[Federal Register Volume 61, Number 232 (Monday, December 2, 1996)]
[Rules and Regulations]
[Page 63712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30589]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 524


Ophthalmic and Topical Dosage Form 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 the change of sponsor for an approved new 
animal drug application (NADA) for Biocraft Laboratories, Inc., and A. 
H. Robins Co.

EFFECTIVE DATE: December 2, 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: A. H. Robins Co., P.O. Box 518, Fort Dodge, 
IA 50501-0518, and Biocraft Laboratories, Inc., 92 Route 46, Elmwood 
Park, NJ 07407, are no longer cosponsors of NADA 140-889. This 
arrangement was terminated sometime ago, but the agency failed to 
reflect the change in the regulations. Biocraft Laboratories, Inc., now 
exclusively owns NADA 140-889 and A. H. Robins Co. is the sponsor of 
new NADA 141-003. A. H. Robins Co. filed a supplement to NADA 140-889 
to provide for the establishment of a new NADA. Therefore, the agency 
is amending 21 CFR 524.1600a to reflect the change of sponsorship.

List of Subjects in 21 CFR Part 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 524.1600a  [Amended]

    2. Section 524.1600a Nystatin, neomycin, thiostrepton, and 
triamcinolone acetonide ointment is amended in paragraph (b) by 
removing ``See Nos. 000031/000332 (cosponsors), 000069, 025463, 051259, 
and 053501 in Sec. 510.600(c) of this chapter'' and by adding in its 
place ``See Nos. 000031, 000069, 000332, 025463, 051259, and 053501 in 
Sec. 510.600(c) of this chapter''.

    Dated: November 21, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-30589 Filed 11-29-96; 8:45 am]
BILLING CODE 4160-01-F