Foa_Content_of_CDC-RFA-DD-24-0065.pdf

Division of Birth Defects and Infant Disorders

Notice of Funding Opportunity

Application due April 15, 2024 - 11:59 p.m. ET

Surveillance of Spina Bifida across the Lifespan Opportunity number: CDC-RFA-DD-24-0065

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Program description 9

Step 2: Get Ready to Apply 27

Get registered 28

Step 3: Prepare Your Application 30

Application contents and format 31

Step 4: Learn About Review and Award 38

Application review 39

Award notices 43

Step 5: Submit Your Application 44

Application submission and deadlines 45

Application checklist 47

Step 6: Learn What Happens After Award 48

Post-award requirements and administration 49

Contacts and Support 53

Endnotes 55

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 April 15, 2024 Applications are due by 11:59 p.m. Eastern Time on April 15, 2024.

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

Jump to a step

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

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 7

Program description 9

Basic information Centers for Disease Control (CDC)

National Center on Birth Defects and Developmental Disabilities

Division of Birth Defects and Infant Disorders

Collecting data to improve the lives of people with spina bifida.

Have questions?

See Contacts and Support.

Key facts

Opportunity Name:

Surveillance of Spina Bifida across the Lifespan

Opportunity Number:

CDC-RFA-DD-24-0065

Federal Assistance Listing:

93.07

Key dates

Application deadline:

April 15, 2024, 11:59 p.m. ET

Optional letter of intent deadline:

March 15, 2024

Informational webinar:

March 1, 2024, 11:00 a.m. ET

Expected award date:

July 11, 2024

Expected start date:

August 12, 2024

Summary Our goal is to develop a multi-site system for population-based, non-research surveillance of spina bifida, or SB, across the lifespan (SB Surveillance). Our focus is to collect data to improve our knowledge of prevalence, mortality, and health outcomes for people with SB of all ages.

• Under Component A, we (CDC) will expect you to collect, manage, and analyze data, submit data to us, and disseminate information to partners.

• Under Component B, you can develop a special project related to SB.

Key activities

Component A:

• Conduct population-based surveillance of SB among people of all ages

• Manage, clean, and analyze SB surveillance data

• Submit data to us for inclusion in a pooled analytic dataset to be used by all sites

• Share information and results from your project

Component B (optional, for organizations that apply to Component A):

• Develop, implement, and evaluate a special SB project.

Step 1: Review the Opportunity 5

Funding details Type: Cooperative Agreement

Expected total program funding over the performance period:

• Component A: $8,000,000

• Component B: $400,000

Expected total program funding per budget period:

• Component A: $1,600,000

• Component B: $200,000 (for 2 years only)

Expected awards:

• Component A: We will award up to 4 recipients for 5 years.

• Component B: Beginning in year 2 or 3, we will award 1 to 2 recipients for 2 years. This means that for year 1 (and potentially year 2), recipients will be awarded but unfunded.

Funding range per budget period:

• Component A: $300,000 to $450,000 per applicant

• Component B: $100,000 to $200,000 per applicant

Expected average award amount per budget period:

• Component A: $400,000

• Component B: $200,000

Budget and performance periods:

• For Component A, we plan to award projects for five 12-month budget periods, for a 5-year period of performance.

• For Component B, we plan to award projects for two 12-month budget periods, for a 2-year period of performance.

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 on your keyboard.

Step 1: Review the Opportunity 6

Eligibility Who can apply

Eligible applicants 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

Other required qualifying factors To be eligible for Component A, you must have all of the following:

• Demonstrated authority or ability to collect data on people with SB across all ages (see Documentation of Eligibility)

• Access to state birth defects surveillance data on SB and state vital records data

• Access to additional data sources for information on the health status and outcomes for people of all ages with SB, such as electronic health records from clinics or other healthcare facilities, administrative data sources such as state Medicaid data, hospital discharge data, or other types of state registries

Step 1: Review the Opportunity 7

You must provide documentation to support your ability to do the above. You must include this information in your Documentation of Eligibility attachment.

To be eligible for Component B (optional), you must demonstrate that you have applied for Component A by providing a copy of the front page from your Component A application. See Attachments.

