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Federal Register / Vol. 73, No.

51 / Friday, March 14, 2008 / Rules and Regulations 13785

GENERAL SERVICES per mile determination. Based on cost You may submit comments in one of
ADMINISTRATION studies conducted by GSA, I have four ways (please choose only one of the
REPORTING TO CONGRESS—THE determined the per-mile operating costs ways listed):
COSTS OF OPERATING PRIVATELY of a POA to be $0.505. Reimbursement 1. Electronically. You may submit
OWNED AUTOMOBILES rates for the use of a privately owned electronic comments on this regulation
Paragraph (b) of Section 5707 of Title airplane and a privately owned to http://www.regulations.gov. Follow
5, United States Code, requires the motorcycle remain unchanged at this the instructions for ‘‘Comment or
Administrator of General Services to time as these investigations are still Submission’’ and enter the filecode to
periodically investigate the cost to pending. find the document accepting comments.
Government employees of operating This report to Congress on the cost of 2. By regular mail. You may mail
privately owned vehicles (airplanes, operating POAs will be published in the written comments (one original and two
automobiles, and motorcycles) while on Federal Register. copies) to the following address only:
official travel, to report the results of the [FR Doc. E8–5091 Filed 3–13–08; 8:45 am] Centers for Medicare & Medicaid
investigations to Congress, and to Services, Department of Health and
BILLING CODE 6820–14–S
publish the report in the Federal Human Services, Attention: CMS–2238–
Register. This report on the privately IFC, P.O. Box 8016, Baltimore, MD
owned automobile mileage 21244–8016.
reimbursement rate is being published DEPARTMENT OF HEALTH AND Please allow sufficient time for mailed
in the Federal Register. The HUMAN SERVICES comments to be received before the
investigations pertaining to the close of the comment period.
reimbursement rates for airplanes and Centers for Medicare & Medicaid 3. By express or overnight mail. You
motorcycles are still pending. Therefore, Services may send written comments (one
there are no changes to these rates at original and two copies) to the following
this time. 42 CFR Part 447 address only: Centers for Medicare &
Dated: February 20, 2008. Medicaid Services, Department of
Lurita Doan, [CMS–2238–IFC] Health and Human Services, Attention:
Administrator of General Services. CMS–2238–IFC, Mail Stop C4–26–05,
Reporting To Congress—The Costs of RIN 0938–AP26
7500 Security Boulevard, Baltimore, MD
Operating Privately Owned 21244–1850.
Automobiles Medicaid Program; Multiple Source
Drug Definition 4. By hand or courier. If you prefer,
5 U.S.C. 5707(b)(1)(A) requires that
you may deliver (by hand or courier)
the Administrator of General Services, AGENCY: Centers for Medicare & your written comments (one original
in consultation with the Secretary of Medicaid Services (CMS), HHS. and two copies) before the close of the
Defense, the Secretary of
ACTION: Interim final rule with comment comment period to either of the
Transportation, and representatives of
period. following addresses: a. Room 445–G,
Government employee organizations,
Hubert H. Humphrey Building, 200
conduct periodic investigations of the SUMMARY: On July 17, 2007, we Independence Avenue, SW.,
cost of travel and operation of privately published a final rule with comment Washington, DC 20201.
