[Federal Register Volume 62, Number 139 (Monday, July 21, 1997)]
[Rules and Regulations]
[Page 38907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19126]


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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; 
Enrofloxacin 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 Bayer Corp., Agriculture Div., Animal 
Health. The supplemental NADA provides for revised indications for use 
of enrofloxacin injectable solution in dogs for the management of 
diseases associated with bacteria susceptible to enrofloxacin.

EFFECTIVE DATE: July 21, 1997.

FOR FURTHER INFORMATION CONTACT:  Linda M. Wilmot, Center for 
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Div., Animal 
Health, P.O. Box 390, Shawnee Mission, KS 66201, filed supplemental 
NADA 140-913 Baytril Injectable Solution (22.7 milligrams enrofloxacin 
per milliliter) to provide for revised indications for use of 
enrofloxacin for dogs for management of diseases associated with 
bacteria susceptible to enrofloxacin. The supplemental NADA is approved 
as of June 19, 1997. The basis of approval is discussed in the freedom 
of information summary.
    The regulations are amended in Sec. 522.812 (21 CFR 522.812) by 
redesignating paragraph (c) as paragraph (d) and by reserving paragraph 
(c) to provide for more uniform regulations and future expansion. Newly 
redesignated Sec. 522.812(d)(2) is revised to reflect the approval.
    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 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 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 522.812 is amended by redesignating existing paragraph 
(c) as paragraph (d), by reserving paragraph (c), and by revising newly 
redesignated paragraph (d)(2) to read as follows:


Sec. 522.812  Enrofloxacin solution.

 * * * * *
    (c) [Reserved]
    (d) * * *
    (2) Indications for use. Dogs for management of diseases associated 
with bacteria susceptible to enrofloxacin.
 * * * * *

    Dated: July 9, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-19126 Filed 7-18-97; 8:45 am]
BILLING CODE 4160-01-F