Cost sharing and matching funds This program has no cost-sharing requirement or matching funds requirement. Although not required, you are strongly encouraged to use other resources and related activities to help enhance and sustain the work done under this award. 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, you will be required to report on voluntary cost-sharing funds.

Step 1: Review the Opportunity 8

Program description Background Overview Conducting population-based surveillance of children and adults with SB can be challenging. Surveillance systems for birth defects identify babies born with a birth defect, but rarely follow them as children and adults.

The purpose of this non-research surveillance project is to conduct population-based surveillance of SB across the lifespan. This will help us estimate prevalence and mortality and assess health status and healthcare use for children and adults with SB.

For this project, you will need to combine information from different sources, including state birth defects surveillance systems and vital records, and other data sources, such as electronic health records and administrative data. CDC, project sites, and public health and clinical partners may use these data to:

• Estimate the prevalence of SB for all age groups

• Describe healthcare use and sources of care

• Assess health status and long-term outcomes

• Advance health equity by describing any disparities

Because of advances in care and treatment, people with SB are living longer.

However, we know little about the prevalence of SB across all ages. Among the few studies involving both children and adults, prevalence estimates vary widely from 3.47 per 10,000 to 17 per 10,000.[1] We want to add to this literature and further refine prevalence estimates.

We fund sites for the National SB Patient Registry (NSBPR) to collect longitudinal data on people with SB who visit SB clinics. We use the registry data to describe:

• sociodemographic characteristics

• healthcare interventions, such as surgical and non-surgical procedures, and bowel and bladder management techniques

• healthcare outcomes, such as bowel and bladder continence, mobility, and skin problems

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

Step 1: Review the Opportunity 9 https://www.cdc.gov/ncbddd/spinabifida/materials/spina-bifida-patient-registry-info-flyer.html

For this new project, we want to work with project sites to collect population-based data on SB across all ages to add to our knowledge of the SB population, regardless of whether they receive care in SB clinics.

Related work

• National SB Patient Registry (NSBPR)

• Urologic Management to Preserve Initial Renal Function Protocol for Young Children with SB (UMPIRE)

• State-Based Birth Defects Tracking Systems

Purpose We want to improve the health and quality of life for people with SB. To do this, we need better data on the prevalence of SB across all ages. We want you to help us by:

• Conducting population-based SB surveillance across all ages

• Linking data from various sources

• Disseminating results

CDC, project sites, and public health and clinical partners may use data from this project to:

• Estimate prevalence, mortality, and survival for all age groups

• Inform clinicians, public health programs, the SB community, and the public about health status and outcomes for people with SB

Approach Overview The logic model below 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 5-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 table shows how they apply. You will use these outcomes as a guide for developing performance measures.

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

Step 1: Review the Opportunity 10 https://www.cdc.gov/ncbddd/spinabifida/materials/spina-bifida-patient-registry-info-flyer.html https://www.cdc.gov/ncbddd/spinabifida/umpire.html https://www.cdc.gov/ncbddd/spinabifida/umpire.html https://www.cdc.gov/ncbddd/birthdefects/states/index.html

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 below.

Strategies and Activities Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Component A Strategy 1. Surveillance Capacity

• Use state birth defects surveillance system and vital records data to identify cases of SB for the surveillance area, conduct retrospective follow-up, and perform death ascertainment

• Identify and use additional clinical and administrative data sources to collect information on SB health status and long-term outcomes

• Develop a procedural manual for your surveillance area

Strategy 2. Data Management and Reporting

• Link data from various data systems to create standardized, anonymized SB dataset for submission to CDC

• Routinely monitor SB data quality and improve quality as needed

Strategy 3. Dissemination

• Share information about SB with partners and key audiences, communicate results

• Collaborate with CDC in the analysis and dissemination of SB surveillance data

Component B (optional) Strategy 1. [Special Project]

Component A

• Increased access of public health and clinical data on SB by public health and clinical researchers, providers, individuals with SB, and families or caregivers*

Components A and B

• Improved accuracy or efficiency in SB case-finding, reporting, or outcome prediction*

Components A and B

• Improved ability of policymakers to make data-informed decisions about SB

• Improvements to clinical care for individuals with SB

• Improvements to public health materials, programs, and interventions for SB

• Improved SB data quality and availability of data for action*

Components A and B

• Improved health for individuals with SB

• Improved quality of life for individuals of all ages with

SB

Step 1: Review the Opportunity 11

Strategies and Activities Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes

• Develop, implement, and evaluate novel approaches to SB case-finding, reporting, or outcome prediction

* Indicates outcomes you are required to report on.

