[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)] [Rules and Regulations] [Page 71640] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-33123] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Atipamezole; Technical Amendment
Agency
Food and Drug Administration, HHS.
Action
Final rule; technical amendment.
-----------------------------------------------------------------------
Summary
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect that Orion Corp. is the correct sponsor of a new animal drug application (NADA) for Atipamezole Injection. When FDA issued the regulation reflecting the NADA approval, Pfizer, Inc., the U.S. agent for Orion Corp., was incorrectly listed as the sponsor of the application. This document corrects that error.
EFFECTIVE DATE: December 22, 1999.
For Further Information Contact
David L. Gordon, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1739.
Supplementary Information
FDA has discovered an error in the agency's regulations for animal drugs, feeds, and related products. A final rule published in the Federal Register of September 17, 1996 (61 FR 48829), added Sec. 522.147 (21 CFR 522.147) and incorrectly stated that Pfizer, Inc., was the sponsor of the NADA. FDA is amending Sec. 522.147 to correctly identify Orion Corp. as the sponsor. 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 522
Animal drugs. 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 522 is amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.147 [Amended]
2. Section 522.147 Atipamezole hydrochloride is amended in paragraph (b) by removing ``000069'' and adding in its place ``052483''.
Dated: December 14, 1999. Claire M. Lathers, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 99-33123 Filed 12-21-99; 8:45 am] BILLING CODE 4160-01-F