Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal, 18440-18441 [E8-7107]
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18440
Federal Register / Vol. 73, No. 66 / Friday, April 4, 2008 / Rules and Regulations
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contain aircraft executing Standard
Instrument Approach Procedures
(SIAPs). Two new Standard Instrument
Approach Procedures (SIAPs) are being
developed for the New Stuyahok
Airport. This action revises existing
Class E airspace upward from 700 feet
(ft.) and 1,200 ft. above the surface at
New Stuyahok Airport, New Stuyahok,
AK.
EFFECTIVE DATE: 0901 UTC, June 5, 2008.
The Director of the Federal Register
approves this incorporation by reference
action under title 1, Code of Federal
Regulations, part 51, subject to the
annual revision of FAA Order 7400.9
and publication of conforming
amendments.
FOR FURTHER INFORMATION CONTACT: Gary
Rolf, AAL–538G, Federal Aviation
Administration, 222 West 7th Avenue,
Box 14, Anchorage, AK 99513–7587;
telephone number (907) 271–5898; fax:
(907) 271–2850; e-mail:
gary.ctr.rolf@faa.gov. Internet address:
https://www.alaska.faa.gov/at.
SUPPLEMENTARY INFORMATION:
History
On Friday, February 1, 2008, the FAA
proposed to amend part 71 of the
Federal Aviation Regulations (14 CFR
part 71) to revise Class E airspace
upward from 700 ft. above the surface
and from 1,200 ft. above the surface at
New Stuyahok, AK (73 FR 6057). The
action was proposed in order to create
Class E airspace sufficient in size to
contain aircraft while executing SIAPs
for the New Stuyahok Airport. The
Notice of Proposed Rulemaking
contained airport location data, which
has since been updated. The revised
airport location coordinates are listed in
this rule. Class E controlled airspace
extending upward from 700 ft. above the
surface and from 1,200 ft. above the
surface in the New Stuyahok Airport
area is revised by this action.
Interested parties were invited to
participate in this rulemaking
proceeding by submitting written
comments on the proposal to the FAA.
No comments were received. The rule is
adopted as proposed.
The area will be depicted on
aeronautical charts for pilot reference.
The coordinates for this airspace docket
are based on North American Datum 83.
The Class E airspace areas designated as
700/1,200 ft. transition areas are
published in paragraph 6005 of FAA
Order 7400.9R, Airspace Designations
and Reporting Points, signed August 15,
2007, and effective September 15, 2007,
which is incorporated by reference in 14
CFR 71.1. The Class E airspace
designations listed in this document
VerDate Aug<31>2005
13:41 Apr 03, 2008
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will be published subsequently in the
Order.
The Rule
This amendment to 14 CFR part 71
revises Class E airspace at the New
Stuyahok Airport, Alaska. This Class E
airspace is revised to accommodate
aircraft executing new SIAPs, and will
be depicted on aeronautical charts for
pilot reference. The intended effect of
this rule is to provide adequate
controlled airspace for Instrument Flight
Rules (IFR) operations at the New
Stuyahok Airport, New Stuyahok,
Alaska.
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. It, therefore—(1) is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this rule will not have
a significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the United States Code.
Subtitle 1, Section 106 describes the
authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority.
This rulemaking is promulgated
under the authority described in
Subtitle VII, Part A, Subpart 1, Section
40103, Sovereignty and use of airspace.
Under that section, the FAA is charged
with prescribing regulations to ensure
the safe and efficient use of the
navigable airspace. This regulation is
within the scope of that authority
because it creates Class E airspace
sufficient in size to contain aircraft
executing instrument procedures for the
New Stuyahok Airport and represents
the FAA’s continuing effort to safely
and efficiently use the navigable
airspace.
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
I
PART 71—DESIGNATION OF CLASS A,
CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS;
AIRWAYS; ROUTES; AND REPORTING
POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace
Designations and Reporting Points,
signed August 15, 2007, and effective
September 15, 2007, is amended as
follows:
*
*
*
*
*
I
Paragraph 6005 Class E Airspace Extending
Upward from 700 feet or More Above the
Surface of the Earth.
*
*
*
*
*
AAL AK E5 New Stuyahok, AK [Revised]
New Stuyahok, New Stuyahok Airport, AK
(Lat. 59°27′06″ N., long. 157°22′23″ W.)
That airspace extending upward from 700
feet above the surface within a 6.9-mile
radius of the New Stuyahok Airport; and that
airspace extending upward from 1,200 feet
above the surface within a 71-mile radius of
the New Stuyahok Airport.
*
*
*
*
*
Issued in Anchorage, AK, on March 24,
2008.
Anthony M. Wylie,
Manager, Alaska Flight Services Information
Area Group.
[FR Doc. E8–6921 Filed 4–3–08; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 210 and 211
[Docket No. FDA–2008–N–0179] (formerly
Docket No. 2007N–0280)
Amendment to the Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals; Withdrawal
AGENCY:
Food and Drug Administration,
HHS.
List of Subjects in 14 CFR Part 71
ACTION:
Airspace, Incorporation by reference,
Navigation (air).
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing a
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Direct final rule; withdrawal.
