CDC-RFA-CK-23-0003.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Strengthening Global Capacity for Molecular Surveillance and Outbreak Response for Enteric Diseases

CDC-RFA-CK-23-0003

05/15/2023

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- CK-23-0003. 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:

Strengthening Global Capacity for Molecular Surveillance and Outbreak Response for Enteric Diseases 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-CK-23-0003

E. Assistance Listings Number:

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

93.318 F. Dates:

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

04/14/2023

2. Due Date for Applications:

05/15/2023 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

March 29, 2023, at 8:00 AM U.S. Eastern Standard Time

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G. Executive Summary:

1. Summary Paragraph This NOFO aims to build regional and country capacity to prevent, detect, respond to and control diseases spread through food, water, and animal contact, also referred to as enteric diseases.

This NOFO will be funded through 2 components. Applicants must apply for both components to be considered.

Component 1: Core surveillance, preparedness, and emergency response activities.

Component 2: Expanded surveillance, preparedness, and emergency response activities as identified by current or future appropriations or funding availability.

There are 2 strategies that apply to both components in this NOFO. Applicants must propose at least one activity for each strategy.

Strategy 1: Strengthen public health and environmental surveillance of enteric diseases Strategy 2: Build country capacity to prepare for and respond to enteric disease outbreaks

Up to three applicants will be selected to receive initial funding for Component 1 to conduct core surveillance, preparedness, and emergency response activities. Applicants not initially selected for a Component 1 award will be included on the Approved but Unfunded (ABU) roster and may be eligible for an award if additional funding becomes available.

This NOFO will also establish an ABU list for Component 2 to conduct expanded surveillance, preparedness, and emergency response activities if additional funding becomes available in the https://www.grants.gov/ https://teams.microsoft.com/l/meetup-join/19%3ameeting_ZGNhZDM2MjYtZDFkMy00YmEzLTk4ZjMtZGYwMGY2YzNmMDFk%40thread.v2/0?context=%7b%22Tid%22%3a%229ce70869-60db-44fd-abe8-d2767077fc8f%22%2c%22Oid%22%3a%22a3ac5ef6-a3f6-4d6f-ba0d-3f926f4f694c%22%7d tel:+14047183800,,89516562 tel:8889944478,,89516562 event of a large-scale public health threat. The number of recipients will depend on the availability of funding.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards Component 1: Up to three applicants will be selected to receive initial funding for Component 1 to conduct core surveillance, preparedness, and emergency response activities. Applicants not initially selected for a Component 1 award will be included on the ABU roster and may be eligible for an award if additional funding becomes available.

Component 2: This NOFO will also establish an ABU list to conduct expanded surveillance, preparedness, and emergency response activities if additional funding becomes available in the event of a large-scale public health threat. The number of awardees will depend on the availability of funding.

d. Total Period of Performance Funding:

$30,000,000

e. Average One Year Award Amount:

$2,000,000 Component 1: $333,333 average funding available per fiscal year per recipient

Component 2: $1,666,667 average funding available per fiscal year per recipient

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

September 01, 2023

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 Diseases spread through food, water or animal contact (enteric diseases) pose a significant global health threat, especially in low- and middle-income countries. Annually, 1 in 10 people worldwide acquire a foodborne illness. These illnesses can lead to severe morbidity and mortality if not treated correctly. The outcome of this NOFO is to improve global capacity to conduct genomic-testing and investigation, improved data integration and sharing, and sustained resource and workforce development to reduce morbidity and mortality from enteric diseases.

Within this approach are two components: 1. Core surveillance, preparedness, and emergency response activities; and 2. Expanded surveillance, preparedness, and emergency response activities as identified by current or future appropriations or funding availability in the event of a large-scale public health threat. Component #2 is intended to fund expansions or scale-up of the strategies and activities with recipients, in the event of a large-scale public health emergency where additional funding becomes available.

