CDC-RFA-CK21-2104 rev.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Global Healthcare Detection and Response

CDC-RFA-CK21-2104

June 26, 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- CK21-2104. 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:

Global Healthcare Detection and Response 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)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-CK21-2104

E. Assistance Listings Number:

93.318 F. Dates:

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

May 27, 2021

2. Due Date for Applications:

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

June 26, 2021 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

Informational Call/Webinar I – May 18, 2021, 9 – 11 AM

Join ZoomGov Meeting https://cdc.zoomgov.com/j/1608908023?pwd=ZHhuU0hXU3RSUEhJelBvNmtYUTZtdz09 Meeting ID: 160 890 8023: Passcode: ++YeX8F& One tap mobile +16692545252,,1608908023#,,*77201071# US (San Jose) +16468287666,,1608908023#,,*77201071# US (New York)

Informational Call/Webinar II – May 20, 2021, 7 – 9 PM

Join ZoomGov Meeting https://cdc.zoomgov.com/j/1614726088?pwd=UFZyZ1I5aDl5dmtsdmhGVWp6OUtTQT09 Meeting ID: 161 472 6088 Passcode: B#hR4F!D One tap mobile +16692545252,,1614726088#,,*23626182# US (San Jose) +16468287666,,1614726088#,,*23626182# US (New York)

G. Executive Summary:

1. Summary Paragraph This Notice of Funding Opportunity (NOFO) intends to enhance detection and response to infectious disease threats globally by developing networks to implement prevention and containment strategies at local, national, and regional levels. Interventions to prevent, detect, and respond to infectious disease threats in healthcare, including antimicrobial resistance (AMR), healthcare-associated infections (HAIs), and COVID-19, will be developed and implemented within networks. Additionally, this NOFO aims to improve the detection of emerging AMR threats and identify AMR risk factors and prevention strategies across healthcare and the community to inform global AMR containment efforts.

The main outcomes are to: 1). reduce HAI’s and deliver safe healthcare; 2). ensure facilities and countries are better prepared to respond to emerging AMR threats in healthcare; 3). countries and regions better understand AMR in enteric pathogens, fungal pathogens, invasive bacterial and respiratory pathogens, and N. gonorrhoeae; and 4). control and prevent outbreaks and emergencies in healthcare facilities and affected communities.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

https://www.grants.gov/ https://cdc.zoomgov.com/j/1608908023?pwd=ZHhuU0hXU3RSUEhJelBvNmtYUTZtdz09 https://cdc.zoomgov.com/j/1614726088?pwd=UFZyZ1I5aDl5dmtsdmhGVWp6OUtTQT09

$ 150,000,000

e. Average One Year Award Amount:

$ 800,000 Funding amount may vary by Component.

f. Total Period of Performance Length:

g. Estimated Award Date:

September 30, 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 Around the world, fighting emerging infections, antibiotic resistance, and delivering essential medical care depend on a safe and functional healthcare system. The COVID-19 pandemic has demonstrated the importance of protecting healthcare facilities during outbreaks, and the critical role of hospitals to actively detect, monitor, and respond to emerging infectious disease threats. Protecting healthcare workers and patients, and maintaining essential services through safe delivery of care, is a critical priority to reducing morbidity and mortality from COVID-19 infection.

The pandemic has also exposed critical weaknesses in healthcare, which have led to large numbers of COVID-19 infections in healthcare workers, healthcare-associated outbreaks of COVID-19, and the emergence of antibiotic resistant healthcare-associated infections (HAIs).

Studies have found that 1 in 7 hospitalized patients with COVID-19 has acquired a secondary bacterial infection, and 50% of those patients who died had an antibiotic resistant HAI. It is possible that the COVID-19 pandemic will lead to an increased burden of antimicrobial resistance (AMR), which in turn could lead to higher levels of AMR infections in both community and healthcare settings and result in worse outcomes in hospitalized patients, including those with COVID-19.

Improving infection prevention and control (IPC) in healthcare facilities can prevent the transmission of emerging infectious diseases, including COVID-19 and HAIs caused by pathogens exhibiting AMR, and contain outbreaks of these diseases before they spread widely within the facility and into the community. Conducting assessments to better understand the burden, risk factors, and prevention strategies for AMR in both healthcare and community settings will inform local, regional, and global responses to contain the emergence of concerning

AMR.

Globally and regionally, healthcare facilities confront similar challenges when detecting and responding to new threats, including COVID-19 and emerging AMR in many pathogens. Therefore, supporting rapid local analysis and exchange of prevention strategies will be pivotal to collectively build response capacity at national, regional, and global levels.

Countries and facilities across the globe can accelerate progress toward safeguarding the health system by working together on common priorities of improving healthcare settings and containing AMR through detection and response of emerging threats.

The NOFO will have three components to support this approach. Component One: Detect and Respond to Infectious Disease Threats in Healthcare Facilities, creates collaborative networks to prevent transmission of infections in healthcare settings and contain emerging AMR threats.

