[Federal Register Volume 59, Number 110 (Thursday, June 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14021]


[[Page Unknown]]

[Federal Register: June 9, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 453]

 

Cooperative Agreements for Active Varicella Surveillance and 
Epidemiologic Studies

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1994 funds for a program for 
competitive cooperative agreement applications to conduct surveillance 
and case investigations for varicella disease (chickenpox). Funds will 
be provided to conduct active surveillance and epidemiologic studies to 
monitor disease trends prior to licensure of varicella vaccine and 
continuing for a period after vaccine licensure.
    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 to improve the quality of life. This announcement is related to the 
priority areas of immunization and infectious diseases, and 
surveillance and data systems. (For ordering a copy of ``Healthy People 
2000,'' see the section ``Where to Obtain Additional Information.'')

Authority

    This program is authorized under sections 301(a) and 317(k)(3) of 
the Public Health Service Act [42 U.S.C. 241(a), 247b (k)(3)].

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 this program are the official State and 
local public health agencies. To ensure statistical validity, these 
surveillance areas must have populations of at least 100,000 to provide 
a sufficient number of varicella cases each year during the anticipated 
period of declining varicella incidence after vaccine licensure and 
expected wide use of the vaccine in children.

Availability of Funds

    Approximately $500,000 is available in FY 1994 to fund 2 to 4 
cooperative agreements. It is expected that the average award will be 
$165,000, ranging from $100,000 to $250,000. It is expected that awards 
will begin on or about August 15, 1994, 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 and the availability of funds. There are no matching or cost 
participation requirements; however, the applicant's anticipated 
contribution to the overall program costs, if any, should be provided 
on the application. Funds awarded under this cooperative agreement 
cannot be used to supplant existing State expenditures in this area.

Objectives

    1. To establish a reporting system to accurately define the 
baseline incidence and epidemiological profile of varicella disease 
prior to licensure and wide use of varicella vaccine.
    2. To maintain and expand the reporting system to obtain similar 
data for a period of time after vaccine licensure in order to identify 
changes occurring in the epidemiology of varicella as a result of 
vaccine usage, and to ascertain the immunization status of cases and 
evaluate the demographic and clinical profiles of vaccinated and 
unvaccinated cases.

Purpose

    The purpose of these cooperative agreements is to provide 
assistance to selected State, city, or local areas in developing, 
maintaining and evaluating active surveillance systems that will 
provide (1) age-, gender-, race-, and ethnicity-specific incidence and 
clinical information on cases of varicella disease prior to or at the 
time of licensure of varicella vaccine in a defined population; and (2) 
similar information in addition to immunization status of cases 
following licensure of varicella vaccine.

Program Requirements

    In conducting the activities to achieve the purpose of this 
program, the recipient will be responsible for the activities listed 
under Item A. (Recipient Activities) and CDC will be responsible for 
the activities listed under Item B. (CDC Activities). The application 
should be presented in a manner that demonstrates the applicant's 
ability to address the proposed activities in a collaborative manner 
with CDC.

A. Recipient Activities

    1. Survey and describe the demography of health care providers, 
physicians, schools, and institutions within the surveillance area or 
population under study and identify appropriate reporting and sampling 
units for surveillance and epidemiologic studies.
    2. Establish, maintain, and evaluate an active surveillance system 
with the capacity to monitor varicella disease trends in a well-defined 
population and to identify changes in disease incidence and prevalence 
as a result of the use of varicella vaccine.
    3. Using this active surveillance system, collect, analyze and 
disseminate information that should include age-, gender- and race- and 
ethnicity-specific incidence of varicella disease; clinical data on 
reported cases that include the types of complications, rates of 
hospitalization, lengths of stay, and use of serologic tests to confirm 
the diagnosis of varicella; detection of outbreaks; and, in selected 
samples of cases, incidence of illness in household contacts and 
information on the number of school days lost to children and work days 
lost to adult patients and parents of children with varicella disease. 
Such information will likely require specific investigation (follow-up 
of each reported case in the study population).
    4. Following licensure of the vaccine, the immunization status of 
all reported cases, including age of vaccination, other vaccines 
simultaneously administered, etc., should be ascertained in addition to 
the information obtained prior to licensure, as described in item 3 
above. With wide use of the vaccine, it is anticipated that the 
incidence of varicella disease will be reduced (by 50%-90%) to a level 
that will permit the collection of more detailed data for all cases 
(e.g., incidence of illness in household contacts, number of school 
days lost to children and work days lost to adult patients and parents 
of children with varicella disease, risk of specific complications and 
clinical course of disease).
    5. Participate in the analysis of data, writing of reports and 
presentation of findings.
    The timing of activities following the establishment of an active 
surveillance system will depend on when the vaccine is licensed and how 
quickly populations become vaccinated. Pending the availability of 
funds, recipients may be requested to perform the following additional 
activities:
    1. Compare trends in incidence and the epidemiology of varicella 
before and after licensure of varicella vaccine.
    a. This should include, but not be limited to, rates of disease 
specific for age, sex, race and ethnicity, and if feasible, other 
demographic characteristics such as socioeconomic status.
    b. Determine the relative impact of vaccine use with respect to 
age-specific rates of complications and hospitalization.
    2. Ascertain the immunization status of cases and evaluate the 
demographic and clinical characteristics of vaccinated and unvaccinated 
cases.
    3. Evaluate the surveillance system for the purpose of recommending 
methods that can be used to enhance national surveillance.

