Foa_Content_of_CDC-RFA-EH-24-0044.pdf

National Center for Environmental Health

Notice of Funding Opportunity

Application due June 4, 2024

Centers of Excellence to Enhance Disease Detection in Newborns Opportunity number: CDC-RFA-EH24-0044

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 8

Program description 12

Step 2: Get Ready to Apply 36

Get registered 37

Step 3: Prepare Your Application 39

Application contents and format 40

Step 4: Learn About Review and Award 48

Application review 49

Award notices 53

Step 5: Submit Your Application 54

Application submission and deadlines 55

Step 6: Learn What Happens After Award 58

Post-award requirements and administration 59

Contacts and Support 64

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 registration is 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 June 4, 2024 Applications are due by 11:59 p.m. Eastern Time on June 4, 2024.

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 8

Program description 12

Basic information Centers for Disease Control and Prevention (CDC)

National Center for Environmental Health

Establish a Center of Excellence that will enhance and scale newborn screening conducted by laboratories to improve and save lives.

Have questions?

See Contacts and Support.

Key facts

Opportunity Name:

Centers of Excellence to Enhance Disease Detection in Newborns

Opportunity Number:

CDC-RFA-EH24-0044

Federal Assistance Listing:

93.065

Key dates

Application deadline:

June 4, 2024 at 11:59 p.m. ET

Optional letter of intent deadline:

April 26, 2024

Informational call:

April 12, 2024

Expected award date:

July 2024

Expected start date:

September 30, 2024

Summary This funding opportunity will establish a newborn screening (NBS) Center of Excellence that will work collaboratively with CDC’s Newborn Screening and Molecular Biology Branch (NSMBB), partner jurisdictions, and other relevant partners, to:

• Develop infrastructure to implement advanced technologies to expand NBS system capacity.

• Use advanced technologies as first and/or higher tier testing platforms to optimize screening performance.

• Incorporate bioinformatics to analyze complex biochemical and molecular NBS data.

To be successful, you will need a strong history of implementing accurate and precise NBS laboratory methods and the capacity to scale up additional testing services and translate innovations to public health.

The focus is on all liveborn newborns in your jurisdiction and will also include newborns in one or more collaborative partner jurisdictions.

As the funded Center, you will be expected to focus on both biochemical and molecular laboratory testing activities and collaborate with other jurisdictional public health laboratories and relevant partners to:

• Perform a landscape and gap analysis.

• Pilot and implement methods to enhance NBS practices.

• Evaluate the impact of advanced laboratory technologies (molecular and biochemical NBS platforms).

• Share findings with the NBS community.

Step 1: Review the Opportunity 5

• Partner with CDC subject matter experts for the duration of the period of performance on all activities, including method development, data harmonization, and modernization efforts.

Definitions

Partner jurisdictions: Jurisdictions outside your own with defined needs (such as laboratory methods, analysis, interpretation, capacity, and other testing challenges) that you will work with to advance newborn screening (NBS) practices.

Advanced technologies: Technological innovations in molecular and biochemical NBS platforms leading to marked improvements in at least one of the following areas: analytical sensitivity, analytical accuracy, throughput, clinical sensitivity or specificity, and multiplexing of NBS disorders into one assay.

Examples include but are not limited to the following:

• Genomic sequencing as a higher tier test.

• High Resolution Mass Spectrometry (HRMS).

• (Differential) Ion Mobility.

• Ultrafast chromatographic or electrophoretic separations.

• Direct sampling devices that can be interfaced with mass spectrometry, such as acoustic ejection or high speed autosamplers.

• Automation of emerging approaches with applicability to newborn screening, such as peptide immunoaffinity enrichment coupled with selected reaction monitoring mass spectrometry (Immune-SRM).

Key activities

• Use innovative technologies.

• Gather and use data (data advancement).

• Translate innovations to public health.

• Demonstrate the impact of advanced technologies on NBS practices.

Step 1: Review the Opportunity 6

Funding details Type: Cooperative agreement

Expected total program funding over the performance period: $4,000,000

Expected total program funding per budget period: $1,000,000

Expected awards: 1

Maximum funding per applicant per budget period: $1,000,000

Expected average award amount per budget period: $1,000,000

We plan to award funding for four 12-month budget periods, for a 4-year period of performance.

We will award funding for the Center of Excellence for the first 12 months and expect to award 3 more separate 12-month budget periods after that.

Those separate budget period awards depend on whether:

• Funds are available.

• The recipient achieves satisfactory progress.

• Making the award is in the best interest of the federal government and the people they serve.

