MCHB HRSA-22-086--22-099(UT7 UT6)_Autism SIIP_FINAL.pdf

U.S. Department of Health and Human Services

Maternal and Child Health Bureau

Division of Research

Autism Single Investigator Innovation Program (Autism-SIIP) – Autism Longitudinal Data Project (ALDP)

Funding Opportunity Number: HRSA-22-086 Funding Opportunity Type: New

Autism Single Investigator Innovation Program (Autism-SIIP) –

Autism Transitions Research Project (ATRP) Funding Opportunity Number: HRSA-22-099

Funding Opportunity Type: New

Assistance Listings (AL/CFDA) Number: 93.877

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: April 4, 2022 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA 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, 2022

Autism Longitudinal Data Project (ALDP) Jessica DiBari, Ph.D. and Dana Mason, Ph.D.

Office of Epidemiology and Research

Email: AutismSIIPNOFO@hrsa.gov

Autism Transitions Research Project (ATRP) Lisa Hund, MPH and Evva Assing-Murray, Ph.D.

Office of Epidemiology and Research

Email: AutismSIIPNOFO@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:AutismSIIPNOFO@hrsa.gov

HRSA-22-086: ALDP and HRSA-22-099: ATRP i

508 COMPLIANCE DISCLAIMER

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

Agency Contacts.

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for two (2) separate Autism Single Investigator Innovation Program (SIIP) competitions for the fiscal year (FY) 2022: HRSA-22-086, Autism Longitudinal Data Project (ALDP) and HRSA-22-099, Autism Transitions Research Project (ATRP). The purpose of these programs is to support the conduct of empirical research that advances the evidence base on interventions to improve the health and wellbeing of children and adolescents with autism spectrum disorders (ASD) across the lifespan, with a special focus on addressing the needs of underserved communities.1 These programs address the critical needs that exist for research on the barriers to screening, diagnosis, and receipt of evidence-based interventions for children and adolescents with ASD/DD.

HRSA-22-086: Autism Longitudinal Data Project (ALDP) supports the implementation and completion of research that leverages existing longitudinal data resources and evaluates the effect of early interventions using observational studies/secondary data to improve our understanding of the early life origins, signs, and indicators of ASD/DD and its comorbidities. The ALDP aims to maximize healthy life outcomes (physical, mental/emotional/behavioral, social, and educational/occupational) and trajectories of child development over the life course. This program will fund up to one 5-year award.

HRSA-22-099: Autism Transitions Research Project (ATRP) supports primary and secondary research studies that advance the evidence base available on the social determinants and risk factors associated with healthy life outcomes (physical, mental/emotional/behavioral, social, and educational/occupational) among adolescents and young adults with ASD who are transitioning to adulthood. This program will fund up to one 5-year award.

1 Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, 86 FR 7009, at § 2(b) (Jan. 20, 2021), https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf defines underserved communities as “populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic l ife.” Underserved communities may include Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabil ities;

persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality. See Executive Order 13985, at § 2(a).

https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf

HRSA-22-086: ALDP and HRSA-22-099: ATRP ii

Funding Opportunity Title: Autism Longitudinal Data Project (ALDP)

Autism Transitions Research Project (ATRP)

Funding Opportunity Number: HRSA-22-086 (ALDP)

HRSA-22-099 (ATRP)

Due Date for Applications: April 4, 2022

Anticipated Total Annual Available FY 2022 Funding:

ALDP: $500,000

ATRP: $500,000

Estimated Number and Type of Award(s):

HRSA-22-086 (ALDP): Up to one (1) cooperative agreement

HRSA-22-099 (ATRP): Up to one (1) cooperative agreement

Estimated Annual Award Amount: Up to $500,000 per award subject to the availability of appropriated funds

Cost Sharing/Match Required: No

Period of Performance: September 1, 2022 through August 31, 2027 (five (5) years)

Eligible Applicants: Eligible applicants include any domestic public or private entity, including research centers or networks. Domestic faith-based and community-based organizations, tribes, and tribal organizations are eligible to apply.

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

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 R&R Application Guide, available online at http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf, except where instructed in this NOFO to do otherwise.

http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

HRSA-22-086: ALDP and HRSA-22-099: ATRP iii

Technical Assistance

HRSA has scheduled the following technical assistance webinars:

Day and Date: Tuesday, January 18, 2022 Time: 3 - 4 p.m. ET Call-In Number: 1-833-568-8864 Meeting ID: 160 212 8979 Passcode: 55452459 Weblink: https://hrsa-gov.zoomgov.com/j/1602128979?pwd=L2RVbXVZMTYyeUYzMHlyL0NzbFVtZz09

In an attempt to more effectively utilize our Technical Assistance (TA) webinar time, if you have questions about the NOFO, please send them prior to the webinar via email to AutismSIIPNOFO@hrsa.gov. We will compile and address these questions during the TA webinar.