04APR1
Federal Register / Vol. 73, No. 66 / Friday, April 4, 2008 / Rules and Regulations
direct final rule that published in the
Federal Register of December 4, 2007
(72 FR 68064), to amend certain
regulations as the first phase of an
incremental approach to modernize or
clarify some of the current good
manufacturing practice (CGMP)
regulations for finished
pharmaceuticals, as well as harmonize
some of the CGMP requirements with
those of other foreign regulators and
other FDA regulations. The comment
period closed February 19, 2008. FDA is
withdrawing the direct final rule
because the agency received significant
adverse comments. FDA will consider
the comments received under our usual
procedures for notice and comment in
connection with the notice of proposed
rulemaking that was published in the
Federal Register of December 4, 2007,
as a companion to the direct final rule
(72 FR 68113).
DATES: The direct final rule published at
72 FR 68064 on December 4, 2007, is
withdrawn as of April 4, 2008.
FOR FURTHER INFORMATION CONTACT:
Mary Malarkey, Center for Biologics
Evaluation and Research (HFM–
600), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852–1448,
301–827–6190, or
Dennis Bensley, Center for Veterinary
Medicine (HFV–140), Food and
Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8268, or
Brian Hasselbalch, Center for Drug
Evaluation and Research (HFD–
320), Food and Drug
Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–3279.
Authority: Therefore, under the
Federal Food, Drug, and Cosmetic Act,
and under authority delegated to the
Commissioner of Food and Drugs, the
direct final rule published on December
4, 2007 (72 FR 68064) is withdrawn.
Dated: March 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–7107 Filed 4–3–08; 8:45 am]
BILLING CODE 4160–01–S
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations by removing
those portions that reflect approval of
seven new animal drug applications
(NADAs) because FDA is withdrawing
approval of the NADAs.
DATES:
This rule is effective April 4,
2008.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–212), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9067; e-mail:
pamela.esposito@fda.hhs.gov.
The
following sponsors have requested that
FDA withdraw approval of the seven
NADAs listed below because the
products are no longer manufactured or
marketed:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 526, and 558
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of
NADAs; Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Sponsor
21 CFR Cite Affected
(Sponsor Drug Labeler Code)
NADA Number Product (Drug)
Eon Labs Manufacturing, Inc.,
227–15 North Conduit Ave.,
Laurelton, NY 11413
NADA 65–063,
Tetracycline capsules
520.2345a (000185)
NADA 65–345,
Chloramphenicol capsules
520.390b (000185)
G.C. Hanford Manufacturing Co.,
P.O. Box 1017,
Syracuse, NY 13201
NADA 65–465,
AQUA-MAST
(penicillin G procaine)
526.1696a (010515)
International Nutrition, Inc.,
7706 ‘‘I’’ Plaza,
Omaha, NE 68127
NADA 95–551,
TYLAN 5 Premix
(tylosin phosphate)
558.625 (043733)
NADA 109–688,
HYGROMIX 2.4 Premix
(hygromycin B)
558.274 (043733)
NADA 109–816,
TYLAN 10 SULFA-G Premix
(tylosin phosphate and sulfamethazine)
558.630 (043733)
NADA 103–758,
TERAMIX–10 Premix
(oxytetracycline)
Not codified
Pfizer, Inc.,
235 East 42d St.,
New York, NY 10017
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18441
Following the withdrawal of approval
of these NADAs, Eon Labs
Manufacturing, Inc., is no longer
sponsor of an approved application.
VerDate Aug<31>2005
13:41 Apr 03, 2008
Jkt 214001
Therefore, 21 CFR 510.600(c) is
amended to remove entries for this
sponsor.
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As provided below, the animal drug
regulations are amended to reflect the
withdrawal of approvals. The
regulations for penicillin G procaine
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]]>Agencies
[Federal Register Volume 73, Number 66 (Friday, April 4, 2008)]
[Rules and Regulations]
[Pages 18440-18441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7107]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 210 and 211
[Docket No. FDA-2008-N-0179] (formerly Docket No. 2007N-0280)
Amendment to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing a
[[Page 18441]]
direct final rule that published in the Federal Register of December 4,
2007 (72 FR 68064), to amend certain regulations as the first phase of
an incremental approach to modernize or clarify some of the current
good manufacturing practice (CGMP) regulations for finished
pharmaceuticals, as well as harmonize some of the CGMP requirements
with those of other foreign regulators and other FDA regulations. The
comment period closed February 19, 2008. FDA is withdrawing the direct
final rule because the agency received significant adverse comments.
FDA will consider the comments received under our usual procedures for
notice and comment in connection with the notice of proposed rulemaking
that was published in the Federal Register of December 4, 2007, as a
companion to the direct final rule (72 FR 68113).
DATES: The direct final rule published at 72 FR 68064 on December 4,
2007, is withdrawn as of April 4, 2008.
FOR FURTHER INFORMATION CONTACT:
Mary Malarkey, Center for Biologics Evaluation and Research (HFM-
600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852-1448, 301-827-6190, or
Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8268, or
Brian Hasselbalch, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, 301-796-3279.
Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act,
and under authority delegated to the Commissioner of Food and Drugs,
the direct final rule published on December 4, 2007 (72 FR 68064) is
withdrawn.
Dated: March 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7107 Filed 4-3-08; 8:45 am]
BILLING CODE 4160-01-S
