[Federal Register Volume 69, Number 229 (Tuesday, November 30, 2004)]
[Notices]
[Pages 69608-69611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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) and the National 
Center on Minority Health and Health Disparities (NCMHD) announce the 
2005 Extramural Clinical Research Loan Repayment Program for 
Individuals from Disadvantaged Backgrounds (ECR-LRP or Program). The 
ECR-LRP provides for the repayment of educational loan debt of up to 
$35,000 annually for qualified health professionals from disadvantaged 
backgrounds conducting clinical research for domestic non-profit or 
government entities. In addition, the program will cover up to 39 
percent of the Federal tax liability resulting from loan repayments, 
and may provide reimbursement for State and local tax liabilities.
    The purpose of the Extramural Clinical Research Loan Repayment 
Program for Individuals from Disadvantaged Backgrounds is the 
recruitment and retention of highly qualified health professionals from 
disadvantaged backgrounds in careers in clinical research. Through this 
notice, the NIH and NCMHD invite qualified health professionals who are 
from disadvantaged backgrounds and interested in engaging in clinical 
research for at least two years, and who agree to engage in this area 
of research for at least 50 percent of their time, i.e., no less than 
20 hours per week, to apply for participation in the NIH Extramural 
Clinical Research Loan Repayment Program for Individuals from 
Disadvantaged Backgrounds (ECR-LRP).

DATES: Interested persons may request information about the Program 
beginning on November 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 information regarding the requirements, application deadline dates, 
and on-line application for the ECR-LRP program, please visit the NIH 
Loan Repayment Program Web site at http://www.lrp.nih.gov, send an e-
mail to [email protected], call the LRP helpline at 866-849-4047 (toll-free 
number) or contact the NCMHD Loan Repayment Coordinator, Kenya McRae, 
at 301-402-1366 (not a toll-free number) or via e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The Extramural Clinical Research Loan 
Repayment Program for Individuals from Disadvantaged Backgrounds, which 
was originally authorized by section 487E of the Public Health Service 
(PHS) Act (42 U.S.C. 288-5), as amended by the National Institutes of 
Health Revitalization Act of 1993 (Pub. L. 103-43), provides for the 
repayment of the educational loan debt of health professionals who are 
from disadvantaged backgrounds, who have substantial debt relative to 
income, and who agree to conduct clinical research as employees of the 
NIH. The Consolidated Appropriations Act of 2001 (Pub. L. 106-554) 
amended section 487E of the PHS Act to allow expansion of the existing 
program to include health professionals who are not employees of the 
National Institutes of Health. Under the expanded authority, the 
Secretary of Health and Human Services (HHS) in consultation with the 
Director of NIH will enter into contracts with qualified health 
professionals from disadvantaged backgrounds under which such health 
professionals agree to conduct clinical research; in return, the 
Federal Government agrees to repay for each year of such research, up 
to $35,000 of their student loan debt.
    The objective of the ECR-LRP is the recruitment and retention of 
highly qualified health professionals from disadvantaged backgrounds to 
clinical research careers. The emphasis on clinical research and 
individuals from disadvantaged backgrounds highlights the need for the 
involvement of a cadre of competent health professionals in clinical 
research.
    ``Clinical research'' as defined in section 206 of Pub. L. 106-505, 
the Public Health Improvement Act, enacted on November 13, 2000, 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 
epidemiological or behavioral studies, outcomes research or health 
services research, or developing new technologies, therapeutic 
interventions, or clinical trials.
    ``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 the U.S. Department of 
Health and Human Services (Secretary) for use in all health professions 
programs. The Secretary

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periodically publishes these income levels in the Federal Register. An 
applicant must certify his or 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 or she 
qualified for Federal disadvantaged assistance during attendance; or 
(b) documentation that he or she received any financial aid from Health 
Professions Student Loans (HPSL) or Loans for Disadvantaged Student 
Program; or (c) documentation that he or she received scholarships from 
the U.S. Department of Health and Human Services (HHS) under the 
Scholarship for Individuals with Exceptional Financial Need.

