[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Rules and Regulations]
[Pages 70997-70998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Boldenone

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 a supplemental new animal drug 
application (NADA) filed by Fort Dodge Animal Health. The supplemental 
NADA provides for

[[Page 70998]]

revised labeling for the veterinary prescription use of injectable 
boldenone solution in horses.

DATES: This rule is effective November 25, 2005.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
<a href="/cdn-cgi/l/email-protection#365b535a57585f53185453444559587650525718515940"><span class="__cf_email__" data-cfemail="04696168656a6d612a666176776b6a446260652a636b72">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, A Division of 
Wyeth Holdings Corp., P.O. Box 1339, Fort Dodge, IA 50501, filed a 
supplement to NADA 34-705 that provides for veterinary prescription use 
of EQUIPOISE (boldenone undecylenate) by injection in horses. The 
supplemental NADA provides for a revised indication and food safety 
warning on labeling. The supplemental NADA is approved as of October 7, 
2005, and the regulations are amended in 21 CFR 522.204 to reflect the 
approval and a current format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data. Therefore, a freedom of 
information summary is not required.
    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 in 21 CFR Part 522

    Animal drugs.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Section 522.204 is revised to read as follows:


Sec.  522.204  Boldenone.

    (a) Specifications. Each milliliter of solution contains 25 or 50 
milligrams (mg) boldenone undecylenate.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.5 mg per pound body 
weight by intramuscular injection. Treatment may be repeated at 3-week 
intervals.
    (2) Indications for use. As an aid for treating debilitated horses 
when an improvement in weight, hair coat, or general physical condition 
is desired.
    (3) Limitations. Do not administer to horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-23295 Filed 11-23-05; 8:45 am]
BILLING CODE 4160-01-S


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