Opportunity snapshot

Eligible applicants: Unrestricted

Expected funding: $4 million total over 4 years

Expected awards: 1

Match or cost share: None

Funding range: Up to $1 million per budget period

Period of performance: 48 months

Budget period: 12 months

Expected start date: September 30, 2024

Step 1: Review the Opportunity 7

Eligibility Who can apply

Eligible applicants Unrestricted (open to any of the following types of entities):

• 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 and Indian housing authorities

• Native American tribal organizations, other than federally recognized tribal governments

• Territorial governments in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau

• Nonprofits having a 501(c)(3) status, other than institutions of higher education

• State-controlled institutions of higher education

• Nonprofits without 501(c)(3) status, other than institutions of higher education

• Private institutions of higher education

Step 1: Review the Opportunity 8

Eligibility conditions The maximum award for the first budget period is $1,000,000.

This NOFO intends to fund a recipient who has:

• The necessary technical expertise, infrastructure, academic and public health partnerships, and management capabilities.

• The potential to make substantial contributions to the activities and outcomes in the logic model.

To demonstrate that you meet these requirements, your application must include the following Attachments:

• Letter(s) of support from relevant partners (such as parent advocacy, advisory board, or academic institutions). Clearly describe successful work within the last 2 years in newborn screening laboratory methods and relevant cross-collaboration. Minimum 1 letter required.

• Documentation of one of the following NBS-related certifications:

◦ Clinical Laboratory Improvement Amendments (CLIA) Certificate of Compliance.

▪ CLIA may not be required for laboratories in New York or Washington States.

▪ If your laboratory is in Washington State, please provide proof of a Medical Test Site License.

▪ If your laboratory is in New York State, please provide proof of a valid permit under the New York State Public Health Law.

◦ CLIA Certificate of Accreditation, such as College of American Pathologists (CAP) Laboratory Accreditation Program Certification.

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

Step 1: Review the Opportunity 9 https://www.cdc.gov/clia/about.html https://www.cdc.gov/clia/about.html https://www.cap.org/laboratory-improvement/accreditation/laboratory-accreditation-program

Newborn screening-related certifications

Clinical Laboratory Improvement Amendments (CLIA) Certificate of Compliance: CLIA was passed by Congress in 1988. It establishes authority to set standards for certain laboratory testing to ensure the accuracy, reliability, and timeliness of test results, regardless of where or by whom the test was performed.

CLIA generally requires all facilities to meet certain federal requirements if they perform even one applicable test, including waived tests, on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.”

CLIA compliance may not be required for laboratories in New York or Washington states.

College of American Pathologists (CAP) Laboratory Accreditation Program Certification: The Centers for Medicare and Medicaid Services (CMS) granted the CAP Laboratory Accreditation Program “deeming” authority, which allows CAP inspection in lieu of a CMS inspection.

CAP accredits laboratories that perform testing on specimens from humans or animals, using methodologies and clinical applications within the expertise of the program. Laboratories must be appropriately licensed to perform testing when required by law.

You are also required to include a:

• Table of contents

• Project abstract summary

• Project narrative that includes each section specified in the NOFO

• Budget narrative

See initial review for other factors that will make your application non-responsive.

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

Step 1: Review the Opportunity 10 https://www.cdc.gov/clia/about.html https://www.cdc.gov/clia/about.html

Cost sharing and matching funds This funding opportunity has no cost-sharing requirement or matching funds requirement.

If you choose to include cost-sharing funds as a contribution to the award, we won’t 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.

Step 1: Review the Opportunity 11

Program description Background Overview Newborn Screening (NBS) public health programs enable the early identification of infants who are born with rare and life-threatening diseases.

This early identification saves lives and improves health and outcomes, mitigating the life-altering health impacts of these serious diseases. Most jurisdictional NBS programs screen for a majority of the diseases on the Recommended Uniform Screening Panel (RUSP), as recommended by the Secretary of the U.S. Department of Health and Human Services.

NBS is a multifaceted program consisting of components spanning public health, clinical care, intervention, and education. To be successful, jurisdictional NBS programs must effectively coordinate across all components to provide timely and accurate screening that leads to early diagnosis, treatment, and intervention.

Ways to advance newborn screening NBS programs have made many improvements to increase screening capacity and timeliness over the past decade; however, challenges still exist.

Advancing NBS involves building the capacity and capability of newborn screening laboratories, which includes expanding testing for new conditions, improving performance of existing tests for current conditions, and increasing analytic capacity.

Advanced technologies, such as biochemical and molecular technologies, improve disease detection for newborns. To fully realize the benefits of these technologies, newborn screening programs must:

• Provide accurate interpretation of complex biomarker profiles.

• Develop analytic and interpretive tools for genetic testing.

