Rules and Regulations. Final rule

Agency: Food and Drug Administration
Action: Final rule
Citation: FR Doc. 00-18824 · 21 CFR 510

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor address for Wellmark International.

Dates

This rule is effective July 26, 2000.

Supplementary Information

Wellmark International, 1000 Tower Rd., suite 245, Bensenville, IL 60106, has informed FDA of a change of sponsor address to 1100 East Woodfield Rd., suite 500, Schaumburg, IL 60173. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of sponsor 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 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 revising the entry for “Wellmark International” and in the table in paragraph (c)(2) by revising the entry for “011536” to read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. (c) * * * (1) * * * Firm name and address Drug labeler code * * * * * * * Wellmark International, 1100 East Woodfield Rd., suite 500, Schaumburg, IL 60173 011536 * * * * * * * (2) * * * Drug labeler code Firm name and address 011536 Wellmark International, 1100 East Woodfield Rd., suite 500, Schaumburg, IL 60173 * * * * * * * Dated: July 18, 2000. Claire M. Lathers, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 00-18824 Filed 7-25-00; 8:45 am]