Foa_Content_of_CDC-RFA-DD22-2203.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES

Population-based Surveillance of Outcomes, Needs, and Well-being of Children and Adolescents with Congenital Heart Defects

CDC-RFA-DD22-2203

05/28/2022

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- DD22-2203. 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) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Population-based Surveillance of Outcomes, Needs, and Well-being of Children and Adolescents with Congenital Heart Defects 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)).

New - Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DD22-2203

E. Assistance Listings Number:

93.073 F. Dates:

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

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

04/22/2022

2. Due Date for Applications:

05/28/2022 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

4/26/2022; 1:00 EDT; Zoom https://cdc.zoomgov.com/j/1618323691?pwd=WTkxUTdJYXZuV0RvZXhhaUt4T Uh5QT09 Meeting ID: 161 832 3691; Passcode: $Ba0JKDv Dial by your location +1 669 254 5252 US (San Jose) +1 646 828 7666 US (New York)

+1 551 285 1373 US

Meeting ID: 161 832 3691; Passcode: 49531055

G. Executive Summary:

1. Summary Paragraph NOFO #CDC-RFA- DD22-2203 solicits non-research, cooperative agreement applications to identify a population-based sample of children and adolescents born between 2006 and 2021 (cases 2-17 years of age at survey completion) with congenital heart defects (CHD) from U.S.

birth defects surveillance systems with active case-ascertainment and to survey their parents or caregivers to collect information regarding the children’s outcomes, including cardiac and other healthcare utilization, barriers to health care, quality of life, social and educational outcomes, transition of care from childhood to adulthood, and mortality, as well as needs and experiences of their caregivers. Improved understanding of the longer-term outcomes and healthcare needs among children and adolescents with CHD and their caregivers may inform development of strategies directed at decreasing mortality and improving the health and well-being of children and adolescents with CHD and their families. Measurable outcomes of the program will be in alignment with the following performance goal for the National Center on Birth Defects and Developmental Disabilities (NCBDDD): 1) Enhance the quality and utility of birth defects surveillance systems.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards Range: 2-4 awards

d. Total Period of Performance Funding:

$4,000,000

e. Average One Year Award Amount:

$350,000 https://www.grants.gov/ https://cdc.zoomgov.com/j/1618323691?pwd=WTkxUTdJYXZuV0RvZXhhaUt4TUh5QT09 https://cdc.zoomgov.com/j/1618323691?pwd=WTkxUTdJYXZuV0RvZXhhaUt4TUh5QT09

f. Total Period of Performance Length:

g. Estimated Award Date:

August 31, 2022

h. Cost Sharing and / or Matching Requirements:

No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview Congenital heart defects (CHD) are the most common type of structural birth defects in the United States, affecting approximately 1 in 110 live-born children, and are a leading cause of birth defect-associated infant mortality, morbidity, and healthcare costs. Due to advances in survival, there are approximately 1 million children and adolescents with CHD in the U. S. With vast declines in mortality from pediatric heart disease over the past 30 years, it is vital to evaluate health, social, educational, and quality of life outcomes beyond infancy and early childhood.

However, current population-based research on these longer-term outcomes among children with CHD rely on national survey data (e.g. National Survey of Children’s Health) or administrative healthcare data, which lack detailed information on type of CHD, presence of other birth defects, details at birth (e.g. preterm birth), or non-medical outcomes (e.g. educational needs).

Existing birth defects surveillance systems identify babies born with birth defects, but do not track identified cases through later childhood and adolescence. Data is limited to their birth defect diagnoses and characteristics at birth. Therefore, for this surveillance project, we intend to use data from U.S. birth defect surveillance systems with active case-ascertainment to identify a population-based sample of children and adolescents with CHD born between 2006 and 2021 (i.e. 2 to 17 years of age at survey completion). Surveys will be completed by caregivers and linked to vital record and birth defect surveillance system data to assess the children’s longer-term outcomes including cardiac and other healthcare utilization, barriers to health care, quality of life, social and educational outcomes, transition of care planning from childhood to adulthood, and mortality as well as needs and experiences of their caregivers. Collected data will offer new opportunities to assess health equity among those with CHD.

