Foa_Content_of_CDC-RFA-IP22-2203.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

Tracking the burden, distribution, and impact of Post COVID-19 conditions in diverse populations for children, adolescents, and adults (Track PCC)

CDC-RFA-IP22-2203

Application Due Date will be submitted as: date based on the value specified for Due Date for

Applications

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Required Registrations

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- IP22-2203. 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) B. Notice of Funding Opportunity (NOFO) Title:

Tracking the burden, distribution, and impact of Post COVID-19 conditions in diverse populations for children, adolescents, and adults (Track PCC) 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-IP22-2203

E. Assistance Listings Number:

93.185 F. Dates:

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

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

Recommended but not Required 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

LOIs may be sent via email, U.S. express mail or delivery service to:

Elizabeth Sullivan MS H24-5

[CDC-RFA- IP22-2203]

CDC/ National Center for Immunization and Respiratory Diseases (NCIRD) Division of Viral Diseases (DVD)/ Respiratory Viruses Branch (RVB) 1600 Clifton Road, NE Atlanta, GA 30329-4027

EMB1@CDC.GOV

2. Due Date for Applications:

03/08/2022 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

January 12, 2022 CDC-RFA- IP22-2203 Tracking the burden, distribution, and impact of Post COVID-19 Conditions in diverse populations for children, adolescents, and adults (Track PCC)

Date: Wednesday, January 12, 2022 Time: 2:00 PM to 3:00 PM Eastern Time Call information: Phone number 888.994.4478 (toll free) Conference ID: 958 630 203#

CDC Staff will provide overview of CDC- RFA-IP22-2203 Notice of Funding Opportunity (NOFO) information followed by a question-and-answer session. A frequently answered question document will be posted after the completion of this informational call.

F. Executive Summary:

Summary Paragraph The purpose of this project is to track and investigate the burden and impact of post COVID-19 conditions (PCC) in diverse populations, within the United States through surveillance and long-term follow-up of cohorts with PCC in collaboration with public health, academic, or healthcare partners. This is a multi-year cooperative agreement with two components (4 Surveillance Sites, Component A; 1 Coordinating Center, Component B). The surveillance sites will conduct a standardized population-based approach to estimate and track post COVID-19 conditions by age, sex, race/ethnicity, geographic area, severity of initial infection, and risk factors among persons with evidence of SARS-CoV-2 infection (based on the Council of State and Territorial Epidemiologist [CSTE] case definitions for confirmed cases or laboratory confirmed evidence of infection). Each site will enroll at least 1,000 persons, monitor how post COVID-19 conditions change over time within persons at 3, 6, 12, and18 months post infection and track the prevalence of post COVID-19 conditions at the population level at 3, 6, 12, and18 months. The Coordinating Center will provide an infrastructure for standardized approaches, analytical methods, and measures to be used for surveillance and provide consolidated estimates. These activities will provide information for estimating the population-level burden from SARS-CoV-2 and PCC.

a. Eligible Applicants:

https://www.grants.gov/

Open Competition

b. NOFO Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards Component A: 4 Awards Component B: 1 Award

d. Total Period of Performance Funding:

$45,000,000

e. Average One Year Award Amount:

$1,800,000 Component A individual awards ranging from $1,600,000 to $2,000,000 and for Component B awards range from $900,000 to $1,000,000 for the first year.

f. Total Period of Performance Length:

g. Estimated Award Date:

May 01, 2022

h. Cost Sharing and / or Matching Requirements:

No Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview The acute phase of the SARS-CoV-2 pandemic in the United States has been devastating, with >31 million cases and over 800,000 deaths as of late December 2021. (1) While vaccination raises optimism for ending this phase of the pandemic, we must be prepared for the continued health impacts from this virus, which will involve persons suffering from ongoing consequences of SARS-CoV-2 infection, referred to as post COVID-19 conditions. Based on initial reports from COVID-19 survivors, the health burden is likely to be substantial (1,2), with millions of Americans impacted across all age groups. However, these initial reports are limited. There is a need to understand longer-term effects among patients who had acute disease, whether severe, mild, or moderate, or asymptomatic infection. Sequelae appear to be related to severity but frequently occur among patients with milder illness as well. Health consequences of infection are highly variable, and effects can persist for many months. Many individuals report being unable to return to work after infection. So far, few studies of the sequelae of SARS-CoV-2 infection have been population-based. It can be challenging to distinguish the effects of SARS-CoV-2 infection from known pre-existing health conditions, the indirect effects of the pandemic such as fatigue and anxiety, and previously undetected chronic conditions prior to the infection. Initial population-based estimates can range from 2% to 20% of persons with history of COVID. Based on the latest case data, this could translate into more than 500,000 persons suffering from persistent effects of SARS-CoV-2 infection in the United States. Characterizing ongoing morbidity from SARS-CoV-2 beyond the acute period is critical to understanding the population health burden, identifying who is most vulnerable, and informing prevention and treatment efforts. High quality data are needed to estimate and track the burden and impact of post COVID-19 conditions. These data can help identify which groups are most affected, what health disparities exist, and identify geographic regions with greater burden, as well as indicate potential barriers to care. These additional levels of granularity can inform public health action and help direct needed clinical care for patients.

The purpose of this notice of funding opportunity is to track and investigate the burden and impact of post COVID-19 conditions (PCC) in diverse populations, within the United States through surveillance and long-term follow-up of cohorts with PCC in collaboration with public health, academic, or healthcare partners. Post COVID conditions include a wide range of health consequences that occur more than 4 weeks after the initial SARS-CoV-2 infection. Studies will also explore risk factors and mitigating factors as they relate to the development, resolution, and prevention of PCC.

This NOFO has two components:

Component A focuses on a cohort of children (0 – 11 years), adolescents (12- 17 years), and adults (18 years and older) with evidence of SARS-CoV-2 infection for the surveillance of incidence and prevalence of PCC by time since diagnosis, age, sex, race/ethnicity, and geographic area. (4 awards)

Component B serves as a Coordinating Center to provide an infrastructure for standardized approaches, analytical methods, and surveillance measures. It also serves as a repository for the data generated by Component A. Component B provides consolidated estimates by time since diagnosis, age, sex, race/ethnicity and geographic area. (1 award)

b. Statutory Authorities Public Health Service Act, Section 317(k) [42 U.S.C. §247b(k)(1)], as amended and Public Law 117-2 American Rescue Plan Act.

c. Healthy People 2030 This NOFO supports the Healthy People 2030 topic area on Infectious Diseases to reduce the rates of infectious diseases and improve the health for people with chronic infections.

d. Other National Public Health Priorities and Strategies This NOFO directly supports CDC Science Agenda Priority III: Natural History of SARS-CoV- 2 infection aligns directly with Objective 1 to define the spectrum and clinical course of SARS- CoV-2 infection, including long term sequelae and priority question 14: How do we effectively conduct surveillance for post COVID-19 conditions? This NOFO will help answer the question of what are the prevalence and incidence of the various post-COVID-19 conditions overall and in various populations and settings. CDC Public Health Science Agenda for COVID-19 | CDC

e. Relevant Work CDC has many surveillance platforms to track/monitor SARS-CoV-2 infections and COVID illness (CDC COVID Data Tracker) and supports many activities to estimate the burden of COVID-19 infections/disease. In addition to national surveillance for COVID-19 cases, CDC is generating estimates of infection numbers through model-based approaches and serologic surveys. CDC continues to work to identify how common longer-term effects are, who is most likely to get them, and whether symptoms eventually resolve through multi-year studies.

https://www.cdc.gov/coronavirus/2019-ncov/science/science-agenda-covid19.html https://covid.cdc.gov/covid-data-tracker/#datatracker-home

Surveillance to estimate the burden of post-COVID conditions is needed to monitor trends over time and identify populations with higher burden of post-COVID conditions.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-IP22-2203 Tracking the burden, distribution and impact of Post COVID-19 Conditions in diverse populations for children, adolescents and adults (TrackPCC)

Strategies and Activities Short-term Outcomes Intermediate Outcomes Long-Term

Outcomes Data collection and use Systematically collect, analyze, interpret, and disseminate data to describe, characterize, and detect trends of Post COVID Conditions (PCC) among persons with SARS-CoV-2 infection.