Component Two: Improve Capacity to Detect and Monitor Antimicrobial Resistance, aims to improve detection and monitoring of AMR in pathogens commonly found in healthcare settings and the community. Component Three: Rapid Response to Infectious Disease Outbreaks or Other Public Health Emergencies in Healthcare Facilities, supports efforts to effectively respond to outbreaks in healthcare facilities, keeping them from becoming amplifiers of disease transmission.

The strategies and activities outlined in this funding opportunity directly support the mission of the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) to prevent disease, disability, and death caused by a wide range of infectious agents.

b. Statutory Authorities This program is authorized under Public Health Service Act, Sections 301(a), 307 and 317, as amended [42 U.S.C. Sections 241(a), 242l, and 247b]. Authority may also stem from an applicable emergency supplemental appropriation; such appropriation and any requirements and/or limitation associated with that emergency supplemental will be added to the notice of award.

Possible applicable supplemental appropriations include, but may not be limited to: P.L. 116-123

- Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 [March 6, 2020] P.L 116–136 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) [ March 27, 2020].

c. Healthy People 2030 This project supports the following Healthy People 2030 goals and objectives:

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

Increase the number of globally important public health events that are tracked and reported.

Increase the number of individuals trained globally to prevent, detect, or respond to public health threats.

Increase laboratory diagnostic testing capacity, surveillance, and reporting globally.

Global Health - Healthy People 2030 | health.gov

d. Other National Public Health Priorities and Strategies https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health

Activities funded through this cooperative agreement must align with the following USG and HHS/CDC strategies and policies:

National Strategy for Combating Antibiotic-Resistant Bacteria https://www.cdc.gov/drugresistance/pdf/carb_national_strategy.pdf

National Health Security Strategy https://www.phe.gov/Preparedness/planning/authority/nhss/Documents/NHSS-Strategy-

508.pdf CDC's strategy for improving global health security (GHS), based on three concepts to protect public health worldwide: 1) Prevent 2) Detect 3) Respond https://www.cdc.gov/globalhealth/security/index.htm

The Department of Health and Human Services' (HHS) Global Health Strategy https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html

e. Relevant Work This NOFO supports the Division of Healthcare Quality Promotion’s (DHQP) priority of protecting patients and healthcare personnel globally. DHQP works with partners to implement IPC programs, identify and refine best practices, and promote innovative solutions for preventing infections and controlling AMR in healthcare settings and communities. DHQP collaborates with partners through NOFOs including CK18-1801 and GH20-2110.

2. CDC Project Description

a. Approach Bold indicates period of performance outcome.

The Logic Model shows the high-level strategies and activities, as well as short-term and long-term outcomes. The Outcomes section has the descriptions of short- and long-term outcomes bolded in the logic model. The Strategies and Activities section includes the full descriptions of strategies/activities listed in the logic model.

Component 1 – Detect and Respond to Infectious Disease Threats in Healthcare Facilities

Strategies & Activities

Short-term Outcomes Intermediate Outcomes Long-Term Outcomes

Strategy 1:

Prevent Transmission of Infections in Healthcare Facilities

Healthcare workers increase collection and use of HAI surveillance and IPC monitoring data

Healthcare workers increase knowledge of IPC interventions and approaches to prevent HAIs

Healthcare facilities increase implementation of IPC

Infectious disease threats, including emerging AMR, are identified and contained in healthcare facilities

Healthcare workers use HAI surveillance, IPC monitoring, and AMR data to inform, monitor, and improve prevention

HAIs are reduced and safe healthcare is delivered

Facilities and countries are better prepared to respond to infectious disease threats https://www.cdc.gov/drugresistance/pdf/carb_national_strategy.pdf https://www.phe.gov/Preparedness/planning/authority/nhss/Documents/NHSS-Strategy-508.pdf https://www.phe.gov/Preparedness/planning/authority/nhss/Documents/NHSS-Strategy-508.pdf https://www.cdc.gov/globalhealth/security/index.htm https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html strategies to prevent transmission of infectious disease threats

Strategy 2:

Detect and Respond to Emerging Antimicrobial Resistance in Healthcare

Clinical and reference laboratory staff increase ability to detect emerging AMR

Healthcare workers increase collection and use of AMR data interventions

Supportive systems for IPC, HAI prevention, and AMR containment are improved in healthcare, including emerging AMR

Spread of infectious disease threats is decreased within communities and across borders

Emerging AMR threats are contained at regional and global levels

Component 2 – Improve Capacity to Detect and Monitor Emerging Antimicrobial Resistance

Strategies & Activities

Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

Strategy 1:

Assess Antimicrobial Resistance in Healthcare Settings

Strategy 2:

Assess Antimicrobial Resistance in Enteric Pathogens

Strategy 3:

Assess Antimicrobial Resistance in Fungal Pathogens

Strategy 4:

