Title 42—Public Health--Volume 1
PART 66—NATIONAL RESEARCH SERVICE AWARDS
§ 66.101   Applicability.
The regulations in this subpart apply to National Research Service Awards made by the Secretary to individuals for research and training to undertake research, under section 487 of the Public Health Service Act, as amended (42 U.S.C. 288).
§ 66.102   Definitions.
As used in this subpart:
(a) Act means the Public Health Service Act, as amended.
(b) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.
(c) Nonprofit institution means a corporation or association in which no part of the net earnings inures or may lawfully inure to the benefit of any private shareholder or individual.
(d) Award means a National Research Service Award under section 487 of the Act (42 U.S.C. 288).
(e) Residency means post-graduate training for doctors of medicine, osteopathy, dentistry, optometry, and podiatry, nurses, and other individuals providing health care directly to patients, in which the majority of the time is spent in non-research clinical training.
(f) Noncitizen national of the United States means a person who, though not a citizen of the United States, owes permanent allegiance to the United States [8 U.S.C. 1101(a) (22)].
(g) Predoctoral training means training at the post-baccalaureate level in a program leading to the award of a doctor of philosophy of science, or equivalent degree. For purposes of Awards under the Minority Access to Research Careers programs of the National Institute of General Medical Sciences and the Career Opportunities in Research Education and Training programs of the National Institute of Mental Health, predoctoral training also means training in a program leading to the award of a baccalaureate in science or equivalent degree.
(h) Postdoctoral training means training of individuals holding a doctor of philosophy, science, medicine, dentistry, osteopathy, optometry, podiatry, veterinary medicine, engineering, nursing sciences, public health, or equivalent degree.
§ 66.103   Eligibility.
To be eligible for a National Research Service Award an individual must:
(a) Be a citizen, noncitizen national of the United States, or lawfully admitted to the United States for permanent residence at the time of the award.
(b) Propose to engage in such research, or training to undertake research, in a program specified in section 487(a)(1)(A) of the Act; and
(c) Propose to engage in such research or training to undertake research on a full-time basis except in cases of disability or pressing family need.
§ 66.104   Application.
(a) Eligible individuals may apply for an Award using the form and by the dates the Secretary prescribes.
(b) In addition to any other pertinent information that the Secretary may require, each application shall detail:
(1) The applicant's educational background and other qualifications and experience, including previous academic and professional degrees;
(2) The subject area of the proposed research or training;
(3) The proposed period of Award:
(4) If the proposed period of Award would provide the individual with aggregate support in excess of five years at the predoctoral level or three years at the postdoctoral level, the justification for this request; and
(5) The availability of necessary resources and facilities at the institution where the research or training would be conducted.
§ 66.105   Requirements.
The Secretary shall make an Award to an individual under this subpart only if:
(a) For any Award made for an individual's initial twelve months of NRSA postdoctoral research or training, the individual has assured the Secretary, in the form and manner the Secretary may prescribe, that he or she will satisfy the requirements of § 66.110.
(b) If the proposed research or training would take place at an institution other than the National Institutes of Health, the institution has assured the Secretary, in the form and manner the Secretary may prescribe, that:
(1) The applicant has been accepted to the institution for the purpose of engaging in the research or training for which an Award is being sought;
(2) The Award will not be used to support a residency; and
(3) In the event an Award is made the institution will make available to the applicant any resources and facilities described in the application as necessary to carry out the research or training; and
(c) The individual has assured the Secretary, in the form and manner the Secretary may prescribe, that the Award to the individual will not be used to support a residency.
§ 66.106   Awards.
(a) Within the limits of funds available, the Secretary shall make Awards to those applicants:
(1) Who have satisfied the requirements of § 66.105; and
(2) Whose proposed research or training would, in the judgment of the Secretary, best promote the purposes of section 487(a)(1)(A) of the Act, taking into consideration among other pertinent factors:
(i) The scientific, technical, or educational merit of the particular proposal;
(ii) The availability of resources and facilities to carry it out;
(iii) The qualifications and experience of the applicant; and
(iv) The need for personnel in the subject area of the proposed research or training.
(b) In making Awards, the Secretary shall take account of the Nation's overall need for biomedical research by giving special consideration to physicians who agree to undertake a minimum of two years of biomedical research.
(c) All Awards shall be in writing. Each shall specify:
(1) The period of the Award;
(2) The total recommended stipends and allowances provided for the entire Award period;
(3) The amount awarded for the intitial year of that period (see § 66.107); and
(4) The amount of the payments to the institution for the cost of services provided the awardee by the institution during the initial year of that period (see § 66.108).
(d) Neither the approval of any application nor any Award shall commit or obligate the United States in any way to make additional, supplemental, continuation, or other Award with respect to any approved application or portion thereof.
