National Institutes of Health Contraception and Infertility Research Loan Repayment Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 68c

RIN 0925-AA19

National Institutes of Health Contraception and Infertility

Research Loan Repayment Program

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The National Institutes of Health (NIH) through the Center for

Population Research of the National Institute of Child Health and Human

Development (NICHD) proposes to issue regulations to implement

provisions of the Public Health Service (PHS) Act authorizing the NICHD

Contraception and Infertility Research Loan Repayment Program (CIR-

LRP). The purpose of the CIR-LRP is the recruitment and retention of

highly qualified health professionals conducting contraception and/or

infertility research.

DATES: Comments must be received on or before February 8, 2000 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, 6011 Executive Blvd.,

Room 601, MSC 7669, Rockville, MD 20852. Comments may also be sent

electronically by FAX (301-402-0169) or email ([email protected]).

FOR FURTHER INFORMATION CONTACT: Jerry Moore at the address above, or

telephone (301) 496-4607 (not a toll-free number). For program

information contact: Dr. Louis V. DePaolo, Contraception and

Infertility Research Loan Repayment Program, Center for Population

Research, National Institute of Child Health and Human Development,

NIH, Building 61E, Room 8B01, Bethesda, Maryland 20892-7510; telephone

(301) 496-6515 (not a toll-free number); FAX (301) 496-0962; e-mail

([email protected]).

SUPPLEMENTARY INFORMATION: The NIH Revitalization Act of 1993 (Public

Law 103-43) was enacted on June 10, 1993, adding section 487B of the

Public Health Service (PHS) Act, 42 U.S.C. 288-2. Section 410(b) of

Public Law 105-392, the Heath Professions Education Partnership Act of

1998, amended section 487B of the PHS Act to increase the maximum

annual loan repayment from $20,000 to $35,000. Section 487B, as

amended, authorizes the Secretary of Health and Human Services to

establish a program of entering into contracts with qualified health

professionals under which such professionals agree to conduct

contraception and/or infertility research in consideration of the

Federal Government agreeing to repay, for each year of such service,

not more than $35,000 of the principal and interest of their

outstanding graduate and/or undergraduate educational loans.

The Secretary, in consultation with the Director of NICHD, has

established the NICHD Contraception and Infertility Research Loan

Repayment Program (CIR-LRP) to implement this statutory authority. In

return for loan repayments, applicants must agree to participate in

contraception and/or infertility research for a period of obligated

service of not less than two years. Selected applicants become

participants in the CIR-LRP only upon the signing of a written contract

by the Director, NICHD. The NIH is proposing to amend title 42 of the

Code of Federal Regulations by adding a new Part 68c to govern the

administration of this loan repayment program.

The proposed regulations specify 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 was reviewed under Executive Order 12866 by OIRA and was deemed to

be significant. Therefore it has been reviewed by OMB prior to

publication.

Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that

regulatory proposals be analyzed to determine whether they create a

significant impact on a substantial number of small entities. The

Secretary certifies that any final rule resulting from this proposal

will not have any such impact.

Paperwork Reduction Act

The application forms for use by the NICHD Contraception and

Infertility Loan Repayment Program have been approved by OMB under OMB

Approval No. 0925-0040 (expires December 31, 1999). This proposed rule

does not contain any other 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).

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance (CFDA) numbered program

affected by the proposed regulation is:

93.209--NICHD Contraception and Infertility Research Loan Repayment

Program.

List of Subjects in 42 CFR Part 68c

Health professions, Loan programs--health, Medical research,

Reporting and recordkeeping requirements.

Dated: June 29, 1999.

Harold Varmus,

Director, National Institutes of Health.

Approved: August 26, 1999.

Donna E. Shalala,

Secretary.

For the reasons presented in the preamble, it is proposed to amend

chapter I of title 42 of the Code of Federal Regulations by adding a

new Part 68c to read as follows:

PART 68c--NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM

Sec.

68c.1 What is the scope and purpose of the National Institute of

Child Health and Human Development (NICHD) Contraception and

Infertility Research Loan Repayment Program (CIR-LRP)?

68c.2 Definitions.

68c.3 Who is eligible to apply?

68c.4 Who is eligible to participate?

68c.5 Who is ineligible to participate?

68c.6 How do individuals apply to participate in the CIR-LRP?

68c.7 How are applicants selected to participate in the CIR-LRP?

68c.8 What does the CIR-LRP provide to participants?

68c.9 What loans qualify for repayment?

68c.10 What does an individual have to do in return for loan

repayments received under the CIR-LRP?

68c.11 How does an individual receive loan repayments beyond the

initial two-year contract?

68c.12 What will happen if an individual does not comply with the

terms and conditions of participation in the CIR-LRP?

