[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 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
