Oral Dosage Form New Animal Drugs; Amprolium; Correction, 70276 [E8-27646]

Download as PDF 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. * * * * * 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]


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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.

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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