00-3194. New Animal Drugs; 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 an approved new animal drug application (NADA) from Bayer Corp., Agriculture Division, Animal Health to Schering-Plough Animal Health Corp.

DATES:

This rule is effective February 11, 2000.

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:

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.

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:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 522.460

[Amended]

4. Section 522.460 Cloprostenol sodium is amended in paragraphs (a)(2) and (b)(2) by removing “000859” and adding in its place “000061”.

Dated: January 24, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.