Monitor and use data to guide strategic action and inform future surveillance

Develop surveillance data use plan

Develop surveillance reports and disseminate to public health agencies, organizations, and community;

community members;

collaborators; health care organizations Enhancements

Maintain and/or enhance integrated

Improved ability of the recipient to provide completeness, timeliness, and quality of PCC surveillance data

Improved accuracy in defining the populations at risk for PCC based on evidence SARS-CoV- 2 infection

Improved data exchange and use of data among public health agencies, organizations, and community; community members;

collaborators; health care organizations

Improved collaborations and data sharing

Develop and provide training to staff to increase capacity and improve surveillance system

Improved monitoring of trends in PCC

Increased use of surveillance and epidemiological data by public health agencies and organizations to guide prevention and care efforts.

Increased use of surveillance and epidemiological data to monitor health outcomes including PCC following SARS-CoV-2 infection.

Increased ability of recipients to describe the geographic distribution, social determinants of health, and health disparities related to PCC attributable to SARS-CoV-2 infection.

Increased knowledge of surveillance system among partners through dissemination of surveillance results to public health, scientific and health care communities.

Track and monitor on-going burden of

PCC

following

SARS-

CoV-2 infection.

Increase the ability to track changes in the incidence of PCC in the United States

Increase the ability to track changes in health disparities surveillance information systems

Enhance health information systems Partnerships Advance electronic information/data exchange

Collaborate with programs supporting similar surveillance systems Workforce Capacity Enhance health information systems workforce related to

PCC

i. Purpose The project will track and investigate the burden and impact of post COVID-19 conditions (PCC) in diverse populations, in the US through surveillance and long-term follow-up of cohorts with PCC with public health, academic, or healthcare partners. This cooperative agreement has two components (4 Surveillance Sites, Component A; 1 Coordinating Center, Component B).

Surveillance sites conduct standardized population-based approach to estimate and track post COVID conditions. Coordinating Center provides infrastructure for standardized approaches and analytic methods for consolidate estimates.

ii. Outcomes Outcomes from the activities of this NOFO Short term outcomes:

Improved ability of the recipient to provide completeness, timeliness, and quality of PCC surveillance data

Improved accuracy in defining the populations at risk for PCC based on evidence SARS- CoV-2 infection

Improved data exchange and use of data among public health agencies, organizations, and community; community members; collaborators; health care organizations

Improved collaborations and data sharing

Intermediate outcomes:

Improved monitoring of trends in PCC

Increased used of surveillance and epidemiological data by public health agencies and organizations to guide prevention and care efforts.

Increased used of surveillance and epidemiological data to monitor health outcomes including PCC following SARS-CoV-2 infection.

Improved monitoring of trends in PCC

Increased used of surveillance and epidemiological data by public health agencies and organizations to guide prevention and care efforts.

Increased knowledge of surveillance system among partners through dissemination of surveillance results to public health, scientific and health care communities.

iii. Strategies and Activities Data collection and use

All components (A and B) applicant must describe how they plan to:

Systematically collect, analyze, interpret, and disseminate data to describe, characterize and detect trends of Post COVID-19 Conditions (PCC) among persons with SARS-CoV-2 infection. Use CDC or standardized global guidance for identification of SARS-CoV-2 infections and post COVID-19 conditions.

Develop surveillance data use plan. Provide detailed timeline including realistic and measurable milestones for the proposed activities. Include detailed budget plan that is linked to the activities and milestones. Monitor and use data to guide strategic action and inform future surveillance

Develop surveillance reports and disseminate to public health agencies, organizations, and community; community members; collaborators; health care organizations. Describe plans for data dissemination and production of reports. Describe plans for providing semi-annual estimates of incidence and prevalence of PCC. Data on incidence and prevalence estimates should be provided within 6 months of completion of data collection and cleaning with a final dataset provided at study completion. Reports include interim progress and final reports, technical reports, professional presentations, and publications that will be produced collaboratively with CDC.

