[Federal Register: April 27, 2004 (Volume 69, Number 81)]
[Notices]
[Page 22806-22810]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap04-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Development of Influenza Surveillance Networks
Announcement Type: New.
Funding Opportunity Number: 04106.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Letter of Intent Deadline: May 27, 2004.
Application Deadline: June 28, 2004.
Executive Summary: An influenza pandemic has greater potential than
any other naturally occurring infectious disease event to cause large
and rapid global and domestic increases in deaths and serious
illnesses. Preparedness is the key to substantially reducing the
health, social, and economic impacts of an influenza pandemic and other
public health emergencies. One component of preparedness involves
understanding the impact that annual epidemics of influenza has on the
population. These data regarding impact are critical to the development
of prevention and control measures such as vaccination policies.
Vaccination efforts are the cornerstone of influenza prevention and
will be the primary means of mitigating the impact of an influenza
pandemic.
The systematic collection of influenza surveillance data over time
is necessary to monitor and track influenza virus and disease activity
and is essential to understanding the impact influenza has on a
country's population. Improving surveillance systems by developing
influenza surveillance networks is critical for the rapid detection of
new variants, including those with pandemic potential, to contribute to
the global surveillance system. Global collaboration, under the
coordination of the World Health Organization (WHO), is a key feature
of influenza surveillance. WHO established an international laboratory-
based surveillance network for influenza in 1948. The network currently
consists of 112 National Influenza Center (NIC) laboratories in 83
countries, and four WHO Collaborating Centers for Reference and
Research of Influenza (including one located at the Centers for Disease
Control and Prevention). The primary purposes of the WHO network are to
detect the emergence and spread of new antigenic variants of influenza,
to use this information to update the formulation of influenza vaccine,
and to provide as much warning as possible about the next pandemic.
This system provides the foundation of worldwide influenza prevention
and control.
Monitoring of influenza viruses and providing contributions to the
global surveillance system, will assure that data used in annual WHO
vaccine recommendations are relevant to each country that participates.
Increased participation in the global surveillance system for influenza
viruses will enhance each country's ability to monitor severe
respiratory illness, to develop vaccine policy and to help build global
and regional strategies for the prevention and control of influenza.
Monitoring influenza disease activity is important to facilitate
resource planning, communication, intervention, and investigation.
This announcement seeks to support foreign governments through
their Ministries of Health or other responsible Ministries for human
health in the development or improvement of epidemiologic and virologic
influenza surveillance networks. These networks will focus on the
systematic collection of virological and epidemiological information
for influenza. This support is meant to enhance, and not to supplant,
current influenza surveillance activities and proposals should build
upon infrastructure already in place. Preference will be given to
countries where resources are currently limited and influenza
surveillance is not well established due to lack of resources.
I. Funding Opportunity Description
Authority: This program is authorized under sections 301(a) and
307 of the Public Health Service Act, [42 U.S.C. sections 241(a),
and 2421], as amended.
Purpose: The purpose of the program is to provide support and
assistance to foreign governments for the development or improvement of
influenza surveillance networks. These networks will focus on the
systematic collection of virological and epidemiological information
for influenza. Countries applying for support must have an active WHO
National Influenza Center recognized by WHO. This program addresses the
``Healthy People 2010'' focus area of Immunization and Infectious
diseases.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for Infectious
Diseases: Protect Americans from infectious diseases.
The objectives of this program are to (1) Establish or enhance an
active influenza surveillance network that uses standardized data
collection instruments, operational definitions, and laboratory
diagnostic tests to enhance surveillance for influenza at three or more
sites within the country; (2) use the experience gained to expand the
surveillance system to include additional sites; (3) improve local
laboratory diagnostic capabilities by supporting and enhancing those
local laboratories that participate in influenza surveillance; (4)
develop educational and training opportunities for local public health
practitioners as part of broader efforts to improve public health
infrastructure in the region; and (5) improve communications and data
exchange between laboratories and epidemiologists in the global
influenza surveillance network by expanding the network and improving
the reporting of data from surveillance sites, laboratories, and
National Influenza Centers.
