Revised Foa_Content_of_CDC-RFA-CK24-2401.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Emerging Infections Program

CDC-RFA-CK24-2401

06/20/2023

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- CK24-2401. 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:

Emerging Infections Program 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)).

Please note for this particular NOFO, CDC-RFA-CK24-2401, research activities are allowable and will be subject to all applicable laws, regulations and policy requirements.

Note research and human subjects protection requirements inserted throughout this NOFO. All instructions pertaining to research should be addressed and followed as indicated in this NOFO. Please refer to the Strategies and Activities and Attachment 1 for more details.

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.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-CK24-2401

E. Assistance Listings Number:

93.317 F. Dates:

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

05/21/2023

2. Due Date for Applications:

06/20/2023 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

Webinar Info: Public Webinar for 2024 EIP NOFO Applicants

Date: May 1, 2023 from 2:00 - 4:00 PM Eastern Time (US and Canada)

Website: Please click the link below to join the webinar:

https://cdc.zoomgov.com/j/1616323657?pwd=ejB0d3JTMmFtK1NsOUZXQ2pDSzdOQT09

Passcode: x!QAWW^6

Or One tap mobile :

US: +16692545252,,1616323657#,,,,*43094319# or +16469641167,,1616323657#,,,,*43094319#

Audio Call-in: Participant Passcode:

Or Telephone:

Dial (for higher quality, dial a number based on your current location):

US: +1 669 254 5252 or +1 646 964 1167 or +1 646 828 7666 or +1 669 216 1590 or +1 415 449 4000 or +1 551 285 1373

Webinar ID: 161 632 3657

Passcode: 43094319

International numbers available: https://cdc.zoomgov.com/u/aKLxnpxzU

Or an H.323/SIP room system:

H.323: 161.199.138.10 (US West) or 161.199.136.10 (US East)

Meeting ID: 161 632 3657

Passcode: 43094319

SIP: 1616323657@sip.zoomgov.com

Passcode: 43094319 https://www.grants.gov/ https://cdc.zoomgov.com/j/1616323657?pwd=ejB0d3JTMmFtK1NsOUZXQ2pDSzdOQT09 https://cdc.zoomgov.com/u/aKLxnpxzU mailto:1616323657@sip.zoomgov.com

The replay of the recorded EIP NOFO webinar will occur on Tuesday, May 16th from 1:00

– 3:00pm ET

When: May 16, 2023 01:00 PM Eastern Time (US and Canada)

Topic: Public Webinar for 2024 EIP NOFO Applicants – Replay Recorded Webinar

Please click the link below to join the webinar:

https://cdc.zoomgov.com/j/1617992179?pwd=bzc5L21Zd1RtRnlWUjV1SnA1cXpnUT09

Passcode: 7h*sNJPX

Or One tap mobile :

US: +16692545252,,1617992179#,,,,*17344209# or +16469641167,,1617992179#,,,,*17344209#

Or Telephone:

Dial(for higher quality, dial a number based on your current location):

US: +1 669 254 5252 or +1 646 964 1167 or +1 646 828 7666 or +1 669 216 1590 or +1 415 449 4000 or +1 551 285 1373

Webinar ID: 161 799 2179

Passcode: 17344209

International numbers available: https://cdc.zoomgov.com/u/aeuGsPm2f

Or an H.323/SIP room system:

H.323: 161.199.138.10 (US West) or 161.199.136.10 (US East)