Enhancements Component A:

Maintain and/or enhance integrated surveillance information systems. Describe the method of surveillance for incidence and prevalence of post COVID-19 conditions. Describe the demographics of the population source/denominator. Include details on representativeness to the source population and the general, geographic population. Include information on racial/ethnic minority and socio-economically disadvantaged populations. Describe how the population size will be ascertained for the estimation of incidence, prevalence, and secular trends for the five years of the study.

Enhance health information systems. Describe surveillance infrastructure and summary of site-specific data sources to identify incidence and prevalence of post COVID-19 conditions the population.

Component B:

Maintain and/or enhance integrated surveillance information systems. See Organizational capacity section of this NOFO.

Enhance health information systems. See Organizational capacity section of this

NOFO.

Partnerships Component A:

Advance electronic information/data exchange. Describe partnership/network(s) which will provide information on SARS-CoV-2 cases and post COVID-19 conditions within the population source. Describe expected work with local partners and CDC programs to address data collection processes. Describe plan for partners and collaboration to accomplish goals of surveillance effort including identification of roles, effort, and commitment.

Component B:

Advance electronic information/data exchange. Describe methods for study-wide coordination. Include plans for development and maintenance of central data system or data base, data management and coordination with sites. Describe expected work with funded site partners and CDC programs to address data collection processes. Describe readiness/preparation to coordinate with other sites/recipients on data base development, data management, data sharing, development of data reports, data analysis, protocol development.

All Components (A and B):

Collaborate with programs supporting similar surveillance systems. Describe experience in collaborating with other partners in a multi-center study. Describe readiness/preparation to coordinate with other sites/recipients (Component A), including the Coordinating Center (Component B), on data base development, data management, data sharing, development of data reports, data analysis, and protocol development. Include letters of support, publications, abstracts, and reports demonstrating previous collaborations. Documents reflecting previous experience with partners must be provided in a PDF format as an attachment in the Grants.gov application package. Label the file name as Partner Collaboration.

Workforce Capacity All components (A and B):

Enhance health information systems workforce. Describe the applicant institutional infrastructure to carry out large, complex, population-based projects. Include information on applicant’s physical facilities, data management, and computer resources and facilities for data retrieval and storage. Include description of staffing and management plans.

Describe training or developing doctoral, post-doctoral, and junior investigators. This may include investigators with a demonstrated interest and history in working with populations with health disparities and planning for training and developing post-doctoral and junior investigators.

1. Collaborations

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

For Component A all applicants are expected:

To have access to an institutional infrastructure and established access to representative persons with SARS-CoV-2 test results. This should include partnership/networks(s) which will provide information to SARS-CoV-2 cases and post COVID-19 conditions with the population resource. And could include working with state/local public health departments in accordance with the applicable federal, state, and local privancy laws to identify persons tested for SARS-CoV-2.

To adequately describe their catchment area for surveillance activities.

To provide evidence of established and well-defined working relationships with organizations and/or outside entities expected to participate in the proposed surveillance project.

To demonstrate partnerships with health care partners or systems to access information on both initial infection and on post COVID-19 conditions. Applicants should demonstrate experience in working collaboratively with surveillance partners. Letters of support, MOUs, or MOAs can be provided as evidence of collaboration with partnering organization and supporting context of the partnership. Follow instructions below to upload these documents as part of the Grants.gov application package.

To describe methods for study-wide coordination. Include plans for development and maintenance of central data system or data base, data management and coordination with sites.

To describe readiness/preparation to coordinate with the CDC programs and other sites/recipients on data base development, data management, data sharing, development of data reports, data analysis, protocol development.

For Component B all applicants are expected:

To collaborate with the CDC programs and recipients of Components A and other partners to accomplish the goals and objectives of the study.