Activities: Awardee activities for this program are as follows:
Develop a nationwide system to collect virologic
and epidemiologic data for influenza by establishing 5 or more sites
with good geographic distribution throughout the country. Each site
will consist of a local laboratory and one or more clinics or hospitals
for data collection. Each site should:
[ctrcir] Conduct virologic and epidemiologic surveillance for
influenza by collecting information year round in countries or regions
of countries with tropical and subtropical climates; and/or by
collecting surveillance information during the period of respiratory
illness circulation in countries or regions of countries with temperate
climates.
[ctrcir] Have laboratory capacity for performing influenza virus
isolation and typing.
[[Page 22807]]
[ctrcir] Collect information on influenza like illnesses and/or
severe respiratory disease at each site by building on information that
is already available. Possible sources of information are (1) recording
influenza-like-illness visits to physicians or primary care clinics or
hospitals based on a standard case definition. (2) Monitoring hospital
admissions for severe respiratory illness and pneumonia based on a case
definition. Patient information such as age, patient history and other
relevant information should be collected.
[ctrcir] Collect a subset of at least 10 (and preferably up to 25)
specimens from the patient populations under surveillance with febrile,
acute upper respiratory illness. These specimens should be collected
weekly during the period of surveillance (based on climate) using a
standard case definition (preferably WHO) and should be submitted to
the local laboratory for the site.
[ctrcir] During unusual outbreaks of influenza, such as outbreaks
with unusual epidemiologic characteristics, or those related to
infections by avian or other animal influenza viruses, collect
epidemiologic information to characterize the outbreak and collect
additional samples for viral isolation and submittal to the site
laboratory. Report the outbreak to the National Influenza Center.
[ctrcir] Prepare and provide regular weekly reports on the
epidemiologic information that has been collected (influenza-like-
illness and/or severe respiratory illness) to the local laboratory and
to the National Influenza Center.
[ctrcir] The laboratory will perform viral isolation for influenza
viruses either in tissue culture or in eggs. Type positive isolates for
influenza A and B, and if possible, subtype influenza viruses.
[ctrcir] Store original clinical materials at -70 until the
beginning of the next influenza season.
[ctrcir] Submit viral isolates to the National Influenza Center
within the country on at least a monthly basis for more complete
analysis.
The WHO National Influenza Center (NIC) within a
country can be one of the surveillance sites and as such conduct all
the activities listed above. If there are two or more NICs within a
country each NIC could participate as a site, however NICs within a
single country should work together and place emphasis on the addition
of new surveillance sites. In addition, the NIC(s) should act as the
focal point and authority within their country on influenza
surveillance and be the main point of communication with WHO and WHO
Collaborating Centers for the submittal of virus isolates and
information into the global surveillance system. Each National
Influenza Center (NIC) also will be responsible for the following
activities:
[ctrcir] Performing preliminary antigenic and, if possible genetic,
characterization on the virus isolates submitted from the laboratories
in the surveillance sites (including those isolates grown at the NIC).
[ctrcir] Send representative virus isolates to one of the four WHO
Collaborating Centers for Influenza, including any low reacting
viruses, as tested using the WHO reagent kit, each month during the
period of surveillance and more frequently, if possible.
[ctrcir] If any viruses are unsubtypable as tested using the WHO
kit, alert WHO and send the virus isolate to one of the four WHO
Collaborating Centers for Influenza immediately.
[ctrcir] During the period of surveillance, provide weekly
influenza surveillance information to WHO through FluNet.
[ctrcir] Provide an annual national summary on influenza activity,
virological information and other relevant information on influenza to
WHO and the WHO Collaborating Center in Atlanta, GA.
[ctrcir] Provide technical expertise and training to support the
surveillance sites and laboratories in the national network.
Foreign Governments applying for funding through
this cooperative agreement should play a substantial role in the
development and support of the influenza surveillance network.
