nation of grant support pursuant to Subpart M of 45 CFR Part 74, whichever first occurs. [37 FR 3902, Feb. 24, 1972, as amended at 38 FR 26917, Sept. 19, 1973] § 55.61 [Reserved] § 55.62 Accounting for grant related income. (a) 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. [37 FR 3902, Feb. 24, 1972, as amended at 38 FR 26917, Sept. 19, 1973] § 55.63 Final settlement. There shall be payable to the Federal Government as final settlement with respect to each approved project the total sum of (a) any amount not accounted for pursuant to § 55.60 and (b) 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. [38 FR 26917, Sept. 19, 1973] Subpart H-Applicability of 45 CFR Part 74-HHS Administrative Requirements and Cost Principles AUTHORITY: (5 U.S.C. 301); Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216). Reorg. Plan No. 3 of 1966, 31 FR 8855, 3 CFR 1966-1970 Comp. Office of Management and Budget Circulars A-102, A-87 and A-21. Sec. 55a.1 55a.2 To whom do these regulations apply? 55a.3 Who is eligible to apply for a Black Lung Clinics grant? 55a.4 What must an application for a Black Lung Clinics grant contain? 55a.5 What requirements must a Black Lung Clinic meet? 55a.6 What criteria has HHS established for deciding which grant applications to fund? 55a.7 How may project funds be used? 55a.8 What other HHS regulations apply? 55a.9 What confidentiality requirements must be met? AUTHORITY: Sec. 508, 83 Stat. 803; 30 U.S.C. 937. SOURCE: 45 FR 72161, Oct. 31, 1980, unless otherwise noted. § 55a.1 To whom do these regulations apply? This part applies to the award of grants pursuant to section 427(a) of the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 937(a)). These grants support the operation of clinical facilities known as Black Lung Clinics, for analysis, examination and treatment of respiratory and pulmonary impairments in coal miners. § 55a.2 Definitions. Any term not defined here shall have the meaning given it in the Act. As used in this part: "Act" means the Federal Mine Safety and Health Act of 1977, as amended (30 U.S.C. 801 et seq.). "Applicant" means any public or nonprofit private agency or institution which files an application for a grant under this part. "Miner" or "coal miner" means any individual who works or has worked in or around a coal mine or coal preparation facility in the extraction or preparation of coal. The term also includes an individual who works or has worked in coal mine construction or transportation in or around a coal mine, to the extent that the individual was exposed to coal dust as a result of employment. "Nonprofit," as applied to an agency or institution, means that no part of the net earnings of such agency or institution benefits, or may lawfully benefit, any private shareholder or individual. "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 may be delegated. § 55a.3 Who is eligible to apply for a Black Lung Clinics grant? (a) Any public or private nonprofit entity may apply for a grant under this part. (b) Eligible projects: grants pursuant to section 427(a) of the Act and this part may be made to eligible applicants for carrying out area or statewide clinical services for the analysis, examination, and treatment of occupational respiratory and pulmonary impairments in coal miners. § 55a.4 What must an application for a Black Lung Clinics grant contain? An approvable application must contain each of the following: (a) A plan for the provision of the services required by this part containing at least the following elements: (1) A description of the target population to whom services are to be provided, including a statement of the need for services; (2) A description of the area in which the target population resides, including descriptions of geographical barriers to service, availability of transportation, and each of the health service providers in the area which provide any of the services required under this part; (3) A statement of the goals and objectives of the program, how the program intends to achieve them, and how progress toward their achievement will be measured; (4) A description of how existing resources in the community will be utilized to maximize the effectiveness and efficiency of the use of grant funds; and (5) Letters of intent from each entity which is expected to provide any service under the Black Lung Clinics Program, including a statement that, contingent upon a grant award, services will be provided in accordance with the requirements under this part. (b) An assurance that, should an award be made, the grantee will enter into binding agreements with each of the listed clinics providing letters of intent which shall include provisions that: (1) No person will be denied services because of inability to pay; (2) Services will be made available regardless of how long the miner has lived in the service area or whether anyone referred the miner to the clinic; (3) Services will be made available in a manner calculated to preserve human dignity and to maximize acceptability and utilization of services; (4) Charges shall be made for services rendered as follows: (i) A schedule shall be maintained listing fees or payments for the provi sion of services, designed to cover reasonable costs of operation; (ii) A schedule of discounts adjusted on the basis of a patient's ability to pay shall be maintained. The schedule of discounts must provide for a full discount to individuals and families with annual incomes at or below the levels set forth in the most recent Community Services Administration Income Poverty Guidelines at 42 CFR 1060.2 (except that nominal fees for service may be collected from individuals and families with annual incomes at or below those levels if imposition of the fees is consistent with project goals). No discounts shall be provided to individuals and families with annual incomes greater than twice those set forth in the Guidelines; (iii) Where third-party payors (including Government agencies) are authorized or under a legal obligation to pay all or a portion of such charges, all services covered by that reimbursement plan will be billed and every reasonable effort will be made to obtain payment; and (iv) Where the cost of care and services furnished under the program is to be reimbursed under Title XIX of the Social Security Act, a written agreement with the Title XIX agency will be obtained by the clinic unless the Title XIX agency refuses to enter into the agreement and the clinic provides evidence of the refusal to