[Federal Register Volume 65, Number 196 (Tuesday, October 10, 2000)]
[Rules and Regulations]
[Pages 60097-60098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25965]


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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.

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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 
Rhone-Poulenc, Inc.

DATES:  This rule is effective October 10, 2000.

FOR FURTHER INFORMATION CONTACT: Norman J. Turner, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0214.

SUPPLEMENTARY INFORMATION:  Rhone-Poulenc, Inc., P.O. Box 125, Black 
Horse Lane, Monmouth Junction, NJ 08852, has informed FDA of a change 
of sponsor name and address to Aventis Animal Nutrition, Inc., 3480 
Preston Ridge Rd., suite 650, Alpharetta, GA 30005-8891. Accordingly, 
the agency is amending the regulations in 21 CFR 510.600(c) to reflect 
the change of sponsor name and address.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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: 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 ``Rhone-Poulenc, Inc.'' and alphabetically 
adding an entry for ``Aventis Animal Nutrition, Inc.'' and in the table 
in paragraph (c)(2) by revising the entry for ``011526'' to read as 
follows:


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

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

------------------------------------------------------------------------
       Firm name and address                  Drug labeler code
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  *                    *                    *                    *
                   *                    *                    *
Aventis Animal Nutrition, Inc.,      011526
 3480 Preston Ridge Rd., suite 650,
 Alpharetta, GA 30005-8891
 
  *                    *                    *                    *
                   *                    *                    *
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    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
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  *                    *                    *                    *
                   *                    *                    *
011526                               Aventis Animal Nutrition, Inc.,
                                      3480 Preston Ridge Rd., suite 650,
                                      Alpharetta, GA 30005-8891
 
  *                    *                    *                    *
                   *                    *                    *
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[[Page 60098]]

    Dated: September 28, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-25965 Filed 10-6-00; 8:45 am]
BILLING CODE 4160-01-F