Federal Register / Vol. 62, No. 27 / Monday, February 10, 1997 / Proposed Rules 5953

EPA, with concurrence from the State

on December 16, 1996, has determined

that the response actions undertaken at

the Conklin Dumps site are protective of

human health and the environment.

In accordance with 40 CFR

300.425(e), sites may be deleted from

the NPL where no further response is

appropriate. EPA, in consultation with

the State, has determined that all

appropriate responses under CERCLA

have been implemented and that no

further cleanup by responsible parties is

appropriate. Having met the deletion

criteria, EPA proposes to delete the

Conklin Dumps site from the NPL.

Dated: January 17, 1997.

William J. Muszynski,

Acting Regional Administrator.

[FR Doc. 97–2994 Filed 2–7–97; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

42 CFR Part 68a

RIN 0905–AE56

National Institutes of Health Clinical

Research Loan Repayment Program

for Individuals from Disadvantaged

Backgrounds

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The National Institutes of

Health (NIH) proposes to issue a

regulation to implement provisions of

the Public Health Service Act

authorizing the NIH Clinical Research

Loan Repayment Program for

Individuals from Disadvantaged

Backgrounds. The purpose of the

program is the recruitment and

retention of highly qualified health

professionals who are from

disadvantaged backgrounds to clinical

research, as employees of the NIH, by

providing repayment of qualified

educational loans.

DATES: Comments must be received on

or before April 11, 1997, in order to

assure that NIH will be able to consider

the comments in preparing the final

rule.

ADDRESSES: Comments should be sent to

Jerry Moore, NIH Regulations Officer,

Office of Management Assessment, NIH,

Building 31, Room 1B05, 31 CENTER

DR MSC 2075, BETHESDA, MD 20892–

2075.

FOR FURTHER INFORMATION CONTACT: Jerry

Moore at the address above, or

telephone (301) 496–4606 (not a toll-free

number).

SUPPLEMENTARY INFORMATION: The NIH

Revitalization Act of 1993 (Pub. L. 103–

43) was enacted June 10, 1993, adding

section 487E of the Public Health

Service (PHS) Act, 42 U.S.C. 288–5.

Section 487E authorizes the Secretary to

carry out a program of entering into

contracts with appropriately qualified

health professionals from disadvantaged

backgrounds with substantial

educational loan debt relative to

income. Under such contracts, qualified

health professionals agree to conduct

clinical research as NIH employees for

a minimum of two years, in

consideration of the Federal

Government agreeing to repay a

maximum of $20,000 annually of the

principal and the interest of the

educational loans of such health

professionals. This program is known as

the NIH Clinical Research Loan

Repayment Program for Individuals

from Disadvantaged Backgrounds. The

NIH is proposing to amend title 42 of

the Code of Federal Regulations by

adding a new part 68a to govern the

administration of this loan repayment

program.

The proposed regulation specifies the

scope and purpose of the program, who

is eligible to apply, how individuals

apply to participate in the program, how

participants are selected, and the terms

and conditions of the program. The

purpose of this notice is to invite public

comment on the proposed regulation.

The following is provided as public

information.

Executive Order 12866

Executive Order 12866 requires that

all regulatory actions reflect

consideration of the costs and benefits

they generate, and that they meet certain

standards, such as avoiding the

imposition of unnecessary burdens on

the affected public. If a regulatory action

is deemed to fall within the scope of the

definition of the term ‘‘significant

regulatory action’’ contained in section

3(f) of the Order, pre-publication review

by the Office of Management and

Budget’s Office of Information and

Regulatory Affairs (OIRA) is necessary.

This proposed rule has been reviewed

under Executive Order 12866 by OIRA

and has been deemed not significant.

Regulatory Flexibility Act

The Regulatory Flexibility Act of 1980

requires that regulatory proposals be

analyzed to determine whether they

create a significant impact on a

substantial number of small entities. I

certify that any final rule resulting from

this proposal will not have any such

impact.

