cdc-rfa-dd-26-0222_forPublication.pdf

Notice of Funding Opportunity

Application due Monday, October 26, 2026

Division of Birth Defects and Infant Disorders National Center on Birth Defects and Development Disabilities

Long-term health outcomes of people living with spina bifida Opportunity number: CDC-RFA-DD-26-0222

Contents

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Agency priorities 10

Program description 13

Step 2: Get Ready to Apply 33

Get registered 34

Find the application package 35

Help applying 35

Join the informational call 35

Step 3: Build Your Application 37

Application checklist 38

Application contents and format 40

Step 4: Understand Review, Selection, and Award 50

Application review 51

Award notices 53

Step 5: Submit Your Application 54

Submission requirements and deadlines 55

Step 6: Learn What Happens After Award 56

Post-award requirements and administration 57

Contacts and Support 60

Before you begin 3

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 Monday, October 26, 2026.

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/

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 7

Agency priorities 10

Program description 13

Basic information Centers for Disease Control and Prevention (CDC)

Division of Birth Defects and Infant Disorders

National Center on Birth Defects and Development Disabilities

Ensuring long-term follow-up to improve health outcomes for people living with spina bifida.

Have questions?

Go to Contacts and Support.

Key facts

Opportunity name:

Long-term health outcomes of people living with spina bifida

Opportunity number:

CDC-RFA-DD-26-0222

Assistance listing:

93.073

NOFO version: Original

Key dates

Application submission deadline:

Monday, October 26, Informational call:

September 17, 2026

Optional letter of intent deadline:

September 26, 2026

Expected award date:

August 1, 2027

Expected start date:

September 1, 2027

See Submit Your Application for other time frames that may apply to this NOFO.

Summary This NOFO has two funding components:

• Component A: National Spina Bifida Patient Registry (NSBPR).

• Component B: Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina Bifida (UMPIRE).

The purpose of this NOFO is to:

• Component A: Collect high-quality longitudinal data on children and adults with spina bifida (SB) who get care in specialized SB clinics that are part of the National Spina Bifida Patient Registry (NSBPR).

• Component B: Carry out and evaluate the Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina Bifida (UMPIRE) iterative protocol in infants and young children with myelomeningocele.Building on existing longitudinal data collection, recipients will collect and analyze data on patients with SB to:

◦ Better understand health outcomes after interventions and treatments.

◦ Share findings to identify opportunities to improve care of patients with SB.

You may apply to either Component A or Component B, or both.

Step 1: Review the Opportunity 5

Funding details Funding type: Cooperative agreement

Expected awards:

• Component A: 8-11

• Component B: 6-9

Period of performance: Three years in 12-month budget periods.

Expected total program funding over the performance period:

• Component A: $2,400,000 – $6,600,000

• Component B: $900,000 – $2,700,000

Estimated average award per applicant over the period of performance:

• Component A: $300,000 – $600,000

• Component B: $150,000 – $300,000

Expected funding per applicant per 12-month budget period:

• Component A: $100,000 - $200,000

• Component B: $50,000- $100,000

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

Funding strategy Average one-year award, per recipient:

• Component A: $100,000-$200,000.

• Component B: $50,000-$100,000.

Step 1: Review the Opportunity 6

Eligibility Eligible applicants Only these types of organizations may apply.

• 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.

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

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

• Private institutions of higher education.

• For-profit organizations other than small businesses.

• Small businesses.

• Bona fide agents applying on behalf of state, territorial, local, and tribal government organizations.

Bona fide agents must submit documentation that demonstrates their arrangement with the eligible applicant. See attachments.

Responsiveness criteria We will review your application to make sure it meets these requirements.

These are the basic requirements you must meet to move forward in the competition. We won’t consider an application that:

• Is from an organization that doesn’t meet all eligibility criteria. See requirements in eligibility.

• Is submitted after the deadline.

Step 1: Review the Opportunity 7

You must provide a document labeled “Responsiveness criteria” for each component you apply to.

For Component A, the document should include:

• The number of patients currently enrolled in NSBPR, with at least one visit in the registry between January 2020 and August 2024, and one of the following diagnoses:

◦ Myelomeningocele.

◦ Meningocele.

◦ Lipomyelomeningocele.

◦ Fatty/thickened filum.

◦ Split cord malformation.

◦ Terminal myelocystocele.

• The proportion of individuals seen between January 2020 and August 2024 who have more than five visits.

• At least one letter of commitment from a representative of the participating clinic or hospital system where patients receive care that documents:

◦ Access to patients with spina bifida.

◦ The collection of the data elements in the NSBPR (see Findings from the National Spina Bifida Patient Registry | Spina Bifida | CDC to view some of the data elements collected).