HRSA will record the webinars and make them available approximately 2 weeks after the webinar at: https://mchb.hrsa.gov/research.

https://hrsa-gov.zoomgov.com/j/1602128979?pwd=L2RVbXVZMTYyeUYzMHlyL0NzbFVtZz09 https://hrsa-gov.zoomgov.com/j/1602128979?pwd=L2RVbXVZMTYyeUYzMHlyL0NzbFVtZz09 https://mchb.hrsa.gov/research

HRSA-22-086: ALDP and HRSA-22-099: ATRP iv

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/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. Program-Specific Forms

vi. Attachments

3. Dun and Bradstreet Data Universal Numbering System (DUNS) Number Transition to the 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: APPLICATION COMPLETENESS CHECKLIST

APPENDIX B: KEY TERMS FOR PROJECT ABSTRACTS

APPENDIX C: COLLABORATION PLAN GUIDANCE

APPENDIX D: LOGIC MODEL

APPENDIX E: FREQUENTLY ASKED QUESTIONS (FAQS)

HRSA-22-086: ALDP and HRSA-22-099: ATRP 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under two (2) separate Autism Single Investigator Innovation Program (SIIP) competitions for the fiscal year (FY) 2022: HRSA-22-086: Autism Longitudinal Data Project (ALDP) and HRSA-22- 099: Autism Transitions Research Project (ATRP). The purpose of these programs is to support the conduct of empirical research that advances the evidence base on interventions to improve the health and wellbeing of children and adolescents with autism spectrum disorders (ASD) across the lifespan, with a special focus on addressing the needs of underserved communities. Autism SIIPs address the critical needs that exist for research on the barriers to screening, diagnosis, and receipt of evidence-based interventions2 for children and adolescents with ASD/DD, while also addressing Health Resources and Services Administration's FY22 (Interim) Strategic Plan Objective 1.2 to promote overall health and disease prevention across populations, providers, and communities. Collectively, priority topic areas for Autism SIIPs include:

longitudinal data analysis of genetic and environmental factors contributing to ASD/DD, trajectories of child development, and healthy life transitions among adolescents and young adults with ASD/DD.

HRSA-22-086: Autism Longitudinal Data Project (ALDP)

The HRSA-22-086: ALDP supports the implementation and completion of research that leverages existing longitudinal data resources and evaluates the effect of early interventions using observational studies/secondary data to improve our understanding of the early life origins, signs, and indicators of ASD/DD and its comorbidities.

Applicants to the HRSA-22-086: ALDP will conduct research on topics of interest to HRSA’s Maternal and Child Health Bureau (MCHB), including studies that build on our current knowledge base and leverage existing longitudinal data analyses to:

• Study genetic and environmental maternal and perinatal contributing and/or predictive factors for ASD/DD;

• Consider physical and behavioral trajectories of ASD/DD and assessment at different stages of life course development;

• Explore primary prevention of ASD/DD;

2 For the purpose of this NOFO, an intervention is defined as a manipulation of the subject or subject’s environment to modify one or more health-related biomedical or behavioral processes and/or endpoints or outcomes for children and adolescents. Examples include, but are not l imited to, delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior(s); treatment strategies; prevention strategies; and diagnostic strategies. A manipulation or task would be regarded as an intervention if it is used to modify a health-related biomedical or behavioral outcome. A manipulation or task used expressly for measurement, and not modification, would not be considered as an intervention. Source: National Institutes of Health, Office of Extramural Research. Frequently Asked Questions: NIH Clinical Trial Definition. Available at:

https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5226.

https://www.hrsa.gov/about/strategic-plan/index.html https://www.hrsa.gov/about/strategic-plan/index.html

HRSA-22-086: ALDP and HRSA-22-099: ATRP 2

• Study the effects of various ASD/DD interventions using observational studies/secondary data; and

• Promote greater national and public awareness of the early life origins, signs, indicators, and interventions for ASD/DD and its comorbidities by providing leadership in the dissemination of findings from ALDP research.

HRSA-22-099: Autism Transitions Research Project (ATRP)

The HRSA-22-099: ATRP supports primary and secondary research studies that advance the evidence base available on the social determinants and risk factors associated with healthy life outcomes (physical, mental/emotional/behavioral, social, and educational/occupational) among adolescents and young adults with ASD who are transitioning to adulthood. Applicants to the HRSA-22-099: ATRP will conduct primary and secondary research studies, including at least one pilot intervention study,3 and try to leverage external funding for full intervention studies in the future. Studies should:

• Consider important priority areas (e.g., co-occurring mental health conditions in transition-age youth with ASD; training the pediatric and adult health care workforce on health care transition for ASD; employment, career development, economic well-being, and transportation for transition-age youth with ASD);

