[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Rules and Regulations]
[Page 51995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14508]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Carprofen

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 IMPAX Laboratories, Inc. The 
supplemental ANADA provides for veterinary prescription use of 
carprofen caplets in dogs for the control of postoperative pain 
associated with soft tissue and orthopedic surgeries.

DATES: This rule is effective September 1, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: IMPAX Laboratories, Inc., 30831 Huntwood 
Ave., Hayward, CA 94544, filed a supplement to ANADA 200-366 for NOVOX 
(carprofen) caplets which are approved for veterinary prescription use 
in dogs for the relief of pain and inflammation associated with 
osteoarthritis (70 FR 30625, May 27, 2005). The supplement provides for 
use of NOVOX caplets for the control of postoperative pain associated 
with soft tissue and orthopedic surgeries. The supplemental ANADA is 
approved as of July 27, 2006, and 21 CFR 520.309 is amended to reflect 
the approval.
    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.

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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

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

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

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2. In Sec.  520.309, remove paragraphs (d)(2)(i) and (d)(2)(ii), and 
revise paragraphs (b)(2) and (d)(2) to read as follows:


Sec.  520.309  Carprofen.

* * * * *
    (b) * * *
    (2) No. 000115 for use of product described in paragraph (a)(1) as 
in paragraph (d) of this section.
* * * * *
    (d) * * *
    (2) Indications for use. For the relief of pain and inflammation 
associated with osteoarthritis and for the control of postoperative 
pain associated with soft tissue and orthopedic surgeries.
* * * * *

    Dated: August 18, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-14508 Filed 8-31-06; 8:45 am]
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