MCHB-HRSA-25-023-(R42)-MCH-SDAR+HRSA-25-024-(R43)-Autism-SDAR-final.pdf

Maternal and Child Health Bureau (MCHB)

Notice of Funding Opportunity

Application due February 25, 2025

Maternal and Child Health Secondary Data Analysis Research (MCH SDAR) and Autism Secondary Data Analysis Research (Autism

SDAR)

Opportunity number: MCH SDAR: HRSA-25-023; Autism SDAR: HRSA-25-024

Contents Before you begin 4

Step 1: Review the Opportunity 5

Basic information 6

Summary 6

Funding details 7

Eligibility 8

Program description 11

Award information 15

Step 2: Get Ready to Apply 17

Get registered 18

Find the application package 18

Application writing help 18

Step 3: Prepare Your Application 20

Application contents and format 21

Step 4: Learn About Review and Award 32

Application review 33

Award notices 39

Step 5: Submit Your Application 40

Application submission and deadlines 41

Application checklist 43

Step 6: Learn What Happens After Award 45

Post-award requirements and administration 46

Reporting 49

Contents 2

Contacts and Support 51

Appendix 54

Endnotes 61

Contents 3

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 February 25, 2025.

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

Before you begin 4 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 6

Summary 6

Funding details 7

Eligibility 8

Program description 11

Award information 15

Basic information Health Resources and Services Administration (HRSA)

Maternal and Child Health Bureau (MCHB)

Office of Epidemiology and Research (OER), Division of Research (DOR)

Supporting research to analyze national data sets or records to improve the health and well-being of mothers and children.

Have questions?

Go to Contacts and Support.

Key facts

Opportunity name:

Maternal and Child Health Secondary Data Analysis Research (MCH SDAR) and Autism Secondary Data Analysis Research (Autism

SDAR)

Opportunity number:

HRSA-25-023 and

HRSA-25-024

Announcement version:

New

Federal assistance listing:

93.110 and 93.877

Statutory authority number:

• MCH SDAR:42 U.S.C. §

701(a)(2) (Title V, § 501(a)(2) of the Social Security Act).

• Autism SDAR:42 U.S.C. § 280i-1(f) (Title III, § 399BB(f) of the Public Health Service Act)

Summary The Health Resources and Services Administration (HRSA) is accepting applications for two separate Secondary Data Analysis Research (SDAR) competitions for the fiscal year

(FY) 2025:

• HRSA-25-023: Maternal and Child Health Secondary Data Analysis Research (MCH

SDAR)

• HRSA-25-024: Autism Secondary Data Analysis Research (Autism SDAR)

The purpose of the SDAR programs is to support research that analyzes existing national data sets or administrative records to answer questions that can improve the health and well-being of maternal and child health populations, including children and adolescents with autism and other developmental disabilities (DD).

HRSA-25-023: Maternal and Child Health Secondary Data Analysis (MCH SDAR) The Maternal and Child Health Secondary Data Analysis program supports applied research through analysis of existing databases or administrative records to improve health outcomes, and the quality, efficiency, and accessibility of health care services for maternal and child health populations. This program will fund up to ten 2-year grants.

HRSA-25-024: Autism Secondary Data Analysis (Autism SDAR) The Autism Secondary Data Analysis program supports applied research through analysis of existing databases or administrative records to improve health outcomes,

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

Step 1: Review the Opportunity 6 https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&req=granuleid%3AUSC-2007-title42-section701&num=0#701_2_target https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&req=granuleid%3AUSC-2007-title42-section701&num=0#701_2_target https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&req=granuleid%3AUSC-2007-title42-section701&num=0#701_2_target https://uscode.house.gov/view.xhtml?req=(title:42%20section:280i-1%20edition:prelim) https://uscode.house.gov/view.xhtml?req=(title:42%20section:280i-1%20edition:prelim) http://www.hrsa.gov/

Key dates

NOFO issue date: November 26, 2024

Informational webinar:

December 3, 2024

Application deadline:

February 25, 2025

Expected award date is by:

June 1, 2025

Expected start date: July 1, See other submissions for other time frames that may apply to this NOFO.

and the quality, efficiency, and accessibility of health care services for children and adolescents with autism and other developmental disabilities (DD) across the lifespan. This program will fund up to eight 2-year grants.

Funding details Application type: New

Expected total available funding in FY 2025:

• MCH SDAR: $600,000

• Autism SDAR: $480,000

Expected number and type of awards:

• MCH SDAR: Up to 10 grants

• Autism SDAR: Up to 8 grants

Funding range per award: up to $60,000 per year.

We plan to fund awards in two 12-month budget periods, for a total 2-year period of performance from July 1, 2025, to June 30, 2027.

