CDC-RFA-IP21-2101 rev3.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

Surveillance and Response to Avian and Pandemic Influenza by National Health Authorities outside the United States

CDC-RFA-IP21-2101

Application Due Date: 05/04/2021

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- IP21-2101. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Surveillance and Response to Avian and Pandemic Influenza by National Health Authorities outside the United States C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr- 46/index.html (See section 45 CFR 46.102(d)).

New-Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-IP21-2101

E. Assistance Listings Number:

93.318 F. Dates:

1. Due Date for Letter of Intent (LOI):

https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

NA

2. Due Date for Applications:

05/04/2021 11:59 p.m. U.S. Eastern Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

3/23/2021 – 7:00 pm ET US; 3/24/2021 – 7:00 am ET US; 3/24/2021 – 10:00 am ET US

Zoom information for CDC-RFA-IP21-2101 calls is below:

March 23, 2021 - 7:00 pm ET US:

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March 24, 2021 - 7:00 am ET US:

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March 24, 2021 - 10:00 am ET US:

Join by Zoom Meeting:

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Join by phone:

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G. Executive Summary:

1. Summary Paragraph This Notice of Funding Opportunity (NOFO) will support recipients to improve or maintain capacity to conduct routine influenza surveillance and detect and respond to pandemic influenza.

A second intent is to ensure capacity to respond to highly pathogenic viruses transmissible among humans, including epidemiologic and virologic detection and to respond and monitor influenza virus changes, as well as identify outbreaks of severe respiratory illness syndromes. A third intent is to help strengthen connections between national institutions, especially National Influenza Centers (NIC), to fully participate in the WHO Global Influenza Surveillance and Response System (GISRS), and maintain capacity to share specimens, clinical and epidemiologic data related to influenza circulation.

Finally, this NOFO will support monitoring highly pathogenic viruses and bacteria transmissible to humans and identification of outbreaks of severe respiratory illness.

This program aligns with the Health and Human Services (HHS) Pandemic Influenza Operational Plan, the President’s National Strategy for Pandemic Influenza, the principles of the International Partnership on Avian and Pandemic Influenza, the International Health Regulations (IHR) (2005) Joint External Evaluation Process (JEE), CDC Strategic Framework Priorities of “Securing Global Health and America’s Preparedness”, “Eliminating Disease” and “Ending Epidemics,” and NCIRD’s performance goal "Protect Americans from infectious diseases".

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards https://cdc.zoomgov.com/j/1609424763?pwd=QkcxTEI0Z2kyOWdsUWJPZ2FlSjc0Zz09 mailto:U@9ry5 https://cdc.zoomgov.com/u/adzF8LfotM mailto:1609424763@sip.zoomgov.com

d. Total Period of Performance Funding:

$ 120,000,000 Total period of performance funding: Up to $120,000,000

Component 1 (Influenza Core Activities): up to $85,000,000 (Component 1 estimated at $13,000,000 in Year One)

Component 2 (Non-Influenza Viral and Bacterial Respiratory and Vaccine-preventable Pathogen activity): up to $10,000,000 (Component 2 is estimated at $1,000,000 in Year One)

Component 3 (Rapid Response to Infectious Disease Outbreaks or other Public Health Emergencies): Up to $15,000,000 (Component 3 is expected to be approved but unfunded). This program notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for a designated public health threat, CDC can process applications and award funds in a timely manner. In the event that no designated public health threat is declared, no awards will be made.

Final award amounts may be less than requested. Funding is subject to the availability of appropriated funds.

e. Average One Year Award Amount:

$ 400,000 This announcement contains two separate annual components, and a third component aimed at providing a quick funding mechanism for pre-approved recipients faced with an identified public health threat.

The average Year One Award Amount refers to the two annual components:

Estimated Award Ranges:

Influenza Core Activities (Component 1): $50,000 to $200,000 award range

Non-Influenza Viral and Bacterial Respiratory and Vaccine-preventable Pathogen (Component 2): $50,000 to $200,000 award range.

Rapid Response to Infectious Disease Outbreaks or other Public Health Emergencies (Component 3): Approved but Unfunded:

$20,000 - $1,000,000 award range. Funds will only be available if and when a public health emergency is declared.

Potential amounts are subject to the availability of funds.

f. Total Period of Performance Length:

g. Estimated Award Date:

August 31, 2021

h. Cost Sharing and / or Matching Requirements:

No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview Spread of infectious diseases between countries remains a major global threat. Specifically, influenza epidemics are difficult to predict but recognized as recurring yearly events that can, and do, have serious global health and economic consequences. Influenza surveillance is essential in understanding the magnitude and impact of these annual influenza epidemics, to select influenza vaccine components, and to detect novel influenza viruses that may signal the start of a pandemic. Maintaining a worldwide surveillance network that systematically collects and analyzes data over time is an important step in addressing the potential risk of an influenza pandemic.

