approved application and budget, the regulations of this part, the terms and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.

(e) The Secretary may, at the time of award, impose additional conditions, including conditions governing the use of information or consent forms, when, in the Secretary's judgment, they are necessary to advance the approved program, the interest of the public health, or the conservation of grant funds.

$51b.107 Is participation in preventive health service programs required by these regulations?

Nothing in these regulations shall be construed to require any State or political subdivision to have a preventive health service program which would require any person who objects to treatment to be treated under the program.

Subpart B-Grants for Childhood Immunization Programs

SOURCE: 44 FR 40501, July 11, 1979, unless otherwise noted.

§ 51b.201 To which programs does this subpart apply?

The regulations in this subpart apply to the award of grants under section 317 of the Act for programs to immunize children against vaccine preventable diseases.

§ 51b.202 Definitions.

As used in this subpart:

Childhood immunization program means a preventive health service program to immunize children against vaccine preventable diseases including poliomyelitis, measles, mumps, rubella, diphtheria, pertussis, and tetanus. $51b.203 Who is eligible for a grant under this subpart?

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

§ 51b.204 What information is required in the application?

(a) The initial application must cover the project period, and must include a description of the following:

(1) The need for grant support.

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

(3) Current immunization programs and the additional or intensified activities to be carried out to meet the objectives and priorities.

(4) The following program elements should be included and described:

(i) A plan to assure that children begin and complete their immunizations on schedule, including the use of a standard immunization record card, a provider-based tickler system (public and private) for the recall of children, and a hospital-based immunization education program for new mothers.

(ii) Assessment of immunization status of school enterers, children attending licensed day-care centers, and children under 2 years of age and new enrollees under age 5 served in public clinics.

(iii) A plan for surveillance of vaccine-preventable diseases that includes morbidity and mortality reporting as well as field and laboratory investigations.

(iv) Procedures for prompt review of the data collected from the morbidity surveillance system to allow for immediate response to all occurrence of suspected diphtheria and polio cases upon notification and response to suspected measles cases within 48 hours.

(v) A system for monitoring vaccineassociated reactions including a mechanism for responding to persons with vaccine-related complaints.

(vi) A plan to systematically immunize susceptible children at school entry through vigorous enforcement of school immunization laws.

(5) The manner in which the applicant intends to evaluate the project.

(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.

[48 FR 4474, Feb. 1, 1983]

§ 51b.205 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 part of the cost of a childhood immunization program. Grants will be awarded to those applicants whose projects he determines will best promote the purposes of section 317 of the Act. Before awarding a grant to a local public entity of a State, the Secretary will consult with the State health authority.

(b) Priorities for funding will be based on the following factors:

(1) The relative extent of the problems which are caused by one or more of the vaccine preventable diseases in the area served by the applicant.

(2) The extent to which the proposed program is designed to eliminate or reduce the problems.

(3) The extent to which the proposed program will increase the immunization rates in population groups identified as having the lowest immunity levels.

(4) The extent to which the grantee will cooperate with and use public and nonprofit private entities and volunteers.

(5) The extent to which a strong commitment to the objectives of the program is reflected in the commitment of grantee resources to the program.

[44 FR 40501, July 11, 1979, as amended at 48 FR 4475, Feb. 1, 1983]

§ 51b.206 How can grant funds be used?

Grant funds awarded under this subpart may be used to purchase supplies, materials, and equipment for childhood immunization programs. Grant funds also may be used to pay for salaries or wages and related expenses for personnel directly involved in the planning, organization, promotion, epide

miology, surveillance, and other program activities.

Subpart C [Reserved]

Subpart D-Grants for Venereal Disease Control Programs

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

§ 51b.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.

§ 51b.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.

§ 51b.404 What are the confidentiality requirements?

All information obtained by program personnel in connection with the examination, care, and treatment of an individual 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.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 appropriate allied health personnel) venereal disease education, training, and clinical skills improvement activities, including efforts to assure high quality clinical services in public venereal disease clinics.

(5) At the option of the applicant, special studies or demonstrations to evaluate or test venereal disease prevention and control strategies and activities.

(6) The manner in which the applicant intends to conduct and evaluate the project, including a system for analysis of morbidity data so that control activities can be efficiently evaluated and targeted.

(7) The diagnostic and treatment services that will be provided.

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

(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.406 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 cost of a venereal disease control program. Before awarding a grant to a political subdivision of a State, the Secretary will consult with the State health authority.

(b) Priorities for funding will be based on the following factors:

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

(2) The design of the venereal disease prevention and control program.

(3) The general quality of the applicant's plan of operation and objectives in 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 subpart 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 individual 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:

(i) 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 assist

ance.

(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 of section 318?

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

(4) Does the method of operation include an assessment of any possible impact, both positive and negative, that the conduct of the proposed initiative might have upon the established venereal disease control program in the locality or localities in which the project will be undertaken?

(5) Does the proposal include a comprehensive and realistic plan for the evaluation of the project, and specify the measures and instruments of measurement 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 objectives substantially different from those

(a) Grant funds may be used for the costs associated with planning, organizing, and conducting applied research, demonstrations, and public information and education programs.

(b) Grant funds may also be used to reimburse individuals who agree to be participants in the applied research projects. This reimbursement, however, must be justified as necessary and reasonable. A schedule of reimbursements must be submitted with the application and approved as part of the program plan.

(c) Grant funds may not be used to supplant funds supporting existing venereal disease control services provided by a State or locality.