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74764 Federal Register / Vol. 71, No.

239 / Wednesday, December 13, 2006 / Rules and Regulations

[FR Doc. E6–20941 Filed 12–12–06; 8:45 am] code_of_federal_regulations/ also identifies the airport, its location,
BILLING CODE 4910–13–P ibr_locations.html. the procedure identification and the
For Purchase—Individual SIAP and amendment number.
Weather Takeoff Minimums copies may
DEPARTMENT OF TRANSPORTATION The Rule
be obtained from:
1. FAA Public Inquiry Center (APA– This amendment to 14 CFR part 97 is
Federal Aviation Administration 200), FAA Headquarters Building, 800 effective upon publication of each
Independence Avenue, SW., separate SIAP and/or Weather Takeoff
14 CFR Part 97 Washington, DC 20591; or Minimums as contained in the
[Docket No. 30525 Amdt. No. 3196 ] 2. The FAA Regional Office of the transmittal. Some SIAP and/or Weather
region in which the affected airport is Takeoff Minimums amendments may
Standard Instrument Approach located. have been previously issued by the FAA
Procedures, Weather Takeoff By Subscription—Copies of all SIAPs in a Flight Data Center (FDC) Notice to
Minimums; Miscellaneous and Weather Takeoff Minimums mailed Airmen (NOTAM) as an emergency
Amendments once every 2 weeks, are for sale by the action of immediate flight safety relating
Superintendent of Documents, U.S. directly to published aeronautical
AGENCY: Federal Aviation Government Printing Office, charts. The circumstances which
Administration (FAA), DOT. Washington, DC 20402. created the need for some SIAP, and/or
ACTION: Final rule. FOR FURTHER INFORMATION CONTACT: Weather Takeoff Minimums
Donald P. Pate, Flight Procedure amendments may require making them
SUMMARY: This amendment establishes,
Standards Branch (AFS–420), Flight effective in less than 30 days. For the
amends, suspends, or revokes Standard Technologies and Programs Division, remaining SIAPs and/or Weather
Instrument Approach Procedures Flight Standards Service, Federal Takeoff Minimums, an effective date at
(SIAPs) and/or Weather Takeoff Aviation Administration, Mike least 30 days after publication is
Minimums for operations at certain Monroney Aeronautical Center, 6500 provided.
airports. These regulatory actions are South MacArthur Blvd., Oklahoma City,
needed because of the adoption of new Further, the SIAPs and/or Weather
OK 73169 (Mail Address: P.O. Box Takeoff Minimums contained in this
or revised criteria, or because of changes 25082 Oklahoma City, OK 73125)
occurring in the National Airspace amendment are based on the criteria
telephone: (405) 954–4164. contained in the U.S. Standard for
System, such as the commissioning of
new navigational facilities, addition of SUPPLEMENTARY INFORMATION: This Terminal Instrument Procedures
new obstacles, or changes in air traffic amendment to Title 14 of the Code of (TERPS). In developing these SIAPs
requirements. These changes are Federal Regulations, Part 97 (14 CFR and/or Weather Takeoff Minimums, the
designed to provide safe and efficient part 97), establishes, amends, suspends, TERPS criteria were applied to the
use of the navigable airspace and to or revokes SIAPs and/or Weather conditions existing or anticipated at the
promote safe flight operations under Takeoff Minimums. The complete affected airports. Because of the close
instrument flight rules at the affected regulatory description of each SIAP and immediate relationship between
airports. and/or Weather Takeoff Minimums is these SIAPs and/or Weather Takeoff
contained in official FAA form Minimums and safety in air commerce,
DATES: This rule is effective December documents which are incorporated by I find that notice and public procedure
13, 2006. The compliance date for each reference in this amendment under 5 before adopting these SIAPs and/or
SIAP and/or Weather Takeoff U.S.C. 552(a), 1 CFR part 51, and 14 Weather Takeoff Minimums are
Minimums is specified in the CFR part 97.20. The applicable FAA impracticable and contrary to the public
amendatory provisions. Forms are identified as FAA Forms interest and, where applicable, that
The incorporation by reference of 8260–3, 8260–4, 8260–5 and 8260–15A. good cause exists for making some
certain publications listed in the Materials incorporated by reference are SIAPs and/or Weather Takeoff
regulations is approved by the Director available for examination or purchase as Minimums effective in less than 30
of the Federal Register as of December stated above. days.