The federal Patient Protection and Affordable Care Act (PL 111-148, Section 10411) authorized CDC to “enhance and expand infrastructure to track the epidemiology of congenital heart disease and to organize such information into a nationally-representative, population-based surveillance system” for the purpose of facilitating “further research into the types of health services patients use and to identify possible areas for educational outreach and prevention.”

In FY15, via a cooperative agreement with March of Dimes, CDC funded the Congenital Heart Survey To Recognize Outcomes, Needs, and well-beinG (CH-STRONG), a project that surveyed 19- to 38-year-olds with CHD identified from three U.S. birth defects surveillance systems with active case-ascertainment to collect information on their longer-term outcomes. This NOFO will use similar case identification, tracking and tracing, and recruitment methodology as CH- STRONG to collect information on longer-term outcomes of children and adolescents with CHD and their families.

b. Statutory Authorities This program is authorized under Section 301 of the Public Health Service Act [42 U.S.C. 241], as amended.

c. Healthy People 2030 'NCBDDD is committed to achieving the health promotion objectives of " Healthy People 2030 "This NOFO addresses the following priority areas:

Reduce the rate of deaths in children and adolescents aged 1-19 years Increase the proportion of children and adolescents who o Receive a developmental screening o Are developmentally ready for school o Receive care in a medical home o Get support for their transition to adult health care

Increase the proportion of children with o developmental delays who get intervention services by age 4 years o special health care needs who have a system of care o mental health problems who get treatment

d. Other National Public Health Priorities and Strategies CDC’s mission is to promote health and quality of life by preventing and controlling disease, injury, and disability. One of the strategies that CDC employs to accomplish this goal includes monitoring health through surveillance. Disease specific surveillance systems are critical for the accomplishment of this and other objectives that support CDC’s mission.

This program is aligned with CDC's mission of saving lives and protecting people from health threats (http://www.cdc.gov/about/organization/mission.htm) and with CDC's role of conducting critical science, providing health information that protects our nation against expensive and dangerous health threats, and responding when these arise.

e. Relevant Work This NOFO expands the National Center on Birth Defects and Developmental Disabilities’ programs conducting birth defects surveillance across the lifespan. In FY15, via a cooperative agreement with March of Dimes, CDC funded the Congenital Heart Survey To Recognize Outcomes, Needs, and well-beinG (CH-STRONG), a project that surveyed 19 to 38-year-olds with CHD identified from three U.S. birth defects surveillance systems with active case-ascertainment to collect information on their longer-term outcomes. Refer to https://www.cdc.gov/ncbddd/heartdefects/research.html.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

https://health.gov/healthypeople https://health.gov/healthypeople http://www.cdc.gov/about/organization/mission.htm https://www.cdc.gov/ncbddd/heartdefects/research.html

Bold indicates period of performance outcome.

CDC-RFA-DD22-2203 Logic Model: Population-based Surveillance of Outcomes, Needs, and Well-being of Children and Adolescents with Congenital Heart Defects Bold indicates period of performance outcome

Strategies and Activities

Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

Program Planning

· Engage partners;

prioritize program goals

· Implement management and staffing plans

Tracking and Tracing and Recruitment

· Identify eligible cases with CHD;

track and trace their parents/ caregivers

· Recruit parents/ caregivers to participate in survey project

Data Management and Reporting

· Link birth defect surveillance system, vital status, tracking & tracing, recruitment, and census data; create standardized dataset

· Submit all standardized de-identified individual-level data to CDC for linkage to survey data

· Assess quality and completeness of data

· Describe outcomes of children and adolescents with CHD; describe needs

· Improved understanding of healthcare barriers, utilization, and other outcomes

· Improved understanding of needs and experiences of caregivers of individuals with CHD

· Improved understanding of racial/ethnic and socioeconomic patterns in experiences and outcomes

