[Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
[Rules and Regulations]
[Page 28629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13820]
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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 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 an abbreviated new animal drug
application (ANADA) filed by Ivy Laboratories, Inc. The ANADA provides
for the use of trenbolone acetate and estradiol implants for increased
rate of weight gain and improved feed efficiency in feedlot steers.
EFFECTIVE DATE: May 27, 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 200-221, which provides for
the use of trenbolone acetate and estradiol implants for increased rate
of weight gain and improved feed efficiency in feedlot steers.
The ANADA is approved as a generic copy of Roussel UCLAF's
Revalor S, NADA 140-897. ANADA 200-221 is approved as of
March 20, 1997, and the regulations are amended in 21 CFR 522.2477 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).
2. Section 522.2477 is amended by revising paragraph (a) to read as
follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
(a) Sponsor. See No. 012579 in Sec. 510.600(c) of this chapter for
use as in paragraphs (c)(1), (c)(2), and (c)(3) of this section. See
No. 021641 in Sec. 510.600(c) of this chapter for use as in paragraph
(c)(1) of this section.
* * * * *
Dated: May 6, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-13820 Filed 5-23-97; 8:45 am]
BILLING CODE 4160-01-F