To demonstrate experience in coordination of multi-center studies, data management, and analysis. Applicants should demonstrate experience in working collaboratively with surveillance partners.

Applicants must file the MOU or MOA or Letter of support, as appropriate including name of partner organization. MOU documents must be provided in a PDF format as an attachment in the Grant.gov application package. Label the file name as MOUs.

b. With organizations not funded by CDC:

For Component A all applicants are expected:

To adequately describe their catchment area for surveillance activities.

To provide evidence of established and well-defined working relationships with organizations and/or outside entities expected to participate in the proposed surveillance project.

To demonstrate partnerships with health care partners or systems to access information on both initial infection and on post COVID-19 conditions. Applicants should demonstrate experience in working collaboratively with surveillance partners.

For Component B all applicants are expected:

To collaborate with recipients of Components A and other partners to accomplish the goals and objectives of the study.

To demonstrate experience in coordination of multi-center studies, data management, and analysis. Applicants should demonstrate experience in working collaboratively with surveillance partners.

Applicants must submit the MOU/MOA or Letter of support, as appropriate, including the name of the partner organization. MOU documents must be provided in a PDF format as an attachment in the Grants.gov application package. Label the file name as MOUs.

2. Target Populations The target U.S. populations are children (0 – 11 years), adolescents (12-17 years), and/or adults (≥18 years), including populations disproportionately affected by SARS-CoV-2 infections. The population under surveillance at each applicant’s site should be demographically and geographically representative of the population included in the applicant’s site.

Each site applying for Component A must demonstrate ability to include two or more of the target age populations and/or two or more populations disproportionately affected by SARS- CoV-2 infections.

a. Health Disparities Applicants should use surveillance data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by COVID-19 disease, related diseases, and post COVID-19 conditions, and identify/plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, applicants should consider social determinants of health in the development, implementation, and evaluation of specific surveillance efforts and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

iv. Funding Strategy COVID-19 American Recovery Plan of 2021(ARP) [P.L. 117-2] funding will be used to support this NOFO. A recipient of a grant or cooperative agreement made available under ARP awarded by the Department of Health and Human Services (HHS) agrees, as applicable to the award, to:

1) comply with existing and/or future directives and guidance from the Secretary regarding the control of the spread of COVID-19; 2) in consultation and coordination with HHS, provide, commensurate with the conditions of the individual, COVID-19 patient 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.

An applicant can apply to Component A, Component B, or both Component A and Component B. Separate applications are required for each component.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Strategy

All Components (A and B):

A data management plan is required for the proposed project and should include the following:

Description of the data to be collected or generated in the proposed project

Standards used for the collected or generated data

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

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

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified

Plans for quarterly data sharing with funding agency.

Component A:

These evaluation/performance measures are expected to include methods to assess SARS-CoV-2 infection and post COVID-19 condition (PCC) identification, and to estimate the contribution of SARS-CoV-2 infection to observed health conditions or symptoms in the population and to provide completeness, timeliness, and quality of PCC surveillance data. This will include accuracy in defining the populations at risk for PCC based on evidence of SARS- CoV-2 infection and improving data exchange and use of data among public health agencies, organizations, and community; community members; collaborators; health care organizations. Selected evaluation methods should provide for assessment of whether the accuracy of the methods differ by race/ethnicity, socioeconomic status, insurance coverage or geographic area.

Further, selected evaluation/performance measures should provide an assessment of consistency of methods over time, and measurement of completeness of case ascertainment. Selected evaluation measures are expected to include a description of the population under surveillance and how it will be ascertained for estimation of incidence and prevalence.

Component B:

Evaluation/performance measures are expected to include quality assurance and quality control measures. Description of activities for on-going study progress, oversight, data management, and quality control and assurance measures should include metrics that will be used and methods to ensure high data quality and accuracy of incidence and prevalence results. Performance measurements should include statistical approaches to adjust for data limitations and/or combine data sources to produce estimates. These measures will evaluate improvement in the ability of the recipient to provide completeness, timeliness, and quality of PCC surveillance data, and to improve data exchange and use of data among public health agencies, organizations, and community; community members; collaborators; health care organizations, and to improve collaborations and data sharing.

