Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Proposed Rules 34627

IV. Procedural Determinations

Executive Order 12866—Regulatory

Planning and Review

This rule is exempted from review by

the Office of Management and Budget

under Executive Order 12866 .

Executive Order 12630—Takings

This rule does not have takings

implications. This determination is

based on the analysis performed for the

counterpart federal regulation.

Executive Order 13132—Federalism

This rule does not have federalism

implications. SMCRA delineates the

roles of the Federal and State

governments with regard to the

regulation of surface coal mining and

reclamation operations. One of the

purposes of SMCRA is to ‘‘establish a

nationwide program to protect society

and the environment from the adverse

effects of surface coal mining

operations.’’ Section 503(a)(1) of

SMCRA requires that State laws

regulating surface coal mining and

reclamation operations be ‘‘in

accordance with’’ the requirements of

SMCRA, and section 503(a)(7) requires

that State programs contain rules and

regulations ‘‘consistent with’’

regulations issued by the Secretary

pursuant to SMCRA.

Executive Order 12988—Civil Justice

Reform

The Department of the Interior has

conducted the reviews required by

section 3 of Executive Order 12988 and

has determined that, to the extent

allowed by law, this rule meets the

applicable standards of subsections (a)

and (b) of that section. However, these

standards are not applicable to the

actual language of State regulatory

programs and program amendments

since each such program is drafted and

promulgated by a specific State, not by

OSM. Under sections 503 and 505 of

SMCRA (30 U.S.C. 1253 and 1255) and

30 CFR 730.11, 732.15, and

732.17(h)(10), decisions on proposed

State regulatory programs and program

amendments submitted by the States

must be based solely on a determination

of whether the submittal is consistent

with SMCRA and its implementing

Federal regulations and whether the

other requirements of 30 CFR parts 730,

731, and 732 have been met.

National Environmental Policy Act

Section 702(d) of SMCRA (30 U.S.C.

1292(d)) provides that a decision on a

proposed State regulatory program

provision does not constitute a major

federal action within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (NEPA) (42

U.S.C. 4332(2)(C)). A determination has

been made that such decisions are

categorically excluded from the NEPA

process (516 DM 8.4.A).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by the Office of

Management and Budget under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The State submittal

which is the subject of this rule is based

upon counterpart Federal regulations for

which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions for the

counterpart federal regulations.

Small Business Regulatory Enforcement

Fairness Act

This rule is not a major rule under 5

U.S.C. 804(2), the Small Business

Regulatory Enforcement Fairness Act.

This rule:

a. Does not have an annual effect on

the economy of $100 million.

b. Will not cause a major increase in

costs or prices for consumers,

individual industries, Federal, State, or

local government agencies, or

geographic regions.

c. Does not have significant adverse

effects on competition, employment,

investment, productivity, innovation, or

the ability of U.S. based enterprises to

compete with foreign-based enterprises.

This determination is based upon the

fact that the State submittal which is the

subject of this rule is based upon

counterpart Federal regulations for

which an analysis was prepared and a

determination made that the Federal

regulation was not considered a major

rule.

Unfunded Mandates

This rule will not impose a cost of

$100 million or more in any given year

on any governmental entity or the

private sector.

List of Subjects in 30 CFR Part 917

Intergovernmental relations, Surface

mining, Underground mining.

Dated: May 19, 2000.

Allen D. Klein,

Regional Director, Appalachian Regional

Coordinating Center.

[FR Doc. 00–13551 Filed 5–30–00; 8:45 am]

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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

RIN 0720–AA57

Civilian Health and Medical Program of

the Uniformed Services (CHAMPUS);

Methodology for Coverage of NIHSponsored Clinical Trials

AGENCY: Office of the Secretary, DoD.

ACTION: Proposed rule.

SUMMARY: This proposed rule modifies

the general prohibition against

CHAMPUS cost-sharing of unproven

drugs, devices, and medical treatments

or procedures by adding a provision

allowing a waiver of the prohibition in

connection with clinical trials

sponsored or approved by the National

Institutes of Health, if it is determined

that such a waiver will promote access

by covered beneficiaries to promising

new treatments, and contribute to the

development of such treatments.

DATES: Public comments must be

received by July 31, 2000.

ADDRESSES: TRICARE Management

Activity (TMA), Program Development

Branch, Aurora, CO 80045–6900.

FOR FURTHER INFORMATION CONTACT:

Kathleen Larkin, Office of the Assistant

Secretary of Defense (Health Affairs)/

TRICARE Management Activity,

telephone (703) 681–3628.

SUPPLEMENTARY INFORMATION: 

I. Proposed Changes

Introduction and Background

On January 24, 1996, the Department

provided notice in the Federal Register

(61 FR 1899) of an expansion of an

existing demonstration to provide

coverage for all cancer treatment clinical

trials under approved National Cancer

Institute (NCI) clinical trials. The

demonstration’s purpose was to

improve beneficiary access to promising

new therapies, assist in meeting the

National Cancer Institute’s clinical trial

34628 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Proposed Rules

goals, and arrival at conclusions

regarding the safety and efficacy of

emerging therapies in the treatment of

cancer. The demonstration was further

expanded on June 21, 1999 (64 FR 109)

to include cancer prevention clinical

trials. Based on the improved

beneficiary access to these trials, and

the contributions to the development of

such treatments, it is in the best interest

of the Department and its beneficiaries

to continue to provide access through an

authorized waiver as outlined in the

proposed rule.