There are two strategies for both components. Strategy 1, strengthen public health and environmental surveillance of enteric diseases, includes strengthening laboratory capacity and wastewater and environmental surveillance. By strengthening laboratory capacity, countries can correctly identify the cause of illness and link them to potential sources, ensuring timely case management and rapid outbreak response. Global laboratory capacity building includes laboratory system evaluation, diagnostic and identification capacity reinforcement, and whole genome sequencing-based characterization approaches to improve lab-based enteric disease surveillance, monitoring antimicrobial resistance and strain spread and transmission. Wastewater and environmental surveillance are effective tools to inform public health response to disease threats by providing infection data within communities. Environmental microbiology laboratory capacity building and best practices for data collection, interpretation, and integration into existing surveillance activities are critical to building robust, sustainable wastewater or environmental surveillance systems.

Strategy 2, country capacity building for preparation and response to enteric disease outbreaks, includes improving resource acquisition and utilization, as well as workforce development and taking a multi-sectoral and One Health approach. As highlighted in the COVID-19 pandemic, there is a need for the development and evaluation of evidence-based practices in implementing and managing Water, Sanitation, and Hygiene (WASH) infrastructure for improved response capacity. Improved access to and use of WASH preparedness and mitigation measures promotes equity in low-resource, vulnerable populations, especially if promoted in key settings like public spaces, border crossings, healthcare settings, and markets.

Similarly, the development of a country’s public health workforce through early career training and continuing education can improve a country's capacity for enteric disease outbreaks.

Expanded knowledge and expertise development creates a sustainable resource in country and decreases the reliance on external resources to address public health emergencies. It addresses the health equity pillars of availability, accessibility, acceptability and quality through human resources. Increasing access to resources and improving education can reduce illness and death from disease, leading to improved health, poverty reduction, and socio-economic development.

b. Statutory Authorities This program is authorized under Public Health Service Act Sections 301(a) [42 U.S.C.

241(a)] and 317(k) (2) [42 U.S.C. 247b (k) (2)], as amended. 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.

c. Healthy People 2030 https://www.unicef.org/media/91266/file/UNICEF-Strategy-for-WASH-2016-2030.pdf https://www.unicef.org/media/91266/file/UNICEF-Strategy-for-WASH-2016-2030.pdf https://www.cdc.gov/globalhealth/equity/vision.html

This project supports the following Healthy People 2030 topic areas:

1. Global Health

2. Public Health Infrastructure

3. Health Care Access and Quality

4. Infectious Disease

5. Emergency Preparedness

d. Other National Public Health Priorities and Strategies Activities funded through this cooperative agreement must align with the following United States Government (USG) and HHS/CDC strategies and policies:

CDC’s strategy for improving global health security (GHS), based on three concepts embedded in the agency’s mission to protect public health worldwide: 1) Prevent 2) Detect 3) Respond

The Department of Health and Human Services’ (HHS) Global Health Strategy International Health Regulations (IHR) 2005 and supporting policies

e. Relevant Work The Division of Foodborne, Waterborne, and Environmental Diseases (DFWED) works internationally to prevent death or disability caused by enteric diseases. The Division’s overall global program mission is to strengthen global health security through epidemiological and laboratory capacity building; strategic partnerships, and; preparedness for detection, control, and prevention of enteric disease threats. DFWED supports PulseNet International, build laboratory capacity to identify pathogens or antimicrobial resistance, and assist with outbreaks.

CDC/DFWED advances the health of people through improved and sustained access to safe water, adequate sanitation, and hygiene (WASH).

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Component 1: Core surveillance, preparedness, and emergency response activities.

Component 2: Expanded surveillance, preparedness, and emergency response activities as identified by current or future appropriations or funding availability in the event of a public health threat.