The program and awards depend on the appropriation of funds and are subject to change based on the availability and amount of appropriations.

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

Step 1: Review the Opportunity 7 https://www.grants.gov/learn-grants/grant-terminology#g https://www.grants.gov/learn-grants/grant-terminology#g

Eligibility Who can apply

• Maternal and Child Health SDAR: Only public or non-profit institutions of higher learning (i.e., education) and public or private non-profit agencies engaged in research or in programs relating to maternal and child health and/or services for children with special health care needs may apply. See 42 CFR § 51a.3 (b).

• Autism SDAR: Any public or private entity, including research centers or networks.

• Foreign entities are not eligible to apply.

• Individuals are not eligible to apply for this NOFO.

Types of eligible organizations The following types of domestic* organizations (who are otherwise eligible as per the criteria above) may apply:

• Public institutions of higher education

• MCH SDAR: Non-profit institutions of higher education; Autism SDAR: private institution of higher education

• Private non-profit entities

• State, county, city, township, and special district governments, including the District of Columbia, domestic territories, and freely associated states

• Independent school districts

• Native American tribal governments

• Native American tribal organizations

* “Domestic” means the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

For-profit entities (not eligible for MCH SDAR; only eligible for Autism SDAR)

• For-profits

Step 1: Review the Opportunity 8

Other eligibility criteria We may not consider an application for funding if it contains any of the following nonresponsive criteria:

• Exceeds the funding ceiling amount $60,000 per year.

• Fails to satisfy the deadline requirements.

Completeness and responsiveness criteria We will review your application to make sure it meets these basic requirements to move forward in the competition.

We will not consider an application that:

• Is from an organization that does not meet all eligibility criteria.

• Requests funding above the award ceiling shown in the funding range.

• Is submitted after the deadline.

Other required responsiveness criteria Due to funding limitations, the need to diversify the MCHB research portfolio, and ensuring that investigators devote substantial time to funded grants, the following are additional application responsiveness criteria. All applications that do not comply with these criteria will be deemed nonresponsive and will not be considered for funding under this notice.

• You should propose analysis of existing national data sets or administrative records.

• We will not consider projects that include the collection of data or biological specimens. This program funds secondary analysis of existing national databases and administrative data on MCH populations, including children and adolescents with Autism/DD.

• You are expected to establish an early-stage investigator (ESI)[1] and senior investigator pair as co-investigators.

• Ensure you apply to the correct funding opportunity.

◦ Applications on Autism topics that are incorrectly submitted to HRSA-25-023 MCH SDAR will not be considered.

◦ Applications on general MCH topics that are incorrectly submitted to HRSA-25-024 Autism SDAR will not be considered.

Step 1: Review the Opportunity 9

• An individual cannot be named as the project director (PD) or principal investigator (PI) on more than one application for each program (MCH SDAR and Autism SDAR).

• We expect the PD/PI to dedicate at least 20% of a full-time equivalent (FTE). The Co-PI should dedicate 10 percent of an FTE to this grant to demonstrate their commitment to the project.

• A PD/PI cannot have two active awards at the same time with HRSA/MCHB/OER/ DOR. An award in a no-cost extension year is considered active and the PD/PI is not allowed to receive another award unless the PD/PI decides to step down from their role in the previously funded award.

If you apply to both the MCH SDAR and Autism SDAR and are selected for funding based on merit review in both competitions, only one application will be awarded. HRSA will determine which application gets funded depending on factors such as the number and quality of the applications and the availability of funds.

Application limits An institution may submit multiple applications under the same Unique Entity Identifier (UEI) if each application proposes distinct projects.

For example, different investigators (or research teams) from the same institution can apply for the same funding opportunity.

If you submit your application multiple times, we will only review your last validated application before the Grants.gov due date.

Cost sharing This program has no cost-sharing requirement. If you choose to share in the costs of the project, we will not consider it during merit review.

We will hold you accountable for any funds you add, including through reporting.

Step 1: Review the Opportunity 10

Program description Purpose The purpose of the SDAR programs is to support research that analyzes existing national data sets or administrative records to answer questions that can improve the health and well-being of MCH populations, including children and adolescents with Autism/DD.

Program goals and objectives For Maternal and Child Health SDAR The goals of research supported by the HRSA-25-023 MCH SDAR program are to:

• Strengthen and expand the evidence base on topics addressed by:

◦ The Title V Maternal and Child Health Services Block Grant National Performance Measures or

◦ Align with HRSA MCHB’s Strategic Research Issues or

◦ MCHB Strategic Plan Goals or

◦ Healthy People 2030 objectives

• Enhance the evidence and strategies for reducing and eliminating health disparities[2] for all MCH populations.

