[Federal Register Volume 64, Number 90 (Tuesday, May 11, 1999)]
[Notices]
[Pages 25347-25349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11773]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 99132]
Notice of Availability of Funds; Varicella Surveillance and
Epidemiologic Studies
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1999 funds for a cooperative agreement
program to conduct surveillance and case investigations for varicella
disease (chickenpox). This program will supplement existing local,
State and national surveillance efforts and will facilitate research on
impact of varicella vaccine on disease. Funds will be provided to
conduct active surveillance and epidemiologic studies to monitor
disease trends related to vaccine coverage. This program addresses the
``Healthy People 2000'' priority area 20, Immunization and Infectious
Diseases.
The purpose of this program is:
1. To maintain a surveillance system to accurately monitor trends
in varicella incidence by age group.
2. To monitor varicella vaccine coverage by age group.
3. To develop, implement, and evaluate strategies for the
prevention and control of varicella.
4. To conduct other applied epidemiological research related to
varicella disease and varicella vaccine.
B. Eligible Applicants
Assistance will be provided only to official State and local public
health agencies or their bona fide agents including the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the
Commonwealth of the Northern Mariana Islands, American Samoa, Guam,
federally-recognized Indian tribal governments the Federated States of
Micronesia, the Republic of the Marshall Islands, and the Republic of
Palau.
C. Availability of Funds
1. Approximately $665,000 is available in FY 1999 to fund two to
three awards. The average award will be about $200,000, ranging from
$150,000 to $250,000. It is expected that awards will begin on or about
September 30, 1999, and will be made for a 12-month budget period
within a project period of up to 5 years. Funding estimates may vary
and are subject to change. Continuation awards within the project
period will be made on the basis of satisfactory progress as evidenced
by required reports and the availability of funds. Funds awarded under
this cooperative agreement cannot be used to supplant existing state
expenditures in this area.
D. Program Requirements
In conducting the activities to achieve the purpose of this
program, the recipient will be responsible for the activities listed
under (1.) Recipient Activities and CDC will be responsible for the
activities listed under (2.) CDC Activities.
1. Recipient Activities
a. Establish, maintain, and evaluate a surveillance system with the
capacity to monitor varicella disease trends by age group in a well-
defined population. To ensure statistical validity, these surveillance
areas must have populations of at least 300,000 to provide a sufficient
number of varicella cases each year as varicella incidence declines
with increasing use of the vaccine in children.
b. Perform case investigations and collect, analyze, and
disseminate information using this information.
c. Collect and verify with health care providers the immunization
status of all reported cases of breakthrough disease, including age of
vaccination and other vaccines administered simultaneously or within 30
days.
d. Collect and report information on vaccine coverage by age group
(age groups <1 year,="" 1="" year,="" 2="" years,="" 3="" years,="" 4="" years,="" 5="" years,="" 6="" years,="" 7="" years,="" 8-9="" years,="" 10-12="" years,="" 13-14="" years,="" 15-19="" years="" and="">20 years).
e. Develop, implement and evaluate varicella prevention and control
strategies including outbreak control.
f. Conduct applied epidemiological research. Examples of such
projects include but are not limited to the following: evaluation of
risk factors for vaccine failure; evaluation of completeness of
reporting by age group; risk factors for severe varicella disease and
hospitalization; studies of vaccine effectiveness; reliability of
physician diagnosis of breakthrough disease and reliability of parental
history of varicella among children less than 10 years.
g. Provide laboratory specimens such as disease-causing isolates to
appropriate organizations (which may include CDC) for laboratory
evaluation needed for varicella surveillance or as part of
epidemiological studies, e.g. virus strain identification, confirmation
of breakthrough disease, and molecular epidemiological studies.
h. Manage, analyze and interpret data and present and publish
important public health findings.
i. Participate in planning meetings to coordinate varicella
surveillance project activities.
j. Function as part of a network of varicella surveillance sites.
3. CDC Activities
a. Provide consultation, scientific and technical assistance in
general operation of the project and in the design and conduct of
applied research projects.
b. Provide assistance to recipients regarding development and
implementation of all surveillance activities, data collection methods
including a standard case investigation form, and analysis of data.
c. Assist in the development and implementation of a standard data
management process, including development of computer programs for data
entry and interim analyses.
d. Assist in monitoring and evaluating scientific and operational
accomplishments of the varicella surveillance project and progress in
achieving the purpose and overall goals of this program.
e. Participate in analysis and interpretation of data and in
presentation and publication of findings.
E. Application Content
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. The program narrative should include the following
sections: background, objectives,
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methods, plan of operation, and plan of evaluation. The narrative
should describe:
1. The demographic characteristics of the general population upon
which the surveillance system will focus.
2. The epidemiology of varicella in the surveillance population
during the period 1995-1999 and varicella vaccine coverage among
specified age groups during the period 1995-1999. The availability of
historical data for baseline disease trends by age group prior to, and
following, implementation of a vaccination program is required. These
data should be comparable to that proposed for collection through this
project in order to monitor trends.
