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58993

Rules and Regulations Federal Register


Vol. 72, No. 201

Thursday, October 18, 2007

This section of the FEDERAL REGISTER long.113°30′00″ W.’’ This action corrects DEPARTMENT OF HEALTH AND
contains regulatory documents having general that error. HUMAN SERVICES
applicability and legal effect, most of which
are keyed to and codified in the Code of Correction to Final Rule Food and Drug Administration
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510. ■ Accordingly, pursuant to the authority 21 CFR Part 314
delegated to me, the legal description as
The Code of Federal Regulations is sold by [Docket No. 2000N–1545] (formerly 00N–
published in the Federal Register on
the Superintendent of Documents. Prices of 1545)
new books are listed in the first FEDERAL August 10, 2007 (72 FR 44955),
REGISTER issue of each week. Airspace Docket No. 06–ANM–12, FAA Applications for Food and Drug
Docket No. FAA–2006–26364, and Administration Application Approval to
incorporated by reference in 14 CFR Market a New Drug; Revision of
DEPARTMENT OF TRANSPORTATION 71.1, is corrected as follows: Postmarketing Reporting
Requirements
Federal Aviation Administration § 71.1 [Amended]
■ On page 44956, correct the legal AGENCY: Food and Drug Administration,
14 CFR Part 71 HHS.
description for Beaver, UT, to read as
[Docket FAA No. FAA–2006–26364; follows: ACTION: Final rule.
Airspace Docket No. 06–ANM–12]
Paragraph 6005—Class E airspace areas SUMMARY: The Food and Drug
Establishment of Class E Airspace; extending upward from 700 feet or more Administration (FDA) is amending its
Beaver, UT above the surface of the earth. regulations describing postmarketing
* * * * * reporting requirements to implement
AGENCY: Federal Aviation certain provisions of the Food and Drug
Administration (FAA), DOT. ANM UT E5 Beaver, UT [Corrected] Administration Modernization Act of
ACTION: Final rule; correction. Beaver Municipal Airport, UT (lat. 1997 (the Modernization Act). The
SUMMARY: This action corrects a final
38°13′51″ N., long. 112°40′31″ W.) changes apply to drug products that are
rule published in the Federal Register
Bryce Canyon VORTAC (lat. 37°41′21″ N., life supporting, life sustaining, or
August 10, 2007 (72 FR 44955),
long. 112°18′14″ W.) intended for use in the prevention of a
That airspace extending upward from 700 serious disease or condition and that
Airspace Docket No. 06–ANM–12, FAA
feet above the surface within a 5.0-mile were not originally derived from human
Docket No. FAA–2006–26364. In that
radius of Beaver Municipal Airport and tissue and replaced by a recombinant
rule, an error was made in the legal
within 3 miles each side of the 261° bearing product. The final rule implements
description for Beaver, UT. Specifically,
from the Airport extending from the 5.0-mile provisions of the Modernization Act by
the longitude referencing V–293 stated
radius to 14.0 miles west of the Airport, and requiring an applicant who is the sole
‘‘* * * long. 133°00′00″ W.’’ instead of that airspace extending upward from 1,200
‘‘* * * long.113°30′00″ W.’’ This action manufacturer of one of these products to
feet above the surface beginning at lat. notify FDA at least 6 months before
corrects that error. 38°19′24″ N., long. 113°30′00″ W.; thence east discontinuing manufacture of the drug
DATES: Effective Date: 0901 UTC, on V–244 to lat. 38°22′22″ N., long. product.
October 25, 2007. The Director of the 112°37′47″ W.; thence south on V–257 to
Federal Register approves this BRYCE CANYON VORTAC; thence west on DATES: This rule is effective December
incorporation by reference action under V–293 to lat. 37°56′30″ N., long. 113°30′00″ 17, 2007.
1 CFR part 51, subject to the annual W.; to point of beginning. FOR FURTHER INFORMATION CONTACT:
revision of FAA Order 7400.9 and S. Mitchell Weitzman, Center for Drug
* * * * *
publication of conforming amendments. Evaluation and Research (HFD–7),
FOR FURTHER INFORMATION CONTACT: Issued in Seattle, Washington, on October Food and Drug Administration,
Eldon Taylor, Federal Aviation 5, 2007. 5600 Fishers Lane, Rockville, MD
Administration, System Support Group, Clark Desing, 20857, 301–443–5535, or
Western Service Area, 1601 Lind Manager, System Support Group, Western Stephen Ripley, Center for Biologics
Avenue, SW., Renton, WA 98057; Service Center. Evaluation and Research (HFM–17),
telephone (425) 917–6726. [FR Doc. E7–20389 Filed 10–17–07; 8:45 am] Food and Drug Administration,
SUPPLEMENTARY INFORMATION: BILLING CODE 4910–13–P
1401 Rockville Pike, Rockville, MD
20852–1448, 301–827–6210.
History
SUPPLEMENTARY INFORMATION:
On August 10, 2007, a final rule for
Airspace Docket No. 06–ANM–12, FAA I. Background
Docket No. FAA–2006–26364 was In the Federal Register of November
published in the Federal Register (72 7, 2000 (65 FR 66665), we (FDA) issued
yshivers on PROD1PC62 with RULES

FR 44955), establishing Class E airspace a proposed rule to revise our


in Beaver, UT. The longitude postmarketing reporting requirements to
referencing V–293 was incorrect in that implement section 506C of the Federal
the longitude stated ‘‘* * * long. Food, Drug, and Cosmetic Act (the act)
133°00′00″ W.’’ instead of ‘‘* * * (21 U.S.C. 356c). Section 506C of the act

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