Paperwork Reduction Act

This proposed rule does not contain

any information collection requirements

which are subject to Office of

Management and Budget (OMB)

approval under the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). The application forms for

use by the NIH Clinical Research Loan

Repayment Program for Individuals

from Disadvantaged Backgrounds have

been submitted to OMB for approval.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic

Assistance numbered program affected

by the proposed regulation is:

93.220—NIH Clinical Research Loan

Repayment Program for Individuals

from Disadvantaged Backgrounds

List of Subjects in 42 CFR Part 68a

Health—clinical research, medical

research; Loan programs—health.

Dated: December 2, 1996.

Harold Varmus,

Director, National Institutes of Health.

For reasons presented in the

preamble, it is proposed to amend title

42 of the Code of Federal Regulations by

adding a new Part 68a to read as set

forth below.

PART 68A—NATIONAL INSTITUTES

OF HEALTH (NIH) CLINICAL

RESEARCH LOAN REPAYMENT

PROGRAM FOR INDIVIDUALS FROM

DISADVANTAGED BACKGROUNDS

(CR–LRP)

Sec.

68a.1 What is the scope and purpose of the

NIH Clinical Research Loan Repayment

Program for Individuals from

Disadvantaged Backgrounds (CR–LRP)?

68a.2 Definitions.

68a.3 Who is eligible to apply?

68a.4 Who is eligible to participate?

68a.5 Who is ineligible to participate?

68a.6 How do individuals apply to

participate in the CR–LRP?

68a.7 How are applicants selected to

participate in the CR–LRP?

68a.8 What does the CR–LRP provide to

participants?

68a.9 What loans qualify for repayment?

68a.10 What does an individual have to do

in return for loan repayments received

under the CR–LRP?

68a.11 How does an individual receive loan

repayments beyond the initial two-year

contract?

68a.12 What will happen if an individual

does not comply with the terms and

conditions of participation in the CR–

LRP?
5954 Federal Register / Vol. 62, No. 27 / Monday, February 10, 1997 / Proposed Rules

68a.13 Under what circumstances can the

service or payment obligation be

canceled, waived, or suspended?

68a.14 When can a CR–LRP payment

obligation be discharged in bankruptcy?

68a.15 Additional conditions.

68a.16 What other regulations and statutes

apply?

Authority: 42 U.S.C. 288–5.

§ 68a.1 What is the scope and purpose of

the NIH Clinical Research Loan Repayment

Program for Individuals from

Disadvantaged Backgrounds (CR–LRP)?

This part applies to the award of

educational loan payments under the

NIH Clinical Research Loan Repayment

Program for Individuals from

Disadvantaged Backgrounds (CR–LRP)

authorized by section 487E of the Public

Health Service Act (42 U.S.C. 288–5).

The purpose of this program is to recruit

and retain appropriately qualified

health professionals, who are from

disadvantaged backgrounds and have

substantial educational debt relative to

income, to conduct clinical research as

NIH employees.

§ 68a.2 Definitions.

As used in this part:

Act means the Public Health Service

Act, as amended (42 U.S.C. 201 et seq.).

Applicant means an individual who

applies to, and meets the eligibility

criteria for the CR–LRP.

Approved clinical research means

clinical research approved by the

Clinical Research Loan Repayment

Committee.

Clinical privileges means the

delineation of privileges for patient care

granted to qualified health professionals

by the NIH Medical Board or other

appropriate credentialing board.

Clinical research means activities

which qualify for inclusion as clinical

research in the CR–LRP as determined

by the Clinical Research Loan

Repayment Committee.

Clinical Research Loan Repayment

Committee (CR–LRC) means the

scientific board assembled to review,

rank, and approve or disapprove

Clinical Research Loan Repayment

Program applications. The CR–LRC is

composed of NIH scientific staff and cochaired by the Associate Director for

Clinical Research, NIH, and the

Associate Director for Research on

Minority Health, NIH. Members are

nominated by the Deputy Director,

Intramural Research, NIH, and the cochairs, and appointed by the Director,

NIH.