Strategies and Activities

Short-term Outcomes

Intermediate Outcomes

Long-term Outcomes https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health https://health.gov/healthypeople/objectives-and-data/browse-objectives/public-health-infrastructure https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care-access-and-quality https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease https://health.gov/healthypeople/objectives-and-data/browse-objectives/emergency-preparedness 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.who.int/health-topics/international-health-regulations#tab=tab_1 https://www.cdc.gov/ncezid/dfwed/international/gfin.html https://www.cdc.gov/pulsenet/index.html https://www.cdc.gov/ncezid/dfwed/edlb/index.html https://www.cdc.gov/ncezid/dfwed/edlb/index.html https://www.cdc.gov/ncezid/dfwed/waterborne/index.html https://www.cdc.gov/ncezid/dfwed/waterborne/index.html

1. Strengthen public health and environmental surveillance of enteric diseases

Build or reinforce country- or regional-level laboratory infrastructural, operational, and workforce capacity to conduct genomic surveillance, bioinformatics, and antimicrobial susceptibility testing

Strengthen national or sub-national public health and clinical laboratory capacity for enteric disease diagnosis, case confirmation, quality, and data reporting

Develop and improve systematic collection of epidemiologic data related to outbreak surveillance and response.

Develop or improve the integration of laboratory and epidemiologic data for enteric disease surveillance

Build environmental microbiology

Increased laboratory capacity to conduct and interpret whole genome sequencing

Increased specimen referral, data sharing, information exchange, and collaboration capacity to link epidemiologic data to whole genome sequencing results capacity to conduct case confirmation for antimicrobial-resistant pathogens

Improved ability to detect, identify and confirm cases of enteric diseases

Improved global openness, interoperability, accessibility, and Reproducibility in public health bioinformatics for public health action

Improved countries’ capacity to conduct investigation, case management, outbreak response and surveillance of enteric diseases.

Improved countries’ capacity to conduct and integrate environmental and wastewater surveillance data into existing public health surveillance systems to plan and implement public health action

Improved countries’ surveillance and workforce capacities that are well-equipped and integrated for early warning, risk reduction, and response to national and global health threats

Improved availability of WASH functional resources for routine and emergency use

Improved global capacity to conduct genomic-testing and investigation, improved data integration and sharing, and sustained resource and workforce development to reduce morbidity and mortality from enteric diseases.

laboratory capacity to conduct testing of environmental samples, including water and wastewater

Develop, implement, or improve wastewater or environmental surveillance systems for existing or emerging infectious disease threats

Develop and/or implement best practices for environmental and wastewater surveillance programs and activities

2. Build country capacity to prepare for and respond to enteric disease outbreaks

Develop and strengthen the public health emergency response workforce

Provide technical assistance on enteric disease outbreaks

Support the provision of laboratory equipment and supplies during public number of integrated surveillance systems at the national and regional levels country-level capacity to conduct and interpret environmental and wastewater sampling

Identified country targets for environmental wastewater surveillance for public health threats and have started country-specific best-practices countries’ capacity to investigate cases and public health emergencies disease outbreak case management and infection

i. Purpose The purpose of this NOFO is to reduce morbidity and mortality due to enteric diseases globally.

Within this approach are two core strategies: 1. Strengthen public health and environmental surveillance of enteric diseases 2. Build country capacity to prepare for and respond to enteric disease outbreaks. These strategies will be achieved through two components: 1) Core health emergencies

Evaluate and improve access to WASH resources in healthcare and community spaces

Monitor and evaluate new WASH technologies and approaches to improve health outcomes control countries’ access to necessary supplies and equipment to rapidly detect and report public health threats access to and use of WASH resources

Increased use of fit-for-purpose WASH innovations surveillance, preparedness, and emergency response activities, 2) Expanded surveillance, preparedness and emergency response activities as identified by funding availability in the event of a large-scale public health threat.

ii. Outcomes Increased laboratory capacity to conduct and interpret whole genome sequencing Increased specimen referral, data sharing, information exchange, and collaboration Increased capacity to link epidemiologic data to whole genome sequencing results Increased capacity to conduct case confirmation for antimicrobial-resistant pathogens Improved ability to detect, identify and confirm cases of enteric diseases Increased number of integrated surveillance systems at the national and regional levels Improved country-level capacity to conduct and interpret environmental and wastewater sampling Identified country targets for environmental wastewater surveillance for public health threats and have started country-specific best-practices Improved countries’ capacity to investigate cases and public health emergencies Improved disease outbreak case management and infection control Increased access to and use of WASH resources Increased use of fit-for-purpose WASH innovations

iii. Strategies and Activities There are two strategies. Applicants must propose at least one activity under each strategy.