· Improved understanding of the strengths and limitations of population-based surveillance among children and adolescents with CHD

· Improved information to stakeholders on outcomes of children with CHD and needs/experiences of caregivers

· Improved ability of policymakers to make data-informed decisions

· Improved ability to develop effective secondary prevention strategies to reduce the public health impact of

CHD

· Increased awareness among stakeholders of issues and disparities among U.S. children with CHD and their caregivers

· Improved ability to develop surveillance programs to understand the outcomes of individuals with

CHD

· Improved health among children and adolescents with

CHD

· Improved quality of life of children and adolescents with CHD and their caregivers

· Improved continuity of care of individuals with

CHD

and experiences of caregivers

Dissemination

· Share information with stakeholders, communicate results

i. Purpose This NOFO supports population-based surveillance of children with CHD to examine childhood and adolescent outcomes as well as needs and experiences of their caregivers. High-quality data will improve understanding of the epidemiology and public health significance of CHD.

Surveillance data will also allow monitoring of special sub-populations with CHD (e.g., racial/ethnic, sociodemographic diversity), and potentially identify factors to inform development of effective secondary prevention strategies.

ii. Outcomes As identified in the logic model, the following are the outcomes the recipient is expected to achieve during the period of performance:

Short-term outcomes:

Improved understanding of healthcare barriers, utilization, and other outcomes Improved understanding of needs and experiences of caregivers of individuals with CHD Improved understanding of racial/ethnic and socioeconomic patterns in experiences and outcomes Improved understanding of the strengths and limitations of population-based surveillance among children and adolescents with CHD Improved information to stakeholders on outcomes of children with CHD and needs/experiences of caregivers

Intermediate outcomes:

Increased awareness among stakeholders of issues among U.S. children with CHD and their caregivers

Improved ability to develop surveillance programs to understand the outcomes of individuals with CHD

iii. Strategies and Activities The logic model presents the strategies and component activities to be undertaken to achieve the period of performance outcomes.

Program Planning

Identify and engage partners: Demonstrate effective relationships and cooperation with appropriate partners (e.g., birth defects surveillance program, state health department).

Identify and prioritize program goals: Identify goals, measurable objectives, performance measures, responsible parties, and timeline to achieve the desired outcomes of the project.

Develop a management and staffing plan for implementation of this program.

Applicant must identify and describe any database or data transmission restrictions and whether and how these restrictions may limit descriptive analyses and reporting of results required by this NOFO.

Describe how information about this project will be disseminated to stakeholders (meetings, leadership briefings, newsletters, website, etc.)

Participate on all cooperative agreement calls and on-site meetings. All sites will have at least one representative on all group calls and will lead projects on a shared basis.

Join the CDC shared project folder where all NOFO # DD22-2203 documents (e.g., meeting minutes, project protocols) will be stored. All recipients are expected to post relevant documents to this folder during the period of performance.

Update CDC and other recipients monthly on project status and outputs. Maintain recipient-specific documentation on data sources, collection methods, linkage, data quality assessment.

Tracking and Tracing and Recruitment

Access, link, and use data from birth defects surveillance systems with active case-ascertainment to identify eligible cases with CHDs. Applicants should demonstrate, through memorandums of understanding/ agreement (MOUs/MOAs) and/or letters of support from the owners of the data and/or any revelant authorities. the ability to access and share the data per the NOFO guidelines. Applicants must file the MOUs or MOAs, as appropiate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov .

o Applicants must confirm that from CYs 2006-2021, a minimum of 30,000 births per year occurred within the catchment area of their proposed birth defect surveillance system.

Eligible cases o Born between 2006-2021 o Identified in a birth defect surveillance registry with active case ascertainment and eligible ICD-9-CM/BPA (or equivalent ICD-9-CM/ICD-10-CM) CHD codes All cases with CHD codes in Appendix A must be included, at a minimum.

Recipients are encouraged to expand upon the included list of CHDs (i.e.

identify and include children with CHDs outside of the list in Appendix A). Applicants should list the additional CHD codes captured by their birth defect surveillance system that they would like to propose for inclusion, if funded. A final list of eligible CHD cases will be discussed and agreed upon with CDC.

