[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Rules and Regulations]
[Page 22887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10912]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
Animal Drugs, Feeds, and Related Products; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for three new animal
drug applications (NADA's) from Ciba-Geigy Animal Health, Ciba-Geigy
Corp. to Novartis Animal Health US, Inc.
EFFECTIVE DATE: April 28, 1997.
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: Ciba-Geigy Animal Health, Ciba-Geigy Corp.,
P.O. Box 18300, Greensboro, NC 27419-8300, has informed FDA that it has
transferred ownership of, and all rights and interests in, NADA's 140-
915, 141-026, and 141-035 to Novartis Animal Health US, Inc., P.O. Box
18300, Greensboro, NC 27419-8300. Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c)(1) and (c)(2) by removing Ciba-
Geigy Animal Health, Ciba-Geigy Corp., because the firm is no longer
the sponsor of any approved NADA's, and by alphabetically adding a new
listing for Novartis Animal Health US, Inc. The drug labeler code
assigned is being retained for the new sponsor.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 is
amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 376e).
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 ``Ciba-Geigy Animal Health, Ciba-Geigy
Corp., P.O. Box 18300, Greensboro, NC 27419-8300'' and by
alphabetically adding a new entry for ``Novartis Animal Health US,
Inc.''; and in the table in paragraph (c)(2) in the entry for
``058198'' by removing the sponsor name ``Ciba-Geigy Animal Health,
Ciba-Geigy Corp.'' and adding in its place ``Novartis Animal Health US,
Inc.''
Dated: April 8, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-10912 Filed 4-25-97; 8:45 am]
BILLING CODE 4160-01-F