Component 1: Core surveillance, preparedness, and emergency response activities.

Strategy 1. Strengthen public health and environmental surveillance of enteric diseases

Build or reinforce country- or regional-level laboratory infrastructural, operational, and workforce capacity to conduct genomic surveillance, bioinformatics, and antimicrobial susceptibility testing

Strengthen national or sub-national public health and clinical laboratory capacity for enteric disease

Develop and improve systematic collection of epidemiologic data related to outbreak surveillance and response.

Develop or improve the integration of laboratory and epidemiologic data for enteric disease surveillance

Build environmental microbiology laboratory capacity to conduct testing of environmental samples, including water and wastewater

Develop, implement, or improve wastewater or environmental surveillance systems for existing or emerging infectious disease threats

Develop and/or implement best practices for environmental and wastewater surveillance programs and activities

Strategy 2. Build country capacity to prepare for and respond to enteric disease outbreaks

• Develop and strengthen the public health emergency response workforce

• Provide technical assistance on enteric disease outbreaks

• Support the provision of laboratory equipment and supplies during public health emergencies

• Evaluate and improve access to WASH resources in healthcare and community spaces

• Monitor and evaluate new WASH technologies and approaches to improve health outcomes

Component 2: Expanded surveillance, preparedness, and emergency response activities as identified by current or future appropriations or funding availability in the event of a large-scale public health threat.

Component #2 is intended to fund expansions or scale-up of the strategies and activities with recipients, in the event of a public health emergency where additional funding becomes available.

1. Collaborations

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

Recipient(s) are required to work with other CDC implementing partners, including non-governmental organizations, universities, Ministries of Health and other host governmental bodies and multi-lateral organizations that receive CDC funds. Recipient(s) should ensure their proposed activities are not duplicating activities already implemented by other CDC-funded organizations.

b. With organizations not funded by CDC:

The recipient(s) will work primarily and directly with partner governments, specifically the Ministries of Health and other government entities who work towards the objectives of this NOFO. In addition, the recipient(s) will be expected to work with other in-country and global stakeholders, including but not limited to government entities, non-governmental organizations, universities, civil society, the private sector, and other USG agencies. The recipient(s) will be expected to collaborate with other partners with human and animal surveillance experience.

2. Target Populations The target populations for this NOFO include, but are not limited to, those individuals/communities disproportionally infected and affected by enteric diseases, at risk for becoming infected by enteric diseases and/or include at-risk populations for public health emergencies. In describing the target population and approaches, the applicant will describe to what extent their approach advances one or more of the four core pillars of global health equity (availability, accessibility, acceptability and quality) in the proposed country or countries.

This NOFO has an international/global geographic scope. Although a pre-determined list of countries is not provided, applicants should include a justification for proposed work in a geographic location that includes: a description of the enteric disease burden; identified gaps or needs that the project aims to address; applicants should use the foodborne disease burden estimates foodborne disease burden estimates to identify foodborne disease burden for the country proposed, washdata.org to identify WASH capacity in households, schools, and healthcare facilities for the country proposed, the States Parties Self-Assessment Annual Reporting (SPAR) data and Joint External Evaluation (JEE) data to identify International Health https://www.cdc.gov/globalhealth/equity/vision.html https://www.foodbornediseaseburden.org/ferg/estimates https://www.foodbornediseaseburden.org/ferg/estimates https://www.foodbornediseaseburden.org/ferg/estimates https://washdata.org/ https://www.who.int/emergencies/operations/international-health-regulations-monitoring-evaluation-framework/states-parties-self-assessment-annual-reporting https://www.who.int/emergencies/operations/international-health-regulations-monitoring-evaluation-framework/states-parties-self-assessment-annual-reporting https://www.who.int/emergencies/operations/international-health-regulations-monitoring-evaluation-framework/joint-external-evaluations https://www.who.int/health-topics/international-health-regulations#tab=tab_1

Regulations (IHR) core capacities for the country proposed. Any additional data may be included from other published sources as available for the country proposed.

a. Health Disparities Recipients are expected to use epidemiologic, social determinants, and linked laboratory, epidemiological, and surveillance data to identify communities disproportionately affected by enteric diseases in the target areas to ensure that program activities appropriately cover these populations. Recipients will ensure that project approaches help to improve health equity of the populations served as they strive to achieve the outcomes of this NOFO.

iv. Funding Strategy This NOFO is divided into two (2) components. The applicant must apply to both components and include a separate budget and work plan for each component. Applicants may receive a Component 1 award, or a Component 2 award, or both.