owned vehicles (airplanes, automobiles, period in the Federal Register that (Because access to the interior of the HHH
and motorcycles) to Government implemented provisions of the Deficit Building is not readily available to persons
employees while on official travel, and Reduction Act of 2005 pertaining to without Federal Government identification,
report the results to the Congress at least prescription drugs under the Medicaid commenters are encouraged to leave their
once a year. 5 U.S.C. 5707(a)(1) requires program. In that rule, we finalized comments in the CMS drop slots located in
that the Administrator of General certain provisions of the Medicaid drug the main lobby of the building. A stamp-in
Services issue regulations prescribing rebate program, including definitions clock is available for persons wishing to
mileage reimbursement rates and retain a proof of filing by stamping in and
concerning average manufacturer price,
determine the average, actual cost per retaining an extra copy of the comments
best price, single source drug, and being filed.)
mile for the use of each type of privately multiple source drug. In this interim
owned vehicle based on the results of b. 7500 Security Boulevard,
final rule with comment period, we are
these cost investigations. Such figures Baltimore, MD 21244–1850.
revising the definition of ‘‘multiple
must be reported to the Congress within If you intend to deliver your
source drug’’ to better conform with the
5 working days after the cost comments to the Baltimore address,
statutory provisions. This interim final
determination has been made in please call telephone number (410) 786–
rule with comment period solicits
accordance with 5 U.S.C. 5707(b)(2)(C). 7195 in advance to schedule your
additional public comment on the
Pursuant to the above, the General arrival with one of our staff members.
revised definition of ‘‘multiple source Comments mailed to the addresses
Services Administration (GSA), in drug.’’
consultation with the above-specified indicated as appropriate for hand or
parties conducted an investigation of DATES: Effective date: These regulations courier delivery may be delayed and
the cost of operating a privately owned are effective on April 14, 2008. received after the comment period.
automobile (POA). As provided in 5 Comment date: To be assured For information on viewing public
U.S.C. 5704(a)(1), the automobile consideration, comments must be comments, see the beginning of the
reimbursement rate cannot exceed the received at one of the addresses SUPPLEMENTARY INFORMATION section.
single standard mileage rate established provided below, no later than 5 p.m. on FOR FURTHER INFORMATION CONTACT: Gail
by the Internal Revenue Service (IRS). April 14, 2008. Sexton, (410) 786–4583.
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The IRS has announced a new single ADDRESSES: In commenting, please refer SUPPLEMENTARY INFORMATION:
standard mileage rate for POAs of to file code CMS–2238–IFC. Because of Inspection of Public Comments: All
$0.505, which was effective January 1, staff and resource limitations, we cannot comments received before the close of
2008. As required, GSA is reporting the accept comments by facsimile (FAX) the comment period are available for
results of the investigation and the cost transmission. viewing by the public, including any

