[Federal Register Volume 69, Number 150 (Thursday, August 5, 2004)]
[Rules and Regulations]
[Page 47362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Ceftiofur

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of two supplemental new animal 
drug applications (NADAs) filed by Pharmacia & Upjohn Co. The 
supplemental NADAs provide for establishing a 4-day preslaughter 
withdrawal period in swine injected with either a solution made from 
ceftiofur sodium powder or with a ceftiofur hydrochloride suspension.

DATES: This rule is effective August 5, 2004.

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 & Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed supplements to NADA 140-338 for NAXCEL 
(ceftiofur sodium) Sterile Powder for Injection and to NADA 140-890 for 
EXCENEL RTU (ceftiofur hydrochloride) Sterile Suspension. The 
supplemental NADAs provide for establishing a 4-day preslaughter 
withdrawal period in swine injected with either product. The 
supplemental applications are approved as of June 18, 2004, and the 
regulations are amended in 21 CFR 522.313 and 522.314 to reflect the 
approval. 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), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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 these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required for either.
    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.

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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

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  522.313  [Amended]

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2. Section 522.313 is amended in paragraph (d)(2)(iii) by adding 
``Treated swine must not be slaughtered for 4 days following the last 
treatment.'' as the last sentence.


Sec.  522.314  [Amended]

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3. Section 522.314 is amended in paragraph (d)(1)(iii) by adding 
``Treated swine must not be slaughtered for 4 days following the last 
treatment.'' as the last sentence.

    Dated: July 21, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.>
[FR Doc. 04-17890 Filed 8-4-04; 8:45 am]
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