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$66.208 Additional conditions.

AUTHORITY: Sec. 215, 58 Stat. 860, as amend

ed, 63 Stat. 35 (42 U.S.C. 216), sec. 305, 88 Stat. The Secretary may, with respect to

363 (42 U.S.C. 242c), unless otherwise noted. any grant award, impose additional conditions prior to or at the time of

SOURCE: 43 FR 34472, Ang. 4, 1978, unless

otherwise noted. any award when in the Secretary's judgment those conditions are necessary to assure or protect advance - Subpart A-Grants for Health Servment of the approved program, the in

ices Research, Evaluation, terests of the public health, or the con

and Demonstration Projects servation of grant funds.

867.10 Purpose and scope. PART 67-NATIONAL CENTER FOR The regulations of this subpart art

HEALTH SERVICES RESEARCH applicable to the award through the GRANTS

National Center for Health Servica

Research of grants under section 3061 Subpart A-Grants for Health Services, Re

of the Public Health Service Act search, Evaluation, and Demonstration

U.S.C. 242c(b)) to support identifio Projects

health services research, evaluation,

demonstration projects to investigate: Sec.

(a) The accessibility, acceptability 67.10 Purpose and scope.

planning, organization, distribution 67.11 Definitions.

technology, utilization, quality, and 67.12 Eligibility.

nancing of health services and system 67.13 Application.

(b) The supply and distribution, et 67.14 Evaluation of applications.

cation and training, quality, utilis 67.16 Disposition of applications. 67.16 Grant award.

tion, organization, and cost of heall 67.17 Project requirements.

manpower; and 67.18 Grant payments.

(c) The design, construction, utilis 67.19 Use of project funds.

tion, organization, and cost of facilita 67.20 Termination.

and equipment. 67.21 Nondiscrimination. 67.22 Human subjects and animal welfare. 8 67.11 Definitions. 67.23 Publications and copyright.

As used in this subpart: 67.24 Confidentiality. 67.25 Control of data.

(a) Act means the Public Health Serage

ice Act. 67.26 Grantee accountability. 67.27 Applicability of 45 CFR part 74.

(b) Budget period means the inters 67.28 Additional conditions.

of time (usually 12 months) into wet

the project has bee divided for boleto Subpart B-Grants for Health Services etary and reporting purposes and Research Centers

which the Government has made

nancial commitment to fund a parties et 67.101 Purpose and scope.

lar project. 67.102 Definitions.

(c) Direct costs means the costs 67.103 Eligibility. 67.104 Application.

can be identified specifically with me 67.105 Evaluation and disposition of applica- particular cost objective, such as on tions.

pensation of employees for the ti 67.106 Grant awards.

and effort devoted specifically to 67.107 Operational requirements.

approved project, and the costs of 67.108 Grant payments.

terials acquired, consumed or expende 67.109 Use of project funds.

specifically for the purpose of the 67.110 Nondiscrimination.

proved project. 67.111 Publications and copyright.

(d) Grantee means the public or su 67.112 Confidentiality.

profit entity or individual that receit 67.113 Control of data. 67.114 Grantee accountability.

a grant under section 305(b) and 67.115 Reports.

subpart for a health services researd 67.116 Human subjects.

evaluation or demonstration proje 67.117 Applicability of 45 CFR part 74.

and assumes legal and financial res 67.118 Additional conditions.

sibility for the funds awarded and

Che performance of the grant supported ctivity.

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

(1) Nonprofit as applied to a private tity, means that no part of the net arnings of such entity inures or may wfully inure to the benefit of any pareholder or individual. (8) 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, oplemental or continuation support yond the current budget period. b) 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 Servs to whom the authority involved been delegated. ) Peer review group means a panel of erts who are neither officers nor sloyees, other than by reason of rappointment, of the United bes qualified by training and experi; in particular scientific and tech1 fields to give expert advice, in aclance with the provisions of this art, on the scientific and technical it of grant applications. 12 Eligibility. ) Eligible applicants. Any public or ate nonprofit entity and any indial is eligible to apply for a grant or 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.

