AUTHORITY: Sec. 215, 58 Stat. 690, as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 305, 88 Stat. 363 (42 U.S.C. 242c), unless otherwise noted.

SOURCE: 43 FR 34472, Aug. 4, 1978, unless otherwise noted.

Subpart A-Grants for Health Services Research, Evaluation, and Demonstration Projects

$67.10 Purpose and scope.

The regulations of this subpart are applicable to the award through the National Center for Health Service Research of grants under section 3050 of the Public Health Service Act U.S.C. 242c(b)) to support identified health services research, evaluation, ( demonstration projects to investigate:

(a) The accessibility, acceptability planning, organization, distribution technology, utilization, quality, and a nancing of health services and systems

(b) The supply and distribution, edn cation and training, quality, utiliz tion, organization, and cost of heal manpower; and

(c) The design, construction, utiliz tion, organization, and cost of facilit and equipment.

$67.11 Definitions.

As used in this subpart:

(a) Act means the Public Health Ser ice Act.

(b) Budget period means the inter of time (usually 12 months) into whit the project has been divided for bud etary and reporting purposes and which the Government has made a nancial commitment to fund a partia lar project.

(c) Direct costs means the costs t can be identified specifically with particular cost objective, such as co pensation of employees for the ti and effort devoted specifically to approved project, and the costs of terials acquired, consumed or expend specifically for the purpose of the proved project.

(d) Grantee means the public or profit entity or individual that receiv a grant under section 305(b) and subpart for a health services resear evaluation or demonstration proj and assumes legal and financial resp sibility for the funds awarded and f

the performance of the grant supported activity.

(e) National Center for Health Services Research means that unit of the Department of Health and Human Services established by section 305(a) of the Act.

(f) Nonprofit as applied to a private ntity, means that no part of the net arnings of such entity inures or may wfully inure to the benefit of any hareholder or individual.

(g) Project period means the total peod of time for which support for a oject has been approved as specified the grant award document. Such apoval does not commit or obligate the deral Government to any additional, pplemental or continuation support yond the current budget period.

h) Principal investigator means a sinindividual, designated in the grant plication and approved by the Secary, who is responsible for the sciific and technical direction of the ject.

) Secretary means the Secretary of alth and Human Services and any er officer or employee of the Detment of Health and Human Serv3 to whom the authority involved been delegated.

) Peer review group means a panel of erts who are neither officers nor ployees, other than by reason of r appointment, of the United tes qualified by training and experi> in particular scientific and techJ fields to give expert advice, in aclance with the provisions of this art, on the scientific and technical it of grant applications.

› Eligible applicants. Any public or ate nonprofit entity and any indial is eligible to apply for a grant er this subpart.

› Eligible projects. Grants pursuant ection 305(b) of the Act and this art may be made to eligible applis for the purpose of assisting in ting the costs of health services rech, evaluation, or demonstration ects as described in §67.10; Provided, t no grant may be made under this art for any health services rech, evaluation, or demonstration ect for which a grant under an

other provision of the Act (other than section 304) may be made.

$67.13 Application.

(a) An application for a grant under this subpart shall be submitted at such time and in such form and manner as the Secretary may prescribe, and shall be executed by an individual authorized to act for the applicant and to assume for the applicant the obligations imposed by the act, the regulations of this subpart and any additional terms or conditions of any grant awarded.

(b) In addition to such other information as the Secretary may require, an application under this subpart must contain the following:

(1) A description of the problem in the area of health services that the project will address;

(2) A description of the hypotheses that will be tested or the specific objectives that will be served by the project as they relate to the general problem area;

(3) A description of the manner in which the project will be organized and managed;

(4) A specification of the data that will be collected or used in the project;

(5) A description of the analytic procedures that will be employed in the project;

(6) The names and qualifications of the principal investigator and principal members of the staff that will be assigned to the project and their roles;

(7) A description of the facilities and resources that will be available to the applicant, if any; and

(8) A complete and detailed budget and justification for the amount of grant funds being requested.

§ 67.14 Evaluation of applications.

(a) Projects with direct costs over the project period in excess of $35,000. (1) All applications for grant support under this subpart for a project with estimated direct costs over the project period in excess of $35,000 will be submitted by the Secretary for review to a peer review group whose members will be selected based upon their training and experience in relevant scientific and technical fields taking into account among other factors:

(1) The level of formal education (e.g., M.A., Ph. D., M.D.) completed by the individual;

(ii) The extent to which the individual has engaged in relevant research, the capacities (e.g., principal investigators, assistant) in which the individual has done so, and the quality of such research;

(iii) The extent of the professional recognition received by the individual as reflected by awards and other honors received from scientific and professional organizations outside the Department of Health and Human Services; and

(iv) The need of the peer review group to include within its membership experts from various areas of specialization within relevant scientific and technical fields.

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

(1) 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 proposed project;

(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) The peer review group to which an application has been submitted pursuant to this paragraph shall make a written report to the Secretary on each application so submitted which shall n the following parts:

first part shall consist of a Summary of the proposed including a description of its

purpose, scientific approach, location, total budget and manpower requirements.

