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 Secretary 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 Secretary'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 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 45 FR 68392, Oct. 15, 1980]

§ 52c.7 Other HHS regulations that apply.

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

37 CFR part 401-Rights to inventions made by nonprofit organizations and small business firms under government grants, contracts, and cooperative agreements 42 CFR part 50, subpart A-Responsibilities 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 procedures 45 CFR part 16-Procedures of the Departmental Grant Appeals Board

45 CFR part 91-Nondiscrimination on the basis of age in HHS programs and activities receiving Federal financial assistance 45 CFR part 92-Uniform administrative requirements for grants and cooperative agreements to State and local governments

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 [58 FR 61030, Nov. 19, 1993]

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 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

AUTHORITY: Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 U.S.C. 216); sec. 404(a)(4), 92 Stat. 3426 (42 U.S.C. 285).

SOURCE: 45 FR 12247, Feb. 25, 1980, unless otherwise noted.

§ 52d.1 Applicability.

The regulations in this part apply to grants under the Clinical Cancer Education Program authorized by section 404(a)(4) of the Public Health Service Act, to encourage planning and development of multidisciplinary educational programs aimed at achieving optimal care of cancer patients and to enable students in the health professions to acquire basic knowledge of neoplastic disease and the preventive

(d) Board means the National Cancer Advisory Board established by section 407 of the Act (42 U.S.C. 286b).

(e) Affiliated teaching hospital means a hospital which, although not owned by such school, has a written agreement with a school of medicine, osteopathy, dentistry, or public health eligible for assistance under this part, providing for effective control by the school of the teaching in the hospital.

(f) Specialized cancer institute means an institution which has as its primary mission the diagnosis, prevention, or treatment of cancer.

[45 FR 12247, Feb. 25, 1980: 45 FR 20096, Mar. 27, 1980, as amended at 47 FR 53012, Nov. 24, 1982]

§ 52d.3 Eligibility.

To be eligible for a grant under this part, an applicant must be:

(a) A public or private school of medicine, osteopathy, dentistry, or public health, affiliated teaching hospital, or specialized cancer institute; 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.

[45 FR 12247, Feb. 25, 1980, as amended at 47 FR 53012, Nov. 24, 1982]

$52d.4 Application.

(a) Application for a grant under this subpart shall be made on an authorized form.1 Applicants shall submit com

1 Applications and instructions are available from the Division of Cancer Research Resources and Centers, Education Branch, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20205.

pleted forms, on or before the dates the Director, NCI, may prescribe.

(b) [Reserved]

(c) In addition to any other pertinent information that the Director, NCI, may require, each application shall set forth in detail:

(1) A program plan defining the objectives of the proposed program and the means by which these objectives would be achieved, including descriptions of:

(i) The general educational level (e.g., pre-doctoral, post-doctoral) of the students to be involved in the program;

(ii) The proposed course of study and its relation to the diagnosis, prevention, control, and treatment of cancer; (iii) The clinical experiences to be provided to the students;

(iv) Multidisciplinary aspects of the program;

(v) The particular schools or branches within the institution which would have responsibility for individual aspects of the program; and

(vi) The teaching mechanisms to be employed, including specific discussion of those techniques which would be innovative.

(2) The availability of personnel, facilities, and resources needed to carry out the program;

(3) The names, qualifications, and proposed duties of the program director and any staff members who would be responsible for the program, including a description of those duties which would actually be carried out by the program director and those which would be shared with or assigned to others;

(4) The names and qualifications of proposed members of a cancer education committee which would be established by the applicant to advise it on the planning, organization, operation and evaluation of the program and the specific duties which would be assigned to said committee;

(5) Insofar as necessary, cooperative arrangements with other schools, hospitals, and institutions which would participate in the program;

(6) The proposed project period, a detailed budget for the first budget period including a list of other anticipated sources of support and anticipated total needs for each of the succeeding budget periods of the requested project period, and a justification for the amount of grant funds requested;

(7) Proposed methods for monitoring and evaluating the program; and

(8) A description of how the education and training effort will be sustained upon expiration of the award.

[45 FR 12247, Feb. 25, 1980, as amended at 47 FR 53012, Nov. 24, 1982]

§ 52d.5 Program requirements.

(a) If the program is to be offered at the graduate level, it must be multidisciplinary in scope involving at least two or more clinical or preclinical sciences relating to cancer;

(b) The cancer education committee provided for in the approved application must meet at least four times per year, and must be chaired by the program director.

§ 52d.6 Grant awards.