For Component B, the document should include:

• The number of patients previously enrolled in UMPIRE with a diagnosis of myelomeningocele, who have at least one visit between January 2020 and August 2024.

• The curriculum vitae of a pediatric urologist who is part of the study team.

• At least one letter of commitment from a representative of the participating clinic or hospital system where patients receive care that documents:

◦ Access to patients with spina bifida.

◦ The collection of the data elements in the UMPIRE (see Findings from the National Spina Bifida Patient Registry | Spina Bifida | CDC to view some of the data elements collected).

See the application checklists to understand which elements of your application are part of the responsiveness criteria.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 8 https://www.cdc.gov/spina-bifida/data/findings-from-the-nsbpr-registry.html https://www.cdc.gov/spina-bifida/data/findings-from-the-nsbpr-registry.html https://www.cdc.gov/spina-bifida/data/findings-from-the-nsbpr-registry.html

Application limits You must follow these limits on the number of applications your organization can submit.

You may apply to either Component A or Component B, or both. Each organization (normally identified by having a unique UEI number) may submit one application for each component. So, at the most, you may submit two applications.

Cost sharing and matching funds This program has no cost-sharing requirement, meaning you do not need to contribute to the costs of this project.

If you choose to include cost-sharing funds, we won’t consider it during review. If you receive an award, we will include your voluntary commitment in the award, and you must report on the funds.

Post-award requirements

Before you apply, make sure you understand the requirements that come with an award.

See Step 6: Learn What Happens After Award for information on regulations that apply, reporting, and more.

Step 1: Review the Opportunity 9

Agency priorities Required alignment with CDC priorities The recipient of this award must implement any funds awarded under this NOFO to effectuate program goals or agency priorities in accordance with the Centers for Disease Control and Prevention (CDC) Priorities when authorized (for a full description of the CDC Priorities please follow the provided hyperlink).

Funded activities must:

• Align with CDC’s core priorities by demonstrating a commitment to gold-standard science, transparency, and evidence-based practices.

• Support CDC’s mission to protect Americans from infectious and chronic diseases, strengthen public health systems, and advance innovation in health data and infrastructure.

• Contribute to rapid, science-driven responses to health threats, promote global health leadership, and adhere to principles of integrity, accountability, and compliance with applicable laws and federal priorities.

Consistent with CDC’s values, in carrying out any project funded under this NOFO, the recipient must adhere to the following principles where consistent with the authority and scope of the award and its activities:

• A commitment to gold-standard science and ensuring trust, transparency, and credibility: To build trust and improve CDC’s ability to lead during health crises, CDC will increase transparency, be more accountable, and follow strict, gold-standard scientific practices that are open, unbiased, and based on clear evidence.

• A commitment to global leadership: With staff in 63 countries and supporting 20 more, CDC’s Global Health Center:

◦ Fights HIV, tuberculosis, vaccine-preventable diseases, and emergency and refugee health.

◦ Detects health threats early, sends response teams, trains health workers, and provides personal protective equipment, vaccines, and medicines.

◦ Tests disease samples from around the world to prepare for flu and other serious outbreaks.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

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

◦ Has strengthened systems to better protect people at home and abroad after the COVID-19 outbreak.

• A commitment to ensuring rapid, evidence-based responses to crises:

During public health emergencies, ensuring rapid, science-driven responses is critical to minimizing harm, maintaining public trust, and restoring stability. To meet this goal, CDC must continue to strengthen its emergency response systems by:

◦ Streamlining internal processes.

◦ Improving risk communication strategies.

◦ Ensuring that laboratory capacity is fully equipped and tested—capable of rapidly developing and deploying scalable diagnostics during crises.

◦ Embedding structures for real-time learning, independent after-action reviews, and the application of lessons learned will ensure that each crisis response is smarter, faster, and more effective than the last.

• A commitment to vaccine safety and efficacy research: CDC will apply “gold-standard” science to all of its vaccine safety and effectiveness research. It will make vaccine data, research methods, and related datasets publicly available through simple data use agreements to improve transparency, accountability, and trust.

• A commitment to advancing our understanding of the causes of autism spectrum disorder (ASD), neurodevelopmental disorders (NDDs), and chronic disease: CDC conducts research and works with partners to better understand the causes of autism spectrum disorder, neurodevelopmental disorders, and chronic diseases. It will use new and existing data to study the rise in these conditions, including the increase in autism diagnoses from 1 in 150 to nearly 1 in 31 over the past 25 years.

• A commitment to modernizing public health infrastructure and enhancing our approach to health data: CDC will modernize public health infrastructure to create a faster, more efficient health system that can detect and respond to outbreaks in real time. This effort includes:

◦ Replacing data silos with integrated systems.

