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;

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(5) The personnel, facilities, and other resources, including community sources, 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, including a list of other anticipated sources of support; and a justification for the amount of grant funds requested.

§ 52e.5 Project requirements.

(a) An approvable application must demonstrate to the satisfaction of the Director, NHLI, 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, NHLI, be necessary for cooperation by the National Heart and Lung 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.

(c) In order for an agency or institution to receive support under this part, the project must be carried out in substantial conformity with the proposal set forth in the approved application.

§ 52e.6 Grant awards.

(a) Within the limits of funds available, after consultation with the Council, the Director, NHLI, may award grants to applicants with proposed projects which in his judgment best promote the purposes of section 414 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) All grant awards shall be in writing and shall specify the project period, the total recommended amount of funds for the entire project period; the approved budget for the initial budget period; and the amount awarded for the initial budget period.

The Director, NHLI, shall from time to time make payments to a grantee of all or a portion of any grant award, either in advance or by way of reimbursement. for expenses incurred or to be incurred in accordance with its approved application.

§ 52e.8 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) Any unobligated grant funds remaining in the grant account at the close of a budget period may, with prior approval by the Director, NHLI, be carried forward and remain available for obligation during the remainder of the project period, subject to such limitations as the Director, NHLI, may prescribe. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account. At the end of the last budget period of the project period, any unobligated grant funds remaining in the grant account must be refunded to the Federal Government.

§ 52e.9 Nondiscrimination.

(a) Attention is called to the requirements of Title VI of the Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) which provides that no person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving federal financial assistance.

A regulation implementing such Title VI, which is applicable to grants made under this part, has been issued by the Secretary of Health, Education, and Welfare with the approval of the President (45 CFR Part 80).

(b) Attention is also called to the requirements of Title IX of the Education Amendments of 1972 and in particular to section 901 of such Act (20 U.S.C. 1681) which provides that no person in the United States shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any education program or activity receiving Federal financial assistance.

(c) Grant funds used for alterations and renovations shall be subject to the condition that the grantee shall comply with the requirements of Executive Order 11246, 30 FR 12319 (Sept. 24, 1965), as amended, and with the applicable rules, regulations, and procedures prescribed pursuant thereto.

(d) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794), which provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.

No award may be made under this part unless the applicant has complied with:

(a) 45 CFR Part 46 and any other applicable requirements pertaining to the protection of human subjects.

(b) Chapter 1-43 of the Department of Health, Education, and Welfare Grants Administration Manual and any other applicable requirements concerning animal welfare.

§ 52e.11 Applicability of 45 CFR Part 74.

The provisions of 45 CFR Part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this part to State and local governments as those terms are defined in Subpart A of that Part 74. The relevant provisions of the following subparts of Part 74 shall also

Each grant award shall require that the grantee maintain such progress and fiscal records and file with the Director, NHLI, such progress and fiscal reports relating to the conduct and results of the approved grant and the use of grant funds as the Director, NHLI, may find necessary to carry out the purposes of section 414 of the Act and the regulations.

§ 52e.13 Grantee accountability.

(a) All payments made by the Director, NHLI, shall be recorded by the grantee in accounting records separate from the records of all other grant funds, including funds derived from other grant awards. With respect to each approved project the grantee shall account for the sum total of all amounts paid by presenting or otherwise making available to the Director, NHLI, satisfactory evidence of expenditures for direct and indirect costs meeting the requirements of this part.

(b) Accounting for royalties. Royalties received by grantees from copyrights on publications or other works developed under the grant, or from patents or inventions conceived or first actually reduced to practice in the course of or under such grant, shall be accounted for as follows:

(1) State and local governments. Where the grantee is a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, royalties shall be accounted for as provided in 45 CFR 74.44.

(2) Grantees other than State and local governments. Where the grantee is not a State or local government as those

terms are defined in Subpart A of 45 CFR Part 74, royalties shall be accounted for as follows:

(A) Patent royalties, whether received during or after the project period, shall be governed by agreements between the Assistant Secretary for Health, Department of Health, Education, and Welfare, and the grantee, pursuant to the Department's patent regulations (45 CFR Parts 6 and 8).

