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Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol Benzoate

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: December 27, 2002 (Volume 67, Number 249)]
[Rules and Regulations]
[Page 78971-78972]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de02-11]

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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; 
Trenbolone Acetate and Estradiol Benzoate

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 use of an implant containing 100 milligrams (mg) 
trenbolone acetate and 14 mg estradiol benzoate for increased rate of 
weight gain in steers fed in confinement for slaughter.

DATES: This rule is effective December 27, 2002.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: dbenz@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
141-043 for SYNOVEX (trenbolone acetate and estradiol benzoate) 
implants. The supplemental NADA provides for use of SYNOVEX Choice, an 
implant containing 100 mg trenbolone acetate and 14 mg estradiol 
benzoate, for increased rate of weight gain in steers fed in 
confinement for slaughter. The supplemental NADA is approved as of 
October 3, 2002, and the regulations are amended in 21 CFR 522.2478 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 Sec.  514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this supplemental 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning October 3, 
2002.
    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. 801-808.

[[Page 78972]]

List of Subjects in 21 CFR Part 522

    Animal drugs.

    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 part 522 is 
amended as follows:

PART 522--IMPLANTATION 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 522.2478 is revised to read as follows:

Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

    (a) Specifications. Each implant dose consists of:
    (1) 8 pellets, each pellet containing 25 milligrams (mg) trenbolone 
acetate and 3.5 mg estradiol benzoate.
    (2) 4 pellets, each pellet containing 25 mg trenbolone acetate and 
3.5 mg estradiol benzoate.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.240 and 556.739 of this 
chapter.
    (d) Conditions of use--(1) Steers fed in confinement for slaughter. 
(i) For an implant as described in paragraph (a)(1) of this section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (C) Limitations. Implant subcutaneously in ear only.
    (ii) For an implant as described in paragraph (a)(2) of this 
section:
    (A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain.
    (C) Limitations. Implant subcutaneously in ear only.
    (2) Heifers fed in confinement for slaughter--(i) Amount. 200 mg 
trenbolone acetate and 28 mg estradiol benzoate (as described in 
paragraph (a)(1) of this section).
    (ii) Indications for use. For increased rate of weight gain.
    (iii) Limitations. Implant subcutaneously in ear only. Not for 
dairy or beef replacement heifers.

    Dated: December 17, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-32750 Filed 12-26-02; 8:45 am]
BILLING CODE 4160-01-S

 
 

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