Meeting ID: 161 799 2179

Passcode: 17344209

SIP: 1617992179@sip.zoomgov.com

Passcode: 17344209

G. Executive Summary:

1. Summary Paragraph The purpose of this NOFO is to sustain and enhance the multi-site Emerging Infections Program (EIP) network (https://www.cdc.gov/ncezid/dpei/eip/index.html) which provides high quality scientific information to monitor emerging infectious diseases in the United States, evaluate public health interventions, and inform public health policy. Activities of the EIP network include infrastructure and data modernization to support: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) rapid and flexible response to public health emergencies and newly emerging issues for infectious diseases. The EIP network addresses key public health issues collaboratively, using population-based data, to inform public health policy https://cdc.zoomgov.com/j/1617992179?pwd=bzc5L21Zd1RtRnlWUjV1SnA1cXpnUT09 https://cdc.zoomgov.com/u/aeuGsPm2f mailto:1617992179@sip.zoomgov.com recommendations and treatment guidelines for the prevention of disease. Required activities include Infrastructure and Data Modernization and Surveillance and Reporting 1 & 2. Other EIP activities include: Influenza (FluSurv-NET), Respiratory Syncytial Virus (RSV-NET), COVID- 19 (COVID-NET), Active Bacterial Core Surveillance (ABCs), Foodborne Diseases Active Surveillance Network (FoodNet), Healthcare-Associated Infections – Community Interface (HAIC), Human Papilloma Virus IMPACT, Lyme and Other Tickborne Diseases (TickNET), Prion Disease, and other infectious-disease related activities. Please refer to Attachment 1 for more details.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards Estimated number of awards: 10-15

d. Total Period of Performance Funding:

$767,000,000

e. Average One Year Award Amount:

$10,200,000

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

December 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 The Emerging Infections Program (EIP) was initiated in 1995 in response to the growing concern over the emergence and re-emergence of infectious diseases. Following the 1992 Institute of Medicine report "Emerging Infections: Microbial Threats to the United States,” CDC developed and published in 1994 a plan for addressing these threats. That plan highlighted the foundational role of public health surveillance and included in its recommendations, the creation of a network of population-based centers of excellence established through state public health departments collaborating with academic institutions, local health departments, public health and clinical laboratories, infection control professionals, healthcare providers, and CDC for special surveillance and applied public health research, which became the EIP network. See CDC's EIP website at https://www.cdc.gov/ncezid/dpei/eip/index.html and specific activities in Attachment 1.

The EIP network assists with local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases. Activities of the EIP network fall into the following overall categories: (1) active infectious disease surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) rapid and flexible response to public health emergencies and newly emerging issues for infectious diseases. The EIP network is particularly suited to address key and emergent public health issues for the U.S. that require a collaborative approach across multiple sites and timely data to inform public health policy and practices and lead directly to the prevention of disease.

The EIP network conducts active, population-based surveillance and special studies for respiratory viral diseases (influenza, COVID-19, RSV), invasive bacterial diseases including antibiotic-resistant infections, foodborne pathogens, healthcare-associated infections (HAIs), and many other infectious diseases. The COVID-19 pandemic has highlighted the importance of having a multi-center surveillance and applied research platform to rapidly respond to public health threats. The EIP network has also played a critical role in responding to emerging infectious diseases by rapidly implementing new collaborative activities, such as the establishment of COVID-NET to rapidly gather public health data for action on COVID-19 hospitalization rates, patient characteristics, and vaccine effectiveness.

For the 2024 NOFO, the EIP network activities will include required components for Infrastructure and Data Modernization (to support core management functions and enhance interoperable data exchange and bioinformatics) and Surveillance and Reporting 1 and 2 for an increase in response efforts for emerging or re-emerging infectious disease(s), outbreak scenarios, or other public health threats. In addition, applicants are encouraged to propose activities for other prioritized areas, described in Attachment 1. Also, enhanced data to understand systemic health and social inequities to advance public health practices and policies that advance health equity, is a new focus for data exchange and across all EIP activities.

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

241(a)], 317(k)(1) [42 U.S.C. 247b(k)(1)], and 317(k)(2) [42 U.S.C. 247b(k)(2)], as amended, and the Patient Protection and Affordable Care Act (PL 111-148), Title IV, Sections 4002 and 4304 (Prevention and Public Health Fund).

c. Healthy People 2030 This program addresses the “Healthy People 2030” focus area(s) of Foodborne Illness, Healthcare-Associated Infections, Immunizations and Infectious Diseases, Respiratory Diseases, and Public Health Infrastructure.

d. Other National Public Health Priorities and Strategies This NOFO supports various national public health strategies/priorities for infectious diseases and other conditions including data modernization, public health infrastructure, health equity, social determinants of health, climate and health, respiratory viral diseases and other infectious diseases, and emerging health threats. See Attachment 1 – EIP 2024 Activities, for specific information regarding national priorities and strategies for each individual EIP activity.

e. Relevant Work EIP network has been in existence and funded by CDC since 1995. There are currently 10 recipients in the EIP that are completing their most recent 5-year EIP period of performance (1/1/2017 – 12/31/2021) plus two extension years (1/1/2022 – 12/31/2023). See https://www.cdc.gov/ncezid/dpei/eip/index.html for details of the relevant work.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-CK24-2401 Logic Model: Emerging Infections Program