◦ Using advanced technology.

◦ Strengthening partnerships with states to ensure shared responsibility and strong local health data systems.

Step 1: Review the Opportunity 11

◦ Emphasizing collaboration across federal and state partners, resilient and adaptable systems, and accountability for funded programs to ensure they align with these priorities and federal requirements.

• Conflicts of interest: CDC will not support funding programs with conflicts of interest and ensure its work is based on transparent, unbiased science.

• Immigration: CDC funds will not be used to support or encourage illegal immigration, consistent with federal law.

• Protecting life and the family: CDC funds will not be used to support elective abortions, consistent with the Hyde Amendment, and will promote maternal health, the dignity of life, and strong families.

• Ending disorder on America’s streets: CDC will prioritize evidence-based programs that reduce homelessness, drug use, and public disorder. It will support comprehensive services for people with serious mental illness and substance use disorder. CDC will not fund housing first strategies, harm-reduction or safe consumption sites, or related activities. To the extent allowable by federal law, CDC intends to give priority to grantees in States and municipalities that have laws and policies that support and enforce CDC’s priorities.

• Gender ideology and protecting children: CDC will not fund medical interventions for minors seeking gender transition and will define sex based on biological criteria.

• DEI: CDC will not fund DEI initiatives based on group identity and focus on merit-based, evidence-driven approaches to improve health outcomes.

• Parental rights: CDC will support policies that protect parental authority, promote transparency, and give parents greater control over their children’s education.

The recipient must demonstrate ongoing compliance with the full description and listing of CDC values and priorities, in all programs that are authorized to advance them, through program design, implementation, reporting, and evaluation.

Failure to meaningfully align funded activities with the applicable requirements may result in corrective action, additional reporting requirements, or other enforcement actions consistent with federal grant regulations found at 2 CFR Part 200 and the terms and conditions of this award. The full CDC Priorities Statement can be found here: Centers for Disease Control and Prevention (CDC) Priorities.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 12 https://opa.hhs.gov/sites/default/files/2025-11/gender-dysphoria-report.pdf

Program description Background Overview An estimated 160,000 people in the United States (U.S.) currently live with spina bifida (SB). It’s the most common permanently disabling birth defect.

The care of individuals with SB is complex, involving different organ systems and different clinical specialists. Many of those affected by SB receive specialty care in one of 96 (estimated) SB multidisciplinary clinics in the U.S.

National Spina Bifida Patient Registry In 2008, the Centers for Disease Control and Prevention (CDC) established the National Spina Bifida Patient Registry (NSBPR) as a cooperative agreement with nine SB clinics across the U.S.

Since then, CDC has continued cooperative agreements with clinics to collect, analyze, and publish findings from longitudinal data. This includes clinical interventions and health outcomes for individuals with some of the more severe types of SB, such as myelomeningocele.

Currently, 14 funded clinics participate in the NSBPR. Six other clinics not currently funded also contribute data to NSBPR. Data with limited identifiers from the NSBPR registry sites are stored at CDC and are managed by CDC staff.

As of September 2024, over 12,000 individuals with SB have been enrolled in the NSBPR. Approximately 17% have two recorded visits. Over 63% have 3-16 recorded visits at NSBPR clinics.

Principal investigators from each of the participating clinics and CDC staff work together to oversee the details of the project in a coordinating committee (CC). The NSBPR Committee on Science and Publications (CSP) reviews analytic proposals and publications that result from NSBPR data.

The UMPIRE protocol In 2014, nine NSBPR clinics were funded to establish and carry out the Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina Bifida (UMPIRE) protocol.

Step 1: Review the Opportunity 13

The UMPIRE protocol was established to evaluate and manage the urinary systems in infants and young children with myelomeningocele to preserve normal kidney function.

Currently, eight clinics participate in UMPIRE. Data with limited identifiers from the UMPIRE registry sites are stored at CDC and managed by CDC staff.

As of October 2024, over 600 infants and young children are enrolled in UMPIRE, with more than 4,000 patient encounters.

Work needed Over the years, the NSBPR and the UMPIRE protocol have made progress in identifying best practices for people living with SB, but more work is still needed.

Most of the NSBPR and UMPIRE publications so far have focused on describing the data. Descriptive investigations are important. But analyses of longitudinal data are necessary to identify the health care and clinic practices associated with the best outcomes for individuals with SB.

Additional years of NSBPR and UMPIRE protocol data will provide insights on long-term outcomes. It’ll help us better understand how current treatment recommendations can benefit these children and their families.

In addition, evaluation and refinement of the UMPIRE surveillance protocol will help identify the best possible course of care for infants and children with myelomeningocele.