The applicant’s package must be inclusive of all component work plans and budgets; multiple applications will not be reviewed. Applicants are encouraged to submit component budgets toward the year one award ceiling for each component. However, budget proposals for year one may not exceed the year one award ceiling. Please note these amounts are subject to approval and the availability of funds.

Component 1: Core surveillance, preparedness, and emergency response activities.

This component is intended to award up to three applicants to support the core surveillance strategies and activities outline in the logic model. Applicants not initially selected for a Component 1 award will be included on the ABU roster and may be eligible for an award if additional funding becomes available.

Component 2: Expanded surveillance, preparedness, and emergency response activities as identified by current or future appropriations or funding availability in the event of a large-scale public health threat.

This component is intended to be approved but unfunded (ABU) as a baseline practice. It would be funded to support additional or expanded surveillance activities needed within a budget period as identified by current or future appropriations during a large-scale emergency response.

Applicants who can support multiple countries in a geographic location or across the globe may be awarded for a higher amount of funds to support a multi-country approach. After award and in consultation/collaboration with CDC, recipients will be provided with an opportunity to develop a more customized project plan and budget that builds off their initial project plan and budget.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Monitoring:

CDC expects that the work conducted under this NOFO will be structured as a series of projects oriented at achieving elements of the NOFO’s strategic objectives. CDC and the recipient will jointly develop formal performance measures shortly after award based on activities within each project. For each project, these performance measures must include https://www.who.int/health-topics/international-health-regulations#tab=tab_1 indicators, as well as other CDC or recipient’s standard indicators relevant to the intended outcomes of the project. The indicators listed below are those that align with required CDC reporting elements for OMB, HHS, USG Global Health Security Agenda (GHSA) interagency, and Healthy People. At a minimum, applicants should describe proposed process measures for the strategies and activities in the logic model, and proposed outcome measures for the period of performance outcomes in the logic model. While recipients will be responsible for reporting on indicators relevant to proposed strategies and activities, they are not limited to only the indicators listed below. Applicants can, and are encouraged to, propose additional relevant indicators that, combined with those below, will be monitored over the life of the NOFO. Recipients will also be encouraged to identify relevant USG GHSA Interagency Metrics, WHO Joint External Evaluation (JEE), and/or Healthy People 2030 standardized metrics and WHO benchmarks.

Technical Area Indicators

SS/LS1: Number and proportion of country-prioritized enteric diseases with laboratory (clinical and environmental) testing capacity, surveillance system, and routine reporting to public health authorities SS2: Number and proportion of countries with a centralized national database that includes linked suspect case reports of enteric diseases and laboratory data from subnational jurisdictions for the country’s priority notifiable diseases/syndromes LS2: Number and proportion of designated laboratories that have bio-risk management policies, physical security controls and inventories for potential high consequence pathogens and toxins LS3: Number of new diagnostic tests established in national or regional laboratories with CDC support LS4: Number of new enteric disease pathogens, strains, or resistance patterns detected or discovered with CDC support LS5: Number and proportion of countries that have developed a national laboratory specimen referral system and transport networks

Surveillance Systems (SS) and Laboratory Systems

(LS)

LS6: Number and proportion of laboratory facilities, designated in the national action plan for antimicrobial resistance (AR) of enteric diseases or as part of a national surveillance system, that conduct antimicrobial susceptibility testing (AST) and have reported susceptibility data to a designated national body WD1: Number of individuals trained by CDC to prevent, detect and respond to public health threats caused by enteric diseases