• Manage complex data systems.

However, incorporating these advanced and complex technologies into NBS often requires substantial resources. Moreover, harmonization of results is needed across laboratories and testing platforms to aid in biomarker interpretation. Currently, NBS data are not harmonized across sectors and jurisdictions, making it hard to show a clear picture of the status of NBS for individual jurisdictions and for the country.

Step 1: Review the Opportunity 12

You will propose activities for both biochemical and molecular NBS platforms based on the following strategies:

• Use innovative technologies.

• Gather and use data (data advancement).

• Translate innovations to public health.

• Demonstrate the impact of advanced technologies on NBS practices.

You can decide whether to focus on biochemical or molecular technologies in your proposed work plan either concurrently or prioritize one or the other at the start of the project period (for example, focusing on molecular activities in project Years 1 and 2, and biochemical activities in Years 3 and 4).

Related work This activity builds on previous successful CDC-funded projects to implement and enhance newborn screening in jurisdictional newborn screening laboratories.

Previous NOFOs aimed to enhance disease detection in newborns by building public health laboratory capacity through 2-year awards to jurisdictional newborn screening laboratories.

The current CDC non-research EH22-2201 award is a 2-year cooperative agreement to build capacity to add new RUSP conditions recommended by the U.S. Health and Human Services (HHS) Advisory Committee on Heritable Disorders in Newborns and Children and to improve performance of existing tests for current newborn conditions.

Additional information can be found at the National Center for Environmental Health (NCEH) Division of Laboratory Sciences (DLS).

Purpose Jurisdictional NBS programs need support to build capacity and capability to test for new conditions and improve performance and analysis of existing tests.

Although disease detection has improved with the introduction of molecular and biochemical analysis, it requires NBS programs to obtain or develop complex analytic and interpretive tools. Moreover, laboratories and testing platforms need to harmonize results to aid in interpretation.

To alleviate some of these challenges, this funded Center of Excellence will:

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

Step 1: Review the Opportunity 13 https://www.grants.gov/search-results-detail/335100 https://www.cdc.gov/nceh/dls/nsmbb_funding.html https://www.cdc.gov/nceh/dls/nsmbb_funding.html

• Develop infrastructure to implement advanced technologies and approaches to expand NBS system capacity.

• Use advanced technologies as first and/or higher tier testing platforms to optimize screening performance.

• Incorporate bioinformatics to analyze complex data.

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 four-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.

Not all outcomes apply to all strategies. The following table shows how they apply. You will use these outcomes as a guide for developing additional performance measures beyond those required.

You will propose activities based on the following strategies:

• Use innovative technologies.

• Gather and use data (data advancement).

• Translate innovations to public health.

• Demonstrate the impact of advanced technologies on NBS practices.

Program logic model The logic model 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.

Step 1: Review the Opportunity 14

Table: Strategies and outcomes

Strategies and Activities

Short-term Outcomes

Year 1

Intermediate Outcomes

Years 2 to 3

Long-Term Outcomes

Year 4

Strategy 1. Use innovative technologies

Expand existing screening capacity.

Implement advanced technologies to enhance NBS

1.1 Improved

understanding by the Center about current NBS program capacity among partner jurisdictions.*

1.2 Improved

understanding of the Center about the needs of NBS programs to implement advanced technologies.*

1.3 Increased

awareness and consideration of challenges related to the use of advanced technologies within public health laboratories (PHLs).*

1.4 Increased

collaboration with CDC and relevant partners to develop an approach for the implementation of innovative technologies and transfer of technology.*

1.5 Increased

implementation of advanced technologies, software, instrumentation, and other relevant tools.*

1.6 Improved NBS

practices through implementation and use of advanced technologies.*

LT1. Improved timely detection of at-risk newborns through increased use of advanced technologies by the Center to support

NBS.*

LT2. Improved capacity and coordination in the identification and treatment of newborn diseases.*

LT3. Reduced health disparities through increased use of advanced technologies in NBS.

LT4. Children diagnosed with rare disorders via public health NBS achieve appropriate developmental milestones.

Strategy 2. Data advancement

Advance NBS data harmonization.

2.1 Increased

collaboration with ED3N to improve result and case interpretation.*

2.2 Improved data

harmonization and alignment with ED3N to support NBS.*

Step 1: Review the Opportunity 15

Use bioinformatics and advanced analytics to increase utility of NBS data.

2.3 Increased ability to

detect current and new diseases by prioritizing biochemical and/or molecular markers and use of innovative technologies.*

Strategy 3.Translate innovations to public health

Adoption of advanced technologies.

NBS programs provide enhanced screening.

