MCHB-HRSA-24-048 (R41) Autism-FIRST-Final.pdf

Department of Health and Human Services

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2024

Maternal and Child Health Bureau

Office of Epidemiology and Research

Division of Research

Autism Field-Initiated Innovative Research Studies (Autism FIRST)

Funding Opportunity Number: HRSA-24-048

Funding Opportunity Type(s): New

Assistance Listing Number: 93.877

Application Due Date: April 3, 2024 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

We will not approve deadline extensions for lack of registration.

Registration in all systems may take up to 1 month to complete.

Issuance Date: January 4, 2024

Emmie Perchak, MPH, MCD & Sibil Varghese, MPH Project Officers, Office of Epidemiology and Research, Division of Research Call: 301-443-0714 & 224-448-9950 Email: AutismFirst@hrsa.gov

See Section VII for a complete list of agency contacts.

Authority: 42 U.S.C. § 280i-1(f) (Title III, § 399BB(f) of the Public Health Service Act) mailto:AutismFirst@hrsa.gov

HRSA-24-048 Autism FIRST i

508 COMPLIANCE DISCLAIMER

Persons using assistive technology may not be able to fully access information in this file. For assistance, email or call one of the HRSA staff listed in Section VII Agency Contacts.

SUMMARY

Funding Opportunity Title: Autism Field-Initiated Innovative Research Studies (Autism FIRST)

Funding Opportunity Number: HRSA-24-048

Assistance Listing Number: 93.877

Due Date for Applications: April 3, 2024

Purpose: The purpose of this program is to support empirical research that advances the evidence on early screening and interventions to improve the health of children, adolescents, and young adults with autism and other developmental disabilities (DD)1 across the lifespan. Research for this program includes a special focus on addressing the needs of underserved populations and, as appropriate, engaging families.

Program Objective(s): • Generate new evidence to address the needs of underserved autistic and DD populations for whom there is limited evidence of the effectiveness of interventions, and limited access to screening, diagnosis, and treatment for autism and DD;

1 The word ‘disorder’ is not used in this NOFO when referring to persons with autism or other developmental disabilities. HRSA MCHB intends for the abbreviated terminology of ‘autism’ used herein to refer to the population of individuals which meet the diagnostic criteria for autism spectrum disorder and autistic disorder, as formally recognized by the American Psychological Association (APA) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR) and the World Health Organization (WHO) in the International Classification of Diseases 11th Revision (ICD-11), respectively.

HRSA-24-048 Autism FIRST ii

• Conduct and disseminate findings from applied and/or translational research on critical and emerging autism/DD issues using a research design including collection of primary data among underserved populations, with a special focus on children, adolescents, and young adults up to the age of 26;

• Inform public health efforts to improve delivery of health and related services that are generalizable and replicable for underserved autism/DD populations; and

• Align research with MCHB’s Blueprint for Change, with an emphasis on promoting health equity, family and child well-being and quality of life, and access to services.

Eligible Applicants: • Public or private entities, including research centers or networks

• Community-based organizations

• Tribal (governments, organizations)

You are required to submit proof of non-profit status as Attachment 5. A foreign applicant will need to be affiliated with a U.S. entity (i.e., university, institution) with a U.S. EIN established and recognized by HRSA to be considered a public or nonprofit institution of higher learning or a public or private nonprofit agency.

See Section III.1 of this notice of funding opportunity (NOFO) for complete eligibility information.

Anticipated FY 2024 Total Available Funding:

$600,000, subject to the availability of appropriated funds

We’re issuing this notice to ensure that, should funds become available for this purpose, we can process applications and award funds appropriately. You should note that we may cancel this program notice before award if funds are not appropriated.

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

HRSA-24-048 Autism FIRST iii

Estimated Number and Type of Award(s):

Up to 2 new grants

Estimated Annual Award Amount:

Up to $300,000 per award

Cost Sharing or Matching Required:

No

Period of Performance: September 1, 2024, through August 31, 2027 (3 years)

Agency Contacts: Business, administrative, or fiscal issues:

David Colwander Grants Management Specialist Division of Grants Management Operations, OFAM Email: DColwander@hrsa.gov

Program issues or technical assistance:

Emmie Perchak, MPH, MCD & Sibil Varghese, MPH

Project Officers, Office of Epidemiology and Research, Division of Research Maternal and Child Health Bureau Email: AutismFirst@hrsa.gov

Application Guide

You (the applicant organization / agency) are responsible for reading and complying with the instructions included in this NOFO and in HRSA R&R Application Guide (R&R Application Guide). Visit HRSA’s How to Prepare Your Application page for more information.

