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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.



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: Moorej@mail.nih.gov, 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 lrp@nih.gov, 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:
mcraek@mail.nih.gov.

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:

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 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