[Federal Register Volume 59, Number 113 (Tuesday, June 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14357]


[[Page Unknown]]

[Federal Register: June 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement No. 101A]

 

Addendum to Announcement 101; Hepatitis B Vaccination 
Demonstration Projects in Asian/Pacific Island Children

Introduction

    The Centers for Disease Control and Prevention (CDC), through the 
National Immunization Program (NIP) and the National Center for 
Infectious Diseases (NCID), announces the availability of supplemental 
funds to demonstrate the most effective method of providing hepatitis B 
vaccine to children 2-13 years of age in the Asian and/or Pacific 
Island (API) populations within the United States. This is an addendum 
to Program Announcement Number 101.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity to reduce morbidity and mortality 
and improve the quality of life. This announcement is related to the 
priority area of Immunization and Infectious Diseases. (For ordering a 
copy of ``Healthy People 2000,'' see the section entitled WHERE TO 
OBTAIN ADDITIONAL INFORMATION.)

Authority

    This program is authorized under Section 317 of the Public Health 
Service Act (42 U.S.C. 247b), as amended. Regulations governing the 
implementation of this legislation are covered under 42 CFR part 51b, 
subparts A and B.

Smoke-Free Workplace

    The Public Health Service strongly encourages all grant recipients 
to provide a smoke-free workplace and promote the non-use of all 
tobacco products. This is consistent with the PHS mission to protect 
and advance the physical and mental health of the American people.

Eligible Applicants

    Eligible applicants for these supplemental funds are the official 
public health agencies who are current recipients of project grants for 
Preventive Health Services--Immunization.

Availability of Funds

    Approximately $500,000 will be available in fiscal year (FY) 1994 
to fund up to five demonstration projects through supplemental grant 
awards to current recipients of immunization project grants. These 
demonstration projects are expected to begin on or about September 30, 
1994, for a twelve-month activity period within a twenty-four-month 
period of performance. Funding estimates may vary and are subject to 
change. Continuation award(s) within the project period will be made on 
the basis of satisfactory progress and availability of funds.

Purpose

    The purpose of the hepatitis B vaccination (HBV) demonstration 
projects in API children is to demonstrate the most effective method of 
providing hepatitis B vaccine to children 2-13 years of age in the API 
populations within the United States and create a practical model to be 
considered for implementation nationwide.
    The goals of this demonstration project are:
    A. To demonstrate and compare the effectiveness (including cost-
effectiveness) of different methods of providing hepatitis B vaccine to 
API children age 2-13 years by: (1) Conducting baseline assessments of 
vaccination rates (coverage), (2) developing and applying the 
interventions, and (3) measuring the effectiveness of the 
interventions.
    B. To determine the factors that are most predictive of acceptance/
completion and the barriers associated with non-acceptance/non-
completion of the hepatitis B vaccination series in a defined target 
group of API children age 2-13 years.