Since November 2005, when the United States (U.S.) National Strategy for Pandemic Influenza was announced and the HHS Pandemic Influenza Plan released, the U.S. Centers for Disease Control and Prevention (CDC) has leveraged global partnerships to increase preparedness and response capabilities around the world with the intent of stopping, slowing or otherwise limiting the spread of an influenza pandemic to the U.S..

For the last 16 years, CDC has worked with public health partners around the world to support and help establish or enhance countries’ capacity to maintain virologic and epidemiologic influenza surveillance systems and gather strong baseline data that can be used to monitor disease severity and quickly identify outbreaks. Through cooperative agreements and technical and logistical support to countries, CDC’s Influenza Division continues to work to increase worldwide capacity to detect, prevent and respond to global threats.

The importance of routine surveillance systems was recently emphasized during the COVID-19 pandemic in which components of influenza surveillance systems worldwide were utilized to detect, prevent, and respond to SARS-coronavirus-2. The rapid detection of pathogenic respiratory viruses with pandemic potential requires both a good routine surveillance system and pandemic preparedness. Additionally, the rapid spread of COVID-19 underscores the importance of routine surveillance and the connection between viruses in animals and their transmission to humans.

CDC will continue to support routine influenza surveillance and the development and maintenance of international capacity to detect and respond to identified influenza pandemics;

support coordination and communication of the animal human interface facilitating the capacity to detect and monitor novel viruses occurring in animals; and support capacity development to detect and respond to the spread of non-influenza respiratory viruses and bacteria.

This NOFO has two annual components designed: 1) to build and/or maintain influenza surveillance and monitor novel viruses in animals (Influenza Activities); 2) to implement non-influenza pathogen surveillance (Non-Influenza Viral and Bacterial Respiratory and Vaccine-preventable Pathogen). A third component is designed to support a response to a designated emergency event (Rapid Response to Infectious Disease Outbreaks or other Public Health Emergencies).

Applicants must apply for the Influenza Activities component and may apply for additional components. Applicants must be approved for funding for Influenza Activities to be considered for funding within other components.

The strategies and activities outlined in this NOFO directly support the mission of the National Center for Immunization and Respiratory Diseases (NCIRD) to prevent disease, disability, and death through immunization and by control of respiratory and related diseases.

b. Statutory Authorities Section 307 of the Public Health Service Act, as amended (42 U.S.C. § 242l).

c. Healthy People 2030 This work contributes to accomplishing the following CDC Healthy People 2030 goals:

Improve health by preventing, detecting, and responding to public health events worldwide.

Healthy People 2030 focuses on increasing disease monitoring and prevention efforts and on improving global capacity to prevent, detect, and respond to public health threats including improvements in surveillance and laboratory systems.

Details can be found: https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health

d. Other National Public Health Priorities and Strategies Measurable outcomes will support the HHS Pandemic Preparedness Operational plan, the President’s National Strategy for Pandemic Influenza, the principles of the International Partnership on Avian and Pandemic Influenza, the CDC Strategic Priorities supporting global health preparedness and the National Center for Immunization and Respiratory Diseases (NCIRD) goal: Protect Americans from infectious diseases. Additionally, outcomes support the Global Health Security Agenda (https://ghsagenda.org) mandate to address priorities and gaps in efforts to build and improve country capacity and leadership in the prevention and early detection of, and effective response to, infectious disease threats.

e. Relevant Work This NOFO continues work initiated in 2004 and continued under recent funding opportunities CDC-RFA-IP19-1902, CDC-RFA-IP16-1603. These agreements were developed to enhance the ability and capacity of foreign governments to conduct surveillance for seasonal influenza and to detect and respond to pandemic influenza threats. The proposed NOFO complements current global pandemic preparedness work and seeks to strengthen the capacity of national health authorities and partners to detect and respond more broadly to respiratory pathogen outbreaks like the response to the SARS-coronavirus-2 and other viral and bacterial pathogens utilizing systems developed to support surveillance for influenza.

https://ghsagenda.org/

2. CDC Project Description

a. Approach Bold indicates period of performance outcome.

CDC-RFA-IP21-2101 Logic Model: Surveillance and Response to Avian and Pandemic Influenza by National Health Authorities outside the United States

The Logic Model shows the high-level strategies and activities, as well as short-term and long-term outcomes. Please see the Outcomes (ii) and Strategies and Activities (iii) sections below for more detailed information.

