local lead-based paint poisoning problem, including an identification of the major areas and population affected by lead-based paint poisoning, and the methods used in determining the nature, effect and extent of the lead-based paint poisoning problem.

(d) The overall objectives of the program (including immediate and longrange objectives) which must be appropriate to the solution of the lead-based paint poisoning problem identified in paragraph (c) of this section.

(e) A description of the manner in which the proposed program will be integrated with existing health service and housing programs.

(f) A description of the involvement of residents of the area to be served by the proposed program in the development of such program.

(g) A description of a comprehensive program for the detection and treatment of incidents of lead-based paint poisoning and for the identification and elimination of the hazards of lead-based paint poisoning, which program must include specific measures taken or to be taken to accomplish the objectives identified pursuant to paragraph (d) of this section, and a schedule for their accomplishment. The program shall emphasize screening and detection activities, and shall include:

(1) The development of effective informational programs designed to develop awareness of the problem among the population of the communities affected:

(2) Community self-help programs to enable residents to remove lead-based paint poisoning hazards from the residential community;

(3) To the maximum extent feasible, opportunities for training, education, and employment of the residents of communities affected by lead-based paint poisoning, and shall include a program for providing information which may be necessary to inform such residents of opportunities for employment in the lead-based paint elimination program;

(4) Establishment of lead-based paint poisoning screening services at such locations and at such times as to be easily accessible to the residents of the communities identified as needing such services;

(5) An intensified community followup program to insure that children with blood lead levels of over 40 micrograms

per 100 milliliters of whole blood are followed under a program of medical surveillance or treatment as medically indicated, and that sources of undue lead intake are identified and controlled;

(6) A comprehensive program of testing to detect the presence of lead-based paints in residential housing; and

(7) A comprehensive program requiring owners or landlords of housing units found to have unacceptable levels of lead-based paint, on interior surfaces or exterior surfaces accessible to children, to eliminate the paint from such surfaces or otherwise control the hazard; and, requiring other actions to eliminate or reduce lead-based paint poisoning.

(h) A description of the ongoing evaluation and planning by which the applicant will measure and further its progress in attaining the program objectives.

(1) An assurance that, in the operation of the program, no charge will be made for screening and detection tests. § 91.6 Evaluation and grant award.

(a) Within the limits of funds available for such purposes, the Secretary may award grants with respect to those projects which will in his judgment best promote the purposes of the act, taking into account:

(1) The significance of each project in terms of the extent of and need for the services to be provided;

(2) The general quality and effectiveness of the lead-based paint poisoning prevention program in relation to the requirements of § 91.5;

(3) The extent to which representatives of the communities to be served have been involved in the development of the project;

(4) The extent to which, in the judgment of the Secretary, a grant under this part will assist in the establishment of a continuing lead-based paint poisoning prevention program which will be conducted by the applicant beyond the termination of Federal financial support

and

(5) The extent to which the Federal and local programs are coordinated and utilized to impact on the lead-based paint poisoning problem.

(b) The amount of any award shall be determined by the Secretary on the basis of his estimate of the sum necessary for all or 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 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 been determined by the Secretary. Provided, however, that no grant under this part shall include an amount for carrying out the purposes of title I of the act which exceeds 75 percent of the cost of carrying out such purposes, as described in the application and determined by the Secretary. In determining the grantee's share of the project costs, costs borne by Federal grants, or costs used to match other Federal grants, may not be included except as may be otherwise provided by law.

(c) Allowability of costs shall be in conformance with the applicable principles prescribed by Subpart Q of 45 CFR Part 74.

(d) All grant awards shall be in writing, shall set forth the respective amounts of funds granted under title I and under title II of the act, 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 any additional, supplemental, continuation or other award with respect to any approved project or portion thereof. For continuation support, grantees must make separate application annually at such times and in such form as the Secretary may direct.

[37 FR 9188, May 5, 1972, as amended at 38 FR 26200, Sept. 19, 1973]

§ 91.7 Grant 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 prompt initiation

and advancement of the approved project.

§ 91.8 Use of grant funds.

(a) Any funds granted pursuant to this part as well as other funds to be used in performance of the approved project shall be expended solely for carrying out the approved project in accordance with the statute, 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. Such funds may be expended for medical care or treatment and the deleading of residential environments only under special circumstances as indicated in the following items:

(1) Providing medical care or treatment on only an emergency basis of victims of lead-based paint poisoning where the applicant finds, and demonstrates to the satisfaction of the Secretary, either before or after the provision of such care or treatment, that no other funds are reasonably available for such care and treatment; or

(2) Deleading of residential dwellings, only where the applicant finds that the presence of lead-based paint on interior surfaces of such a dwelling presents an imminent danger to the health and safety of one or more residents and where the applicant finds, and demonstrates to the satisfaction of the Secretary, either before or after such deleading, that no other funds are reasonably available for such deleading.

(b) Prior approval by the Secretary of revision of the budget and project plan is required whenever there is to be a significant change in the scope or nature of project activities.

[37 FR 9188, May 5, 1972, as amended at 38 FR 26200, Sept. 19, 1973]

(a) Attention is called to the requirements of title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d; 78 Stat. 252) 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 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) All services and employment opportunities provided with the aid of grants under this part shall, except where otherwise medically indicated, be made available without discrimination on the grounds of age, sex, creed, marital status, or duration of residence.