Program Requirements

    To achieve the purpose of this demonstration the successful 
applicant(s) will show in their proposal that they have the following:
    A. A population of at least 10,000 API people within a community or 
geographic area that is well defined and can be approached in total 
with an immunization outreach program.
    B. Established links to the target population (including culturally 
appropriate and sensitive outreach methods).
    C. A history of successful completion of research projects (by the 
Immunization Project or through sub-contracts they have made with 
outside contractors) in medical or public health outreach programs 
within the API communities.
    D. Established and effective perinatal and universal infant 
hepatitis B vaccination programs within the target population.
    In addition, the successful applicant(s) shall be responsible for 
conducting the following activities:
    A. Adhere to the detailed time-line provided by the recipient and 
approved by CDC which includes each step necessary to accomplish the 
recipient activities listed below.
    B. Divide the target API community of at least 10,000 people in 
which effective fully operational perinatal hepatitis B and universal 
infant hepatitis B vaccination programs are being conducted into two 
groups--a study and comparison group--that are similar on all relevant 
characteristics such as demographic, geographic, social economic 
status, and health care profiles.
    C. Follow published scientifically valid methods of sample size and 
power calculations, sample selection, survey design, data collection, 
data management and data analysis.
    D. After completing the design, pretest and approval phases, 
conduct a baseline survey of health care providers serving the target 
population to measure knowledge, attitudes, practices and barriers 
related to hepatitis B vaccination of API children age 2-13.
    E. After completing the design, pretest and approval phases, 
conduct the baseline household survey to measure hepatitis B 
vaccination coverage and knowledge, attitudes, behaviors, and barriers 
related to hepatitis B vaccination in the target population.
    F. Effectively inform all individuals in the target group, their 
parents, and their medical care providers of the availability of free 
hepatitis B vaccinations for all API children age 2-13.
    G. Provide effective culturally appropriate education on the risks 
of HBV infection and benefits of hepatitis B vaccination to all 
individuals in the target group, their parents, and their medical care 
providers. Through development and/or use during this demonstration 
project effective information materials will be available for use in 
similar populations throughout the United States.
    H. Devise and implement an enhanced campaign in the study group 
within the target population. This enhancement should include outreach 
efforts in addition to those in the basic campaign which have been 
shown in the literature to be effective in the target population. The 
enhancement may cost more but must (1) have a strong chance of being 
more cost effective, and (2) be practical for other comparable 
immunization projects or communities to implement across the United 
States.
    I. Properly provide the federally required hepatitis B vaccine 
Important Information Statement (IIS) (consent form) and obtain 
informed consent signatures prior to administration of each dose of 
hepatitis B vaccine.
    J. Deliver hepatitis B vaccine to all eligible API children age 2-
13 within the target communities through a network which may include 
public and private clinics, hospitals, and private doctors offices; 
Women Infant Children (WIC) and Aid to Families with Dependent Children 
(AFDC) sites as well as in day care centers, pre-schools, and 
elementary and high school based clinics; religious and community 
organizations; and in-home visitation and mobile vans.
    K. Utilize a computerized tracking, reminder and recall system in 
the entire target population but add an enhanced system of tracking, 
follow-up and reminder/recall in the study group, including, for 
example, more personnel contact and additional home visits and 
incentives.
    L. After completing the design, pretest and approval phases, 
conduct post intervention Knowledge Attitudes and Practices (KAP) 
surveys of medical care providers in each comparison group.
    M. At the conclusion of the first 12 months of funding determine 
within each comparison group what proportion of eligible API children 
age 2-13 who were not vaccinated with at least one hepatitis B vaccine 
dose, who received only dose 1 or doses 1 and 2, and who completed the 
series (dose 3).
    N. At the conclusion of the first 12 months of funding, after 
completing the design, pretest and approval phases, conduct post 
intervention surveys of a sample in each comparison group of those who 
did not accept the hepatitis B vaccine, those that accepted dose 1 or 
doses 1 and 2 only, and those who accepted dose 3. The survey will be 
designed to provide a demographic and hepatitis B vaccination related 
knowledge, attitude, behavior, and barrier profile for children and 
parents.
    CDC will provide consultation and technical assistance in planning, 
conducting and evaluating this project. CDC will assist with data 
management, analysis and writing the final reports.

Review and Evaluation Criteria

    The application will be evaluated according to the following 
criteria:
    A. The applicant's understanding of the purpose of the study and 
the feasibility of producing the required results.
    B. The extent to which background information and other data 
demonstrate that the applicant has the appropriate organizational 
structure, administrative support and accessibility to an adequate 
number of participants in the target populations to accomplish study 
objectives, including culturally appropriate outreach activities.
    C. The degree to which the applicants's plan is consistent with 
study goals and is realistic, specific, measurable and time-phased.
    D. The quality of the plan of operation for conducting the proposed 
activities and the degree to which the plan covers the ``Program 
Requirements'' and specifies the what, who, where, how, and the timing 
for start and completion of each.
    E. The degree to which the applicant's plan will be able to achieve 
the goals and the quality of the methods and instruments to be used.
    F. The extent to which methods and strategies proposed are 
financially feasible.
    G. The extent to which qualified and experienced personnel are 
available to carry out the proposed activities.
    Site visits may be conducted before final funding decisions are 
made by CDC. Only the organizations with high ranking applications will 
be visited. During the visit, CDC staff will ensure that all necessary 
components for start-up of the project are in place. This meeting will 
be conducted by the NIP/NCID representatives with participation of the 
appropriate regional program consultant, project coordinator, local 
staff and others who may have interest in this project. Visits will be 
made to the local medical care providers, local public health 
departments, administrators of WIC and AFDC, local clinics, schools, 
and with community leaders. Periodic site visits will be held 
thereafter to monitor progress and problems.

