[Federal Register Volume 68, Number 61 (Monday, March 31, 2003)]
[Notices]
[Pages 15463-15467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Extramural Clinical Research Loan Repayment Program for 
Individuals From Disadvantaged Backgrounds

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) invites applications 
for the Extramural Clinical Research Loan Repayment Program for 
Individuals from Disadvantaged Backgrounds (ECR-LRP or Program) for 
fiscal year 2003. Pursuant to authority granted by Public Law 106-554, 
the Consolidated Appropriations Act of 2001, which amended Section 487E 
of the Public Health Service (PHS) Act (42 U.S.C. 288-5), as added by 
the National Institutes of Health Revitalization Act of 1993 (Pub. L. 
103-43), the Secretary of Health and Human Services (Secretary), acting 
through the Director of NIH, has established a loan repayment program 
that offers the repayment of educational loan debt to qualified health 
professionals from disadvantaged backgrounds, who have substantial debt 
relative to income and agree to conduct clinical research. The Director 
of NIH may enter into contracts with qualified health professionals 
from disadvantaged backgrounds who agree to engage in clinical research 
for a minimum of two years in exchange for loan repayments toward their 
outstanding educational loan debt, up to a maximum of $35,000 per year. 
Payments equal to 39 percent of total loan repayments are issued to the 
Internal Revenue Service on behalf of the participants to offset 
Federal tax liabilities incurred due to their participation in the 
Program.

DATES: Information regarding the ECR-LRP is currently available, and 
the following are the application deadline dates: Fiscal Year 2003--
January 31, 2003; Fiscal Year 2004--January 31, 2004; and Fiscal Year 
2005--January 31, 2005. All applications must be submitted on-line by 5 
p.m. (eastern standard time). If an Application Deadline Date falls on 
a weekend or holiday, the application is due on the following business 
day by 5 p.m. (eastern standard time).

ADDRESSES: The information and an on-line application may be obtained 
at the NIH Loan Repayment Program Web site at www.lrp.nih.gov or by 
contacting the National Center on Minority Health and Health 
Disparities, Attention Kenya McRae, non-toll free telephone number 
(301) 402-1366, or via email at [email protected].

SUPPLEMENTARY INFORMATION:

Definitions

    (1) ``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.
    (2) ``Debt threshold'' is the minimum amount of qualified 
educational loan debt an applicant must have in order to be eligible 
for Program benefits. An applicant must have qualified educational loan 
debt equal to at least 20 percent of the applicant's annual

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institutional base salary at the time of award.
    (3) An ``individual from a disadvantaged background'' is defined as 
one who 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 the changes in the Consumer 
Price Index and adjusted by the Secretary of Health and Human Services 
(Secretary) for use in all health professions programs. The Secretary 
periodically publishes these income levels in the Federal Register. An 
applicant must certify his/her disadvantaged status under the above 
definition by submitting (a) a written statement from the individual's 
former health professions school(s) that indicates that he/she 
qualified for Federal disadvantaged assistance during attendance; or 
(b) documentation that he/she received financial aid from either Health 
Professions Student Loans (HPSL) or the Loans for Disadvantaged Student 
Program; or (c) documentation that he/she received scholarships from 
the U.S. Department of Health and Human Services (HHS) under the 
Scholarship for Individuals with Exceptional Financial Need.
    (4) ``Institutional base salary'' is defined as 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, and it may 
not include or comprise any income (salary or wages) earned as a 
Federal employee.
    (5) ``Total educational loan debt'' is defined as the outstanding 
educational loan debt incurred by health professionals for their 
educational expenses incurred at accredited institutions. It consists 
of the principal, interest, and related expenses of qualified U.S. 
Government, academic institutions, and commercial U.S. educational 
loans obtained by the applicant for (a) undergraduate, graduate and 
health professional school tuition expenses; (b) other reasonable 
educational expenses required by the school(s) attended, including 
fees, books, supplies, educational equipment and materials, and 
laboratory expenses; and (c) reasonable living expenses, including the 
cost of room and board, transportation and commuting costs, and other 
reasonable living expenses as determined by the Secretary or his 
designee.
    (6) ``Repayable debt'' means the difference between the applicant's 
total educational loan debt and 50 percent of the applicant's debt 
threshold.

