[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Rules and Regulations]
[Pages 27955-27956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9559]


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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 Powder

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 Superior Equine Pharmaceuticals, Inc. The 
ANADA provides for the veterinary prescription use of phenylbutazone 
powder administered to horses in feed for the relief of inflammatory 
conditions associated with the musculoskeletal system.

DATES: This rule is effective May 18, 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: Superior Equine Pharmaceuticals, Inc., 
Pleasant Grove, UT 84062, filed ANADA 200-333 that provides for the 
veterinary prescription use of SUPERIORBUTE (phenylbutazone) Powder 
administered to horses in feed for the relief of inflammatory 
conditions associated with the musculoskeletal system. Superior Equine 
Pharmaceuticals, Inc.'s SUPERIORBUTE Powder is approved as a generic 
copy of IVX Animal Health, Inc.'s Phenylbutazone Tablets, USP, approved 
under NADA 91-818. The ANADA is approved as of April 20, 2007, and the 
regulations are amended in 21 CFR 520.1720e to reflect the approval. 
The basis of approval is discussed in the freedom of information 
summary.
    In addition, Superior Equine 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.

[[Page 27956]]

    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 in 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 ``Superior Equine 
Pharmaceuticals, Inc.'' and in the table in paragraph (c)(2) by 
numerically adding a new entry for ``027053'' to read as follows:


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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
                                * * * * *
Superior Equine Pharmaceuticals, Inc., Pleasant Grove,            027053
 UT 84062
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
027053                        Superior Equine Pharmaceuticals, Inc.,
                               Pleasant Grove, UT 84062.
                                * * * * *
------------------------------------------------------------------------

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. Revise Sec.  520.1720e, to read as follows:


Sec.  520.1720e  Phenylbutazone powder.

    (a) Specifications--(1) Each 1.15 grams (g) of powder contains 1 g 
phenylbutazone.
    (2) Each 10 g of powder contains 1 g phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 027053 for use of product described in paragraph (a)(1) of 
this section.
    (2) No. 057699 for use of product described in paragraph (a)(2) of 
this section.
    (c) Conditions of use in horses--(1) Amount. Administer 1 to 2 g (1 
to 2 level scoops, using the scoop provided) per 500 pounds of body 
weight on a small amount of palatable feed, not exceed 4 g per animal 
daily.
    (2) Indications for use. For the relief of inflammatory conditions 
associated with the musculosketetal system.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the extralabel use of this product 
in female cattle 20 months of age or older. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

    Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9559 Filed 5-17-07; 8:45 am]
BILLING CODE 4160-01-S