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13786 Federal Register / Vol. 73, No. 51 / Friday, March 14, 2008 / Rules and Regulations

personally identifiable or confidential definition of ‘‘multiple source drug.’’ geographic location. Plaintiffs in the
business information that is included in We believe, however, that when an National Association of Chain Drug
a comment. We post all comments FDA-approved equivalent generic drug Stores litigation contend, however, that
received before the close of the is sold or marketed in the United States, there may be situations where certain
comment period on the following Web at least one generic drug product is sold drug products are not available to the
site as soon as possible after they have or marketed in every State. Accordingly, public through retail pharmacies in
been received: http:// we expect the effect of this revision, if every State. We do not interpret the law
www.regulations.gov. Follow the search any, to be small. to require us to continually survey drug
instructions on that Web site to view This interim final rule to the extent availability in the retail pharmacies of
public comments. that it may affect Medicaid every State, and note that pharmacies
Comments received timely will be reimbursement rates for retail and States are in a substantially better
also available for public inspection as pharmacies is subject to the injunction position to assess the availability of
they are received, generally beginning issued by the United States District drugs in their areas. Therefore, we will
approximately 3 weeks after publication Court for the District of Columbia in consider all covered outpatient drugs to
of a document, at the headquarters of National Association of Chain Drug be generally available in a State except
the Centers for Medicare & Medicaid Stores, et al. v. Health and Human in those situations where there is
Services, 7500 Security Boulevard, Services, Civil Action No. 1:07–cv– evidence to the contrary. Such evidence
Baltimore, Maryland 21244, Monday 02017 (RCL). could include notification from
through Friday of each week from pharmacies to the State that a drug
II. Provisions of the Interim Final Rule
8:30 a.m. to 4 p.m. To schedule an cannot be purchased in that State,
appointment to view public comments, In 42 CFR 447.502, we defined key provided the State can confirm that to
phone 1–800–743–3951. terms used to calculate payment and be the case. CMS will issue regulatory
rebates concerning Medicaid guidance on this issue in the future
I. Background prescription drugs. We defined multiple should the need arise.
On July 17, 2007, we published a final source drug as a covered outpatient drug When the State confirms that a
rule with comment period (72 FR for which there is at least one other drug covered outpatient drug is not a
39142) in the Federal Register product which is rated as multiple source drug in the State, that
implementing the provisions of the therapeutically equivalent, is drug is not subject to the FUL in that
Deficit Reduction Act of 2005 (DRA) pharmaceutically equivalent and State for the applicable rebate period.
pertaining to prescription drugs under bioequivalent, as determined by the Where the drug does not qualify as a
the Medicaid Program. In that rule, we FDA, and is sold or marketed in the multiple source drug in the State, the
defined terms used in the Medicaid United States during the rebate period. State should apply its alternative
drug rebate program. We codified We are revising this definition of pricing methodologies as set forth in the
requirements pertaining to the multiple source drug to state that the approved State plan.
calculation and reporting of the average drug product is sold or marketed in the While this change in the definition of
