[Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
[Rules and Regulations]
[Page 28630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13822]
[[Page 28630]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
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 a change of sponsor for a new animal drug
application (NADA) from Schering-Plough Animal Health Corp. to Walco
International, Inc.
EFFECTIVE DATE: May 27, 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: Schering-Plough Animal Health Corp., P.O.
Box 529, Kenilworth, NJ 07033, has informed FDA that it has transferred
ownership of, and all rights and interests in, approved NADA 031-971
(cupric glycinate injection) to Walco International, Inc., 15 West
Putnam, Porterville, CA 93257. Accordingly, the agency is amending the
regulations in 21 CFR 522.518 to reflect the change of sponsor.
List of Subjects in 21 CFR 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.518 [Amended]
2. Section 522.518 Cupric glycinate injection is amended in
paragraph (b) by removing ``000061'' and adding in its place ``No.
049185''.
Dated: May 6, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-13822 Filed 5-23-97; 8:45 am]
BILLING CODE 4160-01-F
