[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Notices]
[Pages 46643-46645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Loan Repayment Program for Clinical Researchers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: Pending approval by the Office of Management and Budget (OMB) 
under the requirements of the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) announces the availability of 
educational loan repayment under the NIH Loan Repayment Program for 
Clinical Researchers (the Program). The Program, which is authorized by 
section 487F of the Public Health Service (PHS) Act (42 U.S.C. 288-5a), 
as added by the Public Health Improvement Act of 2000 (Pub. L. 106-
505), provides for the repayment of the educational loan debt of 
qualified health professionals who agree to conduct clinical research. 
The Program provides for the repayment of up to $35,000 of the 
principal and interest of the educational loans of such health 
professionals for each year of obligated service. The purpose of the 
Program is the recruitment and retention of highly qualified health 
professionals as clinical investigators. Through this notice, the NIH 
invites qualified health professionals who contractually agree to 
engage in clinical research for at least two years, to apply for 
participation in the NIH Loan Repayment Program for Clinical 
Researchers.

DATES: Interested persons may request information about the Program 
beginning on September 6, 2001.

ADDRESSES: Information regarding the requirements and application 
procedures for the Program may be obtained by calling or writing: Marc 
S. Horowitz, J.D., Office of Loan Repayment and Scholarship, National 
Institutes of Health, 2 Center Drive, Room 2E30, Bethesda, MD 20892-
0230 or call non-toll-free number (301) 402-5666 or e-mail your 
request, including your address, to [email protected]>.

SUPPLEMENTARY INFORMATION: The Public Health Improvement Act of 2000 
(Pub. L. 106-505) was enacted on November 13, 2000 adding section 487F 
of the Public Health Service (PHS) Act (42 U.S.C. 288-5a). Section 487F 
authorizes the Secretary, acting through the Director of the NIH, to 
carry out a program of entering into contracts with appropriately 
qualified health professionals. Under such contracts, qualified health 
professionals agree to conduct clinical research for at least two years 
in consideration of the Federal Government agreeing to repay, for each 
year of service, not more than $35,000 of the principal and interest of 
the educational loans of such health professionals. This program is 
known as the NIH Loan Repayment Program for Clinical Researchers (LRP-
CR).

Eligibility Criteria

    Specific eligibility criteria with regard to participation in the 
LRP for Clinical Researchers include the following:
    (1) Participants must be United States citizens, nationals, or 
permanent residents;
    (2) Participants must have a M.D., Ph.D., Pharm.D., D.O., D.D.S., 
D.M.D., D.P.M., D.C., N.D., or equivalent degree;
    (3) Participants must be affiliated with the NIH in one of the 
following ways:
    (a) a recipient of postdoctoral National Research Service Award 
support on an individual postdoctoral fellowship (F32) or an 
institutional research training grant (T32). NRSA recipients will only 
be eligible for loan repayment during the first and third year of NRSA 
support. The second year of postdoctoral NRSA involves repayment of a 
service obligation incurred during the first year of NRSA support which 
eliminates the possibility of concurrent participation in the loan 
repayment program.
    (b) a recipient of support under an individual or institutional 
research career development award including the following mechanisms:
    (1) K01, the Mentored Research Scientist Development Award,
    (2) K07, the Academic Clinical Scientist Development Award,
    (3) K08, the Mentored Clinical Scientist Development Award,
    (4) K12, Mentored Clinical Scientist Development Program Award,
    (5) K22, the Career Transition Award with an extramural phase,
    (6) K23, the Mentored Patient-Oriented Research Career Development 
Award, or
    (7) K25, the Mentored Quantitative Research Career Development 
Award.
    (c) a first-time recipient of NIH grant support as the principal 
investigator of an
    (1) R01, a research project grant consisting of one research 
project,
    (2) R03, a small research grant,
    (3) R21, an exploratory/developmental grant,
    (4) U01, a cooperative agreement consisting of one research 
project.
    (d) a first-time director of subprojects on multicomponent center 
grants (P series grants, program project grants (P01)), or 
multicomponent cooperative agreements (U series).
    (4) Participants must have qualifying educational debt in excess of 
20 percent of their annual income or compensation, as applicable, at 
their expected date of program eligibility. The expected date of 
program eligibility is the date by which