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

NOFO.

For this project, we are asking you to collect information on people with the following types of SB.

SB type ICD-10 code SNOMED codes

Cervical SB with hydrocephalus Q05.0 203934001, 203941007, 203948001

Thoracic SB with hydrocephalus Q05.1 203935000, 203942000, 203942000

Lumbar SB with hydrocephalus Q05.2 203936004, 203933005, 203950009

Sacral SB with hydrocephalus Q05.3 445307009, 203944004, 203951008

Unspecified SB with hydrocephalus Q05.4 53318002, 735749005, 735749005

Cervical SB without hydrocephalus Q05.5 204003007, 204010001, 203985009

Thoracic SB without hydrocephalus Q05.6 30620003, 204004001, 204011002, 203986005

Lumbar SB without hydrocephalus Q05.7 77224008, 204005000, 204012009, 17761000119109, 17771000119103, 203987001

Sacral SB unspecified Q05.8 204006004, 204013004, 95478002

SB, unspecified Q05.9 67531005, 171131006, 4061000119104, 171131006

Arnold-Chiari syndrome with SB Q07.01 253117002, 253184003

Arnold-Chiari syndrome with SB and hydrocephalus

Q07.03

Step 1: Review the Opportunity 12

SB type ICD-10 code SNOMED codes

Fetal SB N/A 783724009

We will not ask you to collect information on people with SB occulta (Q76.0/ 76916001).

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

Strategy 1: Surveillance Capacity

• Use state birth defects surveillance and vital records data to identify people with SB who reside in your surveillance area (we will work with project sites to determine the date range after funding)

◦ If needed, establish memoranda of understanding (MOUs), memoranda of agreement (MOAs), or data use agreements (DUAs) with state birth defects surveillance and vital records programs

◦ Trace addresses to confirm the residency of people with SB who are followed for your program

◦ At least once during the 5-year performance period, match with the National Death Index to confirm vital status and collect information on cause of death

• Identify and use additional clinical and administrative data sources to collect information on SB health status and long-term outcomes over a proposed 5-year time period (2019 to 2024).

◦ Establish MOUs, MOAs, or DUAs with all clinical and administrative sources you work with

◦ Use clinical and administrative data sources to collect information on SB health status and long-term outcomes, such as ambulation status, surgical procedures, medications, comorbidities, mental health, and health screenings

◦ Use clinical and administrative data sources to conduct retrospective follow-up on people with SB who reside in your surveillance area

• Develop a procedural manual for your surveillance area that addresses:

◦ Accessing state birth defects and vital records data for SB

◦ Accessing additional data sources accompanied by signed MOUs/ MOAs and DUAs (as needed) for these sources

◦ Linking data from all sources

Step 1: Review the Opportunity 13

◦ Verifying residence information for individuals with SB who access care in your catchment area

◦ Sources used for address tracing

◦ Performing death ascertainment and identifying causes of death for SB cases that are followed up on

◦ Deduplicating cases

◦ Geocoding addresses

◦ Training and monitoring the performance of staff

Strategy 2: Data Management and Reporting

• Link data from all sources to create a standardized, anonymized SB dataset for submission to CDC, beginning in early Year 2 or before

◦ Use and adhere to CDC-developed data dictionary (see Spina Bifida Research | CDC for list of proposed data elements)

◦ Perform intrastate deduplication of SB cases (we will determine the frequency after funding)

◦ Geocode addresses in order to link to Census data on social determinants of health (SDOH) and examine topics such as distance to healthcare locations

◦ Submit SB surveillance dataset to CDC for error checks/data quality review

◦ Continue to submit standardized, anonymized SB datasets to CDC on at least an annual basis (we will work with project sites to determine the frequency of data submissions after funding)

• Monitor SB data quality and respond to CDC-generated error checks/data quality reports

◦ Use CDC-generated reports to identify and correct errors

◦ Submit revised, cleaned datasets to CDC for inclusion in pooled, multi-site dataset

Strategy 3: Dissemination

• Share information about SB with partners and key audiences, communicate results

