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Rule

New Animal Drugs; Change of Sponsor Name and Address

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Information about this document as published in the Federal Register.

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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 for Rhone-Poulenc, Inc.

DATES:

This rule is effective October 10, 2000.

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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.

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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.

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List of Subjects in 21 CFR Part 510

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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:

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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:

addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
 *          *          *          *          *          *          *  
Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd., suite 650, Alpharetta, GA 30005-8891011526
 *          *          *          *          *          *          *  

(2) * * *

Drug labeler codeFirm name and address
 *          *          *          *          *          *          *  
011526Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd., suite 650, Alpharetta, GA 30005-8891
 *          *          *          *          *          *          *  
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Dated: September 28, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. 00-25965 Filed 10-6-00; 8:45 am]

BILLING CODE 4160-01-F