improvement needs of administration of these funds would asset management. The rule would
public housing agencies (PHAs). This provide increased benefits to the PHAs. revise the PHAS regulations to reflect
rule will implement the regulatory the new asset-based management
Risks: requirements of the September 19,
framework for the Capital Fund
Program that will govern the use of the This rule poses no threat to public 2005, Operating Fund final rule. In
assistance made available from the safety, health, or the environment. particular, the rule would provide for
Capital Fund formula. The new rule at Timetable: the assessment of PHAs on a project-
part 905 will replace and remove level, rather than on an entity-wide
Action Date FR Cite level. Further, the rule would revise the
several other rules that currently govern
a PHA’s use of HUD assistance NPRM 06/00/07 PHAS regulations to assess PHAs
including part 941 - Public Housing according to an asset management
Regulatory Flexibility Analysis model, consistent with the norms of
Development and part 968 - Public Required:
Housing Modernization. This rule will multifamily housing rental
continue and expand the streamlining No management, including the use of
of procedures and requirements project-based budgeting and project-
Small Entities Affected: based accounting.
initiated under the Comprehensive
Grant and Comprehensive Improvement No Statement of Need:
programs at part 968. Government Levels Affected: The September 19, 2005, Operating
Statement of Need: None Fund Program final rule redirected the
Assistance under the Capital Fund focus of the public housing program to
Program is the primary, regular source Agency Contact: a property-based management model.
of funding made available by HUD to Jeffrey Riddel This change adopted the
a PHA for its capital activities, Acting Director, Office of Capital recommendations of the
including modernization and Improvements congressionally mandated study of the
development of public housing. This Department of Housing and Urban costs of operating well-run public
rule will implement the requirements Development housing. However, the PHAS
for the use of assistance made available Office of Public and Indian Housing regulations are currently not reflective
under the Capital Fund Program. The Phone: 202 401–8812 of this significant change in the
regulations will provide the appropriate direction and management of public
RIN: 2577–AC50 housing, but rather reflect the former
notice of the legal framework for the
program, and clear and uniform agency-centric public housing
guidance for program operation. HUD—PIH management model. The PHAS
regulations must be updated to
Summary of Legal Basis: 60. ∑ REVISIONS TO THE PUBLIC incorporate the asset-based
Sections 518, 519, and 539 of the HOUSING ASSESSMENT SYSTEM management requirements. Updating of
Quality Housing and Work (PHAS) (FR–5094) the regulations will help to ensure that
Responsibility Act, which amended Priority: the PHAS continues to provide
sections 9 and 5 of, and added section appropriate standards for the fair and
35(g) to, the U.S. Housing Act of 1937. Other Significant effective evaluation of PHA
Legal Authority: performance in the management of
Alternatives: public housing.
The amendments to the U.S. Housing 42 USC 1437d(j); 42 USC 3535(d)
Act of 1937 made by the Quality Summary of Legal Basis:
CFR Citation:
Housing and Work Responsibility Act Section 6(j) of the United States
regarding the Capital Fund Program 24 CFR 902 Housing Act of 1937 (42 U.S.C.
required a formula system to be 1437d(j)) requires the Secretary of
Legal Deadline:
established to govern funding of PHAs’ Housing and Urban Development to
public housing capital needs. This None develop and publish, in the Federal
formula was established by final rule Register, indicators to assess the
issued on March 16, 2000. Guidance for management performance of PHAs and
administration of these funds This rule will revise the regulations for resident management corporations.
necessitates a permanent legal the Public Housing Assessment System Section 7(d) of the Department of
framework rather than informal and (PHAS) to reflect the asset-based Housing and Urban Development Act
sporadic HUD notices. management requirements for public (42 U.S.C. 3535(d)) establishes the
housing. The purpose of the PHAS is Department’s general rulemaking
Anticipated Cost and Benefits: to provide a management tool for authority, authorizing the Secretary to
The costs of the program as effectively and fairly measuring the make such rules and regulations as may
administered with one fund from performance of a public housing agency be necessary to carry out the functions
which a PHA would fund all of its (PHA) in essential housing operations, of the Department.
capital needs is the same as under based on standards that are uniform
existing provisions. The benefits of and verifiable. On September 19, 2005, Alternatives:
having one funding mechanism for all HUD published a final rule amending As noted above, HUD is statutorily
such needs, and the provision of the regulations for the Public Housing required to publish the indicators for
additional flexibility to PHAs to Operating Fund Program to provide a assessing public housing management