(e) No individual may receive an aggregate of more than five years of support at the predoctoral level and three years at the postdoctoral level unless the Secretary waives, for good cause shown, this limitation for the individual. In determining what constitutes “good cause,” the Secretary shall take into account such factors as whether the applicant proposes to pursue a combined program leading to the degrees of doctor of medicine and doctor of philosophy.
§ 66.107   Payments to awardees.
(a) Individuals receiving Awards shall be entitled to the stipends, tuition, fees, and allowances the Secretary may designate, taking into account the cost of living, and such other factors as the needs of the program and the availability of funds.
(b) The Secretary shall pay stipends, tuition, fees and allowances to the awardee or the sponsoring institution for payment to the awardee.
§ 66.108   Payments to institutions.
The institution shall be entitled to an allowance to help defray the cost of support services (including the cost of faculty salaries, supplies, equipment, general research support, and related items) provided to the individual by the institution. The Secretary shall determine the amount of payments based upon reasonable costs to the institution of establishing and maintaining the quality of research and training programs for which it receives support under this subpart. The Secretary may make payments to the institution either in advance or by way of reimbursement.
§ 66.109   Termination.
(a) The Secretary may terminate an Award prior to its normal expiration date:
(1) At the written request of the awardee; or
(2) If the Secretary finds that the awardee has materially failed to comply with the terms and conditions of the Award or to carry out the purpose for which it was made.
(b) In the event an Award is terminated, the Secretary shall notify the awardee in writing of this determination, the reasons for termination, the effective date, and any procedural rights available.
§ 66.110   Service, payback, and recovery requirements.
(a) Each individual who receives an Award for postdoctoral research or training shall engage in a month of research training, research, or teaching that is health-related (or any combination thereof) for each month of support received, up to a maximum of twelve months. Such period shall be served in accordance with the usual patterns of such employment or training.
(b) In any case in which an individual receives an Award for more than twelve months, the thirteenth month and each subsequent month of performing activities under the Award shall be considered to be activities toward satisfaction of the requirement established in paragraph (a) of this section.
(c) Except as provided in § 66.111, an individual subject to the requirements for service in paragraph (a) of this section must begin to undertake the service on a continuous basis within two years after the expiration or termination for his or her Award.
(d) If the individual fails to undertake or perform the service in accordance with the requirements of this section, the United States shall be entitled to recover from the individual an amount determined in accordance with the formula:
(e) Except as provided in § 66.111, the individual shall pay to the United States any amount which it is entitled to recover under paragraph (d) of this section within a three-year period beginning on the date the United States becomes entitled to recovery that amount. Interest shall accrue to the United States until any amount due it under paragraph (d) of the section is paid. The rate of interest will be fixed by the Secretary of the Treasury after taking into consideration private consumer rates of interest prevailing on the date the United States becomes entitled to recovery.
§ 66.111   Suspension, waiver, and cancellation.
(a) The Secretary may extend the period for undertaking service described in § 66.110(c), permit breaks in the continuous service required under § 66.110(c), or extend the period of repayment under § 66.110(e) if the Secretary determines that:
(1) An extension or break in service is necessary so the individual may complete his or her research training;
(2) Completion during the period would be impossible because the individual is temporarily disabled; or
(3) Completion during the period would involve a substantial hardship to the individual and failure to extend to the period would be against equity and good conscience.
(b) The Secretary may waive, in whole or in part, the obligation of the individual to repay pursuant to § 66.110(d) if the Secretary determines that:
(1) Fulfillment would be impossible because the individual is permanently and totally disabled; or
(2) Fulfillment would involve a substantial hardship to the individual and enforcement of the obligation would be against equity and good conscience.
(c) In making determinations under § 66.111 (a)(3) and (b)(2), the Secretary will take into consideration such factors as:
(1) The individual's present financial resources and obligations;
(2) The individual's estimated future financial resources and obligations;
(3) The reasons for the individual's failure to complete the requirements within the prescribed period, such as problems of a personal nature;
(4) The extent to which the individual has been engaged in activities encompassed by § 66.110(a) and (b);
(5) Whether the individual has received sufficient training to be qualified to perform any such activities;
(6) The unavailability of employment opportunities appropriate to the individual's education and training; and
(7) Any other extenuating circumstances.
(d) Any obligations of any individual under this subpart will be cancelled upon the death of that individual.
§ 66.112   Other HHS regulations and policies that apply.
Several other regulations and policies may apply to individuals and institutions receiving payments under this subpart. These include, but are not limited to:
This policy is subject to change, and interested persons should contact the Office of Science Policy, Office of Biotechnology Activities, NIH, Suite 302, 6000 Executive Boulevard, MSC 7052, Bethesda, MD 20892-7052, (301) 496-9838 (not a toll-free number) to obtain references to the current version and any amendments.
§ 66.113   Publications.
Publication, distribution, and disposition of all manuscripts and other materials resulting from an Award shall be subject to the conditions that all such materials shall bear appropriate acknowledgement of Department of Health and Human Services support and that the awardee shall furnish copies of these manuscripts or other materials as the Secretary may reasonably request.
