[Federal Register Volume 68, Number 94 (Thursday, May 15, 2003)]
[Rules and Regulations]
[Page 26205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12041]


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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; 
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 new animal drug application 
(NADA) filed by Pfizer, Inc. The NADA provides for the veterinary 
prescription use of carprofen solution in dogs, by subcutaneous 
injection, for the relief of pain and inflammation associated with 
osteoarthritis.

DATES: This rule is effective May 15, 2003.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed NADA 141-199 for RIMADYL (carprofen) Injection. The 
NADA provides for the veterinary prescription use of carprofen solution 
in dogs, by subcutaneous injection, for the relief of pain and 
inflammation associated with osteoarthritis. The application is 
approved as of March 3, 2003, and the regulations in part 522 (21 CFR 
part 522) are amended by adding new Sec.  522.312 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning March 3, 2003.
    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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
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2. Section 522.312 is added to read as follows:


Sec.  522.312  Carprofen.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) carprofen.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. 1 mg per pound (2.2 mg 
per kilogram) body weight twice daily, by subcutaneous injection.
    (2) Indications for use. For the relief of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: May 6, 2003.
Steven F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-12041 Filed 5-14-03; 8:45 am]
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