[Federal Register Volume 68, Number 137 (Thursday, July 17, 2003)]
[Rules and Regulations]
[Pages 42250-42251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18088]


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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, Division 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 and improved feed efficiency in feedlot heifers.

DATES: This rule is effective July 17, 2003.

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; [email protected].

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a 
supplement to ANADA 200-346 for COMPONENT TE-H (trenbolone acetate and 
estradiol), a subcutaneous implant used for increased rate of weight 
gain and improved feed efficiency 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 April 18, 2003, 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 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 (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval 
qualifies for 3 years of marketing exclusivity beginning April 18, 
2003.
    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

0
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 in paragraph (b)(1) by adding 
``(d)(2)(i)(B),'' after ``(d)(2)(i)(A),''; in paragraph (b)(2) by 
removing ``(d)(2)'' and by adding in its place ``(d)(2)(i)(A), 
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii)''; in paragraph 
(d)(2)(i)(A) by removing ``paragraphs (d)(2)(ii)(A) and (d)(2)(ii)(B)'' 
and by adding in its place ``paragraph (d)(2)(ii)(A)''; by 
redesignating paragraphs (d)(2)(i)(B) and (d)(2)(i)(C) as paragraphs 
(d)(2)(i)(C) and (d)(2)(i)(D); and by adding new paragraph (d)(2)(i)(B) 
to read as follows:

[[Page 42251]]

Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (d) * * *
    (2) * * *
    (i) * * *
    (B) 140 mg trenbolone acetate and 14 mg estradiol (one implant 
consisting of 8 pellets, each of 7 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 paragraphs (d)(2)(ii)(A) of 
this section.
* * * * *

    Dated: July 8, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-18088 Filed 7-16-03; 8:45 am]
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