Bold indicates period of performance outcome

Component 1 – Influenza Core Activities

Strategies/Activities Outputs Short-Term Outcomes

Long-Term Outcomes

Strategy 1 - Infrastructure:

Build/establish or maintain current integrated national influenza surveillance system

Develop standard operating procedures

*Written and published strategic plan identifying national surveillance objectives

*Action items identified, and a plan developed

* Documentation of human and financial resources needed *Establish mechanisms for the sharing of information about zoonoses between the ministries of health (MOH) and ministries of agriculture (MOA)

*National surveillance objectives established and published

*Improved communication between MOH and MOA

*Established national influenza surveillance system

*Country ownership of and sustainability of integrated surveillance system

*Improved MOH and MOA coordination

Strategies/Activities Outputs Short-Term Outcomes

Long-Term Outcomes

Strategy 2 - Epidemiological Surveillance:

Establish/improve and/or maintain epidemiologic capacity

Enhance

*Weekly reporting to WHO GISRS (FluID) *Estimate (numbers or rates) of respiratory illness or deaths due to influenza (burden of disease) *Use epidemiological

*Improved epidemiological surveillance system performance *Improved stakeholder engagement and coordination

*Strong, capable data-driven surveillance workforce *Robust quality data used for longitudinal analysis of influenza activity epidemiological surveillance capacity

Coordinate communication with MOA to implement or maintain Animal Human Interface/OneHealth surveillance system data to build evidence base for influenza prevention and control policies

*Surveillance staff skilled in data collection, quality review, analysis and dissemination *Improved understanding of influenza activity *Zoonotic surveillance platform enhanced

*Improved national and interconnected global networks *Improved use of surveillance data to inform public health actions *Sustained ability to monitor the severity of epidemic and pandemic influenza associated illnesses *Improved awareness and response to zoonotic (novel) influenza human infections.

Strategies/Activities Outputs Short-Term Outcomes

Long-Term Outcomes

Strategy 3 - Laboratory Surveillance:

Maintain or improve laboratory capacity

Enhance animal zoonotic influenza virus knowledge to support Animal Human Interface/OneHealth platform

*Documented analysis of existing capabilities and enhancement strategy *Consistent weekly reporting to WHO (FluNet and GISRS) *Shipments of influenza specimens received by designated WHO Collaborating Center (CC) *Influenza-positive samples available for use in vaccine strain selections

* Improved testing capacity for influenza specimens, both quality and quantity *Improved or maintained acceptable performance on external quality assurance panels *Improved performance and consistent weekly influenza specimen testing *Timely notification to World Organization for

*Well prepared and established laboratory testing and surveillance program *Data available for analysis on influenza seasonality and severity and identification of novel viruses *Achievement and/or improvement of WHO NIC testing functions and ability to respond to outbreak and pandemics *Improved

Animal Health

(OIE)

international contribution of specimen data used for vaccine composition decision-making

(VCM)

*Increased capacity to identify new and emerging influenza viruses in animals and humans, and ability to identify pandemic threats

Strategies/Activities Outputs Short-Term Outcomes

Long-Term Outcomes

Strategy 4 - Pandemic Preparedness:

Develop and maintain preparedness plan

*Pandemic Plan created, reviewed and approved and published

*Improved awareness of pandemic influenza preparedness & response capacity *Improved adherence to the WHO Pandemic Influenza Preparedness (PIP) framework

*Updated national pandemic preparedness and response plan *Planned exercises used to test various components of plan, including monitoring

Component 2: Non-Influenza Viral and Bacterial Respiratory and Vaccine-preventable pathogens

Strategies/Activities Outputs Short-Term Outcomes

Long-Term Outcomes

Strategy 1 - Epidemiological Surveillance:

Establish/improve or maintain epidemiologic capacity

Evaluate the impact of interventions

*Strengths and gaps identified, and plan developed to address them *Weekly reporting to ministry of health

*Improved stakeholder engagement and coordination *Surveillance staff skilled in data collection, data quality review, and data dissemination skills

*Strong and capable data-driven surveillance workforce *Weekly and annual national publicly available surveillance report *Robust quality data *Functioning early warning systems to detect emerging pathogens

Strategies/Activities Outputs Short-Term Outcomes

Long-Term Outcomes

Strategy 2: Laboratory Surveillance Enhancement of laboratory testing and quality management systems

Expand laboratory testing capacity

*Documented analysis of existing capabilities and enhancement strategy *Consistent weekly reporting and timely shared reports *Shipments of viable specimens received by CDC in a timely manner

*Achievement of/or improved performance of laboratory functions *Improved timeliness and representativeness of shipments of specimens sent to

CDC

*Identification of newly emerging pathogens *Improved skill among laboratory staff *Improved proficiency panel performance

*Improved availability of indicator results to measure testing and frequency *Increased number of specimens tested *Increased and improved quality measures *Enhanced ability to detect and characterize various pathogens *Data available for seasonal analysis of non-influenza respiratory viruses

Strategy 3: Viral Respiratory Pathogen Surveillance Leverage NCIRD surveillance platforms to improve surveillance capacity

Strengthen existing laboratory networks

*Enhanced sentinel surveillance including event-based surveillance *Established standard data management systems *Enhanced detection and reporting of viral respiratory illness *Enhanced genetic characterization of circulating viruses

