[Federal Register Volume 61, Number 159 (Thursday, August 15, 1996)]
[Rules and Regulations]
[Page 42383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20854]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 522 and 556
Animal Drugs, Feeds, and Related Products; Florfenicol Solution
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 Schering-Plough Animal Health. The NADA provides for
use of florfenicol injectable solution for cattle for the treatment of
bovine respiratory disease.
EFFECTIVE DATE: August 15, 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: Schering-Plough Animal Health, Schering-
Plough Corp., P.O. Box 529, Kenilworth, NJ 07033, has filed NADA 141-
063 Nuflor Injectable Solution (300 milligrams florfenicol
per milliliter) for intramuscular treatment of cattle for bovine
respiratory disease (BRD) associated with Pasteurella haemolytica, P.
multocida, and Haemophilus somnus. The NADA is approved as of May 31,
1996, and the regulations are amended by adding new Sec. 522.955 to
reflect the approval. The regulations are also amended to provide for a
tolerance for florfenicol residues in cattle in new Sec. 556.283. The
basis of 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)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval for use in
food-producing animals qualifies for 5 years of marketing exclusivity
beginning May 31, 1996, because the application is for a new animal
drug, no active ingredient of which has been approved in any other
application.
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, Foods.
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. New Sec. 522.955 is added to read as follows:
Sec. 522.955 Florfenicol solution.
(a) Specifications. Each milliliter of sterile solution contains
300 milligrams of florfenicol.
(b) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
(c) Related tolerance. See Sec. 556.283 of this chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. 20 milligrams per
kilogram body weight (3 milliliters per 100 pounds). A second dose
should be given 48 hours later.
(ii) Indications for use. For treatment of bovine respiratory
disease (BRD) associated with Pasteurella haemolytica, P. multocida,
and Haemophilus somnus.
(iii) Limitations. For intramuscular use only. Do not inject more
than 10 milliliters at each site. Injection should be given only in the
neck musculature. Do not slaughter within 28 days of last treatment. Do
not use in female dairy cattle 20 months of age or older. Use may cause
milk residues. Not for use in veal calves, calves under 1 month of age,
or calves being fed an all milk diet. Use may cause violative tissue
residues to remain beyond the withdrawal time. Not for use in cattle of
breeding age. The effect of florfenicol on bovine reproductive
performance, pregnancy, and lactation have not been determined. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) [Reserved]
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).
4. New Sec. 556.283 is added to read as follows:
Sec. 556.283 Florfenicol.
The safe concentrations for total florfenicol-related residues in
cattle are 2.0 parts per million (ppm) in muscle, 6.0 ppm in liver, and
12.0 ppm in kidney and fat. A tolerance of 3.7 ppm for the marker
residue, florfenicol amine, has been established in cattle liver.
Dated: July 25, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-20854 Filed 8-14-96; 8:45 am]
BILLING CODE 4160-01-F