Bold indicates period of performance outcome

Strategies and Activities

Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Enhance population-based approach to surveillance and public health research

Provide cross-cutting scientific and business support

Maintain flexibility to address emerging/urgent issues with a population-based approach

Enhance partnerships and collaborative network

Improved quality and consistency of data submission and efficiency of data management

Improved timeliness of population-based surveillance and data reporting

Increased availability of baseline incidence/prevalence of infectious diseases and other conditions established

Increased identification of risk factors for infectious diseases and other conditions identified

Increased

Improved availability and timeliness of data for informing public health practices and policy

Increased use of novel and improved surveillance methods

Improved outbreak monitoring and response; trends in infectious diseases and other conditions, including antimicrobial resistance, identified

Increased awareness of the incidence/prevalence in

Improved public health system surveillance and response capacity

Public health system better informed, prepared, and able to identify, control, mitigate, and prevent outbreaks of infectious diseases and other conditions including in disproportionately affected and historically marginalized populations

Improved treatments and guidance to

Provide training and workforce development

Enhance data management and information dissemination

Modernize information systems for data collection and electronic data exchange

Enhance laboratory specimen collection and banking

Enhance active surveillance, applied public health epidemiologic and laboratory activities and public health research, prevention, and evaluation identification of disproportionately affected and historically marginalized populations for infectious diseases and other conditions identified disproportionately affected and historically marginalized populations;

interventions with established effectiveness developed and publicly accessible

Improved disease treatment guidelines and interventions with established effectiveness developed and shared mitigate the impact of infectious diseases and other health threats

Decreased incidence and severity of infectious diseases and other conditions and associated disparities

i. Purpose The purpose of this program announcement is to sustain and enhance the multi-site Emerging Infections Program (EIP) network which provides high quality scientific information to monitor emerging infectious diseases and other health threats, evaluate public health interventions, and inform public health policy.

Specific purpose and objectives of each EIP activity (listed in Section 2.a.3 – “Strategies and Activities,” below) are included in Attachment 1 - EIP 2024 Activities.

ii. Outcomes The overall outcomes will focus on:

• High quality, adequate, and timely data on infectious diseases and other emerging health threats for informing public health policy and practices available

• Novel/improved surveillance methods developed and implemented

• Baseline incidence/prevalence of infectious diseases and other conditions and associated disparities established, and population is monitored for outbreaks

• Risk factors for infectious diseases and other health threats established

• Trends in infectious diseases and other conditions, including antimicrobial resistance, identified and monitored

• Interventions with established effectiveness developed and available

• New/updated disease treatment guidelines and interventions with established effectiveness developed and made accessible for infectious diseases and other health threats

• Disproportionately affected populations for various infectious diseases and other conditions identified and interventions tailored for those populations of focus are developed and publicly accessible For details regarding the expected outcomes of each EIP activity, refer to Attachment 1 - EIP 2024 Activities. Recipients will be responsible for meeting the period of performance outcomes included in Attachment 1.

iii. Strategies and Activities EIP activities include general crosscutting Infrastructure and Data Modernization (e.g., interoperable data exchange and modernization, training, and workforce development) as well as individual programmatic activities.

Following is a brief overview of each EIP activity. Details for each EIP activity are provided in Attachment 1 - EIP 2024 Activities. Recipients will be responsible for all requirements included in Attachment 1 for each Activity for which they are funded.

EIP Activities – Attachment 1, Sections A – C: All applicants must apply.

Infrastructure and Data Modernization (required): Attachment 1, Section A o The purpose of this Infrastructure and Data Modernization activity is to provide support to EIP sites to establish and maintain their cross-cutting scientific, programmatic, data modernization, advanced molecular detection (AMD), and business/administrative capacities across all EIP activities. This is intended to include staff, activities, and related costs that are essential to ensuring general EIP infrastructure, and are not supported by the applicant’s Indirect Cost Rate Agreement or other cooperative agreement activities. These investments in the basic infrastructure are critical for a comprehensive, efficient, and coordinated approach to general program management from which all EIP activities benefit.

