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Subpart C [Reserved] Subpart D-Grants for Venereal Disease

Control Programs 51b.401 To which programs does this subpart

apply? 51b.402 Definitions. 51b.403 Who is eligible for a grant under this

subpart? 516.404 What are the confidentiality re

quirements? 51b.405 What information is required in the

application? 51b.406 How will grant applications be eval

uated and the grants awarded? 51b.407 How can grant funds be used?

851b.102 Definitions.

As used in these regulations:

Act means the Public Health Service Act, as amended.

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

State means one of the 50 States, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.

Subpart E (Reserved]

Subpart Grants for Research, Dem

onstrations, and Public Information and Education for the Prevention and

Control of Venereal Disease 51b.601 To which programs does this subpart

apply? 516.602 Who is eligible for a grant under this

subpart? 516.603 What are the confidentiality re

quirements?

851b.103 What are the general applica

tion requirements? (a) The project application shall contain a full description of the program objectives, plans, and activities. With respect to programs authorized by section 317 of the Act only, the application shall also provide, as the Secretary may require:

(1) The amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program.

(2) A description of the services provided by the applicant for this accounting period covered under paragraph (a)(1) of this section.

(3) The amount of Federal funds 45 CFR part 75—Informal grant appeals proneeded by the applicant to continue

cedures providing these services.

45 CFR part 76-Debarment and suspension (4) A description of any proposed

from eligibility for financial assistance

45 CFR part 80-Nondiscrimination under changes in the provision of the serv

programs receiving Federal assistance ices, reasons and priorities, and the

through the Department of Health and amount of Federal funds needed by the

Human Services effectuation of title VI of applicant to make the changes.

the Civil Rights Act of 1964 (b) The application shall contain evi- 45 CFR part 81—-Practice and procedure for dence satisfactory to the Secretary

hearings under part 80 of this title that it has been submitted, as appro

45 CFR part 84—Nondiscrimination on the priate, for action to the planning agen

basis of handicap in programs and activi

ties receiving or benefiting from Federal cy designated by the Secretary under

financial assistance title XV of the Act (42 CFR parts 122

45 CFR part 86_Nondiscrimination on the and 123). These grants are subject to basis of sex in education programs and acthe intergovernmental review of Fed- tivities receiving or benefiting from Federal programs of Executive Order 12372. eral financial assistance

(c) The application shall contain as- 45 CFR part 91-Nondiscrimination on the surances that no one will be denied

basis of age in HHS programs or activities services because of inability to pay,

receiving Federal financial assistance and that the services are provided in a

[49 FR 38109, Sept. 27, 1984) manner which preserves human dignity and maximizes acceptance.

851b.106 What other conditions apply

to these grants? 851b.104 Can personnel, supplies, and (a) The notice of grant award speci

related items be provided in lieu of fies how long HHS intends to support cash?

the project without requiring the The Secretary may reduce a grant by project to recompete for funds. This pethe amount of the fair market value of riod, called the project period, will usuany supplies (including vaccines and ally be for 2 to 5 years. other preventive agents) or equipment (b) For budgetary and funding purfurnished a grant recipient when fur- poses, the project period is generally nished at the request of the recipient. divided into 12-month intervals called The Secretary also may reduce a grant budget periods. A grantee must submit by the amount of the pay, allowances, a separate application to have the suptravel expenses, and any other costs in port continued for each subsequent connection with the detail of any offi- budget period after the initial award. cer or employee of the Government to Decisions regarding continuation the recipient when the detail is at the awards and the funding level of such request of the recipient. The amount awards will be made after considerthe grant is reduced shall be available ation of such factors as the grantee's for payment by the Secretary of the progress and management practices costs incurred in furnishing the sup- and the availability of funds. In all plies or equipment or in detailing per- cases, continuation awards require & sonnel and shall be deemed to have determination by HHS that continued been paid to the recipient.

funding is in the best interest of the

government. $51b.105 Which other HHS regulations (c) Neither the approval of any appliapply to these grants?

cation nor the award of any grant comSeveral other HHS regulations apply mits or obligates the United States in to grants under this part. These in- any way to make any additional, supclude, but are not limited to:

plemental, continuation, other

award with respect to any approved ap42 CFR part 50, subpart D_Public Health Service grant appeals procedure

plication or portion of an approved ap45 CFR part 16—Procedures of the Depart

plication. mental Grant Appeals Board

(d) Any funds granted pursuant to 45 CFR part 46–Protection of human sub- this subpart shall be expended solely jects

for the purposes for which the funds 45 CFR part 74-Administration of grants were granted in accordance with the

or

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

851b.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:

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.

851b.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.

851b.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.

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.

(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 award

ed? (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]

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. 851b.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.

851b.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

$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.

(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.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.

851b.406 How will grant applications

be evaluated and the grants award

ed? (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. 851b.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),

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