Rules and Regulations. Final rule

443 words·~2 min read·/register/2004/12/29/04-28461·

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BILLING CODE 1505-01-D DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 New Animal Drugs; Change of Sponsor's Name and Address 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's name from Pharmacia & Upjohn Co. to Pharmacia & Upjohn Co., a Division of Pfizer, Inc., and to correct the sponsor's mailing address. DATES: This rule is effective December 29, 2004. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: *david.newkirk@fda.gov.* SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, has informed FDA of a change of sponsor's name and mailing address to Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes. 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 revising the entry for “Pharmacia & Upjohn Co.” and in the table in paragraph (c)(2) by revising the entry for “000009” 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 * * * * * Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017 000009 * * * * *

(2)* * * Drug labeler code Firm name and address * * * * * 000009 Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017 * * * * * Dated: December 10, 2004. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 04-28461 Filed 12-28-04; 8:45 am]

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