Technical Assistance

We have scheduled the following webinar:

Thursday, January 18, 2024 2 – 3 p.m. ET Weblink: https://hrsa-gov.zoomgov.com/j/1613538211?pwd=cHc4ZnZQa1c3UG9zOG90c2xKUCtiQT09

Passcode: kwd0pS1c mailto:DColwanderhrsa.gov mailto:AutismFirst@hrsa.gov https://www.hrsa.gov/sites/default/files/hrsa/grants/sf-424-rr-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/sf-424-rr-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/sf-424-rr-app-guide.pdf https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://hrsa-gov.zoomgov.com/j/1613538211?pwd=cHc4ZnZQa1c3UG9zOG90c2xKUCtiQT09 https://hrsa-gov.zoomgov.com/j/1613538211?pwd=cHc4ZnZQa1c3UG9zOG90c2xKUCtiQT09

HRSA-24-048 Autism FIRST iv

Attendees without computer access or computer audio can use the following dial-in information.

Dial-in: 833 568 8864 Meeting ID: 161 353 8211 Participant Code: 07356472

We will record the webinar. https://mchb.hrsa.gov/research/pre-app-ta-webinars.asp https://mchb.hrsa.gov/research/pre-app-ta-webinars.asp

HRSA-24-048 Autism FIRST v

Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING OR MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Justification Narrative

v. Attachments

3. UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEMENT (SAM)

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: STRATEGIC RESEARCH ISSUES

APPENDIX B: RESEARCH PROGRAM APPLICATION COMPLETENESS CHECKLIST

APPENDIX C: FREQUENTLY ASKED QUESTIONS (FAQS)

APPENDIX D: KEY TERMS FOR PROJECT ABSTRACTS

APPENDIX E: GUIDANCE ON BIOGRAPHICAL SKETCHES

APPENDIX F: RELEVANT WEBSITES

APPENDIX G: PAGE LIMIT WORKSHEET

HRSA-24-048 Autism FIRST 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the FY 2024 Autism Field-Initiated Innovative Research Studies (Autism FIRST) program. The purpose of the Autism FIRST program is to support empirical research that advances the evidence on early screening and interventions to improve the health and well-being of children, adolescents, and young adults with autism and other developmental disabilities (DD) across the lifespan. The Autism FIRST program aims to achieve this goal by testing the implementation of new and/or innovative strategies that address critical issues affecting the health and receipt of related health services among children, adolescents, and young adults with autism/DD, with a special focus on addressing the needs of underserved populations.

The Autism FIRST program objectives to be accomplished during the period of performance are to:

• Generate new evidence to address the needs of underserved autistic/DD populations for whom there is limited evidence of the effectiveness of interventions, and limited access to screening, diagnosis, and treatment for autism/DD;

• Conduct and disseminate findings from applied and/or translational research on critical and emerging autism/DD issues using a research design including collection of primary data among underserved populations, with a special focus on children, adolescents, and young adults up to the age of 26.

• Inform public health efforts to improve delivery of health and related services through studies that are generalizable and replicable for underserved autism/DD populations; and

• Align research with MCHB’s Strategic Research Issues and Blueprint for Change, with an emphasis on promoting health equity, family and child well-being and quality of life, and access to services;

For more details, see Program Requirements and Expectations

2. Background

• This program is authorized by 42 U.S.C. § 280i-1(f) (Title III, § 399BB(f) of the Public Health Service Act), as amended by the Autism Collaboration, Accountability, Research, Education, and Support Act of 2019 (Autism CARES Act of 2019) (Pub. L. 116-60)).

https://mchb.hrsa.gov/research/strategic-research-issues.asp 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://nih.sharepoint.com/sites/HRSA-MCHB/MCHB-Team/opp/grants/Documents%20by%20Fiscal%20Year%20and%20Division/FY%2024/OER/(R41)%20Autism%20FIRST/l https://nih.sharepoint.com/sites/HRSA-MCHB/MCHB-Team/opp/grants/Documents%20by%20Fiscal%20Year%20and%20Division/FY%2024/OER/(R41)%20Autism%20FIRST/l

HRSA-24-048 Autism FIRST 2

A comprehensive picture of autism among children in the U.S is best understood by examining two key estimates of autism prevalence.2 The Centers for Disease Control and Prevention used population-based autism prevalence estimates for U.S. children reported from the Autism Developmental Disabilities Monitoring Network (ADDM) – a surveillance system in local population-based areas in which autism cases are identified through education and health records review – to report that approximately 2.76% children have autism.3 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.4 Estimates from these two systems reflect different data collection periods, populations (local U.S. populations versus the entire U.S.), and ages of children (children aged 8 years in ADDM versus 3-17 years in NSCH) and contribute unique information that, when combined, help form a comprehensive picture of autism among children in the U.S. Autism is a complex neurodevelopmental disorder, and individuals with this condition experience a range of behavioral challenges with social interactions and communication, as well as restrictive and repetitive behaviors, which can be lifelong and pervasive.5