◦ Develop a communication plan for disseminating information on and results from your SB surveillance program, addressing the use of various channels such as presentations, newsletters, reports, journal articles, websites, and dashboards

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

Step 1: Review the Opportunity 14 https://www.cdc.gov/ncbddd/spinabifida/research.html

◦ Annually, deliver at least one presentation to partners, the public (including people with SB and their families or caregivers), or at a national meeting on your SB surveillance program

▪ Communicate any available results on public health (SB prevalence, age-specific mortality and cause of death) and clinical outcomes (healthcare utilization, sources of care, health status, and long-term outcomes) for your surveillance area

• Collaborate with us and other project sites to analyze and disseminate SB surveillance data

◦ Staff from your surveillance program to participate as lead, co-author, or analyst in at least one multi-site analysis for a peer-reviewed publication

Component B (optional) If you apply for Component A, you may also apply for Component B and conduct a special project.

Strategy 1: Special Project

Beginning in Year 2 or 3 of the period of performance, if you are approved, you’ll be expected to implement a 2-year project. For example, you may choose to focus on the following types of activities:

• Use methods, such as machine learning or natural language processing, to improve the accuracy of SB case identification for all ages

• Develop and implement methods for automating or improving the efficiency of data collection, management, analysis, or outcome prediction

• Assess the feasibility of collecting data on education, employment, or social services from other types of data sources, such as education data

Also, you’ll be expected to evaluate and disseminate special project results.

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

We will measure your progress towards the following short and intermediate outcomes from the logic model:

• Increased availability of SB data to inform clinical care and public health materials, programs, and interventions (Component A only)

Step 1: Review the Opportunity 15

• Improved understanding among public health and clinical researchers and providers of SB prevalence, age-specific mortality, and cause of death (Component A only)

• Improved understanding among public health and clinical researchers and providers of healthcare use and sources of care for individuals with SB (Components A and B)

• Improved accuracy or efficiency in SB case-finding, reporting, or outcome prediction (Components A and B)

• Improved SB data quality and availability of data for action (Components A and B)

Focus populations Your focus population is all people with diagnosed SB (excluding SB occulta) who reside in your surveillance area. This includes people with SB who were:

• Diagnosed at or before birth and delivered as live births to women who reside in the catchment area

• Diagnosed during childhood, adolescence, or adulthood

• Previously diagnosed, before the person moved into your surveillance area

For your proposed surveillance area, you should describe:

• The geographic boundaries, such as the entire state, a region or regions that border each other within a state, or bordering counties and population size

• If proposing an area smaller than the entire state, the proportion of the state population covered by this area (for example, the proposed surveillance area, comprised of 10 counties, covers 70 percent of the state population)

• How you will use health disparities data to identify and focus on populations at greatest risk for poor health outcomes

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 16

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 (SDOH) 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.

Your surveillance area should include populations at risk. The data you report to us will include elements such as ethnicity, race, gender, geography (such as rural or urban), disability status, and health insurance coverage.

We will also ask you to geocode people’s addresses and link to Census data on SDOH. However, you would not submit to us any Census tract, county, address, or other geographic information that could be used to identify someone. Proposed data elements, including SDOH data elements, will be posted on the Spina Bifida Research | CDC webpage and included in the informational webinar (see Key Dates).

Organizational capacity Component A For Component A, your organization should have the capacity to conduct population-based SB surveillance.

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

• Program and performance management and evaluation

• Informatics, including experience with data interoperability, systems development and support, data security, data analysis, and data management, including data linkage, cleaning, quality improvement, and geocoding

• SB knowledge and clinical expertise

• Surveillance and epidemiology

• Data dissemination, including presenting and publishing data on SB or similar topics

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

Step 1: Review the Opportunity 17 https://www.cdc.gov/about/sdoh/index.html

Also, you must describe the staff responsible for these activities, the percentage of time they will devote to the project (such as full-time equivalent), and whether they are existing staff or will be hired. See Work Plan.

