[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Notices]
[Pages 58452-58456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institutes of Health Extramural Loan Repayment Program 
for Clinical Researchers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) announces the 
availability of educational loan repayment under the NIH Extramural 
Loan Repayment Program for Clinical Researchers (LRP-CR). The Loan 
Repayment Program for Clinical Researchers, which is authorized by 
section 487F \1\ of the

[[Page 58453]]

Public Health Service (PHS) Act (42 U.S.C. 288-5a), as added by the 
Clinical Research Enhancement Act of the Public Health Improvement Act 
of 2000 (Public Law 106-505), provides for the repayment of the 
existing educational loan debt of qualified health professionals who 
agree to conduct clinical research. The Loan Repayment Program for 
Clinical Researchers provides for the repayment of up to $35,000 of the 
principal and interest of the extant educational loans of such health 
professionals for each year of obligated service. Payments equal to 39 
percent of total loan repayments are issued to the Internal Revenue 
Service on behalf of program participants to offset Federal tax 
liabilities incurred. The purpose of the Loan Repayment Program for 
Clinical Researchers 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, and who agree to engage in such research for at least 50 percent 
of their time, i.e., not less than 20 hours per week, to apply for 
participation in the NIH Loan Repayment Program for Clinical 
Researchers.
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    \1\ So in law. There are two sections 487F. Section 205 of 
Public Law 106-505 (114 Stat. 2329), inserted section 487F after 
section 487E. Previously, section 1002(b) of Public Law 106-310 (114 
Stat. 1129), which relates to a Pediatric Research Loan Repayment 
Program, inserted section 487F after section 487E.

DATES: Interested persons may request information about the Loan 
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Repayment Program for Clinical Researchers on September 30, 2004.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, 
Office of Management Assessment, NIH, 6011 Executive Blvd., Room 601, 
MSC 7669, Rockville, MD 20892, by e-mail [email protected], by fax 
(301) 402-0169, or by telephone (301) 496-4607 (not a toll-free 
number). For program information contact Marc S. Horowitz, e-mail 
[email protected], or telephone (301) 402-5666 (not a toll free number). 
Information regarding the requirements, the application deadline dates, 
and an online application for the Loan Repayment Program for Clinical 
Researchers may be obtained at the NIH Loan Repayment Program Web site, 
http://www.lrp.nih.gov.

SUPPLEMENTARY INFORMATION: The Clinical Research Enhancement Act, which 
is contained in the Public Health Improvement Act of 2000 (Public Law 
106-505), was enacted on November 13, 2000, adding section 487F of the 
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 research service, not more than $35,000 of 
the principal and interest of the extant qualified educational loans of 
such health professionals. Payments equal to 39 percent of total loan 
repayments are issued to the Internal Revenue Service on behalf of 
program participants to offset Federal tax liabilities incurred. 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 
Loan Repayment Program for Clinical Researchers include the following:
    1. Applicants must be a U.S. citizen, U.S. national, or permanent 
resident of the United States;
    2. Applicants must have an M.D., Ph.D., Pharm. D., Psy.D., D.O., 
D.D.S., D.M.D., D.P.M., D.C., N.D., or equivalent doctoral degree from 
an accredited institution;
    3. Applicants must have total qualifying educational loan debt 
equal to or in excess of 20 percent of their institutional base salary 
on the date of program eligibility (the effective date that a loan 
repayment contract has been executed by the Secretary of Health and 
Human Services or designee), expected to be between July 1 and 
September 1, 2005. Institutional base salary is the annual amount that 
the organization pays for the participant's appointment, whether the 
time is spent in research, teaching, patient care, or other activities. 
Institutional base salary excludes any income that a participant may 
earn outside the duties of the organization. Institutional base salary 
may not include or comprise any income (salary or wages) earned as a 
Federal employee;
    4. Applicants must conduct qualifying research supported by a 
domestic non-profit foundation, non-profit professional association, or 
other non-profit institution, or a U.S. or other Government agency 
(Federal, State, or local). A domestic foundation, professional 
association, or institution is considered to be non-profit if exempt 
from Federal tax under the provisions of section 501 of the Internal 
Revenue Code (26 U.S.C. 501);
    5. Applicants must engage in qualified clinical research. Clinical 
research is defined as 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. Applicants must engage in qualified clinical research for at 
least 50 percent of their time, i.e., not less than 20 hours per week;
    7. Full-time employees of Federal Government agencies are 
ineligible to apply for LRP benefits. Part-time Federal employees who 
engage in qualifying research as part of their non-Federal duties for 
at least 20 hours per week, and whose funding source is from a non-
profit source as defined in number 4 of this section, are eligible to 
apply for loan repayment if they meet all other eligibility 
requirements;
    8. Applicants must agree to conduct research for which funding is 
not prohibited by Federal law, regulation, or HHS/NIH policy. 
Recipients who receive LRP awards must conduct their research in 
accordance with applicable Federal, State, and local law (e.g., 
applicable human subject protection regulations);
    9. Applicants will not be excluded from consideration under the 
Loan Repayment Program for Clinical Researchers on the basis of age, 
race, culture, religion, gender, sexual orientation, disability, or 
other non-merit factors; and
    10. No individual may submit more than one LRP application to the 
NIH in any fiscal year. Individuals who have applied previously for the 
LRP-CR but did not receive an award are eligible to submit a new 
application if they meet all of the above eligibility criteria.
    The following individuals are ineligible for participation in the 
Loan Repayment Program for Clinical Researchers:
    1. Persons who are not United States citizens, nationals, or 
permanent residents;
    2. 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;
    3. Any individual who owes an obligation of health professional 
service to the Federal Government, a State, or other entity, unless 
deferrals or

