special knowledge of the problem being addressed in the specific proposal.

(2) In carrying out a review under this paragraph, the reviewers will, take into account where appropriate:

(i) The significance and originality from a scientific or technical standpoint of the goals of the project;

(ii) The adequacy of the methodology proposed to carry out the project;

(iii) The availability of data or the proposed plan to collect data required in the analyses;

(iv) The adequacy and appropriateness of the plan for organizing and carrying out the project;

(v) The qualifications of the principal investigator and proposed staff

(vi) The reasonableness of the proposed budget in relation to the proj. ect;

(vii) The adequacy of the facilities and resources available to the grantee; and

(viii) Where an application involves activities which could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects.

(3) Each reviewer to which an application has been submitted pursuant to this paragraph shall make a written report to the Secretary on each application so submitted. Each report shall summarize the reviewer's findings and provide recommendations with regard to approval, disapproval, or deferral of the application in order to obtain additional information.

308(c) of the act, the Secretary may award grants to those applicants whose approved projects will in his judgment best promote the purposes of section 305(b) of the act and the regulations of this subpart, taking into consideration:

(i) Recommendations made pursuant to $ 67.14.

(ii) The appropriateness of the budget.

(iii) The extent to which the research proposal and the fiscal plan provide assurance that effective use will be made of grant funds.

(iv) The business management capability of the applicant.

(v) The competence and skill of the staff, especially the senior personnel, in light of the scope of the project.

(vi) The probable usefulness of the project results for dealing with national health care problems, policies, and programs.

(vii) The relative priority of the proposed project in light of the established priorities of the National Center for Health Services Research.

(2) In making any grant award the Secretary may add additional conditions to or require specific modifications in the project as proposed in the application including a different level of grant support from that requested in the application. In such cases the Secretary will obtain either the written agreement of the applicant to proceed on such basis prior to making any grant award or such condition modification will appear on the Notice of Grant Award.

(3) All grant awards shall be in writing. The Notice of Grant Award shall set forth the amount of funds awarded for the conduct of the approved project during the first budget period and the amount of annual support recommended for the remainder of the project period.

(4) The project for any grant under this subpart shall be specified in the Notice of Grant Award and shall begin no later than 9 months following the date of such award. In no case will a project be approved for a project period exceeding 5 years. Where the Secretary determines on the basis of a request by the grantee prior to the completion of the currently active

or

8 67.15 Disposition of applications.

On the basis of the Secretary's evaluation of the application as provided in § 67.16, the Secretary shall either (a) approve, (b) defer for a later decision, or (c) disapprove any application for grant assistance under this subpart: Disapproval of an application shall not preclude its reconsideration if the application is resubmitted in the same or a revised version at a later date.

8 67.16 Grant award.

(a) General. (1) Within the limits of funds available for such purpose and subject to the limitation of section

Subpart A-Direct Awards

а

8 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 472(a)(1)(A) of the Public Health Serv. ice Act, as amended [42 U.S.C. 28921(a)(1)(A)).

8 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 472 of the Act (42 U.S.C. 2891-1).

(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 or 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 Alcohol, Drug Abuse, and Mental Health Administration, "predoctoral training" also means training in a program leading to the award of a baccalaureate degree in science or equivalent degree.

(h) “Postdoctoral training” means training of individuals holding 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 application; and

(b) Propose to engage on a full-time basis in research, or training to undertake research, in a program specified in section 472(a)(1)(A) of the Act. 8 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 facilities at the institution where the research or training would be conducted. (Approved by the Office of Management and Budget under control number 09250002.)

8 66.105 Requirements.

The Secretary shall make an Award to an individual under this subpart only if:

(a) For any Award made for a period in excess of twelve months, other than an Award made for research training at the prebaccalaureate level, the individual has submitted to the Secretary a written assurance (in the 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 one operated by the Public Health Service agencies listed in section 472(a)(1)(A) of the Act, the insti. tution has submitted a written assurance (in the manner the Secretary may prescribe). The assurance shall indicate 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 submitted a written assurance (in the manner the Secretary may prescribe) that the Award to individuals will not be used to support a residency. (Approved by the Office of Management and Budget under control number 09250002.)

(b) In making Awards, the Secretary shall take account of the Nation's overall need for biomedical research by giving special consideration to phy. sicians 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.

8 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 472(a)(1)(A) of the Act, taking into consideration among other pertinent factors:

(i) The scientific, technical, or educational merit of the particular pro

sal; (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.

8 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.

8 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.

( t)

8 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.

in which "A" is the amount the United States is entitled to recover; “0” is the sum of the total amount paid under one or more Awards to the individual less the amount paid for the initial twelve months; “t” is total number in months in the individual's sevice obligation; and “s” is the number of months of the obligation served by him or her in accordance with paragraph (a) of this section.

(d) Except as provided in § 66.111, the individual shall pay to the United States any amount which it is entitled to recover under paragraph (c) within a three-year period beginning on the date the United States becomes entitled to recover that amount. Interest shall accrue to the United States until any amount due it under paragraph (c) of this 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 become entitled to recovery.

(48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983)

8 66.110 Service, payback, and recovery

requirements. (a) Each individual who receives an Award for more than twelve months other than an Award for research training at the prebaccalaureate level shall upon completion of the Award engage for a period equal to the period of support (in excess of twelve months) in health research or teaching or, when in academic employment, any combination of research or teaching which is in accordance with the usual patterns of such employment.

(b) 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 termination of his or her Award.

(c) If the individual fails to undertake or perform the service in accordance with the requirements of paragraph (a) of this section, the United States shall be entitled to recover

8 66.111 Suspension, waiver, and cancella

tion. (a) The Secretary may extend the period for undertaking service prescribed in § 66.110(d), permit breaks in service under $ 66.110(b), or extend the period of repayment under $ 66.110(d) 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 indi. vidual 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(c) 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 individ. ual has been engaged in activities encompassed by $ 66.110(a);

(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. [48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983)

45 CFR Part 76-Debarment and suspension

from eligibility for financial assistance. 45 CFR Part 80—Nondiscrimination under

programs receiving federal assistance through the Department of Health and Human Services-Effectuation of Title VI

of the Civil Rights Act of 1964. 45 CFR Part 81-Practice and procedure for

hearings under Part 80. 45 CFR Part 84-Nondiscrimination on the

basis of handicap in federally assisted

programs. 45 CFR Part 86-Nondiscrimination on the

basis of sex in education programs and activities receiving or benefiting from

federal financial assistance. 45 CFR Part 91-Nondiscrimination on the

basis of age in programs and activities

receiving federal financial assistance. 48 FR 24556-Guidelines for Research In

volving Recombinant DNA Molecules published by the National Institutes of

Health. (48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983)

8 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.

8 66.112 Other HHS regulations and poli

cies that apply. Several other regulations and policies may apply to individuals and insti. tutions receiving payments under this sub art. These include, but are not limited to:

8 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.