[Federal Register Volume 65, Number 90 (Tuesday, May 9, 2000)]
[Rules and Regulations]
[Pages 26747-26748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11477]


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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 abbreviated new 
animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy 
Animal Health, Inc. The supplemental ANADA provides for subcutaneous 
use of a cattle ear implant containing trenbolone and estradiol for 
pasture cattle for increased rate of weight gain. Technical changes are 
also made.

DATES: This rule is effective May 9, 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: Ivy Laboratories, Div. of Ivy Animal Health, 
Inc., 8857 Bond St., Overland Park, KS 66214, filed supplemental ANADA 
200-221 for use of Component<Register> TE-G (40 milligrams (mg) 
trenbolone acetate and 8 mg estradiol, in 2 pellets, each pellet 
containing 20 mg of trenbolone acetate and 4 mg of estradiol) for 
increased rate of weight gain in pasture cattle (slaughter, stocker, 
and feeder steers and heifers). The supplemental ANADA is approved as 
of March 6, 2000, and the regulations in 21 CFR 522.2477 are amended 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.
    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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because

[[Page 26748]]

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 paragraphs (b), 
(d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), (d)(1)(ii), (d)(2)(i), 
(d)(2)(ii), and (d)(3)(i) to read as follows:


Sec. 522.2477  Trenbolone acetate and estradiol.

* * * * *
    (b) Sponsors. See No. 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 No. 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), (d)(1)(iii), and (d)(3) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (A) 120 milligrams (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.
    (B) 120 mg trenbolone acetate and 24 mg estradiol (one implant 
consisting of 7 pellets, each of 6 pellets containing 20 mg trenbolone 
acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
    (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.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
* * * * *
    (2) Heifers fed in confinement for slaughter--(i) Amount. 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.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
* * * * *
    (3) * * * (i) Amount. 40 mg trenbolone acetate and 8 mg estradiol 
(one implant consisting of 2 pellets, each pellet containing 20 mg 
trenbolone acetate and 4 mg estradiol) per implant dose.
* * * * *

    Dated: April 25, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-11477 Filed 5-8-00; 8:45 am]
BILLING CODE 4160-01-F