[Federal Register Volume 65, Number 40 (Tuesday, February 29, 2000)]
[Rules and Regulations]
[Pages 10706-10707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4667]


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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.

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 Hoechst Roussel Vet. The supplemental NADA 
provides for use of a higher dose ear implant containing trenbolone 
acetate and estradiol for steers fed in confinement for slaughter for 
increased rate of weight gain and improved feed efficiency.

EFFECTIVE DATE: February 29, 2000.

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: Hoechst Roussel Vet, 30 Independence Blvd., 
P.O. Box 4915, Warren, NJ 07059, filed supplemental NADA 140-992 that 
provides for use of Revalor-200, an ear implant containing 
200 milligrams (mg) of trenbolone acetate and 20 mg of estradiol in 10 
pellets. The implant is used for steers fed in confinement for 
slaughter for increased rate of weight gain and improved feed 
efficiency. The supplemental NADA is approved as of November 29, 1999, 
and the regulations are amended in 21 CFR 522.2477 by revising 
paragraph (b), the heading in paragraph (d)(1), and by adding paragraph 
(d)(1)(i)(C) 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 on November 29, 1999, 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 and conducted or 
sponsored by the applicant. The 3 years of marketing exclusivity 
applies only to use of the ear implant containing 200 mg trenbolone 
acetate and 20 mg estradiol for increased rate of weight gain and 
improved feed efficiency in steers fed in confinement for slaughter.
    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 
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 revising paragraph (b), by 
removing in paragraph (d)(1) the heading ``Feedlot steers'' and by 
adding in its place ``Steers fed in confinement for slaughter'', and by 
adding paragraph (d)(1)(i)(C) to read as follows:


Sec. 522.2477  Trenbolone acetate and estradiol.

* * * * *
    (b) Sponsors. See 012799 in Sec. 510.600(c) of this chapter for use 
as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(ii), (d)(1)(iii), 
(d)(2), and (d)(3) of this section. See 021641 in Sec. 510.600(c) of 
this chapter for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B), 
(d)(1)(ii), and (d)(1)(iii) of this section.
* * * * *

[[Page 10707]]

    (d) * * *
    (1) * * *
    (i) * * *
    (C) 200 milligrams of trenbolone acetate and 20 milligrams of 
estradiol (one implant consisting of 10 pellets, each pellet containing 
20 milligrams of trenbolone acetate and 2 milligrams of estradiol) per 
implant dose.
* * * * *

    Dated: January 28, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-4667 Filed 2-28-00; 8:45 am]
BILLING CODE 4160-01-F