[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]
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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
ACTION: Notice.
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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.
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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