Process Measures Strategies and Activities Measures

Data Monitoring, Use, and Dissemination Strategy

Systematically collect, analyze, interpret, and disseminate data to describe, characterize and detect trends in PCC

Data related to post COVID-19 conditions will be reported in monthly dashboard and biannual interim dataset reports.

Data will include results by severity of SARS-CoV-2 infection, post COVID-19 condition, laboratory results (including viral sequencing), vaccine history, clinical information, and medical history including chronic underlying medical conditions. This information will be provided by age, sex, race/ethnicity, and geographic area.

High level data will be shared with the CDC via dashboard on a semi-annual basis for the duration of the study.

The interim dataset reports will be securely transmitted to CDC every six months for the duration of the study.

Monitor and use data to guide strategic action

Ongoing data monitoring focused on results by severity of SARS-CoV-2 infection, post COVID-19 condition, laboratory results (including viral sequencing), vaccine history, clinical information, and medical history including chronic underlying medical conditions. This information will be provided by age, sex, race/ethnicity, and geographic area.

Accurate and timely assessment of PCC following SAR- CoV-2 infection

Quarterly report on prevalence and incidence of PCC by severity of SARS-CoV-2 infection, laboratory results (including viral sequencing), vaccine history, clinical information, and medical history including chronic underlying medical conditions to track changes over time.

Produce plan for use of surveillance data

Plan for use of findings developed including dissemination, informing overall burden from SARS-CoV-2 infection

Develop surveillance reports and disseminate to key stakeholders

Regular surveillance reports produced and disseminated

Enhancement Strategy Strong surveillance information system or database

Maintain and/or enhance integrated surveillance information systems

Enhance health information systems

Improved data exchange and use among key partners and stakeholders

Measures of successful data exchange and transmission of data from Component A to Component B.

Integration of data from sites funded in Component A by coordinating center (Component B) to produce estimates.

Measures of data standardization and generation of reports (Component B).

Partnerships Strategy

Advance electronic information/data exchange

Collaborate with programs supporting similar surveillance systems

Improved data exchange and use among key partners and stakeholder.

Documented engagement with partners and stakeholders.

Improved collaboration and data sharing to track and monitor the on-going burden of post COVID-19 conditions following SARS-CoV-2 infection.

Increased knowledge of surveillance systems through dissemination of surveillance results to public health, scientific, and health communities through peer reviewed publications, surveillance reports, web-reports and dashboards.

Workforce Capacity Strategy

Enhance health information system workforce

Improved data exchange or and use among key partners and stakeholder

Well-trained staff capable of using and improving surveillance system to develop and maintain of central data system or data base, data management and coordination with sites.

Expansion of data base development, data management, data sharing, development of data reports, data analysis, protocol development.

Outcomes Measures Short Term/Intermediate Outcomes

Improved monitoring of trends in PCC

Improved completeness, timeliness, and quality of PCC surveillance data

Increased used of surveillance and epidemiological data to guide prevention and care efforts, monitor PCC health outcomes, develop policy, Number of data collection activities that include data on PCC

Number and proportion of sites with relevant data in the data system meeting minimum standards

Average length of time between data submission and reports

Number of public health agencies, community organizations, community members, health care organizations, who received data reports to guide public health actions allocate resources, and plan and implement services

Increased use of data to guide public health actions

Performance monitoring:

To ensure that the activities have been implemented as expected and that the intended project period outcomes have been achieved and CDC will keep track of some performance measures to demonstrate the effectiveness and/or to suggest ways to improve the program as follows:

% activities producing preliminary findings within 3 months of data collection % activities producing project report within 3 months of preliminary findings

Dissemination of Monitoring Results:

Activities outputs will be disseminated through written reports, online and in-person presentations, and/or professional conferences. Potential audiences include funders, Department of Health and Human Services, Departments of Health across levels, and other key stakeholders.