Related work CDC has a long history of support for SB work related to long-term health outcomes.

This NOFO will build on the success of the previous NOFOs:

• Spina Bifida Patient Registry Demonstration Project (U01) DP08-001.

• National Spina Bifida Patient Registry - Clinic Demonstration Project

(U01), DD-11-001.

• Research Approaches to Improve the Care and Outcomes of People Living with Spina Bifida, DD14-002.

• Research Approaches to Improve the Care and Outcomes of People Living with Spina Bifida, DD19-001.

The National Spina Bifida Patient Registry (NSBPR) and Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 14 https://simpler.grants.gov/opportunity/0f00f53b-c995-4dee-9050-11f57eebe368 https://simpler.grants.gov/opportunity/0f00f53b-c995-4dee-9050-11f57eebe368 https://simpler.grants.gov/opportunity/0f00f53b-c995-4dee-9050-11f57eebe368 https://simpler.grants.gov/opportunity/abc25801-0bbb-43be-a6db-74eaf88f2439 https://simpler.grants.gov/opportunity/abc25801-0bbb-43be-a6db-74eaf88f2439 https://simpler.grants.gov/opportunity/5fd77296-ddde-4cb4-9060-412d1a597b88 https://simpler.grants.gov/opportunity/5fd77296-ddde-4cb4-9060-412d1a597b88 https://www.cdc.gov/spina-bifida/programs/index.html#cdc_pir_special_topics_about-national-spina-bifida-patient-registry https://www.cdc.gov/spina-bifida/programs/index.html#cdc_pir_special_topics_important-urologic-protocol-for-young-children https://www.cdc.gov/spina-bifida/programs/index.html#cdc_pir_special_topics_important-urologic-protocol-for-young-children

Bifida (UMPIRE) have improved the understanding of SB care received in SB clinics.

As of October 2025, 35 manuscripts have been published using NSBPR or UMPIRE data. The current NOFO will build upon the work by continuing to follow patients with SB longitudinally to evaluate their clinical outcomes.

Purpose The purpose of this NOFO is to:

• Collect longitudinal data from SB specialty clinics to describe key outcomes.

• Identify healthcare and clinic practices that are associated with the best outcomes for individuals living with SB.

The goal is to improve the health and quality of life for individuals of all ages living with SB.

Approach Overview There are two components to this NOFO with separate, but complementary approaches. Each contributes uniquely to the overall purpose of this NOFO:

Component A The approach of Component A is to track the health status of children and adults with SB who receive care in specialized SB clinics. The longitudinal aspect of data collection is critical for the analytic value of the NSBPR.

This NOFO focuses on expanding longitudinal data collection and incorporating data quality measures in standard activities.

Component B The approach of Component B is to carry out and evaluate the UMPIRE protocol. This iterative protocol aims to clinically manage the urinary system in infants and young children with myelomeningocele to preserve kidney function as much as possible as they age.

As with Component A, the longitudinal aspect of data collection is critical.

Many of the important outcomes can only be measured in individuals who have been enrolled in the protocol for more than five years.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 15 https://www.cdc.gov/spina-bifida/programs/index.html#cdc_pir_special_topics_important-urologic-protocol-for-young-children

Program logic model The following logic model includes the strategies and activities required under this NOFO.

The logic model also includes the program’s expected outcomes. Outcomes are the results that you intend to achieve. They usually show the intended direction of change, such as increase or decrease.

The asterisked ( * ) outcomes are those we expect you to achieve during the 3-year period of performance. You are required to report on these outcomes.

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

Table: Strategies and outcomes

Strategies and activities Short-term outcomes

Intermediate outcomes

Long-term outcomes

Component A

Strategy 1: Collect annual longitudinal data from SB specialty clinics

• Collect follow-up visit data on children and adults with SB already enrolled in NSBPR.

• Prevent loss to follow-up in participants already enrolled in

NSBPR.

• Approach all eligible potential enrollees and collect longitudinal data on participants who enroll.

Strategy 2: Data management and reporting

• Securely submit standardized and validated data with limited identifiers to CDC for data pooling.

• Conduct data quality checks, address data quality errors, and

Components A and B

Improved longitudinal data quality from SB specialty clinics and increased information for clinical decision-making.*

Improved science base of SB care among key audiences.*

Increased awareness of findings among key audiences.*

Components A and B

Improved standard of care for children and adults living with

SB.

Component B

Improved management of the urinary and kidney systems in infants and young children living with SB.

Components A and B

Improved health and quality of life for children and adults living with SB.

Step 1: Review the Opportunity 16

Strategies and activities Short-term outcomes

Intermediate outcomes

Long-term outcomes report on findings in collaboration with CDC.

