Page images
PDF
EPUB

project period; and a justification for the amount of grant funds requested.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]

$52e.5 What are the project requirements?

(a) An approvable application must demonstrate to the satisfaction of the Director that:

(1) With respect to applications relating to projects covered by §52e.1(a)(1), the techniques or procedures to be demonstrated and evaluated have been found safe and effective in the research setting and, based upon research findings, appear to have the potential for general applicability to the prevention, diagnosis, or treatment of heart, blood vessel, lung, or blood diseases;

(2) With respect to applications relating to projects covered by §52e.1(a)(2) and § 52e.1(a)(3), the project will include development and evaluation of one or more methods for educating health practitioners or the public concerning advances in the prevention, diagnosis, or treatment of such diseases; and

(3) The nature of the project is such that its completion may be anticipated within the project period, or such other period as may be specified in the application.

(b) The project must, in the judgment of the Director, be necessary for cooperation by the National Heart, Lung, and Blood Institute with one or more other Federal Health agencies, State, local or regional public health agencies, or nonprofit private health agencies in the diagnosis, prevention, or treatment of heart, blood vessel, lung or blood diseases.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298 and 54299, Oct. 21, 1993]

§ 52e.6 How will NIH evaluate applications?

(a) Within the limits of funds available, after consultation with the Council, the Director may award grants to applicants with proposed projects which in the Director's judgment will best promote the purposes of section 419 of the Act, taking into consideration among other pertinent factors:

(1) The scientific and technical merit of the proposed project;

(2) The significance of the project in relation to the goals of the National Program;

(3) Whether the project appropriately emphasizes the prevention, diagnosis, or treatment of heart, blood vessel, lung, or blood diseases of children;

(4) The qualifications and experience of the project director and other key personnel;

(5) The administrative and managerial capability and fiscal responsibility of the applicant;

(6) The reasonableness of the proposed budget in relation to the proposed project;

(7) The adequacy of the methods proposed for monitoring and evaluating the proposed project; and

(8) The degree to which the application adequately provides for the requirements set forth in §§ 52e.5(a) and 52e.5(b).

(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 1-5 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 an approved application.

(e) Any funds granted under this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms, and conditions of

the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]

$52e.7 What are the terms and conditions of awards?

(a) Any funds granted pursuant to this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed by subpart Q of 45 CFR part 74.

(b) The Director may permit unobligated grant funds remaining in the grant account at the close of a budget period to be carried forward for obligation during a subsequent budget period, provided a continuation award is made for that period and the NHLBI Director's written approval is obtained. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298 and 54299, Oct. 21, 1993]

§ 52e.8 Other HHS regulations and policies that apply.

Several other regulations apply to grants under this part. These include but are not necessarily limited to:

42 CFR part 50, subpart A-Responsibility of PHS awardee and applicant institutions for dealing with and reporting possible misconduct in science

42 CFR part 50, subpart D-Public Health Service grant appeals procedure

45 CFR part 16-Procedures of the Departmental Grant Appeals Board

45 CFR part 46-Protection of human subjects

45 CFR part 74-Administration of grants 45 CFR part 75-Informal grant appeals procedures

45 CFR part 76-Governmentwide debarment and suspension (nonprocurement) and governmentwide requirements for drug-free workplace (grants)

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 of this title

45 CFR part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from Federal financial assistance

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 HHS programs or activities receiving Federal financial assistance 45 CFR part 92-Uniform administrative requirements for grants and cooperative agreements to State and local govern

ments

45 CFR part 93-New restrictions on lobbying 51 FR 16958 or successor-NIH Guidelines for Research Involving Recombinant DNA Molecules

"Public Health Service Policy on Humane Care and Use of Laboratory Animals," Office for Protection from Research Risks, NIH (Revised September 1986), or successor 59 FR 14508 (as republished March 28, 1994), as may be amended, or its successor-NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.

[58 FR 54298, Oct. 21, 1993, as amended at 59 FR 59372, Nov. 17, 1994]

[blocks in formation]

52h.10 Contract projects involving solicited contract proposals; matters to be reviewed.

52h.11 Contract projects and proposals; review criteria.

52h.12 Applicability of other regulations.

