(a) "Act" means the Public Health Service Act, as amended.

(b) "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.

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

(d) “Ethnic minorities" includes but is not limited to such groups as blacks, Spanish-speaking Americans, and American Indians.

(1) A public or private nonprofit university, four year college, or other institution offering undergraduate, graduate, or health professional degrees, with a traditionally high (more than 50 percent) minority student enrollment;

(2) A public or private nonprofit two year college with a traditionally high (more than 50 percent) minority student enrollment;

(3) A public or private nonprofit university, four year college, or other institution offering undergraduate, graduate, or health professional degrees, with a student enrollment a significant proportion (but not necessarily more than 50 percent) of which is derived from ethnic minorities, provided the Secretary determines that said institution has a demonstrated commitment to the special encouragement of and assistance to ethnic minority faculty, students, and investigators; or

(4) An Indian tribe which has a recognized governing body which performs substantial governmental functions, or an Alaska Regional Corporation as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.), 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 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

§ 52c.4 Application.

(a) Application for a grant under this subpart shall be made on an authorized form. Applicants shall submit completed forms on or before the dates the Secretary 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) Each application shall contain a narrative description of the institution's present biomedical research program; the nature and purpose of the proposed biomedical research program; the manner in which the institution intends to conduct said pro

gram in conformity with this part; and the value of the program to the overall mission and objectives of the institution. The application shall also set forth the proposed project period (not to exceed five years), a detailed budget for the first budget period and anticipated total needs for each of the succeeding budget periods of the requested project period, a justification for the amount of grant funds requested, the names and qualifications of the program director and the directors of individual projects within the program, the total facilities and resources that will be available (including where necessary collaborative arrangements with other institutions), and such other pertinent information as the Secretary may require.

(d) An institution seeking continued support under this part at the end of a project period must submit a new application in accordance with this section.

§ 52c.5 Grant awards.

(a) Within the limits of funds available, and upon such recommendation as may be required by law, the Secretary shall award grants to those applications with proposed biomedical research programs which will, in the Secretary's judgment, best promote the purposes of this part, taking into consideration among other pertinent factors:

(1) The benefits that can be expected to accrue to the national effort in biomedical research;

(2) The institution's capability, from a scientific and technical standpoint, to engage in biomedical research;

(3) The benefits that can be expected to accrue to the institution and its students;

(4) The administrative and managerial capability and competence of the applicant;

(5) The availability of the facilities and resources (including where necessary collaborative arrangements with other institutions) to engage in biomedical research;

(6) The applicant's relative need for funding; and

(7) The overall significance of the proposal in terms of numbers of ethnic minority persons benefited thereby.

(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.

[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

§ 52c.6 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 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 apply to grants under this subpart. These include, but are not limited to:

45 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 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

48 FR 24556-Guidelines for Research Involving Recombinant DNA Molecules published by the National Institutes of Health

[49 FR 38111, Sept. 27, 1984]

(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]

(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 completed 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

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

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