Access to adequate health care is a significant problem for children, adolescents, and young adults with special health care needs, and is even more pronounced for those with autism/DD.6 Many gaps in research remain regarding effective interventions for their complex needs. Furthermore, the impact of racial and ethnic disparities in the early evaluation and diagnosis of autism/DD may be compounded by social determinants of health (SDOH) across the lifespan. SDOH are conditions in which people are born, live, work, learn, play, worship, and age.7 SDOH include factors like socioeconomic status, 2Kogan, et al. (2018) The Prevalence of Parent-Reported Autism Spectrum Disorder Among US Children.

Pediatrics 142(6).

3 Autism and Developmental Disabilities Monitoring Network (2020 data). Accessed 08/01/2023.

(http://www.cdc.gov/ncbddd/autism/data.html)

4 Child and Adolescent Health Measurement Initiative. 2022 National Survey of Children’s Health (NSCH) data query. Data Resource Center for Child and Adolescent Health supported by the U.S. Department of Health and Human Services, Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB). Retrieved 10/3/2023 from NSCH 2022: NOM 17.3: Percent of children diagnosed with an autism spectrum disorder, Nationwide (childhealthdata.org).

5 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders V. Washington, DC: American Psychiatric Publishing; 2022.

6 Bishop-Fitzpatrick L, Kind AJH. A Scoping Review of Health Disparities in Autism Spectrum Disorder. J Autism Dev Disord. 2017 Nov;47(11):3380-3391. doi: 10.1007/s10803-017-3251-9. PMID: 28756549;

PMCID: PMC5693721.

7 Social determinants of health (SDOH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. Accessed 08/02/23. https://health.gov/healthypeople/objectives-and-data/social-determinants-health.

http://www.cdc.gov/ncbddd/autism/data.html https://www.childhealthdata.org/browse/survey/results?q=10027&r=1 https://www.childhealthdata.org/browse/survey/results?q=10027&r=1 https://health.gov/healthypeople/objectives-and-data/social-determinants-health https://health.gov/healthypeople/objectives-and-data/social-determinants-health

HRSA-24-048 Autism FIRST 3 education, neighborhood and physical environment, community violence, employment, and social support networks, as well as access to health care. Addressing SDOH, which affect a wide range of health, functioning, and quality-of-life outcomes and risks, is in line with HRSA’s objective to improve the health and well-being of individuals and the communities in which they reside.

The Autism FIRST program aims to improve the quality of care for those who have or are at risk for developing autism/DD through education, early detection, and intervention. For FY 2024, the Maternal and Child Health Bureau will solicit studies addressing HHS/HRSA’s priorities and the MCHB strategic plan goals, as well as studies that align with the Title V Block Grant National Performance and Outcome Measures, and focus on underserved populations.

About MCHB and its Strategic Plan

The HRSA Maternal and Child Health Bureau (MCHB) administers programs that focus on maternal and women’s health, adolescent and young adult health, perinatal and infant health, child health, and children with special health care needs. To achieve its mission of improving the health and well-being of America’s mothers, children, and families, MCHB is implementing a strategic plan that includes the following four goals:

Goal 1: Assure access to high quality and equitable health services to optimize health and well-being for all MCH populations

Goal 2: Achieve health equity for MCH populations

Goal 3: Strengthen public health capacity and workforce for MCH

Goal 4: Maximize impact through leadership, partnership, and stewardship

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

The Autism FIRST program addresses MCHB’s Goal 1 and Goal 2 to assure access to high quality and equitable health services to optimize health and well-being for all children, adolescents, and young adults with autism/DD and their families and achieve health equity for MCH populations. This program advances Goal 3 by supporting innovative interventions that build the evidence base in MCH. Goal 4 is addressed through the broad dissemination of research findings to health care providers, other practitioners, researchers, policy makers, public health systems, Title V Block Grant programs, and the MCH community.

Promoting Health Equity

Promoting equity is essential to the Department’s mission of protecting the health of Americans and providing essential human services. This view is reflected in Executive Order (E.O.) 13985 entitled, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government” issued on January 20, 2021, and E.O.

https://mchb.tvisdata.hrsa.gov/PrioritiesAndMeasures/NationalPerformanceMeasures https://mchb.tvisdata.hrsa.gov/PrioritiesAndMeasures/NationalOutcomeMeasures https://mchb.hrsa.gov/about-us/mission-vision-work https://mchb.hrsa.gov/about-us/mission-vision-work https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.whitehouse.gov/briefing-room/presidential-actions/2023/02/16/executive-order-on-further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/

HRSA-24-048 Autism FIRST 4

14094 entitled, “Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government” issued on February 16, 2023.