Surveillance and Reporting 1 (required): Attachment 1, Section B o To ensure rapid and flexible response, this potential funding would provide additional epidemiologic, laboratory, and/or health information systems surge capacity necessary for enhanced public health surveillance or applied research activities due to factors such as an increase in response efforts for emerging or re-emerging infectious disease(s), outbreak scenarios, or other public health threats.

Surveillance and Reporting 2 (required): Attachment 1, Section C o To ensure rapid and flexible response, this potential funding would provide additional epidemiologic, laboratory, and/or health information systems surge capacity necessary for enhanced public health surveillance or applied research activities due to factors such as an increase in response efforts for emerging or re-emerging infectious disease(s), outbreak scenarios, or other public health threats.

EIP Activities – Attachment 1, Sections D – N: Applicants must apply for at least one (or more) of these activities. Those applicants with relevant experience with these activities are encouraged to apply.

Influenza (FluSurv-NET): Attachment 1, Section D o Population-based surveillance to provide near real-time weekly rates of laboratory-confirmed influenza-associated hospitalizations and data on disparities during each influenza season. Special studies will be conducted to better understand laboratory practices and evaluate prevention strategies in disproportionately affected and historically marginalized populations. Two activity tiers will be offered to sites for FY24. Applicants are required to choose to participate in either Tier 1 or Tier 2 activities. Recipients will be required to complete all activities outlined in their selected tier.

Respiratory Syncytial Virus (RSV-NET): Attachment 1, Section E o Population-based surveillance for laboratory confirmed RSV-associated hospitalizations and associated disparities among children and adults to inform decisions aimed at reducing morbidity and mortality due to RSV. Special studies, such as studies examining testing practices and prevention strategies in disproportionately affected and historically marginalized populations, will be conducted to better understand additional aspects of RSV burden, epidemiology, prevention, and clinical care.

COVID-19 (COVID-NET): Attachment 1, Section F o Population-based surveillance for laboratory confirmed COVID-19-associated hospitalizations and associated disparities among children and adults to inform decisions aimed at reducing morbidity and mortality due to SARS-CoV-2. Special studies, including studies examining testing practices and prevention strategies in disproportionately affected and historically marginalized populations, will be conducted to better understand additional aspects of COVID-19 burden, epidemiology, prevention, and clinical care.

Active Bacterial Core surveillance (ABCs): Attachment 1, Section G o Active, laboratory, population-based surveillance and conduct special studies for invasive group A Streptococcus, H. influenzae, N.meningitidis, group B Streptococcus and S. pneumoniae to monitor their disease burden, track antimicrobial resistance and evaluate prevention strategies. Enhanced pertussis surveillance and other special studies will be done to better understand rising disease rates and evaluate prevention strategies to reverse these rising trends, including among disproportionately affected populations.

Foodborne Diseases Active Surveillance Network (FoodNet): Attachment 1, Section H o Active, population-based surveillance at EIP sites for laboratory-confirmed infections of 8 bacterial and parasitic pathogens transmitted commonly through food (Campylobacter, Cyclospora, Listeria monocytogenes, Salmonella, Shiga toxin-producing Escherichia coli (STEC), Shigella, Vibrio, and Yersinia).

FoodNet also conducts active surveillance for pediatric cases of Hemolytic Uremic Syndrome (HUS) through a network of nephrologists and infection control practitioners and by hospital discharge data review.

Healthcare-Associated Infections – Community Interface (HAIC): Attachment 1, Section I o Population-based surveillance and special projects to inform HAI and AR prevention activities and strategies. The two HAIC Activity categories of work are: 1) population-based surveillance for specific pathogens or infections; and 2) special projects, including HAI and antimicrobial use prevalence surveys.

Population-based surveillance monitors the incidence and disparities of infections due to healthcare-associated pathogens at the population level to track changes over time, identify disproportionately affected populations, estimate disease burden, and identify drivers of disparities (i.e., inequities in the social determinants of health). Special projects are limited-duration projects that address specific healthcare safety-related public health questions.

HPV-IMPACT: Attachment 1, Section J o Evaluate the impact and effectiveness of the Human Papilloma Virus (HPV) vaccination program by monitoring trends and disparities in overall CIN2+ and determine HPV type distribution in CIN2+ lesions through a population-based surveillance system. Optional projects could also address other HPV-associated outcomes.