AUTHORITY: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 360, 89 Stat. 351 (42 U.S.C. 2891-4); sec. 955(a), Pub. L. 97-35, 95 Stat. 590 (42 U.S.C. 300z-7(e)).

SOURCE: 43 FR 7862, Feb. 24, 1978, unless otherwise noted.

§ 52h.1 Applicability.

The regulations in this part apply to: (a) Applications for grants for biomedical and behavioral research, under the Act to the National Institutes of Health; the Alcohol, Drug Abuse, and Mental Health Administration; or any of their components; or the Division of Nursing, Bureau of Health Professions, Health Resources and Services Administration. These regulations do not apply to applications for:

(1) Continuation funding for budget periods within an approved project period;

(2) Supplemental funding to meet increased administrative costs within a project period; or

(3) Construction grants.

(b) Biomedical and behavorial research and development contract projects administered by the National Institutes of Health; the Alcohol, Drug Abuse, and Mental Health Administration; or any of their components; or the Division of Nursing, Bureau of Health Professions, Health Resources and Services Administration.

(c) Applications for grants and contracts under section 2008 of the Act.

(Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 360, 89 Stat. 351, 92 Stat. 3436 (42 U.S.C. 2891-4))

[45 FR 35328, May 27, 1980, as amended at 47 FR 50261, Nov. 5, 1982; 49 FR 38111, Sept. 27, 1984]

[blocks in formation]

the project period is divided for budgetary and reporting purposes.

(d) Awarding official 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; Except that, where the Act specifically authorizes another official to make awards in connection with a particular program, the "awarding official" shall mean said other official and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.

(e) Peer review group means a group of experts qualified by training and experience in particular scientific or technical fields to give expert advice, in accordance with the provisions of this part, on the scientific and technical merit of grant applications or contract projects in those fields.

(f) Research means systematic study directed toward new or fuller knowledge and understanding of the subject studied.

(g) Development means the systematic use of knowledge and understanding gained from research, directed toward creating useful materials, devices, systems, or methods.

(h) Research and development contract project means an identified, circumscribed activity, involving a single contract or two or more similar, related, or interdependent contracts, intended and designed to acquire new or fuller knowledge and understanding of a subject and/or to use such knowledge and understanding to develop useful materials, devices, systems, or methods. The terms include (but are not limited to) development and utilization of resources, testing, demonstrations, clinical trials, preparation of reports, and production of experimental or test models necessary or incidental to a research and/or development activity, but exclude quantity production and routine product testing and quality control.

(i) Project concept means the basic purpose, scope, and objectives of the project.

(j) Project approach means the methodology to be followed and the resources needed in carrying out the project.

(k) Contract proposal means a written offer to enter into a contract, submitted to an awarding official by an individual or non-Federal organization, and including as a minimum a description of the nature, purpose, duration, and cost of the project and the methods, personnel, and facilities to be utilized in carrying it out.

(1) Solicited contract proposal has the same meaning as in 41 CFR 31.353(b)(2).

(m) Unsolicited contract proposal has the same meaning as in 41 CFR 3-4.5201.

(n) Request for proposals means a Government solicitation to prospective offerors, under procedures for negotiated contracts, to submit a proposal to fulfill specific agency requirements based on terms and conditions defined in the request for proposals. The request for proposals contains information sufficient to enable all offerors to prepare competitive proposals, and is as complete as possible with respect to: Nature of work to be performed; descriptions and specifications of items to be delivered; performance schedule; special requirements clauses, or other circumstances affecting the contract; format for cost proposals; and evaluation criteria by which the proposals will be evaluated.

§ 52h.3 Establishment and operation of peer review groups.

(a) To the extent applicable, the Federal Advisory Committee Act (5 U.S.C. App. I), Department of Health and Human Services (45 CFR part 11), implementing regulations and chapter 9 of the Department of Health and Human Services General Administration Manual1 will govern the establishment and operation of peer review groups, including that meetings shall

1The Department of Health and Human Services General Administration Manual is available for public inspection and copying at the Department's and Regional Offices' information centers listed in 45 CFR 5.31 and may be purchased from the Superintendent of Documents, U.S. Printing Office, Washington, DC 20402.

be open to the public except as determined by the Secretary.

