[Federal Register Volume 65, Number 228 (Monday, November 27, 2000)]
[Rules and Regulations]
[Pages 70662-70663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30049]


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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, Inc. The 
supplemental ANADA provides for adding tylosin tartrate as a local 
antibacterial to an approved subcutaneous cattle ear implant containing 
trenbolone and estradiol used in pasture cattle for increased rate of 
weight gain.

DATES: This regulation is effective November 27, 2000.

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.

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Inc., 8857 Bond St., 
Overland Park, KS 66214, filed supplemental ANADA 200-221 for 
COMPONENT<Register> TE-G (trenbolone acetate/estradiol) with 
Tylan<Register>, a subcutaneous ear implant containing 40 of milligrams 
(mg) trenbolone acetate and 8 mg of estradiol, in 2 pellets, each 
pellet containing 20 mg of trenbolone acetate and 4 mg of estradiol, 
and an additional pellet containing 29 mg of tylosin tartrate as a 
local antibacterial. The implants are used in pasture cattle 
(slaughter, stocker, and feeder steers and heifers) for increased rate 
of weight gain. The supplemental application is approved as of 
September 18, 2000, 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 (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning September 18, 2000, because the 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 the 
addition of tylosin tartrate to the implant for which the supplemental 
application was 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.
    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.


[[Page 70663]]


    2. Section 522.2477 is amended in the first sentence of paragraph 
(b) by removing ``(d)(3)'' and by adding in its place ``(d)(3)(i)(A), 
(d)(3)(ii), and (d)(3)(iii)''; in the second sentence of paragraph (b) 
by removing ``(d)(3)'' and by adding in its place ``(d)(3)(i)(A), 
(d)(3)(i)(B), (d)(3)(ii), and (d)(3)(iii)''; and by revising paragraph 
(d)(3)(i) to read as follows:


Sec. 522.2477  Trenbolone acetate and estradiol.

* * * * *
    (d) * * *
    (3) * * *
    (i) Amount. (A) 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.
    (B) 40 mg trenbolone acetate and 8 mg estradiol (one implant 
consisting of 3 pellets, each of 2 pellets containing 20 mg trenbolone 
acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
* * * * *

    Dated: October 11, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-30049 Filed 11-24-00; 8:45 am]
BILLING CODE 4160-01-F