When describing your capacity to implement SB surveillance, address the following requirements:

• Demonstrated authority or ability to collect data on individuals who were diagnosed with SB before and after birth (see Documentation of Eligibility)

• Access to state birth defects surveillance and vital records data to identify individuals with SB

• For the latest 3 years of data on birth defects for your surveillance area:

◦ An average of at least 15 cases of SB per year

◦ At least 30,000 live births per year

◦ An estimated annual state population of at least 3,000,000

• Access to other data sources on health status and outcomes for children and adults with SB (for example, electronic health records, claims data, hospital discharge data, or other administrative data sources)

• Ability to submit standardized, anonymized data to CDC for inclusion in a pooled dataset

Also, describe existing processes you have in place to share data with us. And, if relevant, barriers that you have experienced in doing so.

Component B (optional) If you choose to apply for Component B, you must describe your organization’s capacity to develop, implement, and evaluate the special project you intend to undertake. Also, describe the knowledge, skills, and abilities of staff who will work on the project and their experience with similar projects.

Collaborations If you receive awards, you’ll be expected to collaborate and coordinate with other award recipients and us to perform strategies and activities and share information on best practices and lessons learned. Examples of collaborations with other recipients and us include:

• Developing and finalizing methods for collecting and reporting data to us

Step 1: Review the Opportunity 18

• Identifying key public health questions to be answered through SB surveillance data

• Analyzing, presenting, and publishing multi-site data

• Training surveillance program staff

• Participating in project conference calls and workgroups

Also, you’ll be expected to collaborate with relevant local or national partners to perform strategies and activities. Examples of collaborations include:

• Finalizing data-sharing agreements with sources of project-related data for your surveillance area, such as vital records; state Medicaid program;

and health systems, clinics, and providers who serve children and adults with SB

• Working with information technology or data modernization staff to expand existing data systems or develop new systems for SB surveillance

• Collaborating with local patient or caregiver advocacy groups or other organizations serving people with SB to disseminate information about the surveillance program

You must submit letters of support, MOUs, MOAs, or DUAs for any proposed data sources. You must include this information in your Documentation of Eligibility attachment.

Data, monitoring, and evaluation CDC strategy 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

Step 1: Review the Opportunity 19

CDC and recipients will use evaluation findings to:

• Make sure that improvements are continually being made

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

• Improve ongoing and future surveillance activities

Required performance measures Following are the draft performance measures you will need to report on after the 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.

Table: Draft process measures

Component Strategy Process measures

A 1.

Surveillance Capacity

• Documentation of the procedural manual for your surveillance area that addresses the components described in Strategies and Activities.

A 2. Data Management and Reporting

• For SB cases identified through state birth defects surveillance or vital records, number you’ve begun to collect follow-up data on.

• Data from all proposed sources are linked prior to data submission.

• Submission of first clean, anonymized dataset that aligns with the CDC data dictionary, for inclusion in a pooled, multi-site dataset

• Data are deduplicated (according to the frequency established after funding)

• Average time of your response to data quality reports that we provide to you

A 3.

Dissemination

• Completed communication plan for disseminating information on and results from your SB surveillance program

• Annually, at least one presentation to partners or at a national meeting on your SB surveillance program

• One report or peer-reviewed publication involving multi-site data; number of multi-site analyses you’ve proposed or participated in

Step 1: Review the Opportunity 20

Component Strategy Process measures

B 1. Special Project

• Completed project plan that describes how you will implement and evaluate the project and includes key aspects (such as staffing, methodology, and data sources)

• At least one presentation on your project to partners or at a national meeting

• One completed project summary (such as a final report or peer-reviewed publication)

Table: Outcome measures

Component Outcome Measures

A Increased access of public health and clinical data on SB by public health and clinical researchers, providers, individuals with SB, and families or caregivers

Number of attendees at presentations; other examples, depending upon your communication plan:

• Number of website hits

• Number of file downloads

• Number of emails sent

A and B (if applicable)

Improved accuracy and/or efficiency in SB case-finding, reporting, or outcome prediction

• Calculation of quantitative measures for assessing improvement, such as positive predictive value for case ascertainment, reporting lag for your SB surveillance and, if applicable, special project data

• Quantitative measures show improvements in the accuracy, completeness, or timeliness of case ascertainment or measurement of health outcomes

Step 1: Review the Opportunity 21

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

Include the following elements:

Methods Describe:

• How you will:

◦ collect the performance measures

◦ use evaluation findings for continuous program quality improvement

◦ incorporate evaluation and performance measurement into the planning, implementation, and reporting of project activities

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

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

• How you will share evaluation findings with communities and populations of interest in a way that meets their needs

Data management 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

◦ if there are reasons why you cannot share data collected or generated under this award with CDC. 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 represent, and data limitations

◦ archival and long-term data preservation plans

◦ how you will update the DMP as new information is available over the life of the project. You will provide updates to the DMP in annual

Step 1: Review the Opportunity 22 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.