Workforce Development

WD2: Number of Field Epidemiology Training Program (FETP) residents trained by CDC that have participated in enteric disease outbreak investigations and responses

WD3: Number and proportion of subnational jurisdictions per country that have had at least one staff member trained by FETP- Frontline

EMR1: Number of enteric disease public health events of international importance monitored and reported

EMR2: Number of enteric disease public health events and other global health emergency responses supported by CDC

EMR3: Number of enteric disease outbreaks investigated and responded to by the country

Emergency Management and Response (EMR)

EMR4: Number and proportion of countries with an established Public Health Emergency Operations Center (PHEOC) that have used their PHEOC for a real-world response or simulation for enteric diseases

Performance reports will be based on which NOFO activities and outcomes are identified in the logic model. Performance reports will be submitted to CDC in accordance with the requirements listed under this NOFO and overall performance will be reviewed on regular technical calls as well as through joint strategic review meetings.

Evaluation

The potential evaluation questions and/or topics below are examples of what the applicant may be expected to answer through evaluation(s). Applicants should include at least 1, but no more than 3 potential evaluation questions, or evaluation topics if specific questions are unknown. It is acceptable to provide only evaluation questions, only evaluation topics, or a combination of both evaluation questions and topic, as needed. Applicants should consider but are not limited to the following areas when developing evaluation questions and/or topics.

Sample Evaluation Topics:

Program evaluations to measure the differences in outbreak responses, or other public health responses, in a country, before and after public health investments (in terms of days of outbreak start, days to outbreak detection, laboratory confirmation of outbreak, days to control outbreak, etc.).

Extent to which enhancements in public health surveillance in a country improved outbreak response (in terms of outbreak(s) controlled, cases averted, and time lags from specimen detection to collection).

Extent to which enhancements of the public laboratory systems, such as addition of a specific laboratory capacity in a country, improved outbreak response (in terms of outbreaks detected controlled, cases averted, and time lags from specimen collection to detection).

Program evaluations to measure if the coverage and capacity of the specimen referral network increased

Final evaluation questions and data sources will be determined together with CDC within six months after the award and will be included in the submission of the evaluation and performance measurement plan (EPMP). Evaluations are expected to align with national, USG, and agency priorities and programmatic gaps, and maybe be reviewed by global action committees. As such, the evaluation topics listed in this announcement may be amended.

Dissemination of Evaluation and Performance Measures: By the end of the period of performance, evaluation and performance measures will yield findings to demonstrate the value of the NOFO. The findings should be disseminated through the Annual Performance Report (APR) and the recipient is expected to pursue additional dissemination in public domains, including in public health journals, including global health journals, conferences and through informal channels (e.g., website, newsletters) where applicable.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How the applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additional-requirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

https://www.cdc.gov/grants/additional-requirements/ar-25.html

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

The applicant should describe how they plan to measure and collect data on the funded activities and bolded outcomes identified in the logic model. The purpose of collecting and reporting these data is to determine the progress toward achieving the NOFO activities and outcomes. The results will also be used for program planning, development and improvement, accountability, and reporting, and for sharing with partners and other stakeholders. CDC will work with the recipient throughout the life of this award to ensure that all activities and expected outcomes are in alignment with current USG and the recipient’s strategies and goals. The recipient should dedicate funds made available under this NOFO for evaluation and performance monitoring within each project. The final funding amount will be agreed upon by both CDC and the recipient; however, it should be expected that approximately 3% (of a given project’s funding) will be dedicated to monitoring, reporting, and evaluation activities. CDC and the recipient will agree upon the specific funding amounts within review of each project’s work plan and budget.

c. Organizational Capacity of Recipients to Implement the Approach The applicant should succinctly describe their capacity (skills, expertise, experience) to implement the activities in the sub-national, national, and supra-national levels proposed under this NOFO. Applicants are encouraged to describe their ability to cover the proposed geographic scope; experience working with the target population; ability to implement project strategies/activities; ability to build sub-national, national or supra-national public health capacity; ability to expand or scale-up activities in the event of a public health emergency;

established collaborations, coalitions, or networks to achieve the project aims; and organizational infrastructure, if applicable. The applicant should describe the sub-national, national, and supra-national levels experience and institutional capacity (both management and technical) to achieve the outcomes of the NOFO with good governance practices including a management structure.

The applicant should also describe their history of building the capacity of indigenous organizations and individuals.

Applicants are expected to:

Describe their organizational capacity and skills to implement the award, including their geographic reach, their collaborators, coalitions, or networks, their history executing global public health work, and experience to implement the required activities

Describe their organizational capacity to implement a functional response to a public health threat, including distributing public health guidance, recommendations, and tools and providing support to implement these resources

Describe the national priorities for addressing the problem/project aims Describe their organizational capacity to inform, educate, and empower frontline staff engaged in the prevention and control of infectious diseases Describe their organizational capacity to assemble and provide individual expert opinions from occupational groups to achieve more successful implementation of public health recommendations and tools

Describe existing organizational capacity for program and staffing management;

performance measurement, and evaluation systems; financial reporting systems;

communication, technological, and data systems required to implement the activities in an effective and expedited manner; physical infrastructure and equipment; and workforce capacity to successfully execute all proposed strategies and activities based on the planning scenario, including the capacity to expand/scale-up efforts during public health emergencies.

Provide a clear organizational chart that is relevant for the completion of the proposed project plan

The applicant should provide as part of their appendix the following documents:

1. Curricula vitae (CVs)/Resumes for positions related to Principal Investigator, Project Director, Business Official, and other key staff related to program planning and implementation, finance, and monitoring and evaluation.

2. Job descriptions (maximum 1 page per job description) for key positions including:

Principal Investigator, Project Director, Business Official, and other key staff related to program planning and implementation, finance, and monitoring and evaluation.

3. Organizational chart (maximum 1 page)

4. Financial management statement that demonstrates experience in managing USG or CDC funds that are similar in size and scope of this NOFO (maximum 1 page).

5. Letters of support from key in-country or regional collaborators or partners, if applicable.

6. Memorandum of Agreement or Memorandum of Understanding, if applicable.

The above referenced documents to be submitted in the appendix should demonstrate the organization's capacity to address the requirements of the NOFO. Applicants must title these documents in their appendix as follows: "CVs/Resumes," "Job Descriptions," "Organizational Chart," "Financial Statement", “Letters of Support”, and upload as PDF files at www.grants.gov.

d. Work Plan There are two strategies under each component of the NOFO. Applicants must propose at least one activity under each strategy.

Applicant must include a work plan that demonstrates how the outcomes, strategies, activities, timelines, and staffing will take place over the course of the award. Applicants must submit a detailed work plan for the first year of the project, and a high-level work plan for subsequent years. A sample work plan template is provided below. Applicants are not required to use this format, as long as the information above is demonstrated.

This NOFO has a required component funding structure. Applicants are required to apply for all components and include a separate budget and work plan for each component.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance

Measurement section]

Strategies and

Activities

Process Measure

[from Evaluation and

Performance

Measurement section]

Potential for

Scale-up Responsible

Position /

Party

Project

Timeline

Budget Deadline (if applicable)

1.

2.

3.

4.

5.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

The recipient(s) will be required to collaborate with CDC in-country offices for technical oversight of project activities to be implemented under this NOFO. For countries where there is no in-country CDC office, the recipient will be required to work with CDC headquarters (HQ) for technical oversight of project activities to be implemented under this NOFO. In addition to the CDC Project Officer, the recipient will collaborate with in-country or HQ contacts, Subject Matter Experts (SMEs), and technical leads. The Project Officer for this award will provide relevant contacts of CDC staff and coordinate discussions with the award recipients.

f. CDC Program Support to Recipients

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program include, but are not limited to, the following:

1. Organize an orientation meeting with the recipient for a briefing on applicable U.S.

Government and HHS/CDC expectations, regulations and key management requirements, as well as report formats and contents. The orientation could include meetings with staff from HHS agencies and/or other parts of the USG.