867.14 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 purpose, scientific approach, location, (e.8., M.A., Ph. D., M.D.) completed by total budget and manpower requirethe individual;

ments. (11) The extent to which the individ- (ii) The second part shall address the ual has engaged in relevant research, scientific and technical merit of the the capacities (e.g., principal investiga- proposed project and shall consist of a tors, assistant) in which the individual critique of the proposed project with has done so, and the quality of such re- regard to the factors described in search;

$67.14(aX2). This portion of the report (111) The extent of the professional shall include a set of recommendations recognition received by the individual to the Secretary with respect to the as reflected by awards and other hon- disposition of the application based ors received from scientific and profes- upon its scientific and technical merlt. sional organizations outside the De- The peer review panel may recommend partment of Health and Human Serv- that the Secretary approve, disapprove ices; and

or defer a decision on the application (1v) The need of the peer review group in order to obtain further information. to include within its membership ex- Where the peer review panel recperts from various areas of specializa- ommends deferral, it shall specify the tion within relevant scientific and additional information it deems neotechnical fields.

essary for an adequate review of the (2) In carrying out a review under application. Where the peer revier this paragraph the peer review group panel recommends approval, it shall will take into account where appro- also provide its recommendation of priate:

garding the appropriate project period (1) The significance and originality and level of support for the proposed from a scientific or technical stand- project. point of the goals of the project;

(iii) The third part of the report shal(11) The adequacy of the methodology describe the peer review panel's revier proposed to carry out the project;

of the importance of the problem the (111) The availability of data or the is to be addressed by the proposed proposed plan to collect data required project and its potential impact. in the analyses;

(b) Project with direct costs over the (iv) The adequacy and appropriate- project period of $35,000 or less. (1) Appis ness of the plan for organizing and car- cations for grant support under the rying out the project;

subpart for a project with estimated a (v) The qualifications of the principal rect costs over the project period investigator and proposed staff;

$35,000 or less (hereinafter sometimes (vi) The reasonableness of the pro- referred to as “small grants") will posed budget in relation to the pro- submitted by the Secretary for revier posed project;

to members of the staff of the National (vil) The adequacy of the facilities Center for Health Services Research and resources available to the grantee; and where desirable to assess the sch and

entific merit of an application to all (vill) Where an application involves least two outside experts who are Dela activities which could have an adverse ther officers nor employees of the Unit effect upon humans, animals, or the en- ed States selected by the Director of vironment, the adequacy of the pro- the National Center for Health Serra posed means for protecting against or ices Research on the basis of their minimizing such effects.

training and experience in particular (3) The peer review group to which an scientific and technical fields, their application has been submitted pursu- knowledge of health services research ant to this paragraph shall make a and the application of research finde written report to the Secretary on each ings, and their special knowledge of the application so submitted which shall problem being addressed in the specific ithe following parts:

proposal. first part shall consist of a (2) In carrying out a review under ummary of the proposed this paragraph, the reviewers will, take including a description of its into account where appropriate:

(1) The significance and originality (ii) The appropriateness of the budg- from a scientific or technical stand- et. point of the goals of the project;

(iii) The extent to which the research (11) The adequacy of the methodology proposal and the fiscal plan provide asproposed to carry out the project; surance that effective use will be made

(ill) The availability of data or the of grant funds. -proposed plan to collect data required (iv) The business management capa- the analyses;

bility of the applicant. (iv) The adequacy and appropriate- (v) The competence and skill of the ess of the plan for organizing and car- staff, especially the senior personnel, ying out the project;

in light of the scope of the project. (v) The qualifications of the principal (vi) The probable usefulness of the ivestigator and proposed staff;

project results for dealing with na(vi) The reasonableness of the pro- tional health care problems, policies, osed budget in relation to the project; and programs. (vil) The adequacy of the facilities

(vii) The relative priority of the proad resources available to the grantee; posed project in light of the established id

priorities of the National Center for (vill) Where an application involves Health Services Research. tivities which could have an adverse (2) In making any grant award the sect upon humans, animals, or the en- Secretary may add additional condironment, the adequacy of the pro- tions to or require specific modificased means for protecting against or tions in the project as proposed in the inimizing such effects.

application including a different level 3) Each reviewer to which an appli

of grant support from that requested in tion has been submitted pursuant to the application. In such cases the Secis paragraph shall make a written re

retary will obtain either the written rt to the Secretary on each applica- agreement of the applicant to proceed in so submitted. Each report shall on such basis prior to making any mmarize the reviewer's findings and grant award or such condition or modiovide recommendations with regard fication will appear on the Notice of approval, disapproval, or deferral of Grant Award. e application in order to obtain addi