13, 2006. The large number of SIAPs and/or
Conclusion
ADDRESSES: Availability of matters Weather Takeoff Minimums, their
incorporated by reference in the complex nature, and the need for a The FAA has determined that this
amendment is as follows: special format make their verbatim regulation only involves an established
For Examination— publication in the Federal Register body of technical regulations for which
1. FAA Rules Docket, FAA expensive and impractical. Further, frequent and routine amendments are
Headquarters Building, 800 airmen do not use the regulatory text of necessary to keep them operationally
Independence Avenue, SW., the SIAPs and/or Weather Takeoff current. It, therefore—(1) is not a
Washington, DC 20591; Minimums but refer to their depiction ‘‘significant regulatory action’’ under
2. The FAA Regional Office of the on charts printed by publishers of Executive Order 12866; (2) is not a
region in which the affected airport is aeronautical materials. Thus, the ‘‘significant rule’’ under DOT
located; advantages of incorporation by reference Regulatory Policies and Procedures (44
3. The National Flight Procedures are realized and publication of the FR 11034; February 26, 1979); and (3)
Office, 6500 South MacArthur Blvd., complete description of each SIAP and/ does not warrant preparation of a
Oklahoma City, OK 73169 or, or Weather Takeoff Minimums regulatory evaluation as the anticipated
4. The National Archives and Records contained in FAA form documents is impact is so minimal. For the same
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Administration (NARA). For unnecessary. The provisions of this reason, the FAA certifies that this
information on the availability of this amendment state the affected CFR amendment will not have a significant
material at NARA, call 202–741–6030, sections, with the types and effective economic impact on a substantial
or go to: http://www.archives.gov/ dates of the SIAPs and/or Weather number of small entities under the
federal_register/ Takeoff Minimums. This amendment criteria of the Regulatory Flexibility Act.

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Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Rules and Regulations 74765

List of Subjects in 14 CFR Part 97 Perryville, AK, Perryville, Takeoff Minimums Minneapolis, MN, Anoka County-Blaine Arpt
& Textual DPs, Amdt 1 (Janes Field), RNAV (GPS) RWY 27, Orig
Air Traffic Control, Airports, Sitka, AK, Sitka Rocky Gutierrez, Takeoff Minneapolis, MN, Anoka County-Blaine Arpt
Incorporation by reference, and Minimums & Textual DPs, Amdt 3 (Janes Field), GPS RWY 27, Orig
Navigation (Air). Togiak Village, AK, Togiak, Takeoff CANCELLED
Minimums & Textual DPs, Amdt 1 Minneapolis, MN, Anoka County-Blaine Arpt
Issued in Washington, DC on December 1,
Oakland, CA, Metropolitan Oakland Intl, ILS (Janes Field), Takeoff Minimums & Textual
2006.
OR LOC/DME RWY 27R, Amdt 35 DPs, Amdt 4
James J. Ballough, Sacramento, CA, Sacramento Mather, RNAV Sidney, NE, Sidney Muni/Lloyd W. Carr
Director, Flight Standards Service. (GPS) RWY 4R, Amdt 1 Field, RNAV (GPS) RWY 12, Amdt 1
Albany, GA, Southwest Georgia Regional, Sidney, NE, Sidney Muni/Lloyd W. Carr