• Participate in initial and ongoing data collection training.

Strategy 3: Data analysis and sharing

• Collaborate with CDC to develop data analysis proposals, analyze data, and share findings with key audiences.

• Attend annual, quarterly, workgroup, and committee meetings in collaboration with

CDC.

Component B

Strategy 1: Collect longitudinal data from SB specialty clinics

• Collect follow-up visit data on participants already enrolled in

UMPIRE.

• Prevent loss to follow-up in participants already enrolled in

UMPIRE.

Strategy 2: Data management and reporting

• Securely submit standardized and validated data with limited identifiers to CDC.

• Conduct data quality checks, address data quality errors, and report on findings in collaboration with CDC.

• Participate in initial and ongoing data collection training.

Strategy 3: Data analysis and sharing

• Collaborate with CDC to develop data analysis proposals, analyze data, and share findings.

Step 1: Review the Opportunity 17

Strategies and activities Short-term outcomes

Intermediate outcomes

Long-term outcomes

• Attend annual, quarterly, workgroup, and committee meetings in collaboration with

CDC.

• Evaluate and refine UMPIRE protocol.

Strategies and activities This section elaborates on the strategies and activities described in the logic model and provides details about how we expect you to implement your program.

Component A For Component A, you will perform the following strategies and activities:

Strategy 1: Collect annual longitudinal data from SB specialty clinics

• Collect follow-up visit data on children and adults with SB already enrolled in NSBPR.

◦ Enhance participant retention by conducting or enhancing activities to follow-up with enrolled NSBPR participants to increase the likelihood that the patients return to the clinic. Collect and report additional data on enrolled participants who are lost to follow-up.

• Approach all eligible individuals for participation. For those who have provided consent, collect data according to the surveillance protocol.

NSBPR eligible SB diagnoses include:

◦ Myelomeningocele.

◦ Meningocele.

◦ Lipomyelomeningocele.

◦ Fatty/thickened filum.

◦ Split cord malformation.

◦ Terminal myelocystocele.

• Each year, collect and report to CDC on minimal non-identifiable data (e.g. sex, race/ethnicity, insurance status) on eligible patients who did not enroll in the NSBPR to identify potential differences with enrolled patients.

Step 1: Review the Opportunity 18

• Clinics should describe their ability to participate in other optional data collection efforts such as:

◦ Skin breakdown bundle materials.

◦ Quality of life.

◦ Sleep disordered breathing.

◦ Cognitive and adaptive testing.

• Conduct a linkage with state death records or the National Death Index to identify deaths among enrolled patients.

Strategy 2: Data management and reporting

• Adhere to and use the CDC-developed data collection instruments and data system.

• Submit standardized, validated data with limited identifiers (e.g., date-shifted birth date, clinic visits, surgeries, and procedures, as well as zip code) monthly to CDC for additional data quality review and data pooling.

◦ Date shifting is a method of date de-identification using a complex randomized algorithm embedded in the data collection tool, so no true date is shared.

• Conduct data quality checks, address data quality issues, and report on findings per CDC guidance.

• Participate in initial and ongoing data collection and data management training per CDC guidance.

Strategy 3: Data analysis and sharing

• Participate in quarterly virtual meetings, one annual in-person or virtual principal investigator meeting, and other committee or workgroup meetings, as appropriate.

• Collaborate with CDC and other recipients to develop data analysis proposals, analyze data, and share findings with key audiences, based on pooled NSBPR data.

◦ Participate in the development of data analysis proposals and analytic plans using pooled NSBPR data.

◦ Perform analysis of pooled NSBPR data and interpret results.

◦ Share findings from data analysis projects, using pooled NSBPR data, in presentations and publications.

◦ Annually, deliver at least one presentation on NSBPR data to key audiences.

◦ Key audiences include:

Step 1: Review the Opportunity 19

▪ Public health and clinical researchers.

▪ Providers.

▪ SB partners.

▪ Individuals with SB.

▪ Families or caregivers of individuals with SB.

Component B For Component B, you will perform the following strategies and activities:

Strategy 1: Collect longitudinal data from SB specialty clinics

• Collect longitudinal data, according to the UMPIRE surveillance protocol for participants currently enrolled.

• Enhance participant retention by conducting or enhancing activities to follow-up with enrolled UMPIRE participants to increase the likelihood that the patients return to the clinic.

◦ Collect and report additional data on enrolled participants who are lost to follow-up.

• Collect information regarding any deviation from the UMPIRE surveillance protocol. Include a description of the type of protocol deviation and the reason for deviating from the protocol.

