Subpart C-(Reserved)

Subpart D-Grants for Venereal Disease Control Programs

SOURCE: 48 FR 4475, Feb. 1, 1983, unless otherwise noted.

851b.401 To which programs does this subpart apply?

The regulations in this subpart apply to the award of project grants under section 318(c) of the Act for venereal disease prevention and control programs, and under section 318(b) of the Act with respect to public information and education activities which are integral to a balanced, comprehensive venereal disease control program.

$51b.402 Definitions.

As used in this subpart:

Venereal disease means gonorrhea, syphilis, or any other disease which can be sexually transmitted and which the Secretary determines is or may be amenable to control with assistance provided under this authority and which is of national significance.

Venereal disease control program means a program designed to carry out activities or to provide services to systematically detect and prevent venereal disease as distinguished from those activities or services which are designed to diagnose or treat venereal disease patients or suspects.

851b.403 Who is eligible for a grant

under this subpart?

An applicant must be a State agency or a political subdivision of a State which has legal responsibility for disease control under the laws of the State.

other form, or for clinical or research purposes, but only if the disclosure does not identify particular individuals.

$51b.405 What information is required in the application?

(a) The initial application must include a description of the following: (1) The nature and extent of the venereal disease problem in the area. (2) The need for project grant support.

(3) The immediate (1-year budget period) and long-range (2-5 year project period) objectives of the project in specific and measurable terms.

(4) The activities to be carried out to meet the objectives. The following program elements must be included and described:

(i) Venereal disease surveillance. (ii) Casefinding and case followup. (iii) Interstate epidemiologic referral and followup.

(iv) Public venereal disease information and education.

(v) Professional (including appro priate allied health personnel) venereal disease education, training, and clini cal skills improvement activities, including efforts to assure high quality clinical services in public venereal dis ease clinics.

(5) At the option of the applicant special studies or demonstrations to evaluate or test venereal disease pre vention and control strategies and ac tivities.

(6) The manner in which the app cant intends to conduct and evaluate the project, including a system for analysis of morbidity data so that con trol activities can be efficiently evalu ated and targeted.

(7) The diagnostic and treatment

(8) A budget and justification for the grant funds requested. Since public information and education activities are authorized separately from other cotrol program activities, funds requested for this purpose must be itemized and justified separately in the nar rative part of the application.

(b) An application for a continuation grant must be submitted for each funding period. This continuation applica tion must include the following:

– (1) A budget and justification for the rant funds requested.

(2) A summary of the progress chieved during the previous budget eriod.

(3) A description of any changes in he information shown in the project pplication.

51b.406 How will grant applications be evaluated and the grants awarded?

(a) Within the limits of funds availble, the Secretary may award a grant o assist in meeting the cost of a veneeal disease control program. Before warding a grant to a political subdiviion of a State, the Secretary will conult with the State health authority. (b) Priorities for funding will be ased on the following factors:

(1) The relative extent of the veneeal disease problem in the area served by the applicant.

(2) The design of the venereal disease revention and control program. *(3) The general quality of the appliant's plan of operation and objectives n accordance with the requirements in these regulations. Emphasis will be placed on determining the extent to which services are coordinated among health care providers in the area served and integrated into a cohesive plan for delivery of service to groups having the highest incidence of venereal disease.

(4) The capacity of the applicant to make effective use of Federal funds.

(5) The commitment of the applicant to the control of venereal disease as reflected in the commitment of applicant resources to the program.

$51b.407 How can grant funds be used?

Grant funds awarded under this sub*part may be used only for programs approved under section 318(c), and with respect to public information and education, those programs approved under section 318(b) of the Act. Unless specifically approved, grant funds shall not be used for performing diagnostic tests (other than gonorrhea screening tests), maintaining central registries, purchasing data processing equipment, or providing diagnostic and treatment facilities and services. The applicant must provide assurances, however, that

these services will be available as needed as an adjunct to control program activities supported with grant funds. To obtain special approval for grant support of such activities, the grantee shall justify the exception to the satisfaction of the Secretary that funds for this purpose are necessary for the proper conduct of the program and are otherwise unavailable. Support of these services will generally be approved only in the following situations:

(a) Special studies or demonstrations, (b) the support of developmental or start-up activity, or (c) the support of an essential service which will result in a savings to a detection or prevention activity supported by the grant. Unless otherwise approved, exceptions based on paragraphs (b) and (c) of this section are only allowed during one funding period. The grantee is expected to support these activities in subsequent funding periods.

Subpart E-(Reserved)

Subpart F-Grants for Research, Demonstrations, and Public Information and Education for the Prevention and Control of Venereal Disease

SOURCE: 48 FR 4476, Feb. 1, 1983, unless otherwise noted.

$51b.601 To which programs does this subpart apply?

The regulations in this subpart apply to the award of venereal disease control project grants for research, demonstrations, public information, and education activities which can be applied to achieve improvements in venereal disease prevention and control under section 318(b) of the Act.

§ 51b.602 Who is eligible for a grant under this subpart?

An applicant must be a State, political subdivision of any State, or any other public or nonprofit private entity.

§ 51b.603 What are the confidentiality requirements?

All information obtained by program personnel in connection with the examination, care, and treatment of an indi

vidual in this program shall be held confidential. It shall not be disclosed without the individual's consent except as may be required by the law of a State, or political subdivision of a State, or as may be necessary to provide services to the individual. Information may be disclosed in summary, statistical, or other form, or for clinical or research purposes, but only if the disclosure does not identify particular individuals.

§ 51b.604 What information is required in the application?

(a) The initial application must include a description of the following:

(1) The setting and circumstances for which project grant support is being requested, including:

(1) The immediate and long-range objectives of the project in specific and measurable terms.

