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Supporting and Improving the Chronic Kidney Disease Surveillance System in the United States
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CDC-RFA-DP21-2107
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Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion

Supporting and Improving the Chronic Kidney Disease Surveillance System in the United

States

CDC-RFA-DP21-2107

Application Due Date: 03/01/2021

Supporting and Improving the Chronic Kidney Disease Surveillance System in the United

States

CDC-RFA-DP21-2107

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text 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 Information 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- DP21-2107. 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:

Supporting and Improving the Chronic Kidney Disease Surveillance System in the United States C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52.

This Notice of Funding Opportunity (NOFO) solicits non-research cooperative agreement applications to build upon previous work in chronic kidney disease (CKD) surveillance to continue supporting, updating, and improving the CKD Surveillance System in the United States https://nccd.cdc.gov/CKD/. The recipients will have access to the current documentation and existing data in the system.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DP21-2107

E. Assistance Listings (CFDA) Number:

93.833 F. Dates:

1. Due Date for Letter of Intent (LOI): 01/20/2021 Is a LOI: Recommended but not Required

2. Due Date for Applications: 03/01/2021, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A

G. Executive Summary:

1. Summary Paragraph:

This NOFO solicits non-research cooperative agreement applications for these components:

Component A: To build upon previous work in chronic kidney disease (CKD) surveillance to continue supporting, updating, and improving the current CKD Surveillance System in the United States https://nccd.cdc.gov/CKD/. This is a comprehensive surveillance system that resides in a website application and integrates existing CKD data from multiple US data sources such as national surveys and registries, health care administrative data, and large cohort studies.

https://www.grants.gov https://www.grants.gov https://www.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52 https://www.grants.gov

This surveillance system will enable the government and others to monitor trends in the burden of CKD and its risk factors over time and also monitor trends in Healthy People 2030 objectives related to CKD prevention and control.

Component B: To provide computer support and technical management, updates, and enhancements to the currently functional and interactive website application of the CKD Surveillance System https://nccd.cdc.gov/CKD/. The website will be used to 1) document the burden of CKD and its risk factors in the United States population over time, 2) disseminate timely and accurate CKD surveillance data and trends, 3) track the progress of efforts to achieve Healthy People 2030 objectives to prevent, detect, and manage CKD, and 4) provide the means for monitoring risk factors and preventive care practices to assist stakeholders in targeting interventions and reducing health disparities.

The recipients will have access to the current documentation and existing data in the system.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 2 One award will be made for Component A and one award will be made for Component B.

d. Total Period of Performance Funding: $6,000,000

e. Average One Year Award Amount: $1,200,000 The approximate average award will be $700,000 for Component A and $500,000 for Component B.

f. Number of Years of Award: 5

g. Estimated Award Date: 08/30/2021

h. Cost Sharing and / or Matching Requirements: N 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 Chronic kidney disease (CKD), the ninth leading cause of death in the United States, affects an estimated 37 million people or about 15% of the US adult population. Nine in ten people with CKD are not aware of having the disease before the onset of kidney failure and presenting for dialysis or transplantation. In 2017, diabetes accounted for nearly half of all new cases of kidney failure. With the high prevalence of diabetes and hypertension, the burden of CKD and the number of new cases of kidney failure in the United States are expected to grow. Furthermore, people with diabetes and CKD have a higher risk of cardiovascular disease and premature death compared to those without CKD.

In the United States, improvements in diabetes care have contributed to a 68% decline in cardiovascular events between 1990 and 2010 in people with diabetes, whereas the decline in kidney failure incidence was 28%. Unfortunately, these trends stalled or reversed after 2010, particularly in young and middle-aged adults, and the reasons for the resurgence in these diabetes complications are unclear. Preventing CKD and its complications is possible by managing risk factors such as diabetes and high blood pressure and treating the disease to slow its progression and reduce the risk of complications. In people with diabetes, blood pressure and blood sugar control have been shown to delay or prevent CKD and kidney failure. Continued efforts to document and monitor trends in CKD, its risk factors, care practices, and outcomes will be crucial in assessing the success of preventive interventions and in reducing health disparities.

