MCHB-HRSA-25-021-(UM4)-ARC-final.pdf

Maternal and Child Health Bureau (MCHB)

Notice of Funding Opportunity

Application due April 23, 2025

Autism Research Consortium (Autism RC) Opportunity number: HRSA-25-021

Modified on 1/28/25 Updated TA Webinar information

Contents Before you begin 4

Step 1: Review the Opportunity 5

Basic information 6

Eligibility 8

Program description 10

Award information 16

Step 2: Get Ready to Apply 19

Get registered 20

Find the application package 20

Application writing help 20

Step 3: Prepare Your Application 22

Application contents and format 23

Step 4: Learn About Review and Award 33

Application review 34

Selection process 38

Award notices 38

Step 5: Submit Your Application 39

Application submission and deadlines 40

Application checklist 41

Step 6: Learn What Happens After Award 43

Post-award requirements and administration 44

Contacts and Support 49

Contents 2

Appendix A: MCHB Research Program Organizational Structure 52

Appendix B: Frequently Asked Questions (FAQs) 53

Endnotes 59

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 April 23, 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

Eligibility 8

Program description 10

Award information 16

Basic information Health Resources and Services Administration (HRSA)

Maternal and Child Health Bureau (MCHB)

Office of Epidemiology and Research, Division of Research (OER/DoR)

Supporting research to improve the health and well-being of children and adolescents with autism.

Have questions?

See Contacts and Support.

Key facts Opportunity name: Autism Research Consortium (Autism RC)

Opportunity number:

HRSA-25-021

Announcement version:

New

Federal assistance listing:

93.877

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

Key dates NOFO issue date:

January 17, 2025

Informational webinar:

See Webinar Section

Application deadline: April 23, 2025

Expected award date is by:

August 1, 2025

Expected start date:

September 1, 2025

See other submissions for other time frames that may apply to this NOFO.

Summary The HRSA Maternal and Child Health Bureau Research Consortium Program (MCHB RCP) will support a national group of researchers to study maternal and child health (MCH) and improve MCH outcomes. This program will ensure that resources are available to conduct research and share findings broadly to inform policy and practice.

The MCHB RCP contains three different investments (see Appendix A):

• Autism Research Consortium (Autism RC) (this competition)

• Maternal and Child Health Research Consortium (MCH RC) (under a separate Notice of Funding Opportunity (NOFO); HRSA-25-020)

• Research Coordinating Center (RCC) (under a separate mechanism)

The Autism RC will fund up to five research centers that will conduct research on MCHB priorities. The Autism RC supports both research infrastructure and research studies that will create, adapt, and share evidence-based strategies and interventions to increase the impact and efficiency of MCHB’s research investments. We anticipate that the studies will promote health and reduce health disparities.[1]

The Autism RC will align research priorities with MCHB program needs and address critical evidence gaps. A coordinating center will support collaborations across MCHB’s research portfolio.

Funding details Application types: New

Expected total available funding in FY 2025 (FY25): $5,000,000

Total number and type of awards: Up to 5 cooperative agreements

Funding range per award: Up to $1,000,000 each year

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

Step 1: Review the Opportunity 6 https://www.grants.gov/learn-grants/grant-terminology#c

We plan to fund awards in 12-month budget periods for a total of three-year period of performance from September 1, 2025 to August 31, 2028.

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

Step 1: Review the Opportunity 7

Eligibility Who can apply You can apply if you are a public or private entity, including research centers or networks.

• Foreign entities are not eligible to apply.

• Individuals are not eligible applicants under this NOFO.

Types of eligible organizations These types of domestic organizations may apply. “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.

• Public institutions of higher education

• Private institutions of higher education

• Nonprofits with or without 501(c)(3) IRS status

• For-profit organizations, including small businesses

• 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

Qualifications for principal investigator or project director

• Only one PD/PI (Project Director/Principal Investigator) can be named on the SF-424 R&R application. They will be the key point of contact. You can include co-investigators as key personnel on the project.

• Generally, a PD/PI cannot have two active HRSA/MCHB/OER/DoR awards at the same time.

◦ If you have an award that is in a no-cost extension year, it 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.

◦ However, if you are a current grantee of OER/DoR Autism CARES funding and your period of performance ends by 2026, you can apply for this opportunity.

Step 1: Review the Opportunity 8

◦ If you receive this award, we may ask you to relinquish the final year of your current award under certain circumstances.

• We expect the PD/PI to dedicate a minimum of 20% full-time equivalent (FTE) to the project.

