[Federal Register Volume 66, Number 234 (Wednesday, December 5, 2001)]
[Rules and Regulations]
[Pages 63165-63166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30039]


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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 new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides 
for a once daily, 2-milligram per pound (mg/lb) dosage of carprofen, by 
oral caplet, for the relief of pain and inflammation associated with 
osteoarthritis in dogs.

DATES: This rule is effective December 5, 2001.

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.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed a supplement to approved NADA 141-053 that provides 
for veterinary prescription use of RIMADYL (carprofen) Caplets for the 
relief of pain and inflammation associated with osteoarthritis in dogs. 
The supplemental NADA provides for a once daily, 2-mg/lb dosage for the 
oral caplet dosage form. The supplemental application is approved as of 
September 27, 2001, and the regulations are amended in 21 CFR 520.309 
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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for non-
food-producing animals qualifies for 3 years of marketing exclusivity 
beginning September 27, 2001, because the application contains 
substantial evidence of effectiveness of the drug involved or any 
studies of animal safety required for approval of the application and 
conducted or sponsored by the applicant.
    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.
    2. Section 520.309 is amended in paragraph (a) by adding ``(mg)'' 
after ``milligrams''; and by revising paragraph (d) to read as follows:


Sec. 520.309  Carprofen.

* * * * *
    (d) Conditions of use in dogs--(1) Amount--(i) Caplet. 2 mg per 
pound (/lb) of body weight once daily or 1 mg/lb twice daily.
    (ii) Chewable tablet. 1 mg/lb twice daily.
    (2) Indications for use. For the relief of pain and inflammation 
associated with osteoarthritis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


[[Page 63166]]


    Dated: November 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-30039 Filed 12-4-01; 8:45 am]
BILLING CODE 4160-01-S