Other regulations which apply to the Black Lung Clinics Program include, but are not limited to, the following:

42 CFR part 50, subpart D-Public Health Service grant appeals procedure;

42 CFR part 50, subpart E-Maximum allowable cost for drugs;

45 CFR part 16-Procedures of the Departmental Grant Appeals Board;

45 CFR part 19-Limitations on payment or reimbursement 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 and Human Services effectuation of title VI of the Civil Rights Act of 1964;

45 CFR part 81-Practice and procedure for hearings under part 80;

45 CFR part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from Federal financial assistance; and

45 CFR part 91-Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance.

Subpart B-Grants to States

§ 55a.201 What is required for a State application?

An approvable State application must contain assurances that the State will:

(a) Provide the following services for active and inactive miners in the State:

(1) Primary care;

(2) Patient and family education and counseling;

(3) Outreach;

(4) Patient care coordination, including individual patient care plans for all patients;

(5) Antismoking advice; and

(6) Other symptomatic treatments. (b) Provide medical services in consultation with a physician with special training or experience in the diagnosis and treatment of respiratory diseases.

(c) Meet all criteria for approval and designation by the Department of Labor under 20 CFR part 725 to perform disability examination and provide treatment under the Act.

(d) Use grant funds under this part to supplement and not supplant existing services of the State.

(e) Provide the services described above for those miners previously served by a Black Lung Clinic in the State for which grant support expires during the funding period of the State's grant.

(f) Provide services described above regardless of a person's ability to pay. (g) Audit its expenditures from amounts received under this part in accordance with the provisions of Attachment P, Audit Requirements, of Office of Management and Budget Circular A102, Uniform Requirements for Assistance to State and Local Governments, as adopted for the Department of

Health and Human Services by 45 CFR part 74.

(Approved by the Office of Management and Budget under control number 0915-0081)

[50 FR 7913, Feb. 27, 1985, as amended at 50 FR 53156, Dec. 30, 1985]

Subpart C-Grants to Entities
Other Than States

§ 55a.301 What is required for an application from an entity other than a State?

An approvable application must contain the following:

(a) A plan for the provision of the services required by §55a.201(a), consistent with the requirements of § 55a.201 (b) and (c). The plan must also contain at least the following ele

ments:

(1) A description of the target population to whom services are to be provided, including a statement of the need for services;

(2) An assurance that charges shall be made for services rendered as follows:

(i) A schedule shall be maintained listing fees or payments for the provision of services, designed to cover reasonable costs of operations;

(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 poverty line established in accordance with section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)), (except that nominal fees for service may be requested, but not required, from individuals and families with annual incomes at or below the poverty line). No discounts shall be provided to individuals and families with annual incomes greater than twice the poverty line; and

(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.

56.504 Grant evaluation and award.

Subpart F-Grants for Operating Migrant Health Programs

56.601 Applicability.

56.602 Application.

56.603 Project elements.

56.604 Grant evaluation and award.

Subpart G-Grants for Technical Assistance

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 the purposes of this part, the detection and alleviation of unhealthful conditions of the environment includes the notification of appropriate Federal, State, or local authorities responsible for correcting such conditions and the making of arrangements therefor with such authorities.

(e) Health professionals means professionals (such as physicians, dentists, nurses, podiatrists, optometrists, and physicians' extenders) who are engaged in the delivery of health services and who meet all applicable Federal or State requirements to provide their professional services.

(f) High impact area means a catchment area which has not less than 6,000 migratory agricultural workers, seasonal agricultural workers, and members of the families of such workers residing within its boundaries for more than two months in the most recent calendar year for which statistical data acceptable to the Secretary is available.

(g)(1) Migrant health center means an entity which either through its staff and supporting resources or through contracts or cooperative arrangements with other public or private entities provides for migratory agricultural workers, seasonal agricultural workers, and the members of the families of such workers, within its catchment area:

(i) Primary health services;

(ii) As determined by the Secretary to be appropriate for particular centers, supplemental health services necessary for the adequate support of primary health services;

(iii) Referral to providers of supplemental health services and payment, as determined by the Secretary to be appropriate and feasible, for the provision of such services;

(iv) Environmental health services, as determined by the Secretary to be appropriate for particular centers;

(v) As determined by the Secretary to be appropriate for particular centers, infectious and parasitic disease screening and control services;

(vi) As determined by the Secretary to be appropriate for particular centers, accident prevention programs, including prevention of excessive exposure to pesticides through, but not limited to, notification of appropriate Federal, State or local authorities of hazardous conditions due to pesticide use; and

(vii) Information on the availability and proper use of health services.

(2) For purposes of paragraph (g)(1) of this section, the provision of a given service by a center will be determined by the Secretary to be appropriate where

(i) There is a need, as determined by the Secretary, for the provision of such service to individuals described in paragraph (g)(1) of this section in the catchment area; and

(ii) The provision of such service by the center is feasible, taking into consideration the center's projected revenues, other resources, and grant support under this part.

