[Federal Register Volume 64, Number 38 (Friday, February 26, 1999)]
[Rules and Regulations]
[Page 9435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4762]



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  Federal Register / Vol. 64, No. 38 / Friday, February 26, 1999 / 
Rules and Regulations  

[[Page 9435]]


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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 use of florfenicol injectable solution 
in cattle for treatment of foot rot (bovine interdigital phlegmon).

EFFECTIVE DATE: February 26, 1999.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7570.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., P.O. Box 1982, Union, NJ 07083-1982, filed supplemental 
NADA 141-063 that provides for veterinary prescription use of 
Nuflor Injectable Solution (florfenicol) for treatment of 
cattle for bovine interdigital phlegmon (foot rot, acute interdigital 
necrobacillosis, infectious pododermatitis) associated with 
Fusobacterium necrophorum and Bacteroides melaninogenicus. The 
supplemental NADA is approved as of January 14, 1999, and the 
regulations are amended by revising 21 CFR 522.955(d)(1) 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 supplement 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under 21 U.S.C. 360b(c)(2)(F)(iii), this supplemental approval for 
food-producing animals qualifies for 3 years of marketing exclusivity 
beginning January 14, 1999, because the supplemental application 
contains substantial evidence of the effectiveness of the drug 
involved, any studies of animal safety or, in the case of food-
producing animals, human food safety studies (other than bioequivalence 
or residue studies) required for approval and conducted or sponsored by 
the applicant. Three years marketing exclusivity is limited to use of 
the drug for treatment of bovine interdigital phlegmon associated with 
F. necrophorum and B. melaninogenicus.
    The agency has determined under 21 CFR 25.33(d)(5) 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.

    2. Section 522.955 is amended by revising paragraph (d)(1)(i)(B) to 
read as follows:


Sec. 522.955  Florfenicol solution.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (B) Indications for use. For treatment of bovine respiratory 
disease (BRD) associated with Pasteurella haemolytica, P. multocida, 
and Haemophilus somnus. For treatment of bovine interdigital phlegmon 
(foot rot, acute interdigital necrobacillosis, infectious 
pododermatitis) associated with Fusobacterium necrophorum and 
Bacteroides melaninogenicus.
* * * * *

    Dated: February 1, 1999.
 Andrew J. Beaulieu,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-4762 Filed 2-25-99; 8:45 am]
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