[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Pages 29478-29479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14651]



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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 Hydrochloride Sterile Suspension

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 new animal drug application 
(NADA) filed by The Upjohn Co. The NADA provides for use of ceftiofur 
hydrochloride sterile suspension for intramuscular injection in swine 
for treatment and control of certain forms of swine bacterial 
respiratory disease.
EFFECTIVE DATE: June 11, 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 NADA 140-890, which provides for use of Excenel<Register> 
Sterile Suspension (ceftiofur hydrochloride equivalent to 50 milligrams 
(mg) per milliliter ceftiofur). The NADA provides for intramuscular 
injection in swine for treatment and control of swine bacterial 
respiratory disease (swine bacterial pneumonia) associated with 
Actinobacillus (Haemophilus)

[[Page 29479]]

pleuropneumoniae, Pastureurella multocida, Salmonella choleraesuis, and 
Streptococcus suis Type 2 at 1.36 to 2.27 mg/pound body weight (3 to 5 
mg/kilograms). The NADA is approved as of April 26, 1996, and the 
regulations are amended by adding new 21 CFR 522.314 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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning April 26, 1996, because it 
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. New Sec. 522.314 is added to read as follows:


Sec. 522.314  Ceftiofur hydrochloride sterile suspension.

    (a) Specifications. Each milliliter contains ceftiofur 
hydrochloride equivalent to 50 milligrams of ceftiofur.
    (b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.113 of this chapter.
    (d) Conditions of use. (1) Swine--(i) Amount. 3 to 5 milligrams per 
kilogram (1.36 to 2.27 milligrams per pound) of body weight.
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus (Haemophilus) pleuropneumoniae, Pastureurella 
multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
    (iii) Limitations. For intramuscular use only. Treatment should be 
repeated at 24-hour intervals for a total of 3 consecutive days. Do not 
use in animals previously found to be hypersensitive to the drug. Use 
of dosages in excess of those indicated or route of administration 
other than that recommended may result in illegal residues in tissues. 
Safety of ceftiofur has not been determined in breeding swine. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

    Dated:May 28, 1996
Stephen F. Sundlof
Director,Center for Veterinary Medicine
[FR Doc. 96-14651 Filed 6-10-96; 8:45 am]
BILLING CODE 4160-01-F