[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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
