Oral Dosage Form New Animal Drugs; Amprolium; Correction, 70276 [E8-27646]
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70276
Federal Register / Vol. 73, No. 225 / Thursday, November 20, 2008 / Rules and Regulations
Judge’s decision is appealable first to
the Commission and from there to a U.S.
Court of appeals. In the event an award
of post-judgment interest is
inadvertently omitted, such interest
nevertheless shall run according to the
terms of 28 U.S.C. 1961 and the Part 12
Rules.
*
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Issued in Washington, DC, on October 20,
2008 by the Commission.
David A. Stawick,
Secretary of the Commission.
[FR Doc. E8–27177 Filed 11–19–08; 8:45 am]
BILLING CODE 6351–01–P
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.100
[Corrected]
2. In § 520.100(b)(2), remove ‘‘Nos.
051311 and 066104’’ and add in its
place ‘‘No. 66104’’.
■
Dated: October 17, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–27646 Filed 11–19–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF JUSTICE
28 CFR Part 14
Food and Drug Administration
Administrative Claims Under the
Federal Tort Claims Act; Delegation of
Authority
21 CFR Part 520
[Docket No. FDA–2008–N–0039]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Correcting amendments.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
document amending the animal drug
regulations to reflect approval of a
supplemental new animal drug
application (NADA) that appeared in
the Federal Register of August 6, 2008
(73 FR 45610). FDA is correcting a
paragraph designating the sponsors of
approved applications for oral dosage
forms of amprolium. This correction is
being made to improve the accuracy of
the animal drug regulations.
DATES: This rule is effective November
20, 2008.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019, email: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: For
reasons set forth in this preamble, FDA
is correcting 21 CFR part 520 as follows:
rwilkins on PROD1PC63 with RULES
List of Subjects in 21 CFR Part 520
Animal drugs.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 520 is corrected by making the
following amendment:
VerDate Aug<31>2005
18:21 Nov 19, 2008
Jkt 217001
Department of Justice.
Final rule.
AGENCY:
Oral Dosage Form New Animal Drugs;
Amprolium; Correction
ACTION:
SUMMARY: This Directive delegates
authority to the Postmaster General to
settle administrative tort claims
presented pursuant to the Federal Tort
Claims Act where the amount of the
settlement does not exceed $300,000.
This Directive implements the
Administrative Dispute Resolution Act.
This Directive will alert the general
public to the new authority and is being
published in the Code of Federal
Regulations to provide a permanent
record of this delegation.
DATES: Effective Date: November 20,
2008.
FOR FURTHER INFORMATION CONTACT:
Phyllis J. Pyles, Director, Torts Branch,
Civil Division, U.S. Department of
Justice, P.O. Box 888, Washington, DC
20044, (202) 616–4400.
SUPPLEMENTARY INFORMATION: This
Directive has been issued to delegate
settlement authority and is a matter
solely related to the division of
responsibility between the Department
of Justice and the United States Postal
Service. As such, this rule is a rule of
agency organization, procedure, and
practice that is limited to matters of
agency management and personnel.
Accordingly: (1) This rule is exempt
from the notice requirement of 5 U.S.C.
553(b) and is made effective upon
issuance; (2) the Department certifies
under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact
on a substantial number of small entities
and further that no Regulatory
Flexibility Analysis was required to be
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
prepared for this final rule since the
Department was not required to publish
a general notice of proposed
rulemaking; (3) this action is not a
‘‘regulation’’ or ‘‘rule’’ as defined by
Executive Order 12866, ‘‘Regulatory
Planning and Review,’’ § 3(d)(3) and,
therefore, this action has not been
reviewed by the Office of Management
and Budget.
This rule will not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or on
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with Executive Order 13132,
‘‘Federalism,’’ it is determined that this
rule does not have sufficient federalism
implications to warrant the preparation
of a Federalism Assessment. This
regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988, ‘‘Civil
Justice Reform.’’ This rule will not
result in the expenditure by state, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more in any one year, and it will not
significantly or uniquely affect small
governments. Therefore, no actions were
deemed necessary under the provisions
of the Unfunded Mandates Reform Act
of 1995.
Finally, this action pertains to agency
management, personnel, and
organization and does not substantially
affect the rights or obligations of nonagency parties and, accordingly, is not
a ‘‘rule’’ as that term is used by the
Congressional Review Act (Subtitle E of
the Small Business Regulatory
Enforcement Fairness Act of 1996).
Therefore, the reporting requirement of
5 U.S.C. 801 does not apply.
List of Subjects in 28 CFR Part 14
Authority delegations (government
agencies), Claims.
By virtue of the authority vested in me
by part 0 of title 28 of the Code of
Federal Regulations, including §§ 0.45,
0.160, 0.162, 0.164, and 0.168, 28 CFR
part 14 is amended as follows:
■
PART 14—ADMINISTRATIVE CLAIMS
UNDER FEDERAL TORT CLAIMS ACT
1. The authority citation for part 14 is
revised to read as follows:
■
Authority: 5 U.S.C. 301; 28 U.S.C. 509,
510, and 2672.
2. The appendix to part 14 is amended
by revising the heading and text for the
‘‘Delegation of Authority to the
Postmaster General’’ to read as follows:
■
E:\FR\FM\20NOR1.SGM
20NOR1
Agencies
[Federal Register Volume 73, Number 225 (Thursday, November 20, 2008)]
[Rules and Regulations]
[Page 70276]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27646]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2008-N-0039]
Oral Dosage Form New Animal Drugs; Amprolium; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Correcting amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a
document amending the animal drug regulations to reflect approval of a
supplemental new animal drug application (NADA) that appeared in the
Federal Register of August 6, 2008 (73 FR 45610). FDA is correcting a
paragraph designating the sponsors of approved applications for oral
dosage forms of amprolium. This correction is being made to improve the
accuracy of the animal drug regulations.
DATES: This rule is effective November 20, 2008.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail:
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: For reasons set forth in this preamble, FDA
is correcting 21 CFR part 520 as follows:
List of Subjects in 21 CFR Part 520
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
corrected by making the following amendment:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.100 [Corrected]
0
2. In Sec. 520.100(b)(2), remove ``Nos. 051311 and 066104'' and add in
its place ``No. 66104''.
Dated: October 17, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-27646 Filed 11-19-08; 8:45 am]
BILLING CODE 4160-01-S