For a definition of “public health data” and other key information, see AR 25:

Data Management and Access on our website.

We do not require a data use agreement (DUA) between you and us, since the NOFO itself serves that function. If you require a DUA with us or other recipients, you must document this in your application and work with us to develop and sign DUAs that reflect the data sharing anticipated under this award within the first 6 months of the award.

Evaluation activities In addition to the evaluation activities for the Required Performance Measures, you may choose to take on additional evaluation activities. For example, activities to 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 (EPMP), including the DMP, should be submitted with your application. You must submit a more detailed EPMP and DMP within the first six 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 Component A, you must provide a work plan with details for Year 1 of the project and high-level plans for subsequent years.

If you’re also applying for Component B, you must cover details for Year 1 of the project and high-level details for Year 2.

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

Step 1: Review the Opportunity 23 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html

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 and Percentage of Time

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. Collections include items like surveys and questionnaires.

Funding policies and limitations General guidance

• Your budget is arranged in eight categories: salaries and wages, fringe benefits, consultant costs, equipment, supplies, travel, other, and contractual.

• 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. Questions about this determination should be posed to the grants management specialist.

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

Step 1: Review the Opportunity 24 https://www.cdc.gov/os/integrity/reducepublicburden/index.htm

• Generally, you may not use funds to purchase furniture or equipment.

Clearly identify and justify any such proposed spending in the budget.

• If needed, you may use funds to meet national standards or seek health department accreditation or reaccreditation through the Public Health Accreditation Board (PHAB). This allowability applies only to state, Tribal, local, and territorial government agencies within the U.S. and its territories. Include the proposed activities and a description of the connection to national standards or accreditation achievement in the budget narrative.

• You may use funds to support your jurisdiction’s vital records office (VRO) to build its capacity through partnerships; provide technical or financial assistance to improve vital records timeliness, quality, or access; or support vital records improvement efforts.

• You should include funds for 1 to 2 people to attend two project meetings in Atlanta. Plan 2 days for each meeting.

• If you are applying for Component A and B, you must submit a budget narrative and justification for each component.

Unallowable costs You may not use funds for:

• Research

• Clinical care except as allowed by law

• Pre-award costs unless CDC gives 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 Recipients.

Indirect costs Indirect costs are those for a common or joint purpose across more than one project and that cannot be easily separated by project. Learn more at 45 CFR 75.414, Indirect Costs and CDC Budget Preparation Guidelines.

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

Step 1: Review the Opportunity 25 https://phaboard.org/ https://phaboard.org/ https://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf https://www.ecfr.gov/current/title-45/section-75.414 https://www.ecfr.gov/current/title-45/section-75.414 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf

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

Method 1 – Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency.

Justification: Provide a summary of the rate. Enclose a copy of the current approved rate agreement in the Attachments.

Method 2 – De minimis rate. Per 45 CFR 75.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. If you are awaiting approval of an indirect cost proposal, you may also use the de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is 10 percent of modified total direct costs (MTDC). See 45 CFR

75.2 for the definition of MTDC. You can use this rate indefinitely.

Other Indirect Cost Policies

• As described in 45 CFR 75.403(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.

National public health priorities and strategies HHS Strategic Goal 4, Objective 4.3: Strengthen surveillance, epidemiology, and laboratory capacity to understand and equitably address diseases and conditions.

Statutory authority This program is authorized under Section 317C of the Public Health Service Act (also cited as 42 U.S.C. 247b-4).

More specifically, as set out in 317C(a)(2), CDC acting through the Secretary is authorized to collect and analyze data on birth defects and developmental disabilities, operate regional centers for the conduct of applied epidemiological research on the prevention of birth defects and developmental disabilities, and provide information and education to the public on the prevention of birth defects and developmental disabilities.