[[Page 58454]]

extensions are granted for the length of their Extramural Loan 
Repayment Program service obligation. The following are examples of 
programs with service obligations that disqualify an applicant from 
consideration, unless a deferral for the length of participation in the 
Loan Repayment Program for Clinical Researchers is obtained: Armed 
Forces (Army, Navy, or Air Force) Professions Scholarship Program, 
Exceptional Financial Need (EFN) Scholarship Program, Financial 
Assistance for Disadvantaged Health Professions Students (FADHPS), 
Indian Health Service (IHS) Scholarship Program, National Health 
Service Corps (NHSC) Scholarship Program, National Institutes of Health 
Undergraduate Scholarship Program (UGSP), Physicians Shortage Area 
Scholarship Program, Primary Care Loan (PCL) Program, Public Health 
Service (PHS) Scholarship Program, and National Research Service Award 
(NRSA) Program;
    4. Full-time employees of Federal Government agencies. Part-time 
Federal employees who engage in qualifying research supported by a 
domestic non-profit institution, as part of their non-Federal duties, 
for an outside entity for at least 20 hours per week, based on a 40-
hour week, are eligible to apply for the LRP-CR if they meet all other 
eligibility requirements;
    5. Current recipients of NIH Intramural Research Training Awards 
(IRTA) or Cancer Research Training Awards (CRTA);
    6. Individuals conducting research for which funding is precluded 
by Federal law, regulations or HHS/NIH policy, or that does not comply 
with applicable Federal, State, and local law regarding the conduct of 
the research (e.g., applicable human subject protection regulations); 
and
    7. Individuals with ineligible loans, which include loans that have 
been consolidated with a loan of another individual (including spouses 
or children), or loans that are not educational, such as home equity 
loans.

