New Animal Drug Applications; Confirmation of Effective Date, 10413 [2010-4923]
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10413
Federal Register / Vol. 75, No. 44 / Monday, March 8, 2010 / Rules and Regulations
No.’’ and adding in its place ‘‘CBP Dec.
10–01’’.
David V. Aguilar,
Acting Deputy Commissioner, U.S. Customs
and Border Protection.
Approved: March 2, 2010.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 2010–4783 Filed 3–5–10; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 514
[Docket No. FDA–2009–N–0436]
New Animal Drug Applications;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Direct final rule; confirmation
of effective date.
SUMMARY: The Food and Drug
Administration (FDA) is confirming the
effective date of March 8, 2010, for the
final rule that appeared in the Federal
Register of October 23, 2009 (74 FR
54749). The direct final rule amends the
regulations regarding new animal drug
applications (NADAs). Specifically, this
direct final rule is being issued to
provide that NADAs shall be submitted
in the described form, as appropriate for
the particular submission. Currently, the
regulation requires that all NADAs
contain the same informational sections
and does not explicitly provide the
appropriate flexibility needed to address
the development of all types of new
animal drug products. This amendment
will allow the agency to appropriately
review safety and effectiveness data
submitted to support the approval of
new animal drug products. This
document confirms the effective date of
the direct final rule.
DATES: Effective date confirmed: March
8, 2010.
FOR FURTHER INFORMATION CONTACT: Urvi
Desai, Center for Veterinary Medicine
(HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8297,
e-mail: urvi.desai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of October 23, 2009 (74
FR 54749), FDA solicited comments
concerning the direct final rule for a 75day period ending January 6, 2010. FDA
stated that the effective date of the
direct final rule would be on March 8,
2010, 60 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA did
not receive any significant adverse
comments.
Authority: Therefore, under the Federal
Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of
Food and Drugs, 21 CFR part 514 is
amended. Accordingly, the amendments
issued thereby are effective.
Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
exemptions under the International
Regulations for Preventing Collisions at
Sea, 1972 (72 COLREGS). The document
contained an incorrect hull number.
DATES: This correcting amendment is
effective March 8, 2010, and is
applicable beginning February 1, 2010.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Commander Ted Cook,
JAGC, U.S. Navy, Admiralty Attorney,
(Admiralty and Maritime Law), Office of
the Judge Advocate General, Department
of the Navy, 1322 Patterson Ave., SE.,
Suite 3000, Washington Navy Yard, DC
20374–5066, telephone number: 202–
685–5040.
Need for Correction
In the Federal Register (75 FR 6858)
of February 12, 2010, in an amendment
to § 706.2 Table Five, an incorrect hull
number for the USS PHILIPPINE SEA
was presented.
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water), and
Vessels.
For the reasons set forth in the
preamble, the Navy amends part 706 of
title 32 of the Code of Federal
Regulations by making the following
correcting amendment:
■
[FR Doc. 2010–4923 Filed 3–5–10; 8:45 am]
BILLING CODE 4160–01–S
PART 706—CERTIFICATIONS AND
EXEMPTIONS UNDER THE
INTERNATIONAL REGULATIONS FOR
PREVENTING COLLISIONS AT SEA,
1972
DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 706
1. The authority citation for part 706
continues to read as follows:
■
Certifications and Exemptions Under
the International Regulations for
Preventing Collisions at Sea, 1972;
Correction
Authority: 33 U.S.C. 1605.
Department of the Navy, DoD.
ACTION: Final rule; correcting
amendment.
AGENCY:
SUMMARY: The Department of the Navy
published a document in the Federal
Register of February 12, 2010,
concerning certifications and
2. Section 706.2 is amended in Table
Five by revising the entry for USS
PHILIPPINE SEA (CG 58) to read as
follows:
■
§ 706.2 Certifications of the Secretary of
the Navy under Executive Order 11964 and
33 U.S.C. 1605.
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TABLE FIVE
pwalker on DSK8KYBLC1PROD with RULES
Vessel
Number
Masthead lights not over
all other lights and
obstructions. Annex I,
Section 2(f)
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USS PHILIPPINE SEA
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VerDate Nov<24>2008
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Jkt 220001
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Frm 00005
Forward masthead light
not in forward quarter of
ship. Annex I,
Section 3(a)
After masthead light less
than 1⁄2 ship’s length aft
of forward masthead
light. Annex I,
Section 3(a)
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[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Rules and Regulations]
[Page 10413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4923]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 514
[Docket No. FDA-2009-N-0436]
New Animal Drug Applications; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of March 8, 2010, for the final rule that appeared in
the Federal Register of October 23, 2009 (74 FR 54749). The direct
final rule amends the regulations regarding new animal drug
applications (NADAs). Specifically, this direct final rule is being
issued to provide that NADAs shall be submitted in the described form,
as appropriate for the particular submission. Currently, the regulation
requires that all NADAs contain the same informational sections and
does not explicitly provide the appropriate flexibility needed to
address the development of all types of new animal drug products. This
amendment will allow the agency to appropriately review safety and
effectiveness data submitted to support the approval of new animal drug
products. This document confirms the effective date of the direct final
rule.
DATES: Effective date confirmed: March 8, 2010.
FOR FURTHER INFORMATION CONTACT: Urvi Desai, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8297, e-mail: urvi.desai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 23, 2009
(74 FR 54749), FDA solicited comments concerning the direct final rule
for a 75-day period ending January 6, 2010. FDA stated that the
effective date of the direct final rule would be on March 8, 2010, 60
days after the end of the comment period, unless any significant
adverse comment was submitted to FDA during the comment period. FDA did
not receive any significant adverse comments.
Authority: Therefore, under the Federal Food, Drug, and Cosmetic
Act and under authority delegated to the Commissioner of Food and
Drugs, 21 CFR part 514 is amended. Accordingly, the amendments
issued thereby are effective.
Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4923 Filed 3-5-10; 8:45 am]
BILLING CODE 4160-01-S
