[Federal Register: September 23, 2003 (Volume 68, Number 184)]
[Rules and Regulations]
[Page 55199-55200]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se03-5]
-----------------------------------------------------------------------
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; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
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 an
additional dose of trenbolone acetate and estradiol implant for use in
feedlot steers for increased rate of weight gain and improved feed
efficiency. This section of the regulations is also being amended to
remove a redundant description of another strength implant. This action
is being taken to improve the accuracy of the regulations.
DATES: This rule is effective September 23, 2003.
[[Page 55200]]
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: edubbin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed
supplemental ANADA 200-221 for COMPONENT TE-IS (trenbolone acetate/
estradiol), a subcutaneous ear implant containing 80 milligrams (mg)
trenbolone acetate and 16 mg estradiol, in four pellets, each pellet
containing 20 mg of trenbolone acetate and 4 mg of estradiol. The
implants are used in steers fed in confinement for slaughter for
increased rate of weight gain and improved feed efficiency. Ivy
Laboratories' COMPONENT TE-IS is approved as a generic copy of
Intervet, Inc.'s REVALOR-IS, approved under NADA 140-897. The
supplemental application is approved as of September 3, 2003, and 21
CFR 522.2477 is amended to reflect the approval. The basis of approval
is discussed in the freedom of information summary.
In addition, Sec. 522.2477 is being amended to remove a redundant
description of another strength implant. This action is being taken to
improve the accuracy of the regulations.
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.
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
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.
0
2. Section 522.2477 is amended in paragraph (b)(1) by removing
``(d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), (d)(1)(ii)'' and by adding
in its place ``(d)(1)''; and by revising paragraph (d)(1)(i)(D) to read
as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(d) * * *
(1) * * *
(i) * * *
(D) 80 mg trenbolone acetate and 16 mg estradiol (one implant
consisting of 4 pellets, each pellet containing 20 mg trenbolone
acetate and 4 mg estradiol) per implant dose.
* * * * *
Dated: September 15, 2003.
Steven D. Vaugh,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 03-24161 Filed 9-22-03; 8:45 am]
BILLING CODE 4160-01-S