• If you are selected, you will need to verify that percent effort across all federally-funded awards does not exceed 100%.

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.

• Is incomplete or non-responsive to the NOFO guidance.

Application limits You may submit more than one application under the same Unique Entity Identifier (UEI) if each application proposes a distinct project. This means that different investigators (or research teams) from the same institution can apply for the same funding opportunity.

We will only review your last validated application for each project.

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.

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

Step 1: Review the Opportunity 9 https://apply07.grants.gov/help/html/help/ManageWorkspaces/SubmissionStatus.htm#:~:text=Validated%3A%20This%20means%20that%20Grants,the%20package%20from%20Grants.gov

Program description Purpose The purpose of the Autism RC is to advance the evidence base on effective interventions, services, supports, and systems for children and adolescents with autism[2] and other developmental disabilities (DD) across the lifespan.

Program goals and objectives The program goals are to research MCHB priority areas and emerging issues that affect children and adolescents with autism, and to translate[3] research into practice. The overall goal is to improve health outcomes and reduce disparities at the population level.

Research centers funded through the Autism RC will conduct multiple research studies and build research infrastructure to facilitate the coordination and implementation of research activities.

Research infrastructure includes providing resources, logistical support, and coordinating partnerships, to support research and translate research into practice.

Research centers will conduct single-site or multi-site research studies that address the priorities listed.

In FY25, MCHB will fund five research centers related to priority autism research topics.

We anticipate funding up to two awards in each category.

To support program goals, each research center is expected to accomplish the following program objectives during the period of performance:

• Work with strategic partners, including people and families with lived experience, to inform research design, implementation, dissemination, and evaluation.

• Conduct studies related to priority research topics, focusing on reducing health disparities.

• Share research findings, including at least two peer-reviewed publications per year, and other dissemination products for non-academic stakeholders and partners.

• Mentor early career investigators, especially those from underserved communities.[4]

Step 1: Review the Opportunity 10

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 The Maternal and Child Health Bureau Research Consortium Program (MCHB RCP) creates a national group of researchers to study maternal and child health (MCH).

In the past, MCHB funded research networks, single investigator innovation studies, and field-initiated research studies. The MCHB RCP merges these programs into one. In FY25, this NOFO replaces the Research Network program, including the Autism Intervention Research Network on Behavioral Health (AIR-B) and the Autism Intervention Research Network on Physical Health (AIR-P).

Parent-reported data from the 2022 National Survey of Children’s Health (NSCH) documented that 3.6% of children ages 3-17 years had a current diagnosis of autism, representing nearly 2.2 million children and adolescents.[5] Autistic children have higher rates of co-occurring mental and behavioral health conditions compared to children without autism, and access to adequate health care is a significant challenge for children with autism.[6]

Of particular concern are the disparities in timing of diagnosis, access to services, and quality of care.[7] Research about effective and scalable interventions and services is needed to address the diverse and complex needs of autistic children and their families, with a focus on underserved and vulnerable populations.

Autism RC recipients will develop research-practice partnerships[8] with community organizations, people and families with lived experience,[9] and MCHB programs.

Through these partnerships, you will identify best practices for maximizing the impact of research. Research Centers will improve systems of care by translating and implementing evidence-based interventions to improve physical and behavioral health of children with autism and other DD across the lifespan.

The Autism RC will advance the evidence base on effective interventions, services, supports, and systems for children and adolescents with autism and other DD. Priority areas for the Autism RC were selected based on alignment with MCHB’s strategic priorities including the Blueprint for Change,[10] and the 2021-2023 IACC Strategic Plan.[11]

Each application under this NOFO will focus on one of the following categories.

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

Step 1: Review the Opportunity 11 https://mchb.hrsa.gov/about-us/mission-vision-work https://mchb.hrsa.gov/about-us/mission-vision-work https://mchb.hrsa.gov/programs-impact/focus-areas/children-youth-special-health-care-needs-cyshcn/blueprint-change

We anticipate funding up to 2 awards in each category. You are expected to focus on one or more of the priority topics listed within your chosen category (if applicable). To respond to this NOFO, you must focus on children or adolescents with autism and other

DD.

Category 1: Interventions related to physical health

• Healthy lifestyle factors such as nutrition, physical activity, or sleep, with the aim of reducing preventable morbidity and premature mortality.

• Physical health conditions that disproportionately impact children and adolescents with autism, such as obesity and oral health.

• Unmet physical health service needs for children and adolescents with autism.

