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[Federal Register: October 23, 2002 (Volume 67, Number 205)]
[Rules and Regulations]               
[Page 65038]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc02-9]                         

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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 oral caplets in dogs 
for the control of postoperative pain associated with soft tissue and 
orthopedic surgery.

DATES: This rule is effective October 23, 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: 
<A HREF="mailto:mberson@cvm.fda.gov">mberson@cvm.fda.gov</A>.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d Street, New York, 
NY 10017-5755, filed a supplement to NADA 141-053 for RIMADYL 
(carprofen) Caplets for Dogs. The supplemental NADA provides for the 
veterinary prescription use of carprofen oral caplets in dogs for the 
control of postoperative pain associated with soft tissue and 
orthopedic surgery. The supplemental application is approved as of July 
8, 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 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 
Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies 
for 3 years of marketing exclusivity beginning July 8, 2002.
    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 (a), (b), and 
(d) to read as follows:


Sec.  520.309  Carprofen.

    (a) Specifications. (1) Each caplet contains 25, 75, or 100 
milligrams (mg) carprofen.
    (2) Each chewable tablet contains 25, 75, or 100 mg carprofen.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter for 
use of caplets described in paragraph (a)(1) of this section as in 
paragraphs (d)(1)(i), (d)(2), and (d)(3) of this section and chewable 
tablets described in paragraph (a)(2) of this section as in paragraphs 
(d)(1)(ii), (d)(2)(ii), and (d)(3) of this section.
* * * * *
    (d) Conditions of use in dogs--(1) Amount--(i) 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.
    (ii) 2 mg/lb of body weight once daily or 1 mg/lb twice daily.
    (2) Indications for use. (i) For the control of postoperative pain 
associated with soft tissue and orthopedic surgery.
    (ii) 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: September 30, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-26876 Filed 10-22-02; 8:45 am]
BILLING CODE 4160-01-S

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