[Federal Register Volume 64, Number 237 (Friday, December 10, 1999)]
[Proposed Rules]
[Pages 69213-69217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31986]


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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