The CKD Surveillance System https://nccd.cdc.gov/CKD/ is the only interactive and most comprehensive collection of CKD-related data in the United States, crucial for tracking national trends in the number of cases, risk factors, health consequences, and care practices that affect CKD prevention and control, and for monitoring progress and informing national Healthy People objectives. Analyses of health care data allow observation of real-world diagnostic and therapeutic practice patterns in both those with risk factors and those already diagnosed with CKD. Together, these elements provide comprehensive tracking of all aspects of CKD, including current health care utilization, with the potential for improved outcomes, increased lifespan, and lower societal costs. Surveillance findings on processes of care, among other findings, have informed patient education campaigns and patient care guidelines.

This NOFO will build upon the previous CKD surveillance work to continue supporting, updating, and improving the CKD Surveillance System with relevant data sources and indicators, to enhance the CKD Surveillance System website with state-of-the-art technologies and visualization tools, and to assist CDC, prevention researchers, policy makers, medical practitioners, and states in developing and evaluating programs and policies to better prevent, detect, and manage CKD. The website application resides on the server of the National Center for Chronic Disease Prevention and Heath Promotion (NCCDPHP) at CDC, conforms to CDC information technology requirements, and is accessible to both internal and external CDC users.

NOFO goals are to:

• Support, update, and improve the CKD Surveillance System in the United States https://nccd.cdc.gov/CKD/ with relevant data sources and indicators and up-to-date data and trends (Component A), and

• Support, update, and enhance the currently functional and interactive website application of the CKD Surveillance System https://nccd.cdc.gov/CKD/ with data updates and state-of-the-art technologies and visualization tools (Component B).

Eligible applicants may apply for one or both components and may only submit a single application for this NOFO. If applying for both components, a separate workplan and budget narrative must be submitted for each component.

b. Statutory Authorities Section 317(k)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2), Section 301(a) of the PHS Act, 42 U.S.C. 241(a).

c. Healthy People 2030 This NOFO addresses the Healthy People 2030 focus area of Chronic Kidney Disease https://health.gov/healthypeople/objectives-and-data/browse-objectives/chronic-kidney-disease.

d. Other National Public Health Priorities and Strategies This NOFO supports the national initiatives, Advancing American Kidney Health (https://aspe.hhs.gov/system/files/pdf/262046/AdvancingAmericanKidneyHealth.pdf) and Million Hearts (https://millionhearts.hhs.gov/) aimed at reducing CKD risk factors and its complications.

e. Relevant Work This NOFO builds on CDC-RFA-DP16-1604 and CDC-RFA-DP11-1109 and supports:

CDC’s National Center for Chronic Disease Prevention and Health Promotion/Division of Diabetes Translation (DDT) Government Performance Results Act

Strategic Goal 2: Advance Scientific Knowledge and Innovation Objective E: Improve laboratory, surveillance, and epidemiology capacity Strategic Goal 3: Advance the Health, Safety, and Well-Being of the American People Objective D: Promote prevention and wellness across the life span

DDT’s Core function: Surveillance

Strategic Goal 2: Prevent complications, disabilities, and burden associated with diabetes Priority C: Conduct surveillance and applied research to identify and prioritize effective approaches and targeted sub-populations for diabetes prevention and control.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-DP21-2107: Supporting and Improving the Chronic Kidney Disease Surveillance System in the United States

STRATEGIES AND

ACTIVITIES

SHORT-TERM

OUTCOMES

INTERMEDIATE

OUTCOMES

LONG-TERM

OUTCOMES

COMPONENT A: COMPONENT A: COMPONENT A: COMPONENT A:

Support the CKD surveillance system with up-to-date data and trends.

Obtain access to data relevant to

CKD

surveillance.

