[Federal Register Volume 66, Number 146 (Monday, July 30, 2001)]
[Notices]
[Pages 39325-39327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18911]


-----------------------------------------------------------------------

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) hereby announces the 
availability of educational loan repayment under the NIH Clinical 
Research Loan Repayment Program for Individuals from Disadvantaged 
Backgrounds (the Program). The Program, 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 (Public Law 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 (Public Law 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 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 invites 
health professionals, who are from disadvantaged backgrounds and 
interested in engaging in clinical research for at least two years, to 
apply for participation in the NIH Extramural Clinical Research Loan 
Repayment Program for Individuals from Disadvantaged Backgrounds (ECR-
LRP). Concurrent with the publication of this notice, NIH is publishing 
elsewhere in the Federal Register Notification of Request for Emergency 
Clearance for Modification of the information collection, OMB No. 0925-
0361, ``National Institutes of Health Loan Repayment Programs,'' to 
obtain approval for the additional information in connection with the 
application process, with the comment period to close July 31, 2001.

DATES: Interested persons may request information about the Program 
beginning on July 30, 2001.

ADDRESSES: Information regarding the requirements and application 
procedures for the Program may be obtained by calling or writing: 
National Center on Minority Health and Health Disparities, National 
Institutes of Health, Democracy II, Suite 800, 6707 Democracy Blvd, MSC 
5465, Bethesda, Maryland 20892-5465, Attention: Kenya McRae, telephone 
(301-402-1366).

SUPPLEMENTARY INFORMATION: The definition of clinical research is found 
in section 206 of Public Law 106-505, the Public Health Improvement 
Act, enacted on November 13, 2000: The term clinical research means 
patient-oriented clinical research conducted with human subjects, or 
research on the causes and consequences of disease in human populations 
involving material of human origin (such as tissue specimens and 
cognitive phenomena) for which the 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. An ``individual from a disadvantaged 
background'' (see 42 CFR 68a.2) is one who: (1) Comes from an 
environment that inhibited the individual from obtaining the knowledge, 
skill and ability required to enroll in and graduate from a health 
professions school; or (2) 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 
changes in the Consumer Price Index, and adjusted by the Secretary for 
use in all health professions programs. The Secretary periodically 
publishes these income levels in the Federal Register. Applicants must 
certify disadvantaged status under the above definition by submitting: 
(1) A personal statement explaining the applicability of the above 
definition to his/her circumstances; or (2) a letter in the application 
package from the individual's former health professions school(s) or 
other documentation verifying that the applicant qualified for Federal 
disadvantaged assistance during attendance. Current financial need 
alone is not sufficient to classify an individual as being from a 
disadvantaged background.
    The Consolidated Appropriations Act, 2001 (Public Law 106-554) was 
enacted on December 21, 2000, and amends section 487E of the PHS Act to 
allow the Secretary of HHS, in consultation with the Director of NIH, 
to enter into contracts for loan repayment with appropriately qualified 
health professionals from disadvantaged backgrounds who agree to 
conduct clinical research, at NIH-supported or otherwise funded 
research sites, but not as employees of NIH. This program is known as 
the NIH Extramural Clinical Research Loan Repayment Program for 
Individuals from Disadvantaged Backgrounds (ECR-LRP). Under the 
contracts, qualified health professionals who are from disadvantaged 
backgrounds with substantial educational loan debt relative to income 
agree to conduct clinical research for at least two years in 
consideration of the Federal Government agreeing to repay, for each 
year of service, not more than $35,000 of the principal and interest of 
the educational loans of such health professionals. The Acting Director 
of NIH delegated authority for implementation of the Extramural 
Clinical Research Loan Repayment Program for Individuals from 
Disadvantaged Backgrounds (ECR-LRP) for fiscal year 2001 to the 
Director, National Center on Minority Health and Health Disparities 
(NCMHD), NIH.

[[Page 39326]]

