71768 Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Rules and Regulations

§ 71.1 [Amended] DATES: Effective Date: 0901 UTC, executing new and amended SIAPs, and I 2. The incorporation by reference in February 14, 2008. The Director of the will be depicted on aeronautical charts 14 CFR 71.1 of Federal Aviation Federal Register approves this for pilot reference. The intended effect Administration Order 7400.9R, Airspace incorporation by reference action under of this rule is to provide adequate Designations and Reporting Points, title 1, Code of Federal Regulations, part controlled airspace for Instrument Flight signed August 15, 2007, and effective 51, subject to the annual revision of Rules (IFR) operations at the McGrath September 15, 2007, is amended as FAA Order 7400.9 and publication of Airport, McGrath, Alaska. follows: conforming amendments. The FAA has determined that this * * * * * FOR FURTHER INFORMATION CONTACT: Gary regulation only involves an established Rolf, AAL–538G, Federal Aviation body of technical regulations for which Paragraph 6005 Class E Airspace Extending Administration, 222 West 7th Avenue, frequent and routine amendments are Upward from 700 feet or More Above the necessary to keep them operationally Surface of the Earth. Box 14, Anchorage, AK 99513–7587; telephone number (907) 271–5898; fax: current. It, therefore—(1) is not a * * * * * (907) 271–2850; e-mail: ‘‘significant regulatory action’’ under AAL AK E5 Soldotna, AK [Revised] [email protected]. Internet address: Executive Order 12866; (2) is not a Soldotna, Soldotna Airport, AK http://www.alaska.faa.gov/at. ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 (Lat. 60°28′30″ N., long. 151°02′17″ W.) SUPPLEMENTARY INFORMATION: Soldotna NDB FR 11034; February 26, 1979); and (3) (Lat. 60°28′30″ N., long. 150°52′44″ W.) History does not warrant preparation of a That airspace extending upward from 700 On Tuesday, October 16, 2007, the regulatory evaluation as the anticipated feet above the surface within a 10.1-mile FAA proposed to amend part 71 of the impact is so minimal. Since this is a radius of the Soldotna Airport and within 4 routine matter that will only affect air miles either side of the 270° bearing of the Federal Aviation Regulations (14 CFR part 71) to revise Class E airspace traffic procedures and air navigation, it Soldotna NDB, AK, extending from the 10.1- is certified that this rule will not have mile radius to 21 miles west of the Soldotna upward from 700 ft. above the surface Airport, AK, and within 4.6 miles north and and from 1,200 ft. above the surface at a significant economic impact on a 4 miles south of the 090° bearing of the McGrath, AK (72 FR 58569). The action substantial number of small entities Soldotna NDB, AK, extending from the 10.1- was proposed in order to create Class E under the criteria of the Regulatory mile radius to 14.3 miles east of the Soldotna airspace sufficient in size to contain Flexibility Act. Airport, AK; and that airspace extending aircraft while executing SIAPs for the The FAA’s authority to issue rules upward from 1,200 feet above the surface McGrath Airport. Class E controlled regarding aviation safety is found in within a 73-mile radius of the Soldotna Title 49 of the United States Code. Airport. airspace extending upward from 700 ft. above the surface and from 1,200 ft. Subtitle 1, Section 106 describes the * * * * * above the surface in the McGrath authority of the FAA Administrator. Issued in Anchorage, AK, on December 11, Airport area is revised by this action. Subtitle VII, Aviation Programs, 2007. Interested parties were invited to describes in more detail the scope of the Anthony M. Wylie, participate in this rulemaking agency’s authority. Manager, Alaska Flight Services Information proceeding by submitting written This rulemaking is promulgated Area Group. comments on the proposal to the FAA. under the authority described in [FR Doc. E7–24409 Filed 12–18–07; 8:45 am] No comments were received. The rule is Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of airspace. BILLING CODE 4910–13–P adopted as proposed. The area will be depicted on Under that section, the FAA is charged aeronautical charts for pilot reference. with prescribing