Background

    The Consolidated Appropriations Act of 2001 (Pub. L. 106-554) was 
enacted on December 21, 2000, amending Section 487E of the Public 
Health Service (PHS) Act to authorize the Secretary of the Department 
of Health and Human Services (Secretary), through the Director of the 
National Institutes of Health (NIH), to enter into contracts with 
qualified health professionals from disadvantaged backgrounds. These 
health professionals are required to engage in clinical research in 
consideration of the Federal Government repaying a portion of the 
principal and interest of their extant educational loans, up to a 
maximum of $35,000 per year, for each year of service. The program is 
known as the Extramural Clinical Research Loan Repayment Program for 
Individuals from Disadvantaged Backgrounds (ECR-LRP). Selected 
applicants become participants of the ECR-LRP only upon the execution 
of a contract by the Secretary or his designee.

Eligibility Criteria

    Specific eligibility criteria with regard to participation in the 
ECR-LRP include the following:
    (1) Applicants must be U.S. citizens, U.S. nationals, or permanent 
residents of the United States;
    (2) Applicants must have a Ph.D., M.D., D.O., D.D.S., D.M.D., 
D.P.M., Pharm.D., D.C., N.D., or equivalent doctoral degree from an 
accredited institution;
    (3) Applicants must come from a disadvantaged background;
    (4) Applicants must have total qualifying educational loan debt 
equal to or in excess of 20 percent of their annual institutional base 
salary at the time their loan repayment contract is executed by the 
Secretary or designee (example: an applicant with a base salary of 
$40,000 per year must have a minimum outstanding educational loan debt 
of $8,000);
    (5) Applicants must engage in qualified clinical research supported 
by a non-profit foundation, non-profit professional society, non-profit 
institution, or a U.S. or other government agency (Federal, State, or 
local). A foundation, professional society, 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);
    (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) Applicants must agree to conduct research for which funding is 
not prohibited by Federal law, regulations, or HHS/NIH policy. 
Recipients of LRP awards must conduct their research in accordance with 
applicable Federal, State and local law (e.g., applicable human subject 
protection regulations);
    (8) 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 
the required percentage of time, are eligible to apply for loan 
repayment if they meet all other eligibility requirements;
    (9) Applicants must have a research supervisor or mentor with 
experience in the area of proposed research;
    (10) Applicants will not be excluded from consideration under the 
ECR-LRP on the basis of age, race, culture, religion, gender, sexual 
orientation, disability or other non-merit factors; and
    (11) No individual may submit more than one LRP application to the 
NIH in any fiscal year. Individuals who have applied previously for the 
Program or any other NIH Loan Repayment Program but did not receive an 
award are eligible to submit a new application if they meet the above 
eligibility criteria.
    The following individuals are ineligible for participation in the 
ECR-LRP:
    (1) Persons who are not United States citizens, nationals, or 
permanent residents;
    (2) Individuals who have a Federal judgment lien against their 
property arising from a Federal debt are barred from receiving Federal 
funds until the judgment is paid in full or satisfied;
    (3) Individuals who owe an obligation of health professional 
service to the Federal Government, a State, or other entity, unless 
deferrals or extensions are granted for the length of the ECR-LRP 
service obligation. The following are examples of programs with service 
obligations that disqualify applicants from consideration, unless a 
deferral for the length of participation in the ECR-LRP is obtained:
    [sbull] Physicians Shortage Area Scholarship Program,
    [sbull] Primary Care Loan (PCL) Program--recipients of PCLs incur a 
service obligation to practice primary care. PCL recipients are 
eligible to apply for the ECR-LRP if the PCL has been paid in full. If 
still repaying the PCL, LRP applicants must submit documentation, via 
facsimile to (866) 849-4046, from the Health Resources and Services 
Administration (HRSA) that

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demonstrates that the LRP applicant is satisfying the terms and 
conditions of the PCL,
    [sbull] Public Health Service Scholarship Program,
    [sbull] National Health Service Corps Scholarship Program,
    [sbull] Armed Forces (Army, Navy, or Air Force) Professions 
Scholarship Program,
    [sbull] Indian Health Service Scholarship Program,
    [sbull] National Research Service Award Program--a current 
recipient of a postdoctoral National Research Service Award support 
from an individual postdoctoral fellowship (F32) or an institutional 
research training grant (T32) will not be eligible for loan repayment 
during the second year of NRSA support without a formal deferral of the 
NRSA service obligation (see http://grants1.nih.gov/grants/guide/pa-files/PA-02-109.html). Concurrent repayment of service obligations is 
prohibited. Participation in an NIH LRP is only permissible by first 
satisfying the NRSA service obligation, which is satisfied either by 
completing the second year of NRSA support or by requesting a deferral 
of the NRSA service obligation. (Note--first year NRSA recipients are 
eligible to apply for and receive NIH loan repayment. Second year NRSA 
recipients can apply to participate in the ECR-LRP, but can only 
receive loan repayment during the second year if an extension of time 
is obtained to satisfy the NRSA service obligation. If an extension is 
not obtained, loan repayment will commence after the completion of the 
NRSA service obligation. LRP payments are NOT retroactive.);
    (4) Full-time employees of Federal Government agencies;
    (5) 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);
    Individuals with ineligible loans, which include loans that have 
been consolidated with a loan of another individual (including spouses 
and children), or loans that are not educational, such as home equity 
loans;
    (8) Individuals with existing service obligations to Federal, 
State, or other entities may not apply for the ECR-LRP, unless and 
until the existing service obligation is discharged or deferred for the 
length of program participation; and
    (9) Individuals that have a Federal judgment lien against their 
property arising from a Federal debt may not apply for the ECR-LRP 
until the judgment has been paid in full or otherwise satisfied.

Application Procedures

    Applications must be submitted electronically to the Office of Loan 
Repayment (OLR). The NIH LRP Web site is www.lrp.nih.gov. The site has 
an Applicant Information Bulletin with the current deadlines, sources 
for assistance, and additional details regarding application 
procedures.
    Application materials from the applicant, the supervisor/mentor, 
recommenders, and institutional officials must be submitted prior to 
the application deadline.
    The following information must be provided by the applicant:
    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. Contact Information for Three Recommenders (one of whom is 
identified as research supervisor or mentor).
    6. Contact Information for Institution Official able to serve as 
the Institutional Contact and verify an applicant's employment/research 
appointment and research funding status.
    7. On-line Certification.
    8. Loan information, which includes the 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. Notice of Grant/Award (or PHS Form Number 2271 for T32 
recipients) if applying based on NIH support.
    10. Certification of Disadvantaged Background, which verifies the 
applicant's disadvantaged status and consists of one of the following: 
(a) Written statement from the applicant's former health professions 
school(s) that indicates that the applicant qualified for Federal 
disadvantaged assistance during attendance; (b) documentation that the 
applicant received financial aid from either Health Professions Student 
Loans (HPSL) or the Loans for Disadvantaged Students Program; or (c) 
documentation that the applicant received a scholarship from the HHS 
under the Scholarship for Individuals with Exceptional Financial Need.
    The following information must be provided by the Research 
Supervisor/Mentor and submitted electronically via the NIH-LRP Web 
site:
    1. Recommendation.
    2. Biosketch.
    3. Assessment of the Research Activities Statement submitted by the 
applicant.
    4. Description of the Research Environment. (Please provide 
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. (Includes a detailed discussion of 
the training and/or mentoring plan, as well as the research methods and 
scientific techniques to be taught.)
    6. Biosketch of other pertinent staff members involved in training 
or mentoring the applicant.
    Recommenders must submit their recommendations electronically.
    Institutional Contacts must electronically submit a certification, 
via the NIH-LRP Web site, 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 funding foundation, 
professional society, or institution is considered to be non-profit as 
provided under Section 501 of the Internal Revenue Code (26 U.S.C. 501) 
or is a U.S. or other government entity (Federal, State or local), and 
(d) provides the applicant's institutional base salary.

Review Process

    Applications that are received and complete by the deadline will 
undergo peer review by a Special Emphasis Panel (SEP). The reviewers 
will use the review criteria in assessing and rating each application.

Review Criteria

    a. Potential of the applicant to pursue a career in clinical 
research.
    [sbull] Appropriateness of the applicant's previous training and 
experience to prepare him/her for a clinical research career.
    [sbull] Suitability of the applicant's proposed clinical research 
activities in the two-year loan repayment period to foster a research 
career.
    [sbull] Assessment of the applicant's commitment to a research 
career as

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reflected by the personal statement of long-term career goals and the 
plan outlined to achieve those goals.
    [sbull] 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.
    [sbull] Availability of appropriate scientific colleagues to 
achieve and/or enhance the applicant's research independence.
    sbull Quality and appropriateness of institutional resources and 
facilities.

Program Administration and Details

    Under the ECR-LRP, a portion of the participants' outstanding 
educational loan debt will be repaid. Participants will not 
automatically qualify for the maximum amount of loan repayment. The 
amount the NCMHD will consider for repayment during the initial two-
year contract shall be calculated as follows: one-fourth the repayable 
debt per year, up to a maximum of $35,000 per year. For example, a 
participant with a base salary of $40,000 per year and an outstanding 
eligible educational loan debt of $100,000, would have a debt threshold 
of $8,000 (the debt threshold is 20 percent of an applicant's annual 
institutional salary). All participants are responsible for paying one-
half of their debt threshold amount. This amount is known as the 
participant's obligation and is subtracted from the total outstanding 
loan debt. In this case, the participant's obligation would be $4,000 
and the participant's eligible loan debt would be reduced to $96,000. 
This reduced amount is known as the repayable debt ($100,000-$4,000 = 
$96,000). Of the $96,000 repayable debt amount, the NCMHD would repay 
$24,000 a year in loan repayments (one-fourth of the repayable debt 
amount), plus tax benefits.
    Loan repayments will be made to the designated lender following the 
completion of each full quarter (3 months) of service by the 
participant and upon the receipt of requested documentation from the 
participants and their supervisors/mentors. Because the first payment 
to the lenders on behalf of the participants will not commence until 
the end of the first full quarter of obligated service, participants 
should continue to make monthly loan payments until they have been 
informed that payments have been forwarded to their lenders. This 
measure enables the participants to maintain their loans in a current 
payment status.
    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; 
(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.
    Repayments are made directly to lenders, following the 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:
    [sbull] Health Education Assistance Loan (HEAL);
    [sbull] Health Professions Student Loan (HPSL);
    [sbull] Loans for Disadvantaged Students (LDS); and
    [sbull] Nursing Student Loan Program (NSL);
    (2) Loans guaranteed by the U.S. Department of Education:
    [sbull] Direct Subsidized Stafford Loan;
    [sbull] Direct Unsubsidized Stafford Loan;
    [sbull] Direct Consolidation Loan;
    [sbull] Perkins Loan;
    [sbull] FFEL Subsidized Stafford Loan;
    [sbull] FFEL Unsubsidized Stafford Loan; and
    [sbull] 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:
    [sbull] MEDLOANS; and
    [sbull] Private (non-guaranteed) Consolidation Loans.
    The following loans are NOT repayable under the ECR-LRP:
    (i) Loans not obtained from a U.S. or other government entity, 
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;
    (ii) Loans for which contemporaneous documentation (current account 
statement and promissory note or lender disclosure statement) is not 
available;
    (iii) Loans that have been consolidated with loans of other 
individuals, such as a spouse or child;
    (iv) Loans or portions of loans obtained for educational or living 
expenses that 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;
    (v) 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:
    [sbull] Physicians Shortage Area Scholarship Program (Federal or 
State);
    [sbull] National Research Service Award Program;
    [sbull] Public Health Service and National Health Service Corps 
Scholarship Program;
    [sbull] Armed Forces (Army, Navy, or Air Force) Health Professions 
Scholarship Program; and
    [sbull] Indian Health Service Scholarship Program;
    (vi) Delinquent loans, loans in default, or loans not current in 
their payment schedule;
    (vii) PLUS Loans;
    (viii) Loans that have been paid in full;
    (ix) Loans obtained after the execution of the LRP Contract (e.g., 
promissory note signed after the LRP contract has been awarded); and
    (x) Primary Care Loans.
    During lapses in loan repayments, due either to NIH 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 NIH 
administrative complications to maintain a current payment status may 
not be considered for reimbursement.

Additional Program Information

    This program is not subject to the provision of Executive Order 
12372, Intergovernmental Review of Federal Programs. Under the 
requirements of the Paperwork Reduction Act of 1995, OMB has approved 
the application forms for use by the ECR-LRP under OMB Approval No. 
0925-0361 (expires December 31, 2004).

    The Catalog of Federal Domestic Assistance number for the ECR-
LRP is 93.308.

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    Dated: February 5, 2003.
Elias A. Zerhouni,
Director, NIH.
[FR Doc. 03-7580 Filed 3-28-03; 8:45 am]
BILLING CODE 4140-01-P