[ctrcir] Facilitate the sharing of influenza surveillance
information with the WHO Global Influenza Surveillance network by
facilitating the regular exchange of information and viruses with one
of the four WHO Collaborating Centers.
[ctrcir] Provide continued support for influenza activities within
the country and develop a plan for increased participation in the
global influenza surveillance network over a five-year period.
[ctrcir] Consider developing a task force or working group for
influenza to determine ways to improve national influenza surveillance,
develop prevention and control measures such as vaccine policy and work
on pandemic preparedness.
Facilitate communication between the veterinary
and the human side of influenza surveillance. Develop systems for the
sharing of information.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
Provide technical assistance on techniques and
reagents for the identification of influenza viruses. Annually provide
the WHO reagent kit, which is produced and distributed by the WHO
Collaborating Center for Influenza in Atlanta, GA.
Provide epidemiological and laboratory training.
Provide technical consultation on the
development of country networks.
Provide confirmation of antigenic analysis and
more detailed characterization information on the influenza virus
isolates submitted to CDC with written reports back to the National
Influenza Center.
Provide technical advice on the conduct of
epidemiologic outbreak investigations.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Fiscal Year Funds: 2004.
Approximate Total Funding: $1,000,000.
Approximate Number of Awards: 5-10.
Approximate Average Award: $ 50,000 to 250,000 (This amount is for
the first 12-month budget period, and includes both direct and indirect
costs).
Floor of Award Range: None.
Ceiling of Award Range: $250,000.
Anticipated Award Date: August 1, 2004.
Budget Period Length: 12 months.
Project Period Length: 5 years.
Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal Government.
III. Eligibility Information
III.1. Eligible applicants
Applications may be submitted by foreign governments, Ministries of
Health, or other government offices responsible for disease
surveillance in humans. Only one application per country will be
accepted.
III.2. Cost Sharing or Matching
Cost sharing or matching is not required for this program. However,
the support provided through this cooperative agreement is meant to
enhance, and not supplant, current influenza surveillance activities.
[[Page 22808]]
III.3. Other
If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
If your application is incomplete or non-responsive to the
requirements listed in this section, it will not be entered into the
review process. You will be notified that your application did not meet
submission requirements.
This program is not designed or intended to support research,
therefore no research will be supported under this cooperative
agreement. Any applications proposing research will be considered non-
responsive.
In order to apply and be eligible for this funding, your Country
must have at least one National Influenza Center (NIC) of record at
WHO. Documentation of WHO National Influenza Center status by the
Ministry of Health and WHO will be sufficient to establish eligibility.
Participation as a NIC is a requirement because to meet the goal of
this announcement a significant number of the recipient activities
require information and work to be conducted, reported and submitted
through the WHO Surveillance network.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant, or loan.
IV. Application and Submission Information
IV.1. Address To Request Application Package
To apply for this funding opportunity use application form PHS
5161. Application forms and instructions are available on the CDC Web
site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm
.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Submission
Letter of Intent (LOI): An LOI is requested. Your LOI must be
written in the following format:
Maximum number of pages: 4
Font size: 12-point unreduced
Single spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Written in plain language, avoid jargon
Your LOI must contain the following information:
Name of the government entity that is applying
Documentation of National Influenza Center
status
Name and contact information for point of
contact
Application: You must submit a project narrative with your
application forms. The narrative must be submitted in the following
format:
Maximum number of pages: 25
If your narrative exceeds the page limit, only the first pages,
which are within the page limit, will be reviewed.
Font size: 12 point unreduced
single spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Held together only by rubber bands or metal
clips; not bound in any other way.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
Plan
Documentation of Results
Capacity
Proposed Program Plan
Goals
Objectives
Operational Plan
Evaluation Plan
Collaborations
Budget and justification (not included in page
limit) With staffing breakdown and justification, provide a line item
budget and a narrative with justification for all requested costs, and
separate line-item budgets for each research area. Be to include, if
any, in-kind support or other contributions that will be provided by
your country as part of the total project, but for which you are not
requesting funding. Budgets should be consistent with the purpose,
objectives and research activities and include:
Line-item breakdown and justification for all
personnel, i.e., name, position title, annual salary, percentage of
time and effort, and amount requested.