II. Award Information

1. Type of Application and Award

Application type(s): New

We will fund you via a grant. You must follow all relevant federal regulations and public policy requirements.

2. Summary of Funding

We estimate $600,000 will be available each year to fund 2 recipients. You may apply for a ceiling amount of up to $300,000 annually (reflecting direct and indirect costs).

The period of performance is September 1, 2024, through August 31, 2027 (3 years).

This program notice depends on the appropriation of funds. If funds are appropriated for this purpose, we will proceed with the application and award process.

Support beyond the first budget year will depend on:

• Appropriation

• Satisfactory progress in meeting the project’s objectives

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

45 CFR part 75 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards applies to all HRSA awards.

If you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate of 10 percent of modified total direct costs (MTDC)*. You may use this for the life of the award. If you choose this method, you must use it for all federal awards until you choose to negotiate for a rate. You may apply to do so at any time. See Section 4.1.v. Budget Justification Narrative in the R&R Application Guide.

*Note: One exception is a governmental department or agency unit that receives more than $35 million in direct federal funding.

https://www.whitehouse.gov/briefing-room/presidential-actions/2023/02/16/executive-order-on-further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.whitehouse.gov/briefing-room/presidential-actions/2023/02/16/executive-order-on-further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75

HRSA-24-048 Autism FIRST 5

III. Eligibility Information

1. Eligible Applicants

You can apply if your organization is a:

• Public or private entity, including research centers or networks

• Community-based organization

• Tribal (governments, organizations)

You are required to submit proof of non-profit status as Attachment 5. A foreign applicant will need to be affiliated with a U.S. entity (i.e., university, institution) with a U.S. EIN established and recognized by HRSA to be considered a public or nonprofit institution of higher learning or a public or private nonprofit agency.

2. Cost Sharing or Matching

Cost sharing or matching is not required for this program.

3. Other

We may not consider an application for funding if it contains any of the following non-responsive criteria:

• Exceeds the funding ceiling amount

• Fails to satisfy the deadline requirements referenced in Section IV.4

Due to funding limitations and to diversify the MCHB research portfolio 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.

• An individual cannot be named as the project director (PD) or principal investigator (PI)8 on more than one application for the Autism FIRST Program;

• The current PD/PI of an active HRSA/MCHB/Office of Epidemiology and Research (OER)/Division of Research (DOR) award can serve for no more than 10 percent time on a new proposal;

• A PD/PI cannot have two (2) active HRSA/MCHB/OER/DOR awards at the same time. An award in a no-cost extension year is considered active and the PD/PI is not allowed to receive another award;

8 HRSA allows one PD/PI to be named on the face page of the SF-424 R&R application, who will serve as the key point of contact, yet multiple co-PI/co-PDs are allowed. This application responsiveness criterion only applies to current MCHB PI/PDs, not co-PI/PDs.

HRSA-24-048 Autism FIRST 6

• Longitudinal follow-up studies for previously funded MCH or Autism FIRST studies will NOT be considered for funding;

• Projects that focus primarily on secondary data analysis will not be considered for funding under this award as there are separate competitions that focus on secondary data analyses, the MCH and Autism Secondary Data Analysis Research competitions;

• Projects which include the collection of biological specimens will not be considered for the award competition as this program funds translational intervention research on ASD/DD populations.

Multiple Applications

You may submit multiple applications under the same Unique Entity Identifier (UEI), if each proposes distinct projects. We will only review your last validated application for each distinct project before the Grants.gov due date.

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

IV. Application and Submission Information

1. Address to Request Application Package

We require you to apply online through Grants.gov. Use the SF-424 Research and Related (R&R) workspace application package associated with this notice of funding opportunity (NOFO). Follow these directions: How to Apply for Grants. If you choose to submit using an alternative online method, see Applicant System-to-System.

Form Alert: For the Project Abstract Summary, applicants using the SF-424 R&R Application Package are encountering a “Cross-Form Error” associated with the Project Summary/Abstract field in the “Research and Related Other Project Information” form, Box 7. To avoid the “Cross-Form Error,” you must attach a blank document in Box 7 of the “Research and Related Other Project Information” form, and use the Project Abstract Summary Form in workspace to complete the Project Abstract Summary. See Section IV.2.i Project Abstract for content information.

Note: Grants.gov calls the NOFO “Instructions.”

