[Federal Register Volume 62, Number 30 (Thursday, February 13, 1997)]
[Rules and Regulations]
[Pages 6723-6724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 520


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 a new animal drug 
application (NADA) from Biocraft Laboratories, Inc., to Teva 
Pharmaceuticals USA.

EFFECTIVE DATE: February 13, 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: Biocraft Laboratories, Inc., 92 Route 46, 
Elmwood Park, NJ 07407, has informed FDA that it has transferred 
ownership of, and all rights and interests in NADA 131-806 for 
furosemide tablets or boluses to Teva Pharmaceuticals USA, 650 Cathill 
Rd., Sellersville, PA 18960. Accordingly, the agency is amending the 
regulations in 21 CFR 510.600(c)(1) and (c)(2) by alphabetically adding 
a new listing for Teva Pharmaceuticals USA. The agency is also amending 
21 CFR 520.1010a to reflect the transfer of ownership.

[[Page 6724]]

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    Animal drugs.
    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 
520 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).

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Teva Pharmaceuticals USA'' and 
in the table in paragraph (c)(2) by numerically adding a new entry for 
``000093'' to read as follows:


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

*  *  *  *  *
    (c) * * *
    (1) * * *

                                                                        
------------------------------------------------------------------------
          Firm name and address                  Drug labeler code      
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Teva Pharmaceuticals USA, 650 Cathill      000093                       
 Rd., Sellersville, PA 18960.                                           
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

    (2) * * *

                                                                        
------------------------------------------------------------------------
            Drug labeler code                  Firm name and address    
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
000093...................................  Teva Pharmaceuticals USA, 650
                                            Cathill Rd., Sellersville,  
                                            PA 18960                    
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 520.1010a  [Amended]

    4. Section 520.1010a Furosemide tablets or boluses is amended in 
paragraph (b) by removing the number ``000332'' and adding in its place 
``000093''.

    Dated: February 4, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-3662 Filed 2-12-97; 8:45 am]
BILLING CODE 4160-01-F