Loan Repayment Program for Clinical Researchers

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

Pending approval by the Office of Management and Budget (OMB) under the requirements of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) announces the availability of educational loan repayment under the NIH Loan Repayment Program for Clinical Researchers (the Program). The Program, which is authorized by section 487F of the Public Health Service (PHS) Act (42 U.S.C. 288-5a), as added by the Public Health Improvement Act of 2000 (Pub. L. 106-505), provides for the repayment of the educational loan debt of qualified health professionals who agree to conduct clinical research. The Program provides for the repayment of up to $35,000 of the principal and interest of the educational loans of such health professionals for each year of obligated service. The purpose of the Program is the recruitment and retention of highly qualified health professionals as clinical investigators. Through this notice, the NIH invites qualified health professionals who contractually agree to engage in clinical research for at least two years, to apply for participation in the NIH Loan Repayment Program for Clinical Researchers.

DATES:

Interested persons may request information about the Program beginning on September 6, 2001.

ADDRESSES:

Information regarding the requirements and application procedures for the Program may be obtained by calling or writing: Marc S. Horowitz, J.D., Office of Loan Repayment and Scholarship, National Institutes of Health, 2 Center Drive, Room 2E30, Bethesda, MD 20892-0230 or call non-toll-free number (301) 402-5666 or e-mail your request, including your address, to <lrp@nih.gov>.

SUPPLEMENTARY INFORMATION:

The Public Health Improvement Act of 2000 (Pub. L. 106-505) was enacted on November 13, 2000 adding section 487F of the Public Health Service (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 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. This program is known as the NIH Loan Repayment Program for Clinical Researchers (LRP-CR).

Eligibility Criteria

Specific eligibility criteria with regard to participation in the LRP for Clinical Researchers include the following:

(1) Participants must be United States citizens, nationals, or permanent residents;

(2) Participants must have a M.D., Ph.D., Pharm.D., D.O., D.D.S., D.M.D., D.P.M., D.C., N.D., or equivalent degree;

(3) Participants must be affiliated with the NIH in one of the following ways:

(a) a recipient of postdoctoral National Research Service Award support on an individual postdoctoral fellowship (F32) or an institutional research training grant (T32). NRSA recipients will only be eligible for loan repayment during the first and third year of NRSA support. The second year of postdoctoral NRSA involves repayment of a service obligation incurred during the first year of NRSA support which eliminates the possibility of concurrent participation in the loan repayment program.

(b) a recipient of support under an individual or institutional research career development award including the following mechanisms:

(1) K01, the Mentored Research Scientist Development Award,

(2) K07, the Academic Clinical Scientist Development Award,

(3) K08, the Mentored Clinical Scientist Development Award,

(4) K12, Mentored Clinical Scientist Development Program Award,

(5) K22, the Career Transition Award with an extramural phase,

(6) K23, the Mentored Patient-Oriented Research Career Development Award, or

(7) K25, the Mentored Quantitative Research Career Development Award.

(c) a first-time recipient of NIH grant support as the principal investigator of an

(1) R01, a research project grant consisting of one research project,

(2) R03, a small research grant,

(3) R21, an exploratory/developmental grant,

(4) U01, a cooperative agreement consisting of one research project.

(d) a first-time director of subprojects on multicomponent center grants (P series grants, program project grants (P01)), or multicomponent cooperative agreements (U series).

(4) Participants must have qualifying educational debt in excess of 20 percent of their annual income or compensation, as applicable, 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) Award date of a qualifying grant, and (b) the Secretary executes a LRP-CR contract. Contracts are not effective retroactive to the award date of the grant.

(5) Participants must engage in clinical research, as defined by Section 206 of Public Law 106-505, the Public Health Improvement Act, which states: “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.”

(6) Individuals with existing service obligations to Federal, State, or other entities will not be considered for the Program unless and until the existing service obligation is discharged or deferred for the length of Program participation. Further, 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.

(7) Applicants will not be excluded from consideration under the Program on the basis of age, race, culture, religion, gender, sexual orientation, disability, or other non-merit factors.

NIH will evaluate the applicant and awardee pools after the first year of operation to assess and measure the extent of recruitment and retention of qualified health professionals to clinical research. At that time, NIH will expand the pool of individuals eligible to apply for loan repayment.

