[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) * * *

------------------------------------------------------------------------
                                                                   Drug 
                     Firm name and address                       labeler
                                                                   code 
------------------------------------------------------------------------
                   *        *        *        *        *                
Sandoz Agro, Inc., 1300 East Touhy Ave., Des Plaines, IL 60018.   011536
                   *        *        *        *        *                
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
  Drug                                                                  
labeler                       Firm name and address                     
  code                                                                  
------------------------------------------------------------------------
                   *        *        *        *        *                
011536.  Sandoz Agro, Inc., 1300 East Touhy Ave., Des Plaines, IL 60018 
                   *        *        *        *        *                
------------------------------------------------------------------------


    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