PKG00263691-instructions.pdf

Centers for Disease Control and Prevention

National Center on Birth Defects and Developmental Disabilities

Advancing Population-Based Surveillance of Birth Defects

CDC-RFA-DD21-2101

Application Due Date: 12/08/2020

Advancing Population-Based Surveillance of Birth Defects

CDC-RFA-DD21-2101

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- DD21-2101. 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:

Advancing Population-Based Surveillance of Birth 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.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DD21-2101

E. Assistance Listings (CFDA) Number:

93.073 F. Dates:

1. Due Date for Letter of Intent (LOI): 11/06/2020 Is a LOI: Recommended but not Required

2. Due Date for Applications: 12/08/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A Not applicable.

G. Executive Summary:

1. Summary Paragraph:

NOFO #CDC-RFA-DD21-2101 solicits non-research, cooperative agreement applications to strengthen the capacity of birth defects surveillance programs to respond to emerging threats to mothers and babies as a key component of preparedness, identify and address mechanisms contributing to health disparities, and improve health outcomes among affected populations.

Objectives include: 1) improving birth defect surveillance capacity, including leveraging electronic health records (EHRs) and interoperability capabilities to enhance surveillance of birth defects, 2) improving birth defects surveillance data quality, and 3) using the surveillance data to improve health outcomes of affected populations.

This NOFO consists of 3 components. Component A (8-12 awards): improve surveillance capacity, improve surveillance data quality, improve knowledge of birth defects epidemiology, improve primary and secondary prevention, and evaluate the effectiveness of activities and disseminate findings. Component A applicants may, but are not required to apply for optional Component B and/or Component C activities. Only applicants funded under Component A may receive funds under optional Component B and/or Component C. Component B (1-2 awards):

https://www.grants.gov https://www.grants.gov https://www.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52 https://www.grants.gov develop interoperability capacity between birth defects surveillance systems and EHRs.

Component C (4-12 awards): link data on timing and method of detection of critical congenital heart defects (CCHDs) and individual-level screening results with surveillance data. Recipients will report individual-level birth defects data (Appendix A) and/or CCHD data (Appendix B) to CDC. NCBDDD performance goal: Enhance the quality and utility of birth defects surveillance systems.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 10 Component A: 8-12 awards.

Component B: 1-2 awards. Only applicants funded under Component A are eligible to receive a Component B award.

Component C: 4-12 awards. Only applicants funded under Component A are eligible to receive a Component C award.

d. Total Period of Performance Funding: $15,500,000

e. Average One Year Award Amount: $250,000 Component A: $250,000 average award per budget period which includes total direct and indirect cost.

Component B: $225,000 average award per budget period which includes total direct and indirect cost.

Component C: $50,000 average award per budget period which includes total direct and indirect cost.

f. Number of Years of Award: 5

g. Estimated Award Date: 03/01/2021

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 Birth defects are a leading cause of infant mortality in the United States and contribute substantially to health care costs and life-long disabilities. They affect 1 in every 33 babies in the United States, account for more than 20% of all infant deaths, and contribute to $22.9 billion annually in hospital costs (Arth). The Birth Defects Prevention Act of 1998 directed CDC to carry out programs to collect data on birth defects and provide information to the public about the prevention of birth defects. Accurately tracking birth defects and analyzing the collected data is the first step in preventing birth defects.

Population-based birth defects surveillance is an important function performed by state and territorial health departments. Data from birth defects surveillance programs can be used to drive the development of policies and programs to help ensure high-quality health programs for children and families in the United States. Although the U.S. lacks a unified national population-based surveillance system to collect data on major birth defects, 42 states and Puerto Rico currently have a system to monitor these conditions. Population-based birth defects surveillance programs focus their activities on generating prevalence data and understanding the impact of these conditions on the community. Birth defects surveillance data have been used to identify racial/ethnic disparities in prevalence, as well as outcomes (e.g. survival). Population-based surveillance programs also focus on epidemiological studies, service planning, and referral of affected infants to medical and social services.

Although CDC has been funding surveillance of birth defects since the 1990s, changes in health risks to mothers and babies and changes in health care management require that birth defects surveillance programs evolve and develop new capacities. The Zika virus outbreak demonstrated the need for more timely surveillance of birth defects and underscored the importance of strengthening state and territorial health department capacity for responding to emerging threats.

