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Code · REGISTER · 2000-10-10 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

433 words·~2 min read·/register/2000/10/10/00-25965·

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Agency: Food and Drug Administration, HHS
Action: Final rule
Citation: FR Doc. 00-25965 · 21 CFR 510

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.

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: § 510.600Names, addresses, and drug labeler codes of sponsors of approved applications. (c) * * * (1) * * * Firm name and address Drug labeler code * * * * * * * Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd., suite 650, Alpharetta, GA 30005-8891 011526 * * * * * * * (2) * * * Drug labeler code Firm name and address * * * * * * * 011526 Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd., suite 650, Alpharetta, GA 30005-8891 * * * * * * * 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]

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  • 21 CFR 510
  • 5 USC 801-808
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