3.1 Increased

collaboration with identified jurisdictional and relevant partners to address NBS needs.*

3.2 Increased

laboratory capacity by the Center to provide expanded screening for other programs, as needed.*

3.3 Increased

collaboration, technology transfer, document sharing (like standard operating procedures or SOPs, training, best practices), and coordination among relevant partners related to NBS laboratory technology and follow-up practices.*

Strategy 4. Impact of advanced technologies on NBS practices

Determine the impact on the Center’s use of advanced technologies on follow-up practices.

4.1 Increased

awareness of the NBS community and relevant partners around the progress, lessons learned, and newly developed approaches established by the Center.*

Step 1: Review the Opportunity 16

Strategies and activities This section elaborates on the strategies and activities described in the logic model and provides details on expectations for applicants to implement the

NOFO.

By the end of Year 1, you are expected to:

• Complete assessments internally and across partner jurisdictions to improve understanding about current NBS program capacity.

• Understand needs and gaps to improve use of advanced technology.

• Describe an approach for improving and expanding current NBS capacity (like enhanced sequencing, variant interpretation, and reporting) and use of advanced technologies in collaboration with partner jurisdictions and

ED3N.

To accomplish these short-term outcomes, you will:

• Partner with additional jurisdictional public health NBS programs throughout the 4 years of the cooperative agreement.

• Carry out an assessment among partner jurisdictions to learn more about the current technology capacity of NBS programs. This may include an assessment of internal and external capacities related to screening practices, methods, and current technology.

• Carry out a gap analysis to have an improved understanding of the needs of the Center to implement advanced technologies.

• Share knowledge from the analysis of current capacity and gaps among partner jurisdictions to increase awareness and consideration of the challenges relating to advanced technology use within labs.

• Increase collaboration with CDC and other relevant partners, such as partner jurisdictions, subject matter experts, and academic institutions.

You will use the findings from the assessment of current capacity and gap analysis to develop an approach that describes how you will implement advanced technologies and transfer technology to improve detection of at-risk newborns. This approach should include a governance structure and a process that will be used in subsequent years to expand the capacity of NBS through the use of innovative technologies.

• Increase collaboration with the CDC Newborn Screening and Molecular Biology BranchED3N initiative to improve result and case interpretation among the NBS programs.

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

Step 1: Review the Opportunity 17 https://www.cdc.gov/nceh/dls/ed3n.html https://www.cdc.gov/nceh/dls/ed3n.html https://www.cdc.gov/nceh/dls/ed3n.html

Enhanced Data-Driven Disease Detection (ED3N)

ED3N is designed to serve as a secure, central, and national platform for the NBS community, containing a data warehouse and data sharing resources for NBS data.

It will include three functional modules (biochemical data, molecular data, and clinical data) intended to support NBS program best practices.

For example, the molecular module will address challenges associated with identification and curation of variants to inform interpretations, by offering guided NBS-specific variant interpretation, re-interpretation, and reporting tools.

This will allow NBS programs a collaborative platform to interpret and compare variants across programs.

During the period of performance, you will execute the following strategies and activities:

Strategy 1: Use of innovative technologies This strategy aims to increase knowledge about current capacity, needs, and considerations for implementing and using advanced technologies. You will develop an approach for how you will implement advanced technologies to improve NBS practices and use of innovative technology internally and across partner jurisdictions.

Proposed plans, at a minimum, should include:

• Expanding existing screening capacity.

• Implementing advanced technologies to enhance NBS.

You will be expected to propose activities to implement both molecular and biochemical advanced technologies over the course of the project. These proposed activities can include potential collaborations with different partners.

You are required to undertake the following activities:

• Conduct internal and partner assessment to better understand the current capacity of NBS programs.

• Analyze gaps to identify considerations and challenges related to the use of advanced technologies within public health labs.

Step 1: Review the Opportunity 18

• Share considerations and challenges related to the use of advanced technologies among the Center and relevant partners in the form of manuscripts, video abstracts, white papers, or other relevant outputs.

• Collaborate with CDC on ED3N and related activities, which may include piloting, implementing, and evaluating the relevant modules. Work will include developing an approach and timeline, reviewing and executing relevant agreements, and developing an evaluation plan.

• Partner with jurisdictional NBS programs to address identified or defined needs, like laboratory methods, analysis, interpretation, capacity, and other testing challenges. Enter formal agreements such as a Memorandum of Understanding (MOU), Memorandum of Agreement (MOA), charter, or similar, within one year of award.

• Procure, implement (through installation, set-up, or other forms of procurement) and use advanced technologies, software, instrumentation, or other relevant tools.

