[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Rules and Regulations]
[Page 48295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Enrofloxacin Tablets

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 Division, Animal 
Health. The supplemental NADA provides for an additional tablet size 
for enrofloxacin tablets used in dogs and cats for the management of 
diseases associated with bacteria susceptible to enrofloxacin and for 
the removal of a tablet size no longer marketed.

EFFECTIVE DATE: September 3, 1999.

FOR FURTHER INFORMATION CONTACT: Dennis M. Bensley, Center for 
Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1705.

SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Division, Animal 
Health, P.O. Box 390, Shawnee Mission, KS 66201, filed supplemental 
NADA 140-441 Baytril tablets (enrofloxacin) that provides for 
136-milligram (mg) tablet size in addition to 22.7- and 68.0-mg 
tablets. Furthermore, the sponsor stated that the 5.7-mg tablets are no 
longer marketed and has requested the size be deleted. The supplemental 
NADA is approved as of August 3, 1999, and the regulations are amended 
in 21 CFR 520.812(a) 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
     The agency has determined under 21 CFR 25.33(d)(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.
     This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

 List of Subjects in 21 CFR Part 520

     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 520 is 
amended as follows:

 PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 520 continues to read as 
follows:

     Authority: 21 U.S.C. 360b.


Sec. 520.812   [Amended]

     2. Section 520.812 Enrofloxacin tablets is amended in paragraph 
(a) by removing ``5.7, 22.7, or 68.0'' and adding in its place ``22.7, 
68.0, or 136.0'' .

    Dated: August 24, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 99-22998 Filed 9-3-99; 8:45 am]
BILLING CODE 4160-01-F