Establish vital status of cases: Link identified cases to death certificate data to establish vital status. Recipients should link to in-state death certificates, at minimum. If possible, recipients should further attempt to link birth defects surveillance data to out-of-state death certificates or the National Death Index.

https://www.grants.gov/

Leverage online databases and search engines to track and trace current contact information of parents/caregivers of eligible cases with CHD, including those who have moved out-of-state o Tracking and tracing must be performed at the individual level. The more limited quality and completeness of data produced from batch tracing will not be sufficient for this project.

o Applicant must describe in detail all databases for tracking and tracing that they currently have the ability to link to and all databases they have future plans to link to (e.g. Accurint, Whitepages, and other databases that may include current contact information such as Women, Infants, and Children [WIC] or Department of Motor Vehicles [DMV]). Applicants should further specify the owners of each database and which databases will identify current contact information for parents/caregivers who currently reside out-of-state.

o At a minimum, the recipient should plan to abstract the following information from the respective birth defects surveillance systems and vital records data to use in tracking and tracing:

Birth date Race and/or ethnicity Last name of infant with CHD Mother’s maiden name and/or married name City and county of birth and zip code of residence

Provide input on formatting of survey material and standardized recruitment procedures Using address information from tracking and tracing, mail surveys and other recruitment materials to parents/ caregivers of eligible cases with CHD to participate in survey project

Data Management and Reporting

Collect/store standardized data from birth defect surveillance system, vital records, and from operational processes including tracking & tracing and recruitment o Applicants must provide letters of support or a memorandum of agreement / understanding / engagement, or other documentation from the agency authorized to grant access to each required data source that may be used for tracking and tracing (e.g., vital records, WIC, DMV, etc), linked to additional data sources, submitted to CDC, and distributed to other recipients as a multi-site dataset for analyses. The letters of support or agreement must specify all the years for which data are available and state that data access is granted (or will be granted, if the applicant is awarded, along with a reasonable timeline for obtaining access), as well as any limitations regarding data use. If applicable, a copy of these documents should accompany each application.

o Recipients will use a standardized REDCap database to organize and manage their tracking and tracing and recruitment processes. All recipients will be responsible for using and maintaining the database to facilitate and evaluate the progress of both locating and recruiting participants. This database will be site-specific; sites will use this information to monitor their progress and inform CDC of the number and status of eligible adults tracked and traced and, if unsuccessful, the reason why.

o All completed survey data will be collected and managed by CDC - Return envelopes for completed surveys will include CDC’s address. CDC will inform project staff from funded sites upon receipt of surveys completed by individuals recruited by their site so that recipients can update their database.

Geocode address at birth and, for survey responders, address at time of survey, and link to census tract-level indicators of socioeconomic status (e.g. percent of families in the census tract living below the federal poverty level). Link birth defects surveillance, vital status information, tracking and tracing status, recruitment status, and census tract level indicators to create a standardized dataset for submission to CDC.

Following an established and agreed-upon timeline, submit standardized de-identified individual-level data to CDC, including standardized data elements using a common database in a secure manner. CDC will link site-transmitted data to survey data to create a complete project analytic dataset. CDC has a secure network that will be used for this project and recipients will need to obtain and maintain access o Under applicable grant regulations in 45 CFR 75.322, CDC is authorized to collect data first produced under a funded award. All data submitted to CDC becomes subject to applicable federal law, including but not limited to the Freedom of Information Act and Federal Records Act.

Before and after submission to CDC, assess site-specific and pooled datasets for data quality and completeness; collaborate with other recipients and CDC on data formatting and cleaning decisions

Compare and assess differences between survey respondents and non-respondents Describe population of individuals born between 2006-2021 with CHD and their caregivers, including o cardiac and other healthcare utilization, o barriers to health care, quality of life, o social and educational outcomes, o transition of care from childhood to adulthood, o mortality o needs and experiences of the caregivers

Decide upon priority analyses using pooled data from all recipients with CDC and other recipients.