• Conduct pilots to demonstrate or test advancement in one or more of the following areas: improved test performance, increased test throughput, improved clinical sensitivity or specificity, improved accuracy of newborn reference ranges, improved variant identification and interpretation, or improved multiplexing of biomarker or disease assay.

Strategy 2. Data advancement This strategy aims to advance data harmonization and increase the ability to detect current and new diseases by prioritizing biochemical or molecular markers and use of new technologies.

Proposed plans, at a minimum, should include activities to:

• Advance NBS data harmonization.

• Use bioinformatics and advanced analytics to increase the utility of NBS data.

You are required to undertake the following activities:

• Establish or execute a data use agreement or other relevant formal agreement with CDC to engage with ED3N and draft governance documentation on your approach.

• Draft an approach on how you will align with ED3N, partner jurisdictions, and other relevant partners such as contractors, academic institutions, and organizational partners to implement innovative technologies and transfer technology to improve NBS capacity and detection.

Step 1: Review the Opportunity 19

• Create a prioritized listing of biochemical or molecular markers, or both, and new technologies needed for detection of current and new diseases.

Strategy 3. Translate innovations to public health This strategy aims to apply new technologies to public health newborn screening and increase capacity of partner jurisdictions through expanded screening services or bridge screening.

Work under this strategy makes sure that lessons learned and updated protocols, approaches, and implementation practices are shared with the appropriate audience — including jurisdictional public health programs and labs, the public, and other relevant stakeholders.

Proposed plans, at a minimum, should include details to help public health laboratories adopt advanced technologies and provide enhanced screening to NBS programs.

You are required to undertake the following activities:

• Draft an approach on how to increase capacity to provide bridge screening for current and newly added conditions to partner jurisdictions.

• Adopt advanced technologies at the Center and among partner jurisdictions to provide enhanced screening.

• Revise protocols to document changes in workflow, such as updated standard operating procedures and troubleshooting guidance.

Definitions

Expanded screening: Screening provided by the Center of Excellence to one or more partner jurisdictions to enhance, improve, or advance laboratory methods, analysis, interpretation, or other relevant laboratory challenges.

Bridge screening: Screening services provided during a period of public health emergency.

Step 1: Review the Opportunity 20

Strategy 4. Demonstrate the impact of advanced technologies on NBS This strategy aims to assess the impact of the use of advanced technologies on follow-up practices in newborn screening programs.

Proposed plans, at a minimum, should include determining the impact of your use of advanced technologies on follow-up practices.

You are required to undertake the following activities:

• Assess the impact of the Center’s use of newly implemented advanced technologies on follow-up practices, including programmatic impact on diversity, equity, inclusion, and accessibility that have been made or could be made by these technological advancements.

• Share findings around the progress, lessons learned, best practices, and newly developed approaches established by the Center among relevant partners and the NBS community.

Outcomes This section includes outcomes you are expected to report progress on and achieve within the performance period. You are welcome to propose measures in addition to those provided if the proposed process and outcome measures align to the logic model and proposed work plan.

During the performance period, you will execute the proposed strategies and activities to improve capacities of the Center and partner jurisdictions’ public health newborn screening laboratories.

You should work toward the short-term, intermediate, and long-term outcomes that are asterisked in the logic model. You are responsible for achieving only the asterisked outcomes.

The short-term period (Year 1) of performance includes:

• Improved Center’s understanding of current NBS program capacity among partner jurisdictions.

• Improved Center’s understanding about the needs of NBS programs to implement advanced technologies.

• Increased awareness and consideration of challenges related to the use of advanced technologies within PHLs.

• Increased collaboration with CDC and relevant partners to develop an approach for the implementation of innovative technologies and transfer of technology.

Step 1: Review the Opportunity 21

• Increased collaboration with ED3N to improve result and case interpretation.

• Increased collaboration with identified jurisdictions and relevant partners to address NBS needs.

The intermediate period (Years 2 to 3) of performance includes:

• Increased implementation of advanced technologies, software, instrumentation, and other relevant tools.

• Improved NBS practices through implementation and use of advanced technologies.

• Increased laboratory capacity by the Center to provide expanded screening for other programs, as needed.

• Improved data harmonization and alignment with ED3N to support NBS.

• Increased ability to detect current and new diseases by prioritizing biochemical or molecular markers, or both, and use of innovative technologies.

• Increased collaboration, technology transfer, document sharing (SOPs, training, best practices), and coordination among relevant partners related to NBS laboratory technology and follow-up practices.

• Increased awareness of the NBS community and partners around the progress, lessons learned, and newly developed approaches established by the Center.

The long-term period (Year 4) of performance includes:

• Improved timely detection of at-risk newborns through increased use of advanced technologies by the Center to support NBS.