B. Centers for Disease Control and Prevention (CDC) Activities

    1. Provide technical assistance in the design and execution of the 
project.
    2. Provide assistance to recipients regarding development and 
implementation of all surveillance activities, data collection methods 
including case investigation forms, and analysis of data.
    3. Assist in the development and implementation of data management 
processes, including development of computer programs for data entry 
and interim analyses.
    4. Participate in the analysis of data, writing of reports, 
presentation and publication of findings, and development and 
dissemination of information to enhance national surveillance.

Review and Evaluation Criteria

A. Initial Application

    Applications will be reviewed and evaluated according to the 
following weighted criteria:
    1. The applicant's understanding of the purpose of the proposed 
activity and the feasibility of accomplishing the outcomes described. 
(10%)
    2. The extent to which background information and other data 
demonstrate that the applicant has the appropriate organizational 
structure, administrative support, and ability to access appropriate 
target sources of reporting. (10%)
    3. The adequacy of the description of an appropriate plan, and the 
extent to which these proposed sources of case reports will ensure an 
adequate sample size and representativeness of populations at risk for 
varicella to ensure that the epidemiologic analysis of the impact of 
varicella vaccine, and the assessment of cases with respect to 
vaccination status will be appropriate and statistically valid. (15%)
    4. The adequacy of the plan for establishing the active 
surveillance system described under recipient activities and supporting 
evidence that the applicant can implement and maintain these systems. 
(25%)
    5. The extent to which the applicant demonstrates capacity for 
timely access to public health surveillance data from the jurisdiction 
or area under study, and a capacity to integrate future surveillance 
activities into existing surveillance systems. (15%)
    6. The degree to which the proposed objectives are specific, 
measurable, time-phased, and consistent with the defined purpose of 
this program, and the quality of the methods and instruments to be used 
to evaluate the program. (15%)
    7. The qualifications, including training and experience, of 
project personnel and the projected level of effort by each toward 
accomplishment of the proposed activities. (10%)
    In addition, consideration will be given to the extent to which the 
budget is reasonable, clearly justified, and consistent with the 
intended use of cooperative agreement funds.

B. Continued Funding

    Continuation awards within the project period will be made on the 
basis of the following criteria:
    1. The degree to which accomplishments in the prior budget period 
show that the applicant is meeting its objectives;
    2. The extent to which objectives for the new budget period are 
consistent with the purpose of the cooperative agreement and are 
specific, measurable, and time-phased.
    3. The degree to which the proposed methods of achieving the stated 
objectives are likely to be successful.
    4. The adequacy of methods and plans to evaluate program 
activities.
    5. The extent to which the budget is clearly explained, reasonable, 
and consistent with the intended use of the cooperative agreement 
funds.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order 12372. This order sets up a 
system for State and local review of proposed Federal assistance 
applications. Applicants should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to prospective 
applications and receive any necessary instructions on the State 
process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC of each affected State. A 
current list of SPOCs is included in the application kit. If SPOCs have 
any State recommendations on applications submitted to CDC, they should 
forward them to the CDC, Attention: Elizabeth M. Taylor, Grants 
Management Officer, Procurement and Grants Office, 255 East Paces Ferry 
Road, NE., Mailstop E-16, Atlanta, Georgia 30305, no later than 60 days 
after the application deadline date for the new awards. The granting 
agency does not guarantee to ``accommodate or explain'' for 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 is 93.185, 
Immunization Research, Demonstration, Public Information and Education, 
Training, and Clinical Skills Improvement Projects.

Other Requirements

Paperwork Reduction Act

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

Application Submission and Deadline

    The original and two copies of the completed application Form PHS-
5161-1 must be submitted to Elizabeth M. Taylor, Grants Management 
Officer, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-16, 
Atlanta, Georgia 30305, on or before June 30, 1994.
    Applications will be considered to meet the deadline if they are:
    1. Received on or before the stated deadline date, or,
    2. Sent on or before the deadline date and received in time for 
submission to the independent 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 will not be acceptable proof of timely mailing.)
    Applications which do not meet the criteria in 1. or 2. above, are 
considered late applications. Late applications will not be considered 
in the current competition 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, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., 
Mailstop E-16, Atlanta, Georgia 30305, telephone (404) 842-6805.
    Programmatic technical assistance may be obtained from Sandra J. 
Holmes, Ph.D., M.H.A., Medical Epidemiologist, Surveillance, 
Investigation and Research Branch, National Immunization Program, 
Centers for Disease Control and Prevention (CDC), Mailstop E-61, 
Atlanta, Georgia 30333, telephone (404) 639-8257.
    Please refer to Announcement Number 453 when requesting information 
and submitting an application in response to this Request for 
Assistance.
    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 
``Introduction,'' through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238.

    Dated: June 3, 1994.
Ladene H. Newton,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 94-14021 Filed 6-8-94; 8:45 am]
BILLING CODE 4163-18-P