Clinical Research Loan Repayment

Program (CR–LRP or Program) means

the NIH Clinical Research Loan

Repayment Program for Individuals

from Disadvantaged Backgrounds

authorized by section 487E of the Act,

as amended.

Clinical Research Loan Repayment

Program (CR–LRP or Program) contract

refers to the agreement, which is signed

by an applicant and the Secretary,

wherein the applicant from a

disadvantaged background agrees to

engage in clinical research as an

employee of the NIH and the Secretary

agrees to repay qualified educational

loans for a prescribed period as

specified in this part.

Clinical researcher means an NIH

employee with clinical privileges who is

conducting approved clinical research.

Commercial loans means loans made

by banks, credit unions, savings and

loan associations, not-for-profit

organizations, insurance companies,

schools, and other financial or credit

institutions which are subject to

examination and supervision in their

capacity as lending institutions by an

agency of the United States or of the

State in which the lender has its

principal place of business.

Current payment status means that a

qualified educational loan is not past

due in its payment schedule as

determined by the lending institution.

Debt threshold refers to the minimum

amount of qualified educational debt an

individual must have, on his/her

program eligibility date, in order to be

eligible for Program benefits and, for

purposes of eligibility under this part,

debt threshold means that the qualified

educational debt must equal or exceed

20 percent of an individual’s annual

NIH salary on his/her program

eligibility date.

Educational expenses means the cost

of the health professional’s education,

including the tuition expenses and other

educational expenses such as fees,

books, supplies, educational equipment

and materials, and laboratory expenses.

Government loans means loans made

by Federal, State, county, or city

agencies which are authorized by law to

make such loans.

Individual from disadvantaged

background means an individual who:

(1) comes from an environment that

inhibited the individual from obtaining

the knowledge, skill and ability required

to enroll in and graduate from a health

professions school; or

(2) comes from a family with an

annual income below a level based on

low-income thresholds according to

family size published by the U.S.

Bureau of the Census, adjusted annually

for changes in the Consumer Price

Index, and adjusted by the Secretary for

use in all health professions programs.

The Secretary periodically publishes

these income levels in the Federal

Register.

Institute, Center, or Agency (ICA)

means an institute, center, or agency of

the National Institutes of Health.

Living expenses means the reasonable

cost of room and board, transportation

and commuting costs, and other

reasonable costs incurred during an

individual’s attendance at an

educational institution.

Participant means an individual

whose application to the CR–LRP has

been approved and whose Program

contract has been executed by the

Secretary.

Program means the NIH Clinical

Research Loan Repayment Program for

Individuals from Disadvantaged

Backgrounds.

Program eligibility date means the

date on which an individual’s Program

contract is executed by the Secretary

and that individual is engaged in

approved clinical research as an

employee of the NIH.

Qualified educational loans and

interest/debt include Government and

commercial educational loans and

interest for:

(1) Undergraduate, graduate, and

health professional school tuition

expenses;

(2) Other reasonable educational

expenses required by the school(s)

attended, including fees, books,

supplies, educational equipment and

materials, and laboratory expenses; and

(3) Reasonable living expenses,

including the cost of room and board,

transportation and commuting costs,

and other reasonable living expenses

incurred.

Reasonable educational and living

expenses means those educational and

living expenses which are equal to or

less than the sum of the school’s

estimated standard student budget for

educational and living expenses for the

degree program and for the year(s)

during which the participant was

enrolled in school. If there is no

standard budget available from the

school or if the participant requests

repayment for educational and living

expenses which exceed the standard

student budget, reasonableness of

educational and living expenses

incurred must be substantiated by

additional contemporaneous

documentation, as determined by the

Secretary.

Repayable debt means the portion, as

established by the Secretary, of an

individual’s total qualified educational

debt relative to the NIH salary, which

can be paid by the CR–LRP.