3. The sources of reporting within the reporting area under study.
Appropriate reporting and sources for surveillance should be identified
and described in detail. If sampling is proposed, it must be described
in detail including how it will be performed and how validity will be
assured.
4. The operation of the surveillance system. This should include
details of reporting, type and format of data to be obtained, mechanism
for monitoring the system, and personnel requirements for obtaining,
managing and analyzing data. The proposed surveillance system should
provide the basis for epidemiological studies of the impact of
varicella vaccine, identify cases occurring in vaccinated individuals,
document the severity of disease and facilitate public health action.
5. A brief proposal for implementing and evaluating a disease
prevention and/or control strategy.
6. A brief proposal for an applied epidemiological research study
(addressing issues other than disease prevention and control
strategies).
7. Background information and other data to demonstrate that the
applicant has the appropriate organizational structure, administrative
support, and ability to access appropriate target populations or study
subjects.
8. The qualifications, including training and experience, of
project personnel, and projected level of effort by each toward
accomplishment of the proposed activities.
Budget Instructions
For each line item (as identified on the Form 424a of the
application), show both Federal and non-Federal (e.g., State funding)
shares of total cost for the varicella surveillance project. For each
staff member listed under the Personnel line item, indicate their
specific responsibilities relative to each of the proposed projects.
Include provisions for travel of the principal investigator and one
varicella surveillance project participant to two meetings at CDC in
Atlanta during the first year of the program.
A budget justification is required for all budget items, consistent
with the purpose and objectives of the project. Letters of support
should be included if applicants anticipate the participation of other
organizations in conducting proposed activities.
The application narrative (excluding budget, appendices, and
required forms) must not exceed 30 single-spaced pages, printed on one
side, with one-inch margins, and unreduced font. Only the following
information should be presented in appendices: Letters of support,
documentation of bona fide agent status, curricula vitaes, and budget.
All other materials or information that should be included in the
narrative will not be accepted if placed in the appendices.
F. Submission and Deadline
Letter of Intent
In order to enable CDC to determine the level of interest in the
program announcement, a non-binding letter-of-intent to apply is
requested from potential applicants. The letter-of-intent should
include: (1) Name and address of institution, and (2) name, address,
and telephone number of contact person. The letter-of-intent should be
submitted to the Grants Management Specialist identified in Section J
``Where to Obtain Additional Information on or before June 11, 1999.''
Application
Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are provided in the application kit. On or before July 12,
1999, submit the application to: Mattie Jackson, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Announcement 99132, Centers for Disease Control and Prevention (CDC),
2920 Brandywine Road, Room 3000,Atlanta, GA 30341-4146,
Deadline: Applications shall be considered as meeting the deadline
if they are either:
(a) Received on or before the deadline; or
(b) Sent on or before the deadline date and received in time for
submission to the review panel. (Applicants must request a legibly
dated U.S. Postal Service postmark or obtain a legibly dated receipt
from a commercial carrier of U.S. Postal Service. Private metered
postmarks shall not be acceptable as proof of timely mailing).
Late Applications: Applications which do not meet the criteria (a)
or (b) above a considered late applications, will not be considered,
and will be returned to the applicant.
G. Evaluation Criteria
Each application will be evaluated individually by an independent
review group appointed by CDC according to the following criteria:
(1) Understanding the objectives of the varicella surveillance
project (5 points).
(a) Demonstration of a clear understanding of the background and
objectives of this cooperative agreement program and the feasibility of
accomplishing the outcomes described.
(2) Description of the population base and the vaccine providers in
the varicella surveillance project site (5 points)
(a) Clear definition of the geographic area and population base in
which the varicella surveillance site will operate. Detailed
description of the demographics of the proposed population base
including the extent to which the population base is diverse in terms
of demographics and special populations.
(b) Description of vaccination providers in both the private and
public sectors within the varicella surveillance site.
(3) Adequacy of baseline data for varicella surveillance;
availability of trend data for varicella surveillance from 1995-1999
and comparability of these data to the proposed surveillance system (20
points).
(4) Description of existing capacity to perform surveillance for
varicella, to assess vaccine impact, and to perform other applied
epidemiological research (40 points).
(a) Adequacy of plan for performing and maintaining varicella
surveillance that will cover all age groups. Description of methods for
monitoring varicella disease in all age groups including the adequacy
of an appropriate plan, and the extent to which the proposed sources of
case reports will ensure an adequate sample size and representativeness
of populations and all age groups at risk for varicella to ensure that
the epidemiological analysis of the impact of varicella vaccine will be
appropriate and statistically valid. If sampling is proposed, provide a
detailed description of how sampling will be performed and how validity
will be assured.
(b) Adequacy of plan for monitoring vaccine coverage. Description
of plan for obtaining information on vaccine
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coverage by age group on an ongoing basis.
(c) Adequacy of plans for data management. Description of plans for
data management and analysis.
(d) Quality of proposals submitted for:
(i) Implementing and evaluating a disease prevention and/or control
strategy.