Conduct analyses of multi-site data from all recipients.

Dissemination

Use the multi-site data to communicate project information and results to healthcare providers, patients, families, stakeholders, the public, and other target audiences via publications, presentations, and other methods, together with CDC and other recipients.

Participate in collaborative projects/manuscripts using multi-site data whenever possible, with CDC and other recipients.

1. Collaborations

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

Collaborate with CDC and other NOFO #DD22-2203 recipients and provide input on standardized processes, methods, standardization of data collection and analysis, dissemination, and other project activities.

b. With organizations not funded by CDC:

Demonstrate effective relationships and cooperation with appropriate partners (e.g., birth defects surveillance program, state or local officials, cross-department personnel, including informatics personnel, community-based organizations, medical centers specializing in congenital heart defects). Applicants must provide letters of support or a memorandums of understanding/agreement (MOUs/MOAs), or other documentation from the agency authorized to grant access to each required data source: 1) birth defects surveillance data; 2) data that may be used for tracking and tracing (e.g., vital records, DMV, etc.). The letters of support or agreement must specify all the years for which data are available and state that data access is granted (or will be granted, if the applicant is awarded, along with a reasonable timeline for obtaining access), de-identified data linked to survey data and census data can be shared with CDC and other NOFO recipients, as well as any limitations regarding data use. If applicable, a copy of these documents should accompany each application. Applicants must file the MOUs or MOAs, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov.

Grant regulations found at 45 CFR Part 75 apply to this NOFO, which govern the CDC’s access to data being collected or developed under a grant/cooperative agreement, thereby negating the need for a Data Use Agreement (DUA) with CDC on this project.

2. Target Populations Applicants should describe the population of individuals born between 2006-2021 who have been diagnosed with the CHDs identified by diagnosis codes in Appendix A at a minimum, as evidenced by inclusion in a population-based birth defects surveillance system with active case-ascertainment, including demographics such as race/ethnicity, socioeconomic status, and rural/urban distribution. Recipients are encouraged to expand upon the included list of CHDs (i.e., identify and include children with CHDs outside of the list in Appendix A). Therefore, applicants should list the additional CHD codes captured by their birth defect surveillance system that they would like to propose for inclusion, if funded.

a. Health Disparities Surveillance data should be population-based, and not limited to children and adolescents receiving healthcare, receiving cardiology care, or based on type of health insurance (e.g., Medicaid). The applicant’s defined geographic area and population covered should include all children with the CHDs listed in Appendix A at a minimum. To address health disparities, data reported to CDC will include, but are not limited to ethnicity, race, gender, geography (e.g., rural, urban), and language spoken at home.

iv. Funding Strategy Not Applicable

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy http://www.grants.gov

Evaluation and progress reports:

Prepare a written assessment of the accomplishments, challenges, and opportunities of the CHD surveillance project including, but not limited to problems encountered, lessons learned, and potential improvements. CDC will work with recipients to finalize measures within the first six months of the period of performance.

Strategies and Activities:

Program planning activities: identify/engage partners, prioritize program goals. Indicators for success:

o Partners are identified and letters of support are included in application.

o Updates are provided to CDC on routine partner meetings and calls.

o Program goals are identified and prioritized.

Project management activities: develop a management and staffing plan; develop and implement a communication plan. Indicators for success:

o Comprehensive management and staffing plan provided in application.

o Communication plan developed and implemented.

Case identification activities: use population-based birth defects surveillance systems with active case-ascertainment to identify eligible cases with CHDs. Cases must be included for each of the birth years between 2006-2021 and have at a minimum, but not limited to, the CHD diagnoses listed in Appendix A. Indicators for success:

o Identified all individuals born between 2006-2021 with CHD, including, but not limited to the CHD diagnoses in Appendix A, from a population-based birth surveillance program with active case-ascertainment.

o Recipients are encouraged to expand upon the included list of CHDs (i.e., identify and include children with CHDs outside of the required list in Appendix A).