Executive Order 12372 Review

    Applications are subject to review as governed by Executive Order 
(E.O.) 12372, Intergovernmental Review of Federal Programs. E.O. 12372 
sets up a system for State and local government review of proposed 
Federal assistance applications. Applicants should contact their State 
Single Point of Contact (SPOC) as early as possible to alert them to 
the prospective applications and receive any necessary instructions on 
the State process. A current SPOC list is included in the application 
kit. The SPOC should send any State process recommendations to Ms. 
Elizabeth M. Taylor, Grants Management Officer, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-16, Room 
300, Atlanta, GA 30305, no later than 60 days after the application 
deadline. CDC does not guarantee to ``accommodate or explain'' State 
process recommendations it receives after that date.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number for this project 
grant is 93.268, Preventive Health Services--Childhood Immunization 
Grants.

Other Requirements

Paperwork Reduction Act

    Projects that involve collection of information from 10 or more 
individuals and funded by the grant will be subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction 
Act.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations (45 CFR part 46) regarding the protection of human 
subjects. Assurance must be provided which demonstrates that the 
project will be subject to initial and continuing review by an 
appropriate institutional review committee. The applicant will be 
responsible for providing evidence of this assurance in accordance with 
the appropriate guidelines and forms provided in the application kit.

Application Submission and Deadline

    The applicant must submit an original and two copies of the 
application form PHS-5161-1 (including forms SF 424 and SF 424a), on or 
before July 8, 1994, to Elizabeth M. Taylor, Grants Management Officer, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., 
Mailstop E-16, Atlanta, GA 30305.
    A. Deadline: Applications will meet the deadline if they are:
    1. Received on or before the deadline date, or
    2. Sent on or before the deadline date and received in time to 
submit the application to an independent objective review group. 
(Applicants must request a legibly dated U.S. Postal Service postmark 
or obtain a legibly dated receipt from a commercial carrier or the U.S. 
Postal Service. Private metered postmarks are not acceptable as proof 
of timely mailing.)
    B. Late Applications: Late applications will not be considered in 
the current funding cycle and will be returned to the applicant.

Where To Obtain Additional Information

    A complete program description, information on application 
procedures, an application package, and business management technical 
assistance may be obtained from Eddie L. Wilder, Senior Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Road, NE., Mailstop E-16, Atlanta, GA 30305, telephone 
(404) 842-6805. Programmatic technical assistance may be obtained from 
Dennis O'Mara, Chief, Program Operations Section, National Immunization 
Program, Centers for Disease Control and Prevention (CDC), 1600 Clifton 
Road, NE., Mailstop E-52, Atlanta, GA 30333, telephone (404) 639-8215, 
or Edith Gary, Hepatitis B Prevention Coordinator, National 
Immunization Program, Centers for Disease Control and Prevention (CDC), 
1600 Clifton Road, NE., Mailstop E-52, Atlanta, GA 30333, telephone 
(404) 639-8222, or Gary L. Euler, Dr.P.H., Epidemiologist, 
Surveillance, Investigations and Research Branch, National Immunization 
Program, Centers for Disease Control and Prevention (CDC), 1600 Clifton 
Road, NE., Mailstop E-61, Atlanta, GA 30333, telephone (404) 639-8257.
    Announcement number 101A, ``Supplemental Funds for Hepatitis B 
Vaccination Demonstration Projects in Asian/Pacific Island Children,'' 
must be referenced in all requests for information for these projects.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full Report; Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary Report; Stock No. 017-001-00473-1) referenced in the 
introduction through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238.

    Dated: June 7, 1994.
Ladene H. Newton,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 94-14357 Filed 6-13-94; 8:45 am]
BILLING CODE 4163-18-P