[Federal Register Volume 66, Number 46 (Thursday, March 8, 2001)]
[Rules and Regulations]
[Page 13848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Clindamycin Hydrochloride 
Liquid

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 abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for oral use of clindamycin hydrochloride 
liquid for treatment of soft tissue and dental infections in cats.

DATES: This rule is effective March 8, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed a 
supplement to approved ANADA 200-193 for Clindamycin Hydrochloride Oral 
Liquid. The supplemental ANADA provides for use of clindamycin 
hydrochloride liquid for treatment of soft tissue and dental infections 
in cats caused by or associated with susceptible strains of certain 
bacterial species. The supplemental application is approved as of 
December 27, 2000, and the regulations are amended in 21 CFR 520.447 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 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(a)(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. 520.447  [Amended]

    2. Section 520.447 Clindamycin hydrochloride liquid is amended in 
paragraph (b) in the first sentence by removing ``No. 000009'' and 
adding in its place ``Nos. 000009 and 059130'' and by removing the 
second sentence.

    Dated: January 30, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-5683 Filed 3-7-01; 8:45 am]
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