• Address existing and new research topics of regional and national significance and highlight new data, knowledge, evidence, and strategies for addressing the burden of diseases that affect MCH populations.

• Prepare ESIs from diverse[3] backgrounds to successfully obtain and complete federal research awards.

For Autism SDAR The goals of research supported by the HRSA-25-024 Autism SDAR program are to:

• Address how your project aligns with the Interagency Autism Coordinating Committee’s Strategic Plan Objectives, MCHB’s strategic plan, and Blueprint for Change.

• Generate new evidence to address the needs of underserved[4] populations with autism/DD for whom there is limited evidence of the effectiveness of interventions, and limited access to screening, diagnosis, and treatment for autism/DD across the lifespan.

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

Step 1: Review the Opportunity 11 https://mchb.tvisdata.hrsa.gov/PrioritiesAndMeasures/NationalPerformanceMeasures https://mchb.tvisdata.hrsa.gov/PrioritiesAndMeasures/NationalPerformanceMeasures https://mchb.hrsa.gov/data-research/research-investments/strategic-research-issues https://mchb.hrsa.gov/sites/default/files/mchb/about-us/maternal-child-health-bureau-strategic-plan.pdf https://health.gov/healthypeople/objectives-and-data https://iacc.hhs.gov/publications/strategic-plan/2019/introduction.shtml https://iacc.hhs.gov/publications/strategic-plan/2019/introduction.shtml https://mchb.hrsa.gov/sites/default/files/mchb/about-us/maternal-child-health-bureau-strategic-plan.pdf https://mchb.hrsa.gov/programs-impact/focus-areas/children-youth-special-health-care-needs-cyshcn/blueprint-change https://mchb.hrsa.gov/programs-impact/focus-areas/children-youth-special-health-care-needs-cyshcn/blueprint-change

• Enhance the evidence and strategies for reducing and eliminating health disparities for children and adolescents with autism/DD.

• Contribute to a broad public health impact by improving patient engagement and care delivery through studies that are generalizable and replicable across underserved children and adolescents with autism/DD.

• Prepare ESIs from diverse backgrounds to successfully obtain and complete federal research awards.

For both programs The following objectives should be accomplished by both HRSA-25-023: MCH SDAR and HRSA-25-024: Autism SDAR by the end of the period of performance:

• Completion of a secondary data analysis research project in the field of MCH or Autism/DD.

• Submission of at least two manuscripts to peer-reviewed journals.

• Meaningful mentorship of an ESI by the senior investigator[5] through all stages of the project.

About MCHB and its strategic plan The HRSA Maternal and Child Health Bureau (MCHB) administers programs with focus areas in maternal and women’s health, adolescent and young adult health, perinatal and infant health, child health, and children with special health care needs.

To learn more about MCHB and the bureau’s strategic plan, visit Mission, Vision, and Work | MCHB.

Background Secondary analysis of existing data is an inexpensive way to study new and important research questions. The SDAR program is one of the few federal programs that supports analysis of existing national databases or administrative records in the MCH field.

These SDAR programs aim to improve the quality, efficiency, and accessibility of health care services and health outcomes for all MCH populations, including disparities in health outcomes.

MCH populations face severe challenges such as high rates of maternal mortality and morbidity, infant mortality, and children’s mental health conditions. Severe disparities in MCH raise public health concerns. Black women are three times more likely to die from a pregnancy-related causes than white women.[6]

The program also aims to improve access to autism/DD screening, diagnosis, and treatment, and to identify effective autism/DD interventions. Autism is a complex, life-

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

Step 1: Review the Opportunity 12 https://mchb.hrsa.gov/about-us/mission-vision-work https://mchb.hrsa.gov/about-us/mission-vision-work long neurodevelopmental condition that can cause significant and pervasive physical and behavioral health challenges. Parent-reported data from the Maternal and Child Health Bureau’s 2022 National Survey of Children’s Health (NSCH) showed that 3.6% of children ages 3 to 17 years had a current diagnosis of autism, representing nearly 2.2 million children and adolescents.[7] Children with autism/DD have a higher prevalence of at least one co-occurring condition such as seizures, sleep problems, gastrointestinal disorders, food selectivity, or speech disorders.[8] Disparities in access to diagnostic and early intervention services for autism are well documented, which could exacerbate the disparities in health outcomes and health later in life.[9]

As of FY 2023, SDAR program grantees have published more than 222 peer-reviewed papers that have helped advance the MCH field. For example, one SDAR study showed that younger children (ages 0 to 4 years) with short durations of nighttime sleep were more likely to become overweight or obese, compared to those with longer nighttime sleep duration.[10] This single study was cited 279 times by other studies, and contributed to pediatric sleep recommendations endorsed by the American Academy of Pediatrics.[11]

For FY 2025, HRSA/MCHB solicits studies addressing HRSA/MCHB priorities as well as existing and new issues impacting MCH and children and youth with Autism/DD.