(b) Subject to §52h.5 and paragraph (a) of this section, the Director of the National Institutes of Health, the Administrator of the Alcohol, Drug Abuse and Mental Health Administration, and the Administrator of the Health Resources and Services Administration will adopt procedures for the conduct of reviews and the formulation of recommendations under §§ 52h.7, 52h.9 and 52h.10 within their respective agencies.

(Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 360, 89 Stat. 351, 92 Stat. 3436 (42 U.S.C. 2891-4))

[43 FR 7862, Feb. 24, 1978, as amended at 45 FR 35328, May 27, 1980; 49 FR 38111, Sept. 27, 1984]

$52h.4 Composition of peer review

groups.

(a) To the extent applicable, the selection and appointment of members of peer review groups and their terms of service will be governed by Chapter 9 of the Department of Health and Human Services General Administration Manual. 1

(b) Subject to paragraph (a) of this section, members will be selected based upon their training and experience in relevant scientific or technical fields, taking into account, among other factors:

(1) The level of formal scientific or technical education completed or experience acquired by the individual;

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

(3) Recognition as reflected by awards and other honors received from scientific and professional organizations outside the Department of Health and Human Services; and

(4) The need for the group to have included within its membership experts from various areas of specialization within relevant scientific or technical fields.

(c) Not more than one-fourth of the members of any peer review group to which these regulations are applicable may be officers or employees of the

United States. For purposes of the preceding sentence, membership on such groups does not make an individual an officer or employee of the United States.

$52h.5 Conflict of interest.

(a) Members of peer review groups covered by this part are subject to relevant provisions in title 18 of the United States Code, relating to criminal activity, the Department of Health and Human Services Standards of Conduct (45 CFR part 73), and Executive Order 11222, as amended.

(b) In addition to any restrictions imposed under paragraph (a) of this section:

(1) No member of a peer review group may participate in or be present during any review by said group of a grant application, contract project, or contract proposal in which, to the member's knowledge, any of the following has a financial interest: (i) The member or his or her spouse, parent, child, or partner, (ii) any organization in which the member or his or her spouse, parent, child, or partner is serving as an officer, director, trustee, partner, or employee, or is otherwise similarly associated, or (iii) any organization with which the member or his or her spouse, parent, child, or partner is negotiating or has any arrangement concerning prospective employment or other similar association.

or

(2) In the event any member of a peer review group or his or her spouse, parent, child, or partner is currently or expected to be the principal investigator or member of the staff responsible for carrying out any research or development activities contemplated as part of a grant application, contract project, contract proposal, that group is disqualified and the review will be conducted by another group with the expertise to do so. If there is no other group with the requisite expertise, the review will be conducted by an ad hoc group no more than 50 percent of whose members may be from the disqualified group. The composition of any such ad hoc group will be determined in accordance with

§ 52h.4(b) and § 52h.4(c) of this part and, to the extent feasible, §52h.4(a) of this part.

(3) Where a member of a peer review group participates in or is present during:

(i) Development or review of a project approach or request for proposals by said group or

(ii) Review by said group under § 52h.10(b) or §52h.10(c), i.e. after the issuance of a request for proposals, no contract may thereafter be awarded as the result of such development or review to said member, his or her spouse, parent, child, or partner or any organization in which the member, his or her spouse, parent, child, or partner was serving as officer, director, trustee, partner, or employee at the time of such development or review or with which the member, his or her spouse, parent, child, or partner was negotiating or had any arrangement concerning prospective employment at said time.

(4) No member of a peer review group may participate in any review under this part of a specific grant application or contract project for which the member has had or is expected to have any other responsibility or involvement (whether preaward or postaward) as an officer or employee of the United

States.

(c) Where permissible under the statutes, standards, and order cited in paragraph (a) of this section, the Director of the National Institutes of Health, the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration, the Administrator of the Health Resources and Services Administration, or their designees may waive the requirements in paragraph (b) of this section if he or she determines that there is no other practical means for securing appropriate expert advice on a particular grant application, contract project, or contract proposal.

(Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 360, 89 Stat. 315, 92 Stat. 3436 (42 U.S.C. 2891-4))

[43 FR 7862, Feb. 24, 1978, as amended at 45 FR 35328, May 27, 1980; 49 FR 38111, Sept. 27, 1984]

§ 52h.6 Availability of information.

Transcripts, minutes, and other documents made available to or prepared for or by a peer review group will be

« PreviousContinue »