Federal Register, Volume 61 Issue 159 (Thursday, August 15, 1996)

[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