[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Rules and Regulations]
[Page 5724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2949]


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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 and Estradiol

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 Intervet, Inc. The supplemental NADA 
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.

DATES: This rule is effective February 7, 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: [email protected].

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 405 State St., 
Millsboro, DE 19966, filed supplemental NADA 140-992 that provides for 
REVALOR-200 ear implants containing 200 milligrams (mg) trenbolone 
acetate and 20 mg estradiol for heifers fed in confinement for 
slaughter for increased rate of weight gain and improved feed 
efficiency. The supplemental NADA is approved as of December 6, 2001, 
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 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 (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval 
for food-producing animals qualifies for 3 years of marketing 
exclusivity beginning December 6, 2001, because the application 
contains substantial evidence of the effectiveness of the drugs 
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 approval of the application and 
conducted or sponsored by the applicant.
    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.

    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

    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 adding paragraph (d)(2)(i)(C) to 
read as follows:


Sec. 522.2477  Trenbolone acetate and estradiol.

* * * * *
    (d) * * * 
    (2) * * * 
    (i) * * * 
    (C) 200 mg trenbolone acetate and 20 mg estradiol (one implant 
consisting of 10 pellets, each pellet containing 20 mg trenbolone 
acetate and 2 mg estradiol) per implant dose for use as in paragraph 
(d)(2)(ii)(A) of this section.
* * * * *

    Dated: January 11, 2002.
Claire M. Lathers,
Director, Office of New Animal Drug Evualtion, Center for Veterinary 
Medicine.
[FR Doc. 02-2949 Filed 2-6-01; 8:45 am]
BILLING CODE 4160-01-S