68c.13 Under what circumstances can the service or payment

obligation be canceled, waived, or suspended?

68c.14 When can a CIR-LRP payment obligation be discharged in

bankruptcy?

68c.15 Additional conditions.

68c.16 What other regulations and statutes apply?

Authority: 42 U.S.C. 288-2.

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Sec. 68c.1 What is the scope and purpose of the National Institute of

Child Health and Human Development (NICHD) Contraception and

Infertility Research Loan Repayment Program (CIR-LRP)?

This part applies to the award of educational loan payments under

the NICHD Contraception and Infertility Research Loan Repayment Program

(CIR-LRP) authorized by section 487B of the Public Health Service Act

(42 U.S.C. 288-2). The purpose of this CIR-LRP is the recruitment and

retention of highly qualified health professionals conducting

contraception and/or infertility research.

Sec. 68c.2 Definitions.

As used in this part:

Act means the Public Health Service Act, as amended (42 U.S.C. 201

et seq.).

Allied health professional means:

(1) A physician assistant; or

(2) A research assistant with at least a bachelor's degree and

applicable career goals.

Applicant means an individual who applies to, and meets the

eligibility criteria for the CIR-LRP.

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.

Contraception and Infertility Research Loan Repayment Program (CIR-

LRP or Program) means the NICHD Contraception and Infertility Research

Loan Repayment Program authorized by section 487B of the Act.

Contraception and Infertility Research Loan Repayment Program (CIR-

LRP or Program) contract refers to the agreement, which is signed by an

applicant and the Secretary, wherein the applicant agrees to

participate in research on infertility or contraceptive development and

the Secretary agrees to repay qualified educational loans for a

prescribed period as specified in this part.

Contraception and Infertility Research Loan Repayment Program (CIR-

LRP or Program) Panel means a board assembled to review, rank, and

approve or disapprove CIR-LRP applications. The Panel is composed of

the Deputy Director, NICHD, representatives of NICHD's Office of

Administrative Management, respective Program Officers of the Center

for Population Research, and other special consultants as required.

Contraceptive development means research whose ultimate goal is to

provide new or improved means of preventing pregnancy.

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.

Eligible NICHD-supported extramural site means a site funded by

NICHD that can be identified as one of the following:

(1) A Cooperative Specialized Contraception and Infertility

Research Center;

(2) A Cooperative Specialized Research Center in Reproduction

Research;

(3) A Women's Reproductive Health Research Career Development

Center; or

(4) A Reproductive Medicine Unit identified as a clinical site for

the National Cooperative Reproductive Medicine Network.

Government loans means loans made by Federal, State, county, or

city agencies which are authorized by law to make such loans.

Health professional means an individual who is a physician, Ph.D-

level scientist, nurse, or a graduate student or postgraduate research

fellow working toward a degree that will enable them to practice in one

of those professions.

Infertility research means research whose long-range objective is

to evaluate, treat or ameliorate conditions which result in the failure

of couples to either conceive or bear young.

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.

NICHD intramural laboratory means a laboratory that is supported by

the NICHD intramural research program.

Panel means the NICHD Contraception and Infertility Research Loan

Repayment Program Panel.

Participant means an individual whose application to the CIR-LRP

has been approved and whose Program contract has been executed by the

Secretary.

Qualified educational loans include Government and commercial

educational loans, interest and related expenses 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.

Research on infertility or contraceptive development means

activities which qualify for participation in the CIR-LRP as determined

by the Program Panel.

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.

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 an individual's cessation of participation in the

Program pursuant to a request by that participant that is implemented

by the Secretary prior to the Program making payments on the

participant's behalf. A withdrawal is without penalty to the

participant and without obligation to the Program.

Sec. 68c.3 Who is eligible to apply?

To be eligible to apply to the CIR-LRP, an individual must be a

qualified health or allied health professional who is at the time of

application, or will be at the time of inception into the CIR-LRP,

engaged in employment/training at

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an NICHD intramural laboratory or an eligible NICHD-supported

extramural site.

Sec. 68c.4 Who is eligible to participate?

To be eligible to participate in the CIR-LRP, the applicant must

have institutional assurance of employment/affiliation with the NICHD

intramural laboratory or eligible NICHD-supported extramural site and

approval of the CIR-LRP Panel, must meet the criteria specified in

Sec. 68c.3, and not be ineligible to participate under Sec. 68c.5

Sec. 68c.5 Who is ineligible to participate?

The following individuals are ineligible for CIR-LRP participation:

(a) Persons who are not eligible applicants as specified under

Sec. 68c.3;

(b) Persons who owe an obligation of health professional service to

the Federal Government, a State, or other entity. 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, National Health Service Corp. Loan Repayment Program, and the

NIH AIDS Research Loan Repayment Program.

