[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Rules and Regulations]
[Pages 26981-26982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12961]


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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; 
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 supplemental new animal drug 
application (NADA) filed by Schering-Plough Animal Health Corp. The 
supplemental NADA provides for a revised warning against use of 
florfenicol injectable solution in veal calves.

EFFECTIVE DATE: May 15, 1998.

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 Corp., 1095 
Morris Ave., P.O. Box 1982, Union, NJ 07083-1982, is sponsor of NADA 
141-063 Nuflor<SUP></SUP> Injectable Solution (300 milligrams 
florfenicol per milliliter) for veterinary prescription use for 
intramuscular treatment of cattle for bovine respiratory disease. 
Schering-Plough filed a supplemental NADA providing for a revised 
warning against use of the product in veal calves. The supplemental 
NADA is approved as of April 2, 1998, and the regulations are amended 
by revising 21 CFR 522.955(d)(1)(iii) to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    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.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

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: 21 U.S.C. 360b.

Sec. 522.955  [Amended]

    2. Section 522.955 Florfenicol solution is amended in paragraph 
(d)(1)(iii) by removing the sentences

[[Page 26982]]

``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.'' and adding in its place ``A 
withdrawal period has not been established in preruminating calves. Do 
not use in calves to be processed for veal.''

    Dated: May 4, 1998.
 Andrew J. Beaulieu,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-12961 Filed 5-14-98; 8:45 am]
BILLING CODE 4160-01-F