Written reports will be made available in electronic and paper formats.

EVALUATION

Evaluation/performance measures are expected to include quality assurance and quality control measures. Measures should include:

Completeness of data including percent of missingness by variable Timeliness as measured by time from data collection to analysis and reporting of estimates Quality of PCC surveillance data including description of demographic variables provided Improve data exchange and use of data among public health agencies, organizations, and community; community members; collaborators; health care organizations, and improve collaborations and data sharing as measured by number of organizations.

Time it takes to make program changes based on the timeliness of reporting and dissemination of data

Dissemination of Evaluation Results:

Potential evaluation findings will be disseminated through written reports, online and in-person presentations, and/or professional conferences. Potential audiences include: CDC, Departments of Health across levels, and other key stakeholders. Written reports will be made available in electronic and paper formats.

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.

c. Organizational Capacity of Recipients to Implement the Approach All Components (A and B):

Describe experience in directing and operating a coordinating center for collaborative, population based large scale epidemiologic studies, and/or surveillance projects that include coordination of multiple sites, common protocols, monitoring of site performance, monitoring study progress, and providing logistical governance support. Describe experience with government cooperative agreement/grant management for large and/or muli-site projects.

Provide staffing plan that defines roles, responsibilities, and qualifications of the team and expected contribution of key/collaborative partners. Resumes/CVs of staff working on this project must be provided in PDF format as a attachment in the Grants.gov application package. Label the file name as Project staff.

Provide letter (s) of support from the applicant’s institution that commits the institution to

(a) on-going partnerships for this project; (b) a specified percentage of the staff time to spend on this project; (c) continued access to data source(s)/ data set(s); and (d) approval for travel for required staff and PIs to attend project meetings to CDC Atlanta, in local commute area or Steering Committee-related meetings. Letters of support must be https://www.cdc.gov/grants/additional-requirements/ar-25.html provided in a PDF format as an attachment in the Grants.gov application package. Label the file name as Letter of Support.

Applicants have made substantial contributions to characterization of population-based estimates of burdens of infections within the past 5 years, as evidenced by relevant publications. Publications documents must be provided in a PDF format as an attachment in the Grants.gov application package. Label the file name as Publications.

Component A:

Describe the method of surveillance for incidence and prevalence of post COVID-19 conditions. Describe the population source/denominator. Include details on representativeness to the source population and the general, geographic population. Include information on racial/ethnic minority and socio-economically disadvantaged populations. Describe how the population size will be ascertained for the estimation of incidence, prevalence, and secular trends for the five years of the study.

Describe applicant infrastructure and summary of site-specific data sources to identify incidence and prevalence of post COVID-19 conditions in the population.

Describe methods for study-wide coordination. Describe readiness/preparation to coordinate with other sites/recipients including data sharing with Component B.

Describe the applicant institutional infrastructure to carry out large, complex, population-based projects. Include information on applicant’s physical facilities, data management, and computer resources and facilities for data retrieval and storage. Include description of staffing and management plans.

Component B:

Describe experience in directing and operating a coordinating center for collaborative, population-based large scale epidemiologic and/or surveillance projects that include coordination of multiple sites, common protocols, monitoring of site performance, monitoring study progress, and providing logistical governance support.

Describe experience in providing data management, analysis, and statistical support to multi-site projects. Include development and management of multi-site database, design, analyses, and interpretation of data and development and disemination of data summaries and statistical reports.

Describe understanding of surveillance methods and activities including creation of appropriate denominator for incidence and prevalence estimates, potential problems and solutions to address representativeness of estimates and completeness of case identification.

Describe the applicant institutional infrastructure to carry out large, complex, population-based projects. Include information on applicant’s physical facilities, data management, and computer resources and facilities for data retrieval and storage. Include description of staffing and management plans. Resumes/CVs of staff working on this project must be provided in PDF format as a attachment in the Grants.gov application package. Label the file name as Project staff.