Select “Subscribe” and enter your email address for HRSA-24-048 to receive emails about changes, clarifications, or instances where we republish the NOFO. You will also be notified by email of documents we place in the RELATED DOCUMENTS tab that may affect the NOFO and your application. You’re responsible for reviewing all information that relates to this NOFO.

https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-information-kit/unique-entity-identifier-update https://www.grants.gov/ https://www.grants.gov/applicants/grant-applications/how-to-apply-for-grants https://www.grants.gov/system-to-system/applicant-system-to-system/

HRSA-24-048 Autism FIRST 7

2. Content and Form of Application Submission

Application Format Requirements Submit your information as the R&R Application Guide and this program-specific NOFO state. Do so in English and budget figures expressed in U.S. dollars. There’s an Application Completeness Checklist in the R&R Application Guide to help you.

Application Page Limit The total number of pages that count toward the page limit shall be no more than 60 pages when we print them. We will not review any pages that exceed the page limit.

Using the pages within the page limit, HRSA will determine eligibility using Section III.

Eligibility Information of the NOFO.

These items do not count toward the page limit:

• Standard OMB-approved forms you find in the NOFO’s workspace application package

• Abstract (standard form (SF) “Project_Abstract Summary”)

• Indirect Cost Rate Agreement

• Letters of Agreement/Letters of Support

• Biographical sketches of key personnel

If there are other items that do not count toward the page limit, we’ll make this clear in Section IV.2.vi Attachments.

If you use an OMB-approved form that is not in the HRSA-24-048 workspace application package, it may count toward the page limit.

Applications must be complete and validated by Grants.gov under HRSA-24-048 before the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

• When you submit your application, you certify that you and your principals9 (for example, program director, principal investigator) can participate in receiving award funds to carry out a proposed project. That is, no federal department or agency has debarred, suspended, proposed for debarment, claimed you ineligible, or you have voluntarily excluded yourself from participating.

• If you fail to make mandatory disclosures, we may take an action like those in 45 CFR § 75.371. This includes suspending or debarring you.10

• If you cannot certify this, you must include an explanation in Attachments 6-15:

Other Relevant Documents.

9 See definitions at eCFR :: 2 CFR 180.995 -- Principal. and eCFR :: 2 CFR 376.995 -- Principal (HHS supplement to government-wide definition at 2 CFR 180.995).

10 See also 2 CFR parts 180 and 376, 31 U.S.C. § 3354, and 45 CFR § 75.113.

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371 https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180/subpart-I/section-180.995 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376/subpart-I/section-376.995 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376/subpart-I/section-376.995 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-chapter33&edition=prelim https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-B/section-75.113

HRSA-24-048 Autism FIRST 8

(See Section 4.1 viii “Certifications” of the R&R Application Guide)

Program Requirements and Expectations We expect each Autism FIRST award recipient to complete the following major activities:

• Conduct and complete the innovative applied or translational autism intervention research studies using rigorous scientific methodology as described in the application; Recruit, enroll, track, and report study participants using methods that encourage participation in the study by individuals from diverse backgrounds with regard to race/ethnicity, gender/sex, disability, geographic location, and socioeconomic status;

• Submit and carry out a dissemination plan for the distribution of research findings and products to study participants, scientific, professional, and lay audiences;

including a timeline for implementation. Dissemination activities include, but are not limited to, peer-reviewed articles, manuscripts, conference presentations, newsletter articles, webcasts, fact sheets, infographics, policy briefs, websites, and social media posts, as appropriate;

• Produce at least three peer-reviewed publications;

• Present findings at the End of Project Presentation (Research Festival) to MCHB staff; and

• Measure and track program performance on key activities and program objectives. This includes Discretionary Grants Information System (DGIS) measures on Health Equity, Research, and Products and Publications. For more information on these measures, please see the Reporting section.

Program-Specific Instructions Include application requirements and instructions from Section 4 of the R&R Application Guide (budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract).

i. Project Abstract

Use the Standard OMB-approved Project Abstract Summary Form that you’ll find in the workspace application package. Do not upload the abstract as an attachment or it may count toward the page limit. See Form Alert in Section IV.1 Application Package. For information you must include in the Project Abstract Summary Form, see Section 4.1.ix of the R&R Application Guide.

Include the information requested at the top of the abstract. Because the abstract is often distributed to provide information to the public and Congress, be clear, accurate, concise, and do not refer to other parts of the application. Briefly state the principal

HRSA-24-048 Autism FIRST 9 needs and problem, goals, proposed data sets including study population(s), planned coordination, anticipated products, and plans for evaluation.

Provide the information below in the Project Abstract field:

• PROBLEM: Briefly state the needs and problems that are addressed by the project, including the project's relationship to MCHB Strategic Research Issues.

• GOAL(S) AND OBJECTIVES: Identify the major goal(s) and objectives for the period of performance. Typically, the goal is stated in a sentence or paragraph, and the objectives are presented in a numbered list.

• PROPOSED DATA SETS AND PLANNED POPULATION(S): Briefly describe the research design and methods within the abstract and include data collection methods and participant information (i.e., age range and demographic background of planned population) for the project that you propose.

