Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Bayer Corp., Agriculture Division, Animal Health to Schering-Plough Animal Health Corp.
This rule is effective February 11, 2000.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
Bayer Corp., Agriculture Division, Animal Health, P.O. Box 390, Shawnee Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interests in NADA 113-645 (cloprostenol sodium) to Schering-Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083. Accordingly, the agency is amending the regulations in 21 CFR 522.460 to reflect the transfer of ownership.Start List of Subjects
List of Subjects in 21 CFR Part 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:Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation for 21 CFR part 522 continues to read as follows:End Amendment Part
4. Section 522.460 Cloprostenol sodium is amended in paragraphs (a)(2) and (b)(2) by removing “000859” and adding in its place “000061”.End Amendment Part Start Signature
Dated: January 24, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 00-3194 Filed 2-10-00; 8:45 am]
BILLING CODE 4160-01-F