(ii) The second part shall address the scientific and technical merit of the proposed project and shall consist of a critique of the proposed project with regard to the factors described in §67.14(a)(2). This portion of the report shall include a set of recommendations to the Secretary with respect to the disposition of the application based upon its scientific and technical merit. The peer review panel may recommend that the Secretary approve, disapprove or defer a decision on the application in order to obtain further information Where the peer review panel rec ommends deferral, it shall specify the additional information it deems nec essary for an adequate review of the application. Where the peer review panel recommends approval, it shall also provide its recommendation res garding the appropriate project period and level of support for the proposed project.

(iii) The third part of the report shall describe the peer review panel's review of the importance of the problem thin is to be addressed by the propose project and its potential impact.

(b) Project with direct costs over that project period of $35,000 or less. (1) Applie cations for grant support under this subpart for a project with estimated d rect costs over the project period $35,000 or less (hereinafter sometimes referred to as "small grants”) will be submitted by the Secretary for review to members of the staff of the National U Center for Health Services Researche and where desirable to assess the sci entific merit of an application to st least two outside experts who are nea ther officers nor employees of the Unite ed States selected by the Director of the National Center for Health Serv ices Research on the basis of their training and experience in particular scientific and technical fields, their knowledge of health services research and the application of research find ings, and their special knowledge of the problem being addressed in the specifie 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 roposed plan to collect data required n the analyses;

(iv) The adequacy and appropriateess of the plan for organizing and carying out the project;

(v) The qualifications of the principal vestigator and proposed staff;

(vi) The reasonableness of the proosed budget in relation to the project; (vii) The adequacy of the facilities îd resources available to the grantee; id

(viii) Where an application involves tivities which could have an adverse fect upon humans, animals, or the enronment, the adequacy of the prosed means for protecting against or inimizing such effects.

3) Each reviewer to which an applition has been submitted pursuant to is paragraph shall make a written rert to the Secretary on each applicaon so submitted. Each report shall mmarize the reviewer's findings and ovide recommendations with regard approval, disapproval, or deferral of e application in order to obtain addinal information.

7.15 Disposition of applications.

On the basis of the Secretary's evaltion of the application as provided in 1.16, the Secretary shall either (a) apve, (b) defer for a later decision, or disapprove any application for grant istance under this subpart: Disproval of an application shall not eclude its reconsideration if the apcation is resubmitted in the same or evised version at a later date.

7.16 Grant award.

a) General. (1) Within the limits of ads available for such purpose and bject to the limitation of section (c) of the Act, the Secretary may ard grants to those applicants whose proved projects will in his judgment st promote the purposes of section 5(b) of the Act and the regulations of is subpart, taking into consideration: (1) Recommendations made pursuant 867.14.

(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 or 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 grant that additional time is needed to permit the use of funds previously awarded but not expended, the approved project may be extended for a period of time not to exceed 12 months except that in no case may the project period exceed 5 years and 6 months. No additional support may be awarded for any portion of a project period in excess of 5 years.

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(2) For particular categories of small grants, such as dissertation research support, the Secretary may establish a limit on direct costs that is less than $35,000 for the project period. Such limit will be announced in advance of the deadline for receipt of applications for such grants.

(c) Supplemental awards. The Secretary may make supplemental awards during the course of any budget period of an approved project where the Secfetary finds on the basis of the appliCant's written request and such progress and accounting reports as the Secretary may require that the amount of the award initially approved was less than the amount necessary to carry out the approved project activities for that period, or that a supple

mental award to fund incremental activities not initially approved for the period would substantially further the objectives of the project. The Sec retary may also make a supplemental award where in his judgment such as: award is necessary for the preparati of data in suitable form for transmittal in accordance with §67.25. In cases where the award of any supplements grant for a project exceeding $35,000 direct costs would result in supplie mental awards (excluding any suppl mental award for preparation of dia in suitable form for transmittal in cordance with $67.25) during project period in the aggregate exceed ing twenty percent (20 percent) of th approved direct costs of the proje the Secretary will obtain the views the peer review group which first ev nated the initial application prior making any such award. The peer view group shall submit a written port to the Secretary which describ the current status of the project, basis for the request and the potent consequences of any request where recommendation is to disapprove. the case of small grants, the Secreta will not approve any supplemen grant award during the project per (excluding any supplemental award fo preparation of data in suitable form transmittal in accordance with 673 which will in the aggregate exceed percent (10 percent) of the direct cost of the project.

(d) Noncompeting continuation award Where a grantee has filed an applica tion for continuation support and with in the limits of funds available for th purpose, the Secretary may make grant award for an additional budge period of any previously approv project where the Secretary finds the basis of such progress and accou ing reports as may be required an after considering any recommenda tions made pursuant to this paragrap that the project activities during the current budget period justify continued support of the project for an additional budget period. Each project with project period in excess of 2 years and with direct costs over the project pe riod in excess of $35,000 will be reviewed during the second budget period and during each subsequent budget period