• PRODUCTS: Provide a brief description of the anticipated products of this project, including how project activities and findings will be distributed.

• EVALUATION: Briefly describe the evaluation methods used to assess program outcomes as well as the effectiveness and efficiency of the project in attaining goals and objectives.

• KEY TERMS: At the end of your abstract, include the following key terms found in Appendix D to describe: (a) your project (maximum of 10 content terms), (b) planned populations (select all that apply), and (c) age ranges (select all that apply).

NARRATIVE GUIDANCE

The following table provides a crosswalk between the narrative language and where each section falls within the review criteria. Make sure you’ve addressed everything. We may consider any forms or attachments you reference in a narrative section during the merit review.

Narrative Section Review Criteria

I. Specific Aims:

1) Need

2) Significance

3) Goals and Hypotheses

Criterion 1: Need

Criterion 2: Response https://mchb.hrsa.gov/research/strategic-research-issues.asp https://mchb.hrsa.gov/research/strategic-research-issues.asp

HRSA-24-048 Autism FIRST 10

Narrative Section Review Criteria

II. Methodology/Research Strategy:

1) Study Design/Approach

2) Scientific Innovation and Importance

Criterion 3: Study Design/Approach

Criterion 4: Impact

III. Impact and Dissemination

1) Public Health Impact

2) Publication and Dissemination Plan

Criterion 4: Impact

IV. Organizational Information/Environment

1) Organizational Facilities and Other Resources

2) Qualifications of Research Team’s Key Personnel

Criterion 5: Resources/Capabilities

Budget and Budget Justification

Criterion 6: Support Requested

V. Feasibility

1) Proposed Sequence or Timetable

2) Resolution of Challenges

Criterion 7 Program Assurances

VI. Evaluation and Technical Support Capacity

Criterion 7 Program Assurances

VII. Protection of Human Subjects Criterion 7 Program Assurances

VIII. Planned Enrollment Criterion 7 Program Assurances

HRSA-24-048 Autism FIRST 11

ii. Project Narrative

This section must describe all aspects of the proposed project. Make it brief and clear.

Provide the following information in the following order. Please use the section headers.

I. Specific Aims – Corresponds to Section V’s Review Criteria #1 Need and #2 Response

Provide a brief introduction and overview of the proposed research 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.

1) Need -- Corresponds to Section V’s Review Criterion #1 Need

• Briefly describe your study population’s unmet health needs and identify health disparities facing the study population;

• If relevant, include the social determinants of health (SDOH) and health inequities of the population that your project will address;

• Explain the problems and research gaps that your study will address; and

• Briefly outline how your project aligns with MCHB’s Blueprint for Change, with an emphasis on promoting health equity, family and child well-being and quality of life, and access to services.

2) Significance -- Corresponds to Section V’s Review Criterion #2 Response

• Provide an overview of the existing literature that demonstrates the importance of your study’s research objectives;

• Identify how your results may improve care and/or the ways that services are organized and delivered; and/or

• Describe how your study will advance health equity in ASD/DD populations.

3) Goals and Hypotheses -- Corresponds to Section V’s Review Criterion #2 Response

a) Goals and Objectives

• Briefly state the goals and objectives of your research study and what you will accomplish during the grant cycle that address the problems, barriers, and gaps identified. The study objectives should be specific, measurable, achievable, relevant, time bound, inclusive, and equitable (SMARTIE).

https://mchb.hrsa.gov/programs-impact/focus-areas/children-youth-special-health-care-needs-cyshcn/blueprint-change

HRSA-24-048 Autism FIRST 12

b) Hypotheses and Specification of Variables

• Briefly state the specific questions that your study will answer. These should include predictions of findings (hypotheses), as well as the reasoning behind your predictions; and

• Include a summary table of the relevant variables. You should define your variables, including the type of variables (e.g., independent, dependent, mediating, and moderating).

o You can create a graphic describing the theoretical model, conceptual framework, or the variables’ relationships;

o Make sure that any relationships shown in graphics are consistent with your variable table, the statement of hypotheses, and the plan for data analysis.

II. Methodology/Research Strategy – Corresponds to Section V’s Review Criteria #3 Study Design/Approach and #4 Impact

Organize the Methodology section in the specified order using the instructions provided below. Start each section with the appropriate section heading – Study Design/Approach, and Scientific Innovation and Importance. Cite relevant publications in the Methodology section and provide the full reference in the Bibliography and References Cited section.

The Methodology section is recommended to be no more than 12 pages in length.