manufacturer price (AMP) and best ‘‘State’’ during the rebate period, as multiple source drug may impact the
price by pharmaceutical manufacturers opposed to sold or marketed in the FUL program, it should have no impact
and amended existing regulations ‘‘United States’’ during the rebate on the manufacturer’s calculation of
concerning Federal upper payment period. By changing ‘‘United States’’ to rebates. The definition as revised is
limits for certain covered outpatient ‘‘State’’ we define the term, ‘‘multiple consistent with the statutory provision,
drugs. The final rule was effective source drug’’ in accordance with the which has been in effect since the
October 1, 2007. This interim final rule language in the Social Security Act (the inception of the drug rebate program.
is not being issued in response to public Act). Further, in accordance with Manufacturers calculate rebates based,
comments received on the July 2007 section 1927(k)(7)(C)(iii) of the Act, we in part, on whether the drug product is
AMP final rule with comment period. consider the drug to be sold or marketed produced, distributed, or marketed
We are still considering those in a State if it appears in a published under a new drug application approved
comments. national listing of average wholesale by the FDA. In such situations, the
On November 15, 2007, the National prices that we have selected—currently, rebate calculation is based on a
Association of Chain Drug Stores and Red Book, Bluebook, or Medi-Span— percentage of the AMP or the difference
the National Community Pharmacists provided the listed product is generally between AMP and best price, whichever
Association filed a motion for a available to the public through retail is greater. Where a drug is not marketed
preliminary injunction in the United pharmacies in that State. pursuant to such a new drug
States District Court for the District of In light of our experience with the application, the manufacturer calculates
Columbia. They contended, in part, that Federal upper limit (FUL) program, we rebate payments based on a fixed
the definition of ‘‘multiple source drug’’ believe that there is a national market percentage (11 percent) of the average
adopted in the July 17, 2007, final rule for prescription drug products, and that manufacturer price. Accordingly, rebate
(‘‘drug rebate rule’’) is contrary to the if a drug is available in a State, it will calculations should not be affected by
statutory language in that it defined a be available in every State. From our the revisions in this regulation. Thus,
multiple source drug, in part, as a drug experience, once an FDA-approved we are not changing our policy
which is sold or marketed in the United equivalent generic drug enters the regarding rebates or manufacturer
States, as opposed to the State. Plaintiffs market, there are nearly always at least reporting requirements for these drugs.
are concerned that all drug products are two equivalent products available
not generally available in every State. everywhere (the brand drug and at least III. Response to Comments
National Association of Chain Drug one equivalent generic drug) such that Because of the large number of public
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Stores, et al. v. Health and Human a FUL will be properly applied. comments we normally receive on
Services, Civil Action No. 1:07–cv– Furthermore, we do not have any record Federal Register documents, we are not
02017 (RCL). In light of these concerns, of receiving requests to delete or modify able to acknowledge or respond to them
we are issuing this interim final rule a FUL price based on a drug not being individually. We will consider all
with comment period and revising the available in a particular State or a comments we receive by the date and

