504(2), and 511 of the Social Security Act for special projects of regional or national significance which may contribute to the advancement of maternal and child health or of services for crippled children and/or for training personnel for health care and related services for mothers and children.

§ 51a.402 Definitions.

As used in this subpart:

(a) "Act" means the Social Security Act, as amended.

(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) "Institution of higher learning" means any college or university accredited by a recognized body or bodies approved for such purpose by the U.S. Commissioner of Education, and any teaching hospital which has higher learning among its purposes and functions and which has a formal affiliation with an accredited school of medicine and a full-time academic medical staff holding faculty status in such school of medicine.

(d) "Nonprofit”, as applied to any institution of higher learning, refers to an institution of higher learning which is a corporation or association, or is owned and operated by one or more corporations or associations, no part of the net earnings of which inures, or may lawfully inure, to the benefit of any private shareholder or individual.

§ 51a.403 Eligibility.

(a) Eligible applicants. Any public or nonprofit private institution of higher learning is eligible to apply for a grant under this subpart.

(b) Eligible projects. Grants to eligible applicants may be made by the Secretary for projects:

(1) Of regional or national significance which may contribute to the advancement of maternal and child health.

(2) Of regional or national significance which may contribute to the advancement of services for crippled children.

(3) For training personnel for health care and related services for mothers and children.

§ 51a.404 Application for a grant.

(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. The application shall contain a budget and narrative plan of the manner in which the applicant intends to conduct the project and carry out the applicable requirements of this subpart. The plan must describe the project in sufficient detail to identify clearly the nature, need, specific objectives, and methods of the project.

(b) The application must be executed by an individual authorized to act for the applicant and to assume for the applicant the obligations imposed by the statute, the applicable regulations of this subpart, and any additional conditions of the grant.

§ 51a.405 Project requirements.

An approvable application shall contain each of the following:

(a) A statement of the purpose of the project with an identification of the characteristics which will enable the project to:

(1) Contribute to the advancement of maternal and child health; and/or (2) Contribute to the advancement of services for crippled children; and/

or

(3) Train personnel for health care and related services for mothers and children.

(b) A description of the nature and scope of the activities to be undertaken and the methods to be used in accomplishing the purpose.

(c) A proposed budget.

(d) An evaluation methodology, including the manner in which such methodology will be employed to measure the achievement of the purpose of the program.

(e) An assurance that when diagnostic services are provided by project personnel or through use of project facilities, such services will be made available under the plan with:

(1) No charge to the person or his family, except to the extent that payment will be made by a third party (in

(2) No restriction as to the economic status of the person receiving such services under the project or his family or relatives, or their legal residence.

(3) No requirement that referral to the project be made by any individual or agency except as may be described in the application for the project.

(f) The basis on which charges for services other than diagnostic services may be made. (Services which may be provided to persons by staff or facilities supported by project funds shall not relieve other public, including Federal or federally supported, or private agency or insuror of any obligations to pay for services which the recipient would normally be eligible to receive from such agency or insuror. The grantee shall make a reasonable effort to collect from third-party payment sources and from individuals in accordance with their ability to pay.)

(g) Provision that trainees and fellows will be appointed in accordance with the qualifications and conditions in the project application. A trainee or fellow must be a national of the United States or be in the United States for other than temporary purposes and intend to become a permanent resident of the United States.

§ 51a.406 Evaluation and grant award.

(a) Within the limit of funds available for such purposes, the Secretary may award grants to assist in the establishment and operation of those projects which will, in his judgment, best promote the purposes of sections 503(2), 504(2), or 511 of the Act, taking into account:

(1) The need for the services or training to be provided, including the relative extent to which the project will contribute to a nationwide distribution of needed services and training;

(2) The capability of the applicant to provide training or services of higher quality and effectiveness;

(3) The relative extent to which the project will provide more effective utilization of personnel currently providing health services to mothers and children;

(4) The extent to which the project will assist in the development of new information or innovative methods relating to the provision of maternal and child health and crippled children's services.

(b) In the case of grants under section 511 of the Act, the Secretary will give special attention to programs providing training at the undergraduate level and to programs which provide training for health care and related services for mothers and childrenparticularly mentally retarded children and children with multiple handicaps.

(c) The amount of any award will be determined by the Secretary on the basis of his estimate of the sum necessary for the proper performance of the project. In determining the grantee's share of project costs, if any, costs borne by Federal funds, or costs used to match other Federal grants, may not be included except as may be otherwise provided by law.

(d) All grant awards shall be in writing, shall set forth the amount of funds granted, and the period for which support is recommended.

(e) Neither the approval of any project nor any grant award shall commit or obligate the United States in any way to make additional, supplemental, continuation, or other award with respect to any approved project or portion thereof. For continuation support, grantees must make separate application periodically at such times and in such form as the Secretary may direct.

§ 51a.407 Payments.

The Secretary 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 the performance of the project, to the extent he determines such payments necessary to promote

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prompt initiation and advancement of the approved project.

§ 51a.408 Use of project funds.

Any funds granted pursuant to this subpart as well as other funds to be used in performance of the approved project may be expended solely for carrying out the approved project in accordance with the applicable statute, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed by Subpart Q of 45 CFR Part 74.

§ 51a.409 Civil rights.

(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.) and in particular section 601 of such Act which provides that no person in the United States shall, on the grounds 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 applies 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 called to the requirements of title IX of the Education Amendments of 1972 and in particular to section 901 of such Act, 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) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended, 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.

§ 51a.410 Confidentiality of information.