Strategy 2: Data management and reporting

• Use the CDC data collection forms and data system (see findings from the National Spina Bifida Patient Registry | Spina Bifida | CDC to view some critical data elements collected).

• Submit standardized, validated data with limited identifiers (e.g., date-shifted birth date, clinic visits, surgeries, and procedures, as well as zip code) monthly to CDC for additional data quality review and data pooling.

◦ Date shifting is a method of date de-identification using a complex randomized algorithm embedded in the data collection tool, so no true date is shared.

• Conduct data quality checks, address data quality issues, and report on resolution.

• Participate in initial and ongoing data collection training per CDC guidance.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 20

Strategy 3: Data analysis and sharing

• Participate in quarterly virtual meetings, one annual in-person or virtual Principal Investigator meeting, and other committee or workgroup meetings as appropriate.

• Collaborate with CDC and other recipients to develop data analysis proposals, analyze data, and share finding with key audiences, based on pooled UMPIRE data.

◦ Participate in the development of data analysis proposals and analytic plans using pooled UMPIRE data.

◦ Perform analysis of pooled UMPIRE data and interpret results.

◦ Share findings from data analysis projects using pooled UMPIRE data through presentations and publications.

◦ Annually, deliver at least one presentation on UMPIRE data to key audiences.

◦ Key audiences include:

▪ Public health and clinical researchers.

▪ Providers.

▪ SB partners.

▪ Individuals with SB.

▪ Families or caregivers of individuals with SB.

• Collaborate with CDC and other recipients to:

◦ Develop analytic plans.

◦ Analyze and interpret data to inform evaluation and any potential revision of the UMPIRE surveillance protocol for infants and young children.

Outcomes This section includes information about the outcomes we expect you to report progress on and achieve within the performance period.

For Components A and B, you will work to achieve these outcomes:

• Improved longitudinal data quality from SB specialty clinics and increased information for clinical decision making.

• Improved science base of SB care among key audiences.

• Increased awareness of findings among key audiences.

Step 1: Review the Opportunity 21

Key audiences Key audiences include:

• Public health and clinical researchers.

• Providers.

• SB partners.

• Individuals with SB.

• Families or caregivers of individuals with SB.

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

For both Component A and Component B, you must submit a detailed work plan for the first year of the project and a high-level work plan for subsequent years.

Table: Sample format

Activities you will implement

Progress or process measures

From the data, monitoring, and evaluation section.

Relevant period of performance outcomes

From the outcomes section.

Responsible position or party

Completion date

Strategy 1:

1.

2.

3.

Strategy 2:

1.

2.

3.

Step 1: Review the Opportunity 22

Data, monitoring, and evaluation CDC strategy CDC collects and reports on indicators to measure progress toward achieving the activities and outcomes. CDC will also use results for program planning, improvement, accountability, and reporting. CDC may share the results within the Federal government, consistent with applicable law and grant regulations.

CDC will work with you throughout the life of an award to ensure that all activities and expected outcomes align with your strategies and goals, and those of the U.S. government.

You should dedicate some of award funds to evaluate and monitor the performance of your project. You and CDC will agree on the final funding amount, but we expect that you will dedicate approximately 5 to 10% of your project’s funding to monitoring, reporting, and evaluation activities.

The evaluation and performance measurement strategy will assess 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.

With your application, you must include an evaluation plan that:

• Aligns with strategies and activities from the logic model.

• Includes performance measures.

• Describes assigned personnel.

• Includes a timeline.

• Describes expected outcomes.

• Describes the use of results to improve your program.

You and CDC will use evaluation findings to:

• Ensure that improvements are continually being made.

• Show that progress is being made in reaching short-term outcomes and program goals.

• Improve ongoing and future data collection activities.

Step 1: Review the Opportunity 23

Required performance measures This section describes the draft performance measures you will need to report on 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.

Draft process measures Strategy 1: Collect annual longitudinal data from SB specialty clinics

• Report number of follow-up visits among currently enrolled NSBPR or UMPIRE participants.

• Report number of new participants enrolled in NSBPR.

• Report number of individuals who have not been seen in the last three years.

◦ Decrease by 5% over three-year period.

• Report methods (new and ongoing) to prevent or recall lost patients.

• Percent of non-deceased enrollees with a visit in the past 12 months.

◦ Increase by 5% over the three-year period

Strategy 2: Data management and reporting

• Adherence to CDC-developed data dictionary. This includes incorporating any updates or revisions to data collection instruments within two weeks of receiving updates.

• Submission of standardized and validated datasets with limited identifiers to CDC (monthly).

• Return of data quality report findings and correction of any data quality errors (monthly).

Strategy 3: Data analysis and sharing

• Report site representation at annual, quarterly, workgroup, and committee meetings per CDC guidance (annually).

