[Federal Register: December 24, 2002 (Volume 67, Number 247)]
[Rules and Regulations]
[Page 78357-78358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24de02-12]
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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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[[Page 78358]]
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal
Health, Inc. The ANADA provides for subcutaneous use of an implant
containing trenbolone acetate and estradiol for increased rate of
weight gain and improved feed efficiency in feedlot heifers.
DATES: This rule is effective December 24, 2002.
FOR FURTHER INFORMATION CONTACT: Harlan J. Howard, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0231, hhoward@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-
346 for COMPONENT TE-H (140 milligrams (mg) trenbolone acetate and 14
mg estradiol, in seven pellets, each pellet containing 20 mg of
trenbolone acetate and 2 mg of estradiol) for increased rate of weight
gain and improved feed efficiency in heifers fed in confinement for
slaughter. Ivy Laboratories' COMPONENT TE-H is approved as a generic
copy of Intervet's REVALOR-H, approved under NADA 140-992. The
application is approved as of September 27, 2002, 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 Sec. 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 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.
Sec. 522.2477 [Amended]
2. Section 522.2477 Trenbolone acetate and estradiol is amended in
paragraph (b)(1) by adding ``(d)(2)(i)(A), (d)(2)(ii)(A),
(d)(2)(iii),'' after ``(d)(1)(iii),''.
Dated: December 17, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-32342 Filed 12-23-02; 8:45 am]
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