[Federal Register Volume 61, Number 155 (Friday, August 9, 1996)]
[Rules and Regulations]
[Pages 41498-41499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20344]


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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

AGENCY: Food and Drug Administration, HHS.


[[Page 41499]]


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 Roussel-UCLAF, Division Agro-Veterinaire. 
The supplemental NADA provides for use of an ear implant containing 
trenbolone acetate and estradiol in pasture heifers (in addition to a 
previously approved use in pasture steers) for increased rate of weight 
gain.

EFFECTIVE DATE: August 9, 1996.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0217.

SUPPLEMENTARY INFORMATION: Roussel-UCLAF, Division Agro-Veterinaire, 
163 Avenue Gambetta, 75020 Paris, France, filed supplemental NADA 140-
897, which provides for use of Revalor-G, an ear implant, 
each dose containing 2 pellets, each pellet containing 20 milligrams 
(mg) of trenbolone acetate and 4 mg of estradiol. The implant is used 
in pasture heifers (slaughter, stocker, and feeder) (pasture steers 
being already approved) for increased rate of weight gain. The 
supplemental NADA is approved as of July 2, 1996, and the regulations 
are amended in 21 CFR 522.2477(c)(3) to reflect the approval. The basis 
for approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, 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 approval qualifies 
for a 3-year period of marketing exclusivity beginning on July 2, 1996, 
because new clinical or field investigations (other than bioequivalence 
or residue studies) essential to the approval were conducted or 
sponsored by the applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    -2. Section 522.2477 is amended by revising the heading of 
paragraph (c)(3) and paragraph (c)(3)(iii) to read as follows:

Sec. 522.2477   Trenbolone acetate and estradiol.

-*  -*  -*  -*  -*
    -(c) *   *   *
    -(3) Pasture cattle (slaughter, stocker, feeder steers, and 
heifers).
-*  -*  -*  -*  -*
    -(iii) Limitations. Implant subcutaneously in ear only. Not for use 
in animals intended for subsequent breeding or in dairy animals.

    Dated: July 19, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-20344 Filed 8-8-96; 8:45 am]
BILLING CODE 4160-01-F