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Code · REGISTER · 2002-03-26 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

418 words·~2 min read·/register/2002/03/26/02-7147

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BILLING CODE 4160-01-S 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 and address for G.D. Searle & Co. DATES: This rule is effective March 26, 2002. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: lluther@cvm.fda.gov. SUPPLEMENTARY INFORMATION: G.D. Searle & Co., P.O. Box 5110, Chicago, IL 60680, has informed FDA of a change of name and address to G.D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy., Skokie, IL 60077. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change. 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 “G.D. Searle & Co.” and in the table in paragraph (c)(2) by revising the entry for “000014” 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 * * * * * * * G.D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy., Skokie, IL 60077 000014 * * * * * * *
(2)* * * Drug labeler code Firm name and address * * * * * * * 000014 G.D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy., Skokie, IL 60077 * * * * * * * Dated: February 22, 2002. Claire M. Lathers, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 02-7147 Filed 3-25-02; 8:45 am]
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  • 21 CFR 510
  • 5 USC 801-808
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