(ii) An applied epidemiological research study (addressing an issue
other then disease prevention and control strategies).
(5) Operational plan (15 points).
(a) The plan should identify the proposed organizational and
operating structure/procedures including the roles and responsibilities
of all participating agencies, organizations, institutions, and
individuals. Description of applicant's partnerships with necessary and
appropriate organizations for establishing and operating the proposed
varicella surveillance including appropriate public health action in
response to outbreaks.
(b) Ability to function as part of a surveillance network. The
extent to which the applicant describes plans for collaboration with
other varicella surveillance sites in the establishment and operation
of the varicella surveillance and individual varicella surveillance
projects, including project design/development (e.g., protocols) and
synthesis and dissemination of findings.
(c) Quality of the proposed projects (as requested in the
Application Content section above) regarding consistency with public
health needs, intent of this program, feasibility, methodology/
approach, and collaboration/participation of partner organizations. The
degree to which the applicant has met the CDC Policy requirements
regarding the inclusion of women, ethnic, and racial groups in the
proposed research. This includes: (1) the proposed plan for the
inclusion of both sexes and racial and ethnic minority populations for
appropriate representation; (2) the proposed justification when
representation is limited or absent; (3) a statement as to whether the
design of the study is adequate to measure differences when warranted;
and (4) a statement as to whether the plans for recruitment and
outreach for study participants include the process of establishing
partnerships with community(ies) and recognition of mutual benefits.
(d) Demonstration of support from non-applicant participating
agencies, institutions, organizations, etc. indicated in applicant's
operational plan. Applicant should provide (in an appendix) letters of
support which clearly indicate collaborators willingness to be
participants in the varicella surveillance activities. Do not include
letters of support from CDC personnel.
(6) Personnel qualifications and management plan (10 points).
(a) Identification of applicant's key professional personnel to be
assigned to the varicella surveillance site and varicella surveillance
projects (provide curriculum vitae for each in an appendix). Clear
identification of their respective roles in the management and
operation of the varicella surveillance site. Descriptions of their
experience in conducting work similar to that proposed in this
announcement.
(b) Description of all support staff and services to be assigned to
the varicella surveillance project.
(7) Evaluation (5 points).
(a) Quality of plan for monitoring and evaluating the completeness
of surveillance, the quality of vaccine coverage data, and the
scientific and operational accomplishments of the varicella
surveillance site and of individual varicella surveillance projects.
(b) Quality of plan for monitoring and evaluating progress in
achieving the purpose and overall goals of this cooperative agreement
program.
(8) Budget (not scored).
Extent to which the line item budget is detailed, clearly
justified, and consistent with the purpose and objectives of this
program.
If requesting funds for any contracts, provide the following
information for each proposed contract: (1) Name of proposed
contractor, (2) breakdown and justification for estimated costs, (3)
description and scope of activities to be performed by contractor, (4)
period of performance, and (5) method of contractor selection (e.g.,
sole-source or competitive solicitation).
(9) Human Subjects (not scored).
Does the application adequately address the requirements of Title
45 CFR Part 46 for the protection of human subjects?
H. Other Requirements
Technical Reporting Requirements
Provide CDC with the original plus two copies of:
1. Semiannual progress reports
2. Financial status report, no more than 90 days after the end of the
budget period.
3. Final financial report and performance report, no more than 90 days
after the end of the project period
Send all reports to the Grants Management Specialist identified in
Section J ``Where to Obtain Additional Information'' section of this
announcement.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I in the
application kit.
AR98-1 Human Subjects Requirements
AR98-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR98-7 Executive Order 12372 Review
AR98-9 Paperwork Reduction Act Requirements
AR98-10 Smoke-Free Workplace Requirements
AR98-11 Healthy People 2000
AR98-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under Sections 301(a) and 317(k)(1), (2)
of the Public Health Service Act [42 U.S.C. sections 241(a) and
247b(k)(1), (2)], as amended. The Catalog of Federal Domestic
Assistance number is 93.185.
J. Where To Obtain Additional Information
Copies of this announcement and application forms can be downloaded
by using the CDC homepage address on the Internet: http://www.cdc.gov
(click on funding).
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked
to leave your name and address and will be instructed to identify the
Announcement number of interest.
To obtain additional information contact: Mattie Jackson, Grants
Management Specialist, Grants Management Branch, Procurement and Grants
Office Announcement 99132, Centers for Disease Control and Prevention
(CDC), 2920 Brandywine Road, Room 3000 Atlanta, GA 30341-4146,
Telephone (770) 488-2718 E-mail: mij3@cdc.gov.
For programmatic technical assistance, contact: Jane Seward, MBBS,
MPH, Medical Epidemiologist, Varicella Activity, VPDB, National
Immunization Program, Centers for Disease Control and Prevention (CDC),
MS E-61, Atlanta, GA 30333, Telephone (404) 639-8230, E-mail:
jfs2@cdc.gov.
Dated: May 5, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 99-11773 Filed 5-10-99; 8:45 am]
BILLING CODE 4163-18-P