*Enhanced sentinel surveillance *Improved data management *Validated pandemic preparedness and response plans *Integration of laboratory testing procedures for respiratory surveillance *Improved competency for specimen collection, testing, and reporting

Component 3: Rapid Response to Infectious Disease Outbreaks or other Public Health Emergencies

Strategies/Activities Short-Term Outcomes Long-Term Outcomes

Emergency Response:

Respond to a declared public health emergency or identified highly infectious disease outbreaks

*Rapid identification of and response to highly infectious disease outbreaks *Strengthened coordination and robust emergency preparedness and response capacities *Improved identification of cases and conducting appropriate outbreak investigations *Increased awareness, knowledge, and support for local disease outbreak response and prevention

*Achieve timely outbreak response *Reduced time to reinvigorate public health activities *Increased capacity of countries for early warning, risk reduction and management of national and global health risks *Prevention of spread of the outbreak

i. Purpose This NOFO supports building capacity for routine influenza and other respiratory disease surveillance systems to monitor, detect, respond and mitigate transmission; enabling national institutions to maintain their laboratory; participating fully in the Global Influenza Surveillance and Response System (GISRS); enabling influenza surveillance platforms or other existing surveillance platforms to be expanded and utilized for response to outbreaks of pathogens that are of public health importance and utilizing data collected by ministries of health for healthcare policy decisions.

ii. Outcomes Component 1: Influenza Core Activities Strategy 1: Infrastructure Short-Term Outcomes

National surveillance objectives established and published Improved communication between ministries of health and agriculture/animal health via established mechanisms for the daily or weekly sharing of information about zoonoses between the MOH and MOA o Establish mechanisms for sharing of zoonoses information between the MOH and

MOA

Long-Term Outcomes

Established national influenza surveillance system with integrated laboratory and epidemiological data tracking

Country ownership and sustainability of integrated surveillance system Support from government for long-term sustainability

MOH and MOA coordination to ensure knowledge, awareness, and coordinated response and control of disease circulation within and between humans and animals

Strategy 2: Epidemiological Surveillance Short-Term Outcomes

Improved epidemiological surveillance system performance Surveillance staff skilled in data collection, data quality review, and data dissemination skills Improved understanding of influenza activity to properly inform MOH and other public health officials on virus’ transmissibility and severity Zoonotic surveillance platform enhanced to include tracking of virus transmission from animals to humans and potential transmission from humans to animals

Long-Term Outcomes

Strong and capable data-driven surveillance workforce Improved reporting and improved situational awareness in country and globally

Improved utilization of surveillance to inform public health action and support preparedness, response and recovery measures.

Sustained ability to monitor the severity of epidemic and pandemic influenza-associated illnesses (PISA) o Ability to use collected epidemiological data as an evidence base to support the implementation of influenza prevention and control policies for specific at-risk groups

Improved awareness and response to zoonotic (novel) influenza human infections

Strategy 3: Laboratory Surveillance Short-Term Outcomes

Improved testing capacity for influenza specimens, both quality and quantity Improved or maintained acceptable performance on external quality assurance panels Improved international contribution of specimen data used for vaccine composition decision-making (VCM) Improved performance and consistent weekly influenza specimen testing o Timely contribution of influenza positive respiratory specimens to CC for VCM and provide in-depth information about circulating strains

Timely notification to World Organization for Animal Health (OIE) regarding animal influenza outbreaks and/or zoonotic transmission to humans

Long-Term Outcomes

Data available for analysis on influenza seasonality and severity and identification of novel viruses within the country

Improved international contribution of specimen data used for vaccine composition decision-making (VCM) o Identification of novel viruses within the country per WHO IHR guidelines o Established stable routine testing of a defined number of specimens each week based on local capacity

Increased capacity to identify new and emerging influenza viruses in animals and humans, and ability to identify pandemic threats

Strategy 4: Pandemic Preparedness Short-Term Outcomes

Improved awareness of pandemic influenza preparedness & response capacity Improve adherence to the WHO Pandemic Influenza Preparedness (PIP) framework o Immediate sharing of influenza viruses with pandemic potential IVPP with a

WHO CC

Long-Term Outcomes

Updated national pandemic preparedness and response plan that meets country needs, global standards, WHO guidance o Pandemic Plans planned exercises used to test various components for appropriateness and usability and inclusion of a monitoring system with a set testing schedule defined.