regulations to ensure DEPARTMENT OF TRANSPORTATION The coordinates for this airspace docket the safe and efficient use of the are based on North American Datum 83. navigable airspace. This regulation is Federal Aviation Administration The Class E airspace areas designated as within the scope of that authority surface areas are published in paragraph because it creates Class E airspace 14 CFR Part 71 6002 of FAA Order 7400.9R, Airspace sufficient in size to contain aircraft [Docket No. FAA–2007–29012; Airspace Designations and Reporting Points, executing instrument procedures for the Docket No. 07–AAL–15] signed August 15, 2007, and effective McGrath Airport and represents the September 15, 2007, which is FAA’s continuing effort to safely and Revision of Class E Airspace; incorporated by reference in 14 CFR efficiently use the navigable airspace. McGrath, AK 71.1. The Class E airspace areas List of Subjects in 14 CFR Part 71 designated as 700/1,200 ft. transition AGENCY: Federal Aviation Airspace, Incorporation by reference, areas are published in paragraph 6005 of Administration (FAA), DOT. Navigation (air). ACTION: Final rule. FAA Order 7400.9R, Airspace Designations and Reporting Points, Adoption of the Amendment SUMMARY: This action revises Class E signed August 15, 2007, and effective I In consideration of the foregoing, the airspace at McGrath, AK to provide September 15, 2007, which is Federal Aviation Administration adequate controlled airspace to contain incorporated by reference in 14 CFR amends 14 CFR part 71 as follows: aircraft executing Standard Instrument 71.1. The Class E airspace designations Approach Procedures (SIAPs). Five listed in this document will be PART 71—DESIGNATION OF CLASS A, SIAPs and a textual departure procedure published subsequently in the Order. CLASS B, CLASS C, CLASS D, AND (DP) are being amended for the McGrath The Rule CLASS E AIRSPACE AREAS; Airport. Additionally, one SIAP is being AIRWAYS; ROUTES; AND REPORTING developed. This action revises existing This amendment to 14 CFR part 71 POINTS Class E airspace upward from 700 feet revises Class E airspace at the McGrath (ft.) and 1,200 ft. above the surface at the Airport, Alaska. This Class E airspace is I 1. The authority citation for 14 CFR McGrath Airport, McGrath, AK. revised to accommodate aircraft part 71 continues to read as follows:

VerDate Aug<31>2005 18:23 Dec 18, 2007 Jkt 214001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\19DER1.SGM 19DER1 mstockstill on PROD1PC66 with RULES Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Rules and Regulations 71769

Authority: 49 U.S.C. 106(g), 40103, 40113, DEPARTMENT OF HEALTH AND A. Should N9 Remain Available as an 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– HUMAN SERVICES Active Ingredient in OTC Vaginal 1963 Comp., p. 389. Contraceptive Drug Products? Food and Drug Administration B. What Issues Were Raised by § 71.1 [Amended] Comments That Did Not Support I 2. The incorporation by reference in 21 CFR Part 201 the Proposed Warning Statements? 14 CFR 71.1 of Federal Aviation [Docket No. 1980N–0280] (formerly Docket 1. Will Warning Labels Be Seen, Administration Order 7400.9R, Airspace No. 80N–0280) Understood, or Followed? Designations and Reporting Points, RIN 0910–AF44 2. Are the Warnings Supported by the signed August 15, 2007, and effective Scientific Literature? September 15, 2007, is amended as Over-the-Counter Vaginal 3. Is FDA Required To Prove Actual follows: Contraceptive and Spermicide Drug Causation To Justify the Warnings? Products Containing Nonoxynol 9; C. Should Women Ask a Doctor * * * * * Required Labeling Before Using N9 Products? D. Where Will the Warnings Appear Paragraph 6002 Class E Airspace AGENCY: Food and Drug Administration, Designated as Surface Areas. in the Labeling? HHS. E. Where Will the Condom Usage AAL AK E2 McGrath, AK [Revised] ACTION: Final rule. Statement Appear in the Labeling? McGrath, McGrath Airport, AK F. What Were the Comments on ° ′ ″ ° ′ ″ SUMMARY: The Food and Drug (Lat. 62 57 10 N., long. 155 36 20 W.) Administration (FDA) is issuing a final Condoms, Sexual Lubricants, and That airspace within a 7.6-mile radius of rule establishing new warning Barrier Methods? 