[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]
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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.
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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]
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