• Improved capacity and coordination in identifying and treating newborn diseases.

Focus populations This NOFO benefits all liveborn newborns in your jurisdiction and partner jurisdictions. You should clearly identify the state, territory, or tribal lands you will serve.

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.

Step 1: Review the Opportunity 22

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.

Public health newborn screening is a universal program that applies to every newborn in all jurisdictions, territories, and tribal lands. This NOFO aims to improve detection of at-risk newborns through increased use of advanced technologies to support NBS and improve capacity and coordination in the timely identification and treatment of newborn diseases.

The program encourages projects that address disparities as evidenced by relevant data associated with race, ethnicity, gender identity, sexual orientation, geography, socioeconomic status, disability status, primary language, health literacy, and other relevant dimensions.

Organizational capacity You must describe your organizational capacity and how you have the unique and specialized technical expertise needed to implement the award. Describe how you are well suited to implement the activities proposed in your work plan and significantly contribute toward the asterisked (*) outcomes defined in the logic model within the NOFO period of performance. You can involve relevant partners, including with public health and academic organizations.

You should describe technical capabilities related to your:

• Computing environment and how it will meet the needs of the project.

• Track record of innovating in molecular and biochemical methods and analysis, which may include one or more of the following 3 broad areas within NBS:

◦ Developing and validating wet laboratory methods, proficiency testing, technologies, and applications.

◦ Bioinformatics technologies and applications, as well as related technologies.

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

Step 1: Review the Opportunity 23 https://www.cdc.gov/about/sdoh/index.html

◦ Data management experience, such as:

▪ Data standardization

▪ Data security

▪ Data stewardship

▪ Data integration and reporting

▪ Data linkage

▪ Data science

▪ Data analytics

▪ Data visualization including genomic, epidemiologic, clinical, biological, environmental, and other types of data together.

You should also:

• Routinely screen for 80 percent of primary conditions included on the Recommended Uniform Screening Panel (RUSP) as of calendar year 2022.

• Indicate support for proposed newborn screening activities as evidenced by legislation or other support from the jurisdiction (like from a jurisdictional advisory board or Board of Health). This can be described in text and not submitted separately.

• Demonstrate relevant experience and capacity (management, administrative, and technical) to implement the activities and achieve the project outcomes for both the Center and partner jurisdictions.

• Demonstrate engagement with partner jurisdiction NBS programs with a partnership plan. You must demonstrate the ability to scale up to support additional testing services.

◦ Indicate collaborative relationships to support their proposed NBS activities.

• Demonstrate your ability to manage any procurement efforts included in the proposal, including the ability to write and award contracts in accordance with applicable grants regulations.

• Provide experience, background, and the curricula vitae (CV) for project director and key staff in your budget narrative to indicate ability to carry out all activities of the newborn screening program.

• Demonstrate experience collaborating and translating innovations to public health practice, like new or improved processes or methods that led to a change, such as improvement in access, quality, equity, or timeliness at a jurisdictional and national level.

• Demonstrate staffing capacity for:

◦ An evaluator.

Step 1: Review the Opportunity 24

◦ A project coordinator, project manager, or partnership coordinator.

◦ Other key staff in your budget narrative (for individuals not yet identified, include a brief description of the role and expected qualifications).

Assistance provided to partner jurisdictions is not intended to permanently take over or replace routine NBS activities being conducted within jurisdictions. The intent of the assistance provided is to support screening for new conditions and the use of advanced technologies or bridge screening during significant public health events, like a public health emergency.

Collaborations If you receive an award, you are required to collaborate with newborn screening programs in other jurisdictions.

You will provide letters of support in your application from partner jurisdictions and other relevant partners (like professional organizations or academic institutions) to serve as evidence of collaboration and explain how each collaboration will help you implement activities and meet the period of performance outcomes.

Within your first award year, you are also expected to establish formal agreements with partner jurisdictions though a Memorandum of Understanding (MOU), Memorandum of Agreement (MOA), Data Use Agreement (DUA), or Data Sharing Agreement (DSA).

Data, monitoring, and evaluation CDC strategy We will determine whether you have successfully met desired outcomes during the period of performance. Process measures and outcome measures will be evaluated to guide continuous program improvement and determine the success of this NOFO.

We may provide additional guidance on the development of evaluation and performance measurement plans during the award period, as needed.

We will use evaluation findings to:

• Track implementation of your strategies and activities (process evaluation).

• Determine your progress on achieving the period of performance outcomes (outcome evaluation).

