[Federal Register Volume 60, Number 51 (Thursday, March 16, 1995)]
[Rules and Regulations]
[Page 14216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6528]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
Animal Drugs, Feeds, and Related Products; Change of Sponsor Name
and Address
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 and address for a
new animal drug application (NADA) from Zoecon Industries, Inc., to
Sandoz Agro, Inc.
EFFECTIVE DATE: March 16, 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: Due to a merger with Zoecon Industries,
Inc., 12200 Denton Dr., Dallas, TX 75234, and Sandoz Agro, Inc., 1300
East Touhy Ave., Des Plaines, IL 60018, the firms have requested that
FDA publish a notice of a change of sponsor name and address for their
new animal drug application NADA 98-895, Starbar GX-118 (N-
(mercaptomethyl) phthalimide S-(O,O dimethylphosphorodithioate)
emulsifiable liquid). Accordingly, the agency is amending the
regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of
sponsor name and address. The drug labeler code ``011536'' for Zoecon
Industries, Inc., is being retained for the new sponsor.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and record keeping 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).
2. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entry for ``Zoecon Industries, Inc.,'' and alphabetically
adding a new entry for ``Sandoz Agro, Inc.,'' and in the table in
paragraph (c)(2) in the entry for ``011536'' by revising the sponsor
name and address to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug
Firm name and address labeler
code
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* * * * *
Sandoz Agro, Inc., 1300 East Touhy Ave., Des Plaines, IL 60018. 011536
* * * * *
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(2) * * *
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Drug
labeler Firm name and address
code
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* * * * *
011536. Sandoz Agro, Inc., 1300 East Touhy Ave., Des Plaines, IL 60018
* * * * *
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Dated: March 8, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-6528 Filed 3-15-95; 8:45 am]
BILLING CODE 4160-01-F