Applicants should list the additional CHD codes captured by their birth defect surveillance system that they would like to propose for inclusion, if funded.

Tracking and tracing activities: link identified cases to state vital records data, at minimum, and National Death Index data if available, to establish vital status and cause(s) of death. Leverage online databases and search engines to track and trace current contact information of parents/caregivers of cases with CHD. Indicators for success:

o Vital status and if applicable, cause of death, have been established for cases o Most recent addresses have been identified for parents/caregivers of cases

Recruitment activities: Recruit parents/caregivers of eligible cases with CHD to participate in survey project, distribute survey materials. Indicators for success:

o Surveys and related materials have been finalized o Parents/caregivers of eligible cases have been contacted and survey materials have been distributed

Data management and reporting activities: Standardize birth defect surveillance system, tracking & tracing, and recruitment data; geocode address at birth and, for survey responders, address at time of survey and link to census tract socioeconomic indicators;

link birth defects surveillance data, vital status information, tracking & tracing status, recruitment status, and census tract-level socioeconomic indicators for each individual;

create standardized dataset. Indicators for success:

o Standardized tracking and recruitment database has been developed and maintained o Birth defects surveillance data, vital status, census tract-level indicators, and indicators of tracking/tracing and recruitment success have been developed and standardized o All de-identified individual level data on all respondents and non-respondents has been submitted to CDC within agreed benchmarks and timeframes.

Under applicable grant regulations in 45 CFR 75.3222, CDC is authorized to collect data first produed unfer a funded award. All data submitted to CDC becomes subject to applicable federal law, including but not limited to the Freedom of Information Act and Federal Records Act.

Data assessment activities: Jointly with CDC and other funded recipients and using multi-site data, assess quality of data, compare respondents to non-respondents, describe outcomes of children and adolescents with CHD, describe needs and experiences of caregivers. Indicators for success:

o Prior to submission to CDC, site-specific data has been assessed and cleaned o Data cleaning plan for multi-site data has been developed; multi-site analytic dataset distributed by CDC has been assessed to confirm no further cleaning is needed.

o Information on respondents and non-respondents has been compared and documented.

o Multi-site data analysis plan developed, and descriptive statistics generated on child/adolescent population with CHDs o Outcomes including cardiac and other healthcare utilization, barriers to health care, quality of life, social and educational outcomes, transition of care from childhood to adulthood, and mortality for children and adolescents with CHD have been assessed.

o Needs and experiences of the caregivers of children and adolescents with CHD have been assessed.

o Racial/ethnic, socioeconomic, or rural/urban differences in outcomes and caregiver needs have been assessed.

Dissemination activities: share project information results. Indicators for success:

o Communication plan is developed with input and assistance from CDC and implemented.

o Information shared regularly with CDC and other recipients.

o Multi-site project information and results communicated to target audiences via publications, presentations, and other methods.

Outputs:

Population-based cohort of children and adolescents born between 2006-2021 with CHDs o Indicator for success: population-based cohort of children and adolescents with CHDs has been developed, submitted to CDC, included in multi-site database, analyzed, and findings disseminated.

Information on outcomes including cardiac and other healthcare utilization, barriers to health care, quality of life, social and educational outcomes, transition of care from childhood to adulthood, and mortality o Indicator for success: multi-site report(s) on outcomes of children and adolescents with CHDs has/have been drafted and disseminated.

Information of needs and experiences of the caregivers of children and adolescents with

CHD

o Indicator for success: multi-site report(s) on needs and experiences of the caregivers of children and adolescents with CHDs has/have been drafted and disseminated

Outcomes:

Improved understanding of age-specific mortality o Indicator for success: dissemination of multi-site publication(s) and conference presentations/webinars for stakeholders that describe the age-specific mortality of children and adolescents with CHDs

Improved understanding of healthcare utilization, barriers to health care, quality of life, social and educational outcomes, transition of care, and mortality o Indicator for success: dissemination of multi-site publication(s) and conference presentations/webinars for stakeholders that describe the outcomes of children and adolescents with CHDs, including healthcare utilization, barriers to health care, quality of life, social and educational outcomes, transition of care, and mortality