Component 2: Non-Influenza Viral and Bacterial Respiratory and Vaccine-preventable Pathogen Strategy 1: Epidemiological Surveillance Short-Term Outcomes

Surveillance staff skilled in data collection, data quality review, and data dissemination skills leading to improved data quality and outputs

Long-Term Outcomes

Strong and capable data-driven surveillance workforce, improved reporting and situational awareness in country and globally

Weekly and annual national publicly available surveillance report o Includes accurate summaries of epidemiologic and laboratory data generated from all laboratories and sentinel sites

Countries have functioning early warning systems to detect emerging pathogens

Strategy 2: Laboratory Surveillance Short-Term Outcomes

Achievement of/or improved performance of laboratory functions Improved timeliness and representativeness of shipments of specimens received by CDC Improved skill among laboratory staff for non-influenza pathogen characterization and testing Increase in proficiency panel performance

Long-Term Outcomes

Improved availability of indicator results to measure testing and frequency

Increase the annual number of specimens tested Increased and improved quality measures Enhanced ability to detect and characterize various pathogens Data available for analysis of seasonality of non-influenza respiratory and vaccine-preventable pathogens

Strategy 3: Viral Respiratory Pathogen Surveillance Short-Term Outcomes

Enhanced sentinel surveillance including event-based surveillance where utilized Enhanced detection and reporting of viral respiratory illness

Long-Term Outcomes

Enhanced sentinel surveillance to provide timely data about viral respiratory pathogens activity

Validated pandemic preparedness and response plans Improved competency for specimen collection, testing, serologic methods as well as reporting

Component 3: Rapid Response to Infectious Disease Outbreaks or other Public Health Emergencies Short-Term Outcomes

Rapid identification of and containment of highly infectious disease outbreaks Strengthened coordination and robust emergency preparedness and response capacities Increased awareness, knowledge, and support for local disease outbreak response and prevention efforts at the community level

Long-Term Outcomes

Achieve timely outbreak and epidemic/pandemic control Increased capacity of countries for early warning, risk reduction and management of national and global health risks

iii. Strategies and Activities Component 1 – Influenza Core Activities Strategy 1: Infrastructure –

Build/establish or maintain current integrated national influenza surveillance system o Assessment of entire influenza surveillance system with documentation of overall surveillance objectives, including the strengths and weaknesses for all laboratory, epidemiologic objectives and sentinel performance Specifically assess staffing capacity and identify needs to support comprehensive influenza program including overall grant and project management o Develop a sustainability plan for the national influenza surveillance system including budget needed to maintain the system and optimize national integration Analyze the costs of the surveillance system and determine a budget to sustain and optimize a base level national integrated surveillance system o Develop a plan to address organizational capacity, communications, partnerships, and program evaluation

Develop standard operating procedures for the prompt sharing of information about potential outbreaks of consequence to animal and/or human populations with IHR defined timelines o Develop work plans outlining routine communications between Ministries of Health and Agriculture about animal influenza outbreaks and/or human cases of zoonotic (novel) influenza virus Include information on current Animal Human Interface (AHI)/OneHealth activities and plans to either initiate or continue activities to ensure strong connection to and communication with the Ministry of Agriculture (MOA)

Strategy 2: Epidemiological Surveillance o Establish/improve or maintain epidemiologic capacity to monitor seasonal influenza activity and identify potential pandemic outbreak o Conduct critical review/assessment of surveillance system including program costs, identification of data quality indicators, identification of gaps and develop plan to address o Identify, clearly define and document long-term national surveillance objectives o Develop revised protocol/standard operating procedures (SOPs) for sentinel surveillance Utilize tools such as the Joint External Evaluation (JEE) 2.0 framework

(https://www.cdc.gov/globalhealth/healthprotection/ghs/ihr/index.html) to identify gaps and prepare plan for addressing them o Convene annual surveillance meeting with all surveillance staff and key stakeholders Epidemiologic, Laboratory and AHI/OneHealth teams should be included in the meeting

Enhance epidemiological surveillance capacity to monitor influenza activity year-round and to establish >3-year baseline influenza activity o Develop, improve and maintain data management and analysis skills including integration of epidemiologic and laboratory data linkages and reporting.

Include reporting SOP for links to AHI/OneHealth o Design weekly and annual reporting systems, contributing to national and global situational awareness o Conduct a data quality assessment of established influenza like illness (ILI) and/or severe acute respiratory illness (SARI) sentinel sites with at least 3 years of data collected.

https://www.cdc.gov/globalhealth/healthprotection/ghs/ihr/index.html o Develop surveillance data triggers for public health actions and guidance for non-pharmaceutical interventions, antiviral use, and influenza vaccination.

Conduct enhanced surveillance to identify populations at high risk for severe influenza disease or groups that may be priority for targeted vaccination, antiviral treatment, or other non-pharmaceutical interventions

(NPI)

o Enhance existing capacity or expand sources of surveillance to establish national indicators of influenza transmission, disease severity, and impact Develop and disseminate weekly reports of Pandemic Influenza Severity

Assessment (PISA)

Coordinate and communicate with the MOA to implement or maintain Animal Human Interface/OneHealth surveillance system to actively monitor animal and zoonotic viruses o Outbreak investigations of zoonotic (novel) transmission events among humans o Develop or revise plans to conduct surveillance among humans potentially exposed to influenza viruses circulating in animal populations.