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72812 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

performance. The policies and established by the September 19, 2005, Small Entities Affected:
procedures governing the measurement Operating Fund Program final rule. The
of public housing performance under benefit of the regulatory changes will No
the PHAS are codified in HUD’s be to update and conform the PHAS
regulations at 24 CFR part 902. requirements with the asset-based Government Levels Affected:
Accordingly, any revisions to these management requirement, thereby None
policies and requirement must also be helping to ensure the continued
implemented through notice and validity, fairness, and effectiveness of Agency Contact:
comment rulemaking. Promulgation of the performance indicators.
these changes through other, non- Elizabeth Hanson
rulemaking means (such as through Risks: Deputy Assistant Secretary, Departmental
notice of handbook) would not be This rule poses no threat to public Real Estate Assessment Center (REAC)
enforceable. safety, health, or the environment. Department of Housing and Urban
Anticipated Cost and Benefits: Timetable: Development
Office of Public and Indian Housing
The rule would not impose any new Action Date FR Cite
Phone: 202 475–7949
significant costs on PHAs. As noted NPRM 04/00/07
above, the proposed regulatory changes RIN: 2577–AC68
costs update the indicators for assessing Regulatory Flexibility Analysis
PHA performance to reflect the existing Required:
asset-based management requirements No

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Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan 72813

DEPARTMENT OF THE INTERIOR (DOI) Major Regulatory Areas • Perform essential functions that
All of the Department’s bureaus and cannot be handled by non-Federal
Statement of Regulatory Priorities offices have significant regulatory entities;
responsibilities. • Minimize regulatory costs to society
The Department of the Interior (DOI)
The Office of Surface Mining while maximizing societal benefits;
is the principal Federal steward of our
Reclamation and Enforcement (OSM), in and
nation’s public lands and resources,
including many of our cultural partnership with the States and Indian • Operate programs openly, efficiently,
treasures. We serve as trustee to Native tribes, establishes and enforces and in cooperation with Federal and
Americans and Alaska natives and also environmental standards for coal non-Federal entities.
are responsible for relations with the mining and reclamation operations. In
island territories under United States addition, OSM administers the DOI bureaus work with other Federal
jurisdiction. We manage more than 500 abandoned mine land reclamation agencies, non-Federal Government
million acres of Federal lands, including program, which is funded by a fee agencies, and public entities to make
390 park units, 545 wildlife refuges, and assessed on each ton of coal produced. our regulations easier to comply with
approximately 1.7 billion acres Money from these fees is placed in a and understand. Regulatory
submerged in offshore waters. The fund that, subject to appropriation, is improvement is a continuing process
Department protects natural, historic, used to reclaim lands and waters that requires the participation of all
and cultural resources, recovers impacted by historic mining activities affected parties. We strive to include all
endangered species, manages water conducted before the enactment of the affected entities in the decisionmaking
projects, manages forests and fights Surface Mining Control and process and to issue rules efficiently. To
wildland fires, regulates surface coal Reclamation Act of 1977. The collection better manage and review the regulatory
mining operations, leases public lands of the fee for reclamation purposes was process, we have revised our internal
for coal, oil, and gas production to meet originally scheduled to expire in 1992 rulemaking and information quality
the Nation’s energy needs, educates and has been extended through guidance. Our regulatory process
children in Indian schools, and provides September 2007. ensures that bureaus share ideas on how
recreational opportunities for over 400 Other DOI bureaus rely on regulations to reduce regulatory burdens while
million visitors annually in our national to implement legislatively mandated meeting the requirements of the laws
parks, Bureau of Land Management programs that focus on the management they enforce and improving their
public lands, national wildlife refuges, of natural resources and public or trust stewardship of the environment and
and Bureau of Reclamation recreation lands. Some of these regulatory resources under their purview. Results
areas. To fulfill these responsibilities, activities include: included:
the Department generates scientific and • Management of migratory birds and • Increased bureau awareness of and
other information relating to land and preservation of certain marine responsiveness to the needs of small
resource management. mammals and endangered species; businesses and better compliance
with the Small Business Regulatory
The Department is committed to • Management of dedicated lands, such Enforcement Fairness Act (SBREFA);
achieving its stewardship objectives in as national parks, wildlife refuges,
partnership with States, communities, and American Indian trust lands; • A departmental effort to evaluate the
landowners, and others through economic effects of planned rules and
• Management of public lands open to regulations;
consultation, cooperation, and
multiple use;
communication. • Issuance of guidance in the
• Leasing and development oversight of Departmental Manual to ensure the
We will review and update the Federal energy, minerals, and
Department’s regulations and policies to use of plain language;
renewable resources;
ensure that they are effective, efficient, • Issuance of new guidance in the
and promote accountability. Special • Management of revenues from Departmental Manual to ensure that
emphasis will be given to regulations American Indian and Federal National Environmental Policy Act
and policies that: minerals; policies that streamline
• Fulfillment of trust and other decisionmaking and enhance citizen
• Adopt performance approaches
responsibilities pertaining to participation are institutionalized;
focused on achieving cost-effective,
American Indians;
timely results; • Issuance of revised procedures in the
• Natural resource damage assessments; Departmental Manual to clarify the
• Incorporate the best available science, and responsibility to offer cooperating
and utilize peer review where
• Management of financial and agency status to qualified agencies
nonfinancial assistance programs. and governments, and to make clear
• Promote partnerships with States, the role of cooperating agencies in the
tribes, local governments, other Regulatory Policy implementation of the Department’s
groups, and individuals; How DOI Regulatory Procedures Relate NEPA compliance process;
• Provide incentives for private to the Administration’s Regulatory • Increased outreach to involved parties
landowners to achieve conservation Policies in the Natural Resources Damage
goals; and Within the requirements and Assessment Program, stressing
• Minimize regulatory and procedural guidance in Executive Orders 12866, cooperation and restoration of
burdens, promoting fairness, 12630, 13132, 13175, 13211, and 12988, affected sites;
transparency, and accountability by DOI’s regulatory programs seek to: • Streamlined decisionmaking
agency regulators while maintaining • Fulfill all legal requirements as pertaining to fuels-reduction projects
performance goals. specified by statutes or court orders; under the Healthy Forests Initiative

