03-7580. 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) invites applications for the Extramural Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (ECR-LRP or Program) for fiscal year 2003. Pursuant to authority granted by Public Law 106-554, the Consolidated Appropriations Act of 2001, which amended Section 487E of the Public Health Service (PHS) Act (42 U.S.C. 288-5), as added by the National Institutes of Health Revitalization Act of 1993 (Pub. L. 103-43), the Secretary of Health and Human Services (Secretary), acting through the Director of NIH, has established a loan repayment program that offers the repayment of educational loan debt to qualified health professionals from disadvantaged backgrounds, who have substantial debt relative to income and agree to conduct clinical research. The Director of NIH may enter into contracts with qualified health professionals from disadvantaged backgrounds who agree to engage in clinical research for a minimum of two years in exchange for loan repayments toward their outstanding educational loan debt, up to a maximum of $35,000 per year. Payments equal to 39 percent of total loan repayments are issued to the Internal Revenue Service on behalf of the participants to offset Federal tax liabilities incurred due to their participation in the Program.

DATES:

Information regarding the ECR-LRP is currently available, and the following are the application deadline dates: Fiscal Year 2003—January 31, 2003; Fiscal Year 2004—January 31, 2004; and Fiscal Year 2005—January 31, 2005. All applications must be submitted on-line by 5 p.m. (eastern standard time). If an Application Deadline Date falls on a weekend or holiday, the application is due on the following business day by 5 p.m. (eastern standard time).

ADDRESSES:

The information and an on-line application may be obtained at the NIH Loan Repayment Program Web site at www.lrp.nih.gov or by contacting the National Center on Minority Health and Health Disparities, Attention Kenya McRae, non-toll free telephone number [phone], or via email at [e-mail].

SUPPLEMENTARY INFORMATION:

Definitions

(1) “Clinical research” is defined as 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.

(2) “Debt threshold” is the minimum amount of qualified educational loan debt an applicant must have in order to be eligible for Program benefits. An applicant must have qualified educational loan debt equal to at least 20 percent of the applicant's annual institutional base salary at the time of award.

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

(4) “Institutional base salary” is defined as the annual amount that the organization pays for the participant's appointment, whether the time is spent in research, teaching, patient care or other activities. Institutional base salary excludes any income that a participant may earn outside the duties of the organization, and it may not include or comprise any income (salary or wages) earned as a Federal employee.

(5) “Total educational loan debt” is defined as the outstanding educational loan debt incurred by health professionals for their educational expenses incurred at accredited institutions. It consists of the principal, interest, and related expenses of qualified U.S. Government, academic institutions, and commercial U.S. educational loans obtained by the applicant for (a) undergraduate, graduate and health professional school tuition expenses; (b) other reasonable educational expenses required by the school(s) attended, including fees, books, supplies, educational equipment and materials, and laboratory expenses; and (c) reasonable living expenses, including the cost of room and board, transportation and commuting costs, and other reasonable living expenses as determined by the Secretary or his designee.

(6) “Repayable debt” means the difference between the applicant's total educational loan debt and 50 percent of the applicant's debt threshold.

Background

The Consolidated Appropriations Act of 2001 (Pub. L. 106-554) was enacted on December 21, 2000, amending Section 487E of the Public Health Service (PHS) Act to authorize the Secretary of the Department of Health and Human Services (Secretary), through the Director of the National Institutes of Health (NIH), to enter into contracts with qualified health professionals from disadvantaged backgrounds. These health professionals are required to engage in clinical research in consideration of the Federal Government repaying a portion of the principal and interest of their extant educational loans, up to a maximum of $35,000 per year, for each year of service. The program is known as the Extramural Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (ECR-LRP). Selected applicants become participants of the ECR-LRP only upon the execution of a contract by the Secretary or his designee.

Eligibility Criteria

Specific eligibility criteria with regard to participation in the ECR-LRP include the following:

(1) Applicants must be U.S. citizens, U.S. nationals, or permanent residents of the United States;

(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 must come from a disadvantaged background;

(4) Applicants must have total qualifying educational loan debt equal to or in excess of 20 percent of their annual institutional base salary at the time their loan repayment contract is executed by the Secretary or designee (example: an applicant with a base salary of $40,000 per year must have a minimum outstanding educational loan debt of $8,000);

(5) Applicants must engage in qualified clinical research supported by a non-profit foundation, non-profit professional society, non-profit institution, or a U.S. or other government agency (Federal, State, or local). A foundation, professional society, 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;