For each 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; (5) method of contractor selection (e.g., sole-
source of competitive solicitation); and (6) methods of accountability.
Additional information may be included in the application
appendices. The appendices will not be counted toward the narrative
page limit. This additional information includes:
Curriculum Vitaes
Resumes
Organizational Charts
Letters of Support may be included.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-
5711.
For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm
.
If your application form does not have a DUNS number field, please
write your DUNS number at the top of the first page of your
application, and/or include your DUNS number in your application cover
letter.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
LOI Deadline Date: May 27, 2004.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
Application Deadline Date: June 28, 2004.
Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office by 4 p.m. eastern time on the deadline
date. If you send your application by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery of the application by the closing date
and time. If CDC receives your application after closing due to: (1)
carrier error, when the carrier accepted the package with a guarantee
for delivery by the closing date and time, or (2) significant weather
delays or natural disasters, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the
[[Page 22809]]
application as having been received by the deadline.
This announcement is the definitive guide on application submission
address and deadline. It supersedes information provided in the
application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your application. If you
have a question about the receipt of your application, first contact
your courier. If you still have a question, contact the PGO-TIM staff
at: 770-488-2700. Before calling, please wait two to three days after
the application deadline. This will allow time for applications to be
processed and logged.
IV.4. Intergovernmental Review of Applications
Executive Order 12372 does not apply to this program.
IV.5. Funding restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows:
Use of Funds
Funds may be spent for reasonable program
purposes, including personnel, travel, supplies, and services.
Equipment may be purchased if deemed necessary to accomplish program
objectives, however, prior approval by CDC officials must be requested
in writing.
The costs that are generally allowable in grants
to domestic organizations are allowable to foreign institutions and
international organizations, with the following exception: With the
exception of the American University, Beirut and the World Health
Organization, Indirect Costs will not be paid (either directly or
through sub-award) to organizations located outside the territorial
limits of the United States or to international organizations
regardless of their location.
The applicant may contract with other
organizations under this program; however the applicant must perform a
substantial portion of the activities (including program management and
operations, and delivery of prevention services for which funds are
required.)
All requests for funds contained in the budget,
shall be stated in U.S. dollars. Once an award is made, CDC will not
compensate foreign grantees for currency exchange fluctuations through
the issuance of supplemental awards.
You must obtain annual audit of these CDC funds
(program-specific audit) by a U.S.--based audit firm with international
branches and current licensure/authority in-country, and in accordance
with International Accounting Standards or equivalent standard(s)
approved in writing by CDC.
A fiscal Recipient Capability Assessment may be
required, prior to or post award, in order to review the applicant's
business management and fiscal capabilities regarding the handling of
U.S. Federal funds.
Awards will not allow reimbursement of pre-award
costs.
Guidance for completing your budget can be found on the CDC Web
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm
.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or E-mail to: Ken Fortune, National Center for Infectious
Diseases, Center for Disease Control and Prevention, Mailstop C-19,
1600 Clifton Road, NE., Atlanta, GA 30333, FAX: 404-639-4195, E-mail:
kef2@cdc.gov.
Application Submission Address: Submit the original and two hard
copies of your application by mail or express delivery service to:
Technical Information Management-PA 04106, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
You are required to provide measures of effectiveness that will
demonstrate the accomplishment of the various identified objectives of
the cooperative agreement. Measures of effectiveness must relate to the
performance goals stated in the ``Purpose'' section of this
announcement. Measures must be objective and quantitative, and must
measure the intended outcome. These measures of effectiveness must be
submitted with the application and will be an element of evaluation.