the grantee. (5) Grant funds will be used to supplement and not supplant existing services. (6) Medical services will be performed in consultation with a physician with special training or experience in the diagnosis and treatment of respiratory diseases. (c) A description of how each clinic or group of clinics will assure consumer participation in the development of policy applicable to the administration and delivery of black lung clinic services through a policy board or an advisory committee to the policy board. If the policy board consists of a majority of miners or miner-selected representatives, this requirement is satisfied. If this is not the case, an advisory committee to the policy board with a majority of miners or miner-selected representatives, but also including in terested parties, such as health care providers, coal industry employers, representatives of third-party payors, and the general public, must be established. Procedures for the functioning of the advisory committee must be adopted which assure continued ability to represent the varied points of view, including that of consumers, and that committee recommendations are promptly referred to the policy board for consideration. (d) Evidence that a copy of the application was forwarded to each of the affected health systems agencies designated under Title XV of the Public Health Service Act with a request that the agency review and approve the application and forward its comments to the Secretary. Regulations applying to health systems agencies appear in 42 CFR Part 122. (e) Evidence that the application was sent to the appropriate A-95 Clearinghouse(s) for review and comment, in compliance with Office of Management and Budget Circular No. A-95, Revised. in the Secretary's judgment best promote the purposes of section 427(a) of the Act, taking into account: (1) The number of miners to be served and their needs; (2) The quality and breadth of services to be provided; (3) The degree to which other resources are committed to the program; (4) The applicant's ability to manage the proposed program, including its experience with the delivery of medical services by clinical facilities and its ability to make rapid and effective use of the grant funds; and (5) Whether proposed services are complementary to and nonduplicative of existing services, particularly in States or Regions where there are existing programs which are determined to be meeting or making satisfactory progress toward meeting identified needs. (b) The notice of grant award specifies how long the Secretary intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 3 to 5 years. (c) Generally the grant initially will be for 1 year and subsequent continuation awards also will be for 1 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 the Secretary that continued funding is in the best interest of the Federal Government. (d) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application. § 55a.7 How may project funds be used? A grantee shall only spend funds it receives under this part according to the approved application and budget, the authorizing legislation, terms and conditions of the grant award, applicable cost principles specified in Subpart Q of 45 CFR Part 74, and the regulations of this part. § 55a.8 What other HHS regulations apply? Several other HHS regulations apply to grants under this part. These include, but are not limited to: 42 CFR Part 50-Policies of general applicability 42 CFR Part 122-Health systems agency reviews of certain proposed uses of Federal health funds 45 CFR Part 16-Department grant appeals process 45 CFR Part 19-Limitation on payments or reimbursements for drugs 45 CFR Part 74-Administration of grants 45 CFR Part 75-Informal grant appeals procedures 45 CFR Part 80-Nondiscrimination under programs receiving Federal assistance through the Department of Health, Education, and Welfare-Effectuation of Title VI of the Civil Rights Act of 1964 45 CFR Part 81-Practice and procedures for hearings under Part 80 of this title 45 CFR Part 84-Nondiscrimination on the basis of handicap in federally assisted programs and activities receiving or benefiting from Federal financial assistance 45 CFR Part 911-Nondiscrimination on the basis of age in Department programs or activities receiving Federal financial assistance § 55a.9 What confidentiality requirements must be met? All information as to personal facts and circumstances obtained by the grantee's staff about recipients of services shall be held confidential, and shall not be disclosed without the individual's consent except as may be required by law or as may be necessary to provide service to the individual or to provide for medical audits by the Secretary with appropriate safeguards for confidentiality of patient records. Otherwise, information may be dis 1 When issued. Subpart G-Grants for Technical Assistance Sec. 56.701 Applicability. 56.702 Application. 56.703 Project elements. 56.704 Grant evaluation and award. Subpart H-Acquisition and Modernization of Existing Buildings 56.801 Applicability of 42 CFR Part 51c, Subpart E. AUTHORITY: Secs. 215, 319, Public Health Service Act (42 U.S.C. 216, 247d). SOURCE: 42 FR 60406, Nov. 25, 1977, unless otherwise noted. Subpart A-General Provisions § 56.101 Applicability. The regulations of this subpart are applicable to all grants authorized by Section 319 of the Public Health Service Act (42 U.S.C. 247d). § 56.102 Definitions. As used in this part: (a) "Act" means the Public Health Service Act (42 U.S.C. 201 et seq.), as amended. (b)(1) "Agriculture" means farming in all its branches, including (i) Cultivation and tillage of the soil; (ii) The production, cultivation, growing, and harvesting of any commodity grown on, in, or as an adjunct to or part of a commodity grown in, or on, the land; and (iii) Any practice (including preparation and processing for market and delivery to storage or to market or to carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an activity described in subsection (ii). (c) "Catchment area" means the geographic area served by a project funded under section 319 of the Act. (d) "Environmental health services" means the detection and alleviation of unhealthful conditions of the environment of the persons served by the project, such as problems associated with water supply, sewage treatment, solid waste disposal, rodent and parasite infestation, field sanitation, and housing conditions and the treatment of medical conditions arising therefrom. For |