[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Rules and Regulations]
[Pages 66582-66583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32071]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 522 and 556
Animal Drugs, Feeds, and Related Products; 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 Pharmacia & Upjohn Co. The supplemental
NADA provides for intramuscular use in sheep of a reconstituted
solution of ceftiofur sterile powder for treatment of sheep respiratory
disease (pneumonia).
EFFECTIVE DATE: December 18, 1996.
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.
[[Page 66583]]
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd.,
Kalamazoo, MI 49001-0199, filed supplemental NADA 140-338, which
provides for use of Naxcel Sterile Powder (ceftiofur sodium)
in sheep as a 50 milligrams per milliliter reconstituted injectable
solution. The product is currently approved for use in cattle, swine,
day-old chicks, horses, and dogs. The supplemental NADA is approved as
of October 25, 1996, and the regulations are amended in 21 CFR 522.313
to reflect the approval. The basis for approval is discussed in the
freedom of information summary.
Also, the regulations are amended in 21 CFR 556.113 to state that a
tolerance for ceftiofur residues in edible tissues of sheep is not
required.
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 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)), this approval does not
qualify for marketing exclusivity because it does not contain
substantial evidence of the effectiveness of the drug involved, any
studies of animal safety or human food safety (other than
bioequivalence or residue studies) required for 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
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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 parts 522 and
556 are 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 new paragraph (d)(7) to
read as follows:
Sec. 522.313 Ceftiofur sterile powder for injection.
* * * * *
(d) * * *
(7) Sheep--(i) Amount. 0.5 to 1.0 milligram per pound (1.1 to 2.2
milligrams per kilogram) of body weight.
(ii) Indications for use. For treatment of sheep respiratory
disease (pneumonia) associated with Pasteurella haemolytica and/or P.
multocida.
(iii) Limitations. For intramuscular use only. Treatment should be
repeated at 24 hour intervals for a total of 3 consecutive days.
Additional treatments may be given on days 4 and 5 for animals which do
not show satisfactory response. Use of dosages in excess of those
indicated or by unapproved routes of administration may result in
illegal residues in tissues. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
3. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: Secs. 402, 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 360b, 371).
Sec. 556.113 [Amended]
4. Section 556.113 Ceftiofur is amended by removing ``and poultry''
and by adding in its place ``poultry, and sheep''.
Dated: December 6, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-32071 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F