1) Study Design/Approach – Corresponds to Section V’s Review Criterion #3 Study Design/Approach

• Describe the proposed interventions, overall study design, methodology, and analyses you will use to accomplish the specific aims of the project;

• Describe the procedures for data collection and instrumentation, as appropriate;

• Include how you will collect, analyze, and interpret the data, as well as any plans to coordinate data collection and analysis for multi-sites, as appropriate;

• Describe your enrollment and recruitment plan for your planned study participant population, including:

Demographic information on the planned population (e.g., race/ethnicity, gender/sex, disability, geographic location, and socioeconomic status;

A description of strategies for encouraging enrollment from a wide range of people from various backgrounds and communities.

HRSA-24-048 Autism FIRST 13

Address issues regarding sampling design and randomization, as appropriate. Include expected enrollment number and power analyses, as appropriate;

Letters of Agreement from study sites supporting recruitment must be included in Attachment 1, if applicable; and

• Describe your plan to partner with at least one program or institution that works with underserved populations to ensure cultural competency, recruit study participants, and disseminate research findings.

• Preliminary Studies: Include information on preliminary studies as part of the Section (1) Study Design section. Provide a description of the PD/PI’s preliminary studies pertinent to this application. This information will also help to establish the experience and competence of the investigator to pursue the proposed project. Preliminary data often aid the reviewers in assessing the likelihood of the success of the proposed project.

2) Scientific Innovation and Importance – Corresponds to Section V’s Review Criterion #4 Impact

• Explain how your project will add scientific knowledge, expand the evidence base, improve technical capability and/or clinical practice in the ASD/DD field; and

• Describe any novel, including refined or improved, theoretical concepts, approaches or methodologies, policies, instrumentation, or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, policies, or interventions.

III. Impact and Dissemination–Corresponds to Section V’s Review Criterion # 4 Impact

1) Public Health Impact

• Describe the public health impact that study results may have, e.g., how the study can affect care delivery and/or the health and well-being of ASD/DD populations;

• Describe how the study results will be of regional and national significance, including their generalizability; and

• Discuss the potential scalability/sustainability of this project.

HRSA-24-048 Autism FIRST 14

2) Publication and Dissemination Plan

It is expected your project will produce at least three peer-reviewed publications.

• Provide an action plan that describes:

o The number and foci of your proposed peer-reviewed publications, as well as the names and impact factor of the journals where you plan to submit your papers;

o How you will distribute findings, reports, and/or project results broadly; and o How you will inform study participants of the results of your research.

IV. Organizational Information/ Environment– Corresponds to Section V’s Review Criterion # 5 Resources/Capabilities

This information is used to judge the ability of your organization, your organization’s resources, and staff to complete your study. NOTE: The SF-424 R&R Table of Contents Page refers to Environment as “Facilities & Other Resources.” This section on “Environment” can be included as an attachment in the Other Project Information Form, box 10, or included as part of the research narrative.

1) Organizational Facilities and Other Resources

• Identify the facilities you will use (laboratory, clinical setting, computer lab, office, and/or other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity, and extent of availability to the project.

Describe only those resources that are directly applicable to the proposed work;

• Discuss ways in which the study will benefit from your organization’s scientific environment; For Early-Stage Investigators,11 describe institutional investment in the success of the 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

11 An Early Stage Investigator is a program director / principal investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a federal independent research award.

(https://grants.nih.gov/policy/early-investigators/index.htm) https://grants.nih.gov/policy/early-investigators/index.htm

HRSA-24-048 Autism FIRST 15 research with salary support; and if there are multiple sites, describe each site’s resources.

2) Qualifications of Research Team’s Key Personnel

• The merit review panel will use the following to evaluate the research team’s qualifications and research strategy: (a) Preliminary Studies in Section II;

Methodology/Research Strategy 2) Study Design; (b) Staffing Plan in Budget Narrative; and (c) Biographical Sketches of key personnel.

• Please use the MCHB biographical sketch form found here: MCHB Research Applicants Bio sketch 2023 NOTE: While the biographical sketch form does not count against your total page limitation it should not exceed five pages per person. This information allows MCHB to determine to what extent individuals of different backgrounds are expected to be enrolled in the proposed study. This information, in addition to other information including career stage, geographic location of the institution, and educational level, assists MCHB in ensuring that federal grant and cooperative agreement funding opportunities are available to a wide range of people from various backgrounds and communities. A detailed description of information that should be included in the biographical sketches is available in Appendix E.

V. Feasibility – Corresponds to Section V’s Review Criterion #7 Program Assurances This section addresses questions around project feasibility. If funded, it is important that the recipient implements and completes the study as proposed and approved.

1) Proposed Sequence or Timetable

• Provide a sequence or timetable for the project that includes the steps that you will take to achieve each of the activities proposed during the entire period of performance. Use a timeline that includes each activity and identifies responsible staff.

