[Federal Register Volume 60, Number 133 (Wednesday, July 12, 1995)]
[Rules and Regulations]
[Page 35838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16963]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor Name
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 name of approved
applications from A. L. Laboratories, Inc., to A. L. Pharma, Inc.
EFFECTIVE DATE: July 12, 1995.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1646.
SUPPLEMENTARY INFORMATION: A. L. Laboratories, Inc., One Executive Dr.,
P.O. Box 1399, Fort Lee, NJ 07024, has informed FDA of a change of
sponsor name to A. L. Pharma, Inc. Accordingly, FDA is amending the
regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of
sponsor name.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 is
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 in the first column the sponsor name ``A. L.
Laboratories, Inc.'', and by adding in its place ``A. L. Pharma,
Inc.'', and in the table in paragraph (c)(2) in the entry for
``046573'' by removing in the second column the sponsor name ``A. L.
Laboratories, Inc.'', and adding in its place ``A. L. Pharma, Inc.''.
Dated: July 3, 1995.
Robert C. Livingston,
Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 95-16963 Filed 7-11-95; 8:45 am]
BILLING CODE 4160-01-F