Lyme and Other Tickborne Diseases (TickNET): Attachment 1, Section K o Better define the public health and societal burden of tickborne diseases in the

United States, identify risk factors (e.g., socioeconomic and other determinants of health), and evaluate effectiveness of public health prevention and control strategies to reduce morbidity and mortality due to tickborne diseases and associated disparities.

Prion Disease: Attachment 1, Section L o Implement and maintain an active prion surveillance system in the U.S.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and ME/CFS – like Post-COVID Conditions (PCC): Attachment 1, Section M o To advance the understanding of the development and early stages (first 2-5 years) of ME/CFS and ME/CFS-like post-COVID conditions, risk factors, and associated public health burden, and to inform diagnosis and management of these conditions.

Mpox Vaccine Effectiveness Evaluation: Attachment 1, Section N o To evaluate the effectiveness and durability of JYNNEOS™ vaccine against mpox disease. These data will be critical to informing public health decision-making and vaccine policy for the control and prevention of mpox.

Other emerging or site-specific activities: Applicants may apply

Applicants may propose individual projects that address emerging issues and/or locally relevant public health issues that meet the objectives of the EIP. These may include activities addressing non-communicable diseases that have the potential to benefit from EIP abilities and approach.

1. Collaborations

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

EIP is a collaborative network between CDC and EIP Recipients, and often strengthened through relationships with recipients' academic and other health partners. Recipients are expected to collaborate with other EIP recipients and collaborate with CDC programs involved in EIP activities as described in the Infrastructure and Data Modernization section, above, and in Application Content and individual program activity sections of Attachment 1. Applicants should include a Letter of Support from each proposed collaborating academic institution or other partner. Letters of Support are to be included as one combined PDF file under “Other Attachment Forms” which should be labeled “Letters of Support”. Recipients will be responsible for meeting the collaboration requirements included in Attachment 1 - EIP 2024 Activities.

b. With organizations not funded by CDC:

Collaboration with a variety of appropriate partners, including community-based partners and partners from multiple sectors, is strongly encouraged, and the collaboration may be strengthened by including at least one academic institution (if the applicant is not an academic institution). To document these relationships, applicants must include a Letter of Support from each proposed collaborating academic institution or other partner(s). Letters of Support are to be included as one combined PDF file under “Other Attachment Forms” which should be labeled “Letters of Support.” If included, the academic partner chosen by the applicant does not need to be within their jurisdiction, it could be any academic institution within the United States. Also, the academic partner can be engaged in select specific activities within the application.

Recipients are expected to establish and provide evidence of all local collaborations (e.g., with academic institutions and other partners) to facilitate and enhance their capacity, as described in the Application Content and individual program activity sections of Attachment 1. Recipients will be responsible for meeting the collaboration requirements included in Attachment 1 - EIP 2024 Activities.

2. Target Populations The population of focus for outcomes from the EIP network is the U.S. population. See individual program activity sections of Attachment 1 for any applicable guidance regarding identifying populations for the individual activities. Overall and as appropriate, surveillance and other activities should consider representativeness of data and ability to assess disparities based on multiple factors, such as geography, rurality/urbanicity, age distribution, race/ethnicity, and socioeconomic status. Recipients will be responsible for meeting any target population requirements included in Attachment 1 - EIP 2024 Activities.

a. Health Disparities Applicants should select a population base/catchment area for their EIP site that includes a diverse population to the extent feasible for the geography/state as well as both traditional and novel data sources to collect and assess health equity indicators. Factors determining diversity of the population and the assessment and reduction of health disparities could include but are not limited to rurality/urbanicity, race/ethnicity, disability status, socioeconomic status, literacy, health literacy, language, occupation, housing, environment, sexual orientation, gender identity, healthcare access and quality, and other social determinants of health. EIP’s ability to source robust population-based data is unique and provides an opportunity to deepening the understanding of health inequities and populations put at increased risk, better enabling targeted prevention and mitigation efforts.

iv. Funding Strategy Applicants will compete for available funds with all other applications submitted in response to this NOFO that are deemed eligible for funding. Successful applicants will be awarded the required Infrastructure and Data Modernization activity and at least one or more optional activities, as applicable, depending on the availability of funds.

