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PART 52c-MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM

Sec.
52c.1 Applicability.
52c.2 Definitions.
520.3 Eligibility.
52c.4 Application.
52c.5 Grant awards.
52c.6 Expenditure of grant funds.
52c.7 Other HHS regulations that apply.
52c.8 Additional conditions.

AUTHORITY: 42 U.S.C. 216, 241(a)(3).

SOURCE: 45 FR 12246, Feb. 25, 1980, unless otherwise noted.

(3) Standard for Non-Flammable Medical Gas Systems, 1973, NFPA Bulletin No. 56F, National Fire Protection Association, 470 Atlantic Avenue, Boston, MA 02110.

(4) Standard for Medical-Surgical Vacuum Systems in Hospitals, Pamphlet P-2.1: Compressed Gas Association (CGA), 500 Fifth Avenue, New York, NY 10036.

(c) Fire and safety. The fire-resistant design criteria for the facility will be governed by the criteria necessary for that portion of the facility which is subject to the most severe usage. Remodeled structures shall be upgraded, in total, unless it is feasible to isolate the improved portion of the building with fire walls and fire doors. Fire-resistant design shall be in accordance with the standards of Life Safety Code, NFPA No. 101, 1973, National Fire Protection Association, 470 Atlantic Avenue, Boston, MA 02110.

(d) Emergency electrical service. Fire alarm systems and other electrical service shall conform to the standards as specified in Life Safety Code, NFPA No. 101, 1973, National Fire Protection Association, 470 Atlantic Avenue, Boston, MA 02110.

(e) Electrical. All electrical installations and equipment shall be in accordance with State and local codes and applicable sections of National Electric Code, NFPA Bulletin No. 70, 1971, National Fire Protection Association, 470 Atlantic Avenue Boston, MA 02110.

(f) Radiation protection. All areas in which X-ray, gamma-ray, beta-ray producing and similar equipment is located shall be protected from radiation in accordance with the standards which are in the Handbook Reports No. 33 and 34: National Council on Radiation Protection (NCRP), P.O. Box 30175, Washington, DC 20008.

(g) Earthquake. All facilities shall be designed and constructed in accordance with the standards specified in the Uniform Building Code, 1973, International Conference of Building Officials, 5360 South Workman Mill Road, Whittier, CA 90601, unless more restrictive State and local codes govern.

(h) Zoning. State and local codes shall apply. (45 FR 12243, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980)

$52c.1 Applicability.

The regulations in this part apply to grants (under the Minority Biomedical Research Support Program) awarded in accordance with section 301(a)(3) of the Public Health Service (PHS) Act (42 U.S.C. 241(a)(3)) to increase the numbers of ethnic minority faculty, students, and investigators engaged in biomedical research, and to broaden the opportunities for participation in biomedical research of ethnic minority faculty, students, and investigators, by providing general support for biomedical research programs at eligible institutions. [58 FR 61030, Nov. 19, 1993)

$ 52c.2 Definitions.

As used in this part:

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

Ethnic minorities includes but is not limited to such groups as Black Americans, Hispanic Americans, Asian/Pacific Islanders, and American Indians/ Native Alaskans (Native Americans).

HHS means the Department of Health and Human Services.

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.

Program director means a single individual, designated in the grant application, who is scientifically trained and has research experience and who is responsible for the overall execution of the program supported under this part at the grantee institution.

form and manner that the Secretary may prescribe. [58 FR 61030, Nov. 19, 1993)

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. (58 FR 61030, Nov. 19, 1993]

$520.3 Eligibility.

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

(a) One of the following:

(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 successor States of the Trust Territory of the Pacific Islands (the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau). [45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 58 FR 61030, Nov. 19, 1993)

$ 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 and in increasing the pool of biomedical researchers;

(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

852c.4 Application.

An institution interested in applying for a grant under this part must submit an application at the time and in the

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852c.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]

45 CFR part 75—Informal grant appeals pro

cedures 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 activi

ties receiving Federal financial assistance 45 CFR part 86-Nondiscrimination on the

basis of sex in education programs and activities receiving or benefiting from Fed

eral financial assistance 45 CFR part 91-Nondiscrimination on the

basis of age in HHS programs and activi

ties receiving Federal financial assistance 45 CFR part 92—Uniform administrative re

quirements 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 (58 FR 61030, Nov. 19, 1993)

$ 52c.8 Additional conditions.

The Secretary may with respect to any grant award impose additional conditions prior to or at the time of any award when in the Secretary's judgment those conditions are necessary to assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.

$ 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, con

tracts, 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 Depart

mental Grant Appeals Board 45 CFR part 46—Protection of human sub

jects 45 CFR part 74-Administration of grants

PART 520-NATIONAL CANCER IN

STITUTE CLINICAL CANCER EDUCATION PROGRAM

Sec. 52d.1 Applicability. 52d.2 Definitions. 52d.3 Eligibility. 52d.4 Application. 520.5 Program requirements.

52d.6 Grant awards.
52d.7 Expenditure of grant funds.
520.8 Other HHS regulations that apply.
52d.9 Additional conditions.

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.

(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]

$520.1 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 measures and diagnostic and therapeutic skills necessary to the provision of such care.

8520.4 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 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 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;

852d.2 Definitions.

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

(b) Director, NCI, means the Director of the National Cancer Institute and any other officer or employee of said Institute to whom the authority involved has been delegated.

(c) (Reserved]

(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) $520.3 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

or

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.

(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]

852d.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.

(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

852d.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

(including where necessary cooperative arrangements with other institutions or hospitals) to carry out the program;

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