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

Control Programs 516.401 To which programs does this subpart

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

subpart? 51b.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 F-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? 51b.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 needed by the applicant to continue providing these services.

(4) A description of any proposed changes in the provision of the services, reasons and priorities, and the amount of Federal funds needed by the applicant to make the changes.

(b) The application shall contain evidence satisfactory to the Secretary that it has been submitted, as appropriate, for action to the planning agency designated by the Secretary under title XV of the Act (42 CFR parts 122 and 123). These grants are subject to the intergovernmental review of Federal programs of Executive Order 12372.

(c) The application shall contain assurances that no one will be denied services because of inability to pay, and that the services are provided in a manner which preserves human dignity and maximizes acceptance.

45 CFR part 75—Informal grant appeals pro

cedures 45 CFR part 76Debarment and suspension

from eligibility for financial assistance 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 of this title 45 CFR part 84—Nondiscrimination on the

basis of handicap in programs and activities receiving or benefiting from Federal

financial assistance 45 CFR part 86—Nondiscrimination on the

basis of sex in education programs and activities receiving or benefiting from Fed

eral financial assistance 45 CFR part 91—Nondiscrimination on the

asis age in HHS programs or activities receiving Federal financial assistance (49 FR 38109, Sept. 27, 1984)

g516.104 Can personnel, supplies, and

related items be provided in lieu of

cash? The Secretary may reduce a grant by the amount of the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished a grant recipient when furnished at the request of the recipient. The Secretary also may reduce a grant by the amount of the pay, allowances, travel expenses, and any other costs in connection with the detail of any officer or employee of the Government to the recipient when the detail is at the request of the recipient. The amount the grant is reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment or in detailing personnel and shall be deemed to have been paid to the recipient.

851b.106 What other conditions apply

to these grants? (a) The notice of grant award specifies how long HHS intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 2 to 5 years.

(b) For budgetary and funding purposes, the project period is generally divided into 12-month intervals called budget periods. A grantee must submit a separate application to have the support continued for each subsequent budget period after the initial award. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the gra e's progress and management practices and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.

(c) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.

(d) Any funds granted pursuant to this subpart shall be expended solely for the purposes for which the funds were granted in accordance with the

851b.105 Which other HHS regulations

apply to these grants? Several other HHS regulations apply to grants under this part. These include, but are not limited to: 42 CFR part 50, subpart DPublic Health

Service grant appeals procedure 45 CFR part 16–Procedures of the Depart

mental Grant Appeals Board 45 CFR part 46—Protection of human sub

jects 45 CFR part 74-Administration of grants

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.

851b.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 publ 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:

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

851b.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.

surveillance, and other program activities.

Subpart C [Reserved]

(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)

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.

851b.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)

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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, epidemiology,

g516.404. 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.

851b.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.

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