Assess

Clinical and reference laboratory staff increase ability to detect emerging AMR in relevant settings or pathogens

Methods developed to collect epidemiologic data to monitor emerging AMR in relevant settings or pathogens

Emerging AMR threats in relevant settings or pathogens are identified

Risk factors driving the emergence of AMR threats in relevant settings or pathogens are identified

Strategy 5

ONLY:

Molecular assays to detect AMR in N. gonorrhoeae are developed and deployed

Countries and regions better understand AMR in relevant settings or pathogens

Emerging AMR threats in relevant settings or pathogens are contained and AMR drivers are reduced at country, regional, and global levels

Antimicrobial Resistance in Invasive Bacterial and Respiratory Pathogens

Strategy 5:

Assess Antimicrobial Resistance in N.

gonorrhoeae Component 3 – Rapid Response to Infectious Disease Outbreaks or Other Public Health Emergencies in Healthcare Facilities

Strategies and Activities

Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

Strategy 1: Improve Infection Prevention and Control to Prevent Transmission in Healthcare

Healthcare workers increase knowledge of IPC in the context of outbreaks and emergency responses

Local, national, and regional partners increase ability to respond to outbreaks and emergencies in healthcare facilities

IPC in the context of outbreaks and emergencies in healthcare facilities is improved

Outbreaks and emergencies in healthcare facilities and affected communities are controlled and prevented

i. Purpose This NOFO will enhance detection and response to infectious disease threats in healthcare facilities globally by developing networks to implement prevention and containment strategies at local, national, and regional levels. Interventions to prevent, detect, and respond to infectious disease threats in healthcare, including AMR, HAIs, and COVID-19, will be developed and implemented within networks. The NOFO will also improve the detection of emerging AMR and identify AMR risk factors and prevention strategies across healthcare and the community to inform global AMR containment efforts.

ii. Outcomes Component 1 – Detect and Respond to Infectious Disease Threats in Healthcare Facilities

Strategy 1: Prevent Transmission of Infections in Healthcare Facilities Short-Term Outcomes

Healthcare workers increase collection and use of HAI surveillance and IPC monitoring data

Healthcare workers increase knowledge of IPC interventions and approaches to prevent HAIs

Healthcare facilities increase implementation of IPC strategies to prevent transmission of infectious disease threats

Intermediate Outcomes

Infectious disease threats are identified and contained in healthcare facilities Healthcare workers use HAI surveillance and IPC monitoring data to inform, monitor, and improve prevention interventions

Long-Term Outcomes

HAIs are reduced and safe healthcare is delivered

Strategy 2: Detect and Respond to Emerging Antimicrobial Resistance in Healthcare Facilities Short-Term Outcomes

Clinical and reference laboratory staff increase ability to detect emerging AMR Healthcare workers increase collection and use of AMR data

Intermediate Outcomes

Emerging AMR threats are identified and contained within healthcare facilities Healthcare worker use AMR data to inform, monitor, and improve prevention interventions Supportive systems for AMR containment are improved

Long-Term Outcomes

Facilities and countries are better prepared to respond to emerging AMR threats in healthcare

Component 2 – Improve Capacity to Detect and Monitor Emerging Antimicrobial Resistance

Strategy 1: Assess Antimicrobial Resistance in Healthcare Settings Short-Term Outcomes

Clinical and reference laboratory staff increase ability to detect emerging AMR in clinical isolates

Methods developed to collect epidemiologic data to monitor emerging AMR in healthcare

Intermediate Outcomes

Emerging AMR threats in healthcare settings are identified Risk factors driving the emergence of AMR threats in healthcare settings are identified

Long-Term Outcomes

Countries and regions better understand AMR in healthcare settings

Strategy 2: Assess Antimicrobial Resistance in Enteric Pathogens Short-Term Outcomes

Clinical and reference laboratory staff increase ability to detect emerging AMR in enteric pathogens

Methods developed to collect epidemiologic data and/or set up surveillance for emerging AMR in enteric pathogens

Intermediate Outcomes

Emerging AMR threats in enteric pathogens are identified Risk factors driving the emergence of AMR threats in enteric pathogens are identified

Long-Term Outcomes

Countries and regions better understand AMR in enteric pathogens

Strategy 3: Assess Antimicrobial Resistance in Fungal Pathogens Short-Term Outcomes

Clinical and reference laboratory staff increase ability to detect emerging AMR in fungal pathogens

Methods developed to collect epidemiologic data and/or set up surveillance for emerging AMR in fungal pathogens

Intermediate Outcomes

Emerging AMR threats in fungal pathogens are identified Risk factors driving the emergence of AMR threats in fungal pathogens are identified

Long-Term Outcomes

Countries and regions better understand AMR in fungal pathogens

Strategy 4: Assess Antimicrobial Resistance in Invasive Bacterial and Respiratory Pathogens Short-Term Outcomes

Clinical and reference laboratory staff increase ability to detect emerging AMR in invasive bacterial and respiratory pathogens

