[Federal Register Volume 72, Number 233 (Wednesday, December 5, 2007)]
[Rules and Regulations]
[Pages 68477-68478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 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

[[Page 68478]]

animal drug regulations to reflect approval of an original abbreviated 
new animal drug application (ANADA) filed by Belcher Pharmaceuticals, 
Inc. The ANADA provides for veterinary prescription use of carprofen 
caplets in dogs.

DATES: This rule is effective December 5, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Belcher Pharmaceuticals, Inc., 12393 Belcher 
Rd., Suite 420, Largo, FL 33773, filed ANADA 200-397 for VETPROFEN 
(carprofen) Caplets. The ANADA provides for veterinary prescription use 
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. Belcher Pharmaceuticals, 
Inc.'s VETPROFEN Caplets are approved as a generic copy of RIMADYL 
Caplets, sponsored by Pfizer, Inc., under NADA 141-053. The ANADA is 
approved as of November 7, 2007, and 21 CFR 520.309 is amended to 
reflect the approval.
    In addition, Belcher Pharmaceuticals, Inc., has not been previously 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c) is being amended to add 
entries for the firm.
    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 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.
    The agency has determined under 21 CFR 25.33(a)(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

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. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Belcher Pharmaceuticals, Inc.'' 
and in the table in paragraph (c)(2) by numerically adding a new entry 
for ``062250'' 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
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                                * * * * *
Belcher Pharmaceuticals, Inc., 12393         062250
 Belcher Rd., suite 420, Largo, FL 33773
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
062250                       Belcher Pharmaceuticals, Inc., 12393
                              Belcher Rd., suite 420, Largo, FL 33773
                                * * * * *
------------------------------------------------------------------------

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 ``No. 000115'' and add 
in its place ``Nos. 000115 and 062250''.

    Dated: November 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-23516 Filed 12-4-07; 8:45 am]
BILLING CODE 4160-01-S