[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Rules and Regulations]
[Pages 66581-66582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32072]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
New Animal Drugs 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 a new animal drug
application (NADA) from Pfizer, Inc., to Intervet, Inc.
EFFECTIVE DATE: December 18, 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: Pfizer, Inc., 235 East 42d St., New York, NY
10017, has informed FDA that it has transferred ownership of, and all
rights and interests in, approved NADA 140-857 (luprostiol sterile
solution) to Intervet, Inc., P.O. Box 318, 405 State St., Millsboro, DE
19966. Accordingly, FDA is amending the regulations in 21 CFR 522.1290
to reflect the change of sponsor.
List of Subjects in 21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
[[Page 66582]]
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. 522.1290 [Amended]
2. Section 522.1290 Luprostiol sterile solution is amended in
paragraph (b) by removing ``000069'' and adding in its place
``057926''.
Dated: December 5, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-32072 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F
