[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: [email protected].
    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: 
[email protected].

    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