§ 66.114   Copyright.
Where the work accomplished under an Award results in a book or other copyrightable material, the author is free to copyright the work, but the United States reserves a royalty-free, nonexclusive, and irrevocable license to reproduce, publish, or otherwise use, and to authorize others to use, all copyrightable or copyrighted material resulting from the Award.
§ 66.115   Additional conditions.
The Secretary may with respect to any Award or class of Awards impose additional conditions prior to or at the time of any Award when in the Secretary's judgment such conditions are necessary to assure the carrying out of the purposes of the Award, the interests of the public health, or the conservation of funds awarded.
§ 66.201   Applicability.
The regulations in this subpart apply to grants under section 487 of the Public Health Service Act, as amended (42 U.S.C. 288), to public institutions and to nonprofit private institutions to enable those institutions to make National Research Service Awards to individuals for research and training to undertake research, in programs specified in section 487 of the Act.
§ 66.202   Definitions.
The definitions in § 66.102 of subpart A of this part apply to this subpart.
§ 66.203   Eligibility.
To be eligible for a grant under this subpart, an applicant must be:
(a) A public or nonprofit private institution; and
(b) Located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust Territory of the Pacific Islands.
§ 66.204   Application.
(a) Application for a grant under this subpart shall be made on a form approved for that purpose by the Secretary. Applicants shall submit completed forms on or before the dates the Secretary may prescribe.
(b) In addition to any other pertinent information that the Secretary may require, each application shall set forth in detail:
(1) The subject area or areas in which the proposed research or training will be conducted;
(2) The resources and facilities available for use by recipients of Awards in carrying out this research or training;
(3) The names, qualifications, and experience of the program director and principal staff members who will be responsible for the proposed program;
(4) The criteria to be employed in selecting recipients of Awards;
(5) The estimated number of recipients of Awards under the grant;
(6) The proposed project period and a detailed budget and justification for the amount of grant funds requested; and
(7) Proposed methods for monitoring and evaluating the performance of individual recipients of Awards, as well as the overall program.
§ 66.205   Requirements.
(a) No Award shall be made to an individual from a grant under this subpart unless:
(1) For any award made for an individual's initial twelve months of NRSA postdoctoral research training, the individual has assured the Secretary, in the form and manner the Secretary may prescribe, that he or she will satisfy the requirements of § 66.110 of subpart A of this part;
(2) The individual is a citizen or noncitizen national of the United States or has been lawfully admitted to the United States for permanent residence at the time of the award;
(3) The Award includes a provision for termination in the event the recipient is found by the institution to have materially failed to comply with the terms and conditions of the Award or to carry out the purpose for which it was made; and
(4) The Award is not to be used to support a residency.
(b) No Award shall be made to an individual under such grant which would provide that individual with aggregate support in excess of five years for predoctoral training and three years for postdoctoral training, unless the Secretary for good cause shown as provided in § 66.106(e) of subpart A of this part, waives the application of the limitation with respect to that individual;
(c) The provisions of §§ 66.110 and 66.111 of subpart A of this part constitute terms and conditions of any Award made from a grant under this subpart.
§ 66.206   Grant awards.
(a) Within the limits of funds available, the Secretary shall award grants to those applicants:
(1) Whose applications have been reviewed and recommended for approval by the appropriate national advisory council or board;
(2) Who have satisfied the requirements of § 66.105; and
(3) Whose proposed programs would, in the judgment of the Secretary, best promote the purposes of section 487(a)(1)(B) of the Act, taking into consideration among other pertinent factors:
(i) The scientific, technical, or educational merit of the proposed program;
(ii) The adequacy of the resources and facilities available to the applicant;
(iii) The qualifications and experience of the program director and principal staff members;
(iv) The degree of the need for personnel in the subject area or areas of the proposed research or training;
(v) The extent to which the applicant, in making Awards, gives special consideration to physicians who agree to undertake a minimum of two years of biomedical research;
(vi) The administrative and management capability of the applicant;
(vii) The reasonableness of the proposed budget in relation to the proposed program; and
(viii) The adequacy of the methods for monitoring and evaluating the performance of individual recipients and the overall program.
(b) The notice of grant award specifies how long HHS intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 3-5 years.
(c) Generally the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.
(d) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of any approved application.
§ 66.207   Other HHS regulations and policies that apply.
Several other regulations and policies apply to grants under this subpart. These include, but are not limited to:
This policy is subject to change, and interested persons should contact the Office of Biotechnology Activities, NIH, Suite 302, 6000 Executive Boulevard, MSC 7052, Bethesda, MD 20892-7052, (301) 496-9838 (not a toll-free number) to obtain references to the current version and any amendments.
§ 66.208   Additional conditions.
The Secretary may, with respect to any grant award, impose additional conditions prior to or at the time of any award when in the Secretary's judgment those conditions are necessary to assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.