[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Rules and Regulations]
[Pages 46547-46548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 510


New Animal Drugs; 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 from 
Roussel-UCLAF to Roussel-UCLAF SA.

EFFECTIVE DATE: September 4, 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: Roussel-UCLAF, Division Agro-Veterinaire, 
163 Avenue Gambetta, 75020 Paris, France, has informed FDA of a change 
of sponsor name and address to Roussel-UCLAF SA, Animal Health 
Division, 102 Route de Noisy, 93235 Romainville Cedex, France. 
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 ``Roussel-UCLAF'' and adding in its place a new 
entry for ``Roussel-UCLAF SA'' and in the table in paragraph (c)(2) in 
the entry for ``012579'' 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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          Firm name and address                                      Drug labeler code                          
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Roussel-UCLAF SA, Animal Health Division,                                                                       
 102 Route de Noisy, 93235 Romainville                                                                          
 Cedex, France                                                                                           012579 
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    (2) * * *

[[Page 46548]]



                                                                        
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           Drug labeler code                  Firm name and address     
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  *                    *                    *                    *      
                   *                    *                    *          
012579.................................  Roussel-UCLAF SA, Animal Health
                                          Division, 102 Route de Noisy, 
                                          93235 Romainville Cedex,      
                                          France.                       
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: August 20, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-22486 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F