Specifically, qualifying educational debt

amounts in excess of 50 percent of the
Federal Register / Vol. 62, No. 27 / Monday, February 10, 1997 / Proposed Rules 5955

debt threshold will be considered for

repayment.

Salary means base pay plus quarters,

subsistence, and variable housing

allowances, if applicable.

School means undergraduate,

graduate, and health professions schools

which are accredited by a body or

bodies recognized for accreditation

purposes by the Secretary of Education.

Secretary means the Secretary of

Health and Human Services and any

other officer or employee of the

Department of Health and Human

Services to whom the authority

involved has been delegated.

Service means the Public Health

Service.

State means one of the fifty States, the

District of Columbia, the

Commonwealth of Puerto Rico, the

Northern Mariana Islands, the U.S.

Virgin Islands, Guam, American Samoa,

and the Trust Territory of the Pacific

Islands (the Federated States of

Micronesia, the Republic of the

Marshall Islands, and the Republic of

Palau).

Withdrawal means a request by a

participant, prior to the Program making

payments on his or her behalf, for

withdrawal from Program participation.

A withdrawal is without penalty to the

participant and without obligation to

the Program.

§ 68a.3 Who is eligible to apply?

To be eligible to apply to the CR–LRP,

an individual must be a citizen,

national, or permanent resident of the

United States; hold a M.D., Ph.D., D.O.,

D.D.S., D.M.D., A.D.N./B.S.N., or

equivalent degree; have, on his/her

program eligibility date, qualified

educational debt equal to or in excess of

the debt threshold; and be an individual

from a disadvantaged background.

§ 68a.4 Who is eligible to participate?

To be eligible to participate in the

CR–LRP, an applicant must have the

recommendation of the employing ICA

Scientific Program Director, the

concurrence of the employing ICA

Director, and the approval of the CR–

LRC. Since participation in the Program

is contingent, in part, upon employment

with NIH, a Program contract may not

be awarded to an applicant until an

employment commitment has been

made by the employing ICA Personnel

Department.

§ 68a.5 Who is ineligible to participate?

The following individuals are

ineligible for CR–LRP participation:

(a) Persons who are not eligible

applicants as specified under § 68a.3;

(b) Persons who owe an obligation of

health professional service to the

Federal Government, a State, or other

entity, unless a deferral is granted for

the length of his/her service obligation

under the CR–LRP. The following are

examples of programs which have a

service obligation: Physicians Shortage

Area Scholarship Program, National

Research Service Award Program,

Public Health Service Scholarship,

National Health Service Corps

Scholarship Program, Armed Forces

(Army, Navy, or Air Force) Professions

Scholarship Program, Indian Health

Service Scholarship Program, and the

NIH AIDS Research Loan Repayment

Program.

(c) Persons who are not NIH

employees, such as Intramural Research

Training Award (IRTA) recipients,

Visiting Fellows, National Research

Service Award (NRSA) recipients, Guest

Researchers or Special Volunteers, NIHNational Research Council (NRC)

Biotechnology Research Associates

Program participants, and

Intergovernmental Personnel Act (IPA)

participants; or

(d) Persons who do not have clinical

privileges.

§ 68a.6 How do individuals apply to

participate in the CR–LRP?

An application for participation in the

CR–LRP shall be submitted to the NIH

office which is responsible for the

Program’s administration, in such form

and manner as the Secretary may

prescribe.

§ 68a.7 How are applicants selected to

participate in the CR–LRP?

To be selected for participation in the

CR–LRP, applicants must satisfy the

following requirements:

(a) Applicants must meet the

eligibility requirements specified in

§ 68a.3 and § 68a.4.

(b) Applicants must not be ineligible

for participation as specified in § 68a.5.

(c) Applicants must be selected for

approval by the CR–LRC, based upon a

review of their applications.

§ 68a.8 What does the CR–LRP provide to

participants?

(a) Loan repayments: For each year of

service the individual agrees to serve,

with a minimum of 2 years of obligated

service, the Secretary may pay up to

$20,000 per year of a participant’s

repayable debt.