(h) Migratory agricultural worker means an individual whose principal employment is in agriculture on a seasonal basis, who has been so employed within the last 24 months, and who establishes for the purpose of such employment a temporary place of abode;

(i) Nonprofit, as applied to any private agency, institution, or organization, means one 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.

(j) Physician means a licensed doctor of medicine or doctor of osteopathy.

(k) Primary care means preventive, diagnostic, treatment, consultant, referral, and other services rendered by physicians (including, as appropriate, physicians' extenders), routine associated laboratory services and diagnostic radiologic services, and emergency health services.

(1) Primary health services means: (1) Diagnostic, treatment, consultative referral, and other services ren

dered by physicians and, where feasible, by physicians' extenders, such as physicians' assistants, nurse clinicians, and nurse practitioners;

(2) Diagnostic laboratory services and diagnostic radiologic services;

(3) Preventive health services, including children's eye and ear examinations, prenatal and post-partum care, perinatal services, well child care (including periodic screening), immunizations, and voluntary family planning services;

(4) Emergency medical services, including provision, through clearly defined arrangements, for access of users of the center to health care for medical and dental emergencies during and after the center's regularly scheduled hours;

(5) Transportation services as needed for adequate patient care, sufficient so that residents of the catchment area served by the center with special difficulties of access to services provided by the center receive such services; and

(6) Preventive dental services provided by a licensed dentist or other qualified personnel, including

(i) Oral hygiene instruction;

(ii) Oral prophylaxis, as necessary; and

(iii) Topical application of fluorides, and the prescription of fluorides for systemic use when not available in the community water supply.

(m) Seasonal agricultural worker means an individual whose principal employment is in agriculture on a seasonal basis and who is not a migratory agricultural worker.

(n) 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 has been delegated.

(0) Supplemental health services means health services which are not included as primary health services and which

are:

(1) Inpatient and outpatient hospital services;

(2) Home health services;

(3) Extended care facility services; (4) Rehabilitative services (including physical and occupational therapy) and long-term physical medicine;

(5) Mental health services, including services of psychiatrists, psychologists, and other appropriate mental health professionals;

(6) Dental services other than those provided as primary health services;

(7) Vision services, including routine eye and vision examinations and provision of eyeglasses, as appropriate and feasible;

(8) Allied health services;

(9) Pharmaceutical services, including the provision of prescription drugs; (10) Therapeutic radiologic services; (11) Ambulatory surgical services; (12) Public health services (including nutrition education and social services);

(13) Health education services; and

(14) Services including the services of outreach workers, which promote and facilitate optimal use of primary health services and services referred to in the preceding subparagraphs of this paragraph and, if a substantial number of individuals in the population served by the center are of limited Englishspeaking ability, the services of outreach workers and other personnel fluent in the language or languages spoken by such individuals.

§ 56.103 Eligibility.

Any public or nonprofit private entity is eligible to apply for a grant under this part.

$56.104 Application.

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

(b) 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 requirements of this part. The application must describe how and the extent to which the project has met, or plans to meet, each of the requirements in subpart B (relating to grants for planning and development of migrant health centers), subpart C (relating to grants for the operation of migrant health centers), subpart D (relating to grants for the operation of migrant health entities), subpart E (relating to grants for planning and developing mi

grant health programs), subpart F (relating to grants for the operation of migrant health programs), or subpart G (relating to grants for technical assistance), as applicable. In addition, applications must include:

(1) A statement of specific, measurable objectives and the methods to be used to assess the achievement of the objectives in specified time periods and at least on an annual basis.

(2) The precise boundaries of the catchment area to be served by the applicant. In addition, the application shall include information sufficient to enable the Secretary to determine that the applicant's catchment area meets the following criteria:

(i) The size of such area is such that the services to be provided by the applicant are available and accessible to the residents of the area promptly and as appropriate;

(ii) The boundaries of such area conform, to the extent practicable, to relevant boundaries of political subdivisions, school districts, and areas served by Federal and State health and social service programs; and

(iii) The boundaries of such area eliminate, to the extent possible, barriers resulting from the area's physical characteristics, its residential patterns, its economic and social groupings, and available transportation.

(3)(i) The number of migratory agricultural workers and members of their families, and seasonal agricultural workers and members of their families

which resided in the project's

catchment area in the most recent calendar year for which statistical data acceptable to the Secretary is available; and

(ii) The approximate period or periods of residence of all groups of migratory agricultural workers and their families counted under paragraph (b)(3)(i) of this section.

(4) The results of an assessment of the need that the population to be served has for the services to be provided by the project (or in the case of applications for planning and development projects, the methods to be used in assessing such need), taking into consideration the following factors: