[Federal Register Volume 61, Number 79 (Tuesday, April 23, 1996)]
[Rules and Regulations]
[Pages 17829-17830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9870]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 529
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
abbreviated new animal drug application (ANADA) from Macleod
Pharmaceuticals, Inc., to Anthony Products Co.
EFFECTIVE DATE: April 23, 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: Macleod Pharmaceuticals, Inc., 2600 Canton
Ct., Fort Collins, CO 80525, has informed FDA that it has transferred
the ownership of, and all rights and interests in, approved ANADA 200-
115 (Gentamicin Sulfate) to Anthony Products Co., 5600 Peck Rd.,
Arcadia, CA 91006. Accordingly, FDA is amending the regulations in 21
CFR 529.1044a to reflect the change of sponsor.
List of Subjects in 21 CFR Part 529
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 529 is
amended as follows:
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS NOT SUBJECT TO
CERTIFICATION
1. The authority citation for 21 CFR part 529 continues to read as
follows:
[[Page 17830]]
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 529.1044a [Amended]
2. Section 529.1044a Gentamicin sulfate intrauterine solution is
amended in paragraph (b) by removing ``000061, 000856, 054273, 057561,
and 058711'' and adding in its place, ``000061, 000856, 000864, 054273,
and 057561''.
Dated: April 4, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-9870 Filed 4-22-96; 8:45 am]
BILLING CODE 4160-01-F