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Federal Register / Vol. 73, No. 51 / Friday, March 14, 2008 / Rules and Regulations 13787

time specified in the DATES section of 553(b), we find good cause to waive product is available in that State, the
this preamble, and, when we proceed notice and comment rulemaking only effect will be to permit that State
with a subsequent document, we will procedures for this revision, if such to disregard the FUL price for the one
respond to the comments in the procedures are required at all. drug that is available in that State when
preamble to that document. determining the aggregate limit that the
V. Collection of Information
State can reimburse for that drug and
IV. Waiver of Proposed Rulemaking Requirements
claim Federal financial participation.
We ordinarily publish a notice of This document does not impose any States may choose not to change their
proposed rulemaking in the Federal information collection and reimbursement to pharmacies for those
Register and invite public comment on recordkeeping requirements. drugs. Should States decide to change
the proposed rule. The notice of Consequently, it need not be reviewed reimbursement, the change would
proposed rulemaking includes a by the Office of Management and usually be to increase the price paid to
reference to the legal authority under Budget under the authority of the pharmacies.
which the rule is proposed, and the Paperwork Reduction Act of 1995 (44 In addition, section 1102(b) of the Act
terms and substances of the proposed U.S.C. 35). requires us to prepare a regulatory
rule or a description of the subjects and impact analysis if a rule may have a
VI. Regulatory Impact Statement
issues involved. This procedure can be significant impact on the operations of
waived, however, if an agency finds We have examined the impact of this a substantial number of small rural
good cause that a notice and comment rule as required by Executive Order hospitals. This analysis must conform to
procedure is impracticable, 12866 (September 1993, Regulatory the provisions of section 604 of the
unnecessary, or contrary to the public Planning and Review), the Regulatory RFA. For purposes of section 1102(b) of
interest and incorporates a statement of Flexibility Act (RFA) (September 19, the Act, we define a small rural hospital
the finding and its reasons in the rule 1980, Pub. L. 96–354), section 1102(b) of as a hospital that is located outside of
issued, or if the agency is promulgating the Act, the Unfunded Mandates Reform a Metropolitan Statistical Area and has
interpretive rules, general statements of Act of 1995 (Pub. L. 104–4), and fewer than 100 beds. We are not
policy, or rules of agency procedure or Executive Order 13132. preparing an analysis for section 1102(b)
practice. Executive Order 12866 directs of the Act because we have determined,
We do not believe that we need to agencies to assess all costs and benefits and the Secretary certifies, that this
delay publication of this rule pending of available regulatory alternatives and, interim final rule with comment period
completion of a notice and comment if regulation is necessary, to select will not have a significant impact on the
period. We are conforming the regulatory approaches that maximize operations of a substantial number of
regulation to the statutory definition of net benefits (including potential small rural hospitals. Small rural
multiple source drug and informing the economic, environmental, public health hospitals would be affected only to the
public of the procedures and practices and safety effects, distributive impacts, extent that no FDA-approved equivalent
the agency will follow to ensure and equity). A regulatory impact product is available in that State for a
compliance with those statutory analysis (RIA) must be prepared for particular outpatient drug provided
provisions. However, to the extent that major rules with economically through their outpatient pharmacies. As
notice and comment rulemaking would significant effects ($100 million or more discussed above for pharmacies, States
otherwise apply, we find good cause to in any 1 year). This interim final rule may choose to change reimbursement
waive such requirements. does not reach the economic threshold for drugs in such groups, but this
Specifically, we find it unnecessary to and thus is not considered a major rule. change is expected to be to increase
undertake notice and comment The RFA requires agencies to analyze reimbursement. Section 202 of the
rulemaking in this instance in light of options for regulatory relief of small Unfunded Mandates Reform Act of 1995
the statutory language. We are applying entities. For purposes of the RFA, small also requires that agencies assess
the definition specified in statute and entities include small businesses, anticipated costs and benefits before
we believe it is redundant to, in effect, nonprofit organizations, and small issuing any rule whose mandates
propose a rule to incorporate the words governmental jurisdictions. Individuals require spending in any 1 year of $100
of a provision already contained in the and States are not included in the million in 1995 dollars, updated
statute. We would not be able to change definition of a small entity. We are not annually for inflation. That threshold
the definition in this regulation in preparing an analysis for the RFA level is currently approximately $120
response to public comment. We are because we have determined, and the million. This interim final rule will
also describing a procedure to ensure Secretary certifies, that this interim final have no consequential effect on State,
compliance with the relevant provisions rule with comment period will not have local, or tribal governments or on the
of the statute. This description is a significant economic impact on a private sector.
exempt from notice and comment substantial number of small entities. Executive Order 13132 establishes
rulemaking as an interpretive rule, The only small entities that will certain requirements that an agency
general statement of policy, and/or rule potentially be affected by this interim must meet when it promulgates a
of agency procedure or practice. As we final rule are small pharmacies. We proposed rule (and subsequent final
have previously stated, we believe that believe that the effect will be small rule) that imposes substantial direct
there is a national market for because we have not identified any requirement costs on State and local
prescription drugs and that a drug situation in which there is at least one governments, preempts State law, or
product available as a multiple source FDA-approved equivalent generic drug otherwise has Federalism implications.
drug in one State will be available as a available as a multiple source drug in This regulation will impose only a very
multiple source drug in every State. one State but in which no FDA- small burden, if any, on States. When a
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However, in light of the concerns raised approved equivalent generic is available pharmacy has notified a State that a
in litigation, we believe it is necessary in another State. To the extent a State drug on the CMS FUL list may not be
to establish a process to ensure State would find, however, that a drug is not available as a multiple source drug in
availability and consistency with the a multiple source drug in that State that State, the State must confirm that
statute. Therefore, under 5 U.S.C. because no FDA-approved equivalent the drug is generally not available in the

