[Federal Register Volume 67, Number 208 (Monday, October 28, 2002)]
[Rules and Regulations]
[Page 65697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27266]


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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 the veterinary prescription use of carprofen in dogs, by oral 
chewable tablet, for the control of postoperative pain associated with 
soft tissue and orthopedic surgery.

DATES: This rule is effective October 28, 2002.

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 a supplement to NADA 141-111 for veterinary 
prescription use of RIMADYL (carprofen) Chewable Tablets for the 
control of postoperative pain associated with soft tissue and 
orthopedic surgery in dogs. The supplemental NADA provides for use of 
carprofen chewable tablets in dogs for the control of postoperative 
pain associated with soft tissue and orthopedic surgery. The 
supplemental application is approved as of August 21, 2002, 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 Sec.  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(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 by revising paragraphs (b), (d)(1), 
and (d)(2) to read as follows:


Sec.  520.309  Carprofen.

* * * * *
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) * * * (1) Amount. 2 mg per pound (/lb) of body weight once 
daily or 1 mg/lb twice daily. For the control of postoperative pain, 
administer approximately 2 hours before the procedure.
    (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 surgery.
* * * * *

    Dated: September 30, 2002.
Stephen F. Sundlof,
Center for Veterinary Medicine.
[FR Doc. 02-27266 Filed 10-25-02; 8:45 am]
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