[Federal Register Volume 60, Number 14 (Monday, January 23, 1995)]
[Rules and Regulations]
[Pages 4375-4376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1654]
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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 a new animal drug application
(NADA) filed by Roussel-Uclaf. The NADA provides for use of an ear
implant containing trenbolone acetate and estradiol for heifers fed in
confinement for slaughter for increased rate of weight gain and
improved feed efficiency.
EFFECTIVE DATE: January 23, 1995.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1638.
SUPPLEMENTARY INFORMATION: Roussel-Uclaf, Division Agro-Veterinaire,
163 Avenue Gambetta, 75020, Paris, France, represented in the United
States by Hoechst-Roussel Agri-Vet Co., Rt. 202-206, P.O. Box 2500,
Somerville, NJ 08876-1258, filed NADA 140-992 which provides for use of
an ear implant containing 7 pellets, each pellet containing 20
milligrams (mg) of trenbolone acetate and 2 mg of estradiol. The
implant is used in heifers fed in confinement for slaughter for
increased rate of weight gain and improved feed efficiency. The NADA is
approved as of December 13, 1994, 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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
a 3-year period of marketing exclusivity beginning on December 13,
1994, because new clinical or field investigations (other than
bioequivalence or residue studies), or human food safety studies (other
than bioequivalence or residue studies) essential to the approval were
[[Page 4376]] conducted or sponsored by the applicant.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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 revised to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
(a) Sponsor. See No. 012579 in Sec. 510.600(c) of this chapter.
(b) Related tolerances. See Secs. 556.240 and 556.739 of this
chapter.
(c) Conditions of use--(1) Feedlot steers--(i) Amount. 120
milligrams of trenbolone acetate and 24 milligrams of estradiol (6
pellets, each pellet containing 20 milligrams of trenbolone acetate and
4 milligrams of estradiol) per animal.
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency in feedlot steers.
(iii) Limitations. Implant subcutaneously in ear only. Do not use
in animals intended for subsequent breeding or in dairy animals.
(2) Heifers--(i) Amount. 140 milligrams of trenbolone acetate and
14 milligrams of estradiol (7 pellets, each pellet containing 20
milligrams of trenbolone acetate and 2 milligrams of estradiol) per
animal.
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency in heifers fed in confinement for slaughter.
(iii) Limitations. Implant subcutaneously in ear only. Do not use
in animals intended for subsequent breeding or in dairy animals.
Dated: January 13, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-1654 Filed 1-20-95; 8:45 am]
BILLING CODE 4160-01-F