Identify and integrate new CKD surveillance indicators.

Focus on vulnerable populations, risk factors, and data at various geographic levels.

Assess utility of indicators and identify gaps and future needs.

Disseminate CKD surveillance findings.

Support monitoring of Healthy People objectives for

CKD.

Increased number of

CKD

surveillance topics, indicators, or years of data.

Increased number of products and publications of the CKD Surveillance System.

CKD

surveillance data are used to monitor progress on Healthy People 2030

CKD

objectives.

Improved utilization of products and publications support, promote, or inform identification of the at-risk population and improved CKD care and outcomes.

CKD

surveillance data are used to inform the Healthy People 2030 Mid-course Review report.

Improved or consistent comprehensiveness and timeliness of CKD surveillance data maintained on the CKD Surveillance System.

CKD surveillance data are used to inform Healthy People 2040 CKD objectives.

STRATEGIES AND

ACTIVITIES

SHORT-TERM

OUTCOMES

INTERMEDIATE

OUTCOMES

LONG-TERM

OUTCOMES

COMPONENT B: COMPONENT B: COMPONENT B: COMPONENT B:

Provide support and technical management of the CKD Surveillance website application.

Enhance the usability of the website application and the user experience.

Stay up-to-date with the latest developments in computer software, information technology (IT), and visualization tools.

Work in collaboration with the CDC IT program.

Provide feedback and evaluation of the website application.

Provide written documentation of the system.

Increased number of

CKD

surveillance topics, indicators, or years of data.

Twice yearly Web updates to provide timely and accurate dissemination of CKD surveillance data and trends.

Online metrics and data from various sources show increased or consistent use of the CKD Surveillance System.

Improved user experience and usability of the

CKD

Surveillance System website application.

Improved or consistent utilization of the

CKD

Surveillance System website by stakeholders.

i. Purpose This NOFO will build upon previous work in CKD surveillance to continue supporting, updating, and improving the CKD Surveillance System in the United States https://nccd.cdc.gov/CKD/ with CKD indicators, including social determinants of health, up-to-date data and trends, and a state-of-the-art website application. This will assist health care professionals, policymakers, and other stakeholders in documenting the CKD burden in the United States and in targeting interventions, programs, and policies to better prevent, detect, and manage CKD, reduce health disparities, and improve outcomes. The recipients will have access to the current documentation and existing data in the system.

ii. Outcomes By the end of the performance period:

Component A:

Increased number of CKD surveillance topics, indicators, and/or years of data to show the expansion and growth of CKD surveillance data in the United States with up-to-date data and trends and visualization tools.

Increased number of products and publications to raise awareness of CKD and its complications and promote prevention and control of CKD risk factors, earlier diagnosis and treatment of CKD, and improved outcomes.

Component B:

Increased number of CKD surveillance topics, indicators, and/or years of data to show the expansion and growth of CKD surveillance data in the United States with up-to-date data and trends and visualization tools.

Online metrics and data from various sources show increased or consistent use of the CKD Surveillance System and demonstrate acceptability and continued support from policymakers and other stakeholders.

iii. Strategies and Activities COMPONENT A: (in close collaboration with the recipient of Component B)

• Support, update, and improve the existing surveillance system for CKD https://nccd.cdc.gov/CKD/ with up-to-date data and trends and visualization tools.

• Collaborate with programs internal and external to CDC to establish data sharing agreements for access to data relevant to CKD surveillance.

• List, update, and add data to the existing CKD measures and indicators (e.g., incidence, awareness, prevalence, risk factors, health consequences).

• Identify, analyze, assess, and integrate new CKD indicators to the surveillance system as data sources become available and as the science evolves and emerges.

• Focus surveillance data efforts on social determinants of health, populations that are disproportionately affected by CKD, special and vulnerable populations at risk for CKD, and on data sources that provide estimates and indicators at various geographic levels.

• Identify surveillance data and information needs to help address disparities in CKD.