(7) Applicants must agree to conduct research for which funding is not prohibited by Federal law, regulations, or HHS/NIH policy. Recipients of LRP awards must conduct their research in accordance with applicable Federal, State and local law (e.g., applicable human subject protection regulations);

(8) 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 the required percentage of time, are eligible to apply for loan repayment if they meet all other eligibility requirements;

(9) Applicants must have a research supervisor or mentor with experience in the area of proposed research;

(10) Applicants will not be excluded from consideration under the ECR-LRP on the basis of age, race, culture, religion, gender, sexual orientation, disability or other non-merit factors; and

(11) No individual may submit more than one LRP application to the NIH in any fiscal year. Individuals who have applied previously for the Program or any other NIH Loan Repayment Program but did not receive an award are eligible to submit a new application if they meet the above eligibility criteria.

The following individuals are ineligible for participation in the ECR-LRP:

(1) Persons who are not United States citizens, nationals, or permanent residents;

(2) Individuals who have a Federal judgment lien against their property arising from a Federal debt are barred from receiving Federal funds until the judgment is paid in full or satisfied;

(3) Individuals who owe 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 the ECR-LRP service obligation. The following are examples of programs with service obligations that disqualify applicants from consideration, unless a deferral for the length of participation in the ECR-LRP is obtained:

• Physicians Shortage Area Scholarship Program,
• Primary Care Loan (PCL) Program—recipients of PCLs incur a service obligation to practice primary care. PCL recipients are eligible to apply for the ECR-LRP if the PCL has been paid in full. If still repaying the PCL, LRP applicants must submit documentation, via facsimile to [phone], from the Health Resources and Services Administration (HRSA) that demonstrates that the LRP applicant is satisfying the terms and conditions of the PCL,
• Public Health Service Scholarship Program,
• National Health Service Corps Scholarship Program,
• Armed Forces (Army, Navy, or Air Force) Professions Scholarship Program,
• Indian Health Service Scholarship Program,
• National Research Service Award Program—a current recipient of a postdoctoral National Research Service Award support from an individual postdoctoral fellowship (F32) or an institutional research training grant (T32) will not be eligible for loan repayment during the second year of NRSA support without a formal deferral of the NRSA service obligation (see http://grants1.nih.gov/​grants/​guide/​pa-files/​PA-02-109.html). Concurrent repayment of service obligations is prohibited. Participation in an NIH LRP is only permissible by first satisfying the NRSA service obligation, which is satisfied either by completing the second year of NRSA support or by requesting a deferral of the NRSA service obligation. (Note—first year NRSA recipients are eligible to apply for and receive NIH loan repayment. Second year NRSA recipients can apply to participate in the ECR-LRP, but can only receive loan repayment during the second year if an extension of time is obtained to satisfy the NRSA service obligation. If an extension is not obtained, loan repayment will commence after the completion of the NRSA service obligation. LRP payments are NOT retroactive.);

(4) Full-time employees of Federal Government agencies;

(5) 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);

Individuals with ineligible loans, which include loans that have been consolidated with a loan of another individual (including spouses and children), or loans that are not educational, such as home equity loans;

(8) Individuals with existing service obligations to Federal, State, or other entities may not apply for the ECR-LRP, unless and until the existing service obligation is discharged or deferred for the length of program participation; and

(9) Individuals that have a Federal judgment lien against their property arising from a Federal debt may not apply for the ECR-LRP until the judgment has been paid in full or otherwise satisfied.

Application Procedures

Applications must be submitted electronically to the Office of Loan Repayment (OLR). The NIH LRP Web site is www.lrp.nih.gov. The site has an Applicant Information Bulletin with the current deadlines, sources for assistance, and additional details regarding application procedures.

Application materials from the applicant, the supervisor/mentor, recommenders, and institutional officials must be submitted prior to the application deadline.

The following information must be provided by the applicant:

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 in the research project description provided by the applicant.

5. Contact Information for Three Recommenders (one of whom is identified as research supervisor or mentor).

6. Contact Information for Institution Official able to serve as the Institutional Contact and verify an applicant's employment/research appointment and research funding status.

7. On-line Certification.

8. Loan information, which includes the current account statement(s), and promissory note(s) or disclosure statement(s), obtained from lending institution(s), submitted via facsimile to [phone].

9. Notice of Grant/Award (or PHS Form Number 2271 for T32 recipients) if applying based on NIH support.

10. Certification of Disadvantaged Background, which 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 financial aid from either Health Professions Student Loans (HPSL) or the Loans for Disadvantaged Students Program; or (c) documentation that the applicant received a scholarship from the HHS under the Scholarship for Individuals with Exceptional Financial Need.