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

Step 1: Review the Opportunity 26 https://www.ecfr.gov/current/title-45/part-75#p-75.414(f) 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-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-45/part-75#p-75.403(d) https://www.govinfo.gov/app/details/USCODE-2021-title42/USCODE-2021-title42-chap6A-subchapII-partB-sec247b-4/summary

Step 2:

Get Ready to Apply

In this step

Get registered 28

Get registered While you can review the requirements and get started on developing your application before your registrations are complete, you must be registered in both SAM.gov and Grants.gov to apply.

SAM.gov You must have an active account with SAM.gov. This includes having a Unique Entity Identifier. SAM.gov registration can take several weeks. Begin that process today.

To register, go to SAM.gov Entity Registration and click Get Started. From the same page, you can also click on the Entity Registration Checklist for the information you will need to register.

Grants.gov You must also have an active account with Grants.gov. You can see step-by step instructions at the Grants.gov Quick Start Guide for Applicants.

Need help? See Contacts and Support.

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov and search for opportunity number

CDC-RFA-DD-24-0065.

If you have other technical difficulties, including issues with application submission, contact grants.gov for assistance. The www.grants.gov Contact Center is available 24 hours a day, 7 days a week, except federal holidays. The Contact Center is available by phone at 1-800-518-4726 or by e-mail at support@grants.gov.

To get updates on changes to this NOFO, select Subscribe from the View Grant Opportunity page for this NOFO on Grants.gov.

Help applying For help with the application process and tips for preparing your application see How to Apply on our website. For other questions, see Contacts and Support.

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

Step 2: Get Ready to Apply 28 https://sam.gov/content/entity-registration http://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/search-grants http://www.grants.gov/ mailto:support@grants.gov https://www.cdc.gov/grants/applying/index.html

Join the informational call Friday, March 1, 2024 at 11:00 a.m. ET

Join Zoom webinar:

• Join the webinar

• Webinar ID: 161 851 1104

• Passcode: 8eP?tz3B

Join by phone or room system:

• View dial-in number for your region

• H.323: 161.199.138.10 (US West) or 161.199.136.10 (US East)

• SIP: 1618511104@sip.zoomgov.com

• Passcode: 65646954

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

Step 2: Get Ready to Apply 29 https://cdc.zoomgov.com/j/1618511104?pwd=Q2dqNGdKUWRkZ1ExNDcwL1NySGFrUT09 https://cdc.zoomgov.com/zoomconference?m=MTYxODUxMTEwNA.pHl9tKL_ZjlNuBeovPo-Flf7tFBcwu4n

Step 3:

Prepare Your Application

Application contents and format 31

Application contents and format Applications include 5 main elements. This section includes guidance on each.

Make sure you include each of the following.

Element Submission Form

Project Abstract Use the Project Abstract Summary form

Project Narrative Use the Project Narrative Attachment form

Budget Narrative Justification Use the Budget Narrative Attachment form

Attachments Insert each in the Other Attachments form

Standard Forms Upload using each required form

If you are applying for Components A and B, you must include the 5 main elements for each component.

We will provide instructions on document formats in the sections below. If you don’t provide the required documents, your application is incomplete.

See Initial Review to understand how this affects your application.

Required Format for Project Abstract, Project Narrative, and Budget Narrative

Font: Calibri

Format: PDF

Size: 12-point font Footnotes and text in graphics may be 10-point.

Spacing: Single-spaced

Margins: 1-inch Include page numbers

Step 3: Prepare Your Application 31

Project abstract Page Limit: 1

File name: Project Abstract Summary

Provide a self-contained summary of your proposed project, including the purpose and outcomes. Do not include any proprietary or confidential information. We use this information when we receive public information requests about funded projects.

Project narrative Page Limit: 20

File name: Project Narrative

Your project narrative must use the exact headings, subheadings, and order below.

See Merit Review Criteria to understand how reviewers will evaluate your Project Narrative.

Background Describe the problem you plan to address. Be specific to your population and geographic area.

See Program Description, Background.

Approach

Strategies and activities Describe how you will implement the proposed strategies and activities to achieve the period of performance outcomes. Explain whether they are:

• Existing evidence-based strategies

• Other strategies, with a reference to where you describe how you will evaluate them in your Evaluation and Performance Measurement Plan.

See Program Description, Strategies and Activities.

Outcomes Using the logic model in Program Description, Approach, identify the outcomes you expect to achieve or make progress on by the end of the period of performance.