This proposed rule implements title

10, United States Code, section

1079(a)(13) which provides for a waiver

of the general prohibition on coverage of

unproven medical treatments or

procedures in connection with clinical

trials sponsored or approved by the

National Institutes of Health if the

Secretary of Defense so determines that

a waiver will promote access to

promising new treatments and

contributes to the development of such

treatments.

II. Regulatory Procedures

Executive Order 12866 requires

certain regulatory assessments for any

significant regulatory action, defined as

one which would result in an annual

effect on the economy of $100 million

or more, or have other substantial

impacts.

The Regulatory Flexibility Act (RFA)

requires that each Federal agency

prepare, and make available for public

comment, a regulatory flexibility

analysis when the agency issues a

regulation which would have a

significant impact on a substantial

number of small entities.

The proposed rule will not impose

additional information collection

requirements on the public under the

Paperwork Reduction Act of 1995 (44

U.S.C. Chapter 55).

Public comments are invited. All

comments will be carefully considered.

A discussion of the major issues

received by public comments will be

included with the issuance of the

permanent final rule, anticipated

approximately 60 days after the end of

the comment period.

List of Subjects in 32 CFR Part 199

Claims, Fraud, Health care, Health

insurance, Individuals with disabilities,

Military personnel.

Accordingly, 32 CFR part 199 is

proposed to be amended as follows:

PART 199—[AMENDED]

1. The authority citation for Part 199

continues to read as follows:

Authority: 5 U.S.C. 301, 10 U.S.C. Chapter

55.

2. Section 199.4 is proposed to be

amended by adding new paragraph

(e)(21) and revising paragraph (g)(15)

introductory text to read as follows:

§ 199.4 Basic program benefits.

* * * * *

(e) * * *

(21) National Institutes of Health

clinical trials. By law, the general

prohibition against CHAMPUS costsharing of unproven drugs, devices, and

medical treatments or procedures may

be waived in connection with clinical

trials sponsored or approved by the

National Institutes of Health if it is

determined that such a waiver will

promote access by covered beneficiaries

to promising new treatments and

contribute to the development of such

treatments. A waiver shall only be

exercised as authorized under this

paragraph.

(i) Demonstration waiver. A waiver

may be granted through a demonstration

project established in accordance with

§ 199.1(o).

(ii) Continuous waiver. (A) General.

As a result of a demonstration project

under which a waiver has been granted

in connection with a National Institutes

of Health clinical trial, a determination

may be made that it is in the best

interest of the government and

CHAMPUS beneficiaries to end the

demonstration and continue to provide

a wiaver for CHAMPUS cost-sharing of

the specific clinical trial. Only those

specific clinical trials identified under

paragraph (e)(21)(ii) of this section have

been authorized a continuous waiver

under CHAMPUS.

(B) National Cancer Institute (NCI)

Sponsored Cancer Prevention,

Screening, and Early Detection Clinical

Trials. A continuous waiver under

paragraph (e)(21) of this section has

been granted for CHAMPUS costsharing for those CHAMPUS-eligible

patients selected to participated in NCI

sponsored Phase II and Phase III studies

for the prevention and treatment of

cancer.

(1) CHAMPUS will cost-share all

medical care and testing required to

determine eligibility for an NCIsponsored trial, including the

evaluation for eligibility at the

institution conducting the NCIsponsored study. CHAMPUS will costshare all medical care required as a

result of participation in NCI-sponsored

studies. This includes purchasing and

administering all approved

chemotherapy agents (except for NCIfunded investigational drugs), all

inpatient and outpatient care, including

diagnostic and laboratory services not

otherwise reimbursed under an NCI

grant program if the following

conditions are met:

(i) The provider seeking treatment for

a CHAMPUS-eligible patient in an NCI

approved protocol has obtained

preauthorization for the proposed

treatment before initial evaluation; and,

(ii) Such treatments are NCI

sponsored Phase II or Phase III

protocols; and,

(iii) The patient continues to meet

entry criteria for said protocol; and

(iv) The institutional and individual

providers are CHAMPUS authorized

providers.

(2) CHAMPUS will not provide

reimbursement for care rendered in the

National Institutes of Health Clinical

Center or costs associated with nontreatment research activities associated

with the clinical trials.

(3) Cost-shares and deductibles

applicable to CHAMPUS will also apply

under the NCI-sponsored clinical trials.

(4) The Director, OCHAMPUS, shall

issue procedures and guidelines

establishing NCI sponsorship of clinical

trials and the administrative process by

which individual patients apply for and

receive cost-sharing under NCI

sponsored cancer clinical trials.

* * * * *

(g) * * *

(15) Unproven drugs, devices, and

medical treatments or procedures. By

law, CHAMPUS can only cost-share

medically necessary supplies and

services. Any drug, device, or medical

treatment or procedure, the safety and

efficacy of which have not been

established, as described in this

paragraph (g)(15), is unproved and

cannot be cost-shared by CHAMPUS

except as authorized under

§ 199.4(e)(20) of this part.

* * * * *

Dated: May 24, 2000.

L.M. Bynum,

Alternate OSD Federal Register Liaison

Officer, Department of Defense.

[FR Doc. 00–13520 Filed 5–30–00; 8:45 am]

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