Through this SDAR program, MCHB plans to increase the number of ESIs and awardees from diverse backgrounds as it is in alignment with MCHB’s strategic plan of Capacity (strengthen public health capacity and workforce for MCH).

Mentorship serves an important function to provide emotional, logistical, and professional development support for ESIs. Successful mentoring relationships between senior investigators and ESIs can result in promotion and tenure, grant funding, and publications for the ESI. A critical purpose of the SDAR program is to facilitate the transition of ESIs from diverse backgrounds to established investigators in MCH and Autism fields. Supporting successful independent careers for ESIs helps ensure the long-term stability of the MCH research workforce by building career pathways for the next generation of MCH researchers and retaining them as they become established investigators in the field. In addition, research also shows that “diverse research teams are more likely to have diverse ideas.”[12] NIH identified that “diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems”.[13] Similarly, “diverse teams which include health disparities investigators and scientists from high-burden and underrepresented communities produce the best science to understand the complexity of health disparities and implement better solutions”.[14]

Step 1: Review the Opportunity 13

As such, it is important to have diverse MCH researchers in the MCH SDAR and Autism SDAR programs to use secondary data to study research topics that advance health equity for underserved MCH populations. Thus, MCHB plans to increase the number of ESIs from diverse backgrounds in the SDAR program. MCHB also plans to increase the number of awardees from Minority Serving Institutions (MSI)

[15] in the SDAR program due to the unique contributions of MSIs in disparity research and designated resources to engage the communities they serve.

[16] Therefore, the participation of researchers from MSIs in HRSA/MCHB- funded research could be an effective strategy to advance health equity research by increasing the diversity of the researchers, especially from underserved communities/groups.

View our website for more information about the SDAR Program, funded projects, and current activities.

Program requirements and expectations

• Complete the proposed project you described in your application.

• Submit a plan to disseminate research findings and products to study participants, scientific, professional, and lay audiences. Include a timeline for implementation. Dissemination activities can include manuscripts, conference presentations, newsletter articles, webcasts, fact sheets, infographics, policy briefs, publicly available websites, and social media posts.

• Report study sample demographic information to HRSA’s Electronic Handbooks (EHBs).

• Submit at least two manuscripts to peer-reviewed journals.

• Present findings and guidelines to improve the healthcare services and health outcomes of individuals at the end-of-project presentation to MCHB staff.

• Measure and track program performance on key activities and program objectives.

This includes Discretionary Grants Information System (DGIS) measures. For more information on these measures, please see the Reporting section.

Performance measurement, evaluation, and continuous quality improvement

(CQI)

We expect you to measure your performance, evaluate your program, and conduct CQI activities to improve the quality of the project. Actions include measuring performance on key activities and program objectives.

This includes Discretionary Grants Information System (DGIS) measures noted in the Reporting section.

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

Step 1: Review the Opportunity 14 https://mchb.hrsa.gov/data-research/research-investments/funded-project https://mchb.hrsa.gov/data-research/research-investments/funded-project /H:/OFAM/General/DGP/FAP%20Branch/Equity%20in%20Grants/NOFO%20100%20Simplification%20Pilot%20Prototypes/Prototypes/HRSA%20NOFO%20100%20Content%20Guide%20for%20MCHB.docx#_Reporting

Each year, you must collect and report on added measures that align with program goals and objectives in a:

• Non-Competing Continuation (NCC) report (HRSA)

• End of the year project report (Division of Research-specific)

Award information Funding policies and limitations Policies

• We will only make awards if this program receives funding. If Congress appropriates funds for this purpose, we will move forward with the review and award process.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Your satisfactory progress in meeting the project’s objectives.

◦ A decision that continued funding is in the government’s best interest.

• If we receive more funding for this program, we may:

◦ Fund more applicants from the rank order list.

◦ Extend the period of performance.

◦ Award supplemental funding.

General limitations

• For guidance on some types of costs we do not allow or restrict, see Project

Budget Information in Section 3.1.4 of the R&R Application Guide. You can also see 45 CFR part 75, or any superseding regulation, General Provisions for Selected Items of Cost.

• You cannot earn profit from the federal award. See 45 CFR 75.400(g).

• Congress’s current appropriations act includes a salary limitation, which applies to this program. As of January 2024, the salary rate limitation is $221,900. This limitation may be updated.

Program-specific statutory or regulatory limitations Program funds cannot be used for foreign travel.