Eligibility Requirements

    Specific eligibility criteria with regard to participation in the 
ECR-LRP include the following:
    (1) Participants must be United States citizens, nationals, or 
permanent residents.
    (2) Participants must have an M.D., Ph.D., D.O., D.D.S., Sc.D., or 
equivalent professional degree.
    (3) Participants must come from a disadvantaged background. An 
individual from a disadvantaged background (see 42 CFR 68a.2) is one 
who: (a) Comes from an environment that inhibited the individual from 
obtaining the knowledge, skill and ability required to enroll in and 
graduate from a health professions school; or (b) 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 changes in the Consumer Price Index, and adjusted 
by the Secretary for use in all health professions programs. The 
Secretary periodically publishes these income levels in the Federal 
Register. Participants must certify disadvantaged status under the 
above definition by submitting: (a) A personal statement explaining the 
applicability of the above definition to his/her circumstances; or (b) 
a letter in the application package from the individual's former health 
professions school(s) or other documentation verifying that the 
applicant qualified for Federal disadvantaged assistance during 
attendance. Current financial need alone is not sufficient to classify 
an individual as being from a disadvantaged background.
    (4) Participants must have qualifying educational debt in excess of 
20 percent of their annual salary, stipend, or compensation at their 
expected date of program eligibility. The expected date of program 
eligibility is the date by which the following conditions will be met: 
(a) An applicant agrees to begin clinical research and (b) the 
Secretary executes an ECR-LRP contract.
    (5) Participants must not be Federal employees.
    (6) Participants must have a research sponsor or mentor with 
experience in the area of proposed research and may be enrolled in a 
training program or appointed under a temporary (at least two years) or 
permanent employment mechanism.
    (7) Participants must engage in qualified clinical research for a 
minimum of two years.
    (8) Individuals with existing service obligations to Federal, 
State, or other entities will not be considered for the ECR-LRP unless 
and until the existing service obligation is discharged or deferred for 
the length of Program participation.
    (9) Individuals are ineligible who have a Federal judgment lien 
against their property arising from a Federal debt from receiving 
Federal funds, until the judgment is paid in full or satisfied.

Application Procedures and Selection Process

    Submission of applications for participation in the ECR-LRP by 
eligible individuals should be made to the NCMHD on behalf of the 
applicant by the extramural research institution. The application 
package should include: (1) All required forms, completed, signed and 
dated; (2) research and training plan; (3) the credentials or 
curriculum vitae of the applicant and mentor/advisor; and (4) a 
description of the research/training environment. The NCMHD will 
provide current deadlines, sources for assistance, and additional 
details regarding application procedures in an Applicant Information 
Bulletin.
    Individuals may submit their applications to the Director, NCMHD, 
and qualified applications will be forwarded to the NCMHD Loan 
Repayment Review Panel (the Panel), chaired by the Deputy Director, 
NCMHD, for review. The Panel will review, rank, and approve or 
disapprove all applications submitted to the ECR-LRP.
    The Panel will review and select applications for approval based on 
the merit of the proposed clinical research, the credentials of the 
applicant and supervisor, and other criteria the Secretary deems 
appropriate. For example, all of the following contribute to the merit 
of the application: the quality of the mentoring program, which 
includes the journal clubs or other groups available to the applicant 
and the planned conferences and seminars to be attended; the quality of 
the mentor's research program; the proposed training mechanism; and the 
research methods and scientific techniques to be taught.
    The definition of clinical research used by the Panel can be found 
in section 206 of Public Law 106-505, the Public Health Improvement 
Act: The term clinical research means patient-oriented clinical 
research conducted with human subjects, or research on the causes and 
consequences of disease in human populations involving material of 
human origin (such as tissue specimens and cognitive phenomena) for 
which an investigator or colleague directly interacts with human 
subjects in an outpatient or inpatient setting to clarify a problem in 
human physiology, pathophysiology or disease, or epidemiologic or 
behavioral studies, outcomes research or health services research, or 
developing new technologies, therapeutic interventions, or clinical 
trials.
    Funds for repayment will only be awarded to Review Panel-approved 
applications. Priority in funding will be given to qualified health 
professionals who are from disadvantaged backgrounds and/or who are 
underrepresented in biomedical/behavioral research, including members 
from racial and ethnic minority groups and disabled individuals. The 
emphasis on ``clinical research'' and on individuals from 
``disadvantaged backgrounds'' highlights the need for the involvement 
of a cadre of culturally competent physician scientists in clinical 
research. Such a cadre of clinical investigators can impact the medical 
processes within their communities and promote the development of 
clinical research programs that reflect an understanding of the variety 
of issues and problems that impact health outcomes.

