[Federal Register: July 11, 2002 (Volume 67, Number 133)]
[Rules and Regulations]               
[Page 45901-45902]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy02-7]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Ceftiofur Hydrochloride

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 Pharmacia and Upjohn Co. The supplemental 
NADA provides for injection of ceftiofur hydrochloride suspension in 
cattle for the treatment of acute metritis.

DATES:  This rule is effective July 11, 2002.

FOR FURTHER INFORMATION CONTACT:  Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7572, e-mail: 
cburnste@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:  Pharmacia and Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed a supplemental application to NADA 140-
890 that provides for use of EXCENEL (ceftiofur hydrochloride) RTU 
Sterile Suspension by intramuscular or subcutaneous injection in cattle 
for the treatment of acute metritis (0 to 14 days post partum) 
associated with bacterial organisms susceptible to ceftiofur. The 
supplemental NADA is approved as of February 8, 2002, and the 
regulations are amended in Sec. 522.314 (21 CFR 522.314) to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary. Section 522.314 is also being revised to reflect a 
current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
application may be seen in the Dockets Management Branch (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.
    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 supplemental 
application approval qualifies for 3 years of marketing exclusivity 
beginning February 8, 2002, because the supplemental application 
contains substantial evidence of the effectiveness of the drug 
involved, any studies of animal safety or, in the case of food-
producing animals, human food safety studies (other than bioequivalence 
or residue studies) required for approval of the supplemental 
application and conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.33(d)(5) 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.
    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.

    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: 21 U.S.C. 360b.
    2. Section 522.314 is amended by revising the section heading, and 
paragraphs (a), (d)(1)(i), (d)(1)(iii), and (d)(2) to read as follows:


Sec. 522.314  Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of suspension contains 
ceftiofur hydrochloride equivalent to 50 milligrams (mg) of ceftiofur.
* * * * *
    (d) * * * 
    (1) * * * 
    (i) Amount. 3 to 5 mg per kilogram (/kg) of body weight by 
intramuscular injection. Treatment should be repeated at 24-hour 
intervals for a total of 3 consecutive days.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle--(i) Dosage. 1.1 to 2.2 mg/kg of body weight by 
intramuscular or subcutaneous injection, at 24-hour intervals for 3 to 
5 consecutive days. For bovine respiratory disease, 2.2 mg/kg of body 
weight may be administered twice at a 48-hour interval. For acute 
metritis, administer 2.2 mg/kg of body weight daily for 5 consecutive 
days.
    (ii) Indications for use. For treatment of bovine respiratory 
disease (BRD, shipping fever, pneumonia) associated with Mannheimia 
spp. (Pasteurella haemolytica), P. multocida, and Haemophilus somnus; 
acute bovine interdigital necrobacillosis (foot rot, pododermatitis) 
associated with

[[Page 45902]]

Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute 
metritis (0 to 14 days post partum) associated with bacteria 
susceptible to ceftiofur.
    (iii) Limitations. Do not slaughter treated cattle for 48 hours (2 
days) after last treatment. A withdrawal period has not been 
established in preruminating calves. Do not use in calves to be 
processed for veal. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

    Dated: June 26, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-17404 Filed 7-10-02; 8:45 am]
BILLING CODE 4160-01-S