Methods developed to collect epidemiologic data and/or set up surveillance for emerging AMR in invasive bacterial and respiratory pathogens

Intermediate Outcomes

Emerging AMR threats in invasive bacterial and respiratory pathogens are identified Risk factors driving the emergence of AMR threats in invasive bacterial and respiratory pathogens are identified

Long-Term Outcomes

Countries and regions better understand AMR in invasive bacterial and respiratory pathogens

Strategy 5: Assess Antimicrobial Resistance in N. gonorrhoeae Short-Term Outcomes

Clinical and reference laboratory staff increase ability to detect emerging AMR in N.

gonorrhoeae

Methods developed to identify novel strains/isolates, collect epidemiologic data, and/or set up surveillance for emerging AMR in N. gonorrhoeae

Intermediate Outcomes

Emerging AMR threats in N. gonorrhoeae are identified Molecular assays to detect AMR in N. gonorrhoeae are developed and deployed Risk factors driving the emergence of AMR threats in N. gonorrhoeae are identified

Long-Term Outcomes

Countries and regions better understand AMR in N. gonorrhoeae

Component 3 – Rapid Response to Infectious Disease Outbreaks or Other Public Health Emergencies in Healthcare Facilities

Strategy 1: Improve Infection Prevention and Control to Prevent Transmission in Healthcare Facilities Short-Term Outcomes

Healthcare workers increase knowledge of IPC in the context of outbreaks and emergency responses

Local, national, and regional partners increase ability to respond to outbreaks and emergencies in healthcare facilities

Intermediate Outcomes

IPC in the context of outbreaks and emergencies in healthcare facilities is improved

Long-Term Outcomes

Outbreaks and emergencies in healthcare facilities and affected communities are controlled and prevented

iii. Strategies and Activities Component 1 – Detect and Respond to Infectious Disease Threats in Healthcare Facilities

Strategy 1: Prevent Transmission of Infections in Healthcare Facilities

Create and coordinate a network of at least three (3) hospitals with adequate laboratory and IPC capacity in a country or countries to participate in a CDC-organized global “network of networks” focused on harmonized HAI data collection linked to evidence-based and data-driven HAI prevention efforts and innovation to improve the science of HAI prevention.

o Network coordinators should provide additional IPC support to participating hospitals or identify a partner who can do so.

Priority activities for network coordinators include:

o Engage with global network coordinators at CDC to develop surveillance and prevention protocols to implement across network hospitals, with an initial focus on healthcare-associated bloodstream infections (HA-BSI) and healthcare-associated transmission of COVID-19 o Facilitate communication and coordination between network hospitals and partners to support HAI data collection and prevention activities o Coordinate trainings and meetings of network hospitals and partners and provide feedback to network hospitals to ensure standardized implementation of network activities o Collect and share relevant and agreed upon data pertaining to facility and/or network-level HAI surveillance and prevention activities within the network and with CDC using the global network reporting system on an ongoing and routine schedule A commitment to data sharing is necessary for network participation o Adhere to patient privacy and data storage standards as set forth by global, national, and local standards o Adapt information technology (IT) infrastructure to align with CDC reporting requirements and the global network reporting system o Participate in monitoring and evaluation of network performance o Participate in meetings of CDC’s steering group for global network activities o Adapt networks over time to add new HAI surveillance and prevention activities across the global network and/or network-specific discretionary activities in collaboration with CDC’s global network coordinators o Use the network’s expertise to support other hospitals in the region, including provision of technical assistance, mentoring, and/or training in HAI surveillance and prevention techniques

Priority activities to be implemented by network hospitals include:

o Validated collection of HAI data to address network priorities (e.g., HA-BSI and

COVID-19, initially). Data collection activities must be harmonized across network hospitals. These activities may include:

Regular periodic HAI point prevalence surveys (PPS) using standardized methods, harmonized definitions, and standardized presentation of results across the network

Continuous, outcome-based HAI surveillance utilizing methods that assure within-site comparability of results over time (e.g., trend analysis)

Practice-based IPC monitoring activities using methods that assure within-site comparability of results over time (e.g., trend analysis) o Development and support of evidence-based HAI prevention programs to address network priorities (e.g., HA-BSI and COVID-19, initially) and sharing of strategies and experiences with CDC and global network collaborators. These activities may include:

Implementation of core prevention strategies (based on scientific evidence and demonstrated feasibility) for targeted HAIs using standardized methods

Development of new initiatives for supplemental prevention strategies (based on some scientific evidence and variable levels of feasibility) or novel supplemental strategies based on patient population and health system context o Implementation of additional, network-specific discretionary activities in collaboration with CDC’s global network coordinators. Initial discretionary activities may include:

Response to healthcare-associated outbreaks using standardized methods and collaboration across the network Validation and/or feasibility assessments of novel HAI surveillance methods or definitions Pilot implementation of novel IT or information systems to support and enhance HAI surveillance

Priority activities for the network-level IPC team include:

o Participate in trainings and meetings with network coordinators to ensure standardized implementation of network activities o Provide training and technical assistance to IPC teams at network hospitals to implement HAI surveillance and prevention activities o Facilitate communication between IPC teams at hospitals across the network

Strategy 2: Detect and Respond to Emerging Antimicrobial Resistance in Healthcare Facilities

Create and coordinate a network of at least three (3) hospitals within a country or countries and at least one (1) reference laboratory within 18 months to participate in a CDC-organized global “network of networks” focused on the rapid identification, confirmation, response to, and containment of emerging AMR threats in healthcare settings.

o Network coordinators should provide additional IPC support to participating hospitals or identify a partner who can do so.

Priority activities for network coordinators include:

o Identify priority pathogens and AMR profiles to target for the network’s AMR containment response activities with global network coordinators at CDC and partners based on local epidemiology o Facilitate communication and coordination between network hospitals, laboratories, and partners to support AMR detection activities and containment responses o Coordinate trainings and meetings of network hospitals, laboratories, and partners and provide feedback to network hospitals and laboratories to ensure standardized implementation of network activities o Facilitate procurement of supplies and reagents and shipping of isolates between network hospitals and laboratories o Collect and share relevant and agreed upon data pertaining to laboratory results and containment responses with CDC using the global network reporting system routinely A commitment to data sharing is necessary for network participation o Adhere to patient privacy and data storage standards as set forth by global, national, and local standards o Adapt and implement IT infrastructure to align with CDC reporting requirements and the global network reporting system o Participate in monitoring and evaluation of network performance o Participate in meetings of CDC’s steering group for global network activities o Adapt networks over time to add new priority AMR threats, laboratory methods, data collection tools and systems, and IPC strategies o Use the network’s expertise to support other hospital laboratories and IPC teams in the region, including provision of technical assistance, mentoring, and/or training in detection and containment of emerging AMR threats

Priority activities for network hospital clinical laboratories include:

o Test priority pathogen isolates obtained from routine hospital clinical and surveillance cultures to determine if they meet criteria for referral or containment response according to network protocols o Refer all isolates meeting referral criteria and supporting documentation to the network’s reference laboratory within 24 hours for additional characterization if not performed in the hospital laboratory o Store all isolates meeting network referral criteria at -20°C or -70°C for a period of at least 6 months and refer isolates to a supporting national, regional, or global reference laboratory, if needed or requested o For isolates meeting the containment response criteria, report laboratory results to the network’s alert reporting system within 24 hours of detection, and engage appropriate network partners o Share agreed-upon laboratory results and other relevant data to the global network reporting system for all isolates tested as part of network activities on at least a monthly basis A commitment to data sharing is necessary for network participation o Test colonization screening specimens collected during network containment response activities according to network protocols using validated methods o Participate in trainings and meetings to ensure standardized implementation of network activities o Pilot innovative laboratory testing methods in concert with network partners and CDC and share results with global network collaborators

Priority activities for network reference laboratories include:

o Monitor the network’s alert reporting system daily, assist with assessment of any alerts, and coordinate isolate transportation for additional characterization if needed o Test clinical isolates and colonization screening specimens referred from network hospitals according to network protocols o Support network hospitals to test colonization screening specimens using targeted gene testing or other methodology according to network protocols and strengthen colonization screening testing capacity at the hospital laboratories o Store isolate- and specimen-level laboratory results for all isolates tested for the network for a period of at least 2 years after receiving the specimen o Store all isolates received from network hospitals or other laboratories that meet criteria at -70°C for a period of at least 2 years and refer isolates to a supporting national, regional or global reference laboratory, if needed or requested o Ship select isolates to the regional or global reference laboratory for routine confirmatory testing and participate in proficiency testing activities based on methods and timelines developed in collaboration with CDC o Routinely deposit whole genome sequencing data to an agreed upon accessible repository, if performed o Participate in trainings and meetings to ensure standardized implementation of network activities o Pilot innovative reference testing methods in concert with network partners and CDC and share results with global network collaborators

Priority activities for network hospital IPC teams include:

o Monitor the network’s alert reporting system for the facility daily and initiate containment activities for isolates requiring a containment response within 24 hours of receiving the alert o When isolates requiring a containment response are identified, conduct containment activities, including (but not limited to) laboratory data reviews, patient screening, point prevalence surveys, and IPC assessments, according to network protocols with adaptation to the facility’s resources and infrastructure as needed o Collect colonization screening specimens as indicated according to network containment protocols o Report relevant and agreed-upon containment response data to the global network reporting system and key stakeholders at least quarterly A commitment to data sharing is necessary for network participation o Report data for predefined performance measures/metrics for network containment activities annually o Participate in trainings and meetings to ensure standardized implementation of network containment activities o Pilot innovative IPC strategies in concert with network partners and CDC and share experiences and results with global network collaborators

Priority activities for the network-level IPC team include:

o Monitor the network’s alert reporting system daily and proactively reach out to network hospitals reporting alerts to offer assistance within 24 hours o Assist IPC teams at network hospitals to implement containment activities according to network protocols upon request o Monitor and evaluate network containment alerts for patterns in emerging AMR threats across hospitals in the network in collaboration and engage relevant partners o Facilitate communication between IPC teams at hospitals across the network o Coordinate containment responses across hospitals when an outbreak involves multiple hospitals in the network o Participate in trainings and meetings to ensure standardized implementation of network containment activities

Component 2 – Improve Capacity to Detect and Monitor Emerging Antimicrobial Resistance

Activities within this component aim to assess AMR at the interface of healthcare and community settings outside of the United States and may be performed within or outside of an existing network of healthcare facilities and/or community sites, as appropriate. Applicants may propose activities to support a single strategy or multiple strategies.

Strategy 1: Assess Antimicrobial Resistance in Healthcare Settings

Prioritized activities may include the following:

o Design and implement projects to inform, implement, and/or evaluate AMR prevention and control strategies in healthcare settings Develop strategies to better estimate the burden of AMR in healthcare settings and its associated costs and/or cost-effectiveness of AMR prevention interventions (e.g., antimicrobial stewardship, IPC programs, etc.) in healthcare settings

Develop and implement projects to address the limitations of passive, isolate-based AMR surveillance in healthcare settings, including studies to improve diagnostic stewardship and clinicians’ use of microbiology services and surveillance studies using case-based approaches

Improve antimicrobial stewardship in healthcare settings and develop effective, resource-appropriate methods for monitoring antimicrobial use in low- and middle-income countries

Support implementation science-based approaches to improving AMR prevention interventions (e.g., antimicrobial stewardship, IPC programs, etc.) in healthcare settings o Design and implement projects to improve the monitoring of emerging AMR and assess relationships between AMR in healthcare settings, the community, and the environment

Perform whole genome sequencing of isolates exhibiting AMR to describe the molecular epidemiology of AMR in a region, describe the resistome of isolates, or evaluate transmission of AMR in a geographic area (e.g., hospital, community, or region)

Assess risk factors for development of AMR infections in patients with and without exposures to healthcare settings, including colonization with organisms exhibiting AMR o Examine potential relationships between environmental risk factors (e.g., effluent from healthcare facilities, etc.) and AMR infections in humans

Strategy 2: Assess Antimicrobial Resistance in Enteric Pathogens

Prioritized activities may include the following:

o Build whole genome sequencing (WGS) capacity among PulseNet International

(PNI) participants including the 12-country PulseNet Africa (PNAFR) region, the 16-country PulseNet Latin America and the Caribbean (PNLAC) region, the 13-country PulseNet Asia Pacific (PNAP) region, the 13-country PulseNet Middle East (PNME) region, and the country of Georgia to improve detection and surveillance of emerging multidrug-resistant (MDR) enteric bacteria and ensure that data are comparable across countries in these surrounding regions.

Develop action plans in collaboration with existing PulseNet (PN) members in the country/region and laboratory and epidemiology teams to implement and validate WGS as a subtyping method and tool to monitor emerging antibiotic resistance mechanisms

Build laboratory, analysis, and bioinformatics capacities by providing training and technical assistance for PNI countries and laboratory scientists in PNI countries/regions

Launch pilot project to demonstrate the value of using WGS to characterize emerging MDR enteric bacteria and strengthen communication between laboratory scientists and epidemiologists in the PNI countries/regions

Use data generated from improved laboratory and/or epidemiology capacity to inform, implement, and/or evaluate strategies to prevent spread of AMR in enteric pathogens o Build or enhance capacity to isolate, identify, and conduct antimicrobial susceptibility testing and/or whole genome sequencing for enteric/diarrheal infections, measure exposure risk from potential sources (human, animal, environment), and implement and/or evaluate effectiveness of conventional and non-conventional treatments and prevention strategies, with a focus on regions/countries where enteric pathogens are endemic including: Middle East (Lebanon, Saudi Arabia), Africa (Kenya, Tanzania, Mozambique, Ethiopia, Zambia, Uganda), Asia (Pakistan, Bangladesh), and the Americas and Caribbean (Haiti, Guatemala).

