Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations 26747

Substances Limitations

*******

2-[4,6-Bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol

(CAS Reg. No. 2725–22–6).

For use only:

1. At levels not to exceed 0.3 percent by weight of olefin polymers

complying with § 177.1520(c) of this chapter in contact with food

types I, II, IV–B, VI, VII–B, and VIII described in § 176.170(c) of this

chapter, table 1, under conditions of use D through G as described

in § 176.170(c), table 2, of this chapter.

2. At levels not to exceed 0.1 percent by weight of polypropylene complying with § 177.1520(c) of this chapter, items 1.1a, 1.2, and 1.3 in

contact with food under conditions of use A through H as described

in § 176.170(c), table 2, of this chapter.

3. At levels not to exceed 0.04 percent by weight of polyethylene and

olefin copolymers complying with § 177.1520(c) of this chapter, items

2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b having a minimum density of 0.94 gram per cubic centimeter, in contact with food under

conditions of use A through H as described in § 176.170, table 2, of

this chapter provided that the finished articles used in contact with

fatty food types III, IV–A, V, VII–A, and IX as described in table 1 of

§ 176.170(c) of this chapter hold a minimum of 2 gallons (7.6 liters)

of food.

4. At levels not to exceed 0.4 percent by weight of ethylene copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b,

3.1c, 3.2a, and 3.2b, having a density of less than 0.94 gram per

cubic centimeter, in contact with food under conditions of use B

through H, as described in § 176.170(c), table 2, of this chapter provided that the finished articles used in contact with fatty food types

III, IV–A, V, VII–A, and IX hold a minimum of 5 gallons (18.9 liters)

of food.

5. At levels not to exceed 0.04 percent by weight of polyethylene having a density of less than 0.94 gram per cubic centimeter, and olefin

polymers complying with § 177.1520(c) of this chapter, items 2.1,

2.2, 2.3, 3.3a, 3.3b, 3.4, 3.5, 3.6, 4, 5, and 6, in contact with food

under conditions of use D through G as described in § 176.170(c) of

this chapter, table 2, provided that the finished articles used in contact with fatty food types III, IV–A, V, VII–A, and IX hold a minimum

of 5 gallons (18.9 liters) of food.

*******

Dated: April 27, 2000

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–11479 Filed 5–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Trenbolone

and Estradiol

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental abbreviated

new animal drug application (ANADA)

filed by Ivy Laboratories, Div. of Ivy

Animal Health, Inc. The supplemental

ANADA provides for subcutaneous use

of a cattle ear implant containing

trenbolone and estradiol for pasture

cattle for increased rate of weight gain.

Technical changes are also made.

DATES: This rule is effective May 9,

2000.

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, Div. of Ivy Animal Health,

Inc., 8857 Bond St., Overland Park, KS

66214, filed supplemental ANADA 200–

221 for use of Component TE–G (40

milligrams (mg) trenbolone acetate and

8 mg estradiol, in 2 pellets, each pellet

containing 20 mg of trenbolone acetate

and 4 mg of estradiol) for increased rate

of weight gain in pasture cattle

(slaughter, stocker, and feeder steers and

heifers). The supplemental ANADA is

approved as of March 6, 2000, and the

regulations in 21 CFR 522.2477 are

amended to reflect the approval. The

basis of 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, 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

26748 Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

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: 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:

§ 522.2477 Trenbolone acetate and

estradiol.

* * * * *

(b) Sponsors. See No. 012799 in

§ 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

§ 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. 00–11477 Filed 5–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Department of the Navy

32 CFR Part 727

RIN 0703–AA59

Legal Assistance

AGENCY: Department of the Navy, DOD.

ACTION: Final rule.

SUMMARY: The Department of the Navy

is amending its regulations concerning

the provision of legal assistance to

military members and other persons

eligible for legal assistance to reflect

recent changes to Chapter VII of the

Manual of the Judge Advocate General.

DATES: Effective May 9, 2000.

ADDRESSES: Office of the Judge

Advocate General (Code 36), 1322

Patterson Avenue SE, Suite 3000,

Washington Navy Yard, DC 20374–

5066.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Commander Steven L.

Haycock, Judge Advocate General’s

Corps, U.S. Navy, Office of the Judge

Advocate General (Code 36), 1322

Patterson Avenue SE, Suite 3000,

Washington Navy Yard, DC 20374–

5066, Telephone number (202) 685–

4642.

SUPPLEMENTARY INFORMATION: Pursuant

to the authority cited below, the

Department of the Navy amends 32 CFR

Part 727, which is derived from Chapter

VII of the Manual of the Judge Advocate

General, to reflect changes to that

regulation. The amendment relates to

internal naval management and

personnel practices, and is being

published by the Department of the

Navy solely for the guidance and

interest of the public in accordance with

5 U.S.C. 552(a)(1). It has been

determined that invitation of public

comment on this amendment prior to

adoption would be impracticable and is

not required under the public

rulemaking provisions of 32 CFR parts

296 and 701. It has also been

determined that this rule is not a

‘‘significant regulatory action’’ as

defined in Executive Order 12866.

List of Subjects in 32 CFR Part 727

Legal services, Military law, Military

personnel.

Accordingly, 32 CFR part 727 is

amended as follows:

PART 727—LEGAL ASSISTANCE

1. The authority citation for part 727

continues to read as follows:

Authority: 5 U.S.C. 301; 10 U.S.C. 5031

and 5148; 32 CFR 700.206 and 700.1202.

2. Revise § 727.5 to read as follows:

§ 727.5 Persons eligible for assistance.

Legal assistance shall be available to

members of the Armed Forces of the

United States and their dependents, and

military personnel of allied nations

serving in the United States, its

territories or possessions. Legal

assistance is intended primarily for the

benefit of active duty personnel during

active service, including reservists (and

members of the National Guard) on

active duty for 30 days or more. As

resources permit, legal assistance may

be extended to retired military

personnel, their dependents, survivors

of members of the Armed Forces who

would be eligible were the service

member alive, reservists on active duty

for single periods of 29 days or less, and

in overseas areas, to civilians, other than

local-hire employees, who are in the

employ of, serving with, or

accompanying the U.S. Armed Forces,

and their dependents, when and if the

workload of the office renders such

service feasible, and other persons

authorized by the Judge Advocate

General of the Navy.

3. Amend § 727.6 by revising

paragraphs (a) introductory text, (a)(2),

(a)(6), and (d) to read as follows:

§ 727.6 Functions of legal assistance

officers.

(a) Basic duties. A legal assistance

officer, while performing legal

assistance duties, in addition to

performing any other duties which may

be assigned to him/her:

* * * * *

(2) Shall serve as advocate and

counsel for persons eligible for

assistance in connection with their

personal legal problems and may