Adoption of the Amendment RNAV (GPS) RWY 22, Orig Field, RNAV (GPS) RWY 30, Amdt 1
Albany, GA, Southwest Georgia Regional, Sidney, NE, Sidney Muni/Lloyd W. Carr
■ Accordingly, pursuant to the authority RNAV (GPS) RWY 16, Orig Field, Takeoff Minimums and Textual DPs,
delegated to me, under Title 14, Code of Albany, GA, Southwest Georgia Regional, Orig
Federal Regulations, Part 97 (14 CFR RNAV (GPS) RWY 4, Orig Thedford, NE, Thomas County, RNAV (GPS)
part 97) is amended by establishing, Albany, GA, Southwest Georgia Regional, RWY 11, Orig
amending, suspending, or revoking RNAV (GPS) RWY 34, Orig Thedford, NE, Thomas County, RNAV (GPS)
Standard Instrument Approach Albany, GA, Southwest Georgia Regional, RWY 29, Orig
Procedures and Weather Takeoff Takeoff Minimums and Textual DP, Orig Thedford, NE, Thomas County, VOR RWY
Minimums effective at 0901 UTC on the Valdosta, GA, Valdosta Regional, RNAV 11, AMDT 1
(GPS) RWY 17, Orig Thedford, NE, Thomas County, VOR/DME
dates specified, as follows: Valdosta, GA, Valdosta Regional, VOR RWY RWY 29, Orig,
17, Amdt 1 Thedford, NE, Thomas County, GPS RWY 11,
PART 97—STANDARD INSTRUMENT Valdosta, GA, Valdosta Regional, Takeoff Orig, CANCELLED
APPROACH PROCEDURES Minimums and Textual DP, Orig Thedford, NE, Thomas County, GPS RWY 29,
Hailey, ID, Friedman Memorial, RNAV (RNP) Orig, CANCELLED
■ 1. The authority citation for part 97 Z RWY 31, Orig, CANCELLED Thedford, NE, Thomas County, Takeoff
continues to read as follows: Peru, IN, Peru Muni, RNAV (GPS) RWY 1, Minimums and Textual DPs, Orig
Authority: 49 U.S.C. 106(g), 40103, 40106, Orig Manchester, NH, Manchester, ILS OR LOC
40113, 40114, 40120, 44502, 44514, 44701, Peru, IN, Peru Muni, RNAV (GPS) RWY 19, RWY 6, Amdt 1A
44719, 44721–44722. Orig Manchester, NH, Manchester, RNAV (GPS)
Peru, IN, Peru Muni, VOR RWY 1, Amdt 8 RWY 6, Amdt 1
■ 2. Part 97 is amended to read as Peru, IN, Peru Muni, Takeoff Minimums and Albany, NY, Albany Intl, ILS OR LOC RWY
follows: Textual DPs, Amdt 3 1, Amdt 10
Effective 21 December 2006 Portland, IN, Portland Muni, NDB OR GPS Albany, NY, Albany Intl, ILS OR LOC RWY
RWY 9, Amdt 2A, CANCELLED 19, Amdt 22
Lynchburg, VA, Falwell, RNAV (GPS) RWY Portland, IN, Portland Muni, NDB RWY 27, New York, NY, LaGuardia, RNAV (GPS)–B,
28, Orig Amdt 7A, CANCELLED Orig
Effective 18 January 2007 Creston, IA, Creston Muni, RNAV (GPS) New York, NY, LaGuardia, Takeoff
RWY 16, Orig Minimums and Textual DPs, Amdt 7
Deadhorse, AK, Deadhorse, ILS OR LOC/ Creston, IA, Creston Muni, RNAV (GPS) Elizabeth City, NC, Elizabeth City CG Air
DME RWY 4, Amdt 1 RWY 34, Orig Station/Regional, RNAV (GPS) RWY 10,
Deadhorse, AK, Deadhorse, Takeoff Creston, IA, Creston Muni, NDB RWY 34, Amdt 1
Minimums & Textual DPs, Orig Amdt 2 Myerstown, PA, Deck, RNAV (GPS) RWY 19,
Homer, AK, Homer, RNAV (GPS) Y RWY 21, Creston, IA, Creston Muni, Takeoff Orig
Orig Minimums and Textual DPs, Amdt 2 Anderson, SC, Anderson Rgnl, ILS OR LOC
Homer, AK, Homer, RNAV (GPS) Y RWY 3, Des Moines, IA, Des Moines Intl, RNAV RWY 5, Amdt 1
Orig (GPS) RWY 5, Amdt 1 Anderson, SC, Anderson Rgnl, Takeoff
Homer, AK, Homer, GPS RWY 21, Orig-B, Des Moines, IA, Des Moines Intl, RNAV Minimums and Textual DP, Orig
CANCELLED (GPS) RWY 13, Amdt 1 Kingstree, SC, Williamsburg Regional, RNAV