• Provide list of approved data analysis proposals or manuscripts involving multi-site pooled data that you’ve led or participated in (annually).

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Draft outcome measures Outcome 1: Improved longitudinal data quality from SB specialty clinics and increased availability of data

• Quantitative measures showing improvement in the accuracy, completeness, or timeliness of data submission (annually).

◦ 80% of data extracts submitted on time.

◦ 100% of submissions include data validation check prior to export.

Outcome 2: Improve the science base of SB care among key audiences

• Provide list of manuscripts accepted or published in peer-reviewed journals (annually). Include the journal name.

◦ At least one manuscript accepted or published each funding year.

◦ Consistent with the Public Access to CDC Funded Publication Policy, all peer-reviewed publications funded by CDC must be made available to the public for free and full use with no embargo period (see CDC Public Access to Publications).

Outcome 3: Increased awareness of findings among key audiences

• Provide list of presentations given to key audiences (annually). Include the title, presentation venue, type of audience, and number of attendees.

◦ Provide at least one presentation to a key audience each funding year.

• Optional: Share examples of improvements to clinical standard of care of patients (annually).

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

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation questions.

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

• Use evaluation findings for continuous program quality improvement.

Additionally, explain:

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Step 1: Review the Opportunity 25 https://stacks.cdc.gov/pap

• How key program partners will participate in the evaluation and performance measurement process.

• How feasible it will be to collect appropriate evaluation and performance data.

• How you will share evaluation findings with communities.

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

Data management plan For all public health data you plan to collect, you must have a data management plan (DMP). For a definition of “public health data” and more information about CDC’s policy on the DMP, see Data Management and Access.

Submit your DMP with your application and include:

• The data you will collect or generate, and what its sources will be.

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

• Data standards that explain what documentation the released data will have. That documentation should describe collection methods, what the data represent, and data limitations.

• Archival and long-term data preservation plans.

• Any reasons you cannot share data collected or generated under this award with CDC. These could include legal, regulatory, policy, or technical concerns.

• How you will update the DMP as new information becomes available over the life of the project. You will provide updates to the DMP in annual reports.

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

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

• Key evaluation questions these evaluations will address.

• Measures and data sources.

• Any other relevant information.

Submit a draft of your evaluation and performance measurement plan, including the DMP, with your application. You must submit a more detailed plan within the first six months of the award. See reporting.

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Step 1: Review the Opportunity 26 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html

Paperwork Reduction Act Any activities involving information collection from 10 or more individuals or organizations may require the Paperwork Reduction Act (PRA) approval. The PRA requires review and approval of the information collection by the White House Office of Management and Budget. To determine if a proposed activity requires PRA approval, contact your program contact.

Collections include items like surveys and questionnaires. If you have collections requiring PRA approval, CDC is responsible for working with OMB to gain the approval.

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

Organizational capacity You must describe your organization’s capacity to perform project activities, including:

• Performing longitudinal data collection from SB specialty clinics. This includes previous experience minimizing loss to follow-up.

• Program and performance management and evaluation.

• Data management. This includes experience securely transferring data files, data cleaning, and data quality improvement.

• Data analysis. This includes participating in the development of data analysis proposals and analytic plans and performing analyses using NSBPR or UMPIRE data.

• Sharing findings. This includes participating in the development of presentation materials, manuscripts, and the presentation of findings from NSBPR or UMPIRE.

When describing your capacity to collect longitudinal data from SB specialty clinics, address:

• Your ability to submit standardized datasets with limited identifiers to CDC to include in a pooled dataset.

• Your existing processes to share data with us. If relevant, describe any barriers that you’ve experienced in data sharing.

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Step 1: Review the Opportunity 27 https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm#cdc_data_surveillance_section_1-cdc-paperwork-reduction-act-compliance https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm#cdc_data_surveillance_section_1-cdc-paperwork-reduction-act-compliance

Staff capacity You must include a staffing plan that clearly defines staff roles to achieve the project outcomes.

Describe:

• The staff responsible for the activities of this NOFO.

• The percentage of time they’ll devote to the project (such as full-time equivalent).

• Whether they’re existing staff or will be hired.

Include job descriptions, two-page resumes or biosketches, and an organizational chart to help show your organization’s capacity to perform project activities.

For Components A and B, also describe:

• Committed relationships your staff has with relevant specialists who will provide access to patients with SB and to the collection of data.

• Your staff’s ability and previous experience collecting and using or analyzing longitudinal data (including publications, if applicable), for instance from NSBPR or UMPIRE. Include your organization’s enrollment history of individuals in NSBPR or UMPIRE.

