[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Rules and Regulations]
[Page 21768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

[Docket No. FDA-2009-N-0665]


New Animal Drugs; Carprofen

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; technical amendment.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the original approval of an abbreviated new 
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. 
The ANADA provides for the veterinary prescription use of carprofen 
caplets in dogs.

DATES:  This rule is effective May 11, 2009.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed ANADA 200-498 that provides for 
veterinary prescription use of NOROCARP (carprofen) Caplets in dogs for 
the relief of pain and inflammation associated with osteoarthritis and 
for the control of postoperative pain associated with soft tissue and 
orthopedic surgeries. The ANADA is approved as of November 25, 2008, 
and the regulations are amended in 21 CFR 520.309 to reflect the 
approval.
    In addition, FDA has found that a sponsor of another generic 
carprofen caplet product is not currently listed in the animal drug 
regulations as a sponsor of an approved application. Accordingly, 21 
CFR 510.600(c) is being amended to add entries for IMPAX Laboratories, 
Inc.
    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 Division of Dockets Management 
(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.
    FDA has determined under 21 CFR 25.33 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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1) alphabetically 
add a new entry for ``IMPAX Laboratories, Inc.''; and in the table in 
paragraph (c)(2) numerically add a new entry for ``000115'' to read as 
follows:


Sec.  510.600   Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
IMPAX Laboratories, Inc., 30831 Huntwood      000115
 Ave., Hayward, CA 94544
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
000115                       IMPAX Laboratories, Inc., 30831 Huntwood
                              Ave., Hayward, CA 94544
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.


Sec.  520.309   [Amended]

0
4. In paragraph (b)(2) of Sec.  520.309, remove ``000115 and 062250'' 
and add in its place ``000115, 055529, and 062250''.

    Dated: May 6, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-10925 Filed 5-8-09; 8:45 am]
BILLING CODE 4160-01-S