• Collaborate with organizations external to CDC, such as other federal or state government agencies, academic institutions, and non-profit and international organizations, pursuant the intent and goals of this NOFO.

• Develop a plan to integrate and cross-link the CKD surveillance system with other established surveillance systems (e.g., USRDS, USDSS).

• Develop an evaluation plan to assess the utility of CKD indicators and identify gaps in surveillance data and future needs.

• Publish and disseminate CKD surveillance findings and develop practical tools (e.g., risk calculators, screening tools, Web applications) to increase awareness and help improve the identification of the population at risk for CKD.

• Provide data management, analyses, and reports to monitor progress in achieving the Healthy People 2030 CKD objectives.

• Provide written documentation of data sources, data sets, and data analyses (e.g., coding and computer programs) to allow CDC to maintain the surveillance system in the future.

COMPONENT B: (in close collaboration with the recipient of Component A)

• Provide computer support and technical management of the CKD Surveillance System website application https://nccd.cdc.gov/CKD/. Technical management includes developing plans for programming and creating databases and Web systems, coordinating system designs including interfaces, business rules, and security models, and testing and deployment.

• Enhance the usability of the website application and the user experience.

• Stay up-to-date with the latest developments in computer software, information technology (IT), and visualization tools to apply to the website application.

• Work in collaboration with the CDC IT program in performing CKD data uploads and Web updates and in conforming to CDC IT requirements, Web templates, and security clearances. All applications will exist within NCCDPHP- and CDC-supported Internet infrastructure and must conform to all performance, reliability, stability, and security standards.

• Provide feedback and evaluation (e.g., detailed requirements analyses, website analytics, usability testing) of the website application to ensure that program and user needs are identified and met.

• Provide written documentation of the system (e.g., project requirements, system overview and architecture, database specifications, programs and system components) to allow CDC to maintain and modify the Web application in the future.

1. Collaborations The recipients of Component A and Component B are expected to collaborate closely with each other, communicate on a regular and periodic basis, and establish a common protocol outlining their roles, duties, and responsibilities in operationalizing their strategies and activities to accomplish the intent and goals of this NOFO.

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

The recipients are expected to collaborate with CDC programs (e.g., CDC’s National Center for Health Statistics) for access to data relevant to CKD surveillance or surveillance of CKD risk factors, care practices, or health consequences.

As evidence of collaboration, applicants are strongly encouraged to file the MOU/MOA or letter of support, as appropriate, name the file "MOUs/MOAs" or "Letters of Support," and upload as a PDF file to www.grants.gov.

b. With organizations not funded by CDC:

The recipients are expected to 1) collaborate with organizations external to CDC, such as other federal or state government agencies, academic institutions, and non-profit and international organizations for access to data relevant to CKD surveillance, and 2) establish data sharing agreements with appropriate federal and public and private partners for data access.

As evidence of collaboration, applicants are strongly encouraged to file the MOUs/MOAs or letters of support, as appropriate, name the file “MOUs/MOAs" or "Letters of Support," and upload as a PDF file to www.grants.gov.

Applicants are advised that any activities involving information collections (i.e., surveys, questionnaires, applications, audits, data requests, reporting, record-keeping and disclosure requirements) from 10 or more non-Federal entities, including State and local governmental agencies, are subject to the conditions of the Paperwork Reduction Act of 1995 (PRA). Under the PRA, a Federal agency sponsoring a standardized data collection or directly obtaining standardized or substantially similar information from ten or more persons or entities (other than Federal employees within the scope of their employment) in any 12-month period must obtain advance written approval from the Office of Management and Budget (OMB). Regardless of form or format (oral, written, or electronically transmitted), responses of opinion or fact requested or required by or for CDC, except those specifically exempted or excluded, are subject to the provisions of the PRA and its implementing regulation, 5 CFR 1320 (Controlling Paperwork Burdens on the Public).

