[Federal Register Volume 63, Number 210 (Friday, October 30, 1998)]
[Rules and Regulations]
[Pages 58312-58315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29130]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 68a
RIN 0925-AA09
National Institutes of Health Clinical Research Loan Repayment
Program for Individuals from Disadvantaged Backgrounds
AGENCY: National Institutes of Health, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) is issuing regulations
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 conduct clinical research as
employees of the NIH by providing repayment of qualified educational
loans.
EFFECTIVE DATE: This final rule is effective on November 30, 1998.
FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer,
Office of Management Assessment, 6011 Executive Blvd., Suite 601, MSC
7669, Rockville, MD 20852; telephone 301-496-4607 (not a toll-free
number); Fax 301-402-0169; or E-mail ([email protected]). For program
information contact: Marc S. Horowitz, telephone 301-402-5666 (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 amending title 42 of the Code of
Federal Regulations by adding a new part 68a to govern the
administration of this loan repayment program.
The 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 NIH announced its plans to issue the regulations in a notice of
proposed rulemaking (NPRM) published in the Federal Register, February
10, 1997 (62 FR 5953). The NPRM provided for a 60-day comment period.
The NIH received no comments. Consequently, the final regulations are
the same as those originally proposed in February 1997, except for an
editorial change reflecting the NIH Medical Board's change of name to
the ``Medical Executive Committee.''
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 final rule
has been reviewed under Executive Order 12866 by OIRA and has been
deemed not significant.
Regulatory Flexibility Act
The Regulatory Flexibility Act requires that regulatory actions be
analyzed to determine whether they create a significant impact on a
substantial number of small entities. I certify that this final rule
will not have any such impact.
Paperwork Reduction Act
This final 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 used by the NIH Clinical Research Loan
Repayment Program for Individuals from Disadvantaged Backgrounds have
been reviewed and approved by OMB under OMB No. 0925-0361 (expires
September 30, 1998).
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: September 18, 1998.
Harold Varmus,
Director, National Institutes of Health.
For the reasons presented in the preamble, title 42 of the Code of
Federal Regulations is amended 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?
[[Page 58313]]
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?
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.
Sec. 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.
Sec. 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
Executive Committee 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 co-chaired 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 co-chairs, 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.
[[Page 58314]]
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 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.
Sec. 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.
Sec. 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.
Sec. 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
section 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, NIH-National Research Council (NRC) Biotechnology Research
Associates Program participants, and Intergovernmental Personnel Act
(IPA) participants; or
(d) Persons who do not have clinical privileges.
Sec. 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.
Sec. 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
Sec. 68a.3 and Sec. 68a.4.
(b) Applicants must not be ineligible for participation as
specified in Sec. 68a.5.
(c) Applicants must be selected for approval by the CR-LRC, based
upon a review of their applications.
Sec. 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 Sec. 68a.8(a), the Secretary will make payments in the
discharge of debt to the extent appropriated funds are available for
these purposes.
Sec. 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.
[[Page 58315]]
Sec. 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.
Sec. 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.
Sec. 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 Sec. 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.
Sec. 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 such 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 such 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.
Sec. 68a.14 When can a CR-LRP payment obligation be discharged in
bankruptcy?
Any payment obligation incurred under Sec. 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 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. 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.
Sec. 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. 98-29130 Filed 10-29-98; 8:45 am]
BILLING CODE 4140-01-P