In addition, the emergence of electronic heath records and the capability to electronically exchange health data between systems (i.e. interoperability) using standards, such as HL7, for the exchange of clinical and administrative data is changing the way public health interacts with the medical community to support surveillance.

Congenital heart defects occur in approximately eight of every 1,000 live births. Approximately one in four infants born with congenital heart defects have a critical CHD (CCHD), typically requiring surgery or catheterization in the first year of life (Mahle). Prenatal diagnosis, through fetal echocardiogram, and newborn screening, using pulse oximetry, can identify newborns with CCHD before birth or before hospital discharge after birth, respectively, in the absence of signs and symptoms of CCHD. As of 2018, all states and the District of Columbia have implemented policies to screen for CCHD (Glidewell), and state mandates on CCHD screening may decrease early infant death by 33% (Abouk). However, not all states have systematically collected and analyzed data on timing and mode of CCHD detection, including prenatal diagnosis, early clinical detection, CCHD screening, and confirmatory infant echocardiogram. Systematic data collection could help identify program improvement opportunities and monitor the impact of early identification of CCHD (Glidewell).

Using the infrastructure developed via previous funding opportunities that focused on establishing and enhancing population-based surveillance of birth defects, CDC’s National Center on Birth Defects and Developmental Disabilities plans to use this NOFO to strengthen the capacity of birth defects surveillance programs to respond to emerging threats to mothers and babies as a key component of preparedness, identify and address mechanisms contributing to health disparities, and improve health outcomes among affected populations. This will be accomplished by 1) improving birth defects surveillance capacity, including leveraging electronic health records and interoperability capabilities to enhance surveillance of birth defects, 2) improving birth defects surveillance data quality, and 3) using the surveillance data to improve health outcomes of affected populations.

https://doi.org/10.1542/peds.2009-1397 https://www.cdc.gov/mmwr/volumes/68/wr/mm6805a3.htm https://pubmed.ncbi.nlm.nih.gov/29209720/ https://www.cdc.gov/mmwr/volumes/68/wr/mm6805a3.htm

b. Statutory Authorities This program is authorized under Sections 301 and 317C of the Public Health Service Act [42 U.S.C. 241 and 247b-4], as amended.

c. Healthy People 2030 The National Center on Birth Defects and Developmental Disabilities (NCBDDD) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2030”. This NOFO addresses “Healthy People 2030” priority area of Maternal, Infant, and Child Health, and specifically MICH-02, reduce the rate of infant death; and MICH- 12, increase the proportion of women of childbearing age who get enough folic acid.

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 many strategies that CDC employs to accomplish this goal includes monitoring health through the use of public health surveillance. Disease specific surveillance systems are critical for the accomplishment of this and other objectives that support CDC’s mission.

e. Relevant Work Recent relevant NOFO activities include: improve population-based birth defects surveillance and utilize the data for public health action (NOFO #DD16-1601); establish and enhance rapid surveillance of microcephaly and other adverse outcomes possibly linked to Zika virus infection (NOFOs #DD16-1605, #DD16-1606); and support the exchange of electronic health record data with population-based birth defects surveillance (NOFO #OT18-1802).

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-DD21-2101 Logic Model: Advancing Population-Based Surveillance of Birth Defects Bold indicates period of performance outcome

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

Component A Surveillance Capacity

· Conduct surveillance for selected birth defects using active case-finding or passive case-finding with case verification

· Follow the National Birth Defects Prevention Network’s

· Strengthened surveillance of birth defects

· Improved quality of birth defects surveillance data

· Increased contribution of multi-state data in scientific

· Increased ability to rapidly respond to emerging threats to mothers and babies

· Improved understanding of the characteristics of individuals affected by birth defects

· Improved prevention of birth defects

· Improved birth and health outcomes

· Improved quality and duration of life for individuals with birth

(NBDPN’s) Guidelines for Conducting Birth Defects Surveillance

· Improve efficiency and effectiveness of surveillance methodology

· Assess and improve readiness to exchange data with EHRs Surveillance Data Quality

· Collaborate with CDC in the development of quantitative data quality measures and targets