Improved understanding of racial/ethnic and socioeconomic disparities in healthcare use and longer-term outcomes o Indicator for success: dissemination of multi-site publication(s) and conference presentations/webinars for stakeholders that describe the racial/ethnic and socioeconomic disparities in healthcare use and longer-term outcomes among children and adolescents with CHDs

Improved understanding of needs and experiences of caregivers of individuals with CHD o Indicator for success: dissemination of multi-site publication(s) and conference presentations/webinars for stakeholders that describe the needs and experiences of caregivers of individuals with CHD

Increased awareness among people living with CHD, families affected by CHD, healthcare and social service providers, and public of nationwide CHD issues o Indicator for success: dissemination of multi-site publication(s) and their key messages through various media, and conference presentations/webinars for stakeholders that increase awareness of nationwide CHD issues.

Data Management Plan (DMP) Applicants should submit a DMP in their application as part of their Evaluation and Performance Management Plan. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds. The DMP may be outlined in a narrative format or as a checklist, but, at a minimum, should include:

Description of the data to be produced in the proposed project How access will be provided to the data (including provision for protection of privacy, confidentiality, security, intellectual property, or other right) Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

Plans for archival and long-term preservation of the data or explaining why long-term preservation and access cannot be justified

Examples of DMPs include: the USGS site: https://www.usgs.gov/products/data-and-tools/data-management/data-management-plans.

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:

https://www.usgs.gov/products/data-and-tools/data-management/data-management-plans https://www.usgs.gov/products/data-and-tools/data-management/data-management-plans https://www.cdc.gov/grants/additional-requirements/ar-25.html

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 Strong applicants must describe the level of organizational capacity necessary to implement the NOFO successfully.

In their description of organizational capacity, applicants should elaborate on:

Staff with skill sets to implement the awards such as: program and performance management, CHDs clinical expertise, data analysis, data linkage, epidemiologic and surveillance expertise, communication/material development including publication of original manuscripts, evaluation, performance monitoring, informatics, and financial reporting.

o CVs of existing staff should be included. If there are any vacant positions, the applicant should include a job description (including applicant qualifications) and address both the recruiting strategies and estimated timeline for filling the position.

Collaborations with birth defects surveillance programs and state health departments o Applicants should identify the geographic region and characteristics of eligible cases captured in the birth defect surveillances system

Their ability to begin immediate implementation of the NOFO activities Any previous experience successfully recruiting participants, administering surveys, managing data, and disseminating findings in a timely manner as the lead author/lead organization

Their capacity to lead and publish original manuscripts in a timely manner, as evidenced by citations of recent first- or senior-author publications

Describe the availability of facilities and equipment necessary to carry out this project.

Furthermore, applicants must have the public health authority, legislative mandate, or otherwise show legal access to the requisite surveillance data from 2006-2021 and ability to share de-identified individual-level data with CDC. Under applicable grant regulations in 45 CFR 75.3222, CDC is authorized to collect data first produed unfer a funded award. All data submitted to CDC becomes subject to applicable federal law, including but not limited to the Freedom of Information Act and Federal Records Act. Applicants should demonstrate, through MOUs/MOAs and/or letters of support from data owners or relevant authorities, the ability to access and share the data per the NOFO guidelines. Applicants must file the MOUs or MOAs, as appropriate, name the file "MOUs/MOAs”, and upload it as a PDF file at www.grants.gov.

Applicants must address HIPAA and IRB requirements and must provide letters of support from agencies that house source data authorizing its use for case-finding, access, and sharing required data.

d. Work Plan Applicants are required to provide a detailed work plan for Year 1 of the project and a high-level work plan for subsequent years. No specific work plan format is required as long as the work plan crosswalks to the strategies and activities, outcomes, and performance measures presented in the logic model and narrative sections of this NOFO. A sample work plan format is presented below.

