Document ID: FDA-2009-N-0665-0017
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage From New Animal Drugs; Change of Sponsor; Repository Corticotropin Injection
Posted Date: 2009-05-05T04:00Z

[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Rules and Regulations]
[Page 20582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10291]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

Implantation or Injectable Dosage From New Animal Drugs; Change 
of Sponsor; Repository Corticotropin Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor's name from Summit Hill 
Laboratories to Putney, Inc.

DATES: This rule is effective May 5, 2009.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Summit Hill Laboratories, P.O. Box 535, 
Navesink, NJ 07752, has informed FDA that it has transferred ownership 
of, and all rights and interest in, NADA 8-760 for ADRENOMONE 
(repository corticotropin injection U.S.P.) to Putney, Inc., 400 
Congress St., suite 200, Portland, ME 04101. Accordingly, the 
regulations are amended in 21 CFR 522.480 to reflect this change of 
sponsorship.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.480  [Amended]

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2. In paragraph (a)(2) of Sec.  522.480, remove ``037990'' and add in 
its place ``026637''.

    Dated: April 30, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-10291 Filed 5-4-09; 8:45 am]
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