Step 3: Prepare Your Application 32

Evaluation and performance measurement plan You must provide an evaluation and performance measurement plan. This plan describes how you will fulfill the requirements in Program Description, Data, Evaluation, and Performance Measurement.

Work plan Include a work plan using the requirements in Program Description, Work Plan.

Focus populations and health disparities Describe the specific population or populations you plan to address under this award. Explain how you will include them and meet their needs in your project. Describe how your work will benefit public health as well as the populations and alleviate health disparities.

See Program Description, Focus Populations.

Organizational capacity Describe how you will address the organizational capacity requirements in Program Description, Organizational Capacity.

You must provide attachments that support this section including:

• Resumes and Job Descriptions

• Organization Chart

Collaborations Describe how you will collaborate with programs and organizations, either internal or external to CDC. Explain how you will address the Collaboration requirements in Program Description, Collaborations.

Budget narrative Page limit: None

File name: Budget Narrative

The budget narrative supports the information you provide in Standard Form 424-A. See Standard Forms.

As you develop your budget, consider If the costs are reasonable and consistent with your project’s purpose and activities. CDC will review and must approve costs prior to award.

Step 3: Prepare Your Application 33

The budget narrative must explain and justify the costs in your budget.

Provide the basis you used to calculate costs. It must follow this format:

• Salaries and wages

• Fringe benefits

• Consultant costs

• Equipment

• Supplies

• Travel

• Other categories

• Contractual costs

• Total direct costs (total of all items above)

• Total indirect costs

If you’re applying for Components A and B, you must provide a budget narrative for each Component.

See Funding Policies and Limitations for policies you must follow.

Attachments You will upload attachments in Grants.gov using the Other Attachments Form. When adding the attachments to the form, you can upload PDF, Word, or Excel formats.

Table of contents Provide a detailed table of contents for your entire submission that includes all the documents in the application and headings in the Project Narrative section. There is no page limit.

File name: Table of Contents

Indirect cost agreement If you include indirect costs in your budget using an approved rate, include a copy of your current agreement approved by your cognizant agency for indirect costs. If you use the de minimis rate, you do not need to submit this attachment.

File name: Indirect Cost Agreement

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

Step 3: Prepare Your Application 34 https://www.ecfr.gov/current/title-45/part-75#p-75.2(Cognizant%20agency%20for%20indirect%20costs) https://www.ecfr.gov/current/title-45/part-75#p-75.2(Cognizant%20agency%20for%20indirect%20costs)

Proof of nonprofit status If your organization is a nonprofit, you need to attach proof. We will accept any of the following:

• A copy of a current tax exemption certificate from the IRS.

• A letter from your state’s tax department, attorney general, or another state official saying that your group is a nonprofit and that none of your net earnings go to private shareholders or others.

• A certified copy of your certificate of incorporation. This document must show that your group is a nonprofit.

• Any of the above for a parent organization. Also include a statement signed by an official of the parent group that your organization is a nonprofit affiliate.

File name: Nonprofit status

Resumes and job descriptions For key personnel, attach resumes for positions that are filled. If a position isn’t filled, attach the job description with qualifications and plans to hire.

File name: Resumes and job descriptions

Documentation of eligibility You must provide documentation to prove that you qualify under Other Required Qualifying Factors.

For Component A, to be considered responsive, you must:

• Attach documentation to show that you have authority or ability to collect data on people with SB in your proposed surveillance area (for example, documentation of the statute that provides you with public health authority to collect these data, or documentation from the health department that permits you to collect these data)

• Attach letters of support, MOUs, MOAs, or DUAs to demonstrate that you have access to the data sources described in Other Required Qualifying Factors. Address the following:

◦ For birth defects surveillance, how long they have collected data on SB and whether they used active or passive surveillance

◦ For both birth defects surveillance and vital records programs in your surveillance area, their agreement to share data on cases of SB with your SB surveillance program for inclusion in a pooled, multi-site dataset

Step 3: Prepare Your Application 35

◦ For additional data sources, their agreement to share data with your SB surveillance program for inclusion in a pooled, multi-site dataset

For Component B (optional), to be considered responsive, you must:

• Include a copy of the front page from your completed Component A application

File name: Eligibility Documentation

Organizatio…