Describe methods for study-wide coordination. Include plans for development and maintenance of a central data system or data base, data management and coordination with sites. Describe readiness/preparation to coordinate with other sites/recipients on data base development, data management, data sharing, development of data reports, data analysis, protocol development.

d. Work Plan This sample workplan is provided to reflect how the applicant workplan should align with the logic model and narrative.

Period of Performance Outcome:

(From Outcomes section or logic model)

Outcome Measure:

(From Evaluation and Performance Measurement section)

Strategies and activities Process Measure

Responsible position/person

Completion date

The table would be completed for each period of performance outcome. Applicants must provide a detailed work plan for the first year of the project and a high-level work plan for subsequent years. Plan should provide detailed timeline including realistic and measurable milestones for the proposed activities and include detailed budget plan that is linked to the activities and milestones.

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.

Monitoring and feedback information will be provided to recipients in written or verbal comments to award recipients. Recipients are required to address comments by CDC program staff and subject matter experts to work towards the achievement of project outcomes within the timeframes.

f. CDC Program Support to Recipients

CDC will provide general coordination for all sites in Component A, for Component B and the overall study.

Provide coordination on crosscutting activities including quality assurance, validation of SARS- CoV-2 infection, development of common multi-center protocol(s), quality control, interim data monitoring, data analyses, interpretation, reporting, and coordination.

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

NCIRD will serve as a consultant with scientific and programmatic involvement during the conduct of the project, providing management oversight, and scientific consultation as requested by the recipients.

Support the recipients’ activities by consulting and providing scientific and public health consultation and assistance in the development of activities related to the cooperative agreement.

Collaborate to produce technical reports and manuscripts for peer-reviewed publications, as appropriate.

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

Facilitating the development of protocols and procedure manuals

Development of Data Management Plans

Assisting the investigators, as needed, in complying with the Investigator responsibilities described in the Policy on Public Health Research and Non-research Data Management and Access

Analyzing and interpreting data

Disseminating results

Coordinating and facilitating communication and information exchange

Assure assessment of the public health impact of the surveillance conducted under this notice of funding opportunity and promote translation of promising practices, programs, interventions, and other results from the surveillance.

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:

U58

3. Fiscal Year:

Estimated Total Funding:

$45,000,000

4. Approximate Total Fiscal Year Funding:

$9,000,000 This amount is subject to the availability of funds.

5. Approximate Period of Performance Funding:

$45,000,000

6. Total Period of Performance Length:

year(s)

7. Expected Number of Awards:

Component A: 4 Awards Component B: 1 Award

8. Approximate Average Award:

$1,800,000 Per Budget Period

Component A individual awards ranging from $1,600,000 to $2,000,000 and for Component B awards range from $900,000 to $1,000,000 for the first year.

9. Award Ceiling:

$2,000,000 Per Budget Period

10. Award Floor:

$900,000 Per Budget Period

11. Estimated Award Date:

May 01, 2022 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).

12. Budget Period Length:

60 month(s)

Five 12-month budget periods. The first budget period is 6/1/2022 through 5/30/2023.

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)

01 (County governments)

02 (City or township governments)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

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)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

20 (Private institutions of higher education)

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:

Government Organizations:

State (includes the District of Columbia)

Local governments or their bona fide agents

Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau

State controlled institutions of higher education

American Indian or Alaska Native tribal governments (federally recognized or state-recognized)

American Indian or Alaska native tribally designated organizations

Other:

Private colleges and universities

2. Additional Information on Eligibility The award ceiling for this NOFO is $2,000,000 for Component A and $1,000,000 for Component B. CDC will consider any application requesting an award amount higher than the ceiling amount as non-responsive and it will recieve no further review.

Additional requirements for review include: Application table of contents, Project Abstract, project narrative (including work plan), budget narrative, letters of support from any proposed partners, CVs/resumes, organization charts, and copy of indirect cost-rate agreement. Required documents must be submitted, if not submitted the application will be considered non-responsive and will recieve no further review.

3. Justification for Less than Maximum Competition

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Required Registrations

1. Required Registrations An…