[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Page 14300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7548]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
New Animal Drugs; 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 from TRINADA, Inc., to
ALPHARMA INC.
EFFECTIVE DATE: March 26, 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: TRINADA, Inc. (a wholly owned subsidiary of
A. L. Pharma, Inc.), One Executive Dr., P.O. Box 1399, Fort Lee, NJ
07024 has informed FDA that it has transferred ownership of, and all
rights and interests in, approved NADA 91-668 (Chlortetracycline,
procaine penicillin, and sulfamethazine) to ALPHARMA INC., One
Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024. Accordingly, the
agency is amending the regulations in 21 CFR 558.145 to reflect the
change of sponsor and also amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) by removing TRINADA, Inc., because the firm is
no longer the sponsor of any approved NADA's.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 558
Animal drugs, animal feeds.
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 parts 510 and
558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
Sec. 510.600 [Amended]
2. Section 510.600 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) by removing the entry ``TRINADA, Inc.'', and in the table in
paragraph (c)(2) by removing the entry ``058690''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.145 [Amended]
4. Section 558.145 Chlortetracycline, procaine penicillin, and
sulfamethazine is amended in paragraph (a)(1) by removing the number
``058690'' and adding in its place ``046573''.
Dated: March 17, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-7548 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F