Include information on current links to AHI/OneHealth group and identified strengths and weaknesses (if available)

Strategy 3: Laboratory Surveillance

Maintain or improve laboratory capacity to monitor and test samples and strengthen participation in WHO Global Influenza Surveillance and Response System (GISRS) and contribution to VCM o Assess capacity of national reference and provincial laboratories, identify training needs and develop a working plan to improve influenza detection and ensure consistent timely reporting to WHO FluNet Utilize data to document and prepare plan to improve laboratory performance and personnel skill o Develop a working plan to improve influenza detection o Timely and routine submission of specimens to WHO CC o Maintain influenza testing capacity through external quality review

Participation in external quality proficiency panels and needs identified to improve influenza specimen testing

Train laboratory staff and implement new or enhanced testing capabilities Identify areas where quality control measures could be implemented to improve testing results and validity (i.e., monitoring of sample CT values) Assess influenza laboratory manuals (i.e., Biosafety/Biosecurity) and protocols (i.e., Standard Operating Procedure for RT-PCR) that require regular updating

Develop plan to ensure ongoing updates and relevance of manuals is maintained o Monitor or establish inventory levels for influenza laboratory reagents and supplies

Develop a national plan for the procurement of reagents and supplies for influenza virus characterization and testing o Develop and disseminate routine and timely reports of circulating influenza viruses identified through molecular diagnostics to WHO Global Influenza Surveillance and Response Systems (GISRS)

Enhance animal zoonotic influenza virus knowledge to support Animal Human Interface/OneHealth platform o Develop and/or maintain testing algorithms and protocols evaluating clinical presentation of individuals with zoonotic influenza viruses and risk factors for human to human transmission.

Strategy 4: Pandemic Preparedness

Develop and maintain preparedness plan for an influenza outbreak or pandemic o Establish group of national/ international stakeholders to evaluate country-level pandemic preparedness including coordination with animal health surveillance and either draft a new or update the current national pandemic preparedness and response plan If necessary, update the national pandemic preparedness and response plan to meet country needs, global standards, WHO guidance including consideration of challenges experienced during the 2020 COVID-19 pandemic.

Consider including AHI/OneHealth linkages and include AHI group in ongoing surveillance discussions o Test preparedness and response plans by conducting tabletop outbreak and response exercises and responding to real events Create after action report to summarize strengths and weaknesses identified during tabletop exercises o Monitor pandemic preparedness levels and capacity through evaluation tools, training, outbreak reviews

Component 2: Non-Influenza Viral and Bacterial Respiratory and Vaccine-preventable pathogens

Strategy 1: Epidemiological Surveillance

Establish/improve or maintain epidemiologic capacity to monitor seasonal activity and identify potential outbreaks o Conduct critical review/assessment of surveillance system identifying gaps and develop plan to address o Convene annual surveillance meeting with all surveillance staff and key stakeholders o Enhance early warning capacity for emerging and re-emerging pathogens by promoting integrated surveillance and strengthening event-based surveillance

Evaluate the impact of interventions on reducing the burden of diseases caused by pathogens o Develop, improve and maintain data management and analysis skills including integration of epidemiologic and laboratory data linkages and reporting o Design efficient weekly and annual reporting systems, contributing to national and global situational awareness

Strategy 2: Laboratory Surveillance

Enhancement of laboratory testing and quality management systems o Perform laboratory capacity reviews across Member States in conjunction with external collaborators (i.e., WHO, WHO RO and CDC) and follow up with recommendations o Sharing of non-influenza pathogens with CDC

Expand laboratory testing capacity to identify a broader range of pathogens o Training consultations or workshops in conjunction with external collaborators

(i.e, WHO, WHO Regional Office, and CDC) to strengthen laboratory capacity at Regional and national levels.

o Train and certify medical technologists through laboratory trainings and participation in regional workshops/networks

Strategy 3: Viral Respiratory Pathogen Surveillance

Leverage NCIRD led surveillance platforms to improve surveillance capacity for viral respiratory pathogens with pandemic potential o Identify gaps in viral respiratory surveillance and laboratory capacity o Expand epidemiologic and virologic capacity detection of viral respiratory pathogens o Providing training, technical and analytical support to improve or maintain data management systems, o Develop standardized approaches

Promote early detection and surveillance of respiratory pathogens with epidemic potential by strengthening existing laboratory networks o Provide training for specimen collection, testing with the multiplex RT-PCR and serologic methods o Conduct survey of ongoing surveillance to assess the scope of current activities in WHO VPD Laboratories, identify gaps and describe best practices used

Component 3: Rapid Response to Infectious Disease Outbreaks or other Public Health Emergencies

Respond to a declared public health emergency or identified highly infectious disease outbreaks o Intensify active surveillance, case finding, contact tracing, monitoring and other outbreak response measures at national and local levels o Strengthen capabilities for epidemiologic and laboratory analysis and program evaluation o Intensify social mobilization, community and professional education and engagement o Improve outbreak contact tracing management and infection control o Increase security and logistics for local responders

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

Recipients should make every effort to coordinate work with other CDC implementing partners (if known), including non-governmental organizations, universities, Ministry of Health and other host governmental bodies and multi-lateral organizations that receive CDC funds. The recipient should ensure their proposed activities are not duplicating activities already implemented by other CDC-funded organizations.

