[Federal Register: November 25, 2005 (Volume 70, Number 226)]
[Rules and Regulations]
[Page 70997-70998]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25no05-5]
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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:
melanie.berson@fda.gov.
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
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1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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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