[Federal Register Volume 69, Number 109 (Monday, June 7, 2004)]
[Rules and Regulations]
[Pages 31733-31734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12718]


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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 Liquid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 31734]]

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 an expanded dose range and revised 
indications for the use of clindamycin hydrochloride oral liquid in 
both dogs and cats for the treatment of certain bacterial diseases.

DATES: This rule is effective June 7, 2004.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed a supplement to ANADA 200-193 
for Clindamycin Hydrochloride Oral Liquid. The supplemental ANADA 
provides for an expanded dose range and revised indications for the use 
of clindamycin hydrochloride oral liquid in both dogs and cats for the 
treatment of certain bacterial diseases. The supplemental application 
is approved as of April 21, 2004, 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 21 CFR 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 Division of Dockets Management 
(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.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Section 520.447 is amended by revising paragraphs (b)(1) and (b)(2) 
to read as follows:


Sec.  520.447  Clindamycin liquid.

* * * * *
    (b) * * *
    (1) Nos. 000009 and 059130 for use as in paragraphs (d)(1)(i)(A), 
(d)(1)(ii)(A), (d)(2)(i)(A), and (d)(2)(ii)(A) of this section.
    (2) No. 059079 for use as in paragraphs (d)(1)(i)(B), 
(d)(1)(ii)(B), (d)(2)(i)(B), and (d)(2)(ii)(B) of this section.
* * * * *

    Dated: May 19, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-12718 Filed 6-4-04; 8:45 am]
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