[Federal Register Volume 69, Number 28 (Wednesday, February 11, 2004)]
[Notices]
[Page 6669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of New Animal Drug Application; Ceftiofur

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is providing notice 
that it has approved a supplemental new animal drug application (NADA) 
filed by Pharmacia and Upjohn Co. The supplemental NADA provided 
revised susceptibility information for food-animal pathogens listed in 
the clinical microbiology section of labeling for ceftiofur sodium 
sterile powder for injection.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmacia and Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed a supplement to NADA 140-338 which 
provides for the veterinary prescription use of NAXCEL (ceftiofur 
sodium) Sterile Powder for Injection. The supplemental NADA provided 
updated susceptibility data for food-animal pathogens listed in the 
clinical microbiology section of labeling. In accordance with section 
512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) 
and 21 CFR 514.105(a) and 514.106(a), FDA is providing notice that this 
supplemental NADA is approved as of December 31, 2003. The basis of 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

    Dated: January 30, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-2892 Filed 2-10-04; 8:45 am]
BILLING CODE 4160-01-S