§ 91.10 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.

§ 91.11 Inventions or discoveries.

Any grant award pursuant to this part 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, assinments 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.

§ 91.12 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 this part, subject, however, to a royalty-free, nonexclusive, and ir

revocable license or right in the Government to reproduce, translate, publish, use, disseminate, and dispose of such materials and to authorize others to do

So.

§ 91.13 Expenditures by grantee.

The total cost of a project includes the identifiable direct costs and the associated indirect costs. Except as may otherwise be provided by or pursuant to the regulations of this part, the identification of direct and indirect costs will be consistent with the same policies and methods that the grantee applies to its own activities and in conformance with the applicable cost principles prescribed by Subpart Q of 45 CFR Part 74. Funds granted for the direct costs of approved projects may be expended by the grantee to the extent that such items are required to carry out the approved project. The amount of any award for the indirect costs of any project, subject to such maximum amounts or percentages as may be prescribed by law, shall be calculated in accordance with chapter 1-80 of the Department's Grants Administration Manual. The Secretary may issue rules, instructions, interpretations or limitations supplementing the regulations of this part and prescribing the extent to which particular types of expenditures may be charged as direct or indirect costs to the granted funds.

[37 FR 9188, May 5, 1972, as amended at 38 FR 26200, Sept. 19, 1973]

§ 91.14 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 funds, including funds derived from other grant awards and separate records shall be maintained for payment with respect to title I and title II of the act. With respect to each approved project, the grantee shall account for the sum total of all amounts paid out by presenting or otherwise making available evidence, satisfactory to the Secretary, of expenditures for direct and indirect costs meeting the requirements

1 The Department of Health, Education, and Welfare Grants Administration Manual is available for inspection at the Public Information Office of the several department regional offices and available for purchase at the Government Printing Office, GPO document No. 894-523.

of this part: Provided, however, That when the amount awarded for indirect cost 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 this subsection, 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 accounting, 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:

(1) 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;

§ 91.16 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 judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of public health, or the conservation of grant funds.

§ 91.17 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 apply also to grants to all other grantee organizations under this part:

The provisions of this subpart are applicable to agreements entered into by the Secretary with the various States pursuant to section 1122 of the Social Security Act (42 U.S.C. Chap. 7), and to determinations made by the Secretary thereunder, for the purpose of assuring that Federal funds appropriated under titles V, XVIII, and XIX of the Social Security Act are not used to support unnecessary capital expenditures made by or on behalf of health care facilities or health maintenance organizations which are reimbursed under any of such titles and that, to the extent possible, reimbursement under such titles shall support planning activities with respect to health services and facilities in the various States.

(a) “Act” means the Social Security Act, as amended (42 U.S.C. Chap. 7).

(b) "State" means any of the several States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Trust Territory of the Pacific Islands.

(c) "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 may be delegated.

(d) “Person” means an individual, a trust or estate, a partnership, a corporation (including associations, jointstock companies, and insurance companies, a State, or a political subdivision or instrumentality (including a municipal corporation) of a State.

(e) "Health care facility" includes hospitals, psychiatric hospitals, tuberculosis hospitals, skilled nursing facilities, home health agencies, and providers of outpatient physical therapy services (including speech pathology services) as defined in section 1861(e), (f), (g), (j), (o), and (p), respectively, of the Act (except that such term shall not apply with respect to outpatient physical therapy services performed by a physical therapist in his office or in a patient's home); kidney disease treatment centers, including freestanding hemodialysis units; intermediate care facilities as defined in section 1905(c) of the Act; and organized ambulatory health care facilities such as

health centers, family planning clinics, and facilities providing surgical treatment to patients not requiring hospitalization (ambulatory surgical centers), which are not part of a hospital but which are organized and operated to provide medical care to outpatients.

(f) "Health maintenance organization" means a public or private organization, organized under the laws of any State, which

(1) Provides or otherwise makes available to enrolled participants health care services, including at least the following basic health care services: Usual physician services, hospitalization, laboratory, x-ray, emergency and preventive services, and out-of-area coverage;

(2) Is compensated (except for copayments) for the provision of the basic health care services listed in subparagraph (1) of this paragraph to enrolled participants on a predetermined periodic rate basis; and

(3) Provides physicians' services primarily (i) directly through physicians who are either employees or partners of such organization, or (ii) through arrangements with individual physicians or one or more groups of physicians (organized on a group practice or individual practice basis).

[38 FR 31381, Nov. 13, 1973, as amended at 39 FR 32029, Sept. 4, 1974] § 100.103

Expenditures covered.

Any capital expenditure proposed by or on behalf of any health care facility or health maintenance organization, the obligation for which is incurred by or on behalf of a health care facility or health maintenance organization after December 31, 1972, or after the effective date of the agreement entered into pursuant to § 100.104 by the Secretary and the State in which the health care facility or health maintenance organization is located (which effective date may, at the option of the State, be earlier than the date on which such agreement is entered into where the Secretary finds that the procedure utilized by the State for review of proposed capital expenditures as of such earlier date satisfies the requirements of section 1122 and this subpart), whichever is later, is subject to this subpart: Provided, that, In the case of a health care facility providing health care services as of December 18, 1970, which on such date is committed to a formal plan of expansion or replacement, this subpart shall not apply