(ii) The activities which will be undertaken to accomplish the objectives, including the timing of these activities.

(iii) The anticipated application of findings to the national venereal disease control effort.

(iv) Any other information which will support the request for grant assistance.

(2) The relationship between the planned activities and the project objectives. The application must describe in detail how the applicant intends to proceed, particularly if the project is unusually complex and several activities are interdependent or unprecedented.

(3) A comprehensive and realistic plan which the applicant will use to evaluate the project. The plan must include periodic assessment of any possible impact, both positive and negative, that the proposed project might have upon the established venereal disease control program in the locality or localities in which the project will be undertaken.

(b) An application for a continuation grant must be submitted for each funding period. This continuation application must include the following:

(1) A budget and justification for the grant funds requested.

(2) A summary of the progress achieved during the previous budget period.

(3) A description of any changes in the information shown in the project application.

$51b.605 How will grant applications be evaluated and the grants awarded?

(a) Within the limits of funds available, the Secretary may award a grant to assist in meeting the costs of special activities authorized under section 318(b) of the Act.

(b) Grant applications will be reviewed and evaluated according to the following criteria:

(1) Is there adequate evidence that the proposed project is needed and that the outcome has potential to directly benefit the national venereal disease control effort?

(2) Are the project objectives specific, measurable, realistic, time phased, and related to promoting the purposes section 318?

(3) Is the method of operation logical and clearly related to project objec tives, and does it describe how the plicant intends to proceed particularly with activities which are complex interrelated, or unprecedented?

(4) Does the method of operation clude an assessment of any possible im pact, both positive and negative, that the conduct of the proposed initiative might have upon the established vene real disease control program in the le cality or localities in which the project will be undertaken?

(5) Does the proposal include a com prehensive and realistic plan for the evaluation of the project, and specify the measures and instruments of meas urement to be used?

(6) Is the budget request reasonable and consistent with the intended use of grant funds?

(7) If the applicant intends only to evaluate an existing disease prevention and control approach, are the objec tives substantially different from those which could be met by routine program evaluation?

(a) Grant funds may be used for the osts associated with planning, orgaİzing, and conducting applied rearch, demonstrations, and public inrmation and education programs. (b) Grant funds may also be used to eimburse individuals who agree to be articipants in the applied research rojects. This reimbursement, however, ust be justified as necessary and reaonable. A schedule of reimbursements ust be submitted with the application ad approved as part of the program lan.

(c) Grant funds may not be used to ipplant funds supporting existing veereal disease control services provided y a State or locality.

51c.507 Facility which has previously received Federal grant.

AUTHORITY: Sec. 330, Public Health Service Act, 89 Stat. 342, (42 U.S.C. 254c); sec. 215, Public Health Service Act, 58 Stat. 690, (42 U.S.C. 216).

SOURCE: 41 FR 53205, Dec. 3, 1976, unless otherwise noted.

Subpart A-General Provisions $51c.101 Applicability.

The regulations of this subpart are applicable to all project grants authorized by section 330 of the Public Health Service Act (42 U.S.C. 254c).

851c.102 Definitions.

As used in this part:

(a) Act means the Public Health Service Act.

(b) Catchment area means the area served by a project funded under section 330 of the Act.

(c)(1) Community health center or center means an entity which, through its staff and supporting resources or through contracts or cooperative arrangements with other public or private entities, provides for all residents of 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 their provision of such services;

(iv) Environmental health services, as determined by the Secretary to be appropriate for particular centers; and (v) Information on the availability and proper use of health services.

(2) For purposes of paragraph (c)(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 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.

health services

(d) Environmental means the detection and alleviation of unhealthful conditions of the environment of the catchment area, such as problems associated with water supply, sewage treatment, solid waste disposal, rodent and parasite infestation, and housing conditions. For the purposes of this part, the detection and alleviation of unhealthful conditions of the environment includes the notification of and making of arrangements with appropriate Federal, State, or local authorities responsible for correcting such conditions.

(e) Medically underserved population means the population of an urban or rural area designated by the Secretary as an area with a shortage of personal health services or a population group designated by the Secretary as having a shortage of such services. Medically underserved areas will be designated by the Secretary and a list of those designated will be published in the FEDERAL REGISTER from time to time, taking into consideration the following factors, among others:

(1) Available health resources in relation to size of the area and its population, including appropriate ratios of primary care physicians in general or family practice, internal medicine, pediatrics, or obstetrics and gynecology to population;

(2) Health indices for the population of the area, such as infant mortality rate;

(3) Economic factors affecting the population's access to health services, such as percentage of the population with incomes below the poverty level; and

(4) Demographic factors affecting the population's need and demand for health services, such as percentage of the population age 65 and over.

(f) 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 share holder or individual.

(g) Physician means a licensed doctor of medicine or doctor of osteopathy. (h) Primary health services means:

(1) Diagnostic, treatment, consultative, referral, and other services rendered by physicians, and, where feasible, by physician's extenders, such as physicians' assistants, nurse clinicians, and nurse practitioners;

(2) Diagnostic laboratory services and diagnostic radiologic services;

(3) Preventive health services, including medical social services, nutritional assessment and referral, preven tive health education, children's eye and ear examinations, prenatal and post-partum care, prenatal services well child care (including period screening), immunizations, and vol untary 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 emergencies during and after the cen ter'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 dif ficulties of access to services provided by the center receive such services; and

(6) Preventive dental services pro vided by a licensed dentist or other qualified personnel, including (1) oral hygiene instruction; (ii) oral prophy laxis, as necessary; and (iii) topical ap plication of fluorides, and the prescrip tion of fluorides for systemic use when not available in the community water supply.

(1) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Serv ices to whom the authority involved has been delegated.

(j) Supplemental health services means health services which are not included