The following information must be provided by the Research Supervisor/Mentor and submitted electronically via the NIH-LRP Web site:

1. Recommendation.

2. Biosketch.

3. Assessment of the Research Activities Statement submitted by the applicant.

4. Description of the Research Environment. (Please provide 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. (Includes a detailed discussion of the training and/or mentoring plan, as well as the research methods and scientific techniques to be taught.)

6. Biosketch of other pertinent staff members involved in training or mentoring the applicant.

Recommenders must submit their recommendations electronically.

Institutional Contacts must electronically submit a certification, via the NIH-LRP Web site, 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 funding foundation, professional society, or institution is considered to be non-profit as provided under Section 501 of the Internal Revenue Code (26 U.S.C. 501) or is a U.S. or other government entity (Federal, State or local), and (d) provides the applicant's institutional base salary.

Review Process

Applications that are received and complete by the deadline will undergo peer review by a Special Emphasis Panel (SEP). The reviewers will use the review criteria in assessing and rating each application.

Review Criteria

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.

• Availability of appropriate scientific colleagues to achieve and/or enhance the applicant's research independence.

sbull Quality and appropriateness of institutional resources and facilities.

Program Administration and Details

Under the ECR-LRP, a portion of the participants' outstanding educational loan debt will be repaid. Participants will not automatically qualify for the maximum amount of loan repayment. The amount the NCMHD will consider for repayment during the initial two-year contract shall be calculated as follows: one-fourth the repayable debt per year, up to a maximum of $35,000 per year. For example, a participant with a base salary of $40,000 per year and an outstanding eligible educational loan debt of $100,000, would have a debt threshold of $8,000 (the debt threshold is 20 percent of an applicant's annual institutional salary). All participants are responsible for paying one-half of their debt threshold amount. This amount is known as the participant's obligation and is subtracted from the total outstanding loan debt. In this case, the participant's obligation would be $4,000 and the participant's eligible loan debt would be reduced to $96,000. This reduced amount is known as the repayable debt ($100,000−$4,000 = $96,000). Of the $96,000 repayable debt amount, the NCMHD would repay $24,000 a year in loan repayments (one-fourth of the repayable debt amount), plus tax benefits.

Loan repayments will be made to the designated lender following the completion of each full quarter (3 months) of service by the participant and upon the receipt of requested documentation from the participants and their supervisors/mentors. Because the first payment to the lenders on behalf of the participants will not commence until the end of the first full quarter of obligated service, participants should continue to make monthly loan payments until they have been informed that payments have been forwarded to their lenders. This measure enables the participants to maintain their loans in a current payment status.

In return for the repayment of their educational loans, participants must agree to (1) engage in qualified clinical 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; (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.

Repayments are made directly to lenders, following the 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 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 ECR-LRP:

(i) Loans not obtained from a U.S. or other government entity, 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;

(ii) Loans for which contemporaneous documentation (current account statement and promissory note or lender disclosure statement) is not available;

(iii) Loans that have been consolidated with loans of other individuals, such as a spouse or child;

(iv) 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;

(v) 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:

• Physicians Shortage Area Scholarship Program (Federal or State);
• National Research Service Award Program;
• Public Health Service and National Health Service Corps Scholarship Program;
• Armed Forces (Army, Navy, or Air Force) Health Professions Scholarship Program; and
• Indian Health Service Scholarship Program;

(vi) Delinquent loans, loans in default, or loans not current in their payment schedule;

(vii) PLUS Loans;

(viii) Loans that have been paid in full;

(ix) Loans obtained after the execution of the LRP Contract (e.g., promissory note signed after the LRP contract has been awarded); and

(x) Primary Care Loans.

During lapses in loan repayments, due either to NIH administrative complications 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. Penalties assessed participants as a result of NIH administrative complications to maintain a current payment status may not be considered for reimbursement.

Additional Program Information

This program is not subject to the provision of Executive Order 12372, Intergovernmental Review of Federal Programs. Under the requirements of the Paperwork Reduction Act of 1995, OMB has approved the application forms for use by the ECR-LRP under OMB Approval No. 0925-0361 (expires December 31, 2004).

The Catalog of Federal Domestic Assistance number for the ECR-LRP is 93.308.

Dated: February 5, 2003.

Elias A. Zerhouni,

Director, NIH.