[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Pages 45878-45879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18822]


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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 two supplemental new animal 
drug applications (NADA's) filed by Hoechst Roussel Vet. The 
supplemental NADA's provide for use of two additional trenbolone 
acetate and estradiol ear implants, one for heifers fed in confinement 
for slaughter for increased rate of weight gain, and the other for 
steers fed in confinement for slaughter for increased rate of weight 
gain and improved feed efficiency.

DATES:  This rule is effective July 26, 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.

[[Page 45879]]


SUPPLEMENTARY INFORMATION:  Hoechst Roussel Vet, Perryville Corporate 
Park III, PO Box 4010, Clinton, NJ 08809-4010, filed supplemental NADA 
140-897 that provides for Revalor-IS ear implants containing 
80 milligrams (mg) trenbolone acetate (TBA) and 16 mg estradiol for 
steers fed in confinement for slaughter for increased rate of weight 
gain and improved feed efficiency. Hoechst Roussel Vet also filed 
supplemental NADA 140-992 that provides for Revalor-IH ear 
implants containing 80 mg TBA and 8 mg estradiol for heifers fed in 
confinement for slaughter for increased rate of weight gain.
    The supplemental NADA's are approved as of June 19, 2000, and the 
regulations are amended in 21 CFR 522.2477 to reflect the approvals. 
The basis of approval is discussed in the freedom of information 
summaries.
    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 these 
applications 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)), these approvals for food-
producing animals qualify for 3 years of marketing exclusivity 
beginning June 19, 2000, because the applications contain 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 applications and conducted or sponsored by the 
applicant. The 3 years of marketing exclusivity applies only to the 
implants approved in these supplemental NADA's.
    The agency has determined under 21 CFR 25.33(a)(2) 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 the first sentence in 
paragraph (b), by adding paragraph (d)(1)(i)(D), and by revising 
paragraphs (d)(2)(i) and (d)(2)(ii) to read as follows:


Sec. 522.2477  Trenbolone acetate and estradiol.

* * * * *
    (b) 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)(i)(D), (d)(1)(ii), 
(d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(B), (d)(2)(ii), (d)(2)(iii), and 
(d)(3) of this section. * * *
* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (D) 80 mg trenbolone acetate and 16 mg estradiol (one implant 
consisting of 4 pellets), or 120 mg trenbolone acetate and 24 mg 
estradiol (one implant consisting of 6 pellets, each pellet containing 
20 mg trenbolone acetate and 4 mg estradiol) per implant dose.
    (2) * * *
    (i) Amount. (A) 140 mg trenbolone acetate and 14 mg estradiol (one 
implant consisting of 7 pellets, each pellet containing 20 mg 
trenbolone acetate and 2 mg estradiol) per implant dose for use as in 
paragraphs (d)(2)(ii)(A) and (d)(2)(ii)(B) of this section.
    (B) 80 mg trenbolone acetate and 8 mg estradiol (one implant 
consisting of 4 pellets, each pellet containing 20 mg trenbolone 
acetate and 2 mg estradiol) per implant dose for use as in paragraph 
(d)(2)(ii)(B) of this section.
    (ii) Indications for use. (A) For increased rate of weight gain and 
improved feed efficiency.
    (B) For increased rate of weight gain.
* * * * *

    Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-18822 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F