Selection Process

    Upon receipt, applications for the Loan Repayment Program for 
Clinical Researchers will be reviewed for eligibility and completeness 
by the NIH Office of Loan Repayment. Incomplete or ineligible 
applications will not be processed for review. Applications that are 
complete and eligible will be referred to the appropriate NIH Institute 
or Center for peer review by the NIH Center for Scientific Review 
(CSR). In evaluating the application, reviewers will be directed to 
consider the following components as they relate to the likelihood that 
the applicant will continue in a clinical research career:
    a. Potential of the applicant to pursue a career in clinical 
research.
     Appropriateness of the applicant's previous training and 
experience to prepare him/her for a clinical research career.
     Suitability of the applicant's proposed clinical research 
activities in the two-year loan repayment period to foster a research 
career.
     Assessment of the applicant's commitment to a research 
career as reflected by the personal statement of long-term career goals 
and the plan outlined to achieve those goals.
     Strength of recommendations attesting to the applicant's 
potential for a research career.
    b. Quality of the overall environment to prepare the applicant for 
a clinical research career.
     Availability of appropriate scientific colleagues to 
achieve and/or enhance the applicant's research independence.
     Quality and appropriateness of institutional resources and 
facilities.
    Renewal applications are competitive and will be evaluated using 
the same criteria as new applications plus two additional criteria--an 
assessment of research accomplishments and development of an individual 
as an independent investigator.
    The following information is furnished by the applicant or others 
on behalf of the applicant (forms are completed electronically at the 
NIH LRP Web site, http://www.lrp.nih.gov):
    Applicants electronically transmit the following to the NIH Office 
of Loan Repayment:
    1. Applicant Information Statement.
    2. Biosketch.
    3. Personal Statement, which includes a discussion of career goals 
and academic objectives.
    4. Description of Research Activities, which describes the current 
or proposed research project including the specific responsibilities 
and role of the applicant in conducting the research. The research 
supervisor or mentor will be asked to concur in the research project 
description provided by the applicant.
    5. Identification of three Recommenders (one of whom is identified 
as research supervisor or mentor).
    6. Identification of Institutional Contact.
    7. Online Certification.
    8. Current account statement(s) and promissory note(s) or 
disclosure statement(s) obtained from lending institution(s), submitted 
via facsimile to (866) 849-4046.
    9. If applying based on NIH support, Notice of Grant/Award (or PHS 
Form Number 2271 for T32 recipients).
    Research supervisors or mentors electronically transmit the 
following to the NIH Office of Loan Repayment:
    1. Recommendation.
    2. Biosketch.
    3. Assessment of the Research Activities Statement submitted by the 
applicant.
    4. Description of the Research Environment, which provides detailed 
information about the lab where the applicant is or will be conducting 
research, including funding, lab space, and major areas under 
investigation.
    5. Training or Mentoring Plan, which includes a detailed discussion 
of the training or mentoring plan, including a discussion of the 
research methods and scientific techniques to be taught. This document 
is completed by the research supervisor or mentor and is submitted for 
all applicants (except for applicants with an NIH R01 or equivalent 
grant).
    6. Biosketch of a laboratory staff member if involved in training 
or mentoring the applicant.
    The other two Recommenders electronically transmit recommendations 
to the NIH Office of Loan Repayment.
    Institutional Contacts electronically transmit the following to the 
NIH Office of Loan Repayment:
    1. A certification that: (a) Assures the applicant will be provided 
the necessary time and resources to engage in the research project for 
two years from the date a Loan Repayment Program Contract is executed; 
(b) assures that the applicant is or will be engaged in qualifying 
research for 50 percent of his/her time, i.e., not less than 20 hours 
per week; (c) certifies that the institution is a domestic non-profit 
institution (exempt from tax under 26 U.S.C. 501) or is a U.S. 
Government or other Government agency (Federal, State, local); and (d) 
provides the applicant's institutional base salary.

Program Administration and Details

    Under the Loan Repayment Program for Clinical Researchers, the NIH 
will repay a portion of the extant qualified educational loan debt 
incurred to pay for the researcher's undergraduate, graduate, and/or 
health professional school educational expenses. Individuals must have 
total qualified educational debt that equals or exceeds 20 percent of 
their institutional base salary on the date of program eligibility. 
This is called the debt threshold. The formula used to calculate the 
potential annual loan repayment amount is total educational debt less 
the participant