1. Do Warnings Apply to Condoms the McGrath Airport. This Class E airspace statements and other labeling and Sexual Lubricants? area is effective during the specific dates and information for all over-the-counter 2. Are Condoms Lubricated With N9 times established in advance by a Notice to (OTC) vaginal contraceptive drug Safe To Use? Airmen. The effective date and time will products (also known as spermicides, 3. How Do Warnings Apply to N9 thereafter be continuously published in the hereinafter referred to as vaginal Products Used With Barrier Airport/Facility Directory. contraceptives or vaginal Methods? * * * * * contraceptives/spermicides) containing G. Is N9 Safe for Women at Low Risk nonoxynol 9 (N9). These warning Paragraph 6005 Class E Airspace Extending for HIV/AIDS and STDs? Upward from 700 feet or More Above the statements will advise consumers that H. Is N9 Safe for Rectal Use? Surface of the Earth. vaginal contraceptives/spermicides I. Does N9 Increase the Risk of STDs containing N9 do not protect against * * * * * Other Than HIV? infection from the human J. What Issues Did Other Comments AAL AK E5 McGrath, AK [Revised] immunodeficiency virus (HIV), the virus Discuss? McGrath, McGrath Airport, AK that causes acquired immunodeficiency 1. Why Did FDA Define Frequent Use (Lat. 62°57′10″ N., long. 155°36′20″ W.) syndrome (AIDS), or against getting of N9 as ‘‘More Than Once a Day’’? other sexually transmitted diseases That airspace extending upward from 700 2. Should ‘‘Pharmacist’’ or ‘‘Health (STDs). The warnings and labeling feet above the surface within a 8.1-mile Care Provider’’ Be Included on the radius of the McGrath Airport and within 4 information will also advise consumers Label? miles north and 8 miles south of the 123° that use of vaginal contraceptives and 3. What Does ‘‘Unprotected Sex’’ bearing from the McGrath Airport, AK spermicides containing N9 can irritate Mean? extending from the 8.1-mile radius to 16 the vagina and rectum and may increase 4. What Does the Word ‘‘Irritation’’ miles southeast of the McGrath Airport, AK, the risk of getting the AIDS virus (HIV) Mean When Referring To ‘‘Vaginal and within 4 miles east and west of the 008° from an infected partner. This final rule Irritation’’ in the Warning bearing from the McGrath Airport, AK, is part of FDA’s ongoing review of OTC Language? extending from the 8.1-mile radius to 11.2 drug products. FDA is issuing this final 5. Should Warnings Be Printed in miles north of the McGrath Airport, AK; and rule after considering public comments Both English and Spanish? that airspace extending upward from 1,200 on its proposed regulation, and all III. FDA’s Final Conclusions on feet above the surface within a 74-mile radius relevant data and information on N9 Warnings and Other Labeling of the McGrath Airport. that have come to our attention. Information for OTC Vaginal * * * * * DATES: Effective Date: This rule is Contraceptive and Spermicide Drug effective June 19, 2008. Products Containing N9 Issued in Anchorage, AK, on December 11, Compliance Date: The compliance A. New Labeling Requirements 2007. date for all products subject to this final B. Statement About Warnings Anthony M. Wylie, rule, including products with annual IV. Analysis of Impacts Manager, Alaska Flight Services Information sales less than $25,000, is June 19, 2008. V. Paperwork Reduction Act of 1995 Area Group. FOR FURTHER INFORMATION CONTACT: VI. Environmental Impact [FR Doc. E7–24410 Filed 12–18–07; 8:45 am] Arlene Solbeck, Center for Drug VII. Federalism BILLING CODE 4910–13–P Evaluation and Research, Food and VIII. References Drug Administration, 10903 New I. Background Hampshire Ave., Bldg. 22, Silver Spring, MD 20993, 301–796–2090. In the Federal Register of January 16, SUPPLEMENTARY INFORMATION: 2003 (68 FR 2254), FDA (we) published a proposed rule (the proposed rule) to Table of Contents require new labeling warning statements I. Background for all OTC vaginal contraceptive drug II. Comments on the Proposed Rule and products containing N9. These proposed FDA’s Responses warning statements are intended to

VerDate Aug<31>2005 17:31 Dec 18, 2007 Jkt 214001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\19DER1.SGM 19DER1 mstockstill on PROD1PC66 with RULES