[Federal Register Volume 68, Number 112 (Wednesday, June 11, 2003)]
[Rules and Regulations]
[Page 34796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Injectable or Implantable Dosage Form New Animal Drugs; Carprofen

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 dosage of carprofen solution, 
by subcutaneous injection, for the relief of pain and inflammation 
associated with osteoarthritis in dogs.

DATES: This rule is effective June 11, 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 a supplement to NADA 141-199 for RIMADYL (carprofen) 
Injectable used for the relief of pain and inflammation associated with 
osteoarthritis in dogs. The supplemental NADA provides for veterinary 
prescription use of a once daily, 2-milligram-per-pound dosage of 
carprofen solution by subcutaneous injection. The supplemental 
application is approved as of March 25, 2003, and the regulations are 
amended in 21 CFR 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 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 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 March 25, 2003.
    The agency has determined under Sec.  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.

0
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 amended by revising (d)(1) to read as follows:


Sec.  522.312  Carprofen.

* * * * *
    (d) * * *
    (1) Amount. 2 mg/lb (4.4 mg/kg) body weight once daily or 1 mg/lb 
(2.2 mg/kg) twice daily, by subcutaneous injection.
* * * * *

    Dated: May 29, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-14544 Filed 6-10-03; 8:45 am]
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