• A data coordinator should be included on staff, as well as a description of their capacity to support the implementation of data management and timely data submission to CDC.

• Your staff’s ability to develop scientific manuscripts for peer-review.

Demonstrate your organization’s record of research that has advanced the field of SB clinical care.

For Component A only, also describe:

• Your staff’s ability to analyze data (you should have a data analyst).

• Your capacity to support analyses.

For Component B only, also describe:

• Evidence that the pediatric urologist you include in your application works closely with the initial hospital where the affected newborn presents at the hospital/clinic.

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Step 1: Review the Opportunity 28 https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fgrants.nih.gov%2Fgrants%2Fforms%2Fbiosketch-blank-format-rev-10-2021.docx&wdOrigin=BROWSELINK

Collaborations We expect you to maintain existing partnerships and establish new partnerships, as needed, to accomplish the goals of the NOFO. This includes relationships with clinicians and clinician groups who treat patients with SB.

We expect you to collaborate with patient support groups to share information relevant to individuals with SB and their families and caregivers.

If you’re awarded funds under this cooperative agreement, you must collaborate with other awardees and CDC. This includes sharing of data as described in this NOFO.

Funding policies and limitations Changes in HHS regulations As of October 1, 2025, HHS adopted 2 CFR 200, with some exceptions included in 2 CFR 300. These regulations replace those in 45 CFR 75. You can find details in HHS Summary of Regulatory Changes, which is posted in the Grants.gov Related Documents tab for this opportunity.

General guidance All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate;

racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

• You may use funds only for reasonable program purposes consistent with the award, its terms and conditions, and federal laws and regulations that apply to the award. If you have questions about these purposes, ask the grants management specialist.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

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Step 1: Review the Opportunity 29 https://www.ecfr.gov/current/title-2/part-200

◦ Satisfactory progress in meeting your project’s objectives.

◦ A decision that continued funding is in the government’s best interest, program goals, and priorities.

• If needed, and where consistent with the scope of the NOFO:

◦ You may use funds to support your jurisdiction’s vital records office (VRO) to do any of the following:

▪ Build its capacity through partnerships.

▪ Provide technical or financial assistance to improve vital records timeliness, quality, or access.

▪ Support vital records improvement efforts.

If we receive more funding for this program, we will consider options such as:

• Funding more applicants.

• Extending the period of performance.

• Awarding supplemental funding.

See also program-specific limitations.

Unallowable costs You may not use funds for:

• Clinical care, except as allowed by law.

• Pre-award costs, unless we give you prior written approval.

• Other than for normal and recognized executive-legislative relationships:

◦ Publicity or propaganda purposes, including preparing, distributing, or using any material designed to support or defeat the enactment of legislation before any legislative body.

◦ The salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order proposed or pending before any legislative body.

◦ See Anti-Lobbying Restrictions for CDC Grantees.

• For guidance on some types of costs that we restrict or do not allow, see 2 CFR Part 200 Subpart E - General Provisions for Selected Items of Cost.

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Step 1: Review the Opportunity 30 https://www.cdc.gov/grants/documents/Anti-Lobbying-Restrictions.pdf https://www.ecfr.gov/current/title-2/part-200/subject-group-ECFRed1f39f9b3d4e72

Indirect costs Indirect costs are those shared across multiple projects and not easily separated. Learn more at CDC Budget Preparation Guidelines.

To charge indirect costs you can select one of two methods:

Method 1 — Approved rate. If you currently have an indirect cost rate approved by your cognizant federal agency, you may use that rate.

Enclose a copy of the current approved rate agreement in your attachments.

Method 2 — De minimis rate. If you do not have a current negotiated indirect cost rate, you may elect to charge a de minimis rate(see 2 CFR 200.414(f)). This rate may be up to 15% of modified total direct costs (MTDC).

See the definition of MTDC (2 CFR 200.1). You can use this rate indefinitely.

Other indirect cost policies As described in 2 CFR 200.403(d), you must consistently charge items as either indirect or direct costs and may not double charge.

Indirect costs may include the cost of collecting, managing, sharing, and preserving data.

Salary rate limitation The salary rate limitation in the current appropriations act applies to this program. As of January 2026, the salary rate limitation is $228,000. We update this limitation when it changes.

Program income If you earn any money from your award-supported project activities (known as program income), you must use it for the purposes and under the conditions of the award. Find more about program income at 2 CFR 200.307.

Expanded authority For more information on expanded authority and pre-award costs, see the HHS Grants Policy Statement and speak to the grants management contact.

Pre-award costs may be allowable as an expanded authority, but only if we authorize the costs.

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Step 1: Review the Opportunity 31 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-2/part-200#p-200.403(d)…