[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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Rules and Regulations
Federal Register
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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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