· Routinely monitor data quality

· Improve data quality to meet targets Birth Defects Epidemiology

· Link surveillance data and death records to enable assessment of mortality and survival

· Prepare datasets using structure and definition provided by

CDC

· Report birth defects to CDC

· Collaborate with CDC in the analysis and dissemination of surveillance data Primary and Secondary Prevention

· Use surveillance data to identify at risk populations

· Implement data driven prevention strategies

· Improve referral to services

· Assess facilitators and barriers to tracking children prospectively to improve understanding of outcomes Evaluation and Dissemination

· Develop at least two projects to evaluate funded activities understanding of birth defects epidemiology

· Increased knowledge of the prevention of birth defects

· Increased dissemination of birth defects data

· Increased ability to support the primary and secondary prevention of birth defects defects.

· Submit evaluation findings for publication or present at scientific conferences Component B (optional) Electronic Health Records (EHRs)

· Develop a plan for EHR-surveillance system interoperability

· Demonstrate capability to exchange data with EHRs

· Coordinate with CDC to ensure activities align with national and agency objectives.

Component C (optional) Critical Congenital Heart Defects (CCHDs)

· Conduct surveillance on additional CCHD cases

· Ascertain timing and method of CCHD detection for all CCHD cases

· Ascertain individual-level CCHD screening results and timing of confirmatory echocardiogram for CCHD cases

· Report data on CCHD cases to

CDC

i. Purpose The purpose of this NOFO is to strengthen the capacity of birth defects surveillance programs to respond to emerging threats to mothers and babies as a key component of preparedness, identify and address mechanisms contributing to health disparities, and improve health outcomes among affected populations. Objectives to achieve this goal include: 1) improving birth defects surveillance capacity, including leveraging EHRs and interoperability capabilities to enhance surveillance of birth defects, 2) improving birth defects surveillance data quality, and 3) using the surveillance data to improve health outcomes of affected populations.

ii. Outcomes Short-term

Strengthened surveillance of birth defects Improved quality of birth defects surveillance data Increased contribution of multi-state data in scientific understanding of birth defects epidemiology Increased knowledge of the prevention of birth defects

Intermediate

Increased ability to rapidly respond to emerging threats to mothers and babies Increased ability to support the primary and secondary prevention of birth defects

iii. Strategies and Activities Component A Surveillance Capacity

Conduct surveillance for pregnancy outcomes occurring January 1, 2018 through December 31, 2025 using active case-finding or passive case-finding with case verification for all defects listed in Table 1

Follow the National Birth Defects Prevention Network’s (NBDPN) Guidelines for Birth Defects Surveillance

Implement strategies to improve the efficiency and effectiveness of surveillance methods Assess and improve the readiness of the birth defects surveillance system and program to exchange data with electronic health records (EHRs)

Surveillance Data Quality

Collaborate with CDC to develop quantitative data quality measures and targets for data completeness, accuracy, and timeliness

Routinely monitor the completeness, accuracy, and timeliness of surveillance data.

Timeliness monitoring should include time between surveillance steps (e.g., case identification, abstraction, data cleaning, clinical review if applicable)

Implement strategies to meet data completeness, accuracy, and timeliness targets

Birth Defects Epidemiology

Link surveillance data and death records to enable assessment of mortality and survival Prepare datasets using the minimum data structure and definition provided by CDC Report individual-level data specified in Appendix A for pregnancy outcomes affected by a birth defect listed in Table 1 to CDC annually Report individual-level data specified in Appendix A for pregnancy outcomes affected by a birth defect to CDC a minimum of once per month in the event of a public health emergency

Collaborate with CDC in the analysis and dissemination of surveillance data, including prevalence, epidemiology and survival of major birth defects, and surveillance methodologies and data quality

Primary and Secondary Prevention

Use surveillance data to identify at risk populations within the community Develop and implement data driven prevention strategies with the community, using

CDC-developed prevention materials, when available Refer affected individuals to medical and early intervention services Implement strategies to improve the number and timeliness of referrals Assess facilitators and barriers to tracking children prospectively to improve understanding of health outcomes, educational needs, and quality of life for individuals living with birth defects

Evaluation and Dissemination

Submit to CDC two projects for evaluation in two categories listed below. Evaluation projects must include SMART objectives, produce results that can be used to improve surveillance program activities, and be of the rigor to be published in a peer review journal.

