[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Rules and Regulations]
[Pages 67724-67725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33920]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs 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 seven new animal 
drug applications (NADA's) from Rhone-Poulenc, Inc., to Alpharma Inc.

EFFECTIVE DATE: December 30, 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: Rhone-Poulenc, Inc., P.O. Box 125, Black 
Horse Lane, Monmouth Junction, NJ 08852, has informed FDA that it has 
transferred ownership of, and all rights and interests in, the 
following approved NADA's to Alpharma Inc., One Executive Dr., Fort 
Lee, NJ 07024:

                                                                                                                
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                  NADA                                                  Ingredient                              
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039-417                                  Decoquinate                                                            
040-435                                  Decoquinate, roxarsone                                                 
045-348                                  Decoquinate, zinc bacitracin                                           
045-444                                  Decoquinate, chlortetracycline                                         
047-262                                  Decoquinate, lincomycin                                                
091-326                                  Decoquinate, roxarsone, zinc bacitracin                                
092-953                                  Roxarsone                                                              
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[[Page 67725]]

    The agency is amending 21 CFR part 558 to reflect the change of 
sponsor.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: (21 U.S.C. 360b, 371).

Sec. 558.195  [Amended]

    2. Section 558.195 Decoquinate is amended in paragraph (a) by 
removing ``011526'' and adding in its place ``046573'' and in the table 
in paragraph (d), under the ``sponsor column'' by removing ``011526'' 
wherever it appears and adding in its place ``046573''.

Sec. 558.530  [Amended]

    3. Section 558.530 Roxarsone is amended in paragraph (a) by 
removing ``011526'' and adding in its place ``046573''.

    Dated: December 18, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-33920 Filed 12-29-97; 8:45 am]
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