See Manage Your Grant for other information on costs and financial management.

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

Step 1: Review the Opportunity 15 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=15 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/part-75#p-75.216(b) https://www.hrsa.gov/grants/manage-your-grant

Indirect costs Indirect costs are costs you charge across more than one project and that cannot be easily separated by project. For example, this could include utilities for a building that supports multiple projects.

Indirect costs are determined using one of two methods:

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

Method 2 – De minimis rate. Per 2 CFR 200.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. This rate is 15% of modified total direct costs (MTDC). See 2 CFR 200.1 for the definition of MTDC. You can use this rate indefinitely or until you negotiate a rate. If you use the de minimis rate, you must use it for all federal awards unless you negotiate a rate.

Program income Program income is money earned as a result of your award-supported project activities. Program income must be added to the total project costs. Find more about program income at 45 CFR 75.307.

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

Step 1: Review the Opportunity 16 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-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.307

Step 2:

Get Ready to Apply

In this step

Get registered 18

Find the application package 18

Application writing help 18

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

To register, go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist to find out what you’ll need to register.

When you register or update your SAM.gov registration, you must agree to the financial assistance general certifications and representations. You must agree to those for grants specifically, as opposed to contracts, because the two sets of agreements are different. You will have to maintain your registration throughout the life of any award.

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.

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:

• HRSA-25-023 for Maternal and Child Health SDAR

• HRSA-25-024 for Autism SDAR

After you select the opportunity, we recommend that you select the Subscribe button to get updates on the opportunity.

Application writing help Visit HHS Tips for Preparing Grant Proposals.

Visit HRSA’s How to Prepare Your Application page for more guidance.

See Apply for a Grant for other help and resources.

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

Step 2: Get Ready to Apply 18 https://sam.gov/content/entity-registration https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/search-grants https://www.hhs.gov/grants-contracts/grants/get-ready-for-grants-management/tips-for-preparing-grant-proposals/index.html https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://www.hrsa.gov/grants/apply-for-a-grant

Join the webinar For more information about this opportunity, join the webinar on:

• Tuesday, December 3, 2024

• 3 p.m. ET

• Join the webinar on Zoom.

If you are not able to join through your computer, you can call in:

• Phone number: 833 568 8864

• Passcode: 84877255

• Meeting ID: 160 908 1550

We will record the webinar. If you are not able to join live, replay it at: Secondary Data Analysis Research (SDAR) Program | MCHB.

FAQs will be posted on our TA webpage after the webinar

Have 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 19 https://hrsa-gov.zoomgov.com/j/1609081550?pwd=Wwd6k0zkWB7P4hLqaO4LaFcdSyKQbu.1 https://mchb.hrsa.gov/programs-impact/programs/sdar-research

Step 3:

Prepare Your Application

In this step

Application contents and format 21

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

Application page limit: 60 pages.

Submit your information in English and express whole number budget figures using U.S. dollars.

Make sure you include each of these:

Components Submission format

Project abstract Use the Project Abstract Summary form.

Project narrative Use the Research & Related Other Project Information form.

Budget narrative Use the Research & Related Budget form.

Attachments Insert each in the Attachments form.

Other required forms Upload using each required form.

Required format You must format your narratives and attachments using our required formats for fonts, size, color, format, and margins. See the formatting guidelines in Section 3.2 of the R&R Application Guide.

Project abstract Complete the information in the Project Abstract Summary form. Include a short description of your proposed project. Include the needs you plan to address and the population you plan to serve. For more information, see Section 3.1.2 of the R&R Application Guide.

Project narrative Use the Research & Related Other Project Information form to attach the project narrative. In the project narrative, you will describe all aspects of your project. Project activities must comply with the nondiscrimination requirements.

Use the section headers and the order as listed.

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

Step 3: Prepare Your Application 21 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=25 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=25 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=14 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=14

Introduction See merit review criterion 1: Need

Briefly describe the purpose of your project. The purpose of this section is to provide a compelling explanation of your project for the reviewers to clearly understand the scientific value of the proposed study.

Unless otherwise stated, the following narrative elements apply to both MCH SDAR:

HRSA-25-023 and Autism SDAR: HRSA-25-024.

Need See merit review criterion 1: Need

• Briefly describe the study population’s unmet health needs and identify the health disparities they face.

• Briefly outline how the project will benefit the study population and address health disparities.

• Briefly outline how the project aligns with one of the following:

◦ Healthy People 2030 objectives

◦ MCHB Strategic Research Issues

◦ MCH Block Grant National Performance Measures

• Applicants to HRSA-25-024: Autism SDAR should also address how their project aligns with the Interagency Autism Coordinating Committee’s Strategic Plan Objectives, MCHB Strategic Plan Goals and Blueprint for Change.

