[Federal Register Volume 61, Number 130 (Friday, July 5, 1996)]
[Rules and Regulations]
[Pages 35129-35130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17103]


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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 a supplemental new animal drug 
application (NADA) filed by The Upjohn Co. The supplemental NADA 
provides for a revised indication for use of a reconstituted solution 
of ceftiofur sterile powder for injection in day-old chicks for control 
of mortality associated with Escherichia coli organisms susceptible to 
ceftiofur and for use of the reconstituted injection in day-old turkey 
poults for the same indication.

EFFECTIVE DATE: July 5, 1996.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION: The Upjohn Co., Kalamazoo, MI 49001, is 
sponsor of supplemental NADA 140-338, which provides for use of 
Naxcel<Register> Sterile Powder (ceftiofur sodium) as a 50 milligrams 
per milliliter reconstituted injectable for use in cattle, swine, day-
old chicks, horses, and dogs. The supplemental NADA provides for: (1) A 
revised indication for use in

[[Page 35130]]

chicks for control of early mortality associated with E. coli organisms 
susceptible to ceftiofur, and (2) use in a new species, day-old turkey 
poults, for the revised indication. According to 21 CFR 556.113 a 
tolerance for ceftiofur residues in edible tissues derived from treated 
poultry is not needed. The supplemental NADA is approved as of May 21, 
1996, and the regulations are amended in 21 CFR 522.313(d) 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, 12420 
Parklawn Dr., rm. 1-23, 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)), approval for use in 
turkeys qualifies for 3 years of marketing exclusivity beginning May 
21, 1996, because the application contains reports of new clinical or 
field investigations (other than bioequivalence or residue studies) or 
human food safety studies (other than bioequivalence or residue 
studies) essential to the approval 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 revising paragraph (d)(3)(ii), by 
redesignating paragraphs (d)(4) and (d)(5) as paragraphs (d)(5) and 
(d)(6), respectively, and by adding new paragraph (d)(4) to read as 
follows:


Sec. 522.313  Ceftiofur sterile powder for injection.

* * * * *
    (d) * * *
    (3) * * *
    (ii) Indications for use. For control of early mortality associated 
with Escherichia coli organisms susceptible to ceftiofur.
* * * * *
    (4) Day-old turkey poults--(i) Amount. 0.17 to 0.5 milligram per 
poult.
    (ii) Indications for use. For control of early mortality associated 
with E. coli organisms susceptible to ceftiofur.
    (iii) Limitations. For subcutaneous use in the neck of day-old 
poults only. As a single dose only. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
* * * * *

    Dated: June 14, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-17103 Filed 7-3-96; 8:45 am]
BILLING CODE 4160-01-F