[Federal Register Volume 63, Number 221 (Tuesday, November 17, 1998)]
[Rules and Regulations]
[Pages 63788-63789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30611]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, Division of 
American Home Products Corp. The supplemental NADA provides for the use 
of a trenbolone acetate and estradiol benzoate ear implant in heifers 
fed in confinement for slaughter for increased rate of weight gain.

EFFECTIVE DATE: November 17, 1998.

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: Fort Dodge Animal Health, Division of 
American Home Products Corp., 800 Fifth St. NW., Ft. Dodge, IA 50501, 
filed supplemental NADA 141-043 that provides for use of an 
implantation containing 200 milligrams (mg) trenbolone acetate and 28 
mg estradiol benzoate (Synovex Plus) in heifers fed in 
confinement for slaughter for increased rate of weight gain. The 
supplemental NADA is approved as of September 30, 1998, and the 
regulations are amended in 21 CFR 522.2478 by adding paragraph (c)(2) 
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 21 CFR 
part 20 and 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, 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 approval for food 
producing animals qualifies for 3 years of marketing exclusivity 
beginning September 30, 1998, because the supplemental application 
contains substantial evidence of the effectiveness of the drug 
involved, any studies of animal safety, or, in the case of food 
producing animals, human food safety studies (other than bioequivalence 
or residue studies) required for the approval of the supplement and 
conducted or sponsored by the applicant. The 3 years of marketing 
exclusivity applies only to use in confined heifers for increased rate 
of weight gain for which the supplemental application is approved.
    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.

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

[[Page 63789]]

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 amended by adding paragraph (c)(2) to read 
as follows:


Sec. 522.2478   Trenbolone acetate and estradiol benzoate.

* * * * *
    (c) * * *
    (2) Heifers--(i) Amount. 200 milligrams of trenbolone acetate and 
28 milligrams of estradiol benzoate (one implant consisting of 8 
pellets, each pellet containing 25 milligrams of trenbolone acetate and 
3.5 milligrams of estradiol benzoate) per animal.
    (ii) Indications for use. For increased rate of weight gain in 
heifers fed in confinement for slaughter.
    (iii) Limitations. Implant subcutaneously in ear only. Not for 
dairy or beef replacement heifers.

    Dated: November 3, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-30611 Filed 11-16-98; 8:45 am]
BILLING CODE 4160-01-F