(B) Copyright royalties, whether received during or after the project period, shall first be used to reduce the Federal share of the grant to cover the costs of publishing or producing the materials, and any royalties in excess of the costs of publishing or producing the materials shall be distributed in accordance with Chapter 1-420 of the Department of Health, Education, and Welfare Grants Administration Manual.

§ 52e.14 Publications and copyright.

(a) State and

local governments. Where the grantee is a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, the Department of Health, Education, and Welfare copyright requirement set forth in 45 CFR 74.140 shall apply with respect to any book or other copyrightable materials developed or resulting from a project supported by a grant under this part.

(b) Grantees other than State and local governments. Where the grantee is not a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, except as may otherwise be provided under the terms and conditions of the award, the grantee may copyright without prior approval any publications, films, or similar materials developed or resulting from a project supported by a grant under this part, subject to a royalty-free, non-exclusive, and irrevocable license or right in the Government to reproduce, translate, publish, use, disseminate and dispose of such materials, and to authorize others to do so. § 52e.15 Additional conditions.

The Director, NHLI, may with respect to any grant award impose additional conditions prior to or at the time of any award when in his judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of the public health, or the conservation of grant funds.

All terms not defined herein shall have the same meanings as given them in the Act. As used in this part:

(a) "Act" means title VI of the Public Health Service Act, as amended (42 U.S.C. 291 et seq.).

(b) "Secretary" means the Secretary of Health, Education, and Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom the authority involved has been delegated.

(c) "State agency" means the agency designated by a State pursuant to section 604 (a) (1) of the Act.

(d) "Service area" means the geographic territory from which patients come or are expected to come to existing or proposed hospitals or existing or proposed public health centers, or existing or proposed medical facilities (1.e., facilities for long-term care, outpatient facilities, rehabilitation facilities), the delineation of which is based on such factors as population distributon, natural geographic boundaries, and transportation and trade patterns, and all parts of which are reasonably accessible to existing or proposed hospitals, public health centers, or medical facilities. When appropriate, interstate areas may be formed with the mutual agreement of the States concerned.

(e) "Hospital" means general, tuberculosis, mental, and other types of hospitals, and related facilities such as laboratories, outpatient departments, nurses' home facilities, extended care facilities, facilities related to programs for home health services, self-care units, education or training facilities for health professions personnel operated as an integral part of a hospital, and central service facilities operated in connection with hospitals, but does not include any hospital providing primarily domiciliary

care.

(f) "General hospital" means any hospital for short-term inpatient medical or surgical care of illness or injury, which may include obstetrical care.

(g) "Mental hospital" means a hospital (including long-term care, inten

sive care, or both) for the diagnosis and treatment of mental illness.

(h) "Tuberculosis hospital" means a hospital for the diagnosis and treatment of tuberculosis.

(i) "Facility for long-term care" means a facility (including an extended care facility) providing community service for inpatient care for convalescent or chronic disease patients who require skilled nursing care and related medical services

(1) Which is a hospital (other than a hospital primarily for the care and treatment of mentally ill or tuberculosis patients) or is operated in connection with a hospital, or

(2) In which such nursing care and medical services are prescribed by, or are performed under the general direction of, persons licensed to practice medicine or surgery in the State. Institutions furnishing primarily domiciliary care are not included.

"Chronic disease hospitals” and “nursing homes" as used in the document "Minimum Requirements of Construction and Equipment for Hospital and Medical Facilities," incorporated by reference in § 53.101(a), constitute "facilities for long-term care."

(j) "Outpatient facility" means a facility, located in or apart from a hospital, providing community service for the diagnosis or diagnosis and treatment of ambulatory patients (including ambulatory inpatients) in need of physical and/ or mental care

(1) Which is operated in connection with a hospital; or

(2) In which patient care is under the professional supervision of persons licensed to practice medicine or surgery in the State or, in the case of dental diagnosis or treatment, under the professional supervision of persons licensed to practice dentistry in the State; or

(3) Which offers to patients not requiring hospitalization the services of licensed physicians in various medical specialities, and which makes provision for its patients to receive a reasonably full range of diagnostic and treatment services.

(k) "Rehabilitation facility” means a facility providing community service which is operated for the primary purpose of assisting in the rehabilitation of disabled persons through an integrated program under competent professional supervision of: Medical evaluation and services; and psychological, social, or