Your application will be evaluated against the following criteria:
Objectives and Technical Approach (50 points
total)
Does the applicant describe specific objectives
of the proposed program that are consistent with the purpose and goals
of this announcement and which are measurable and time-phased? (10
points)
Does the applicant identify appropriate sites
with adequate geographic distribution for network? (10 points)
Does the applicant present a detailed
operational plan for initiating and conducting the program, which
clearly and appropriately addresses all recipient activities that are
feasible? Does the applicant clearly identify specific assigned
responsibilities for all key professional personnel? Does the plan
clearly describe the applicant's technical approach/methods for
developing and conducting the proposed program and evaluation and does
it appear feasible and adequate to accomplish the objectives? Does the
applicant describe the existence of or plans to establish partnerships?
(10 points)
Does the applicant describe adequate and
appropriate collaborations with other health agencies during various
phases of the project? (10 points)
Has the applicant provided a detailed, adequate
and feasible plan for evaluating program results? This includes plans
for evaluating the improvement of the influenza surveillance network as
well as plans for evaluating other aspects of the collaboration (e.g.,
training). (10 points)
Capacity (35 points total)
Does the applicant describe adequate resources
and facilities (both technical and administrative) for conducting the
project? This includes the capacity to conduct quality laboratory
measurements and produce and distribute reports? (20 points)
Does the applicant provide documentation that
professional personnel involved in the project are qualified and have
past experience and achievements in research and programs related to
the program (as evidenced by curriculum vitae, publications, etc.)? (15
points)
Background and Need (10 points)
Does the applicant adequately discuss the background for the
proposed project and demonstrate a clear understanding of the purpose
and objectives of this cooperative agreement program? Does the
applicant illustrate and justify the need for the proposed project that
is consistent with the purpose and objectives of this program?
Measures of Effectiveness (5 points) Does the
applicant provide Measures of Effectiveness that will demonstrate the
accomplishment of the various identified objectives of the grant and
the degree to which the measures are objective/quantitative and
adequately measure the intended outcome?
Budget and Justification (not scored): Does the
applicant propose a budget that is reasonable, clearly
[[Page 22810]]
justifiable, and consistent with the intended use of cooperative
agreement funds?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) staff, and for responsiveness by the National
Center for Infectious Diseases. Incomplete applications and
applications that are non-responsive to the eligibility criteria will
not advance through the review process. Applicants will be notified
that their application did not meet submission requirements.
An objective review panel will evaluate complete and responsive
applications according to the criteria listed in the ``V.1. Criteria''
section above.
In addition, the following factors may affect the funding decision:
Funding preference will be given to countries where resources are
currently limited and influenza surveillance is not well established
due to lack of resources and where there have been problems with avian
influenza outbreaks posing threats to human health either in their
country or surrounding countries. This would include countries in the
following geographic region: Asia
V.3. Anticipated Announcement and Award Dates
Anticipated Award Date: August 1, 2004.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
VI.2. Administrative and National Policy Requirements
45 CFR Part 74 and Part 92 For more information on the Code of
Federal Regulations, see the National Archives and Records
Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html
.
The following additional requirements apply to this project:
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-15 Proof of Non-Profit Status
AR-25 Release and Sharing of Data
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting Requirements
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, no less than 90 days before the end of
the budget period The progress report will serve as your non-competing
continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report and annual progress report, no more than
90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management or Contract
Specialist listed in the ``Agency Contacts'' section of this
announcement.
VII. Agency Contacts
For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For program technical assistance, contact: Ann Moen, Project
Officer, National Center for Infectious Diseases, Center for Disease
Control and Prevention Mailstop G-16, 1600 Clifton Road, NE., Atlanta,
GA 30333, Telephone: 404-639-4652, E-mail: amoen@cdc.gov.
For financial, grants management, or budget assistance, contact:
Steward Nichols, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2788, E-mail: shn8@cdc.gov.
Dated: April 20, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-9494 Filed 4-26-04; 8:45 am]
BILLING CODE 4163-18-P