program or activity receiving Federal financial assistance.

§ 51a.511 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 otherwise required by applicable law (including this subpart) or 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.512 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 publication, 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. Royalties received by grantees from copyrights on publications or other works developed under the grant 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.513 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

1 The Department of Health, Education, and Welfare Grants Administration Manual is available for public inspection and copying at the Department and Regional Offices' information centers listed in 45 CFR Part 531 and may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

66-019-76- -13

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

(b) 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.

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, functions, or activity involved:

(a) A comparison of actual accomplishments to the goals established for the period. Where the output of grant programs can be 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.

As used in these regulations:

(a) "Act" means the Public Health Service Act.

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

(c) "State" means one of the 50 States, the Commonwealth of Puert Rico, Guam, American Samoa, the Trus Territory of the Pacific Islands, the Virgin Islands, and the District of Columbia.

(d) Communicable disease control program or project means a program o project which is designed and conducted so as to contribute to nationa protection against tuberculosis, venerea disease, rubella, measles, Rh disease poliomyelitis, diphtheria, tetanus, whooping cough or other communicable diseases which are transmitted from State to State, are amenable to reduction, and which are determined by the Secretary to be of national significance.

[37 FR 7000, Apr. 7, 1972, as amended at 41 FR 36814, Sept. 1, 1976]

§ 51b.3 Eligibility.

(a) Eligible applicant. Any State, or with the approval of the appropriate State Health authority, any political subdivision or instrumentality of a State, is eligible for a grant award under these regulations.

(b) Eligible projects. Grants pursuant to section 317 of the Act and these regulations may be made to eligible applicants for the purpose of meeting the cost of communicable disease control programs, including studies to determine the communicable disease control needs of communities and the means of best meeting those needs.

§ 51b.4 Application for grant.

(a) An application for a grant under these regulations shall be submitted to the Secretary at such time and in such form as the Secretary may prescribe.1 The

1 Applications and instructions may be obtained from the Regional Health Director of the Health Services and Mental Health Administration at the Regional Office of the Department of Health, Education, and Welfare for the region in which the project is to be conducted.

application shall contain 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 these regulations, including a description of the nature and extent of the problems to be met, the environment in which the project will function, and the relationship of the applicant to the community, the medical societies, and voluntary health agencies in the area to be served. The application shall also contain a budget and justification of the amount of grant funds requested, and such other pertinent information as the Secretary may require.

(b) The application shall be executed by an individual authorized to act for the applicant and to assume for the applicant the obligations imposed by these regulations and any additional conditions of the grant. § 51b.5

Project requirements.

An approvable project must provide: (a) A plan to initiate and maintain surveillance of the communicable diseases with respect to which funds are granted, which will include, among other things, morbidity and mortality reporting, surveys, and case and laboratory investigation.

(b) Unless for good cause otherwise shown, coordination with other relevant federally assisted programs.

(c) Unless for good cause otherwise shown, arrangements for utilization of facilities of public and private hospital outpatient clinics.

(d) Assurance that the project will be conducted in a manner calculated to preserve human dignity and maximize acceptability and utilization of services.

(e) Assurance that services will be made available without regard to creed, age, sex, or marital status unless otherwise medically indicated (see also § 51b.9).

(f) Assurance that no person will be denied service by reason of his inability to pay therefor: Provided, however, That to the extent that payment for services under the project will be made by a third party (including a Government agency) which is authorized or is under a legal obligation to pay such charge, effort will be made to obtain such third party payment. If charges are to be made for services under the project, such charges must be in accordance with a schedule submitted and approved as part of the project plan.

(g) Assurance that funds granted will be used to supplement and not supplant State or local funds available for communicable disease control programs.

(h) Priority in the delivery of services to population groups having the highest incidence and prevalence of communicable diseases.

§ 51b.6 Grant evaluation and award.

