[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