Homer, AK, Homer, GPS RWY 3, Orig-B, Des Moines, IA, Des Moines Intl, RNAV (GPS) RWY 32, Orig
CANCELLED (GPS) RWY 31, Amdt 1 Kingstree, SC, Williamsburg Regional, NDB
Juneau, AK, Juneau Intl, RNAV (GPS) V RWY Iowa City, IA, Iowa City Muni, VOR–A, Orig RWY 14, Amdt 4
8, Amdt 1 Iowa City, IA, Iowa City Muni, VOR OR GPS Kingstree, SC, Williamsburg Regional,
Juneau, AK, Juneau Intl, LDA X RWY 8, RWY 36, Amdt 10C, CANCELLED Takeoff Minimums and Textual DP, Amdt
Amdt 11 Iowa City, IA, Iowa City Muni, Takeoff 1
Juneau, AK, Juneau Intl, Takeoff Minimums Minimums and Textual DPs, Amdt 3 San Antonio, TX, Boerne Stage Field, RNAV
& Textual DPs, Amdt 3 Phillipsburg, KS, Phillipsburg Muni, RNAV (GPS) RWY 17, ORIG
Northway, AK, Northway, RNAV(GPS) RWY (GPS) RWY 13, Amdt 1 San Antonio, TX, Boerne Stage Field, RNAV
5, Orig Phillipsburg, KS, Phillipsburg Muni, RNAV (GPS) RWY 35, ORIG
Northway, AK, Northway, RNAV(GPS) RWY (GPS) RWY 31, Amdt 1 San Antonio, TX, Boerne Stage Field, Takeoff
23, Orig Phillipsburg, KS, Phillipsburg Muni, Takeoff Minimums and Textual DP’s, Orig
Northway, AK, Northway, NDB OR GPS Minimums and Textual DP, Orig Galax/Hillsville, VA, Twin County, RNAV
RWY 4, Orig, CANCELLED Opelousas, LA, St Landry Parish-Ahart Field, (GPS) RWY 1, Orig
Northway, AK, Northway, NDB OR GPS RNAV (GPS) RWY 18, Orig Galax/Hillsville, VA, Twin County, RNAV
RWY 22, Orig, CANCELLED Opelousas, LA, St Landry Parish-Ahart Field, (GPS) RWY 19, Orig
Northway, AK, Northway, VOR–B, Amdt 3, RNAV (GPS) RWY 36, Orig Marion/Wytheville, VA, Mountain Empire,
CANCELLED Opelousas, LA, St Landry Parish-Ahart Field, RNAV (GPS) RWY 26, Orig
Northway, AK, Northway, VOR/DME–A, NDB RWY 18, Amdt 2 Marion/Wytheville, VA, Mountain Empire,
Amdt 1 Opelousas, LA, St Landry Parish-Ahart Field, GPS RWY 26, Orig-A, CANCELLED
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Northway, AK, Northway, Takeoff VOR/DME RWY 36, Amdt 1 Norfolk, VA, Norfolk Intl, Takeoff Minimums
Minimums & Textual DPs, Amdt 2 Opelousas, LA, St Landry Parish-Ahart Field, and Textual DP’s, Orig
Perryville, AK, Perryville, RNAV (GPS) RWY GPS RWY 35, Orig-A, CANCELLED Lyndonville, VT, Caledonia County, NDB
2, Orig Minneapolis, MN, Anoka County-Blaine Arpt RWY 2, Amdt 4
Perryville, AK, Perryville, RNAV (GPS) RWY (Janes Field), ILS OR LOC/DME RWY 27, Lyndonville, VT, Caledonia County, RNAV
3, Orig, CANCELLED Orig (GPS) RWY 2, Orig

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74766 Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Rules and Regulations

Lyndonville, VT, Caledonia County, GPS Modernization Act of 1997 (the Approved Application
RWY 2, Orig, CANCELLED Modernization Act). The final rule G. Implementation of the Final Rule
Lyndonville, VT, Caledonia County, Takeoff requires manufacturers to assess the
Minimums and Textual DP, Amdt 5 and Guidance
effect of a manufacturing change on the
Seattle, WA, Seattle-Tacoma Intl, RNAV H. General Comments
(GPS) RWY 16L, Amdt 1
identity, strength, quality, purity, and
potency of a drug as those factors relate IV. Unrelated Referenced Comments to
Seattle, WA, Seattle-Tacoma Intl, ILS OR the Proposed Rule
LOC RWY 16L, ILS RWY 16L(CAT II), ILS to the safety or effectiveness of the drug.
