[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Rules and Regulations]
[Pages 41065-41066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17439]


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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; Phenylbutazone Tablets and 
Boluses

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 an abbreviated new animal drug 
application (ANADA) filed by West-Ward Pharmaceutical Corp. The ANADA 
provides for oral use of phenylbutazone tablets in horses for relief of 
inflammatory conditions

[[Page 41066]]

associated with the musculoskeletal system.

DATES: This rule is effective July 10, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: West-Ward Pharmaceutical Corp., 465 
Industrial Way West, Eatontown, NJ 07724, filed ANADA 200-323 for the 
oral use of Phenylbutazone Tablets in horses for relief of inflammatory 
conditions associated with the musculoskeletal system. West-Ward 
Pharmaceutical's Phenylbutazone Tablets are approved as a generic copy 
of Boehringer Ingelheim Vetmedica's BIZOLIN (phenylbutazone) Tablets, 
approved under NADA 99-618. The ANADA is approved as of March 28, 2003, 
and the regulations are amended in 21 CFR 520.1720a to reflect the 
approval and current format. The basis of approval is discussed in the 
freedom of information summary.
    In addition, West-Ward Pharmaceutical Corp., 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 21 CFR part 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.
    FDA 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 ``West-Ward Pharmaceutical 
Corp.'' and in the table in paragraph (c)(2) by numerically adding a 
new entry for ``000143'' 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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                                * * * * *
West-Ward Pharmaceutical Corp., 465           000143
 Industrial Way West, Eatontown, NJ 07724.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
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                                * * * * *
000143                       West-Ward Pharmaceutical Corp., 465
                              Industrial Way West, Eatontown, NJ 07724
                                * * * * *
------------------------------------------------------------------------

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.

0
4. Section 520.1720a is amended by adding paragraph (b)(5) to read as 
follows:


Sec.  520.1720a  Phenylbutazone tablets and boluses.

* * * * *
    (b) * * *
    (5) No. 000143 for use of 1-gram tablets in horses.
* * * * *

    Dated: June 26, 2003.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 03-17439 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S