Program Administration and Details

    Under the ECR-LRP, the NIH will repay a portion of the extant 
qualified educational loan debt incurred by health professionals to pay 
for their undergraduate, graduate, and/or health professional school 
educational expenses. Upon application, individuals must have total 
qualified educational debt that exceeds their anticipated annual 
compensation (``debt threshold'') on the date of program eligibility.
    Only qualified loan amounts in excess of 50 percent of the debt 
threshold will be considered for repayment (``repayable debt''). The 
repayable debt of qualified health professionals will be satisfied at 
the rate of one-half of the repayable debt per year, subject to a 
statutory limit of $35,000 per year, for each year of obligated 
service. Obligated service requires selected individuals to engage in 
qualified clinical research for at least 2 years. Following conclusion 
of the initial two-year contract, participants may apply for renewal 
contracts to satisfy their remaining repayable debt. These continuation 
contracts may be submitted and approved on a competitive year-to-year 
basis, subject to a finding by the NCMHD that the applicant's clinical 
research accomplishments are acceptable and qualified clinical research 
continues. Funding of contracts is contingent upon appropriation and/or

[[Page 39327]]

allocation of funds from the U.S. Congress and/or the NIH.
    Concurrent with the issuance of each loan repayment, a 39% Federal 
tax payment is issued to compensate participants for the tax 
liabilities incurred on their loan payments, which are considered 
taxable income by the IRS. Depending on the availability of funds and 
the final level of benefits offered, the NCMHD may make additional tax 
payments, whether they be for Federal or State taxes, for the 
additional incremental taxes incurred by recipients that are directly 
attributable to the loan repayment and Federal tax payments.
    In return for the repayment of their educational loans, 
participants must agree to: (1) Engage in clinical research for a 
minimum requirement of 2 years; (2) pay monetary damages as required 
for breach of contract; and (3) satisfy other terms and conditions of 
the ECR-LRP's contract and application procedures.
    Applicants must submit a signed contract, prepared by the NIH, 
agreeing to obligated service at the time they apply for consideration 
under the ECR-LRP. Substantial monetary penalties will be imposed for 
breach of contract.
    The NIH will repay lenders for the principal, interest, and related 
expenses (such as the required insurance premiums on the unpaid 
balances of some loans) of qualified Government (Federal, State, local) 
and commercial educational loans obtained by participants for the 
following:
    (1) Undergraduate, graduate, and health professional school tuition 
expenses;
    (2) Other reasonable educational expenses required by the school(s) 
attended, including fees, books, supplies, educational equipment and 
materials, and laboratory expenses; and
    (3) Reasonable living expenses, including the cost of room and 
board, transportation and commuting costs, and other living expenses as 
determined by the Secretary.
    Repayments will be authorized for direct payment to lenders, 
following receipt of: (1) the supervisor's verification of completion 
of the prior period of obligated service and (2) lender verification of 
the crediting of prior loan repayments, including the resulting account 
balances and current account status. The NCMHD will repay loans in the 
following order unless significant savings would result from repaying 
loans in a different priority order:
    (1) Health Education Assistance Loans (HEAL);
    (2) other loans guaranteed by the Federal Government; and
    (3) other qualifying loans.
    The following loans are NOT repayable under the ECR-LRP:
    (1) Loans not obtained from a Government entity or commercial or 
other chartered lending institution, such as loans from friends and 
relatives, or other private individuals;
    (2) Loans for which contemporaneous documentation is not available; 
and
    (3) Loans, or those portions of loans, obtained for educational or 
living expenses which exceed a ``reasonable'' level as determined by a 
review of the standard school budget or additional contemporaneous 
documentation for the year in which the loan was made.
    In addition, for other programs which provide loans, scholarships, 
loan repayments, or similar awards in exchange for a future service 
obligation, the NIH will NOT repay any sums that may result from 
failure to serve as required or conversion of the obligation to a loan 
or debt under these programs. This includes, but is not limited to the 
following:
    (1) Physicians Shortage Area Scholarship Program (Federal or 
State);
    (2) National Research Service Award Program;
    (3) Public Health Service and National Health Service Corps 
Scholarship Programs;
    (4) Armed Forces (Army, Navy, or Air Force) Health Professions 
Scholarship Programs; and
    (5) Indian Health Service Scholarship Program.
    Finally, payments will not be made under the ECR-LRP for loans that 
participants have already repaid, delinquent loans, loans in default, 
loans not current in their payment schedule, or loans for which 
promissory notes have been signed after the program eligibility date 
and PLUS loans. During lapses in loan repayments, due either to 
administrative complications or a break in service, ECR-LRP 
participants are wholly responsible for making payments or other 
arrangements that maintain loans in a current payment status such that 
increases in either principal or interest do not occur. Penalties 
assessed participants as a result of NIH administrative complications 
may be considered for reimbursement.

    Dated: July 13, 2001.
Ruth L. Kirschstein,
Acting Director, NIH.
[FR Doc. 01-18911 Filed 7-27-01; 8:45 am]
BILLING CODE 4140-01-P