(a) Within the limits of funds available, after consultation with the Board, the Director, NCI, may award grants to applicants with proposed programs which in the NCI Director's judgment best promote the purposes of this part, taking into consideration among other pertinent factors:

(1) The relevance of the proposed program to the objectives of this part;

(2) The extent to which the program would involve innovative teaching techniques;

(3) The availability of adequate staff, facilities, and resources (including where necessary cooperative arrangements with other institutions or hospitals) to carry out the program;

(4) The qualifications and experience of the program director;

(5) The authority of the program director to ensure that the program is planned with multidisciplinary input and that multidisciplinary aspects of the program are carried out;

(6) The extent to which the cancer education committee is broadly representative of the disciplines concerned with cancer care and teaching and is allowed to participate in the planning,

organization, operation, and evaluation of the program;

(7) If the program is to be offered at the pre-doctoral level, the extent to which its objectives are designed to aid students:

(i) To acquire a basic understanding of fundamental principles of cancer biology, epidemiology, detection, diagnosis, prevention, treatment and control;

(ii) To interest students in learning more about cancer; and

(iii) To develop an appreciation of the need for a comprehensive multidisciplinary approach to the care of cancer patients;

(8) The administrative and managerial capability of the applicant;

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

(10) The adequacy of the methods for monitoring and evaluating the program on a continuing basis; and

(11) The degree to which the application adequately provides for the requirements set forth in § 52d.5.

(b) The notice of grant award specifies how long HHS intends to support the program without requiring the program 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.

$52d.7 Expenditure of grant funds.

(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 awards, and the applicable cost principles prescribed by subpart Q of 45 CFR part 74, except that grant funds may not be used for costs incurred in connection with activities which, prior to the grant, were part of the grantee's standard curriculum.

(b) The Director, NCI, 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 NCI Director's written approval is obtained. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account.

§ 52d.8 Other HHS regulations that apply.

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

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

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 [49 FR 38111, Sept. 27, 1984]

194-169 D-01--9

with other Federal agencies, with public health agencies of State or local governments, with nonprofit private entities that are community-based health agencies, or with other appropriate public or nonprofit private entities.

[45 FR 12249, Feb. 25, 1980; 45 FR 20097, Mar. 27, 1980, as amended at 58 FR 54298, Oct. 21, 1993; 59 FR 59372, Nov. 17, 1994]

§ 52e.2

Definitions.

As used in this part:

Act means the Public Health Service Act, as amended (42 U.S.C. 201 et seq.)

Council means the National Heart, Lung, and Blood Advisory Council, established under section 406 of the Act (42 U.S.C. 284a).

Director means the Director of the National Heart, Lung, and Blood Institute and any official to whom the authority involved may be delegated.

Emergency medical services means the services utilized in responding to the perceived individual need for immediate medical care in order to prevent loss of life or aggravation of physiological or psychological illness or injury.

HHS means the Department of Health and Human Services.

National program means the National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program referred to in section 421 of the Act (42 U.S.C. 285b-3).

Nonprofit as applied to any agency or institution means an agency or institution which is a corporation or an association, no part of the net earnings of which inures or may lawfully inure to the benefit of any private shareholder or individual.

PHS means the Public Health Service.

[58 FR 54298, Oct. 21, 1993]

§ 52e.3 Who is eligible to apply?

To be eligible for a grant under this part, an applicant must be a public or nonprofit private agency or institution.

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

§ 52e.4 How to apply.

(a) Application for a grant under this subpart shall be made on an authorized form. 2 Applicants shall submit completed forms on or before the dates the Director may prescribe.

(b) Each private institution which does not already have on file with the National Institutes of Health evidence of nonprofit status, must submit with its application acceptable proof of such status.

(c) In addition to any other pertinent information that the Director may require each application shall set forth in detail:

(1) The nature and purpose of the proposed project and the methods to be employed in carrying it out;

(2) The relevance of the proposed project to the National Program;

(3) The defined population to participate in the proposed project and the rationale for its selection;

(4) With respect to applications relating to projects covered by §52e.1(a)(1), prior research findings on which the proposed project is based;

(5) The personnel, facilities, and other resources, including community resources, available to carry out the proposed project;

(6) Current activities of the applicant involving prevention or control of heart, blood vessel, lung, and blood diseases, the sources of funding for such activities, and the anticipated relationship of these activities to the proposed project;

(7) The names and qualifications of the project director and key staff members who would be responsible for conducting the proposed project;

(8) Proposed methods for monitoring and evaluating the project; and

(9) The proposed project period; a detailed budget for the first budget period, including a list of other anticipated sources of support and anticipated total needs for each of the succeeding budget periods of the requested

2 Applications and instructions are available from the Division of Extramural Affairs, National Heart, Lung, and Blood Institute, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20205.