(b) Under § 68a.8(a), the Secretary will

make payments in the discharge of debt

to the extent appropriated funds are

available for these purposes.

§ 68a.9 What loans qualify for repayment?

(a) The CR–LRP will repay

participants’ lenders the principal,

interest, and related expenses of

qualified Government and commercial

educational loans obtained by

participants for the following:

(1) Undergraduate, graduate, and

health professional school tuition

expenses;

(2) Other reasonable educational

expenses required by the school(s)

attended, including fees, books,

supplies, educational equipment and

materials, and laboratory expenses; and

(3) Reasonable living expenses,

including the cost of room and board,

transportation and commuting costs,

and other living expenses as determined

by the Secretary.

(b) The following educational loans

are ineligible for repayment under the

CR–LRP:

(1) Loans obtained from other than a

government entity or commercial

lending institution;

(2) Loans for which contemporaneous

documentation is not available;

(3) Loans or portions of loans

obtained for educational or living

expenses which exceed the standard of

reasonableness as determined by the

participant’s standard school budget for

the year in which the loan was made,

and are not determined by the Secretary

to be reasonable based on additional

documentation provided by the

individual;

(4) Loans, financial debts, or service

obligations incurred under the following

programs: Physicians Shortage Area

Scholarship Program (Federal or State),

National Research Service Award

Program, Public Health and National

Health Service Corps Scholarship

Training Program, National Health

Service Corps Scholarship Program,

Armed Forces (Army, Navy, or Air

Force) Health Professions Scholarship

Program, Indian Health Service

Program, and similar programs, upon

determination by the Secretary, which

provide loans, scholarships, loan

repayments, or other awards in

exchange for a future service obligation;

(5) Any loan in default or not in a

current payment status;

(6) Loan amounts which participants

have paid or were due to have paid

prior to the program eligibility date; and

(7) Loans for which promissory notes

have been signed after the program

eligibility date.

§ 68a.10 What does an individual have to

do in return for loan repayments received

under the CR–LRP?

Individuals must agree to be engaged

in approved clinical research, as

employees of the NIH, for a minimum

initial period of two consecutive years.
5956 Federal Register / Vol. 62, No. 27 / Monday, February 10, 1997 / Proposed Rules

§ 68a.11 How does an individual receive

loan repayments beyond the initial two-year

contract?

An individual may apply for and the

Secretary may grant extension contracts

for one-year periods, if there is

sufficient debt remaining to be repaid

and the individual is engaged in

approved clinical research as an NIH

employee.

§ 68a.12 What will happen if an individual

does not comply with the terms and

conditions of participation in the CR–LRP?

(a) Absent withdrawal (see § 68a.2) or

termination under paragraph (d) of this

section, any participant who fails to

complete the minimum two-year service

obligation required under the Program

contract will be considered to have

breached the contract and will be

subject to assessment of monetary

damages and penalties as follows:

(1) Participants who leave during the

first year of the initial contract are liable

for amounts already paid by the NIH on

behalf of the participant plus an amount

equal to $1,000 multiplied by the

number of months of the original service

obligation.

(2) Participants who leave during the

second year of the contract are liable for

amounts already paid by the NIH on

behalf of the participant plus $1,000 for

each unserved month.

(b) Payments of any amount owed

under paragraph (a) of this section shall

be made within one year of the

participant’s breach (or such longer

period as determined by the Secretary).

(c) Participants who sign a

continuation contract for any year

beyond the initial two-year period and

fail to complete the one-year period

specified are liable for the pro rata

amount of any benefits advanced

beyond the period of completed service.

(d) Terminations will not be

considered a breach of contract in cases

where such terminations are beyond the

control of the participant as follows:

(1) Terminations for cause or for

convenience of the Government will not

be considered a breach of contract and

monetary damages will not be assessed.