Category 2: Interventions related to behavioral health

• Behavioral health[12] concerns that disproportionately impact children and adolescents with autism, such as anxiety and attention deficit hyperactivity disorder.

• Unmet behavioral health service needs for children and adolescents with autism.

Category 3: Systems of care Accelerate the implementation of effective evidence-based interventions at the systems level. Interventions should aim to improve timely screening and diagnosis, and access to appropriate care, services, and support to improve physical and/or behavioral health outcomes and reduce disparities at the population level. Proposals should focus on one or more of these systems:

• Health care systems

• School systems

• Community settings

• Other systems that support children and adolescents with autism

Category 4: Clinical innovations for developmental-behavioral pediatrics (DBP) Advance the evidence base in the developmental, behavioral, and psychosocial aspects of pediatric care. Develop, evaluate, and incorporate effective interventions into clinical services to improve physical and behavioral health for children and adolescents with autism and other DD across the lifespan.

Step 1: Review the Opportunity 12

Category 5: Interventions related to communication needs Advance the evidence base for novel interventions and support strategies to address communication challenges of children and adolescents with autism and other DD across the lifespan. Approaches can incorporate use of new technologies and should address the various communication needs across the autism spectrum.

Program requirements and expectations We expect each Autism RC award recipient to complete the following major activities:

Research

• Carry out single-site or multi-site research studies focusing on priorities identified in this NOFO. At least one of the studies should be an intervention study.[13] For the purpose of this NOFO, intervention studies can be efficacy, effectiveness, or implementation research.

• Ensure all research studies address the needs of underserved communities, are culturally and linguistically appropriate, and incorporate a community-based approach as appropriate.

• Ensure all research studies focus on translation and implementation of effective interventions, evidence-based practices, or guidelines as appropriate.

Research program infrastructure

• Develop and maintain a national, interdisciplinary network of partners that will build and strengthen the evidence for effective interventions, services, supports, and systems.

• HRSA intends to award a Research Coordinating Center (RCC). If awarded, the Research Centers will participate in activities led by the RCC, such as committees and workgroups, attending an annual meeting, and sharing publications and research findings with the RCC for broader dissemination.

Strategic partnerships

• Establish an interdisciplinary governance body (e.g., advisory board or steering committee) that meets biannually to:

◦ Inform research studies and their design, dissemination, implementation, translation, and evaluation.

Step 1: Review the Opportunity 13

◦ Ensure that research activities are aligned with the priorities and needs of children and adolescents with autism and their families and are culturally and linguistically appropriate.

• The governance body should have representation from each of the following groups:

◦ MCHB public health and research programs that support children and youth with special health care needs.

◦ People and families with lived experience, including those from underserved populations.

◦ Community-based organizations that can engage and support underserved communities.

◦ Experts in implementation science.

◦ Key partners needed for translation and implementation of interventions, such as providers, state/local programs, policy makers, and community organizations.

• Collaborate with HRSA to modify the research plan to address emerging priorities based on input from stakeholders.

Dissemination, evaluation, and sustainability

• Develop a plan to disseminate research findings and evidence-based guidelines to multiple audiences in the form of policy briefs, journal manuscripts, presentations to policy makers, and professional conferences.

• Publish at least two peer-reviewed publications per year, as well as other dissemination products for non-academic audiences.

• Submit at least one grant application each year to funders outside of MCHB’s research program to sustain and expand the research studies.

Mentorship

• Identify mentorship needs to build the autism research workforce, with a specific focus on studies of interventions, services, supports and systems for children and adolescents with autism and other DD.

• Mentor emerging and early career investigators, especially those from underserved communities and diverse backgrounds, to build the autism research workforce.

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

Step 1: Review the Opportunity 14 https://data.hrsa.gov/topics/mchb/mchb-grants https://mchb.hrsa.gov/data-research/research-investments

Performance measurement, evaluation, and continuous quality improvement (CQI) We expect you to measure your performance, evaluate your program, and conduct continuous quality improvement (CQI) activities. See the accompanying section titled performance reporting and evaluation. Actions include:

• Measuring performance on key activities and program objectives.

◦ This includes Discretionary Grants Information System (DGIS) measures on Research, Products and Publications, Health Equity and Partnerships and Collaboration.

◦ For more information on these measures, please see the Reporting section.

• Evaluating your program.

◦ In the event HRSA funds the RCC, you are expected to participate in evaluation activities led by the RCC, as well as HRSA’s autism program evaluation activities.

