[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Notices]
[Pages 58456-58459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institutes of Health Pediatric Research Loan Repayment 
Program

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) announces the 
availability of educational loan repayment under the NIH Pediatric 
Research Loan Repayment Program (PR-LRP). The Pediatric Research Loan 
Repayment Program, which is authorized by Section 487F \1\ of the 
Public Health Service (PHS) Act (42 U.S.C. 288-6), as added by the 
Children's Health Act of 2000 (Pub. L. 106-310), provides for the 
repayment of educational loan debt of qualified health professionals 
who agree to conduct pediatric research. Pediatric research is research 
that is directly related to diseases, disorders, and other conditions 
in children. The Pediatric Research Loan Repayment Program provides for 
the repayment of up to $35,000 of the principal and interest of the 
extant educational loans of such health professionals for each year of 
obligated service. Payments equal to 39 percent of total loan 
repayments are issued to the Internal Revenue Service on behalf of 
program participants to offset Federal tax liabilities incurred. The 
purpose of the Pediatric Research Loan Repayment Program is the 
recruitment and retention of highly qualified health professionals as 
pediatric investigators. Through this notice, the NIH invites qualified 
health professionals who contractually agree to engage in pediatric 
research for at least two years, and who agree to engage in such 
research for at least 50 percent of their time, i.e., not less than 20 
hours per week, to apply for participation in the NIH Pediatric 
Research Loan Repayment Program.
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    \1\ So in law. There are two sections 487F. Section 1002(b) of 
Public Law 106-310 (114 Stat. 1129), inserted section 487F above. 
Subsequently, section 205 of Public Law 106-505 (114 Stat. 2329), 
which relates to a Loan Repayment Program for Clinical Researchers, 
inserted a section 487F after section 487E.

DATES: Interested persons may request information about the Pediatric 
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Research Loan Repayment Program on September 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 (<a href="/cdn-cgi/l/email-protection#165b797964735c567b777f7a38787f7e38717960"><span class="__cf_email__" data-cfemail="e6ab89899483aca68b878f8ac8888f8ec8818990">[email protected]</span></a>), by fax 
(301) 402-0169, or by telephone (301) 496-4607 (not a toll-free 
number). For program information contact Marc S. Horowitz, e-mail 
<a href="/cdn-cgi/l/email-protection#d7bba5a797b9bebff9b0b8a1"><span class="__cf_email__" data-cfemail="315d4341715f58591f565e47">[email protected]</span></a>, or telephone (301) 402-5666 (not a toll free number). 
Information regarding the requirements, the application deadline dates, 
and an online application for the Loan Repayment Program for Pediatric 
Researchers may be obtained at the NIH Loan Repayment Program Web site, 
http://www.lrp.nih.gov.

SUPPLEMENTARY INFORMATION: The Pediatric Research Enhancement Act, 
which is contained in the Public Health Improvement Act of 2000 (Pub. 
L. 106-505), was enacted on November 13, 2000, adding section 487F of 
the PHS Act (42 U.S.C. 288-5a). Section 487F authorizes the Secretary, 
acting through the Director of the NIH, to carry out a program of 
entering into contracts with appropriately qualified health 
professionals. Under such contracts, qualified health professionals 
agree to conduct pediatric research for at least two years in 
consideration of the Federal Government agreeing to repay, for each 
year of research service, not more than $35,000 of the principal and 
interest of the extant qualified educational loans of such health 
professionals. Payments equal to 39 percent of total loan repayments 
are issued to the Internal Revenue Service on behalf of program 
participants to offset Federal tax liabilities incurred. This program 
is known as the NIH Extramural Pediatric Research Loan Repayment 
Program (PR-LRP).