Sec. 68c.6 How do individuals apply to participate in the CIR-LRP?

An application for participation in the CIR-LRP shall be submitted

to the Center for Population Research, NICHD, NIH, which is responsible

for the Program's administration, in such form and manner as the

Secretary may prescribe.

Sec. 68c.7 How are applicants selected to participate in the CIR-LRP?

To be selected for participation in the CIR-LRP, applicants must

satisfy the following requirements:

(a) Applicants must meet the eligibility requirements specified in

Sec. 68c.3 and Sec. 68c.4.

(b) Applicants must not be ineligible for participation as

specified in Sec. 68c.5.

(c) Applicants must propose repayment of a loan that meets the

requirements of Sec. 68c.9.

(d) Applicants must be selected for approval by the CIR-LRP Panel

based upon a review of their applications.

Sec. 68c.8 What does the CIR-LRP provide to participants?

(a) Loan repayments. Upon receipt of an individual's written

commitment to serve a minimum initial period of two years of obligated

service in accordance with this part, the Secretary may pay up to

$35,000 per year of a participant's repayable debt for each year the

individual serves.

(b) Under paragraph (a) of this section, the Secretary will make

payments in the discharge of debt to the extent appropriated funds are

available for that purpose. When a shortage of funds exists,

participants may be funded partially, as determined by the Secretary.

However, once a CIR-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 otherwise specified by mutual

written agreement between the Secretary and the applicant. Benefits

will be paid on a quarterly basis after each service period unless

otherwise specified by mutual written agreement between the Secretary

and the applicant.

Sec. 68c.9 What loans qualify for repayment?

(a) The CIR-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 CIR-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 for

payment prior to inception into the CIR-LRP; and

(7) Loans for which promissory notes have been signed after the

individual's acceptance into the CIR-LRP.

Sec. 68c.10 What does an individual have to do in return for loan

repayments received under the CIR-LRP?

Individuals must make a written commitment in accordance with this

part to conduct, and must actually conduct research with respect to

contraception and/or infertility at an NICHD intramural laboratory or

an eligible NICHD-supported extramural site for a minimum initial

period of two years.

Sec. 68c.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 research on infertility

or contraceptive development at an NICHD intramural laboratory or

eligible NICHD-supported extramural site.

Sec. 68c.12 What will happen if an individual does not comply with the

terms and conditions of participation in the CIR-LRP?

(a) Absent withdrawal (see Sec. 68c.2) or termination under

paragraph (d) of this section, any participant who fails to begin or

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 CIR-LRP on behalf

of the participant plus an amount equal to $1,000 multiplied by the

number of months of the original two-year service obligation.

(2) Participants who leave during the second year of the contract

are liable for amounts already paid by the NICHD on

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behalf of the participant plus $1,000 for each unserved month.

(b) 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 rate amount of any benefits

advanced beyond the period of completed service plus an amount equal to

the number of months of obligated service that were not completed by

the participant multiplied by $1,000.

(c) Payments of any amount owed under paragraph (a) or (b) of this

section shall be made within one year of the participant's breach (or

such longer period as determined by the Secretary).

(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

that are not based upon a breach or default of the participant will not

be considered a breach of contract and monetary damages will not be

assessed.

(2) The participant transfers to another NICHD intramural

laboratory or eligible NICHD-supported extramural site, in which case

the participant remains bound to any and all obligations of the

contract.

(3) The participant transfer to a site other than an NICHD

intramural laboratory or eligible NICHD-supported extramural site, in

which case the participant may not be assessed monetary penalties if,

in the judgment of the CIR-LRP Panel, the participant continues to

engage in contraception and/or infertility research for any remaining

period of obligated service as set forth in the contract.

Sec. 68c.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)(1) The Secretary may waive or suspend any service or payment

obligation incurred by the participant upon request whenever compliance

by the participant:

(i) Is impossible;

(ii) Would involve extreme hardship to the participant; or

(iii) If enforcement of the service or payment obligation would be

against equity and good conscience.

(2) 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 pyament

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 result 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;

(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 an

future ability to perform as to raise a presumption that the individual

will be unable to perform the obligation incurred.

Sec. 68c.14 When can a CIR-LRP payment obligation be discharged in

bankruptcy?

Any payment obligation incurred under Sec. 68c.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 five-year 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.

Sec. 68c.15 Additional conditions.

In order to protect or conserve Federal funds or to carry out the

purposes of section 487B of the Act, or of this part, the Secretary may

impose additional conditions as a condition of any approval, waiver or

suspension authorized by this part.

Sec. 68c.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, Public Law 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, Public Law 101-

647(28 U.S.C. 1).

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

[FR Doc. 99-31986 Filed 12-9-99; 8:45 am]

BILLING CODE 4140-01-M