[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
