[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19932]


[[Page Unknown]]

[Federal Register: August 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522

 

Animal Drugs, Feeds, and Related Products; 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 a supplemental new animal drug 
application (NADA) filed by The Upjohn Co. The supplemental NADA 
provides for use of ceftiofur sterile powder intramuscularly in horses 
for treatment of respiratory infections associated with Streptococcus 
zooepidemicus.

EFFECTIVE DATE: August 15, 1994.

FOR FURTHER INFORMATION CONTACT: Charles W. Francis, Center for 
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 
Standish
Pl., Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: The Upjohn Co., Kalamazoo, MI 49001, filed 
supplemental NADA 140-338, which provides for use of Naxcel 
Sterile Powder (ceftiofur sodium) in horses as a 50 milligrams per 
milliliter reconstituted injectable solution. The product is currently 
approved for use in cattle, swine, and day-old chicks. The supplemental 
NADA is approved as of July 13, 1994, and the regulations are amended 
in 21 CFR 522.313 to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies 
for 3 years of marketing exclusivity beginning July 13, 1994, because 
the application contains reports of new clinical or field 
investigations (other than bioequivalence or residue studies) essential 
to the approval of the application and conducted or sponsored by the 
applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 522.313 is amended by adding new paragraph (d)(4) to 
read as follows:

Sec. 522.313  Ceftiofur sterile powder for injection.

* * * * *
    (d) * * *
    (4) Horses--(i) Amount. 2.2 to 4.4 milligrams per kilogram (1.0 to 
2.0 milligrams per pound) of body weight.
    (ii) Indications for use. For treatment of respiratory infections 
in horses associated with Streptococcus zooepidemicus.
    (iii) Limitations. For intramuscular use only. Treatment should be 
repeated every 24 hours, continued for 48 hours after clinical signs 
have disappeared, and should not exceed 10 days. A maximum of 10 
milliliters should be administered per injection site. Not for use in 
horses intended for food. Do not use in animals previously found to be 
hypersensitive to the drug. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.

    Dated: August 8, 1994.
Richard H. Teske,
Deputy Director, Premarket Review, Center for Veterinary Medicine.
[FR Doc. 94-19932 Filed 8-12-94; 8:45 am]
BILLING CODE 4160-01-F