Significance

• Explain the problems and research gaps that your study addresses and why it is important. Provide support with existing literature and data.

• Identify how your results may improve care, or the ways that services are organized and delivered, or achieve health equity in MCH populations (HRSA-25-023), including children and adolescents with autism/DD

(HRSA-25-024).

• Detail the existing literature to show why your study’s research objectives are important.

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

Step 3: Prepare Your Application 22 https://health.gov/healthypeople/objectives-and-data https://mchb.hrsa.gov/data-research/research-investments/strategic-research-issues https://mchb.hrsa.gov/programs-impact/title-v-maternal-child-health-mch-services-block-grant https://iacc.hhs.gov/publications/strategic-plan/2019/introduction.shtml https://iacc.hhs.gov/publications/strategic-plan/2019/introduction.shtml https://mchb.hrsa.gov/sites/default/files/mchb/about-us/maternal-child-health-bureau-strategic-plan.pdf

Methodology See merit review criterion 2: Response Please limit your Methodology to no more than 6 pages.

• Provide a short description of the databases you plan to use, including:

◦ Information on the funder of the data source.

◦ Overall study population.

◦ Sampling design and weighting.

◦ Inclusion and exclusion criteria.

◦ Response rate.

◦ Data collection procedures.

◦ Strengths, limitations, and appropriateness of the data.

◦ A description on how you will access restricted files (if appropriate).

◦ How you will link multiple data sets (if appropriate).

• Detail the statistical methods you will use in your data analysis and explain why they are appropriate for testing the proposed hypotheses. Identify potential biases in the database that the methods cannot address and how the data may be biased.

• Describe how your project will add to scientific knowledge and the evidence base and improve technical capability or clinical practice.

• Explain any novel, refined, or improved theoretical concepts, approaches or methodologies, policies, or analyses used, and any advantage over existing methodologies, or policies.

• Cite published methodological details and provide the full reference in the bibliography and references cited section.

Goals and hypotheses

• Describe the research question, overall study design, strategy, methodology, and analyses you will use to achieve the specific aims of the project.

• State the goals and objectives of your research study that are specific, measurable, achievable, relevant, and time bound, inclusive, and equitable (SMARTIE).

• Describe hypotheses and key variables, how the variables are measured, and the validity of the measurements.

• Create a graphic describing the theoretical model, conceptual framework, or the variables’ relationships. Make sure that any relationship shown in the graphic is consistent with your variable table, the statement of hypotheses, and the plan for data analysis.

Step 3: Prepare Your Application 23

High-level work plan See merit review criteria 2: Response and 4: Impact

Public health impact

• Describe the intended public health impact of the study results. For example, how the study can influence care delivery or the health and well-being of MCH populations.

• Describe how the study results will be generalizable.

Publication and dissemination plan You are expected to submit at least two manuscripts to peer-reviewed journals. Provide a publication and dissemination action plan that:

• Clearly details the number and focus of your proposed peer-reviewed publications, as well as the names of the journals where you plan to submit your papers.

• Describes how you will help put your findings into practice by distributing findings, reports, or project results to the MCH field. You will also include a more detailed work plan in your Attachments.

Resolving challenges See merit review criterion 2: Response

Discuss challenges that you anticipate in designing and carrying out the activities in the high-level work plan. Explain approaches that you will use to resolve them.

Examples include:

• The ability to access the dataset or administrative records within the required timeline to complete the tasks, including the most-recent dataset or administrative records if multiple years exist.

• The ability to complete the proposed work within the timeline.

Sustainability See merit review criterion 4 Impact:

• You must provide a project sequence or timetable. This should include the steps that will be taken to do each of the activities proposed during the entire period of performance. Use a timeline that includes each activity and identifies responsible staff.

• If funded, it is important that you implement and complete the study as proposed and approved.

Step 3: Prepare Your Application 24

Performance reporting, evaluation, and technical support capacity See merit review criteria 3: Performance reporting and evaluation and 5:

Resources and capabilities

Monitoring Describe how you will track project-related processes, activities, and milestones, and use data to identify actual or potential challenges to implementation.

Provide an initial list of measures (indicators, metrics) you will use to monitor progress.

Performance measurement Provide your plan for measuring and tracking program goals and objectives outlined in the purpose section.

The plan should include required or proposed measures outlined in the program requirements and expectations section and plans for the timely collection and reporting of all measures.

See Reporting for more information.

Program evaluation Plans should include a description of data to be collected, and how those data relate to:

• Program goals or objectives

• Performance measurement

• Data management and data submission plans

• Expected products

Continuous quality improvement Describe your plans for using and incorporating information from performance measurement and evaluation to inform and improve processes and outcomes of the proposed research activities.

