§ 68.2 Definitions. As used in this part: *Act* means the Public Health Service Act, as amended (42 U.S.C. 201 *et seq.*).
*AIDS Research* means research activities related to the Acquired Immunodeficiency Syndrome that qualify for inclusion in the AIDS Research LRP.
*Applicant* means an individual who applies to and meets the eligibility criteria for the NIH LRPs.
*Breach of contract* results when a participant fails to complete the research service or other obligation(s) required under the contract and may be subject to assessment of monetary damages and penalties as defined by statute.
*Clinical research* is 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.
*Commercial loans* means loans made for educational purposes by banks, credit unions, savings and loan associations, not-for-profit organizations, insurance companies, schools, 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.
*Contraception research* is defined as research with the ultimate goal of providing new or improved methods of preventing pregnancy.
*Current payment status* means that a qualified educational loan is not past due in its payment schedule, as determined by the lending institution.
*Debt threshold* means the minimum amount of qualified educational debt an individual must have, on their program eligibility date, in order to be eligible for LRP benefits, as established by the NIH Director.
*Director* means the Director of the National Institutes of Health (NIH) or designee.
*Educational expenses* pertain to costs associated with the pursuit of the health professional's undergraduate, graduate, and health professional school's education, including the tuition expenses and other educational expenses such as living expenses, fees, books, supplies, educational equipment and materials, and laboratory expenses.
*Extramural LRP* refers to the program for which health professionals, who are not NIH employees and have program-specified degrees and domestic nonprofit support, are eligible to apply. The Extramural LRP includes subcategories that focus on: ( 1 ) Contraception or infertility research;
( 2 ) Pediatric research, including pediatric pharmacological research;
( 3 ) Minority health disparities research;
( 4 ) Clinical research;
( 5 ) Clinical research conducted by appropriately qualified health professionals who are from disadvantaged backgrounds; and
( 6 ) Research in emerging areas critical to human health.
*General research* pertains to research that falls within the basic science or clinical research parameters and is not targeted toward a specific area (e.g., AIDS) or type of research (e.g., clinical research). The focus is on biomedical and behavioral research studies and investigations across a variety of scientific disciplines within the mission of the NIH.
*Government loans* means educational loans made by U.S. Federal, state, county, or city agencies that are authorized by law to make such loans.
*Health disparities population:* a population is a health disparity population if, as determined by the Director after consultation with the Director of the Agency for Healthcare Research and Quality, there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population.
*Individual from disadvantaged background* means: ( 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 of Health and Human Services (HHS) for use in HHS programs. The Secretary periodically publishes these income levels in the Federal Register.
*Infertility research* is defined as research with the long-range objective of evaluating, treating, or ameliorating conditions that result in the failure of couples to either conceive or bear young.
*Institute or Center (IC)* means an Institute or Center of the National Institutes of Health (NIH).
*Intramural LRP* refers to the program for which applicants must be employed by the NIH. The Intramural LRP includes subcategories that focus on: ( 1 ) General research, including a program for Accreditation Council for Graduate Medical Education (ACGME) Fellows;
( 2 ) AIDS research;
( 3 ) Clinical research conducted by appropriately qualified health professionals from disadvantaged backgrounds; and
( 4 ) An area of emerging scientific or workforce need.
*Institutional base salary or salary* is the annual income or compensation that the organization pays for the applicant's appointment, whether the time is spent on research, teaching, patient care, or other activities.
*Living expenses* means the reasonable cost of room and board, transportation and commuting costs, and other reasonable costs incurred during an individual's attendance at an educational institution and is part of the educational loan.
*Loan Repayment Programs (LRPs)* refers to the NIH Loan Repayment Programs, including those authorized by sections 487A and 487B of the Act, as amended.
*Loan Repayment Program contract* refers to the agreement signed by an applicant and the NIH Director (or an appointed designee). Under such an agreement, an Intramural LRP applicant agrees to conduct qualified research as an NIH employee, and an Extramural LRP applicant agrees to conduct qualified research supported by domestic nonprofit funding, in exchange for repayment of the applicant's qualified educational loan(s) for a prescribed period.
*NIH* refers to the National Institutes of Health.
*Nonprofit research funding/support* means applicants must conduct qualifying research supported by a domestic nonprofit foundation, nonprofit professional association, or other nonprofit institution (*e.g.,* university), or a U.S. or other government agency (Federal, state, or local). A domestic foundation, professional association, or institution is considered to be nonprofit if exempt from Federal tax under the provisions of Section 501 of the Internal Revenue Code (26 U.S.C. 501).
*Participant* means an individual whose application to any of the NIH LRPs has been approved and whose Program contract has been executed by the NIH Director or designee.
*Pediatric research* is defined as research directly related to diseases, disorders, and other conditions in children, including pediatric pharmacology.
*Program* refers to the NIH Loan Repayment Program, or LRP.
*Program eligibility date* means the date on which an individual's LRP contract is executed by the NIH Director or designee.
*Qualified Educational Loans and Interest/Debt* (see the definition of *educational expenses* in this section) as established by the NIH Director, include Government and commercial educational loans and interest for: ( 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 reasonable living expenses incurred.
*Reasonable educational and living expenses* means those educational and living expenses that are equal to or less than the sum of the school's estimated standard student budget for educational and living expenses for the degree program and for the year(s) during which the participant was enrolled in school. If there is no standard budget available from the school, or if the participant requests repayment for educational and living expenses that exceed the standard student budget, reasonableness of educational and living expenses incurred must be substantiated by additional contemporaneous documentation, as determined by the Secretary of HHS.
*Repayable debt* means the proportion, as established by the NIH Director, of an individual's total qualified educational debt that can be repaid by an NIH LRP.
*Research in emerging areas critical to human health* refers to research designed to pursue major opportunities and gaps in biomedical research and expand research in emerging areas of human health. Emerging areas are considered new areas of biomedical and biobehavioral research where a critical mass of capability and expertise is still emerging across the biomedical and biobehavioral research community.
*Salary* has the same meaning as *institutional base salary.*
*School* means undergraduate, graduate, and health professions schools that are accredited by a body or bodies recognized for accreditation purposes by the U.S. Secretary of Education.
*Service* means the Public Health Service.
*State* means one of the fifty states, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. Virgin Islands, Guam, American Samoa, and the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
*Waiver* means a waiver of the service obligation granted by the NIH Director when compliance by the participant is impossible or would involve extreme hardship, or where enforcement with respect to the individual would be unconscionable. (See the definition of *breach of contract* in this section.)
*Withdrawal* means a request by a participant, prior to the Program making payments on his or her behalf, for withdrawal from Program participation. A withdrawal is without penalty to the participant and without obligation to the Program.
[78 FR 20468, Apr. 5, 2013, as amended at 88 FR 4737, Jan. 25, 2023]