Multiple funding streams are available for EIP awards, including special COVID-19 funding. Estimates of anticipated funding levels:

Infrastructure and Data Modernization (required): $3,000,000 to $6,500,000; up to 15 awards

Surveillance and Reporting 1 (required): up to $30,000,000; up to 15 awards

Surveillance and Reporting 2 (required): up to $30,000,000; up to 15 awards

FluSurv-NET: $4,500,000 to $7,000,000; up to 15 awards

COVID-NET: $11,000,000 to $15,000,000; up to 15 awards

RSV-NET: $3,000,000 to $5,000,000; up to 15 awards

ABCs: $11,000,000 to $13,000,000; 10 awards

FoodNet: $5,000,000 to $7,000,000; 10 awards

HAIC: $29,000,000 to $30,000,000; 10-15 awards

HPV-IMPACT: $2,000,000 to $3,000,000; 5 awards

Lyme and Other Tickborne Diseases (TickNET): $500,000 to $2,000,000; up to 4 awards

Prion Disease: $185,000 to $300,000; 2 awards

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and ME/CFS-like Post- COVID Conditions (PCC): $600,000; 1 award

Mpox Vaccine Effectiveness Evaluation: $2,000,000 to $4,000,000; up to 15 awards

Coronavirus Disease 2019 (COVID-19) Funds: A recipient of a grant or cooperative agreement awarded by the Department of Health and Human Services (HHS) with funds made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L.

116-123); the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136); the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116- 139); and/or the Consolidated Appropriations Act and the Coronavirus Response and Relief Supplement Appropriations Act, 2021 (P.L. 116-260) and/or the American Rescue Plan of 2021 [P.L. 117-2] agrees, as applicable to the award, to: 1) comply with existing and/or future directives and guidance from the Secretary regarding control of the spread of COVID-19; 2) in consultation and coordination with HHS, provide, commensurate with the condition of the individual, COVID-19 patient care regardless of the individual’s home jurisdiction and/or appropriate public health measures (e.g., social distancing, home isolation); and 3) assist the United States Government in the implementation and enforcement of federal orders related to quarantine and isolation.

In addition, to the extent applicable, recipient will comply with Section 18115 of the CARES Act, with respect to the reporting to the HHS Secretary of results of tests intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19. Such reporting shall be in accordance with guidance and direction from HHS and/or CDC. HHS laboratory reporting guidance is posted at: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.

Further, consistent with the full scope of applicable grant regulations (45 C.F.R. 75.322), the purpose of this award, and the underlying funding, the recipient is expected to provide to CDC copies of and/or access to COVID-19 data collected with these funds, including but not limited to data related to COVID-19 testing. CDC will specify in further guidance and directives what is encompassed by this requirement.

Should a public health need (such as a public health emergency or infectious disease outbreak) occur during the life cycle of the award funded under this NOFO, the recipient may have an opportunity to request additional funding. This request may be in response to specific administrative supplemental guidance provided by CDC to conduct additional EIP emergency response support activities within the scope of the funded award and/or a recipient-initiated request for additional resources for existing activities. Any supplemental opportunity is subject to the availability of funds and program priorities.

This award is contingent upon agreement by the recipient to comply with existing and future guidance from the HHS Secretary regarding control of the spread of COVID-19. In addition, recipient is expected to flow down these terms to any subaward, to the extent applicable to activities set out in such subaward.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Generally, evaluation and performance measurement for the various EIP activities include quantitative and qualitative measures regarding the following:

For data modernization For surveillance, engagement of applicable partner institutions (clinical institutions, laboratories, etc.)

For studies, enrollment of subjects/cases Completeness of data, including demographic data Quality of data Timeliness of data submission Collection and shipping of isolates and linkage to epidemiological data Adherence to study/project protocols

Staff participation on EIP coordinating group meetings and calls and for individual EIP activity workgroup/committee meetings, calls, trainings, etc.

See each EIP Activity description (Attachment 1) for specifics on measures associated with those specific activities. Each Activity Approach will require its own Evaluation and Performance Measurement plan. See NOFO Section H: Other Information for narrative details that applicants should include for a strong submission.

Specifically, a Data Management Plan (DMP) is required and should include, at a minimum:

A description of the data to be collected or generated in the proposed project;

The standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to the data, including a description for the provisions for the protection of privacy, confidentiality, security, and intellectual property, or other rights;

Statement of the use of data standards that ensure all documentation that describes the method of collection, what the data represent, and

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified; and, Other additional requirements based on the program.

