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(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.

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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]

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grams, and under section 318(b) d Act with respect to public informati and education activities which ar tegral to a balanced, comprehensive nereal disease control program.

$51b.402 Definitions.

As used in this subpart: Venereal disease means gonorÍA syphilis, or any other disease can be sexually transmitted and wh the Secretary determines is or may amenable to control with assistan provided under this authority which is of national significance.

Venereal disease control progid means a program designed to carry activities or to provide services to tematically detect and prevent ve real disease as distinguished fr those activities or services which designed to diagnose or treat vener disease patients or suspects.

§ 51b.403 Who is eligible for a gru under this subpart?

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

§ 51b.404 What are the confidentiality requirements?

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All information obtained by progra personnel in connection with the exam ination, care, and treatment of an ind vidual in this program shall be hel confidential. It shall not be disclosed without the individual's consent except as may be required by the law of 8 State or political subdivision of a State or as may be necessary to provide serv ices to the individual. Information may be disclosed in summary, statistical, other form, or for clinical or research purposes, but only if the disclosure does not identify particular individ uals.

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§ 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.

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

1) The activities to be carried out to Fet the objectives. The following prom elements must be included and cribed:

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

iv) Public venereal disease informan and education.

v) Professional (including approate allied health personnel) venereal #ease education, training, and clini

1 skills improvement activities, iniding efforts to assure high quality nical services in public venereal disse clinics.

(5) At the option of the applicant, ecial studies or demonstrations to valuate or test venereal disease preention and control strategies and acvities.

(6) The manner in which the appliint intends to conduct and evaluate he project, including a system for nalysis of morbidity data so that conrol activities can be efficiently evaluted and targeted.

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

(8) A budget and justification for the rant funds requested. Since public inormation and education activities are uthorized separately from other conrol 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. Infor

mation may be disclosed in summary statistical, or other form, or for chi cal or research purposes, but only: the disclosure does not identify ticular individuals.

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

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

(1) The setting and circumstances fr which project grant support is being r quested, including:

(i) The immediate and long-range o jectives of the project in specific an measurable terms.

(ii) The activities which will be u dertaken to accomplish the objectives | including the timing of these activ ties.

(iii) The anticipated application findings to the national venereal dis ease control effort.

(iv) Any other information which wi support the request for grant assist

ance.

(2) The relationship between the planned activities and the project jectives. The application must describe in detail how the applicant intends t proceed, particularly if the project is unusually complex and several activi ties are interdependent or unprece dented.

(3) A comprehensive and realistic plan which the applicant will use to . evaluate the project. The plan must in clude periodic assessment of any pos sible impact, both positive and nega tive, that the proposed project might have upon the established venereal dis ease control program in the locality of 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.

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51b.605 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 costs of special ctivities authorized under section

18(b) of the Act.

(b) Grant applications will be reiewed and evaluated according to the ollowing criteria:

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

=(2) Are the project objectives specific, neasurable, 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?

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(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 which could be met by routine program evaluation?

$51b.606 How can grant funds be used?

(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

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