[Federal Register Volume 60, Number 199 (Monday, October 16, 1995)]
[Rules and Regulations]
[Page 53509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25504]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs; 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 Syntex Animal Health, Division of Syntex
Agribusiness, Inc., to Hoffman-La Roche, Inc.
EFFECTIVE DATE: October 16, 1995.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1646.
SUPPLEMENTARY INFORMATION: Syntex Animal Health, Division of Syntex
Agribusiness, Inc., 3401 Hillview Ave., Palo Alto, CA 94304, has
informed FDA that it has transferred the ownership of, and all rights
and interests in, approved NADA 141-025 (Laidlomycin) to Hoffman-La
Roche, Inc., Nutley, NJ 07110-1199.
Accordingly, the agency is amending the regulations in 21 CFR
558.305 to reflect the change of sponsor.
List of Subject in 21 CFR Part 558
Animal drugs, Animal feeds.
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 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.305 [Amended]
2. Section 558.305 Laidlomycin propionate potassium is amended in
paragraph (a) by removing ``000033'' and adding in its place
``000004''.
Dated: October 4, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-25504 Filed 10-13-95; 8:45 am]
BILLING CODE 4160-01-F
