[Federal Register Volume 61, Number 5 (Monday, January 8, 1996)]
[Rules and Regulations]
[Pages 514-515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-230]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
Animal Drugs, Feeds, and Related Products; 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 for new animal drug
applications (NADA's) from Whitmoyer Laboratories, Inc., to A. L.
Pharma, Inc.
EFFECTIVE DATE: January 8, 1996.
[[Page 515]]
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: Whitmoyer Laboratories, Inc., 19 North
Railroad St., Myerstown, PA 17067, has informed FDA that it has
transferred the ownership of, and all rights and interests in, approved
NADA's 10-285 (Carbarsone), 39-646 (Carbarsone + Bacitracin Methylene
Disalicylate) and 38-879 (Carbarsone + Zoalene) to A. L. Pharma, Inc.,
One Executive Dr., Fort Lee, NJ 07024. Accordingly, the agency is
amending 21 CFR 510.600(c)(1) and (c)(2) to remove the sponsor name
Whitmoyer Laboratories, Inc., because the firm no longer is the holder
of any approved NADA's. The agency is also amending 21 CFR 558.55,
558.95, and 558.120 to reflect the transfer of ownership.
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 for ``Whitmoyer Laboratories,'' and in the
table in paragraph (c)(2) by removing the entry for ``011794''.
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. 558.55 [Amended]
4. Section 558.55 Amprolium is amended in the table in paragraph
(d)(2), under the entry (iv), appearing under the heading
``Limitations'' at the ``Carbarsone 227 to 340.5'' entry, by removing
``011794'' and adding in its place ``046573''.
Sec. 558.95 [Amended]
5. Section 558.95 Bambermycins is amended in paragraph
(b)(3)(iv)(b) by removing ``011794'' and adding in its place
``046573''.
Sec. 558.120 [Amended]
6. Section 558.120 Carbarsone (not U.S.P.) is amended in paragraphs
(a)(1) and (a)(2) by removing ``011794'' and adding in its place
``046573''.
Dated: December 22, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-230 Filed 1-5-96; 8:45 am]
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