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13788 Federal Register / Vol. 73, No. 51 / Friday, March 14, 2008 / Rules and Regulations

State. The State, however, has no outpatient drug for which there is at rulemaking is necessary because the
obligation to make an independent least one other drug product which— regulations governing the subsistence
assessment of drug availability in the * * * * * harvest of migratory birds in Alaska are
absence of such notification by a (3) Is sold or marketed in the State subject to annual review. This
pharmacy. We believe that the vast during the rebate period as follows: rulemaking enacts region-specific
majority of drugs of manufacturers that (i) A covered outpatient drug is regulations that go into effect on April
participate in the Medicaid program are considered sold or marketed in a State 2, 2008, and expire on August 31, 2008.
generally available on a national basis. if it appears in a published national DATES: The amendments to subpart C of
We believe that all or nearly all of the listing of average wholesale prices, 50 CFR part 92 become effective April
drugs are distributed by national selected by the Secretary, provided the 14, 2008. The amendments to subpart D
wholesalers and are generally available covered outpatient drug is generally of 50 CFR part 92 are effective April 2,
in every State. This interim final rule available to the public through retail 2008, through August 31, 2008.
will only apply in those rare cases in pharmacies in that State.
FOR FURTHER INFORMATION CONTACT: Fred
which a particular FDA-approved drug (ii) A covered outpatient drug is not
product is not available to the retail subject to the FUL for a rebate period if Armstrong, (907) 786–3887, or Donna
pharmacies in a particular State and, as it is not a multiple source drug in the Dewhurst, (907) 786–3499, U.S. Fish
a result, only one FDA-approved drug State for that rebate period. and Wildlife Service, 1011 E. Tudor
product is available to those Road, Mail Stop 201, Anchorage, AK
* * * * * 99503.
pharmacies. In this circumstance, a (Catalog of Federal Domestic Assistance
State would need to verify the Program No. 93.778, Medical Assistance SUPPLEMENTARY INFORMATION:
information received from its Program)
pharmacies that no equivalent drug is How Do I Find the History of These
available. This would impose only a Dated: February 21, 2008. Regulations?
small burden on States. State systems Kerry Weems, Background information, including
are designed to allow for payment Acting Administrator, Centers for Medicare past events leading to this action,
changes as a routine matter and to & Medicaid Services. accomplishments since the Migratory
change the composition of the FUL Approved: February 21, 2008. Bird Treaties with Canada and Mexico
groups or delete FUL groups. Since this Michael O. Leavitt, were amended, and a history addressing
regulation does not impose any Secretary. conservation issues can be found in the
significant costs on State or local [FR Doc. 08–1022 Filed 3–10–08; 2:42 pm] following Federal Register documents:
governments, the requirements of E.O. BILLING CODE 4120–01–P
13132 are not applicable. Date Federal
In accordance with the provisions of Register citation
Executive Order 12866, this regulation
DEPARTMENT OF THE INTERIOR August 16, 2002 ................ 67 FR 53511.
was reviewed by the Office of July 21, 2003 ..................... 68 FR 43010.
Management and Budget. Fish and Wildlife Service April 2, 2004 ...................... 69 FR 17318.
List of Sections in 42 CFR Part 447 April 8, 2005 ...................... 70 FR 18244.
50 CFR Part 92 February 28, 2006 ............. 71 FR 10404.
Accounting, Administrative practice April 11, 2007 .................... 72 FR 18318.
and procedure, Drugs, Grant programs- [FWS–R7–MB–2007–0009; 91200–1231–
health, Health facilities, Health 9BPP L2]
These documents, which are all final
professions, Medicaid, Reporting and RIN 1018–AV53 rules setting forth the annual harvest
recordkeeping requirements, Rural regulations, are readily available at
areas. Migratory Bird Subsistence Harvest in http://alaska.fws.gov/ambcc/
■ For the reasons set forth in the Alaska; Harvest Regulations for regulations.htm.
preamble, the Centers for Medicare & Migratory Birds in Alaska During the
2008 Season Why Is This Current Rulemaking
Medicaid Services amends 42 CFR Necessary?
chapter IV as set forth below: AGENCY: Fish and Wildlife Service,
Interior. This current rulemaking is necessary
PART 447—PAYMENTS FOR because, by law, the migratory bird
ACTION: Final rule.
SERVICES harvest season is closed unless opened
SUMMARY: The U.S. Fish and Wildlife by the Secretary of the Interior, and the
■ 1. The authority citation for part 447
Service (Service or we) is publishing regulations governing subsistence
continues to read as follows:
migratory bird subsistence harvest harvest of migratory birds in Alaska are
Authority: Sec. 1102 of the Social Security regulations in Alaska for the 2008 subject to public review and annual
Act (42 U.S.C. 1302). approval. The Alaska Migratory Bird Co-
season. This proposed rule establishes
■ 2. Section 447.502 is amended by: regulations that prescribe dates when management Council (Co-management
■ A. Republishing the introductory text harvesting of birds may occur, species Council) held a meeting in April 2007
of the definition for ‘‘Multiple source that can be taken, and methods and to develop recommendations for
drug’’; and means excluded from use. These changes effective for the 2008 harvest
■ B. Revising paragraph (3) of the regulations were developed under a Co- season. These recommendations were
definition for ‘‘Multiple Source Drug’’ to management process involving the presented to the Service Regulations
read as follows: Service, the Alaska Department of Fish Committee (SRC) on August 1 and 2,
sroberts on PROD1PC70 with RULES

and Game, and Alaska Native 2007, and were approved.


§ 447.502 Definitions. representatives. These regulations This rule finalizes regulations for the
* * * * * enable the continuation of customary taking of migratory birds for subsistence
Multiple source drug means, with and traditional subsistence uses of uses in Alaska during 2008. This rule
respect to a rebate period, a covered migratory birds in Alaska. The lists migratory bird species that are open

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