[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Rules and Regulations]
[Page 260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-123]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


New Animal Drugs and Related Products; Change of Sponsor

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 for a new animal drug 
application (NADA) from Fort Dodge Laboratories to Wildlife 
Laboratories, Inc.

EFFECTIVE DATE: January 4, 1996.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Fort Dodge Laboratories, Fort Dodge, IA 
50501, has informed FDA that it has transferred ownership of, and all 
rights and interests in approved NADA 47-870 (Etorphine hydrochloride 
injection) to Wildlife Laboratories, Inc., 1401 Duff Dr., suite 600, 
Fort Collins, CO 80524. This NADA was originally owned by American 
Cyanamid Co. and transferred to Fort Dodge Laboratories but was 
inadvertently not codified in the regulations. Accordingly, FDA is 
amending the regulations in 21 CFR 522.883 to reflect the change of 
sponsor.

List of Subjects in 21 CFR Part 522

    -Animal drugs.
    -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

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 522.883  [Amended]

     2. Section 522.883 Etorphine hydrochloride injection is amended in 
paragraph (c) by removing ``010042'' and adding in its place 
``053923''.

    Dated: December 22, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-123 Filed 1-3-96; 8:45 am]
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