2. Target Populations The recipients are expected to focus surveillance efforts and provide data on at-risk, minority, or vulnerable populations that are disproportionately affected by CKD, including tribal, veteran, low-income or medically underserved populations, and on estimates and indicators at various geographic levels (e.g., national/state/county and urban/rural).

a. Health Disparities The NOFO aims to focus surveillance efforts on social determinants of health, on populations that are disproportionately affected by CKD, and on data sources that provide estimates and indicators at various geographic levels (e.g., national/state/county, urban/rural). These efforts to document and monitor trends in CKD, its risk factors, care practices, and outcomes will be crucial in identifying health disparities, helping target interventions, and assessing the success of interventions in reducing health disparities.

iv. Funding Strategy (for multi-component NOFOs only)

NA

http://www.grants.gov

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Performance Measures

Component A:

• Number of CKD surveillance topics, indicators, and/or years of data to show the expansion and growth of the CKD Surveillance System https://nccd.cdc.gov/CKD/ with up-to-date data and trends and visualizations tools.

• Number of publications or products using CKD surveillance data to disseminate CKD surveillance findings, raise awareness of CKD and its risk factors, and promote early detection and treatment and improved outcomes.

• Number of articles or features from media, Web outlets, and professional newsletters showing the impact of CKD surveillance data on recommendations or policy decisions involving CKD care and prevention, particularly as they relate to at-risk or vulnerable populations.

Component B:

• Number of CKD surveillance topics, indicators, and/or years of data to show the expansion and growth of the CKD Surveillance System website https://nccd.cdc.gov/CKD/ with up-to-date data and trends and visualization tools.

• Number of visits, type of unique visits, and diversity of visits (e.g., from researchers, public health practitioners, healthcare providers, policymakers, general public) to the website to demonstrate improved usability and acceptability of the CKD Surveillance System by policymakers and other stakeholders.

Component A and Component B: (if one recipient is funded for both components)

• Number of CKD surveillance topics, indicators, and/or years of data to show the expansion and growth of the CKD Surveillance System https://nccd.cdc.gov/CKD/ with up-to-date data and trends and visualizations tools.

• Number of publications or products using CKD surveillance data to disseminate CKD surveillance findings, raise awareness of CKD and its risk factors, and promote early detection and treatment and improved outcomes.

• Number of visits, type of unique visits, and diversity of visits (e.g., from researchers, public health practitioners, healthcare providers, policymakers, general public) to the website to demonstrate improved usability and acceptability of the CKD Surveillance System by policymakers and other stakeholders.

These measures will be finalized and operationalized after the awards are made.

A data management plan is required for this NOFO and at a minimum needs to include the following requirements:

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, 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.

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 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), if applicable, for accuracy throughout the lifecycle of the project. 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, they 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 https://www.cdc.gov/grants/additional-requirements/ar-25.html

Reporting Section of this NOFO.

For Component A:

In addition to the above requirements, the Evaluation and Performance Measurement Plan must include:

-How the applicant will assess the utility of CKD indicators (e.g., criteria to add or retire indicators from the surveillance system) and processes to identify gaps in surveillance data and future needs.

For Component B:

In addition to the above requirements, the Evaluation and Performance Measurement Plan must include:

-How the applicant will assess Web analytics and usability of the website application to improve the surveillance system and ensure program and user needs are identified and met.

c. Organizational Capacity of Recipients to Implement the Approach

For Component A:

Applicants are expected to, -Demonstrate strong experience with data management and analysis and conducting surveillance of related to CKD or other chronic diseases.

-Describe successes in managing collaborative multi-center projects, in particular for supporting and updating national surveillance systems.

-Describe prior work on surveillance among minority, vulnerable, and at-risk populations for CKD or other chronic diseases, and in monitoring and documenting trends in health disparities, risk factors, social determinants of health, and care and outcomes.

-Demonstrate experience in publishing and disseminating CKD or other chronic disease surveillance findings and in particular highlighting or addressing health disparities.