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the following conditions will be met: (a) Award date of a qualifying 
grant, and (b) the Secretary executes a LRP-CR contract. Contracts are 
not effective retroactive to the award date of the grant.
    (5) Participants must engage in clinical research, as defined by 
Section 206 of Public Law 106-505, the Public Health Improvement Act, 
which states: ``The term clinical research means patient-oriented 
clinical research conducted with human subjects, or research on the 
causes and consequences of disease in human populations involving 
material of human origin (such as tissue specimens and cognitive 
phenomena) for which an investigator or colleague directly interacts 
with human subjects in an outpatient or inpatient setting to clarify a 
problem in human physiology, pathophysiology or disease, or 
epidemiologic or behavioral studies, outcomes research or health 
services research, or developing new technologies, therapeutic 
interventions, or clinical trials.''
    (6) Individuals with existing service obligations to Federal, 
State, or other entities will not be considered for the Program unless 
and until the existing service obligation is discharged or deferred for 
the length of Program participation. Further, any individual who has a 
Federal judgment lien against his/her property arising from a Federal 
debt is barred from receiving Federal funds, until the judgment is paid 
in full or satisfied.
    (7) Applicants will not be excluded from consideration under the 
Program on the basis of age, race, culture, religion, gender, sexual 
orientation, disability, or other non-merit factors.
    NIH will evaluate the applicant and awardee pools after the first 
year of operation to assess and measure the extent of recruitment and 
retention of qualified health professionals to clinical research. At 
that time, NIH will expand the pool of individuals eligible to apply 
for loan repayment.

Selection Process

    Individuals submit their LRP-CR applications to the Director, 
Office of Loan Repayment and Scholarship (OLRS), who forwards those 
satisfying the basic eligibility criteria to the relevant NIH 
Institutes and Centers (IC) for review. The IC Loan Repayment Committee 
(IC-LRC) reviews and ranks applications based upon the following:
    (1) A personal statement, which includes a discussion of career 
goals and research and academic objectives;
    (2) A research statement, which provides a description of the 
proposed research project including the specific responsibilities and 
role of the applicant in conducting the research;
    (3) A research training plan, if applicable, which includes a 
detailed description of the mentoring plan, including a discussion of 
the research methods and scientific techniques to be taught;
    (4) A description of the current research being conducted in the 
lab;
    (5) Recommendation forms submitted by three individuals. 
Information provided addresses the applicant's potential for success in 
clinical research and/or academic medicine, and their main strengths 
and weaknesses; and
    (6) A supporting statement from the sponsoring institution.
    Funds for repayment will only be awarded to IC-LRC-approved 
applications, subject to the receipt of an appropriation and/or 
allocation of funds from the U.S. Congress, the NIH or IC. The 
Director, Office of Loan Repayment and Scholarship (OLRS), provides 
current deadlines, sources for assistance, and additional details 
regarding application procedures in an Applicant Information Bulletin 
that is maintained on the Loan Repayment Program's Internet homepage at 

http://lrp.info.nih.gov>.

Program Administration and Details

    Under the LRP for Clinical Researchers, the NIH will repay a 
portion of the extant qualified educational loan debt incurred by 
health professionals to pay for their undergraduate, graduate, and/or 
health professional school educational expenses. Upon application, 
individuals must have total qualified educational debt that exceeds 20% 
of their anticipated annual compensation (``debt threshold'') on the 
date of program eligibility.
    An amount equal to 50 percent of the debt threshold will not be 
considered for repayment (``participant obligation''). For example, an 
applicant has a loan debt of $100,000 and a university compensation of 
$40,000. Since the loan debt exceeds the ``debt threshold'' (20% of 
university compensation = $8,000), the applicant has sufficient debt 
for loan repayment consideration. The ``participant obligation'' is 
one-half the debt threshold, in this case $4,000. Thus, repayment of 
$4,000 is the applicant's responsibility. The remaining amount 
(``repayable debt'') will be considered for repayment.
    The repayable debt of qualified health professionals will be 
satisfied at the rate of one-quarter per year, subject to a statutory 
limit of $35,000 per year, for each year of obligated service. 
Obligated service requires selected individuals to engage in at least 2 
years of qualified clinical research as an investigator on an NIH grant 
or as the recipient of an NIH award. Following conclusion of the 
initial two-year contract, participants may apply for renewal contracts 
if they have remaining repayable debt and continue to engage in 
qualified clinical research. These continuation contracts may be 
approved on a year-to-year basis, subject to a finding by NIH that the 
applicant's clinical research accomplishments are acceptable and 
qualified clinical research continues. Funding of contracts is 
contingent upon an appropriation and/or allocation of funds from the 
U.S. Congress and/or the NIH or ICs.
    In return for the repayment of their educational loans, 
participants must agree to (1) engage in qualified clinical research as 
an investigator on an NIH grant or as a recipient of an NIH award for a 
minimum period of 2 years; (2) make payments to lenders on their own 
behalf for periods of Leave Without Pay (LWOP); (3) pay monetary 
damages as required for breach of contract; and (4) satisfy other terms 
and conditions of the LRP-CR contract and application procedures. 
Applicants must submit a signed contract, prepared by the NIH, agreeing 
to engage in qualified clinical research at the time they submit an 
application. Substantial monetary penalties will be imposed for breach 
of contract.
    The NIH will repay lenders for the principal, interest, and related 
expenses (such as the required insurance premiums on the unpaid 
balances of some loans) of qualified Government (Federal, State, local) 
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.
    Repayments will be authorized for direct payment to lenders, 
following receipt of (1) the research supervisor's verification of 
completion of the prior period of research, and (2) lender verification 
of the crediting of prior loan repayments, including the resulting 
account balances and current account status. The NIH will repay loans 
in the

