[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Rules and Regulations]
[Page 29013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14104]
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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 Acetate
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 an abbreviated new animal drug
application (ANADA) filed by Ivy Laboratories, Inc. The ANADA provides
for the use of trenbolone acetate implants for improved feed efficiency
in growing-finishing feedlot steers and increased rate of weight gain
and improved feed efficiency in growing-finishing feedlot heifers.
EFFECTIVE DATE: May 29, 1997.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0217.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Inc., 8857 Bond St.,
Overland Park, KS 66214, has filed ANADA 200-224, which provides for
the use of trenbolone acetate implants for improved feed efficiency in
growing-finishing feedlot steers and increased rate of weight gain and
improved feed efficiency in growing-finishing feedlot heifers.
The ANADA is approved as a generic copy of Roussel UCLAF, NADA 138-
612;
Finaplix-S and Finaplix-H. ANADA 200-224 is
approved as of April 30, 1997, and the regulations are amended in 21
CFR 522.2476 to reflect the approval. The basis for 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.24(d)(1)(i) 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.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.2476 [Amended]
2. Section 522.2476 Trenbolone acetate is amended in paragraph (b)
by adding the phrase ``and 021641'' after the number ``012579''.
Dated: May 19, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-14104 Filed 5-28-97; 8:45 am]
BILLING CODE 4160-01-F
