[Federal Register Volume 61, Number 64 (Tuesday, April 2, 1996)]
[Rules and Regulations]
[Pages 14482-14483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7901]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Trenbolone Acetate and Estradiol Benzoate
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 Syntex Animal Health. The NADA provides for use of an
ear implant containing trenbolone acetate and estradiol benzoate in
steers fed in confinement for slaughter for improved feed efficiency.
EFFECTIVE DATE: April 2, 1996.
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: Syntex Animal Health, Division of Syntex
Agribusiness, Inc., 3401 Hillview Ave., Palo Alto, CA 94304, filed NADA
141-043, which provides for use of an ear implant consisting of 8
pellets, each pellet containing 25 milligrams (mg) of trenbolone
acetate and 3.5 mg of estradiol benzoate. The implant is used in steers
fed in confinement for slaughter for improved feed efficiency. The NADA
is approved as of February 22, 1996, and the regulations are amended by
adding new 21 CFR 522.2478 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 February 22,
1996, 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
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. New Sec. 522.2478 is added to read as follows:
Sec. 522.2478 Trenbolone acetate and estradiol benzoate.
(a) Sponsor. See 000033 in Sec. 510.600(c) of this chapter.
(b) Related tolerance. See Secs. 556.240 and 556.739 of this
chapter.
(c) Conditions of use--(1) Steers--(i) Amount. 200 milligrams of
trenbolone acetate and 28 milligrams of estradiol benzoate (one implant
consisting of 8 pellets, each pellet containing 25 milligrams of
trenbolone acetate and 3.5 milligrams of estradiol benzoate) per
animal.
(ii) Indications for use. For improved feed efficiency in steers
fed in confinement for slaughter.
[[Page 14483]]
(iii) Limitations. Implant subcutaneously in ear only.
(2) [Reserved]
Dated: March 14, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-7901 Filed 4-1-96; 8:45 am]
BILLING CODE 4160-01-F