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72814 Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / The Regulatory Plan

and Healthy Forests Restoration Act; reduce the backlog of pending drilling wildlife, and to enhance incentive-based
and permits. As BLM continues to make programs to encourage landowners and
• Promulgated hydropower license steady progress in reducing the backlog, others to implement voluntary
rules jointly with the Departments of it must work even more aggressively in conservation measures. For example,
Agriculture and Commerce, in the face of rising energy prices and the Fish and Wildlife Service has issued
consultation with FERC, that increased demand for drilling permits. guidance to promote the establishment
streamline the licensing and appeals To aid in this effort, new process of conservation banks as a tool to offset
process as called for in the Energy improvement tools have become adverse impacts to species listed under
Policy Act of 2005. available with the passage of the Energy the Endangered Species Act and restore
Policy Act. With these tools, BLM will habitat.
Implementing the President’s National further reduce and ultimately eliminate
Energy Policy and the Energy Policy Act the backlog of pending permits while The Department is improving
allowing the development of energy incentives through administrative
The President’s National Energy flexibility under the Endangered
Policy promotes ‘‘dependable, resources in an environmentally
responsible manner. Species Act. Released in April 2004 was
affordable, and environmentally sound a rule change intended to provide
production and distribution of energy BLM is continuing its program of greater clarity as to what is allowable
for the future.’’ The Department of the environmental Best Management under incidental take permits and to
Interior plays a vital role in Practices (BMPs) to help ensure the provide greater private landowner
implementing the President’s energy continued development of energy protections under safe harbor
policy goals. The lands, waters, and resources in an environmentally agreements.
facilities managed by the Department responsible manner. BMPs are
account for nearly 30 percent of all the innovative, dynamic, and improved The U.S. Geological Survey (USGS) is
energy produced in the United States. environmental protection practices developing a policy and procedures for
Through over 100 actions, the aimed at reducing impacts to the many reporting, investigating, and
Department is implementing the natural resources BLM manages on adjudicating allegations of scientific
President’s energy policy and the behalf of the public. The BLM requires misconduct by USGS employees and
Energy Policy Act of 2005, including that appropriate environmental BMPs be volunteers in accordance with the
numerous regulatory actions. The considered for use in all new oil and gas Federal policy on research misconduct.
Bureau of Land Management and the drilling and production operations on All covered employees and volunteers
Minerals Management Service are the public lands administered by the will be informed of their obligation to
developing proposed rules to implement BLM. A full discussion and many follow this policy and required to sign
the Energy Policy Act. The Office of examples of BMPs can be found at a statement indicating they have
Surface Mining is developing BLM’s BMP website: received, read, and understand the
regulations that will promote better policy. These efforts will help to protect
mining and reclamation practices while Encouraging Responsible Management the public from the effects of inaccurate
maintaining a stable regulatory of the Nation’s Resources or misleading information produced
framework conducive to coal The Department’s mission includes through scientific activities and help to
production. OSM anticipates that protecting and providing access to our ensure scientific integrity in the conduct
Congress will reauthorize the Nation’s natural and cultural heritage of scientific activities.
Abandoned Mine Land Fee. However, and honoring our trust responsibilities In 2006, the Secretaries of Interior and
OSM has published contingency to tribes. We are committed to this Agriculture, Western Governors, county
rulemaking plans should Congress mission and to applying laws and commissioners, and other affected
decide otherwise. These and other regulations fairly and effectively. The parties will complete a revision of the
regulatory actions within the Department’s priorities include 10-Year Comprehensive Strategy
Department will streamline permitting protecting public health and safety,
processes and encourage energy Implementation Plan, a collaborative
restoring and maintaining public lands, national effort to reduce the risk
production while maintaining protecting threatened and endangered
environmental protections. wildland fire poses to people,
species, ameliorating land and resource-