[Federal Register Volume 61, Number 130 (Friday, July 5, 1996)]
[Rules and Regulations]
[Pages 35129-35130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17103]
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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
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 a revised indication for use of a reconstituted solution
of ceftiofur sterile powder for injection in day-old chicks for control
of mortality associated with Escherichia coli organisms susceptible to
ceftiofur and for use of the reconstituted injection in day-old turkey
poults for the same indication.
EFFECTIVE DATE: July 5, 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 supplemental NADA 140-338, which provides for use of
Naxcel Sterile Powder (ceftiofur sodium) as a 50 milligrams
per milliliter reconstituted injectable for use in cattle, swine, day-
old chicks, horses, and dogs. The supplemental NADA provides for: (1) A
revised indication for use in
[[Page 35130]]
chicks for control of early mortality associated with E. coli organisms
susceptible to ceftiofur, and (2) use in a new species, day-old turkey
poults, for the revised indication. According to 21 CFR 556.113 a
tolerance for ceftiofur residues in edible tissues derived from treated
poultry is not needed. The supplemental NADA is approved as of May 21,
1996, and the regulations are amended in 21 CFR 522.313(d) 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)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), approval for use in
turkeys qualifies for 3 years of marketing exclusivity beginning May
21, 1996, because the application 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. Section 522.313 is amended by revising paragraph (d)(3)(ii), by
redesignating paragraphs (d)(4) and (d)(5) as paragraphs (d)(5) and
(d)(6), respectively, and by adding new paragraph (d)(4) to read as
follows:
Sec. 522.313 Ceftiofur sterile powder for injection.
* * * * *
(d) * * *
(3) * * *
(ii) Indications for use. For control of early mortality associated
with Escherichia coli organisms susceptible to ceftiofur.
* * * * *
(4) Day-old turkey poults--(i) Amount. 0.17 to 0.5 milligram per
poult.
(ii) Indications for use. For control of early mortality associated
with E. coli organisms susceptible to ceftiofur.
(iii) Limitations. For subcutaneous use in the neck of day-old
poults only. As a single dose only. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
* * * * *
Dated: June 14, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-17103 Filed 7-3-96; 8:45 am]
BILLING CODE 4160-01-F
