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 or activities receiving federal financial assistance.

43 FR 60108-Guidelines for Research Involving Recombinant DNA Molecules, published by the National Institutes of Health.

§ 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

Inventions and discoveries.

(a) Any Award is subject to the regulations of the Department of Health and Human Services set forth in 45 CFR Parts 6 and 8, as amended. Such regulations shall apply to any activity for which Award funds are in fact used, whether within the scope of the Award as approved or otherwise. Each such invention or discovery shall be promptly and fully reported to the Assistant Secretary for Health, Department of Health and Human Services.

(b) Determination as to ownership and disposition of rights to such invention or discovery, including whether a patent application shall be filed, and, if so, the manner of obtaining, administering, and disposing of rights under any patent application or patent which may issue shall be made either:

(1) By the Assistant Secretary for Health, whose decision shall be final,

or

(2) Where an Award is made to an individual for research or training at a non-Federal public or nonprofit private institution having a separate formal institutional patent agreement with the Department of Health and Human Services, by the institution in accordance with that agreement.

§ 66.116 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.

Subpart B-Institutional Grants

§ 66.201 Applicability.

The regulations in this subpart apply to grants under section 472 (a)(1)(B) of the Public Health Service Act, as amended (42 U.S.C. 28911(a)(1)(B)), to public institutions and to nonprofit private institutions to enable these institutions to make National Research Service Awards to individuals for research, and training to undertake research, in programs specified in section 472(a)(1)(B) 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 Sec

retary. 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.

[45 FR 1822, Jan. 8, 1980; 45 FR 9742, Feb. 13, 1980]

§ 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 a period in excess of three months, the individual has submitted to the Secretary a written assurance (in the form the Secretary may prescribe) that he or she will satisfy the requirements of § 66.110 of Subpart A of this part;

(2) Effective July 1, 1975, any Award is for research or training in a subject area for which there is a need for personnel, as determined under section 473 of the Act (42 U.S.C. 2891-2);

(3) 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 application;

(4) 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

(5) 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(d) 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.

[45 FR 1822, Jan. 8, 1980; 45 FR 9742, Feb. 13, 1980]

§ 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 § 66.205; and

(3) Whose proposed programs would, in the judgment of the Secretary, best promote the purposes of section 472(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 administrative and managerial capability of the applicant;

(vi) The reasonableness of the proposed budget in relation to the proposed program; and

(vii) The adequacy of the methods for monitoring and evaluating the per

formance 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 an 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:

42 CFR Part 50-PHS grant appeals proc

ess.

45 CFR Part 16-Department grant appeal process.

67.25 Control of data.

grants.

67.23 Publications and copyright.

67.24 Confidentiality.

67.26 Grantee accountability.

67.27 Applicability of 45 CFR Part 74. 67.28 Additional conditions.

74-Administration

45 CFR Part 75-Informal grant appeals procedures (indirect cost rates, and other cost allocations).

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.

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 Services Research of grants under section 305(b) of the Public Health Service Act (42 U.S.C. 242c(b)) to support identified health services research, evaluation, or demonstration projects to investigate:

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

(b) The supply and distribution, education and training, quality, utilization, organization, and cost of health manpower; and

(c) The design, construction, utilization, organization, and cost of facilities and equipment.

compensation of employees for the time and effort devoted specifically to the approved project, and the costs of materials acquired, consumed or expended specifically for the purpose of the approved project.

(d) "Grantee" means the public or nonprofit entity or individual that receives a grant under section 305(b) and this subpart for a health services research, evaluation or demonstration project and assumes legal and financial responsibility for the funds awarded and for 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 entity, means that no part of the net earnings of such entity inures or may lawfully inure to the benefit of any shareholder or individual.

(g) "Project period" means the total period of time for which support for a project has been approved as specified in the grant award document. Such approval does not commit or obligate the Federal Government to any additional, supplemental or continuation support beyond the current budget period.

(h) "Principal investigator" means a single individual, designated in the grant application and approved by the Secretary, who is responsible for the scientific and technical direction of the project.

(i) "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.

a

(j) "Peer review group" means panel of experts who are neither officers nor employees, other than by reason of their appointment, of the United States qualified by training and experience in particular scientific and technical fields to give expert advice, in accordance with the provisions of this subpart, on the scientific and technical merit of grant applications.

§ 67.12 Eligibility.

(a) Eligible applicants. Any public or private nonprofit entity and any individual is eligible to apply for a grant under this subpart.

(b) Eligible projects. Grants pursuant to section 305(b) of the act and this subpart may be made to eligible applicants for the purpose of assisting in meeting the costs of health services research, evaluation, or demonstration projects as described in § 67.10; Provided, That no grant may be made under this subpart for any health services research, evaluation, or demonstration project for which a grant under another 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:

(i) 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:

(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 proposed project;