-Establish partnerships and data sharing and access agreements with agencies and organizations serving the target populations.

-Ensure adequate staffing and oversight in support of the project:

Staff members with the appropriate experience in managing chronic disease surveillance systems.

Team members with complementary and integrated expertise in the areas of kidney diseases or other related chronic diseases, biostatistics, epidemiology, and communications.

Team members with extensive, strong, and demonstrable experience in managing and analyzing large datasets containing kidney disease or other chronic disease information.

For Component B:

Applicants are expected to, -Demonstrate strong experience designing, developing, or supporting interactive website applications that disseminate surveillance data and trends related to CKD or other chronic diseases.

-Provide evidence of established infrastructures in building or supporting national surveillance systems for CKD or other chronic diseases in the United States.

-Describe successes in managing collaborative multi-center projects, in particular for supporting and updating interactive surveillance Web applications.

-Ensure adequate staffing and oversight in support of the project:

Staff members with the appropriate experience in managing, integrating, and updating interactive website applications for CKD or other chronic diseases.

Team with complementary and integrated expertise in the areas of informatics, computer programming, graphics and visualization technologies, and Web development and design.

Applicants may include in appendices curriculum vitae and resumes to demonstrate staff experience and expertise, bibliography of relevant publications to demonstrate capacity for doing chronic disease surveillance or supporting website applications, and letters of support or MOAs/MOUs as evidence of partnerships or collaborations for data access and to implement the proposed strategies and activities and achieve outcomes. The appendices will not be counted toward the narrative page limit and there is no limit to the number of allowable electronic attachments uploaded per application. This additional information, which should be uploaded in a PDF file format in Grants.gov, includes (and should be named):

Curriculum Vitae/Resumes Bibliography Letters of Support/MOAs/MOUs Additional subcontractor materials (if applicable)

d. Work Plan Applicants should develop a separate work plan for Components A and B, if applying for both components. Applicants must, For Component A:

-Outline the workplan into outcomes for the budget period and for the performance period, clearly identifying the outcomes expected to be achieved by the end of the budget period and the outcomes expected by the end of the performance period.

-Outline how to carry out the proposed strategies and activities together with the evaluation and performance measurements to assess progress towards achieving the proposed outcomes.

-Include quantitative process and outcome measures and proposed strategies and activities that are feasible and adequate to achieve the desired outcomes.

-Provide a detailed timeline with realistic and measurable outcomes for the proposed project strategies and activities.

-Describe how the plan will accomplish the NOFO goals of supporting and improving the CKD Surveillance System in the United States https://nccd.cdc.gov/CKD/ with relevant data sources and indicators and up-to-date data and trends.

-Describe collaborative agreements to address the intent and goals of this NOFO and provide evidence of demonstrated partnerships for data access or evidence of data use agreements for the existing or proposed collaborations.

-Describe dissemination plans for producing reports, such as interim progress reports, final reports, as well as professional presentations and publications that will be produced in collaboration with CDC and other partners.

For Component B:

-Outline the workplan into outcomes for the budget period and for the performance period, clearly identifying the outcomes expected to be achieved by the end of the budget period and the outcomes expected by the end of the performance period.

-Outline how to carry out the proposed strategies and activities together with the evaluation and performance measurements to assess progress towards achieving the proposed outcomes.

-Include quantitative process and outcome measures and proposed strategies and activities that are feasible and adequate to achieve the desired outcomes.

-Provide a detailed timeline with realistic and measurable outcomes for the proposed project strategies and activities.

-Describe how the plan will accomplish the NOFO goals of updating and enhancing the CKD Surveillance System website https://nccd.cdc.gov/CKD/ with data updates and state-of-the-art technologies and visualization tools.

-Describe collaborative agreements to address the intent and goals of this NOFO.

-Describe dissemination plans for producing reports, such as system documentation, Web analytics, and other technical reports.

Sample template:

Period of Performance Outcome:

[from Outcomes section or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

1.

2.

3.

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.