(3) All grant awards shall be in writinal information.

ing. The Notice of Grant Award shall

set forth the amount of funds awarded 7.15 Disposition of applications.

for the conduct of the approved project On the basis of the Secretary's eval- during the first budget period and the tion of the application as provided in amount of annual support rec1.16, the Secretary shall either (a) ap- ommended for the remainder of the uve, (b) defer for a later decision, or project period. disapprove any application for grant (4) The project for any grant under sistance under this subpart: Dis- this subpart shall be specified in the proval of an application shall not Notice of Grant Award and shall begin xclude its reconsideration if the ap- no later than 9 months following the cation is resubmitted in the same or date of such award. In no case will a evised version at a later date.

project be approved for a project period

exceeding 5 years. Where the Secretary 7.16 Grant award.

determines on the basis of a request by a) General. (1) Within the limits of the grantee prior to the completion of ads available for such purpose and the currently active grant that addibject to the limitation of section tional time is needed to permit the use (c) of the Act, the Secretary may of funds previously awarded but not extard grants to those applicants whose pended, the approved project may be proved projects will in his judgment extended for a period of time not to ex8t promote the purposes of section ceed 12 months except that in no case 5(b) of the Act and the regulations of may the project period exceed 5 years is subpart, taking into consideration: and 6 months. No additional support (1) Recommendations made pursuant may be awarded for any portion of a $67.14.

project period in excess of 5 years.

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beste te Luma I ETT E- mental award to fund incremental de 341-5 I ESTATS I ETT Gattivities not initially approved for the Deir Einz je Fedez period would substantially further the

. . T F am 23 objectives of the project. The Beam

Senka. U retary may also make a supplementa Cars ES tibe award where in his judgment such * EN RIE Tec For award is necessary for the preparatie

of data in suitable form for transmitta D a DSLUT ETTIDERJ in accordance with $67.25. In case US XI I u nas where the award of any supplement

grant for a project exceeding $35,000 - DUIT UNUTILITI direct costs would result in suppi

smalle de mental awards (excluding any suppl 2 SK m de ass mental award for preparation of da 2-2 o 18 sun IRSET in suitable form for transmittal in

I - cordance with $67.25) during *S X i rreS DE 2 BD project period in the aggregate exceed 2 x 2 MESI I ing twenty percent (20 percent) of 29. Auct the approved direct costs of the projes

the Secretary will obtain the vien : 20 Se sss I 1 SZ I be the peer review group which first eve Y me tied uated the initial application prior

making any such award. The peer 23, SSS I I IS view group shall submit a written r . ESCR raun Idee 950- port to the Secretary which describe

» S Tzet wie the current status of the project, are not sure is basis for the request and the potenta

x 28 rru - 16 - consequences of any request where

e scrisa TIR. 200 recommendation is to disapprove. 20 Sica br1 LU 2 X- the case of small grants, the Secretar a TTSO 200 ir ** will not approve any supplemer

grant award during the project per 23 S Lies set to (excluding any supplemental award ad T1563 ISTE de preparation of data in suitable form

2 23 we. 28 Dwived transmittal in accordance with $67 merta to ma costa when the seat which will in the aggregate exceed properly extended try the preside for percent (10 percent) of the direct com provisional items has been determined of the project. by tbe secretary,

(d) Noncompeting continuation award (2) For particular categories of small Where a grantee has filed an applica grants, such as dissertation research tion for continuation support and with support, the secretary may establish a in the limits of funds available for the limit on direct costs that is less than purpose, the Secretary may make $35,000 for the project period. Such grant award for an additional budi limit will be announced in advance of period of any previously approval the deadline for receipt of applications project where the Secretary finds for such krants,

the basis of such progress and account (C) Supplemental awards. The Sec- ing reports as may be required and retary may make supplemental awards after considering any recommendsduring the course of any budget period tions made pursuant to this paragraph of an approved project where the Sec- that the project activities during the Tetary finds on the basis of the appli- current budget period justify continue cant's written requont and such support of the project for an additional progress and accounting reports as the budget period. Each project with Secretary may require that the project period in excess of 2 years and amount of the award initially approved with direct costs over the project pt Witched less than the amount necessary to riod in excess of $35,000 will be reviewat carry out the approved project activi- during the second budget period and ties for that period, or that a supple- during each subsequent budget period

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