[Federal Register Volume 69, Number 57 (Wednesday, March 24, 2004)]
[Rules and Regulations]
[Page 13735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6483]


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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 the addition of 
tylosin tartrate to an approved subcutaneous implant containing 
trenbolone and estradiol used for increased rate of weight gain in 
feedlot heifers.

DATES: This rule is effective March 24, 2004.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health, 
Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to 
ANADA 200-346 for COMPONENT TE-IH (trenbolone acetate and estradiol) 
with TYLAN, a subcutaneous implant used for increased rate of weight 
gain in heifers fed in confinement for slaughter. The supplemental 
ANADA provides for the addition of a pellet containing 29 milligrams 
tylosin tartrate to the approved implant. The supplemental application 
is approved as of February 23, 2004, 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 21 CFR 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 Division of Dockets Management 
(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 qualifies 
for 3 years of marketing exclusivity beginning February 23, 2004.
    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.

0
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

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

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2. Section 522.2477 is amended by revising paragraph (b)(1) and by 
adding paragraph (d)(2)(i)(E) to read as follows:


Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (b) * * *
    (1) No. 021641 for use as in paragraphs (d)(1), (d)(2)(i)(A), 
(d)(2)(i)(B), (d)(2)(i)(C), (d)(2)(i)(E), (d)(2)(iii), and (d)(3) of 
this section.
* * * * *
    (d) * * *
    (2) * * *
    (i) * * *
    (E) 80 mg trenbolone acetate and 8 mg estradiol (one implant 
consisting of 5 pellets, each of 4 pellets containing 20 mg trenbolone 
acetate and 2 mg
estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant 
dose for use as in paragraph (d)(2)(ii)(B) of this section.
* * * * *

    Dated: March 11, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-6483 Filed 3-23-04; 8:45 am]
BILLING CODE 4160-01-S