Applicants may not be able to provide all of this information when applying but should include a DMP that is as complete as possible.

Under 45 CFR 75.322, CDC is able to obtain a copy of data collected under this award and with CDC funds. CDC recognizes there may be certain legal limitations on the recipients for sharing certain data they may collect, and those legal limitations should be identified in their DMP.

For details regarding each EIP activity’s evaluation and performance measurement requirements, refer to each activity section of Attachment 1. Recipients will be responsible for the requirements included in Attachment 1.

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).

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.

Applicants are to develop evaluation and performance measurement plans in each of the separate application narratives for the EIP Activities (in Attachment 1) that they are applying for.

Detailed application instructions are provided in NOFO Section D, below.

c. Organizational Capacity of Recipients to Implement the Approach Competitive applicants must have access to public health data for infectious diseases that are part of the EIP scope (see Attachment 1 – EIP 2024 Activities) including an overall catchment area of one million to eleven million in population. If the applicant is not a state or local public health agency with access and statutory authority to use these data, then applicant must submit a signed letter from public health agency leadership or designee on organizational letterhead. This letter must include the role(s) of the public health agency (e.g., co-lead and participate in which EIP activities throughout the five-year period of performance, etc.) and explicitly state that they agree to provide the applicant access to public health data needed for the proposed EIP activities and have a commitment and pathway to taking public health actions. In addition, applicants are expected to describe an established process for coordination and oversight of data flow and consumption with epidemiology and laboratory agencies, and experience with public health informatics.

Strong applicants will have a demonstrated core organizational capacity to effectively execute the activities outlined by the award. Applicants must describe relevant experience and technical capacity to implement the activities and achieve the project outcomes, experience and capacity to implement the evaluation plan, and a staffing plan and project management structure sufficient to achieve the project outcomes with clearly defined staff roles. This organizational capacity includes skill sets such as program planning and performance management, partnership development, health equity and social and behavioral science, evaluation and program assessment, performance monitoring, financial reporting, budget management and administration, change management, and personnel management (including developing staffing plans and developing and training workforce).

Strong applications will provide evidence of superior organizational capacity to perform as an EIP site, such as:

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

Efficient and timely access to public health data for the entire catchment area proposed in this application (from one million to eleven million people) and be able to provide or collaborate on the provision of public health services to that population.

Experience with program planning, program evaluation, performance monitoring, financial reporting, budget management and administration, personnel management.

Experience participating in public health emergency response activities.

Demonstrated relevant experience and capacity (management, administrative, and scientific/technical) to implement the activities and achieve the project outcomes, experience and capacity to implement the evaluation plan, and a staffing plan and project management structure sufficient to achieve the project outcomes and which clearly defines staff roles.

Existing working relationships with public health entities, academic institutions, and other partners that are critical to successfully implement the EIP.

Effective relationships with the necessary epidemiology, data science, informatics, public health laboratory, clinical laboratory, and other partners to accomplish the work proposed in the application.

Skilled and diverse staff and expertise to support activities, including planning, program implementation and project management, epidemiology, health equity and social and behavioral science, informatics, evaluation, policy, and communications; these capacities may reside within the applicant’s staff or be formally arranged through contracts and other mechanisms of procuring external expertise.

Demonstrated (or commitment to, if not previously demonstrated) experience with timely data sharing with CDC.

Demonstrated success at data modernization, with an emphasis on improved interoperability and systems integration.

Health department applicants may describe their current status in applying for public health department accreditation or provide evidence of accreditation as applicable. If providing evidence of accreditation, document should be uploaded as a PDF and labeled “Evidence of Health Department Accreditation.” Information on accreditation may be found at http://www.phaboard.org.

Details on what to include in application, and in what order, will be found in this NOFO Section H: Other Information and will also be referenced in the evaluation criteria. Applicants are STRONGLY encouraged to use the Application Templates that will be made available to ensure they are addressing critical areas to demonstrate capacity.

d. Work Plan In the application narrative, applicants must provide a detailed work plan for each individual activity. Required EIP Activities (Infrastructure and Data Modernization and Surveillance and Reporting 1 and 2) and other activities (FluSurv-NET, COVID-NET, RSV-NET, ABCs, FoodNet, HAIC, etc.) for the first year of the project and a high-level work plan for subsequent years. See application guidance/instructions in Application Content, below, and the individual activity sections of Attachment 1. Applicants are STRONGLY encouraged to use the Application Templates that will be made available.