2. Review and make recommendations as necessary to the process used by the recipient to select key personnel and/or post-award subcontractors and/or sub recipients to be involved in the activities performed under this agreement.

3. Provide technical assistance, as mutually agreed upon. This could include expert technical assistance and targeted training activities in specialized areas, such as surveillance, use of data for program planning purposes, lab programs etc.

4. Provide technical assistance, where applicable, to help the recipient meet U.S. Government financial and reporting requirements approved by the Office of Management and Budget

(OMB).

5. Collaborate with the recipient on designing and implementing the activities listed above, including, but not limited to: the provision of technical assistance to develop program activities, data management and analysis, quality assurance, surveillance program, the presentation and possibly publication of program results and findings, and the management and tracking of finances.

6. CDC offices in-country, where applicable, may assist the recipient in identifying and connecting with other partners working towards the objective of this NOFO and the recipient shall ensure work is not duplicative but complementary and supportive to existing efforts funded by CDC and the rest of the USG.

7. CDC, via Project Officer, will provide contact for in-country staff, Subject Matter Experts (SMEs) and technical leads from CDC where applicable for the recipient to coordinate activities at the country level.

8. Provide technical assistance or advice on any data collections on 10 or more people that are planned or conducted by the recipient. All such data collections-- where CDC staff will be or are approving, directing, conducting, managing, or owning data-- must undergo OMB project determinations by CDC and may require OMB Paper Reduction Act (PRA) clearance prior to the start of the project.

9. Provide consultation and scientific and technical assistance based on appropriate HHS/CDC documents to promote the use of best practices known at the time.

10. Assist in developing and implementing quality-assurance criteria and procedures.

11. Serve as co-authors on manuscripts and dissemination products developed as part of this project.

12. Facilitate in-country planning and review meetings for technical assistance activities.

13. Provide technical oversight for all activities under this award.

14. Ensure the recipient’s Evaluation and Performance Measurement Plan is aligned with the strategic information guidance established by HHS/CDC and USG.

15. Provide ethical reviews, as necessary, for evaluation activities, including from HHS/CDC headquarters. Evaluations can be process, outcome or impact

16. Process Evaluation: measures how the intervention was delivered, what worked/what did not work, differences between the intended population and the population served, and access to the intervention

17. Outcome Evaluation: determines effects of intervention in target population(s) (e.g., change in knowledge, attitudes, behavior, capacity, etc.)

18. Impact Evaluation: measures net effects of program and prove of causality

19. Supply protocols for related evaluations and/or assessment.

B. Award Information

1. Funding Instrument Type:

CA (Cooperative Agreement) CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism:

U51 Health Planning Strategies/National Academy of Sciences Activities

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$6,000,000

5. Total Period of Performance Funding:

$30,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$30,000,000

6. Total Period of Performance Length:

5 year(s) year(s)

7. Expected Number of Awards:

Component 1: Up to three applicants will be selected to receive initial funding for Component 1 to conduct core surveillance, preparedness, and emergency response activities. Applicants not initially selected for a Component 1 award will be included on the ABU roster and may be eligible for an award if additional funding becomes available.

Component 2: This NOFO will also establish an ABU list to conduct expanded surveillance, preparedness, and emergency response activities if additional funding becomes available in the event of a large-scale public health threat. The number of awardees will depend on the availability of funding.

8. Approximate Average Award:

$2,000,000 Per Budget Period

Component 1: $333,333 average funding available per fiscal year per recipient

Component 2: $1,666,667 average funding available per fiscal year per recipient

9. Award Ceiling:

$0 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$0 Per Budget Period

11. Estimated Award Date:

September 01, 2023

12. Budget Period Length:

12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

C. Eligibility Information

1. Eligible Applicants

Eligibility Category:

00 (State governments)

06 (Public and State controlled institutions of higher education)

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

99 (Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility")

Additional Eligibility Category:

Other

Ministries of Health

2. Additional Information on Eligibility

Complete applications should include: table of contents, project abstract, project narrative (including work plan), budget narrative, letters of support, CVs/resumes, organizational charts, copy of…