[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