Detect emerging resistance to entering pathogens to treatment drugs of choice, including fluoroquinolones, 3rd generation cephalosporins, azithromycin, and carbapenems

Assist regions with the development of protocols to assure that similar laboratory and analytic methods are used and the same nomenclature is applied so that strains with emerging resistance can be tracked regionally and globally

Build surveillance capacity to collect epidemiological (e.g., demographics, exposures) and clinical (e.g., severity, outcomes) data on patients infected with antibiotic resistant enteric bacteria to determine exposures (e.g., food, animal, environment), risk factors, and clinical outcomes of infection

Build capacity to strengthen data systems for surveillance and outbreak investigations and build communication systems for relaying results of investigations to partners

Build capacity to investigate and prevent outbreaks of antibiotic-resistant enteric illness linked to food, animals, animal feed, or the environment

Obtain samples from food, animals, animal feed, and the environment, and associated epidemiologic information, to detect and prevent antibiotic-resistant enteric bacteria

Detect and characterize AMR bacteria in drinking water sources and other water types (e.g., surface water, wells) used for household activities (e.g., washing, cooking)

Implement AMR testing of pathogenic isolates collected from water sources (e.g., taps, surface water, springs) known or suspected to be associated with a disease outbreak

Institute testing or regular monitoring of AMR organisms in wastewater or fecal sludge (e.g. rapid screening of extended-spectrum beta-lactamase-producing E. coli via modified conventional water testing)

Assess the survival and dissemination of AMR bacteria in wastewater or fecal sludge in low sanitation settings (e.g., retention ponds, open drains, latrines)

Assess the impact that inadequate population coverage with safely managed sanitation and drinking water has on creating an environment that facilitates emergence and transmission of new highly resistant enteric pathogens

Assess adult and/or pediatric exposure risks for AMR-specific organisms from poor water, sanitation, and hygiene facilities

Strengthen surveillance of Salmonella Typhi and invasive non-Typhi Salmonella clinical specimens to help target and prioritize typhoid vaccination and prevention strategies in endemic countries

Conduct clinical studies on the effectiveness of different antimicrobial regimens to cure acute episodes of extensively drug-resistant (XDR) typhoid fever and to eliminate carriage of XDR Typhi strains from chronic carriers

Evaluate non-conventional treatment agents for diarrheal diseases that would reduce the demand for antimicrobial treatment (for example, Pepto- Bismol or its active ingredient, bismuth subsalicylate)

Strategy 3: Assess Antimicrobial Resistance in Fungal Pathogens

Prioritized activities may include the following:

o Increase support and capabilities for identification, surveillance, and response to known and emerging antifungal resistant threats (i.e. C. auris, Azole-resistant aspergillus), specifically in the following regions/countries: South and Central American countries, Pacific island countries (including Guam), Dominican

Republic, Southeast Asian countries (including Pakistan, Bangladesh, Indonesia), India, Japan, East African countries (including Tanzania, Kenya), South Africa, Middle East countries (including United Arab Emirates).

Build focused and detailed epidemiology, laboratory, and bioinformatics capacity for antifungal resistant diseases and outbreaks

Engage frontline personnel and lead training in CDC best practices for the broader workforce supporting the prevention and control of antifungal resistant pathogens

Target guidance and tools to better reach communities and populations at increased risk for antifungal resistant diseases and reduce antifungal resistant disease spread in targeted healthcare facilities or high-risk settings

Monitor and evaluate the impact and effectiveness of implemented strategies for improved antifungal resistant infection prevention and control practices

Strategy 4: Assess Antimicrobial Resistance in Invasive Bacterial and Respiratory Pathogens

Prioritized activities may include the following:

o Build or enhance bacterial culture capacity, molecular AMR testing capacity, and/or whole genome sequencing capacity in sites conducting surveillance for meningitis, S. pneumoniae, Group B Streptococcus, or Group A Streptococcus, specifically in the following countries: Burkina Faso, Niger, Mali, Togo, Benin, Senegal, Ghana, South Africa, Kenya, Mozambique, India, Indonesia, Thailand, Haiti, El Salvador, Costa Rica, and Brazil o Enhance B. pertussis laboratory-based surveillance and evaluate macrolide resistance in nasopharyngeal specimens of patients tested positive for pertussis, focusing on participating sites of established platform for culture diagnostics and PCR capacity in the following countries: Mexico, Panama, Colombia, Brazil, Argentina, and Chile o Use data generated from improved laboratory and/or epidemiology capacity to inform, implement, and/or evaluate vaccine efficacy and improvement and other strategies to prevent spread of AMR in invasive bacterial and respiratory pathogens

Strategy 5: Assess Antimicrobial Resistance in N. gonorrhoeae

Prioritized activities may include the following:

o Expand Enhanced Gonococcal Antimicrobial Surveillance Programme (EGASP) activities and capabilities at sites where this work has already begun (Thailand, Philippines), and implement EGASP, per established protocol, in new regions/countries, prioritizing areas with little to no data on gonococcal infection rates and/or antimicrobial resistance levels, with known or suspected high levels of AMR among gonococcal infections, or with existing gonococcal laboratory and/or surveillance capacities, specifically in the following regions/countries:

Africa (South Africa, Côte d’Ivoire, Kenya, Zambia, Uganda), South America

(Brazil, Argentina, Peru), Eastern Mediterranean (Georgia), Southeast Asia (India), Western Pacific (Cambodia, Vietnam) o Use data generated from improved laboratory and/or epidemiology capacity to inform, implement, and/or evaluate strategies to prevent the spread of AMR in N.

gonorrhoeae o Build focused and detailed epidemiology, laboratory, and data sharing capacity for tracking spread of and risk factors for AMR M. genitalium

Component 3 – Rapid Response to Infectious Disease Outbreaks or Other Public Health Emergencies in Healthcare Facilities

Strategy 1: Improve Infection Prevention and Control to Prevent Transmission in Healthcare Facilities

Develop outbreak-specific IPC policies, procedures, guidelines, and trainings in collaboration with government and non-government partners

Identify and train IPC focal persons responsible for implementation of IPC practices at priority healthcare facilities

Provide on-site supportive supervision and mentorship to improve implementation of IPC practices at priority healthcare facilities

Improve screening and triage at healthcare facilities to rapidly identify, isolate, and refer suspect cases for treatment

Implement enhanced surveillance of healthcare workers and inpatients at healthcare facilities

1. Collaborations

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

Recipients are encouraged to work with CDC and other CDC implementing partners, including Ministries of Health, other host government agencies, multilateral organizations, non-governmental organizations, academic institutions, and other entities that receive CDC funds in the country or countries where they implement strategies and activities. Recipients should ensure their proposed activities are not duplicating activities already implemented by other CDC-funded organizations.

b. With organizations not funded by CDC:

Recipients are encouraged to build and sustain strategic partnerships and collaborations with regional, national, and local agencies and organizations that have a role in supporting the implementation of a recipient’s proposed work plan/activities and achieving expected outcomes.

Partners and collaborators may include government agencies, academic institutions, non-governmental organizations, and healthcare facilities and laboratories.

Applicants to Component One must implement activities within a network of hospitals, IPC support partner, and/or reference laboratories. Applicants to Component One must submit letters of support from all hospitals, IPC support partners, and/or reference laboratories proposed in their network that demonstrate their willingness to collaborate in a network.

Applicants to all components may also provide letters of support from host government agencies and other collaborating organizations. Applicants should combine all letters of support into a single document, name the file “Letters of Support,” and upload the file as a pdf at www.grants.gov. A maximum of 15 letters of support per component are allowed.

2. Target Populations The target population includes, but is not limited to, those individuals affected and infected by infectious diseases or at risk for becoming infected by an infectious disease. This may also include at-risk populations for non-communicable diseases and/or other public health emergencies.

a. Health Disparities Epidemic diseases affect the connectivity within societies, and their impacts may be exacerbated by social divides, economic disparities, and injustices that lead to inequities in healthcare. Given that it is possible the COVID-19 pandemic will lead to increased AMR infections in both community and healthcare settings, and result in worse outcomes in hospitalized patients, including COVID-19 patients, these affects will be more pronounced for disproportionately burdened populations, disproportionately burdened healthcare facilities, and healthcare workers working in workplace environments with disproportionate risk. Applicants are encouraged to describe how health disparities will be addressed in their proposals. Applicants may propose evidence-based strategies to better understand the burden, risk factors, and prevention strategies for AMR in both healthcare and community settings and how they will inform local, regional, and global responses to contain the emergence of concerning AMR for populations disproportionately burdened populations.

iv. Funding Strategy This NOFO is divided into three components – the applicant is required to propose work in a country or region with a clearly marked budget and work plan for each component. The NOFO has two core components: Component One: Detecting and Responding to Infectious Disease Threats in Healthcare Facilities and Component Two: Improve Capacity to Detect and Monitor Emerging Antimicrobial Resistance. Component Three is designed to support a response to a designated emergency event (Rapid Response to Infectious Disease Outbreaks or Other Public Health Emergencies in Healthcare Facilities).

Applicants may apply for one or multiple components; a separate application must be submitted for each component. Only recipients selected to receive funding for Component One, Component Two, or both will be considered for funding for Component Three.

Applicants may propose activities to support a single strategy or multiple strategies within each component. Applicants must clearly specify the strategies they plan to support and the activities within each strategy that they plan to implement within a clearly marked budget and work plan.

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 One plan and projection of strategies and activities to be accomplished in later years.

Component One (Detecting and Responding to Infectious Disease Threats in Healthcare Facilities) within this NOFO is intended to be funded on an annual basis. The estimated Year http://www.grants.gov

One funding level $10,000,000. Future year funding levels will be dependent on funding availability.

Component Two (Improve Capacity to Detect and Monitor Emerging Antimicrobial Resistance) within this NOFO is intended to be funded on an annual basis. The estimated Year One funding level $3,000,000. Future year funding levels will be dependent on funding availability.

The final decision on which components and strategies will be funded will be made at the time of award. Applications will be rank ordered. Program will use a separate rank ordered listing for each Component. CDC can fund out of rank order in order: 1) to align with USG and/or agency prioritized technical areas and activities; 2) to align with funding availability for a geographic area at the time of the award; 3) to ensure maximum coverage of activities geographically; 4) to avoid duplication of activities in other CDC funding mechanisms; or 5)…