Applicants supported by CDC’s Global Health Security Agenda (GHSA) are encouraged to collaborate with GHSA counterparts and must describe how they plan to ensure activities conducted for this NOFO complement, without duplicating or supplanting, broader respiratory surveillance packages supported by GHSA.

b. With organizations not funded by CDC:

In collaboration with WHO, WHO regional offices, and country offices, Recipients should submit weekly reporting to WHO FluNet and WHO FluID, which supports the monitoring of circulating influenza viruses and allows rapid identification of an increase in reported influenza cases worldwide.

Shipment of viruses by Recipients to a WHO Collaborating Center (CC) is requested per the guidance of the designated WHOCC up to four times a year.

If CDC is not the routine WHO CC for shipments, recipients are encouraged to ship an additional package of positive original clinical specimens to CDC. Shipments of viruses to WHO CC and/or CDC prior to the annual Vaccine Composition meetings (held in February/September) informs recommendations made on the composition of the influenza vaccines for the following influenza season.

Recipients are expected to participate fully in the WHO Global Influenza Surveillance and Response System (GISRS). Recipients are also expected to adhere to applicable provisions within the International Health Regulations (2005) (IHR). Specifically, countries should have the ability to:

Detect: Make sure surveillance systems and laboratories can detect potential threats Assess: Work together with other countries to make decisions in public health emergencies Report: Report specific diseases, plus any potential international public health emergencies, through participation in a network of National Focal Points Respond: Respond to public health events

In addition, recipients will be expected to work with other stakeholders in country and at the global level including but not limited to other government entities, non-governmental organizations, civil society, the private sector, and other USG agencies.

CDC serves as one of six World Health Organization Collaborating Centers for Influenza (WHOCC). One of CDC’s long-standing terms of reference and responsibilities as a collaborating center is to provide technical support and develop capacity in laboratory and influenza surveillance with global ministries of health. As a result, the CDC Influenza Program works with MOHs to build the capacity of their national laboratory and influenza surveillance systems, and to maintain capacities gained with increased national ownership and to provide a mechanism for emergency fund distribution in case of a worldwide pandemic.

Through CDC’s role as a WHO Collaborating Center for Influenza, CDC works to support country participation in the Global Influenza Surveillance and Response System (GISRS). The GISRS is the only global influenza surveillance system and is responsible for conducting surveillance and collecting specimens and data that contribute to twice annual vaccine strain selection decisions for the world. These updated recommendations are used globally to make new influenza vaccine formulation recommendations every six months. The GISRS is entirely dependent on National Governments and MOHs to collect the specimens and submit data.

National governments and MOHs are the only entities eligible to designate their laboratories as National Influenza Centers. The entire GISRS system is made up of and supported by countries with capacity to conduct influenza surveillance.

This NOFO targets qualified entities (national governments and their MOHs) uniquely positioned to contribute to the Global Influenza Surveillance and Response System through designated National Influenza Centers that share viruses within the GISRS, thereby contributing to the Centers for Disease Control and Prevention's support for international effort to contain and mitigate the spread of an influenza pandemic or other highly pathogenic respiratory viruses. By increasing preparedness and response capabilities around the world, the United States will be much better positioned to protect the health of its citizens.

This NOFO targets countries designated by the World Bank as countries in the low- and middle-income category. These countries need both technical and financial assistance to strengthen surveillance systems, including increasing laboratory capacity to identify and monitor pathogenic viruses. The current list of countries designated as such by the World Bank is attached for review.

2. Target Populations The target populations for this NOFO include but are not limited to those people from countries designated by the World Bank as low- and middle-income whose populations are infected and affected by infectious diseases or other public health emergencies, at risk for becoming infected by an infectious disease, as well as health care workers. In addition, the work under this NOFO will target increased capacity within countries at the national and sub-national level to implement and achieve outbreak/epidemic/pandemic control in line with the recipient’s and USG strategies. The recipient should particularly work to identify WHO-recommended at-risk populations for influenza prevention and other relevant infectious diseases or public health threats and may propose additional target populations based on relevant evidence-based criteria in order to achieve and sustain epidemic control. Recipients are expected to use epidemiologic, social determinants, and linked laboratory surveillance data to identify communities disproportionately affected by influenza or other infectious respiratory diseases in the target areas to ensure that program activities appropriately cover these populations.