All information as to personal facts and circumstances obtained by the project staff in connection with the provision of services under the project shall be treated as privileged communications, shall be held confidential, and shall not be divulged without the individual's consent except as may be necessary to provide services to the individual. Such information may be disclosed in summary, statistical, or other form which does not identify particular individuals.

§ 51a.411 Inventions and discoveries.

Any grant award pursuant to this project is subject to the regulations of the Department of Health, Education, and Welfare as set forth in 45 CFR Parts 6 and 8, as amended. Such regulations shall apply to any activity for which grant funds are in fact used whether within the scope of the project as approved or otherwise. Appropriate measures shall be taken by the grantee and by the Secretary to assure that no contracts, assignments or other arrangements inconsistent with the grant obligation are continued or entered into and that all personnel involved in the supported activity are aware of and comply with such obligations. Laboratory notes, related technical data, and information pertaining to inventions and discoveries shall be maintained for such periods, and filed with or otherwise made available to the Secretary, or those he may designate, at such times and in such manner as he may determine necessary to carry out such Department regulations.

§ 51a.412 Publications and copyright.

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, however, to a royalty-free, nonexclusive, 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.

§ 51a.413 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:

(a) Patent royalties, whether received during or after the grant 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 grant 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 such materials shall be distributed in accordance with Chapter 1-420 of the Department of Health, Education, and Welfare Grants Administration Manual. 1

§ 51a.414 Grantee accountability.

(a) Accounting for grant award payments. All payments made by the Secretary 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 evidence satisfactory to the Secretary of expenditures for direct and indirect costs meeting the requirements of this subpart: Provided, however, That when the amount awarded for indirect costs was based on a predetermined fixed percentage of estimated direct costs, the amount allowed for indirect costs shall be computed on the basis of such predetermined fixed-percentage rates 'The Department of Health, Education, and Welfare Grants Administration Manual is available for public inspection and copying at the Department's and Regional Offices information centers listed in 45 CFR 5.31 and may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

applied to the total, or a selected element thereof, of the reimbursement direct costs incurred.

(b) Accounting for interest earned on grant funds. All grantees under this subpart must return to the Federal Government all interest earned on grant funds.

(c) Grant closeout-(1) Date of final accounting. A grantee shall render, with respect to each approved project, a full account, as provided herein, as of the date of the termination of grant support. The Secretary may require other special and periodic accounting.

(2) Final settlement. There shall be payable to the Federal government as final settlement with respect to each approved project the total sum of:

(i) Any amount not accounted for pursuant to paragraph (a) of this section.

(ii) Any credits for earned interest pursuant to paragraph (b) of this section.

(iii) Any other amounts due pursuant to Subparts F, M, and O of 45 CFR Part 74. Such total sum shall constitute a debt owed by the grantee to the Federal Government and shall be recovered from the grantee or its successors or assignees by setoff or other action as provided by law.

§ 51a.415 Performance report.

With each continuation or renewal application or with each financial status report at the end of a project period, whichever is appropriate, grantees shall submit a performance report for each grant which briefly presents the following for each program, function, or activity involved:

(a) A comparison of actual accomplishments to the goal established for the period. Where the output of grant programs can be readily quantified, such quantitative data should be related to cost data for computation of unit costs.

(b) An explanation when established goals have not been met.

(c) Other pertinent information including, when appropriate, analysis and explanation of cost overruns or higher than anticipated unit costs.

§ 51a.416 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 his judgement such conditions are necessary to assure or protect advancement of the approved project, the interests of public health, or the conservation of grant funds.

§ 51a.417 Applicability of 45 CFR Part 74. The relevant provisions of the following subparts of 45 CFR Part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this subpart: 45 CFR PART 74

SUBPART AND SUBJECT

A General

B Cash Depositories

C Bonding and Insurance

D Retention and Custodial Requirements for Records

F Grant-Related Income

K Grant Payment Requirements

L Budget Revision Procedures

M Grant Closeout, Suspension, and Termination

O Property

Q Cost Principles

Subpart E-Project Grants for Sudden Infant Death Syndrome Information and Counseling

SOURCE: 40 FR 24436, June 6, 1975, unless otherwise noted.

§ 51a.501 Applicability.

The regulations of this subpart are applicable to grants to public and nonprofit private entities pursuant to section 1121(b) of the Public Health Service Act (42 U.S.C. 300c-11) for projects for the collection, analysis and furnishing of information relating to the causes of the sudden infant death syndrome and the provision of information and counseling to families affected by the sudden infant death syndrome.

§ 51a.502 Definitions.

As used in this subpart:

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

(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) "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 private shareholder or individual.

(d) "The Sudden Infant Death Syndrome," for the purpose of this regulation, means the sudden death of any infant which is unexpected by history, and in which a thorough post mortem examination fails to demonstrate an adequate cause for death.

(e) "SIDS" means the sudden infant death syndrome.

(f) “Family” means the parents or other relatives of a SIDS victim or any persons functioning in loco parentis to such victim at the time of a SIDS death.

(g) "Applicant" means a public or nonprofit private entity which applies for a grant.

§ 51a.503 Eligibility.

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

(b) Eligible projects. Grants to eligible applicants may be made by the Secretary for projects which include both:

(1) The collection, analysis, and furnishing of information (derived from post mortem examinations and other means) pertaining to the causes of SIDS; and

(2) The provision of information and counseling to families affected by SIDS.

§ 51a.504 Application for a grant.

(a) An application for a grant under this subpart shall be submitted to the Secretary at such time and in such form and manner as the Secretary may prescribe. The application shall contain:

(1) A full and adequate description of the project and of the manner in which the applicant intends to conduct the project and carry out the requirements of this subpart;

(2) A budget and justification of the amount of grant funds requested;