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following order, unless the Secretary determines that significant 
savings would result from a different order of priority:
    (1) Loans guaranteed by the U.S. Department of Health and Human 
Services:
     Health Education Assistance Loan (HEAL);
     Health Professions Student Loan (HPSL);
     Loans for Disadvantaged Students (LDS);
     Primary Care Loan (PCL); and
     Nursing Student Loan Program (NSL);
    (2) Loans guaranteed by the U.S. Department of Education:
     Direct Subsidized Stafford Loan;
     Direct Unsubsidized Stafford Loan;
     Direct Consolidation Loan;
     Perkins Loan;
     FFEL Subsidized Stafford Loan;
     FFEL Unsubsidized Stafford Loan; and
     FFEL Consolidation Loan;
    (3) Loans made or guaranteed by a State, the District of Columbia, 
the Commonwealth of Puerto Rico, or a territory or possession of the 
United States;
    (4) Loans made by Academic Institutions; and
    (5) Private (``Alternative'') Educational Loans:
     MEDLOANS; and
     Private (non-guaranteed) Consolidation Loan.
    Within each category, loans are repaid in order of interest rate 
(highest first).
    The following loans are NOT repayable under the LRP-CR:
    (1) Loans not obtained from a government entity, academic 
institution, or a commercial or other chartered lending institution 
such as loans from friends, relatives, or other individuals;
    (2) Loans for which contemporaneous documentation is not available;
    (3) Loans or portions of loans obtained for educational or living 
expenses which exceed a reasonable level, as determined by the standard 
school budget for the year in which the loan was made, and are not 
determined by the LRP to be reasonable based on additional 
contemporaneous documentation provided by the applicant;
    (4) Loans, financial debts, or service obligations incurred under 
the following programs, or other programs which incur a service 
obligation which converts to a loan on failure to satisfy the service 
obligation:
     Physicians Shortage Area Scholarship Program (Federal or 
State);
     National Research Service Award Program;
     Public Health and National Health Service Corps 
Scholarship Program;
     Armed Forces (Army, Navy, or Air Force) Health Professions 
Scholarship Program; and
     Indian Health Service Scholarship Program;
    (5) Delinquent loans, loans in default, loans not current in their 
payment schedule, loans already repaid or those for which promissory 
notes have been signed after the program effective date are not 
eligible for repayment; and
    (6) PLUS Loans.
    During lapses in loan repayments, due either to LRP administrative 
complications or a break in service, LRP participants are wholly 
responsible for making payments or other arrangements that maintain 
loans current, such that increases in either principal or interest do 
not occur. Penalties assessed participants as a result of LRP 
administrative complications to maintain a current payment status may 
be considered for reimbursement.

Additional Program Information

    This program is not subject to the provisions of Executive Order 
12372, Intergovernmental Review of Federal Programs.
    This program is subject to OMB clearance under the requirements of 
the Paperwork Reduction Act of 1995. A Request for OMB Review and 
Approval of information collection associated with the program is being 
prepared by the NIH and will be sent to OMB for review and approval 
prior to implementation of the LRP for Clinical Researchers.
    The Catalog of Federal Domestic Assistance number for the LRP for 
Clinical Researchers is 93.280.

    Dated: Augsut 20, 2001.
Yvonne T. Maddox,
Acting Deputy Director, National Institutes of Health.
[FR Doc. 01-22353 Filed 9-5-01; 8:45 am]
BILLING CODE 4140-01-P