Or recurring monitoring meetings with the recipients.

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

CDC staff will act as consultants for this project.

In collaboration with the recipients of Component A and Component B, CDC activities will include:

-Providing consultation and guidance on all phases of the project.

-Providing expert advice on developing and maintaining surveillance systems.

-Providing relevant surveillance findings and public health recommendations related to the project.

-Fostering collaborations with other CDC internal and external partners.

-Following up on the recommendations resulting from this project to continue supporting, updating, and improving the CKD Surveillance System.

B. Award Information

1. Funding Instrument Type: 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: 2021 Estimated Total Funding: $6,000,000

4. Approximate Total Fiscal Year Funding: $1,200,000 Annual funding is $700,000 for Component A and $500,000 for Component B.

This amount is subject to the availability of funds.

5. Approximate Period of Performance Funding: $6,000,000 Period of performance funding is $3,500,000 for Component A and $2,500,000 for Component B subject to availability of funds.

6. Total Period of Performance Length: 5 Length of period of performance is 5 years.

7. Expected Number of Awards: 2 One award will be made for Component A and one award will be made for Component B.

8. Approximate Average Award: $1,200,000 Per Budget Period The approximate average award will be $700,000 for Component A and $500,000 for Component B.

This amount is subject to the availability of funds.

9. Award Ceiling: $1,200,000 Per Budget Period The award ceiling will be $700,000 for Component A and $500,000 for Component B.

10. Award Floor: $600,000 Per Budget Period The award floor will be $400,000 for Component A and $200,000 for Component B.

11. Estimated Award Date: 08/30/2021

Throughout the period of performance, 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 (period of performance) 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: 12 month(s)

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

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional

Information on Eligibility" for clarification)

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)

Non-government Organizations:

American Indian or Alaska native tribally designated organizations

Other:

Private colleges and universities Community-based organizations Faith-based organizations

2. Additional Information on Eligibility

Eligible applicants may apply for one or both components and may only submit a single application for this NOFO. If applying for both components, a separate workplan and budget narrative must be submitted for each component. The workplan and budget narrative must be named and uploaded in grants.gov as, “Component A CKD Surveillance System Workplan and Budget Narrative” and “Component B CKD Surveillance Website Workplan and Budget

Narrative,” accordingly.

Component A: The award ceiling for Component A is $700,000. CDC will consider any application requesting an award higher than this amount as nonresponsive and it will receive no further review.

Component B: The award ceiling for Component B is $500,000. CDC will consider any application requesting an award higher than this amount as nonresponsive and it will receive no further review.

3. Justification for Less than Maximum Competition N/A

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

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

D. Required Registrations

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System: All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do annually. Additional information about registration procedures may be found at https://www.sam.gov/index.html.

c. Grants.gov: The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

Step System Requirements Duration Follow Up 1 Data

Universal Number System

(DUNS)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days To confirm that you have been issues a new DUNS number check online at (http:// fedgov.dn b.com/ webform) or call 1-866-705-

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to https://www.sam.gov/index.html and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/fsd -gov/home.do Calls: 866-606-

3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR)

2. Once the Account is set up the E_BIZ POC will be notified via email

3. Log into grants.gov using the password the E- BIZ POC received and create new password

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants MUST obtain a DUNS number and SAM account before applying to grants.gov)

Register early!

Log into Grants.gov and check AOR status until it shows you have been approved https://www.sam.gov/index.html https://grants.gov/ https://www.grants.gov/ http://www.grants.gov https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html https://fsd.gov/fsd%20-gov/home.do https://fsd.gov/fsd%20-gov/home.do

4. This authorizes the AOR to submit the applications on behalf of the organization

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by

OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: 01/20/2021

b. Application Deadline Due Date for Applications: 03/01/2021 , 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http:// wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) / Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http:// wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) / Homepage.aspx https://www.grants.gov https://www.grants.gov https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

Risk Assessment Questionnaire Requirement CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the…

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