Describe your capacity to collect and manage data to accurately and timely monitoring the performance measures.

Step 3: Prepare Your Application 25

Organizational information See merit review criterion 5: Resources and capabilities

Describe your organizational facilities and other resources:

• Briefly describe how your organizational mission and structure successfully support the scope of your current activities. Explain how they support your ability to carry out the program requirements. Include a project organizational chart.

• Identify the resources you will use in your study (such as a data platform, data center, computer lab, office, and other resources). As appropriate, detail their capacities, relevant capabilities, proximity, and availability.

• Discuss how you will follow the approved plan, account for federal funds, and record all costs to avoid audit findings.

• Briefly describe how the senior investigator will mentor the ESI in this project and any institutional investment in their success as a co-investigator. Examples may include computer and software support, collegial support such as the availability of organized peer groups, logistical support such as administrative management and oversight, and financial support such as protected time for research with salary support.

• Include a staffing plan, adequate staffing time, and job descriptions for key faculty and staff.

• If relevant, describe the organizations you will partner with to fulfill the program goals and meet the mentoring objectives. Include key agreements and letters of support (if applicable).

• Discuss plans to seek Institutional Review Board (IRB) approval or exemption. IRB approval is not required at the time of submission but must be received prior to the study.

Demonstrate qualifications of your research team’s key personnel[17]

• To evaluate the research team’s qualifications and research strategy, reviewers will use your:

◦ Preliminary studies in Methodology

◦ Staffing plan

◦ Biographical sketches of key personnel.

• Include biographical sketches for key staff using the Research & Related Senior/ Key Person Profile form. See Other required forms.

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

Step 3: Prepare Your Application 26 https://mchtraining.net/media/research/documents/FORM-Biosketch-Research-Applicants-2023.docx

Budget and budget narrative See merit review criterion 6: Support Requested

Complete the information in the Research and Related Budget form. Your budget should follow the instructions in Section 3.1.4 Project Budget Information of the R&R Application Guide and any specific instructions listed in this section. Your budget should show a well-organized plan.

HHS now uses the definitions for equipment and supply in 2 CFR 200.1. The new definitions change the threshold for equipment to the lesser of the recipient’s capitalization level or $10,000 and the threshold for supplies to below that amount.

The total project or program costs are all allowable (direct and indirect) costs used for the HRSA activity or project. This includes costs charged to the award and non-federal funds used to satisfy any matching or cost-sharing requirement (which may include maintenance of effort, if applicable).

The budget narrative supports the information you provide in the Research and Related Budget form. See Other required forms. It includes an itemized breakdown and a clear justification of the costs you request. The merit review committee reviews both.

As you develop your budget, consider:

• If the costs are reasonable and consistent with your project’s purpose and activities.

• The restrictions on spending funds. See funding policies and limitations

To create your budget justification narrative, see detailed instructions in Section 3.1.5 of the Application Guide.

Additional instructions specific to this NOFO follow.

Attachments Place your PDF attachments in order in the Attachments form.

Attachment 1: Work plan Attach the project’s work plan. Make sure it includes everything required in the Project Narrative section.

Attachment 2: Staffing plan and job descriptions See Section 3.1.7 of the R&R Application Guide.

Include a staffing plan that shows the staff positions that will support the project and key information about each. Justify your staffing choices, including education and

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

Step 3: Prepare Your Application 27 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=15 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=15 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Equipment) https://www.ecfr.gov/current/title-2/part-200#p-200.1(Supply) https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=18 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=22 experience qualifications. Explain your reasons for the amount of time you request for each staff position.

For key personnel, attach a one-page job description. It must include their role, responsibilities, and qualifications.

Attachment 3: Agreements with other entities Provide any documents that describe working relationships between your organization and others you mention in your project proposal. If you include documents that confirm actual or pending contracts or agreements, the documents should clearly describe the roles of subrecipients and contractors and any product. It is not necessary to include the entire contents of lengthy agreements, so long as the portions you include describe the working relationship between you and the other organization.

Make sure letters of agreement are signed and dated.

Attachment 4: Project organizational chart Provide a 1-page diagram that shows the full project’s organizational structure.

Attachment 5: Tables and charts Provide tables or charts that give more details about the proposal. These might be Gantt, PERT, or flow charts.

Attachment 6: Information regarding the database(s) you propose to use Provide written confirmation of your study’s database availability.

Attachment 7: Explanation on delinquent federal debt If your organization has delinquent federal debt, you need to attach an explanation.