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obligation (an amount equal to 10 percent of institutional base 
salary), which yields the total repayable debt; the total repayable 
debt is divided by 25 percent, which yields the potential annual 
repayment amount (up to $35,000). Participants are encouraged to pay 
the participant obligation during the contract period.
    Following is an example of loan repayment calculations: 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 percent of 
university compensation = $8,000), the applicant has sufficient debt 
for loan repayment consideration. The participant obligation is 10 
percent of the institutional base salary, in this case $4,000. Thus, 
repayment of the $4,000 debt is the applicant's responsibility. The 
remaining amount, in this example $96,000 (total repayable debt), will 
be considered for repayment on a graduated basis. In this case, the 
maximum to be repaid in the initial two-year contract is $48,000 or 
$24,000 per year, plus tax reimbursement benefits.
    The total repayable debt will be paid at the rate of one-quarter 
per year, subject to a statutory limit of $35,000 per year for each 
year of obligated service. Individuals are required to initially engage 
in 2 years of qualified clinical research.
    Following conclusion of the initial two-year contract, participants 
may competitively apply for renewal contracts if they 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, 
qualified clinical research continues, and domestic non-profit 
institutional or U.S. or other Government agency (Federal, State, or 
local) support has been assured. Renewal applications are competitively 
reviewed and the submission of a renewal application does not ensure 
the award of benefits. Renewal applications will be reviewed using the 
same criteria as new applications plus two additional criteria--an 
assessment of research accomplishments and development of an individual 
as an independent investigator. Funding of renewal contracts is also 
contingent upon an appropriation and/or allocation of funds from the 
U.S. Congress and/or the NIH or the NIH Institutes and Centers.
    In return for the repayment of their educational loans, 
participants must agree to (1) engage in qualified clinical research 
for a minimum period of two years; (2) engage in such research for at 
least 50 percent of their time, i.e., not less than 20 hours per week 
based on a 40 hour week; (3) make payments to lenders on their own 
behalf for periods of Leave Without Pay (LWOP); (4) pay monetary 
damages as required for breach of contract; and (5) satisfy other terms 
and conditions of the LRP contract. 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 extant principal, interest, and 
related expenses (such as the required insurance premiums on the unpaid 
balances of some loans) of educational loans from a U.S. Government 
entity, academic institution, or a commercial or other chartered U.S. 
lending institution, such as banks, credit unions, savings and loan 
associations, not-for-profit organizations, insurance companies, and 
other financial or credit institutions that 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, 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 are made directly to lenders, following receipt of (1) 
the Principal Investigator, Program Director, or 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 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); 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 Loans.
    The following loans are NOT repayable under the Loan Repayment 
Program for Clinical Researchers:
    (1) Loans not obtained from a U.S. or other Government entity, 
domestic academic institution, or a commercial or other chartered U.S. 
lending institution, such as loans from friends, relatives, or other 
individuals, and non-educational loans, such as home equity loans;
    (2) Loans for which contemporaneous documentation (current account 
statement, and promissory note or lender disclosure statement) is not 
available;
    (3) Loans that have been consolidated with loans of other 
individuals, such as a spouse or child;
    (4) 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;
    (5) Loans, financial debts, or service obligations incurred under 
the following programs, or other programs that incur a service 
obligation that converts to a loan on failure to satisfy the service 
obligation:
     Armed Forces (Army, Navy, or Air Force) Health Professions 
Scholarship Program;
     Indian Health Service (IHS) Scholarship Program;
     National Institutes of Health Undergraduate Scholarship 
Program (UGSP);
     National Research Service Award (NRSA) Program;

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     Physicians Shortage Area Scholarship Program (Federal or 
State);
     Primary Care Loan (PCL) Program; and
     Public Health Service (PHS) and National Health Service 
Corps (NHSC) Scholarship Program;
    (6) Delinquent loans, loans in default, or loans not current in 
their payment schedule;
    (7) PLUS Loans;
    (8) Loans that have been paid in full; and
    (9) Loans obtained after the execution of the NIH Loan Repayment 
Program Contract (e.g., promissory note signed after the LRP contract 
has been awarded) (this provision does not apply to qualifying loan 
consolidations).
    Before the commencement of loan repayment, or during lapses in loan 
repayments, due to NIH administrative complications, Leave Without Pay 
(LWOP), 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. The 
LRP contract period will not be modified or extended as a result of 
Leave Without Pay (LWOP) or a break in service. Penalties assessed 
participants as a result of NIH administrative complications to 
maintain a current payment status may not be considered for 
reimbursement.
    LRP payments are NOT retroactive. Loan repayment for Fiscal Year 
2005 will commence after a loan repayment contract has been executed, 
which is expected to be no earlier than July 2005.

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. The OMB approval of the 
information collection associated with the Loan Repayment Program for 
Clinical Researchers expires on December 31, 2004. The Catalog of 
Federal Domestic Assistance number for the Loan Repayment Program for 
Clinical Researchers is 93.280.

    Dated: September 21, 2004.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 04-21990 Filed 9-29-04; 8:45 am]
BILLING CODE 4140-01-P