Definitions.

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§ 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 Secretary.

Director means the Director of the National Institute on Minority Health and Health Disparities (NIMHD) or designee.

Educational expenses means the cost 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 LRPs refers to those programs for which health professionals, who are not NIH employees and have program-specified degrees and domestic nonprofit support, are eligible to apply. The Extramural LRPs include:

(1) Contraception and Infertility Research LRP;

(2) Clinical Research LRP for Individuals from Disadvantaged Backgrounds;

(3) Clinical Research LRP;

(4) Pediatric Research LRP; and

(5) Health Disparities Research LRP.

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.

(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 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 LRPs refers to those programs for which applicants must be employed by the NIH. The intramural LRPs include:

(1) AIDS Research LRP;

(2) General Research LRP; and

(3) Clinical Research LRP for Individuals from Disadvantaged Backgrounds.

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, 487B, 487C, 487E, 487F, and 464z-5 of the Act, as amended.

Loan Repayment Program contract refers to the agreement signed by an applicant and the Secretary or Director (for the following extramural LRPs: Health Disparities Research LRP and Clinical Research LRP for Individuals from Disadvantaged Backgrounds only). 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 funding/support: 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 Secretary or the Director.

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 Secretary or the Director.

Qualified Educational Loans and Interest/Debt (see Educational Expenses) as established by the Secretary, 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.

Repayable debt means the proportion, as established by the Secretary, of an individual's total qualified educational debt that can be paid by an NIH LRP.

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.

Secretary means the Secretary of Health and Human Services or designee.

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 Secretary when compliance by the participant is impossible or would involve extreme hardship, or where enforcement with respect to the individual would be unconscionable. (See Breach of contract.)

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.


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