Step 1: Review the Opportunity 25

Measures presented do not need to be final. We will work with you to finalize measures 6 months after the award. Your proposed evaluation plan should offer enough detail to demonstrate and affirm your ability to collect the necessary data. It is not necessary to provide measures for every strategy, activity, or outcome, but your proposed measures should clearly link back to them.

At a minimum, your proposed evaluation plan must include:

• Process measures for the strategies and activities in the logic model.

• Outcome measures for the period of performance outcomes in the logic model.

• Any continuous program improvement activities related to eliminating or reducing health disparities and inequities (regular review of data, discussions on how activities are impacting populations of focus).

• Any evaluation activities that CDC will conduct with you or that you will be expected to conduct (such as special evaluation studies). In these cases, describe key evaluation questions to be answered and potential data sources.

• A Data Management Plan (DMP) is required to collect or generate public health data. (“Public health data” means digitally recorded, factual material commonly accepted in the scientific community as a basis for public health findings, conclusions, and implementation. Public health data includes those from research and non-research activities.) See data management plan.

• How the proposed activities will be sustained after the period of performance.

Required performance measures The following are the required performance measures you will need to report on after the award. You are welcome to propose measures in addition to the following examples provided if the proposed process and outcome measures align to the work plan and logic model.

Required measures for Strategy 1: Use innovative technologies

• A landscape analysis of current platforms, technology, Laboratory Information Management Systems (LIMS), or other. This analysis should summarize how to expand the current capacity of your identified partner jurisdictions and the expected impact on screening outcomes. How

Step 1: Review the Opportunity 26 would access to advanced technologies and expanded capacity improve screening outcomes for families in partner jurisdictions?

• An evaluation plan submitted to CDC within 6 months of award start date.

• A gap analysis submitted to CDC that includes identified needs, considerations, benefits, and strategies and approach for implementation of advanced technologies within the Center.

• Share findings of landscape analysis and gap analysis among NBS community and relevant partners through presentations, video abstracts, and a written report to CDC.

• An approach for the implementation of innovative technologies as it relates to data advancement activities within the Center and among the partner jurisdictions. For example, a project management plan that includes staffing and governance.

• Procure and install identified and approved advanced technologies, software, instrumentation, or other relevant tools related to newborn bloodspot screening. Any equipment purchased must be under the ownership of the jurisdiction or public entity.

• Develop a detailed pilot plan collaboratively with CDC to include methods, timeline, and how success will be evaluated.

• Conduct pilot focusing on the implementation and use of advanced technologies to enhance NBS practices.

Required measures for Strategy 2: Data advancement

• Execute a project charter, MOU, or MOA, or written formal agreement detailing collaboration with ED3N.

• An approach detailing how the Center will align with ED3N to improve data harmonization to support NBS. For example, a project management plan, timeline, and governance structure.

• Prioritized listing of biochemical or molecular markers or both, and new technologies needed for detection of current and new diseases.

Required measures for Strategy 3: Translate innovations to public health

• Establish capacity, such as a draft approach to provide bridge and expanded screening to NBS partner programs for conditions (whether current, newly added, or both) on the Recommended Uniform Screening Panel.

Step 1: Review the Opportunity 27

• Establish formal partnerships with partner jurisdictions in the form of a charter, MOU, MOA, service agreement, or other formal agreement.

• Update protocols to reflect changes in laboratory and follow-up workflows, such as updated standard operating procedures or how to troubleshoot.

• Share a communication and dissemination plan that details how accomplishments and lessons learned will be shared with relevant partners.

• Document the number of screens conducted by the Center using advanced technologies (for example, baseline and annual targets for the Center and partner jurisdictions).

• Submit a plan for a coordinating group to CDC within 4 months. Your plan at minimum should include your proposed members or organizations, frequency of meetings, and mission and vision statement.

This group is expected to:

◦ Consider emergent public health priorities and advancements as it relates to newborn screening.

◦ Coordinate implementation of the Center of Excellence activities among the partner jurisdictions and within the scope of the cooperative agreement.

◦ Foster coordination and information sharing across the NBS community and relevant partners.

◦ Include CDC representatives, the parent perspective, project director, representatives from partner jurisdictions, clinician providers, and representatives from relevant Association of Public Health Laboratories (APHL) work groups.

• Establish this coordinating group during year 1 to manage, provide feedback, and mitigate decisions and agreements.

Required measures for Strategy 4: Impact on follow-up and practices

• A completed evaluation report (year 4).

• A final report submitted to CDC that documents methods, processes, partners, inputs, outcomes, lessons learned, best practices, and planned next steps toward sustainability.

• Disseminate findings to NBS community and relevant partners, that includes at minimum:

◦ At least 1 publication (by Year 4).