a. Health Disparities Implementation of strategies and activities within this NOFO will support establishment of surveillance systems that provide a representative sample of the country population, geographically, socio-demographically, including those populations identified as high-risk for morbidity from respiratory infections. Identification of the burden of disease, through use of surveillance data, will assist countries to plan and implement public health information campaigns and equitable vaccination programs.

iv. Funding Strategy This funding opportunity announcement will support countries designated by the World Bank Income Designation (January 7, 2021) as Low- & Middle-Income Countries: Afghanistan;

Albania: Algeria: American Samoa; Angola; Argentina; Armenia; Azerbaijan; Bangladesh;

Belarus; Belize; Benin; Bhutan; Bolivia; Bosnia and Herzegovina; Botswana; Brazil; Bulgaria;

Burkina Faso; Burundi; Cabo Verde; Cambodia; Cameroon; Central African Republic; Chad;

China; Colombia; Comoros; Congo Dem. Republic; Congo, Republic; Costa Rica; Cote d'Ivoire;

Cuba; Djibouti; Dominica, Dominican Republic; Ecuador; Egypt, Arab Republic; El Salvador;

Equatorial Guinea; Eritrea; Eswatini; Ethiopia; Fiji; Gabon; Gambia, The; Georgia; Ghana;

Grenada; Guatemala; Guinea; Guinea-Bissau; Guyana; Haiti; Honduras; India; Indonesia; Iran;

Islamic Republic; Iraq; Jamaica; Jordan; Kazakhstan; Kenya; Kiribati; Korea, Dem. People’s Rep.; Kosovo; Kyrgyz Republic; Lao PDR; Lebanon; Lesotho; Liberia; Libya; Madagascar;

Malawi; Malaysia; Maldives; Mali; Marshall Islands; Mauritania; Mexico; Micronesia, Fed. Sts.;

Moldova; Mongolia; Montenegro; Morocco; Mozambique; Myanmar; Namibia; Nepal;

Nicaragua; Niger; Nigeria; North Macedonia; Pakistan; Papua New Guinea; Paraguay; Peru;

Philippines; Russian Federation; Rwanda; Samoa; Sao Tome and Principe; Senegal; Serbia;

Sierra Leone; Solomon Islands; Somalia; South Africa; South Sudan; Sri Lanka; St. Lucia; St.

Vincent and the Grenadines; Sudan; Suriname; Syrian Arab Republic; Tajikistan; Tanzania;

Thailand; Timor-Leste; Togo; Tonga; Tunisia; Turkey; Turkmenistan; Tuvalu; Uganda; Ukraine;

Uzbekistan; Vanuatu; Venezuela, RB; Vietnam; West Bank and Gaza; Yemen, Rep.; Zambia;

Zimbabwe

There are three funding components for this NOFO. Applicants must apply for Component 1 (Influenza Activities). Additionally, applicants can choose to apply for Component 2 and/or Component 3.

Applicants must submit a single application with a clearly marked budget, and work plan for each proposed component and strategy. Clearly mark all work plans and budgets indicating Component name. Each component will be reviewed and scored separately. Please note: Components and strategies not outlined in this initial application cannot be added to work plans in subsequent years. The initial project application should contain a detailed Year 1 plan and a projection of strategies and activities to be accomplished in later years.

Applicants should be designated by the World Bank as a low- or middle-income category country.

Final decision on which countries and activities to be funded will be made after application review. CDC can fund out of rank order in order: 1) to align with USG and/or agency prioritized technical areas and activities; 2) to ensure maximum coverage of activities geographically; 3) to avoid duplication of activities in other CDC funding mechanisms; or 4) to respond to an unforeseen public health emergency of an international concern. Decisions will be documented.

Applicants selected to receive funding for Component 1 (Influenza Activities) will be considered for funding for any additional Components included as part of the application.

Component 1 (Influenza Activities) within this NOFO are intended to be funded on an annual basis. Future year funding levels will be dependent on funding availability and satisfactory progress. Satisfactory progress will be determined by successful completion of workplan activities and evaluation metrics agreed to and finalized in discussions with appropriate Influenza Program staff during the first 6 months of Year 1.

Component 2 - Non-Influenza Viral and Bacterial Respiratory and Vaccine-preventable Pathogen

Component 2 activities are intended to be funded on an as needed basis within those countries approved for funding under Component 1 (Influenza activities). Funding will occur when specific public health activities are identified.

Component 3 – Rapid Response to Infectious Disease Outbreaks or other Public Health Emergencies This is intended to be approved but unfunded (ABU) as a baseline practice. It would be funded to support additional activities needed when a disease outbreak or other public health emergency reaches a scale that requires a substantial response.

Final decision on which countries and activities to be funded will be made at the time of award. There are clearly identified definitions of what constitutes an emergency (see below for specifics).

Emergency Funding The ability to respond rapidly and effectively to public health emergencies is a key component of…