(a) Within the limits of funds available for such purpose, the Secretary may award grants to cover part of the cost of communicable disease control projects to those applicants whose projects he determines will, in his judgment, best promote the purposes of the Act taking into account;

(1) The relative extent of the problems relating to one or more of the communicable diseases to which these regulations are applicable,

(2) The levels of performance in preventing and controlling such diseases,

(3) The general quality of the project's plan in accordance with the project requirements set forth in § 51b.5 and in particular the extent to which the project renders services to groups having the highest incidence and prevalence of communicable diseases,

(4) The comments and recommendations of the State comprehensive health planning agency, and

(5) The capacity of the applicant to make prompt and effective use of Federal funds.

(b) The amount of any award shall be determined by the Secretary on the basis of his estimate of the sum necessary for a designated portion of direct project costs plus an additional amount for indirect costs, if any, which will be calculated by the Secretary either (1) on the basis of his estimate of the actual indirect costs reasonably related to the project, or (2) on the basis of a percentage of all, or a portion of, the estimated direct costs of the project when there are reasonable assurances that the use of such percentage will not exceed the approximate actual indirect costs. Such award may include an estimated provisional amount for indirect costs or for designated direct costs (such as hospital per diem rates or fringe benefit rates) subject to upward (within the limits of available funds) as well as downward adjustments to actual costs when the amount properly expended by the grantee for provisional items has

(a) The Serretary as the request Of & venipient of a grans mder Lese relations, may reduce such grant by the fair marken mine of any supplies CCuding ncrines and other preventive agents), or equipment furnished to such resistens and by the amours of the pay. allowances, handling expenses, and act other costa in ccxnection wish the detail of an sicer or employee to the recipiens then te kunst.ng if such suppiles or emtorens, or of he detal of such officer of employee 23 the case may be,, 's for He worence of and as the request of such tendens and for the purpose of artig os the program with respect to which the grant æder these regulaGora la mate. The amount by which any Boch act is so reduced shall be availsole for payment by the Secretary of the costs incurred in furnishing the sup

Attention is called to the requirements of Tinie TI of the Civil Rights Act of 1964 (78 Stat. 25 & CSC. 2000d es sq) and in particular seaton filt of such Act which provides that no person in the Chted States shall on the grounds of race, coícr, or national orign be excluded from participation in be denied the benefits of, or be subjected to discrimingtion under any program or sctivity recerving Pederal financial assistance. A regulation implementing such Title VI, which applies to grants made under these regulations, has been issued by the Secretary of Health, Education, and Welfare with the approval of the President (45 CFR Part 80). § 51b.10

Confidentiality.

Each grant award is subject to the condition that all information obtained by the personnel of the project from participants in the project related to their

examination, care, and treatment, shall be held confidential, and shall not be divulged without the individual's consent except as may be required by law or as may be necessary to provide service to the individual. Information may be disclosed in summary, statistical, or other form which does not identify particular individuals.

§ 51b.11 Inventions or discoveries.

Any grant award pursuant to § 51b.6 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.

§ 51b.12 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 these regulations, 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.

§ 51b.13 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 pre

senting or otherwise making available evidence satisfactory to the Secretary of expenditures for direct and indirect costs meeting the requirements of these regulations: 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 applied to the total, or a selected element thereof, of the reimbursable direct costs incurred.

(b) [Reserved]

(c) Accounting for grant related income-(1) Interest. Pursuant to section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 4213), a State will not be held accountable for interest earned on grant funds, pending their disbursement for grant purposes. A State, as defined in section 102 of the Intergovernmental Cooperation Act, means any one of the several States, the District of Columbia, Puerto Rico, any territory or possession of the United States, or any agency or instrumentality of a State, but does not include the governments of the political subdivisions of the State. All grantees other than a State, as defined in these regulations, must return all interest earned on grant funds to the Federal Government.

(d) 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 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 (c) (1) 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. [37 FR 7000, Apr. 7, 1972, as amended by 38 FR 26196, Sept. 19, 1973]