Browse: Departments   Dates   Agencies  

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 522

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol

DATES: This rule is effective February 18, 2005.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an additional dose of trenbolone acetate and estradiol implant for use in feedlot heifers for increased rate of weight gain and improved feed efficiency.

SUMMARY: Trenbolone acetate and estradiol implant,

SUPPLEMENTAL INFORMATION

Ivy Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond Street, Overland Park, KS 66214, filed a supplement to ANADA 200346. The supplemental ANADA provides for the use of COMPONENT TE200 (trenbolone acetate and estradiol), a subcutaneous implant containing 200 milligrams (mg) trenbolone acetate and 20 mg estradiol in heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency. Ivy Laboratories' COMPONENT TE200 is approved as a generic copy of Intervet, Inc.'s REVALOR200, approved under NADA 140992. The application is approved as of January 14, 2005, and the regulations are amended in 21 CFR 522.2477 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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 (HFA305), 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. 801808.
List of Subjects in 21 CFR Part 522

Animal drugs.
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 522IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.
2. Section 522.2477 is amended by revising paragraph (b)(1) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(b) * * *
(1) No. 021641 for products and uses described in paragraph (d) of this section.
* * * * *

Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 053107 Filed 21705; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Lonnie W. Luther, Center for Veterinary Medicine (HFV104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 3018278549, email:
lonnie.luther@fda.gov.