(2) Occasionally, a participant’s

research assignment may evolve and

change to the extent that the individual

is no longer engaged in approved

clinical research. Similarly, the research

needs and priorities of the ICA and/or

the NIH may change to the extent that

a determination is made that the health

professional’s skills may be better

utilized in a non-clinical research

assignment. Under these circumstances,

the following will apply:

(i) Program participation and benefits

will cease as of the date an individual

is no longer engaged in approved

clinical research; and

(ii) Normally, job changes of this

nature will not be considered a breach

of contract on the part of either the NIH

or the participant. Based on the

recommendation of the ICA Director

and concurrence of the Secretary, the

participant will be released from the

remainder of his or her service

obligation without assessment of

monetary penalties. The participant in

this case will be permitted to retain all

Program benefits made or owed by NIH

on his/her behalf up to the date the

individual is no longer engaged in

approved clinical research, except the

pro rata amount of any benefits

advanced beyond the period of

completed service.

§ 68a.13 Under what circumstances can

the service or payment obligation be

canceled, waived, or suspended?

(a) Any obligation of a participant for

service or payment to the Federal

Government under this part will be

canceled upon the death of the

participant.

(b) The Secretary may waive or

suspend any service or payment

obligation incurred by the participant

upon request whenever compliance by

the participant:

(1) Is impossible,

(2) Would involve extreme hardship

to the participant, or

(3) If enforcement of the service or

payment obligation would be against

equity and good conscience.

(4) The Secretary may approve a

request for a suspension of the service

or payment obligations for a period of 1

year. A renewal of this suspension may

also be granted.

(c) Compliance by a participant with

a service or payment obligation will be

considered impossible if the Secretary

determines, on the basis of information

and documentation as may be required,

that the participant suffers from a

physical or mental disability resulting

in the permanent inability of the

participant to perform the service or

other activities which would be

necessary to comply with the obligation.

(d) In determining whether to waive

or suspend any or all of the service or

payment obligations of a participant as

imposing an undue hardship and being

against equity and good conscience, the

Secretary, on the basis of information

and documentation as may be required,

will consider:

(1) The participant’s present financial

resources and obligations;

(2) The participant’s estimated future

financial resources and obligations; and

(3) The extent to which the

participant has problems of a personal

nature, such as a physical or mental

disability or terminal illness in the

immediate family, which so intrude on

the participant’s present and future

ability to perform as to raise a

presumption that the individual will be

unable to perform the obligation

incurred.

§ 68a.14 When can a CR-LRP payment

obligation be discharged in bankruptcy?

Any payment obligation incurred

under § 68a.12 may be discharged in

bankruptcy under Title 11 of the United

States Code only if such discharge is

granted after the expiration of the fiveyear period beginning on the first date

that payment is required and only if the

bankruptcy court finds that a

nondischarge of the obligation would be

unconscionable.

§ 68a.15 Additional conditions.

When a shortage of funds exists,

participants may be funded partially, as

determined by the Secretary. However,

once a CR-LRP contract has been signed

by both parties, the Secretary will

obligate such funds as necessary to

ensure that sufficient funds will be

available to pay benefits for the duration

of the period of obligated service unless,

by mutual written agreement between

the Secretary and the applicant,

specified otherwise. Benefits will be

paid on a quarterly basis after each

service period unless specified

otherwise by mutual written agreement

between the Secretary and the

applicant.

The Secretary may impose additional

conditions as deemed necessary.

§ 68a.16 What other regulations and

statutes apply?

Several other regulations and statutes

apply to this part. These include, but are

not necessarily limited to:

Debt Collection Act of 1982, Pub. L. 97–365

(5 U.S.C. 5514);

Fair Credit Reporting Act (15 U.S.C. 1681 et

seq.);

Federal Debt Collection Procedures Act of

1990, Pub. L. 101–647 (28 U.S.C. 1); and

Privacy Act of 1974 (5 U.S.C. 552a).

[FR Doc. 97–3215 Filed 2–7–97; 8:45 am]

BILLING CODE 4140–01–P