[Federal Register Volume 60, Number 191 (Tuesday, October 3, 1995)]
[Rules and Regulations]
[Pages 51718-51719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24593]



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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 Sterile Powder For Injection

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 veterinary prescription use of a reconstituted ceftiofur 
sterile powder for injection for the treatment of acute bovine 
interdigital necrobacillosis (foot rot, pododermatitis) in cattle.

EFFECTIVE DATE: October 3, 1995.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1659.

SUPPLEMENTARY INFORMATION: The Upjohn Co., 7000 Portage Rd., Kalamazoo, 
MI 49001, filed a supplemental NADA 140-338, which provides for 
veterinary prescription use of Naxcel (ceftiofur sodium) 
sterile powder for intramuscular use in cattle for the treatment of 
acute bovine interdigital necrobacillosis (foot rot, pododermatitis) 
associated with Fusobacterium necrophorum and Bacteroides 
melaninogenicus. The reconstituted drug contains the equivalent of 50 
milligrams (mg) of ceftiofur per milliliter used at 0.5 to 1.0 mg/pound 
of body weight once daily for up to 5 days. The supplemental NADA is 
approved as of August 24, 1995, and the regulations are amended in 21 
CFR 522.313(d) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.

[[Page 51719]]

    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. to 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 a 3-year marketing exclusivity beginning August 24, 1995, because 
the application contains reports of new clinical or field 
investigations (other than bioequivalence or residue studies) and, in 
the case of food producing animals, human food safety studies (other 
than bioequivalence or residue studies) essential to the approval and 
conducted or sponsored by the applicant. The exclusivity applies only 
to the new indication which is the subject of this supplement.
    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 a sentence to the end of 
paragraph (d)(1)(ii) to read as follows:


Sec. 522.313   Ceftiofur sterile powder for injection.

* * * * *
    (d) * * *
    (1) * * *
    (ii) * * * Also, for the treatment of acute bovine interdigitial 
necrobacillosis (foot rot, pododermatitis) associated with 
Fusobacterium necrophorum and Bacteroides melaninogenicus.
* * * * *

    Dated: September 25, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-24593 Filed 10-2-95; 8:45 am]
BILLING CODE 4160-01-F