2) Resolution of Challenges

• Discuss any challenges that you might encounter in designing and implementing the research activities described in the Study Design/Approach, and approaches that will be used to resolve such challenges. Examples include recruitment of study sites and study participants, staff training and standardization of research protocols across multiple sites, putting culturally/linguistically competent project staff in place quickly, recruiting participants from specific populations, etc.;

• Discuss alternative strategies should any of these potential challenges arise;

https://mchtraining.net/media/research/documents/FORM-Biosketch-Research-Applicants-2023.docx

HRSA-24-048 Autism FIRST 16

• Discuss your strategy to reach planned enrollment levels and how you will address the management of any high-risk aspects or anticipated challenges of the proposed goals; and

• If appropriate, point to any procedures, situations, or materials that may be harmful to the study participants, and precautions you would exercise.

VI. Evaluation and Technical Support Capacity – Corresponds to Section V’s

Review Criterion #7, Program Assurances

• Describe the systems and processes that will support your organization’s performance management tracking and how the organization will collect and manage data;

• As appropriate, describe the strategy to collect, analyze, and track data to measure process and impact/outcomes, and explain how the data will be used to inform program development and service delivery;

• Describe the research team’s current experience, skills, and knowledge that will contribute to the success of your project; and

• Describe any potential obstacles that may affect implementing the program performance evaluation, and your plan to address those obstacles.

VII. Protection of Human Subjects – Corresponds to Section V’s Review Criterion #7 Program Assurances

• 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;

• If awarded, nonexempt human subjects research must comply with the Department of Health and Human Services (HHS) regulations for protection of human subjects (45 CFR part 46) (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html). Refer to instructions provided in HRSA’s R&R Application Guide, Appendix:

Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan and Human Subjects Research Policy for specific instructions on preparing the human subjects section of the application; and

• All institutions that are engaged in nonexempt human subjects research as part of the project, including foreign applicants, must be covered by a Federalwide Assurance (FWA) approved by the Office for Human Research Protections (OHRP). Instructions on how to submit an FWA application, if awarded, can be found on OHRP’s website at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/index.html.

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html https://www.hrsa.gov/sites/default/files/hrsa/grants/sf-424-rr-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/sf-424-rr-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/sf-424-rr-app-guide.pdf https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/index.html

HRSA-24-048 Autism FIRST 17

VIII. Planned Enrollment – Corresponds to Section V’s Review Criterion #7 Program Assurances

Provide details about the range of backgrounds and communitiesof the planned study enrollees. As applicable, information should include study sample totals by:

1) Racial Categories American Indian/Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than One Race Gender/sex distribution within each racial category Total sample by racial category

2) Ethnic Category (Hispanic Heritage): “Hispanic or Latino” or “Not Hispanic or Latino” Gender/sex distribution within each Ethnic Category (Hispanic Heritage);

Total distribution by Ethnic Category (Hispanic Heritage);

The “Ethnic Category (Hispanic Heritage): Total Sample” must be equal to the

“Racial Categories: Total Sample.” List any proposed racial/ethnic subpopulations; and

The “Total Sample” means the number of subjects in the dataset that will be used in your analysis. They will be reported in two ways in the table: by self-reported “Ethnic Category (Hispanic Heritage)” and by self-reported “Racial Categories.”

3) Disability Status

4) Geographic Location Urban Rural

5) Socioeconomic status Level of Education Income-to-Poverty Ratio or Federal Poverty Level Occupational Status

Describe how the project will assure cultural competence in terms of including individuals from the study population in the planning and implementation of the research project and in adapting the research methodology to reflect an understanding of, and valuing the culture of, the study population(s).

HRSA-24-048 Autism FIRST 18

iii. Budget

The R&R Application Guide directions may differ from those on Grants.gov.

Follow the instructions in Section 4.1.iv Budget of the R&R Application Guide and any specific instructions listed in this section. Your budget should show a well-organized plan.

Reminder: 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 (MOE), if applicable).

Program Income

You must use any program income you generate from awarded funds for approved project-related activities. Use program income under the addition alternative (45 CFR § 75.307(e)(2)). Find post-award requirements for program income at 45 CFR § 75.307.

Specific Instructions

As required by the Consolidated Appropriations Act, 2023 (P.L. 117-328), Division H, § 202, “None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II.” Effective January 2024, the salary rate limitation is $221,900. As required by law, salary rate limitations may apply in future years and will be updated.

iv. Budget Justification Narrative

See Section 4.1.v. of the R&R Application Guide.

In addition, the Autism FIRST program requires the following:

Within Personnel Costs, include the staffing plan by providing position descriptions (roles, responsibilities, and qualifications of proposed project staff) in the “Budget Justification” section that you will add to SF-424 R&R Budget Period – Section F – K Form, Box K.