◦ You are expected to develop a preliminary program-specific evaluation plan that includes progress towards long-term goals, including expansion of the evidence base in priority areas, systems-level implementation of interventions, and policy and program impact. If awarded, you can update your plan to align with the other evaluation activities.

◦ Evaluation plans should include the measures listed in the performance measurement expectations section.

• Continuous Quality Improvement (CQI):

◦ You are expected to engage in CQI for your internal use to make sure you meet your goals.

▪ For example, use findings from evaluation work to inform and improve your processes and outcomes.

Step 1: Review the Opportunity 15

Award information Cooperative agreement terms Our responsibilities Aside from monitoring and technical assistance, we also get involved in these ways:

• Helping you to prioritize, plan, and develop all project activities.

• Meeting and communicating with you regularly.

• Participating in project activities, such as webinars, presentations, or meetings on study results and activities.

• Holding you accountable to your project’s goals and objectives.

• Helping you to create and maintain federal contacts both within and outside HRSA/MCHB that are needed to carry out your project.

• Reviewing all products including the methodology, analysis, results, policy implications, format, and tone prior to public dissemination.

Your responsibilities You must follow all relevant laws and policies. Your other responsibilities will include:

• Developing an organizational structure to carry out all award activities.

• Collaborating with MCHB project officer(s) and engaging them as part of your leadership team.

• Ensuring that HRSA is identified as the funder on all products and presentations developed with award funds, including appropriate disclaimers.

• Submitting to MCHB project officer(s) a pre-publication draft of manuscripts and other materials produced under this cooperative agreement before publishing and sharing with the greater public.

• Providing HRSA access to each product, including presentations and manuals, electronically or otherwise.

• Informing project officer(s) when hiring new project staff, planning new activities, and forming new partnerships.

• Responding in a timely manner to your project officer’s comments, questions, and requests, including modifying your research plan and/or carrying out limited qualitative or quantitative analyses to address emerging issues.

Step 1: Review the Opportunity 16

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

◦ Recipients may request supplemental funding during their period of performance to address needs within their scope of work. HRSA may support supplemental projects in accordance with HRSA grants policy if:

▪ Funding is available and able to be allocated.

▪ The request is reasonable and allowed.

▪ Enough time remains in the budget period to approve the request.

▪ The activities are in line with HRSA priorities and are different from other HRSA funded work.

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, 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 2025, the salary rate limitation is $225,700. This limitation may be updated.

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 17 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/subtitle-A/subchapter-A/part-75#75.400 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.

This award funds research activities and research infrastructure development; as such this is not a traditional research project. Many of the research activities may be conducted in communities or other off-site locations other than your institution.

Therefore the “Other Sponsored Program/Activities” or “Off-Site” indirect costs rates may be most appropriate for the activities described.

Program income Program income is money earned as a result of your award-supported project activities. You must use any program income you generate from awarded funds for approved project-related activities. 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 18 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 20

Find the application package 20

Application writing help 20

Get registered SAM.gov You must have an active account with SAM.gov to apply. 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-25-021.

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

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 20 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 More information on this NOFO's webinar will be posted at a later date to the related documents tab here.

We recommend you “Subscribe” to the NOFO on Grants.gov to receive updates when documents are posted.

The Webinar will be recorded.

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 21 https://grants.gov/search-results-detail/355631

Step 3:

Prepare Your Application

In this step

Application contents and format 23

Application contents and format Applications include five 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 Enter 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.

Make sure to:

• Include a short description of your proposed project.

• Include the needs you plan to address, the proposed research projects, and the target populations you plan to serve.

For more information, see Section 3.1.2 of the R&R Application Guide.

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

Step 3: Prepare Your Application 23 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

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.

Introduction See merit review criterion 1: Need

• Specify which research category you are applying for, as described in the Background section:

1. Interventions related to physical health

2. Interventions related to behavioral health

3. Systems of care

4. Clinical innovations for developmental-behavioral pediatrics

5. Interventions related to communication needs

• 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 easily understand the scientific value of the proposed studies.

Need See merit review criterion 1: Need

• Describe the need for the project and its public health significance.

• Summarize the existing literature to show why your project objectives are important, and how they will address a critical barrier or gap in the field.

• Briefly outline how the project aligns with core priorities of the Blueprint for Change and the IACC Strategic Plan. Proposed activities should focus on the translation and implementation of evidence-based interventions, improving systems of care, addressing social determinants of health, and addressing the needs and priorities of autistic children and their families across the life course.

Methodology and approach See merit review criterion 2: Response

We recommend no more than 12 pages for this section.

• Describe the proposed research infrastructure that will support your collaborative research.

• Define overall project goals and objectives.

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

Step 3: Prepare Your Application 24 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 https://iacc.hhs.gov/publications/strategic-plan/2023/

◦ The project objectives should be specific, measurable, achievable, relevant, time-bound, inclusive, and equitable.

◦ Describe how the project objectives link to the goals and objectives described in the Purpose section of this NOFO.

◦ Describe how you will address health disparities in your project’s goals and objectives.

• Describe the approaches or strategies to achieve each goal and objective.

◦ Provide sufficient technical details to show the necessary steps to accomplish each objective.

◦ Give reviewers enough information to assess if your methodology is effective and appropriate.

• Describe how you will address your stated needs and meet the program purpose, requirements and expectations described in this NOFO.

• Describe how you plan to establish a governance structure of the key stakeholders and partners listed in the program requirements and expectations, and how this will inform all stages of the research process, including planning, design, implementation, and evaluation of research activities. Include plans for recruiting members and processes for shared decision-making.

• Describe the research studies that you intend to implement during the period of performance. Include scientific rationale, specific aims, study design, and target populations. At least one study should be an intervention study.

• Provide enough detail for reviewers to evaluate the proposed research studies. If you receive the award, the research plan will be refined in collaboration with HRSA and other partners.

• Describe the anticipated impact of your proposed research, including how the collection and analysis of data by demographic characteristics, including but not limited to, race/ethnicity or socioeconomic status will have an impact on reducing health disparities.

• Describe your plans to disseminate findings widely with diverse stakeholders, including health professionals, policymakers, family members, and the greater public.

◦ Specifically include plans for:

▪ Peer-reviewed publications: You are expected to publish at least two peer-reviewed publications per year.

▪ Dissemination strategies aiming to accelerate the translation of evidence to inform practice and policy at the national, state, and local levels.

Step 3: Prepare Your Application 25

▪ Other forms of communication, such as presentations to policy makers, clinicians, and other stakeholders, webinars, trainings, tools and toolkits.

▪ Your collaboration with partners including the RCC, to share and translate research findings to a variety of audiences.

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

• Provide a work plan and a timeline that describes the activities or steps that you will take to achieve your project’s proposed objectives. Ensure that the program requirements and expectations are included, and that the work plan covers the entire period of performance.

• Describe how you will ensure that all activities will be completed during the period of performance.

• Describe your management plan.

◦ Include personnel, resources, and activities.

◦ If you will make subawards or spend funds on contracts, describe how you will communicate with subrecipients to make sure the work is consistent, timely, and of high-quality.

◦ Describe how your organization will ensure proper documentation of funds for subrecipients.

• Identify meaningful support and collaboration with key stakeholders to plan, design, and carry out all activities.

• Describe how you will collaborate with HRSA to change the research plan to address emerging priorities.

• Describe how you will comply with the Department of Health and Human Services (HHS) regulations for protection of human subjects (45 CFR part 46).

◦ Refer to instructions provided in HRSA’s SF-424 R&R Application Guide for specific instructions on preparing the human subjects section of the application.

◦ Institutional Review Board (IRB) approval is not required when you submit your application but must be received before starting any activities involving human subjects.

◦ All institutions that are engaged in nonexempt human subjects research as part of the project must be covered by a Federalwide Assurance (FWA) approved by the Office for Human Research Protections (OHRP).

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

Step 3: Prepare Your Application 26 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf

Resolving challenges See merit review criterion 2: Response

• Discuss challenges that you are likely to encounter while designing and carrying out the activities in the work plan. Explain approaches that you’ll use to resolve these challenges.

◦ Examples include but are not limited to challenges related to data collection, collaboration with stakeholders, engaging priority populations, synthesizing and translating findings.

Performance reporting and evaluation See merit review criteria 3 and 5: Performance reporting and evaluation and 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 carrying out your plan. 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 and proposed measures outlined in the Program requirements and expectations section, and plans for your timely collection and reporting of all measures. See Reporting for more information.

• Program Evaluation. Describe your program evaluation plans and methods for completing the activities outlined in the Program requirements and expectations section.

◦ Evaluations should follow the HHS Evaluation Policy, as well as the standards and best practices described in OMB Memorandum M-20-12.

◦ Include your timeline for carrying out your evaluation activities, your anticipated evaluation barriers, and your plan to address them.

◦ The evaluation plan will be revised after you are award in order to align with the other planned evaluation activities led by the RCC (under a separate mechanism) as well as HRSA’s autism program evaluation activities.

• Continuous Quality Improvement. Describe your plans for using and incorporating information from performance measurement and evaluation to inform and improve processes and outcomes.

◦ Describe your capacity to collect and manage data in a way that allows for accurate and timely monitoring, performance measurement, evaluation, and continuous quality improvement

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

Step 3: Prepare Your Application 27 https://aspe.hhs.gov/reports/department-health-human-services-evaluation-policy

◦ Include a description of the available resources (for example, organizational profile, collaborative partners, staff skills and expertise, budget), systems, and key processes you will use for monitoring, (for example, data sources, data collection methods, frequency of collection, data management software).

Sustainability See merit review criterion 4: Impact

We expect you to continue key project elements that improve practices and outcomes for the target population beyond the award period. Propose a plan for project sustainability after the period of federal funding ends.

Describe the actions you will take to:

• Identify key elements of your projects that are critical to project sustainability.

• Obtain additional sources of funding.

◦ We expect you to submit at least one application for external funding each year to sustain the research infrastructure and expand the scientific knowledge created from the research supported by this award.

• Discuss challenges that you will likely encounter in continuing the research.

Include how you expect to solve these challenges.

Organizational information See merit review criterion 5: Resources and capabilities

• Briefly describe your mission, structure, and the scope of your current activities.

Explain how they will help you carry out the program requirements. Include a project organizational chart as Attachment 3.

• Discuss how you will follow the approved project, keep track of all federal funds, and record all costs to avoid issues during the project audit.

• Include a staffing plan and job descriptions for key faculty and staff in Attachment 1.

• Describe the organizations you will partner with to fulfill the program goals and meet the project’s objectives. Include key agreements and letters of support in Attachment 2.

• You will also include biographical sketches for key staff using the Research & Related Senior/Key Person Profile form. See other required forms.

• If research will be conducted at more than one site, describe each site’s resources.

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

Step 3: Prepare Your Application 28 https://grants.nih.gov/grants/forms/biosketch-blank-format-rev-10-2021.docx

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

Complete the information in the Research & 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 a 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.

You are expected to budget for in-person attendance at the annual HRSA Research Grantee meeting in the Washington, D.C. area for up to two people (the PI and one other attendee) for 2 days. Meeting attendance is an award requirement. The meeting is expected to alternate between in-person or virtual each year.

Additionally, the PI or designated representative is expected to attend the annual Autism CARES Grantee Meeting. This meeting is held in-person and virtually on alternate years, and sufficient funds should be budgeted to allow for travel to this meeting one time during the award period. We recommend including the travel costs in the budget for Year 3, with rebudgeting allowed based on the meeting schedule.

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

Attachments Place your PDF attachments in order in the Attachments form. See application checklist to determine if they count toward the page limit.

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

Step 3: Prepare Your Application 29 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/subtitle-A/chapter-II/part-200#p-200.1(Supply) https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf

Attachment 1: Staffing plan 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 experience qualifications and your reasons for the amount of time you request for each staff position.

Attachment 2: Agreements with other entities Provide any documents that describe working relationships between your organization and others you refer to in the proposal. Documents that confirm actual or pending contracts or agreements should clearly describe the roles of subrecipients and contractors, as well as any deliverables. Make sure you sign and date any letters of agreement.

Attachment 3: Project organizational chart Provide a one-page diagram that shows the full project’s organizational structure.

Attachment 4: Explanation on delinquent federal debt Only attach this if you have delinquent federal debt that you will explain.

Other required forms You will need to complete some other forms. Upload the following listed 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 & Related Other Project Information With application

SF-424 (R&R) With application

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

Research & 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.

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

Step 3: Prepare Your Application 30 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=1 https://www.grants.gov/forms

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

Research & 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)

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

• For this NOFO only, biographical sketches do not count toward the page limit.

• Try to use no more than 5 pages per person.

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

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

• Upload biographical 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.

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

Step 3: Prepare Your Application 31 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=8 https://grants.nih.gov/grants/forms/biosketch-blank-format-rev-10-2021.docx https://grants.gov/learn-grants/grant-terminology#p

◦ 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, Contribution to Science. 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.

R&R Subaward Budget Attachment(s) Form You will also complete the R&R Subaward Budget Attachment Form for each subaward you propose. These include subcontracts. You will do this using the R & R Subaward Budget Attachment(s) 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) 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 32

Step 4:

Learn About Review and Award

In this step

Application review 34

Selection process 38

Award notices 38

Application review Initial review We will review your application to make sure that it meets eligibility criteria, including the completeness and…