o Improve Surveillance Capacity: Evaluations in this category could include, but are not limited to comparisons of active surveillance versus passive surveillance with verification (e.g., data quality), contribution of diverse case finding sources to data completeness (e.g., discharge indices, clinic logs, prenatal clinics, birth hospitals, pediatric hospitals, etc.)

o Improve Data Quality: Evaluations in this category could include, but are not limited to methods to improve the timeliness of surveillance data o Improve Primary and Secondary Prevention: Evaluations in this category could include, but are not limited to, the effectiveness of referral processes, methods to improve prospective tracking of children with birth defects

For each evaluation project, submit at least one article for publication or present findings at a national scientific conference. At least one manuscript must be submitted for publication during the period of performance.

Table 1

Minimum Conditions to be Collected and Reported to CDC * ICD-10-CM Codes

Anencephaly Q00.0 - Q00.1

Spina bifida without anencephalus Q05.0 - Q05.9, Q07.01, Q07.03 w/o Q00.0 - Q00.1

Anophthalmia / microphthalmia Q11.0 – Q11.2

Atrioventricular septal defect (Endocardial cushion defect) Q21.2

Truncus arteriosus (TA) Q20.0

Double outlet right ventricle (DORV) Q20.1

Hypoplastic left heart syndrome Q23.4

Interrupted aortic arch (IAA) Q25.21

Single ventricle Q20.4

Tetralogy of Fallot (TOF) Q21.3

Total anomalous pulmonary venous connection (TAPVC) Q26.2

Transposition of the great arteries (TGA) Q20.3, Q20.5

Cleft lip with cleft palate Q37.0 - Q37.9

Cleft lip alone (without cleft palate) Q36.0 – Q36.9

Cleft palate alone (without cleft lip) Q35.1 – Q35.9

Esophageal atresia/tracheoesophageal fistula Q39.0 – Q39.4

Small intestinal atresia/stenosis Q41.0 – Q41.9

Diaphragmatic hernia Q79.0, Q79.1

Gastroschisis Q79.3

Limb deficiencies (reduction defects) Q71.0 – Q71.9 Q72.0 – Q72.9 Q73.0 – Q73.8

Omphalocele Q79.2

Trisomy 21 (Down syndrome) Q90.0 – Q90.9

*List may be adapted to address concerns around specific birth defects

Component B (optional for Component A applicants) Electronic Health Records (EHRs)

Develop a comprehensive plan for EHR-surveillance system interoperability. The plan for electronic birth defects reporting should leverage existing assets, utilize knowledge gained from the readiness assessment and other state interoperability initiatives, address barriers to interoperability, and provide detailed descriptions for health information technology (IT) plans in the following domains: Governance, Policy, Security and Privacy, Infrastructure and Operations o Governance – Detail roles, responsibilities, and processes for data ownership, information sharing, and exchange between public and private stakeholders o Policy – Define the federal, state, and local policies that influence data exchange between EHRs and birth defects surveillance o Security and Privacy – Ensure privacy and security requirements meet health IT security standards and comply with state reporting and surveillance regulations o Infrastructure – Identify existing and needed hardware, software, and technical standards to facilitate electronic exchange of health information for birth defects cases o Operations – Define programmatic functions and processes to facilitate electronic exchange of health information for birth defects cases (e.g., data use agreements, provider onboarding procedures, data quality monitoring, etc.)

Demonstrate capability to electronically exchange birth defects surveillance data (e.g. full case reporting, case notification) with EHRs in the state using national standards, best practices, and tools for surveillance. National standards, best practices, and tools should not be modified for implementation unless required by state or local law or regulation.

Coordinate with CDC to ensure activities align with national and agency objectives.

Component C (optional for Component A applicants)

Critical Congenital Heart Defects (CCHDs)

For all CCHD cases (Table 2) from pregnancy outcomes occurring January 1, 2018 through December 31, 2025:

o record the timing and method of detection (e.g., prenatal fetal echocardiogram and gestational age, early clinical detection at hospital delivery and age at (in hours) or date of detection, pulse-oximetry screening at hospital delivery and age at (in hours) or date of screening, detection after birth hospital discharge and age at or date of detection);

o document whether CCHD screening (pulse-oximetry screening) occurred, and, if so, individual-level CCHD screening results (e.g. O2 saturation and/or pass/fail, number of times each infant was screened); and o document timing of confirmatory infant echocardiogram For those CCHD cases included in Table 2 that are not also included in Table 1 (e.g.

coarctation of the aorta, Ebstein's anomaly, pulmonary atresia, and tricuspid atresia), conduct surveillance for CCHDs using multiple data sources with active case-finding or passive case-finding with case verification. Follow the National Birth Defects Prevention Network's (NBDPN) Guidelines for Conducting Birth Defects Surveillance (https://www.nbdpn.org/guidelines.php).

Prepare datasets using the minimum data structure and definition provided by CDC Report individual-level data specified in Appendix A and Appendix B for CCHDs listed in Table 2 to CDC annually

Table 2

Critical Congenital Heart Defects to be Collected and Reported to CDC ICD-10- CM Codes

Coarctation of the aorta Q25.1

Double outlet right ventricle (DORV) Q20.1

Ebstein’s anomaly Q22.5

Hypoplastic left heart syndrome Q23.4

Interrupted aortic arch Q25.21

Pulmonary atresia Q22.0

Single ventricle (not otherwise specified) Q20.4

Tetralogy of Fallot (TOF) Q21.3

Total anomalous pulmonary venous connection (TAPVC) Q26.2

D-transposition of the great arteries Q20.3

Tricuspid atresia Q22.4

Truncus arteriosus (TA) Q20.0

1. Collaborations

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

Work with CDC and other recipients to share strategies and lessons learned to improve birth defects surveillance capacity, data quality, birth defects epidemiology, primary and secondary prevention, and evaluation and dissemination activities (required).

Participate with CDC and the Task Force for Global Health’s Public Health Informatics Institute (PHII) under a CDC funded grant in a community of practice for birth defects surveillance systems working on EHR-surveillance system interoperability to develop solutions and resources (required).

With other funded recipients, have at least one representative on all workgroups/communities, participate in all cooperative agreement calls and meetings, and lead project calls on a shared basis (required).

With the other funded recipients, post relevant documents and data to a shared folder to be housed by a recipient or CDC. CDC will provide the site after award (required).

b. With organizations not funded by CDC:

Involve appropriate state agencies and within-region partners, such as health care providers, community-based organizations, medical centers, newborn screening, and other organizations to assist with data collection (required).

Identify and engage appropriate partners within the region to develop, implement, and expand prevention and referral to services activities (required).

Identify and engage appropriate partners, including state/local IT staff, healthcare providers, and EHR vendors, within the region to assess and/or implement EHR-surveillance system interoperability (required).

Strongly encourage participation in the National Birth Defects Prevention Network (NBDPN) (optional).

Encourage participation with the Association of Public Health Laboratories (APHL) Newborn Screening Technical assistance and Evaluation Program (NewSTEPs) CCHD- Data Response Team workgroup (https://www.aphl.org/rfp/Pages/NewSTEPs- Website.aspx; optional).

For the above collaborations, applicants must name the file “Letters of Support” and upload as a PDF file at www.grants.gov. A maximum of 10 Letters of Support are allowed.

2. Target Populations The population-based birth defects surveillance activities should include all live births, stillbirths, and pregnancy terminations (if authorized) to women who are residents of a defined geographic http://www.grants.gov/ area of the jurisdiction. Applicants should define and describe the geographic area and population covered under this NOFO with specific focus on populations with the highest disease burden as informed through health disparities data and account for sociodemographic characteristics.

a. Health Disparities Since the surveillance data are population-based, the applicant’s defined geographic area and population covered should include populations at risk. To address health disparities, data reported to CDC will include, but are not limited to ethnicity, race, gender, and geography (e.g.

rural, urban).

iv. Funding Strategy (for multi-component NOFOs only) Component A: 8-12 awards; $250,000 average award per budget period Component B: 1-2 awards; $225,000 average award per budget period Component C: 4-12 awards; $50,000 average award per budget period

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Component A Strategies and Activities:

Surveillance Capacity: Indicators for success:

o Active case finding or passive case finding with case verification is implemented for pregnancy outcomes occurring January 1, 2018 through December 31, 2025 affected with a birth defect listed in Table 1.

o Strategies to improve the efficiency and effectiveness of surveillance methodology are implemented.

o Applicant completed a readiness assessment to exchange data with EHRs and shared assessment with CDC.

Surveillance Data Quality: Indicators of success:

o Quantitative data quality measures and targets are developed.

o Baseline data completeness, accuracy and timeliness are measured and documented.

o Data quality measures are improved from baseline and targets are met.

Birth Defects Epidemiology: Indicators of success:

o Surveillance data and death records are linked.

o Datasets are properly formatted; at a minimum contain CDC-defined standard variables o De-duplicated individual-level data (Appendix A) are submitted to CDC within agreed upon timeframes o Review of proposals to analyze multi-state surveillance data; conducting data analyses; preparation of abstracts and manuscripts resulting from approved analyses are documented and submitted to CDC within agree upon timeframes

Primary and Secondary Prevention: Indicators of success:

o Data are used to identify high risk populations in the catchment area and prevention strategies are implemented.

o A plan to improve referral to health care and social services for individual with birth defects is documented and shared with CDC.

o Facilitators and barriers to tracking children prospectively to better understand outcomes are documented and shared with CDC.

Evaluation and dissemination: Indicators of success:

o A minimum of two projects for evaluation in two categories (i.e., surveillance capacity, data quality, primary and secondary prevention) are submitted to CDC;

projects include SMART objectives, produce results that can be utilized to improve surveillance programs activities, and are of rigor to be published in a peer reviewed journal.

o Evaluation findings are submitted for publication or presented at national scientific conferences.

Evaluation and progress reports: CDC will work with recipients to finalize measures within the first six months of the period of performance.

Prepare a written assessment of the accomplishments, challenges and opportunities including a description of the problems encountered, lessons learned, potential improvements, etc.

Outcomes

Increased ability to rapidly respond to emerging threats to mothers and babies. Indicators for success:

o Birth defects cases are reported to CDC annually.

o An EHR-surveillance system interoperability readiness assessment is completed and shared with CDC.

Improved quality of birth defects surveillance data. Indicators for success:

o A plan for data quality improvement is documented and shared with CDC.

o Targets for data completeness, accuracy and timeliness are established and met.

Increased contribution of multi-state data to scientific understanding of birth defects.

Indicator for success:

o Dissemination of publications and conference presentations/webinars describing the characteristics of individuals affected by birth defects, in collaboration with

CDC.

Increased knowledge of the prevention of birth defects. Indicator for success:

o At least one birth defects prevention activity is conducted annually for identified high-risk population in catchment area.

Component B Strategies and Activities:

Electronic Health Records (EHR): Indicator of success:

o An EHR-surveillance system interoperability implementation plan is completed and shared with CDC.

Evaluation and progress reports: CDC will work with recipients to finalize measures within the first six months of the period of performance.

Prepare a written assessment of the accomplishments, challenges and opportunities including a description of the problems encountered, lessons learned, potential improvements, etc.

Outcome

Strengthened surveillance of birth defects. Indicator of success:

o The birth defects surveillance system has the ability to receive and process birth defects case information submitted through an HL7 message that complies with national HL7 messaging standards.

Component C Strategies and Activities:

Critical Congenital Heart Defects (CCHDs): Indicators of success:

o Timing and method of detection are ascertained for all CCHD cases (e.g. prenatal fetal echocardiogram and gestational age, early clinical detection at hospital delivery and age at (in hours) or date of detection, pulse-oximetry screening at hospital delivery and age at (in hours) or date of screening, detection after birth hospital discharge and age at or date of detection).

o Individual-level CCHD screening results (e.g. O2 saturation and/or pass/fail, number of times each infant was screened) are recorded for all screened CCHD cases.

o Timing of confirmatory infant echocardiogram.

o Timing and method of detection of CCHD and CCHD screening results are reported to CDC annually.

o Examine timing and method of detection and screening results by sociodemographic and health characteristics (e.g., race, maternal age, sex at birth, birth weight, timing of first prenatal care visit, etc.).

Evaluation and progress reports: CDC will work with recipients to finalize measures within the first six months of the period of performance.

Prepare a written assessment of the accomplishments, challenges and opportunities including a description of the problems encountered, lessons learned, potential improvements, etc.

Outcome

Increased contribution of multi-state birth defects data to primary and secondary prevention efforts. Indicator of success:

o Annual reporting of CCHD detection and screening data to CDC

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 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 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 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 Reporting Section of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach Successful applicants must describe the level of organizational capacity necessary to implement the NOFO successfully. Organizational capacity includes skill sets to implement the awards such as: program and performance management, data analysis, data linkage, epidemiologic and clinical expertise, public health informatics, evaluation, communication/material development, performance monitoring, and financial reporting. If there are any vacant positions, the applicant should include a 1-2 paragraph job description (including applicant qualifications) and address both the recruiting strategies and estimated timeline for filling the position.

Applicants must have the public health authority, legislative mandate or otherwise show legal access to the requisite surveillance data and share individual-level data, including date of birth (i.e. month/day/year) with CDC. Through letters of support and/or MOAs/MOUs, applicants should provide evidence of strong relationships with key partners/programs (e.g. Children with Special Health Care Needs, newborn screening, etc.) that are necessary to successfully implement the NOFO.

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. A separate work plan for each component that the applicants applies for is required. No specific work plan format is required as long as the work plan crosswalks to the strategies and activities, outcomes, and performance measure presented in the logic model and narrative sections of this NOFO. Below is a sample work plan format.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies/Activities Process Measure [from Evaluation and Performance

Responsible Position / Party

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

Measurement section]

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 (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

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

Provide technical assistance on surveillance of birth defects using multiple data sources Provide technical assistance on quantitative data quality measures for birth defects surveillance data and improving data quality Provide data structure/standards for reporting individual-level data to CDC Provide timelines for ongoing data transmission and other key activities

Assist with drafting and approving data use agreements between recipients, if necessary Facilitate review of proposals to use multi-state data, analyze submitted data and disseminate findings Provide technical assistance for ascertaining CCHD detection and screening results and assessing health outcomes Provide guidance for evaluation of the project.

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: U50 U50 – Special Cooperative Investigations/Assessment of Control/Prevention Methods

3. Fiscal Year: 2021 Estimated Total Funding: $3,100,000

4. Approximate Total Fiscal Year Funding: $3,100,000

This amount is subject to the availability of funds.

5. Approximate Period of Performance Funding: $15,500,000 $15,000,000 – $20,000,000 estimate for 3/1/2021 – 2/28/2026 period of performance.

6. Total Period of Performance Length: 5

7. Expected Number of Awards: 10 Component A: 8-12 awards.

Component B: 1-2 awards. Only applicants funded under Component A are eligible to receive a Component B award.

Component C: 4-12 awards. Only applicants funded under Component A are eligible to receive a Component C award.

8. Approximate Average Award: $250,000 Per Budget Period Component A: $250,000 average award per budget period which includes total direct and indirect cost.

Component B: $225,000 average award per budget period which includes total direct and indirect cost.

Component C: $50,000 average award per budget period which includes total direct and indirect cost.

This amount is subject to the availability of funds.

9. Award Ceiling: $325,000 Per Budget Period

Component A: $325,000 Component B: $300,000 Component C: $75,000

10. Award Floor: $30,000 Per Budget Period Component A: $200,000 Component B: $200,000 Component C: $30,000

11. Estimated Award Date: 03/01/2021

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: 60 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 Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities 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) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category:

Government Organizations:

State (includes the District of Columbia) Local governments or their bona fide agents Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

State controlled institutions of higher education

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

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 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 as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a Bona Fide Agent of a state government, a letter from the state 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".

Only one application per organization as determined by the organization’s Dun & Bradstreet number will be accepted for Component A. Applicants wishing to apply for optional Component B and/or Component C activities can include their Component B information and/or Component C information within their respective Component A application.

The award ceiling for this NOFO is $325,000 for Component A, $300,000 for Component B, and $75,000 for Component C. CDC will consider any application requesting an award higher than this 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. 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 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)

1. Retrieve organizations DUNS number

2. Go to https://www.sam.gov/index.html

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 https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do 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 formerly Central Contractor Registration

(CCR)

and designate an E-Biz…