Eligibility Criteria

    Specific eligibility criteria with regard to participation in the 
Pediatric Research Loan Repayment Program include the following:
    (1) Applicants must be a U.S. citizen, U.S. national, or permanent 
resident of the United States;
    (2) Applicants must have an M.D., Ph.D., Pharm. D., Psy.D., D.O., 
D.D.S., D.M.D., D.P.M., D.V.M., D.C., N.D., or equivalent doctoral 
degree from an accredited institution;
    (3) Applicants must have total qualifying educational loan debt 
equal to or in excess of 20 percent of their institutional base salary 
on the date of program eligibility (the effective date that a loan 
repayment contract has been executed by the Secretary of Health and 
Human Services or designee), expected to be between July 1 and 
September 1, 2005. Institutional base salary is the annual amount that 
the organization pays for the participant's appointment, whether the 
time is spent in research, teaching, patient care, or other

[[Page 58457]]

activities. Institutional base salary excludes any income that a 
participant may earn outside the duties of the organization. 
Institutional base salary may not include or comprise any income 
(salary or wages) earned as a Federal employee;
    (4) 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);
    (5) Applicants must engage in qualified pediatric research. 
Pediatric research is defined as research that is directly related to 
diseases, disorders, and other conditions in children;
    (6) Applicants must engage in qualified pediatric research for at 
least 50 percent of their time, i.e., not less than 20 hours per 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 non-
profit source as defined in number 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, regulation, or HHS/NIH policy. 
Recipients who receive LRP awards must conduct their research in 
accordance with applicable Federal, State, and local law (e.g., 
applicable human subject protection regulations);
    (9) Applicants will not be excluded from consideration under the 
Pediatric Research Loan Repayment Program 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. Individuals who have applied previously for the 
PR-LRP but did not receive an award are eligible to submit a new 
application if they meet all of the above eligibility criteria.
    The following individuals are ineligible for participation in the 
Pediatric Research Loan Repayment Program:
    (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 for Pediatric Researchers is obtained:

Armed Forces (Army, Navy, or Air Force) Professions Scholarship 
Program,
Exceptional Financial Need (EFN) Scholarship Program,
Financial Assistance for Disadvantaged Health Professions Students 
(FADHPS),
Indian Health Service (IHS) Scholarship Program,
National Health Service Corps (NHSC) Scholarship Program,
National Institutes of Health Undergraduate Scholarship Program (UGSP),
Physicians Shortage Area Scholarship Program,
Primary Care Loan (PCL) Program,
Public Health Service (PHS) Scholarship Program, and
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 week, are eligible to apply for the PR-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 the Pediatric Research Loan 
Repayment Program will be reviewed for eligibility and completeness by 
the NIH Office of Loan Repayment. Incomplete or ineligible applications 
will not be processed for review. Applications that are complete and 
eligible will be referred to the appropriate NIH Institute or Center 
for peer review by the NIH Center for Scientific Review (CSR). 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 pediatric research career:
    (a) Potential of the applicant to pursue a career in pediatric 
research.
    <bullet> Appropriateness of the applicant's previous training and 
experience to prepare him/her for a pediatric research career.
    <bullet> Suitability of the applicant's proposed pediatric research 
activities in the two-year loan repayment period to foster a research 
career.
    <bullet> 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.
    <bullet> 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 pediatric research career.
    <bullet> Availability of appropriate scientific colleagues to 
achieve and/or enhance the applicant's research independence.
    <bullet> Quality and appropriateness of institutional resources and 
facilities.
    Renewal applications are competitive and will be evaluated using 
the same criteria as new applications plus two additional criteria--an 
assessment of research accomplishments and development of an individual 
as an independent investigator.
    The following information is furnished by the applicant or others 
on behalf of the applicant (forms are completed electronically at the 
NIH LRP Web site, 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

[[Page 58458]]

in conducting the research. The research supervisor or mentor will be 
asked to concur in the research project description provided by the 
applicant.
    (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) 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 Number 2271 for T32 recipients).
    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 (except for applicants with an NIH R01 or 
equivalent grant).
    (6) Biosketch of a laboratory staff member if involved in training 
or mentoring the applicant.
    The other two Recommenders electronically transmit recommendations 
to the NIH Office of Loan Repayment.
    Institutional Contacts electronically transmit the following to the 
NIH Office of Loan Repayment:
    (1) A certification 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 institution is a domestic 
non-profit institution (exempt from tax under 26 U.S.C. 501) or is a 
U.S. Government or other government agency (Federal, State, local); and 
(d) provides the applicant's institutional base salary.

Program Administration and Details

    Under the Pediatric Research Loan Repayment Program, 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. Individuals must have total 
qualified educational debt that equals or exceeds 20 percent of their 
institutional base salary on the date of program eligibility. This is 
called the debt threshold. The formula used to calculate the potential 
annual loan repayment amount is total educational debt less the 
participant obligation (an amount equal to 10 percent of institutional 
base salary), which yields the total repayable debt; the total 
repayable debt is divided by 25 percent, which yields the potential 
annual repayment amount (up to $35,000). Participants are encouraged to 
pay the participant obligation during the contract period.
    Following is an example of loan repayment calculations: An 
applicant has a loan debt of $100,000 and a university compensation of 
$40,000. Since the loan debt exceeds the debt threshold (20 percent of 
university compensation = $8,000), the applicant has sufficient debt 
for loan repayment consideration. The participant obligation is 10 
percent of the institutional base salary, in this case $4,000. Thus, 
repayment of the $4,000 debt is the applicant's responsibility. The 
remaining amount, in this example $96,000 (total repayable debt), will 
be considered for repayment on a graduated basis. In this case, the 
maximum to be repaid in the initial two-year contract is $48,000 or 
$24,000 per year, plus tax reimbursement benefits.
    The total repayable debt will be paid at the rate of one-quarter 
per year, subject to a statutory limit of $35,000 per year for each 
year of obligated service. Individuals are required to initially engage 
in 2 years of qualified pediatric research.
    Following conclusion of the initial two-year contract, participants 
may competitively apply for renewal contracts if they continue to 
engage in qualified pediatric research. These continuation contracts 
may be approved on a year-to-year basis, subject to a finding by NIH 
that the applicant's pediatric research accomplishments are acceptable, 
qualified pediatric research continues, and domestic non-profit 
institutional or U.S. or other government agency (Federal, State, or 
local) support has been assured. Renewal applications are competitively 
reviewed and the submission of a renewal application does not ensure 
the award of benefits. Renewal applications will be reviewed using the 
same criteria as new applications plus two additional criteria--an 
assessment of research accomplishments and development of an individual 
as an independent investigator. Funding of renewal contracts is also 
contingent upon an appropriation and/or allocation of funds from the 
U.S. Congress and/or the NIH or the NIH Institutes and Centers.
    In return for the repayment of their educational loans, 
participants must agree to: (1) Engage in qualified pediatric 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 
based on a 40-hour 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. Applicants must submit a signed 
contract, prepared by the NIH, agreeing to engage in qualified 
pediatric research at the time they submit an application. Substantial 
monetary penalties will be imposed for breach of contract.
    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, 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:
    (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 are made directly to lenders, following receipt of: (1) 
The Principal Investigator, Program Director, or Research Supervisor's 
verification of

[[Page 58459]]

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:
    <bullet> Health Education Assistance Loan (HEAL);
    <bullet> Health Professions Student Loan (HPSL);
    <bullet> Loans for Disadvantaged Students (LDS); and
    <bullet> Nursing Student Loan Program (NSL);
    (2) Loans guaranteed by the U.S. Department of Education:
    <bullet> Direct Subsidized Stafford Loan;
    <bullet> Direct Unsubsidized Stafford Loan;
    <bullet> Direct Consolidation Loan;
    <bullet> Perkins Loan;
    <bullet> FFEL Subsidized Stafford Loan;
    <bullet> FFEL Unsubsidized Stafford Loan; and
    <bullet> 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:
    <bullet> MEDLOANS; and
    <bullet> Private (non-guaranteed) Consolidation Loans.
    The following loans are not repayable under the Loan Repayment 
Program for Pediatric researchers:
    (1) Loans not obtained from a U.S. or other domestic government 
entity, domestic 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, which 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:
    <bullet> Armed Forces (Army, Navy, or Air Force) Health Professions 
Scholarship Program;
    <bullet> Indian Health Service (IHS) Scholarship Program;
    <bullet> National Institutes of Health Undergraduate Scholarship 
Program (UGSP);
    <bullet> National Research Service Award (NRSA) Program;
    <bullet> Physicians Shortage Area Scholarship Program (Federal or 
State);
    <bullet> Primary Care Loan (PCL) Program; and
    <bullet> 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 
Leave Without Pay (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.

Additional Program Information

    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 Loan Repayment Program for 
Pediatric Researchers expires on December 31, 2004. The Catalog of 
Federal Domestic Assistance number for the Loan Repayment Program for 
Pediatric Researchers is 93.285.

    Dated: September 21, 2004.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 04-21989 Filed 9-29-04; 8:45 am]
BILLING CODE 4140-01-P


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