Selection Process

Individuals submit their LRP-CR applications to the Director, Office of Loan Repayment and Scholarship (OLRS), who forwards those satisfying the basic eligibility criteria to the relevant NIH Institutes and Centers (IC) for review. The IC Loan Repayment Committee (IC-LRC) reviews and ranks applications based upon the following:

(1) A personal statement, which includes a discussion of career goals and research and academic objectives;

(2) A research statement, which provides a description of the proposed research project including the specific responsibilities and role of the applicant in conducting the research;

(3) A research training plan, if applicable, which includes a detailed description of the mentoring plan, including a discussion of the research methods and scientific techniques to be taught;

(4) A description of the current research being conducted in the lab;

(5) Recommendation forms submitted by three individuals. Information provided addresses the applicant's potential for success in clinical research and/or academic medicine, and their main strengths and weaknesses; and

(6) A supporting statement from the sponsoring institution.

Funds for repayment will only be awarded to IC-LRC-approved applications, subject to the receipt of an appropriation and/or allocation of funds from the U.S. Congress, the NIH or IC. The Director, Office of Loan Repayment and Scholarship (OLRS), provides current deadlines, sources for assistance, and additional details regarding application procedures in an Applicant Information Bulletin that is maintained on the Loan Repayment Program's Internet homepage at <http://lrp.info.nih.gov>.

Program Administration and Details

Under the LRP for Clinical Researchers, 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 20% of their anticipated annual compensation (“debt threshold”) on the date of program eligibility.

An amount equal to 50 percent of the debt threshold will not be considered for repayment (“participant obligation”). For example, 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% of university compensation = $8,000), the applicant has sufficient debt for loan repayment consideration. The “participant obligation” is one-half the debt threshold, in this case $4,000. Thus, repayment of $4,000 is the applicant's responsibility. The remaining amount (“repayable debt”) will be considered for repayment.

The repayable debt of qualified health professionals will be satisfied at the rate of one-quarter 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 at least 2 years of qualified clinical research as an investigator on an NIH grant or as the recipient of an NIH award. Following conclusion of the initial two-year contract, participants may apply for renewal contracts if they have remaining repayable debt and continue to engage in qualified clinical research. These continuation contracts may be approved on a year-to-year basis, subject to a finding by NIH that the applicant's clinical research accomplishments are acceptable and qualified clinical research continues. Funding of contracts is contingent upon an appropriation and/or allocation of funds from the U.S. Congress and/or the NIH or ICs.

In return for the repayment of their educational loans, participants must agree to (1) engage in qualified clinical research as an investigator on an NIH grant or as a recipient of an NIH award for a minimum period of 2 years; (2) make payments to lenders on their own behalf for periods of Leave Without Pay (LWOP); (3) pay monetary damages as required for breach of contract; and (4) satisfy other terms and conditions of the LRP-CR contract and application procedures. Applicants must submit a signed contract, prepared by the NIH, agreeing to engage in qualified clinical 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 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 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);
• Primary Care Loan (PCL); 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 Loan.

Within each category, loans are repaid in order of interest rate (highest first).

The following loans are NOT repayable under the LRP-CR:

(1) Loans not obtained from a government entity, academic institution, or a commercial or other chartered lending institution such as loans from friends, relatives, or other individuals;

(2) Loans for which contemporaneous documentation is not available;

(3) 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;

(4) Loans, financial debts, or service obligations incurred under the following programs, or other programs which incur a service obligation which 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 and National Health Service Corps Scholarship Program;
• Armed Forces (Army, Navy, or Air Force) Health Professions Scholarship Program; and
• Indian Health Service Scholarship Program;

(5) Delinquent loans, loans in default, loans not current in their payment schedule, loans already repaid or those for which promissory notes have been signed after the program effective date are not eligible for repayment; and

(6) PLUS Loans.

During lapses in loan repayments, due either to LRP 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 LRP administrative complications to maintain a current payment status may be considered for reimbursement.

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. A Request for OMB Review and Approval of information collection associated with the program is being prepared by the NIH and will be sent to OMB for review and approval prior to implementation of the LRP for Clinical Researchers.

The Catalog of Federal Domestic Assistance number for the LRP for Clinical Researchers is 93.280.