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.

Applicants must respond to the performance measures as described for each individual activity:

Required activities (Infrastructure and Data Modernization and Surveillance and Reporting 1 and

2) and other activities (FluSurv-NET, COVID-NET, RSV-NET, ABCs, FoodNet, HAIC, etc.)

included in Attachment 1 – EIP 2024 Activities. Recipients will also be responsible for meeting recipient reporting (including work plans, performance, and financial reporting). CDC will provide recipient feedback during individual calls and site visits with the recipients. The timing of these feedback activities will be a mutually agreeable timeframe (e.g., at least biannual individual calls with recipients, etc.). CDC will provide aggregated performance feedback for overall NOFO performance to recipients during EIP activity-specific meetings.

f. CDC Program Support to Recipients

In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities

Provide scientific collaboration and subject matter expertise for all EIP sites.

Provide general coordination for all EIP sites and the overall network.

Provide coordination specifically for EIP crosscutting activities such as data modernization, quality assurance, epidemiology-laboratory coordination, advanced molecular detection, etc.

Develop, facilitate, and participate in collaborative multi-site relationships as needed to support the successful completion of projects.

Provide consultation and scientific and technical assistance as necessary in the operation of the EIP. This may include:

o Facilitating the development of protocols and procedure manuals, o Assisting sites with local human subjects requirements, o Assisting with training recipient personnel, o Assisting in the design of projects, o Serotyping isolates, o Performing antimicrobial susceptibility testing, o Assisting with development of detailed Data Management Plans, o Analyzing and interpreting data, o Disseminating results in collaboration with EIP sites, o Coordinating and facilitating communications among EIPs and with other state, tribal, local, and territorial health departments, and o Facilitating and coordinating the development and implementation of electronic information exchange. CDC will consult with sites to assist evolution of EIP-related information systems to conform with applicable (e.g., HHS, CDC) standards.

Obtain determination of research or non-research from the Associate Director for Science for the respective CIO when CDC scientists are engaged in the research.

Obtain IRB approval from the CDC Institutional Review Board for research involving human subjects when CDC is engaged.

Obtain Office of Management and Budget determination and approval per the Paperwork Reduction Act, if necessary.

Assist recipient principal investigators, as needed, in complying with their responsibilities described in the United States Government Policy for Institutional Oversight of Life Science Dual Use Research of Concern (DURC) https://www.phe.gov/s3/dualuse/documents/durc-policy.pdf

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:

U50 Special Cooperative Investigations/Assessment of Control/Prevention Methods

3. Fiscal Year:

https://www.phe.gov/s3/dualuse/documents/durc-policy.pdf

4. Approximate Total Fiscal Year Funding:

$153,400,000

5. Total Period of Performance Funding:

$767,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$767,000,000

6. Total Period of Performance Length:

5 year(s) year(s)

7. Expected Number of Awards:

Estimated number of awards: 10-15

8. Approximate Average Award:

$10,200,000 Per Budget Period

9. Award Ceiling:

$0 Per Budget Period

This amount is subject to the availability of funds.

No Award Ceiling

10. Award Floor:

$0 Per Budget Period

No Award Floor

11. Estimated Award Date:

December 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 available through this NOFO.

Limited opportunities for Direct Assistance (DA) may be available under this award.

The EIP does not currently have plans for robust DA offerings; however, the program recognizes DA can be a useful tool and therefore chooses to keep the option for DA open throughout this Period-of-Performance. In the event of a DA opportunity, the EIP would communicate details to recipients. For example, EIP Activity partners may find opportunities to offer DA and the EIP could collaborate with existing CDC DA mechanisms (e.g., Career Epidemiology Field Officer Program or Public Health Associate Program) to partially support DA positions. It is likely that any DA support provided would be in lieu of financial assistance (i.e., value of DA support would be subtracted from dollars provided to recipient).

For information on Direct Assistance for Assigning CDC Staff to State, Tribal, Local, and Territorial Health Agencies, refer to:

https://www.cdc.gov/publichealthgateway/grantsfunding/direct_assistance.html

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)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments…