cdc-rfa-dd-25-0157_FINAL.pdf

Division of Human Development and Disability

Notice of Funding Opportunity

Application due March 6, 2025

Enhancing Timely Data Reporting, Quality, and Use in Early Hearing Detection and Intervention (EHDI) Surveillance Opportunity number: CDC-RFA-DD-25-0157

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Program description 9

Step 2: Get Ready to Apply 34

Get registered 35

Step 3: Prepare Your Application 37

Application contents and format 38

Step 4: Learn about Review and Award 47

Application review 48

Award notices 54

Step 5: Submit Your Application 55

Application submission and deadlines 56

Application checklist 58

Step 6: Learn What Happens After Award 59

Post-award requirements and administration 60

Contacts and Support 64

Endnotes 66

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on March 6, 2025.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

Jump to a step

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 7

Program description 9

Basic information Centers for Diseases Control (CDC)

National Center on Birth Defects and Developmental Disabilities

Division of Human Development and Disability

Supporting Early Hearing Detection and Intervention (EHDI) surveillance to reduce gaps in diagnosis and services for infants who are deaf or hard of hearing.

Have questions?

See the Contacts and Support section in this document.

Key facts

Opportunity name:

Enhancing Timely Data Reporting, Quality, and Use in Early Hearing Detection and Intervention (EHDI) Surveillance

Opportunity number:

CDC-RFA-DD-25-0157

Federal assistance listing: 93.314

Key dates

Application deadline:

March 6, 2025

Optional letter of intent deadline: January 10, 2025

Informational call:

December 12, 2024

Expected award date:

June 1, 2025

Expected start date:

July 1, 2025

Summary One in every 500 live-born infants are deaf or hard of hearing (D/HH). Early identification and intervention for infants born with congenital hearing loss is important to support their developmental progress. As a result, the Joint Committee on Infant Hearing (JCIH) recommends the following steps:

• Screen all infants for hearing by one month of age.

• Confirm diagnosis by three months of age for those who do not pass screening.

• Enroll infants diagnosed as D/HH in early intervention (EI) services by six months of age.

Together, these three steps are known as EHDI 1-3-6. Moreover, the JCIH suggests that the true value of an effective Early Hearing Detection and Intervention (EHDI) program can only be known when linguistic and literacy performance data are examined for infants who are D/HH.

The Centers for Disease Control and Prevention’s (CDC) EHDI program aims to help every infant born D/HH achieve their optimal health and well-being. This notice of funding opportunity (NOFO) will support this aim by funding EHDI states to improve data quality, using data to inform interventions and collaborations that help link infants to services in a timely manner.

In addition, to set the stage for evaluating the impact of EHDI 1-3-6 on developmental outcomes, this NOFO will fund a small number of EHDI states to incorporate language or communication outcome data collection into the state EHDI Information System (EHDI-IS).

There are two components included in this NOFO:

Step 1: Review the Opportunity 5

Component A: Improving data quality in the state EHDI-IS to inform interventions and building collaborations to facilitate data linkage and integration.

Component B: Incorporating language outcomes data into the EHDI-IS by improving collaboration with early intervention services funded under Part C and other relevant partners that collect language or communication outcomes.

You must apply for Component A to be considered for Component B.

Applying for Component B is optional.

Funding details Type: Cooperative agreement

Funding details for Component A Expected total program funding over the performance period: $33,150,000

Expected total program funding per budget period: $6,630,000

Expected awards: 39

Funding range per budget period: $150,000 to $190,000

Expected average award amount per budget period: $170,000

We plan to award projects for five 12-month budget periods for a five-year period of performance.

The number of awards is subject to available funds and program priorities.

Funding details for Component B Expected total program funding over the performance period: $1,875,000

Expected total program funding per budget period: $375,000

Expected awards: 5

Funding range per budget period: $50,000 to $100,000

Expected average award amount per budget period: $75,000

We plan to award projects for five 12-month budget periods for a five-year period of performance.

The number of awards is subject to available funds and program priorities.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 6 https://sites.ed.gov/idea/early-learning-early-childhood/

Eligibility Statutory authority Section 399M (b) (1) of the Public Health Service Act, [42 U.S.C. 280g-1(b)(1)].

Who can apply Eligible applicants Only these types of organizations may apply:

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Bona fide agents of state and territorial governments.

State and territorial agencies must have the public health authority and/or legislative mandate to conduct Universal Newborn Hearing Screening (UNHS) activities, which include monitoring and tracking the disposition of every occurrent birth in the state. This authority must allow you or a bona fide agent to work collaboratively with multiple reporting sources, including but not limited to:

• State vital records.

• Birthing facilities.

• Diagnostic centers.

• Audiologists.

• Early intervention services.

• Congenital anomaly registries.

• Immunization registries.

• Other newborn screening programs.

The goal of these collaborations is to ensure accurate monitoring and tracking of all births statewide. You must also have the experience, capacity, expertise, and resources to complete the comprehensive activities for this state- or territory-wide surveillance program.

Step 1: Review the Opportunity 7

Other required qualifying factors

Component A To be eligible for Component A, you must have the following:

Vital Records verification

You must document that there are at least 5,000 babies born in your state each year. You must submit a letter of verification from an official in Vital Records (VR) or another agency responsible for determining the number of annual births, verifying the number of resident births occurring in calendar year 2022. Include this documentation in your attachments with the file name Vital Records Verification. Applications that do not include this verification will be considered non-responsive and will not move forward for review.

Tier 1 verification

You must review the tier 1 patient-level data items, and document you can collect them all and report on them biannually. See Data items. You must demonstrate this ability by including documentation in your attachments with the file name Tier 1 Verification. Applications that do not include this verification will be considered non-responsive and will not move forward for review.

Component B To be eligible for Component B, you must apply for Component A.

You must also submit a letter from the principal investigator or program director (PI/PD) documenting your program’s six-month early intervention benchmark average of 40.9% for calendar year 2022. You must include this letter in your attachments with the file name Outcomes Data Collection Verification.

Cost sharing and matching funds This program has a no cost-sharing requirement or matching funds requirement. If you choose to include cost-sharing funds as a contribution to the award, we will not consider it during review of your application. If you receive an award, voluntary cost-sharing funds will be a requirement of your award and you will need to report on them.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 8 https://centersfordiseasecontrol.sharefile.com/public/share/web-sd3f7adabf09d46278413a311f51cd308

Program description Background Overview Congenital hearing loss affects nearly one in every 500 live-born infants.

When left undetected, congenital hearing loss can impact an infant’s developmental progress and necessitate support strategies for infant-caregiver interaction. In response, federally funded EHDI programs were established to ensure all infants have their hearing screened, and those who are identified as deaf or hard of hearing (D/HH) receive timely diagnostic and early intervention services.

National benchmarks for EHDI follow what is known as the EHDI 1-3-6 plan:

• Hearing screening by one month of age.

• Diagnosis by three months of age for infants not passing the screening.

• Enrollment in intervention by six months of age for infants identified as

D/HH.

CDC provides cooperative agreements to state EHDI programs to improve public health surveillance of infant hearing by enhancing EHDI Information Systems (EHDI-IS). States use their EHDI-IS to actively track infants’ hearing screening, as well as timely diagnosis and enrollment in early intervention services for those that do not pass the hearing screening or those at risk for permanent hearing loss. This timely action is crucial to minimizing risks of developmental delays from undetected or late-identified hearing loss.

The most recent notice of funding opportunity (NOFO) to support the optimization of the EHDI-IS, DD20-2006, marked two important shifts in our approach:

• First, while we continued supporting hearing screening-related activities, diagnosis and enrollment in early intervention were a primary focus. This has helped funded states improve documentation and delivery of timely diagnostic and early intervention services by the three- and six-month benchmarks, respectively.

• Second, we supported active tracking and timely surveillance by funding 39 states to build their EHDI-IS capabilities and report limited patient-level data to CDC, in addition to the aggregate survey report.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 9 https://grants.gov/search-results-detail/323657

The successful reporting and analysis of relevant and standardized patient-level data has allowed states and the nation to move beyond the limitations of reporting aggregate data. Now we are more able to identify specific populations within states that may face barriers to receiving follow-up care and direct strategic actions toward improving access to early hearing care. In collaboration with the 39 states funded under DD20-2006, we conducted detailed analyses on the following:

• Factors associated with infants not receiving follow-up services.

• Areas for improvement in receipt and timeliness of newborn hearing screening, diagnosis, and enrollment in early intervention.

• Completeness of sociodemographic factors and EHDI 1-3-6 benchmarks at the national and state level.

• The impact of provider reporting of limited audiometric testing after not passing the hearing screening.

This NOFO further supports use of EHDI surveillance system data to inform efforts to reduce gaps in diagnosis and expand linkage to early intervention services for infants who are D/HH. This includes supporting states to engage with their partners (for example, vital records, hospitals, labs, audiologists, and Part C programs) that submit data to the state’s EHDI-IS.

Component A involves:

• Enhancing state EHDI-IS that conforms to CDC EHDI Functional Standards.

• Strengthening EHDI-IS optimization through improved data linkage and integration.

• Promoting state collaboration through partner engagement around tracking and surveillance activities.

• Maintaining data quality and supporting continuous program improvement through ongoing data analysis.

• Developing detailed data reports to disseminate relevant information among internal and external partners to inform actions for reducing disparities in timely screening, diagnosis, and enrollment in early intervention.

Additionally, this NOFO supports some recipients in the completion of Component B (optional), which focuses on language or communication outcomes data collection and includes:

• Increasing collaboration with Part C and other relevant partners collecting language or communication outcomes.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 10 https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html

• Advancing language or communication outcomes data collection by standardizing outcomes data elements, enhancing your state’s EHDI-IS, and reporting data to CDC.

Related work Several other CDC NOFOs have supported states in implementing a broad range of EHDI activities. These activities included:

• Developing an EHDI-IS and supporting integration with other child health data systems.

• Enhancing the EHDI-IS to support documentation and use of follow-up diagnostic and intervention services data.

• Reporting patient-level data from state EHDI-IS to CDC to strengthen EHDI surveillance.

These efforts helped states screen over 95% of newborns by one month of age and diagnose over 6,500 infants as D/HH in 2021.

Related NOFOs include:

• DD09-903: Early Hearing Detection and Intervention (EHDI) Tracking, Surveillance, and Integration

• DD11-1101: Development, Maintenance and Enhancement of Early Hearing Detection and Intervention Information System (EHDI-IS) Surveillance Programs

• DD17-1701: Documentation and Use of Follow-up Diagnostic and Intervention Services Data through the Maintenance and Enhancement of the Early Hearing Detection and Intervention Information System

• DD20-2006: Improving Timely Documentation, Reporting, and Analysis of Diagnostic and Intervention Data through Optimization of EHDI Surveillance Practices and Information Systems

Purpose The purpose of this funding is to help EHDI states improve data quality and use data to inform interventions and collaborations that address system-based challenges in linking infants that do not pass hearing screening to diagnosis and early intervention services in a timely manner. In addition, this NOFO will fund a small number of EHDI states to incorporate language or communication outcome data collection into the state EHDI-IS. There are two components included in this NOFO:

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 11 https://grants.gov/search-results-detail/46768 https://grants.gov/search-results-detail/65414 https://grants.gov/search-results-detail/290939 https://grants.gov/search-results-detail/323657

Component A: Improving data quality in the state EHDI-IS to inform interventions and building collaborations to facilitate data linkage and integration.

Component B (optional): Incorporating language outcomes data into the EHDI-IS by improving collaboration with early intervention services funded under Part C and other relevant partners that collect language or communication outcomes.

A high-quality data system minimizes the effort of data flow (which may include factors like time, manual labor, and personnel burden) and increases data completeness. High-quality data collection requires a deep understanding of system inputs and analysis of data to determine existing data gaps.

Data for each state’s EHDI-IS is often acquired from a variety of sources with unknown reliability, such as:

• Hospitals.

• Other newborn screening records.

• Electronic birth certificates.

• Audiology clinics.

• Electronically mailed reports from early intervention or other therapeutic service programs.

Through CDC-led technical assistance, EHDI state programs have reported that manual data entry, cross-agency data-sharing concerns, disconnected administrative systems, human error, and other system reporting time delays may be factors that negatively impact the efficiency of their EHDI-IS.

EHDI states will be funded to use their data to inform programmatic actions by examining the timeliness and quality of their data.

The JCIH suggests that the true value of an effective EHDI-IS can only be known when linguistic and literacy performance data are examined for children who are D/HH.[1] Developmental outcomes have not been consistently collected within the EHDI-IS. However, it is well established that children born D/HH are at increased risk for language, cognitive, and socio-emotional delays. [2] [3] [4]

Studies examining the impact of timely diagnostic and intervention services suggest that when children who are D/HH are enrolled in early intervention before six months of age, they have improved language outcomes and kindergarten readiness.[5] [6] [7] Some EHDI-funded states have begun to explore ways to share data between EHDI-IS and early intervention data

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 12 systems that may include language outcomes records. Integrated data systems that allow for language outcomes to be linked or transmitted to the EHDI-IS are rare, but they hold promise. In this funding cycle, CDC will work with a subset of states to help integrate language or communication status data for infants who are under three years old with state EHDI surveillance systems, enhancing their ability to monitor the impact of early diagnosis of D/ HH and subsequent intervention.

Approach Overview The following logic model includes the strategies and activities required under this NOFO. It also includes the program’s expected outcomes. The asterisked outcomes are those we expect you to achieve during the five-year period of performance.

Outcomes are the results that you intend to achieve and usually show the intended direction of change, such as increase or decrease.

You will use these outcomes as a guide for developing performance measures.

Program logic model The logic model below shows the strategies and activities of the program along with the outcomes we expect over time. We will require you to report on the asterisked (*) outcomes as follows.

Table: Strategies and outcomes

Strategies and activities Short-term outcomes Intermediate outcomes Long-term outcomes

COMPONENT A

Strategy 1.

Enhancements

• Maintain and enhance the state EHDI-IS in accordance with the CDC EHDI Functional Standards . Strengthen data integration and linkages through EHDI- IS optimization.

COMPONENT A

• Partners report timely data at each phase of

EHDI 1-3-6

more consistently.

• Increased understanding of challenges with

COMPONENT A

• Decreased data collection and reporting barriers.

• Improved high-quality and timely EHDI data.*

• Increased utilization and dissemination of EHDI data among EHDI programs and partners, for tracking

COMPONENT A

• More infants that do not pass hearing screening receive a diagnosis by three months of age.*

• More infants who are D/HH

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13

Strategy 2. Collaboration

• Engage partners on data reporting, follow-up, and tracking.

Strategy 3. Data analysis and quality improvement process

• Identify barriers and implement solutions on data quality improvement projects across EHDI 1-3-6.

Strategy 4. Data collection, use, and dissemination

• Collect, store, use, and disseminate EHDI data to relevant internal and external partners.

functionality of the EHDI-IS.*

• Increased understanding of incomplete tier 1 EHDI data.*

• Increased identification of disparities across the

EHDI 1-3-6.*

• Improved timely submission of aggregate and patient-level datasets to

CDC.*

and to inform decision making.*

• Increased identification of interventions to address disparities across EHDI 1-3-6.

• Increased standardization and comparability of aggregate and individual-level EHDI follow-up data by CDC at the national level.

enroll in early intervention services by six months of age.*

• More children who are D/HH reach their age-appropriate language or communication milestones.

COMPONENT B

Strategy 5. Collaboration

• Improve collaboration with Part C and other relevant partners that collect language or communication outcomes data.

Strategy 6. Data collection and dissemination

• Improve collection of language or communication outcomes data.

COMPONENT B

• Reduced barriers to collecting individual-level language or communication outcome data.*

COMPONENT B

• Increased standardization of early intervention and outcome data.*

• Enhanced capacity for EHDI-IS to meet EHDI Functional Standard

4.7 .*

• Increased documentation and reporting of individual-level data on language or communication outcomes of D/HH children who receive early intervention services.*

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 14 https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html

* Indicates short-term, intermediate, and long-term outcomes you are required to report on.

Strategies This section elaborates on the strategies and activities described in the logic model and provides details on expectations of recipients to implement the program.

This NOFO has two components:

Component A: Improving data quality in the state EHDI-Information System (EHDI-IS) to inform interventions and building collaborations to facilitate data linkage and integration.

Component B (optional): Incorporating language outcomes data into the state EHDI-IS by improving collaboration with early intervention services funded under Part C and other relevant partners that collect language or communication outcomes.

You must apply for Component A to be considered for Component B.

Applying for Component B is optional.

Component A For Component A, you’ll perform the following strategies and activities.

Strategy 1. Enhancements

Maintain and enhance the state EHDI-IS in accordance with the CDC EHDI- IS Functional Standards. Strengthen data integration and linkages through EHDI-IS optimization.

This strategy includes activities that focus on optimizing the existing EHDI-IS infrastructure and functionalities to improve the collection, management, and use of diagnostic and intervention data.

Some activities for this strategy are required for all recipients. Others are optional. You should indicate in your project narrative whether you plan to engage in any optional activities.

The following are required activities for Strategy 1:

• You must collect and manage hearing screening and audiological diagnostic data. You must also maintain the electronic exchange of demographic data from your state’s vital records and/or any other source of demographic data to the state EHDI-IS. This is required in order to meet the “SHALL” requirements of the Goals 1 and 2 of the Functional Standards.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 15 https://sites.ed.gov/idea/early-learning-early-childhood/ https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/?CDC_AAref_Val=https://www.cdc.gov/ncbddd/hearingloss/ehdi-is-functional-standards.html https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html#cdc_generic_section_1-goal-1 https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html#cdc_generic_section_1-goal-1

• You must enhance the capacity of your state’s EHDI-IS to meet any “SHALL” requirements under Goals 3 through 8 in the Functional Standards that your state’s EHDI-IS does not currently meet.

• You must enhance the capacity of your state’s EHDI-IS to support the preparation of patient-level datasets. Extract data from your EHDI-IS and construct a patient-level limited dataset[8] according to the given standard and format provided by CDC. Develop and implement pseudonymization[9] functionality and protocols to remove direct identifiers from each patient in the system.

• You must ensure that key staff are part of the project team and perform the following responsibilities:

◦ Assisting with EHDI-IS optimization and evaluation, data management, and quality improvement projects.

◦ Identifying data elements affecting data quality (for example, completeness, timeliness, and consistency) and ways to improve data collection.

◦ Ensuring standardized data definitions are applied.

◦ Preparing and validating data files submitted to CDC.

◦ Identifying and resolving any data errors.

The following are optional, but highly encouraged activities for Strategy 1:

• You may develop and implement data linkages to enable data sharing between your state EHDI-IS and other public health information systems.

The goal of these linkages is to improve timeliness and completeness of demographic, follow-up diagnostic, and intervention information.

Examples of other systems you might link with your EHDI-IS include but are not limited to your state Medicaid system, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and early intervention systems.

• You may expand the capacity of your state EHDI-IS to generate automated, on-demand data reports. This should include the ability to generate, present, and transmit both standard and custom-defined reports (for example, CDC Hearing Screening and Follow-up Survey (HSFS) from the individual-level data, loss to follow-up, and other relevant indicators) for a range of partners without assistance from the system vendor or IT personnel.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 16 https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html#cdc_generic_section_3-goal-3 https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html#cdc_generic_section_3-goal-3

Strategy 2. Collaboration

Engage partners on data reporting, follow-up, and tracking.

The following are required activities for Strategy 2:

• Maintain and improve connections with partners around tracking and surveillance activities within the state and provide technical assistance during the reporting process. Partners may include, but are not limited to:

◦ Other states and territories.

◦ Birthing hospitals.

◦ Home birth facilities.

◦ Pediatric clinicians.

◦ Audiologists.

◦ Early intervention programs.

◦ Health care systems and health care provider groups.

◦ Other health and social service organizations.

• Maintain an up-to-date list of audiology diagnostic facilities that see infants in the state.

• Maintain and improve connection and collaboration with audiologists.

Examples include working with audiologists to incorporate data reporting in their regular clinical practice, reviewing key data needs, and addressing data gaps. Train audiologists on EHDI and reporting protocols to improve compliance with established protocols and reduce reporting burden.

• Maintain and improve connection and collaboration with early intervention programs. Examples include collaborating with state and local early intervention programs to review and address key data needs and gaps and improve data exchange methods and protocols.

• Collaborate with CDC through methods including, but not limited to, participation in at least one workgroup, virtual or in-person site visits, and CDC-EHDI webinars and office hours.

Step 1: Review the Opportunity 17

Strategy 3. Data analysis and quality improvement process

Identify barriers and implement solutions on data quality improvement projects across EHDI 1-3-6.

The following are required activities for Strategy 3:

• Assess the quality of data collected in your state’s EHDI-IS, in accordance with standards 5.1 and 5.5 of the EHDI-IS Functional Standards, throughout the duration of the NOFO.

• In Year 1, collaborate with CDC to complete a system assessment that provides a comprehensive background of the data elements collected in your state’s EHDI-IS, including data sources, challenges experienced collecting data, and gaps in types of data collected.

• In Years 1 and 2, conduct a quality improvement project to address data gaps in your state’s EHDI-IS, such as incomplete or missing data. The quality improvement project must occur in two phases.

◦ Phase 1: Develop an EHDI-IS data flow diagram, describing data systems and linkages at the state level that you use to create your state’s EHDI-IS.

◦ Phase 2: Propose and conduct a quality improvement project focused on improving one-, three-, or six-month data quality and systems improvement (such as linkage or interoperability). Your project must be informed by your analysis of patient-level data. If possible, focus on the benchmark that needs the most improvement.

Please see the Six Dimensions of EHDI Data Quality Assessment as a reference.

• Facilitate use of data by engaging partners, conducting analyses, and sharing information to address gaps and disparities in timely screening, diagnosis, and enrollment in early intervention.

Strategy 4. Data collection, use, and dissemination

Collect, store, use, and disseminate EHDI data to relevant internal and external partners.

The following are required activities for Strategy 4:

• You must disseminate the findings of your data analysis and quality improvement processes to key partners. It is essential to engage state or jurisdictional programs (for example, Title V, Part C, and Medicaid) directly around the use of EHDI data to inform actions to address gaps and disparities in timely screening, diagnosis, and enrollment in early

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 18 https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html#cdc_generic_section_5-goal-5 https://www.cdc.gov/hearing-loss-children/media/pdfs/DataQualityWorksheet.pdf intervention. You may share your findings through various channels such as manuscripts, reports, presentations, webinars, or websites.

◦ You must also share key information and lessons learned with other state or jurisdictional EHDI programs through CDC-hosted webinars during this cooperative agreement.

◦ To improve EHDI-IS visibility, you should consider presenting at state, regional, and national meetings and conferences, such as those held by the American Academy of Audiology and the American Speech Language-Hearing Association, early education and child development conferences, and the National EHDI Meeting.

• You must submit data to CDC two times per year. This includes two parts:

◦ You must submit the HSFS survey annually in January.

◦ You must submit a limited, de-duplicated, standardized patient-level limited dataset twice per year (January and May) that includes EHDI information on all occurrent births of a specified calendar year. This requirement applies throughout the period of performance.

• You must complete the following data use activities:

◦ In collaboration with CDC, develop and sign a data use agreement (DUA) within the first six months of the award, if applicable and warranted by your state.

◦ Develop and implement a protocol for the pseudonymization of individual-level EHDI data that will be transmitted to CDC. This requirement also falls under Strategy 1 of Component A.

Component B You must apply for Component A to be considered for Component B.

Component B is optional. Component B includes Strategy 5 and Strategy 6.

Strategy 5. Collaboration

Increase collaboration with Part C and other relevant partners that collect language or communication outcomes data.

The following are required activities for Strategy 5:

• Revise or update your memoranda of understanding/memoranda of agreement (MOU/MOA) and/or data use agreement with Part C or other relevant partners that collect language or communication outcomes data to improve data exchange between programs. For example, improvements could include:

Step 1: Review the Opportunity 19

◦ Increasing the frequency of data sharing over the calendar year between Part C and your EHDI program, particularly if data sharing currently occurs only once per year.

◦ Collecting additional data elements or variables in the EHDI-IS, such as disability status, primary diagnosis listed on Part C, exit date, and exit reason.

• Based on infrastructure assessment or evaluation findings conducted under the Health Resources and Services Administration (HRSA) funding opportunity number HRSA-24-036, develop a plan to address gaps that remain unexamined and barriers to collecting language or communication outcomes data.

• Collaborate with Part C programs to develop a list of partners that provide services to D/HH children enrolled in Part C (local, regional, and statewide) to improve gaps in data collection at the six-month benchmark and to enhance opportunities to collect language or communication outcomes data.

Strategy 6: Data collection and dissemination

Improve collection of language or communication outcomes data.

The following are required activities for Strategy 6:

• Enhance your state’s EHDI-IS to collect and document individual-level language outcome data, in accordance with Standard 4.7 of the EHDI-IS Functional Standards. At minimum, you must engage in the following:

◦ Identify and document the language or communication assessments used by programs in your state.

◦ Work with CDC and other collaborators to evaluate, define, and integrate language or communication outcomes data elements for the EHDI-IS.

◦ Report on current data sharing or linkage of EHDI-IS with Part C (or another language or communication outcomes database) and ensure parental consent to collect language or communication outcomes in your state’s EHDI-IS.

◦ Determine your state’s capacity to increase data linkage and interoperability between systems that collect language or communication outcomes to your state’s EHDI-IS.

◦ Share key information and lessons learned with CDC and other state EHDI programs through webinars during the course of this cooperative agreement.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 20 https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html#cdc_generic_section_4-goal-4

Outcomes This section includes outcomes you are expected to report progress on and achieve within the performance period.

We will measure your progress toward the following short-term, intermediate, and long-term outcomes from the logic model:

Component A outcomes

• Increased understanding of challenges with functionality of the EHDI-IS.

• Increased understanding of incomplete tier 1 EHDI data.

• Increased identification of disparities across the EHDI 1-3-6.

• Improved timely submission of aggregate and patient-level datasets to

CDC.

• Improved high-quality and timely EHDI data.

• Increased utilization and dissemination of EHDI data among EHDI programs and partners, for tracking and to inform decision making.

• More infants that do not pass hearing screening receive a diagnosis by three months of age.

• More infants who are D/HH enroll in early intervention services by six months of age.

Component B outcomes

• Reduced barriers to collecting individual-level language or communication outcome data.

• Increased standardization of early intervention and outcome data.

• Enhanced capacity for the EHDI-IS to meet EHDI Functional Standard 4.7.

• Increased documentation and reporting of individual-level data on language or communication outcomes of D/HH children who receive early intervention services.

Focus populations The target populations for this program are:

• All infants receiving hearing screening at birth.

• Infants referred for audiology diagnostic testing.

• Infants identified as D/HH and referred for early intervention.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 21 https://www.cdc.gov/hearing-loss-children/php/ehdi-is-functional-standards/programmatic-goals.html#cdc_generic_section_4-goal-4

Equal opportunities This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy), or other constitutionally protected statuses.

Health disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Health disparities are often caused by social determinants that influence which populations are most disproportionately affected by health conditions.

A health disparity is a difference in health burdens between groups of people with differing social determinants of health.

Social determinants of health are conditions in the environments where people are born, live, learn, work, play, worship, and age. These determinants affect a wide range of health, functioning, and quality-of-life outcomes and risks.

The collection of patient-level data allows for analysis of health disparities that can provide insights on groups of infants that are not receiving the recommended EHDI services. Using sociodemographic variables, EHDI programs can identify characteristics of these vulnerable groups and use the information to target their programmatic efforts and strengthen their surveillance systems. Understanding the underlying population is an important aspect of moving toward health equity at the program level.

You will work to address disparities using Strategies 2 and 3 of Component A.

Activities under these strategies may include, but are not limited to:

• Using data analysis to identify disparities in the individual-level data.

Analysis may include identifying sociodemographic differences in EHDI 1-3-6 or in populations that do not receive follow-up services.

• Engaging with partners to deliver culturally sensitive interventions to improve programmatic data quality and address disparities in infants receiving timely services.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 22 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

Organizational capacity In this section, you must demonstrate that your program has the capacity to meet the project requirements and successfully complete the activities described in the strategies section.

Specifically, you must demonstrate your organizational capacity to conduct the activities using four key staff members, as described in the following subsections:

• Leadership capacity

• Surveillance capacity

• Evaluation and performance monitoring capacity

• Health informatics capacity

These key roles must be shown on your work plan alongside the activities they will be responsible for.

The budget narrative must include the names of the people who will serve in these four specific roles, whether their work will be funded or in-kind, the percentage of time they will devote to the project, and a description of the specific activities they will be responsible for.

The percentages noted for each role are the percentages of the staff member’s time that we expect them to devote to the role. For example, the project director/principal investigator must devote 15% to 20% of their time to the role.

Leadership capacity (15% to 20%) This individual will be your project director/principal investigator (PD/PI) and will be responsible for the scientific, technical, and programmatic oversight of your project. This individual should have experience with all of the following:

• Managing a state surveillance system.

• Working with project staff to ensure that project goals are met.

• Managing funds.

• Finding resources to collect and use qualitative and quantitative data.

This could include identifying funding to onboard relevant vendors, contractors, and other collaborators to support data collection and analysis.

Lived experience or previous work with populations that include infants with disabilities or families with young children may be helpful.

Step 1: Review the Opportunity 23

Surveillance capacity (25% to 50%) This individual should have knowledge of research and epidemiologic methodology, as well as experience in data collection, data management, and analysis. They should also be able to present both technical and non-technical information to diverse audiences.

Evaluation and performance monitoring capacity (15% to 25%) This individual should be familiar with evaluation methods including the development, coordination, and implementation of an EHDI-IS evaluation plan. They should also have training or prior experience conducting and overseeing evaluation activities. In your application, describe this individual’s most recently implemented evaluation activities.

They should also be able to conduct quality improvement (QI) and Plan-Do- Study-Act (PDSA) cycles and present evaluation findings and conclusions to a variety of audiences.

Health informatics capacity (15% to 25%) This individual should have experience working on the following:

• Public health information systems.

• Large public health datasets.

• Data interoperability.

• Data systems development.

• Data linkage.

• Data modernization (for example, cloud-based data storage, Application Programming Interface (API), Health Level Seven (HL7), Fast Healthcare Interoperability Resources (FHIR)).

In your attachments, you must submit a targeted, abridged resume or CV, limited to five pages, that highlights relevant training and work experience for each individual who will hold one of these positions. For any vacant positions, include the job description and hiring plan you will use for recruitment instead of a resume or CV.

All four roles are considered key personnel. If any of these roles become vacant during the period of performance, you must promptly notify the Office of Grant Services (OGS) at the CDC Office of Financial Resources (OFR).

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 24 https://www.ahrq.gov/evidencenow/tools/pdsa-form.html https://www.ahrq.gov/evidencenow/tools/pdsa-form.html

Collaborations You must collaborate with CDC, other state EHDI programs, and other newborn screening and relevant public health programs to collect and use complete and accurate data. Some organizations to consider include, but are not limited to:

• State vital records.

• Early intervention programs.

• Audiologists.

• Pediatricians.

• Speech language pathologists.

• State and federal department of education Part C partners.

• Part C and other programs that collect language or communication outcomes data.

All collaborations you propose must include sufficient details in a letter of support. Each letter of support should be no longer than one page and summarize your proposed collaboration for data quality improvement, the population (for example, by age or region) impacted, partners that will need to be included, and expected program impact.

Data, monitoring, and evaluation CDC strategy The evaluation and performance measurement strategy will assess your project performance. Measures are subject to change. You must track evaluation and performance measures and report progress to CDC using a CDC-defined format and timeline.

Required performance measures Following are the draft performance measures you will need to report on annually after award. We will likely refine the required measures for this program. If so, we will work with you and finalize them before we require you to submit any data.

Step 1: Review the Opportunity 25

Table: Component A: Draft performance measures

Component A Performance measures

Strategy 1:

Enhancements

Document the number of “SHALL” requirements of the CDC EHDI Functional Standards that you have met. You must maintain all “SHALL” requirements under all functional standards, including Goals 1 through 8.

Please include a functional standards verification letter stating that your state meets these requirements.

Document steps you have taken toward data linkages and integration, to enable data sharing between your state EHDI-IS and other public health information systems.

Strategy 2:

Collaboration

Document strategies to engage partners in the data-reporting process and ensure they are informed about reporting protocols.

Document your strategy to update the directory of audiologists that see infants in the state.

Document that you have a revised and updated MOU/MOA or data-sharing agreement between early intervention and EHDI programs.

Strategy 3:

Data analysis and quality improvement process

Complete your data analysis and quality improvement plan.

Strategy 4:

Data collection, use, and dissemination

Maintain rates of infants who receive hearing screening by one month of age. Achieve a minimum rate of 95%.

You should calculate this rate by dividing the total number of infants who received a hearing screening by one month of age by the total number of births in your state during the same year.

Make at least one presentation each year to partners or at a national meeting on EHDI surveillance data.

Outcome:

Increased understanding of incomplete tier 1 EHDI data

Complete report based on quality improvement project to enhance completeness of data across EHDI 1-3-6.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 26

Component A Performance measures

Outcome:

Improved timely submission of aggregate and patient-level datasets to CDC

Complete, validate, and submit your patient-level and aggregate data files to CDC based on timelines established at the start of the period of performance.

Report improvement over time of the completeness of tier 1 data elements.

Depending on which timepoint your quality improvement process focuses on, reduce the percentage of unknowns for infants at the one-, three-, or six-month benchmark.

Outcome:

Increased identification of disparities across the

EHDI 1-3-6

Disseminate findings about the identification of disparities across the

EHDI-1-3-6.

Outcome:

More infants that do not pass hearing screening receive a diagnosis by three months of age

Percent of children diagnosed by three months of age.

You should calculate this percentage by dividing the total number of children diagnosed by three months of age by the total that did not pass the hearing screening and the total that were directly referred to a diagnostic evaluation.

Baseline: 2022 HSFS data published on CDC’s website.

Target: Increase by 10 percentage points from baseline or achieve a minimum rate of 85%, whichever is lower by the end of the period of performance.[10]

Outcome:

More D/HH infants enroll in early intervention services by six months of age

Percent of children enrolled in early intervention services by six months of age.

You should calculate this percentage by dividing the total number of children enrolled in early intervention services (including both Part C and non-Part C services) by six months of age by the total number of children diagnosed with permanent hearing loss.

Baseline: 2022 HSFS data published on CDC’s website.

Target: Increase by 10 percentage points from baseline, or achieve a minimum rate of 85%, whichever is lower by the end of the period of performance.[11]

Step 1: Review the Opportunity 27

Table: Component B: Draft performance measures

Component B Performance measures

Strategy 5:

Collaboration

Document that you have a revised and updated MOU/MOA and data-sharing agreement with Part C or other partners that collect language or communication outcomes data.

Strategy 6:

Data collection and dissemination

Complete a report that details challenges and barriers to collecting individual-level language outcome data and proposed actions to overcome barriers.

Outcome:

Increased standardization of early intervention and outcome data

Submit to CDC an integrated master list of standardized data elements for language and communication outcome data.

Outcome:

Increased documentation and reporting of individual-level data on language or communication outcomes of D/HH children who receive early intervention services

Submit individual-level language or communications outcome data included in the state EHDI-IS to CDC.

Evaluation and performance measurement plan You must provide an evaluation and performance measurement plan. Use the measures required under the CDC strategy.

In addition to the required performance measures, you must complete the quality improvement activities described under Strategy 3.

An initial draft of your evaluation and performance measurement plan, including the data management plan (DMP), should be submitted with your application. You must submit a more detailed plan within the first six months of the award. See reporting.

Include the following elements.

Step 1: Review the Opportunity 28

Methods Describe the following:

• How you will:

◦ Collect the performance measures.

◦ Use evaluation findings for continuous program quality improvement.

◦ Incorporate evaluation and performance measurement into planning, implementation, and reporting of project activities.

• How findings will contribute to reducing or eliminating health disparities, if relevant.

•…