[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Rules and Regulations]
[Page 29551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Animal Drugs, Feeds, 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 the change of sponsor for an approved new 
animal drug application (NADA) from Deprenyl Animal Health, Inc., to 
Pfizer, Inc.

EFFECTIVE DATE: June 1, 1998.

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: Deprenyl Animal Health, Inc., 7101 College 
Blvd., suite 580, Overland Park, KS 66210, has informed FDA that it has 
transferred the ownership of, and all rights and interests in, the 
approved NADA 141-080 (selegiline hydrochloride tablets) to Pfizer, 
Inc., 235 East 42d St., New York, NY 10017. The agency is amending 21 
CFR 510.600(c)(1) and (c)(2) to remove the sponsor name for Deprenyl 
Animal Health, Inc., because the firm no longer is the holder of any 
approved NADA's. The agency is also amending 21 CFR 520.2098 to reflect 
the change of sponsor.

List of Subjects

 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520

    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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``Deprenyl Animal Health, Inc.''; and 
in the table in paragraph (c)(2) by removing the entry for ``063248''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec. 520.2098  [Amended]

    4. Section 520.2098 Selegiline hydrochloride tablets is amended in 
paragraph (b) by removing ``063248'' and by adding in its place 
``000069''.


    Dated: May 12, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-14299 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F