RWY 16L (CAT III), Amdt 3 The final rule sets forth requirements for V. Conforming Amendments
Green Bay, WI, Austin Straubel International, changes requiring submission and VI. Environmental Impact
RNAV (GPS) RWY 18, Amdt 1 approval of a supplement before the
Green Bay, WI, Austin Straubel International,
VII. Analysis of Impacts
distribution of the drug made using the
RNAV (GPS) RWY 36, Amdt 2 change, changes requiring the VIII. Paperwork Reduction Act of 1995
Green Bay, WI, Austin Straubel International, submission of a supplement at least 30 IX. Federalism
VOR/DME OR TACAN RWY 36, Amdt 9
Fairmont, WV, Fairmont Muni-Frankman
days prior to the distribution of the X. References
Field, RNAV (GPS) RWY 22, Orig drug, changes requiring the submission
of a supplement at the time of I. Background
Fairmont, WV, Fairmont Muni-Frankman
Field, GPS RWY 22, Amdt 1, CANCELLED distribution of the drug, and changes to Section 116 of the Modernization Act
Fairmont, WV, Fairmont Muni-Frankman be described in an annual report. (Public Law 105–115) amended the
Field, Takeoff Minimums and Textual DATES: The final rule is effective Federal Food, Drug, and Cosmetic Act
DP’s, Amdt 5 February 12, 2007. (the act) by adding section 506A (21
Morgantown, WV, Morgantown Muni-Walter
L. Bill Hart Field, ILS OR LOC RWY 18, FOR FURTHER INFORMATION CONTACT: U.S.C. 356a). That section describes
Amdt 13 Dennis M. Bensley, Jr., Center for requirements and procedures for making
Morgantown, WV, Morgantown Muni-Walter Veterinary Medicine (HFV–140), Food and reporting manufacturing changes to
L. Bill Hart Field, VOR–A, Amdt 13 and Drug Administration, 7500 Standish approved new drug and abbreviated
Morgantown, WV, Morgantown Muni-Walter Pl., Rockville, MD 20855, 301–827– new drug applications, to approved new
L. Bill Hart Field, RNAV (GPS) RWY 18, 6956, E-mail: animal drug and abbreviated new
Amdt 2 dennis.bensley@fda.hhs.gov. animal drug applications, and to license
Morgantown, WV, Morgantown Muni-Walter applications for biological products
L. Bill Hart Field, RNAV (GPS) RWY 36, SUPPLEMENTARY INFORMATION:
under section 351 of the Public Health
Orig
Evanston, WY, Evanston-Uinta County Burns Table of Contents Service (PHS) Act. Section 506A of the
Field, ILS OR LOC/DME RWY 23, Orig I. Background act revises current procedures for
Jackson, WY, Jackson Hole, RNAV (RNP) Y A. Development of the Regulation approving manufacturing changes.
RWY 1, Orig B. Risk-Based Approach Major manufacturing changes, as
Jackson, WY, Jackson Hole, RNAV (RNP) Z II. Harmonization and Highlights of defined in section 506A, are of a type
RWY 1, Orig Revisions to the Proposed Rule determined by FDA to have a
Jackson, WY, Jackson Hole, RNAV (RNP) Z substantial potential to adversely affect
RWY 19, Orig
A. Section 514.8(a)—Definitions
B. Section 514.8(b)—Manufacturing the identity, strength, quality, purity,
[FR Doc. E6–20919 Filed 12–12–06; 8:45 am] Changes to an Approved and potency as they may relate to the
BILLING CODE 4910–13–P Application Manufacturing Changes safety and effectiveness of a drug and
Requiring Preapproval of a require prior approval of a supplemental
Supplement (Proposed application. Under section 506A, FDA
DEPARTMENT OF HEALTH AND § 514.8(b)(1)(ii)) may require submission of a
HUMAN SERVICES supplemental application for drugs
C. Labeling and Other Changes to an made with manufacturing changes that
Food and Drug Administration Approved Application are not major and may establish
III. Responses to Comments on the categories of manufacturing changes for
21 CFR Parts 25, 500, 514, and 558 Propose Rule which a supplemental application is
A. Section 514.8(a)—Definitions required. In such a case, the applicant
[Docket No. 1999N–1415] (formerly Docket
No. 99N–1415) B. Section 514.8(b)—Manufacturing may begin distribution of a drug 30 days
Changes to an Approved after FDA receives a supplemental
RIN 0910–AF59 Application application unless the agency notifies
the applicant within the 30-day period
Supplements and Other Changes to C. Changes Requiring Submission and that prior approval of the application is
Approved New Animal Drug Approval of a Supplement Prior to required. Under the statute, FDA may
Applications Distribution of the Drug Made also designate a category of
AGENCY: Food and Drug Administration, Using the Change (Major Changes) manufacturing changes that permit the
HHS. D. Changes Requiring Submission of a applicant to begin distributing a drug
ACTION: Final rule. Supplement at Least 30 Days Prior made with such changes upon receipt
to Distribution of the Drug Made by the agency of a supplemental
SUMMARY: The Food and Drug Using the Change (Moderate application for the change. Finally, FDA
Administration (FDA) is amending its Changes) may also authorize applicants to
regulations on supplements and other distribute drugs manufactured with a
changes to approved new animal drug E. Changes and Updated Stability change without submitting a
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applications (NADAs) or abbreviated Data to be Described and Submitted supplemental application. The law
new animal drug applications in and Annual Report (Minor provides that FDA may establish
(ANADAs) to implement the Changes) categories of manufacturing changes
manufacturing changes provision of the that may be made without submitting a
Food and Drug Administration F. Labeling and Other Changes to an supplemental application.

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