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 (HFA305), 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
[[Page 26748]]
it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801808. 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 522IMPLANTATION 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.

2. Section 522.2477 is amended by revising paragraphs (b), (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), (d)(1)(ii), (d)(2)(i), (d)(2)(ii), and (d)(3)(i) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(b) Sponsors. See No. 012799 in Sec. 510.600(c) of this chapter for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(ii), (d)(1)(iii), (d)(2), and (d)(3) of this section. See No. 021641 in Sec. 510.600(c) of this chapter for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(ii), (d)(1)(iii), and (d)(3) of this section. * * * * *
(d) * * *
(1) * * *
(i) * * *
(A) 120 milligrams (mg) trenbolone acetate and 24 mg estradiol (one implant consisting of 6 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose.
(B) 120 mg trenbolone acetate and 24 mg estradiol (one implant consisting of 7 pellets, each of 6 pellets containing 20 mg trenbolone acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.
(C) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose.
(ii) Indications for use. For increased rate of weight gain and improved feed efficiency.
* * * * *
(2) Heifers fed in confinement for slaughter(i) Amount. 140 mg trenbolone acetate and 14 mg estradiol (one implant consisting of 7 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose.
(ii) Indications for use. For increased rate of weight gain and improved feed efficiency.
* * * * *
(3) * * * (i) Amount. 40 mg trenbolone acetate and 8 mg estradiol (one implant consisting of 2 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose.
* * * * *

Dated: April 25, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 0011477 Filed 5800; 8:45 am] BILLING CODE 416001F

FOR FURTHER INFORMATION CONTACT Jack Caldwell, Center for Veterinary Medicine (HFV126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270217.