Attachment 8: Proof of non-profit status If your organization is a non-profit, 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 non-profit and that none of your net earnings go to private shareholders or others.

Step 3: Prepare Your Application 28

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

• Any of the listed documents for a parent organization. Also include a statement signed by an official of the parent group that your organization is a non-profit affiliate.

Attachments 9 to 15: Other relevant documents Upload Other relevant documents as needed

Other required forms You will need to complete some other forms. Upload the following forms at Grants.gov.

You can find them in the NOFO application package or review them and any available instructions at Grants.gov Forms.

Forms Submission Requirement

Research and Related Other Project Information

With application

SF-424 (R&R) With application

R & R Subaward Budget Attachment(s) Form With application

Research and Related Senior/Key Person Profile (Expanded)

With application

Project/Performance Site Location(s) With application

Disclosure of Lobbying Activities (SF-LLL) If applicable, with the application or before award.

Form instructions In addition to the requirements for the project abstract, budget narrative, project narrative, and attachments, following are instructions for each of the other forms required by this NOFO.

See the application checklist for a full list of all application requirements.

SF 424 (R&R) form This is your application for federal assistance. Follow the instructions in Section 3.1.1 of the R&R Application Guide. This is the application for Federal Assistance.

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

Step 3: Prepare Your Application 29 https://www.grants.gov/forms https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=8

Research and Related Other Project Information In addition to the requirements in the project narrative section, you will provide some additional information in this form.

• Complete sections 1 through 6.

• Upload a blank document in item 7: Project Summary/Abstract to avoid a cross-form error with your Project Abstract Summary Form.

• Upload your project narrative in item 8.

• Leave items 9, 10, and 11 blank.

Research & Related Senior/Key Person Profile (Expanded) form

• Include biographical sketches for people who will hold the key positions.

• Try to use no more than two pages per person. These sketches count toward the page limit.

• Do not include non-public, personally identifiable information.

• If you include someone you haven’t hired yet, include a letter of commitment from that person with their biographical sketch.

• Upload sketches in the Research & Related Senior/Key Person Profile form.

• Include:

◦ Name and title.

◦ Education and training. For each entry, include institution and location, degree and date earned, if any, and field of study.

◦ Section A, personal statement. Briefly describe why the individual’s experience and qualifications make them well-suited for their role.

◦ Section B, positions, and honors. List in chronological order previous and current positions. List any honors. Include present membership on any federal government public advisory committee.

◦ Section C, other support. This section is optional. List selected ongoing and completed projects during the last three years. Begin with any projects relevant to the proposed project. Briefly indicate the overall goals of the projects and responsibilities of the person.

◦ Other information. If they apply, include language fluency and experience working with populations that are culturally and linguistically different from their own.

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

Step 3: Prepare Your Application 30 https://grants.gov/learn-grants/grant-terminology#p

R & R Subaward Budget Attachment(s) form You will also complete the R & R Subaward Budget Attachment Form for each subaward and subcontract you propose. You will do this using the R & R Subaward Budget Attachment Form.

To complete the budget forms, follow the instructions.

• Once you open this form, you can select “Click here to extract the R&R Subaward Budget Attachment.”

• Save the file and then open it to complete it.

• Once you save the file you can upload it within the form.

• Repeat the steps for each subaward.

If you have more than 10 subawards, you may upload the extra budget forms in the Research and Related Other Project Information form in Block 12 “Other Attachments.”

Project/Performance Site Locations(s) form Follow the form instructions in Grants.gov Forms. Use the “Next Site” option rather than “Additional Location(s)” to add more than one project/performance site location.

Disclosure of Lobbying Activities (SF-LLL) form Follow the form instructions in Grants.gov Forms.

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

Step 3: Prepare Your Application 31

Step 4:

Learn About Review and Award

In this step

Application review 33

Award notices 39

Application review Initial review We will review your application to make sure that it meets eligibility criteria, including the completeness and responsiveness criteria. If your application does not meet these criteria, it will not be funded.

We will not review any pages that exceed the page limit.

Merit review A panel reviews all applications that pass the initial review. The members use these criteria.

Criterion Total number of points = 100

1. Need 15 points

2. Response 40 points

3. Performance reporting and evaluation 10 points

4. Impact 15 points

5. Resources and capabilities 15 points

6. Support requested 5 points

Criterion 1: Need 15 points

See the project narrative’s Introduction and Need sections.

Needs Assessment (5 points) The panel will review your application for how well it:

• Provides a compelling introduction and overview of the research project.

• Adequately identifies and provides supporting literature, including appropriate data on the current gaps and challenges related to the research topic.

• Clearly states the scientific rationale for this project.

Step 4: Learn About Review and Award 33

Significance and…