Step 1: Review the Opportunity 28

◦ At least 3 presentations to the NBS community throughout the entire period of performance.

◦ Educational videos from a parent’s perspective, indicating the benefits of expanded screening (optional).

Required measures for overall cooperative agreement (long-term, by end of Year 4) Targets and baselines to be established post award:

• Reduced percentage/number of false positive and false negative screens documented by NBS programs.

• Improved timeliness indicators for testing and follow-up among NBS programs.

• Improved timeliness indicators as it relates to the use of updated practices and standardized procedures by partner jurisdictions.

• Improved timeliness indicators as it relates to the use of advanced technologies by the Center.

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

CDC will provide technical assistance on the selection of performance measures, implementing the measures, and identifying feasible data sources for the performance measures. With CDC, you will have 6 months to finalize performance measures. You are responsible for gathering and analyzing data for performance measures.

You are welcome to propose measures in addition to those examples provided if the proposed process and outcome measures align to the work plan and logic model.

At a minimum, the plan must include the following elements.

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation questions.

• Use evaluation findings for continuous program quality improvement.

• Contribute to reducing or eliminating health disparities using findings, if relevant.

Step 1: Review the Opportunity 29

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

• Participate in the evaluation and performance measurement process with key program partners, such as partner jurisdictions.

• Share evaluation findings with communities and populations of interest in a way that meets their needs.

Data management plan The data management plan (DMP) should be developed during the project planning phase, prior to collecting or generating public health data. It will be submitted with the application. The submitted DMP will be evaluated for completeness and quality at the time of submission.

You must propose a DMP in your application, for finalization within 6 months after the award date. In the DMP, describe how you intend to manage and preserve all data collected, generated, or both. To the extent allowed under the grant award and applicable regulations, CDC may get an aggregate-level summary of data produced under the award for federal purposes.

For all public health data you plan to collect, describe:

• The data you plan to collect and their available data sources.

• The feasibility of collecting appropriate evaluation and performance data.

• A data management plan (DMP) that includes:

◦ The data you will collect or generate.

◦ Reasons why you cannot share data (summary or aggregate) collected or generated under this award with CDC (if there are any).

These could include legal, regulatory, policy, or technical concerns.

◦ Who can access data and how you will protect it.

◦ Data standards that ensure released data have documentation that describes collection methods, what the data represents, and data limitations.

◦ Archival and long-term data preservation plans.

◦ How you will update the Data Management Plan (DMP) as new information is available over the project’s life. You will provide updates to the DMP in annual reports. For more information about CDC’s policy on the DMP, see Data Management and Access Requirement at CDC’s website.

• Other relevant data information, such as performance measures you propose.

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

Step 1: Review the Opportunity 30 https://www.cdc.gov/grants/additional-requirements/ar-25.html

• For data associated with expanded screening for partner jurisdictions, please describe how you will:

◦ Maintain chain-of-custody.

◦ Receive specimens (will specimen cards be shipped to partner jurisdictions along with instructions; how specimens will be shipped to Center of Excellence).

◦ Share expanded screening or increased capacity results with partner jurisdictions.

◦ Collect data or information from partner jurisdictions along with the specimen.

• For a definition of “public health data” and other key information, see AR 25: Data Management and Access on our website.

Evaluation activities You must take on specific evaluation activities. Describe:

• The type of evaluations, such as process, outcome, or both.

• Key evaluation questions addressed by these evaluations.

• Other information such as measures and data sources.

An initial draft of your Evaluation and Performance Measurement Plan, including the DMP, should be submitted with your application. You must submit a more detailed plan within the first 6 months of the award. See Reporting.

Work plan You must provide a work plan for your project. The work plan connects your period of performance outcomes, strategies and activities, and measures. It provides more detail on how you will measure outcomes and processes.

For each strategy, the work plan will include activities, appropriate and relevant process measures (from Evaluation and Performance Measurement), responsible team members, and the planned completion date.

CDC will provide feedback and technical assistance to finalize the work plan activities post-award.

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

Step 1: Review the Opportunity 31

Table: Sample format

Activities to be Implemented

Progress or Process Measure(s) From Data, Monitoring, and Evaluation section

Relevant Period of Performance Outcome(s) From Outcomes section

Responsible Position or Party

Completion Date

Strategy 1:

1.

2.

3.

Strategy 2:

1.

2.

3.

Paperwork Reduction Act Any activities involving information collections from 10 or more individuals or organizations may require you to follow the Paperwork Reduction Act (PRA).

This requires review and approval by the White House Office of Management and Budget.

For further information about CDC’s requirements under PRA see CDC Paperwork Reduction Act Compliance.