[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4735-4736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2688]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 61, No. 27 / Thursday, February 8, 1996 / 
Rules and Regulations  

[[Page 4735]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


21 CFR Part 510

New Animal Drugs; Change of Sponsor Name and Address
AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor name and address from 
DuPont Pharmaceuticals to DuPont Merck Pharmaceutical Co.

EFFECTIVE DATE: February 8, 1996.

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: DuPont Pharmaceuticals, One Rodney Square, 
Wilmington, DE 19898, has informed FDA of a change of sponsor name and 
address to DuPont Merck Pharmaceutical Co., DuPont Merck Plaza, MR2117, 
Wilmington, DE 19805. 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.

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).

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
removing the entry for ``DuPont Pharmaceuticals '' and by 
alphabetically adding a new entry for ``DuPont Merck Pharmaceutical 
Co.,'' and in the table in paragraph (c)(2) in the entry for ``000056'' 
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) * * *

                                                                        
------------------------------------------------------------------------
        Firm name and address--                 Drug labeler code       
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
DuPont Merck Pharmaceutical Co.,        000056                          
 DuPont Merck Plaza, MR2117,                                            
 Wilmington, DE 19805.                                                  
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

    --(2)-* * *

                                                                        
------------------------------------------------------------------------
        Drug labeler code-----                Firm name and address     
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
000056----............................  DuPont Merck Pharmaceuticals    
                                         Co., DuPont Merck Plaza,       
                                         MR2117, Wilmington, DE 19805   
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------


-
[[Page 4736]]

    Dated: February 1, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-2688 Filed 2-7-96; 8:45 am]
BILLING CODE 4160-01-F