In this format, the table would be completed for each period of performance outcome. If a particular activity leads to multiple outcomes, it should be described under each outcomes measure.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

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.

Within 6 months after the period of performance start date, CDC and the funded recipients will finalize the work plan and performance measures.

f. CDC Program Support to Recipients

Functioning as an additional surveillance site, CDC will identify eligible CHD cases using data derived from the Metropolitan Atlanta Congenital Defects Program and will perform tracking and tracing, recruitment, and data linkage for these cases. All survey data from survey participants across all sites will be collected and entered by CDC. Additionally, CDC will provide the following support to recipients:

Provide advisory technical assistance on key design and methodological issues.

Facilitate the communication/coordination among recipients regarding standardization of procedures and tools to improve the efficiency of activities.

Collaborate with recipients on developing timelines for data transmission and other key activities.

Develop survey instruments and submit for Office of Management and Budget approval; collaborate with recipients on minor modifications to the survey, formatting of survey material, and standardized recruitment procedures

Assist in the development of a standardized database used by recipients to organize and manage tracking and tracing and recruitment processes.

Convene recipients regularly by conference call and in-person to support collaboration and shared learning.

If needed, provide on-line webinars and in-person training.

In collaboration with recipients, develop and provide a template for the central reporting of de-identified, individual-level data sets.

Assist in performing data analysis and/or quality assurance verification.

Develop and maintain the centralized database used by recipients for the transmission of de-identified, de-duplicated individual level data. Compile data across sites and perform quality reviews of data.

Work with recipients to develop priority reports and publications.

Analyze data and author/coauthor reports and publications.

Assist with evaluation of the project.

B. Award Information

1. Funding Instrument Type:

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

2. Award Mechanism:

U50 Special Cooperative Investigations/Assessment of Control/Prevention Methods

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$1,000,000

5. Total Period of Performance Funding:

$4,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$4,000,000

6. Total Period of Performance Length:

year(s)

7. Expected Number of Awards:

Range: 2-4 awards

8. Approximate Average Award:

$350,000 Per Budget Period

9. Award Ceiling:

$400,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$150,000 Per Budget Period

11. Estimated Award Date:

August 31, 2022

12. Budget Period Length:

12 month(s)

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

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

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

C. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (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)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

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

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

2. Additional Information on Eligibility Only one application per organization as determined by the organization’s Dun & Bradstreet number will be accepted.

Eligible applicants must have the public health authority, legislative mandate or otherwise show legal access to the requisite data to conduct population-based birth defects surveillance. This authority allows unique and specific access to datasets from multiple data sources that are required to implement the activities outlined in this NOFO. Eligible applicants must document this authority in "Other Attachment Forms" with attachment name "Legal Authority". CDC will consider any application that does not include this required documentation as non-responsive, and it will receive no further review.

A Bona Fide Agent is an agency/organization identified by the state or local government as eligible to submit an application in lieu of a state or local government application. If applying as a Bona Fide agent of a state or local government, a letter from the state or local government as documentation of the status is required and should be submitted under “Other Attachment Forms” with attachment name “Bona Fide Agent.” If the Bona Fide Agent attachment does not specify legal authority, the applicant must include an attachment named “Legal Authority” in “Other Attachment Forms”.

The award ceiling for this NOFO is $400,000. CDC will consider any application requesting an award higher than the ceiling amount as non-responsive and it will receive no further review.

3. Justification for Less than Maximum Competition Not Applicable

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. Application and Submission Information

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.

PLEASE NOTE: For applications due on or after April 4, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission (SF-424, field 8c). In preparation for the federal government’s April 4, 2022 transition to the Unique Entity Identifier (UEI) from the Data Universal Numbering System (DUNS), applicants must obtain a UEI. The UEI is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and grants.gov. Entities registering in SAM.gov prior to April 4, 2022 must still obtain a DUNS number before registering in SAM.gov registration. Additional information is available on the GSA website, SAM.gov, and Grants.gov- Finding the UEI.

https://www.grants.gov/…