extent that the individual was exposed to coal dust as a result of employment.

§ 55a.102 Who is eligible to apply for a Black Lung clinics grant?

Any State or public or private entity may apply for a grant under this part.

§ 55a.103 What criteria has HHS established for deciding which grant application to fund?

(a) The Secretary will give preference to a State, which meets the requirements of this part and applies for a grant under this part, over other applicants in that State.

(b) Within the limits of funds available for these purposes the Secretary may award grants to assist in the carrying out of those programs which will 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; and

(2) The quality and breadth of services to be provided.

$55a.104 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 audits with appropriate safeguards for confidentiality of patient records. Otherwise, information may be disclosed only in summary, statistical, or other form which does not identify particular individuals.

§ 55a.105 How must grantees carrry out their projects?

Grantees must carry out their projects in accordance with their applications and the provisions of this part.

§ 55a.106 Provision for waiver by the Secretary.

The Secretary may, for good cause shown, waive provisions of these regulations.

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 elements:

(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 sec

tion 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.

(b) An assurance that no person will be denied services because of inability to pay.

(c) An assurance that grant funds received under this part will be used to supplement and not supplant existing services of the grantee.

(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]

(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 organiza

tion, 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 rendered 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 migrant 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.