Eligibility Criteria

    Specific eligibility criteria for the ECR-LRP include the 
following:
    1. Applicants must be United States citizens, nationals, or 
permanent residents;
    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 come from a disadvantaged background;
    4. Applicants must have total qualifying educational debt equal to 
or in excess of 20 percent of their institutional base salary at the 
time of award (projected to be between July 1 and September 1, 2005). 
Institutional base salary is the annual amount the organization pays 
for the individual's appointment, whether the time is spent on 
research, teaching, patient care, or other activities. Institutional 
base salary excludes any income that an applicant may earn outside of 
the duties of the organization, and may not include or comprise any 
income (salary or wages) earned as a Federal employee;
    5. 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);
    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 
based on a 40-hour work 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 domestic 
non-profit source as defined in subparagraph 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, regulations, or HHS/NIH policy. 
Recipients who receive ECR-LRP awards must conduct their research in 
accordance with applicable Federal, State and local law (e.g., 
applicable human subject protection regulations) for the entire period 
of time;
    9. Applicants will not be excluded from consideration 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. Unsuccessful ECR-LRP applicants may reapply in 
subsequent fiscal years.
    The following individuals are ineligible for participation in the 
ECR-LRP:
    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 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 is obtained:
    (a) Armed Forces (Army, Navy, or Air Force) Professions Scholarship 
Program,
    (b) Exceptional Financial Need (EFN) Scholarship Program,
    (c) Financial Assistance for Disadvantaged Health Professions 
Students (FADHPS),
    (d) Indian Health Service (IHS) Scholarship Program,
    (e) National Health Service Corps (NHSC) Scholarship Program,
    (f) National Institutes of Health Undergraduate Scholarship Program 
(UGSP),
    (g) Physicians Shortage Area Scholarship Program,
    (h) Primary Care Loan (PCL) Program,
    (i) Public Health Service (PHS) Scholarship Program, and
    (j) 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 work week, are eligible to apply for the ECR-LRP 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 both initial and renewal awards will 
be reviewed for eligibility and completeness. Incomplete or ineligible 
applications will not be considered. Applications that are complete and 
eligible will be forwarded for peer review. 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:

[[Page 69610]]

     Availability of appropriate scientific colleagues to 
achieve and/or enhance the applicant's research independence.
     Quality and appropriateness of institutional resources and 
facilities.
    LRP renewal contracts are available for one- and two-year periods 
and are based upon the same criteria as the initial application plus 
two additional criteria'an assessment of research accomplishments and 
development of an individual as an independent investigator. An 
explanation of research accomplishments during the initial award period 
is required. Progress toward development as an independent investigator 
is a major factor in awarding renewal of loan repayment support. 
Renewal LRP awards are competitive and submission of a renewal 
application does not ensure the award of loan repayment.
    The following information is furnished by applicants or others on 
behalf of applicants (forms are completed electronically at the LRP Web 
site at 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.
    5. Identification of three recommenders (one of whom is identified 
as research supervisor or mentor).
    6. Identification of Institutional Contact.
    7. On-line certification.
    8. Loan information, including 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 2271 for Ruth L. Kirschstein NRSA training fellowships).
    10. Certification of disadvantaged background that 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 any of the following 
financial aid: Health Professions Student Loans (HPSL) or Loans for 
Disadvantaged Student Program; or
    c. Documentation that the applicant received scholarships from the 
U.S. Department of Health and Human Services (HHS) under the 
Scholarship for Individuals with Exceptional Financial Need.
    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.
    6. Biosketch of any supplemental mentors/advisors or laboratory 
staff member if involved in the training and mentoring of the 
applicant.
    The other Recommenders electronically transmit recommendation forms 
to the NIH Office of Loan Repayment.
    Institutional Contacts electronically transmit a certification to 
the NIH Office of Loan Repayment that:
    (a) Assures that 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 work effort or not less than 20 
hours per week based on a 40-hour work week;
    (c) Certifies that the sponsoring entity is a domestic non-profit 
institution (exempt from tax liability under 26 U.S.C. 501); and
    (d) Provides the applicant's institutional base salary.

Program Administration and Details

    Under the ECR-LRP, 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.
    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, an 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:
     Undergraduate, graduate, and health professional school 
tuition expenses;
     Other reasonable educational expenses required by the 
school(s) attended, including fees, books, supplies, educational 
equipment and materials, and laboratory expenses; and
     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

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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 Clinical Research 
Loan Repayment Program for Individuals from Disadvantaged Backgrounds:
    1. Loans not obtained from a U.S. or other government entity, an 
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 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;
    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;
     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 
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.
    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 ECR-LRP expires on December 
31, 2004. The Catalog of Federal Domestic Assistance number for the 
Extramural Clinical Research LRP for Individuals from Disadvantaged 
Backgrounds is 93.308.

    Dated: November 19, 2004.
Elias A. Zerhouni,
Director, NIH.
[FR Doc. 04-26369 Filed 11-29-04; 8:45 am]
BILLING CODE 4140-01-P