• Help set the direction for future research by identifying gaps that currently exist in the understanding of life outcomes, service needs and access, and effective service program models for transitioning adolescents and young adults with ASD;

• Improve the current understanding of desired healthy life outcomes for transitioning youth with ASD; develop measurement tools; and conduct studies that demonstrate the efficacy of innovative service models;

• Develop innovative, empirically sound strategies for increasing equity in desired healthy life outcomes for transitioning adolescents and young adults with ASD with a focus on underserved communities;4

• Identify barriers that limit the timely access to services for transitioning adolescents and young adults with ASD; and

• Promote greater national and public awareness of factors associated with desired healthy life outcomes for this population by providing leadership in the dissemination of findings from ATRP research.

3 For the purpose of this NOFO, a pilot intervention study is defined as a small-scale test of the methods and procedures for an intervention to be used on a larger scale. Source: National Institutes of Health, National Center for Complementary and Integrative Health. Pilot Studies: Common Uses and Misuses. Available at: https://www.nccih.nih.gov/grants/pilot-studies-common-uses-and-misuses.

4 Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, 86 FR 7009, at § 2(b) (Jan. 20, 2021), https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf defines equity as the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment. See Executive Order 13985, at § 2(a).

https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf

HRSA-22-086: ALDP and HRSA-22-099: ATRP 3

2. Background

The Autism SIIP 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 (CARES) Act of 2019 (Pub. L. 116-60). The Autism CARES Act of 2019 emphasizes improving health outcomes and the well-being of individuals with ASD/DD across the lifespan.

In response to the Autism CARES Act of 2019, HRSA’s Maternal and Child Health Bureau supports programs to improve the quality of care among those diagnosed with ASD/DD through education, early detection, and intervention. Specifically, these activities are designed to:

1) Increase awareness of ASD/DD;

2) Reduce barriers to screening and diagnosis;

3) Support research on evidence-based interventions for individuals with ASD/DD;

4) Promote guideline development for ASD/DD interventions; and

5) Train professionals to utilize valid screening tools, to diagnose early and to provide research-informed interventions.

ASD is a complex neurodevelopmental disorder, and individuals with this condition experience core behavioral challenges with social interactions and communication, as well as restrictive and repetitive behaviors.5 The Centers for Disease Control and Prevention used population-based ASD 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 ASD cases are identified through education and health records review – to report that approximately one in 54 children have ASD.6 Parent-reported data from the 2019-2020 National Survey of Children’s Health documented that 2.9 percent (approximately one in 34) of children aged 3–17 years have a diagnosis of ASD.7 Estimates from these two systems reflect different years, populations (11 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 ASD among children in the U.S. Additionally, 83 percent of children with ASD have at least one co-occurring non-ASD/DD condition.8 Children and adolescents with ASD/DD also

5 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders V. Washington, DC: American Psychiatric Publishing; 2013.

6 Autism and Developmental Disabilities Monitoring Network (2016 data) (http://www.cdc.gov/ncbddd/autism/data.html) 7 Child and Adolescent Health Measurement Initiative. 2019-2020 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 October 20, 2021 from www.childhealthdata.org.

8 Levy SE, Giarelli E, Li-Ching L, Schieve LA, Kirby RS, Cuniff C, et al. Autism spectrum disorder and co-occurring developmental, psychiatric, and medical conditions among children in multiple populations of the United States. Journal of Developmental and Behavioral Pediatrics. 2010;31:267–275.

https://mchb.hrsa.gov/maternal-child-health-initiatives/autism https://mchb.hrsa.gov/maternal-child-health-initiatives/autism http://www.cdc.gov/ncbddd/autism/data.html

HRSA-22-086: ALDP and HRSA-22-099: ATRP 4 have greater health service needs, which can place a significant financial and emotional burden on their families.9

Little is currently known, however, about the etiology of ASD/DD or the life course trajectory of children and adolescents with ASD/DD. Furthermore, diagnoses are often delayed or missed altogether, particularly among underserved racial and ethnic minorities. In samples of children meeting the case definition of ASD, Black and Hispanic children are less likely than White children to have a formal ASD diagnosis in their records; Black children are diagnosed at older ages than White children; and Hispanic children are less likely than White children to be diagnosed with ASD at all.10, 11 The Institute of Medicine report, Unequal Treatment, suggests that these differences may be attributable to factors including health care access, cultural, or linguistic barriers, clinicians' and families' misinterpretation of symptoms, and general clinician prejudice or bias.12

Gaps in research, programs, and services to support transition-age youth (adolescents and young adults ages 12-25) with ASD also persist. Quality of life outcomes among this population remain poor across employment, postsecondary education and training, independent living, relationships and social networks, physical and mental health, and access to needed services.13,14,15,16,17 The Interagency Autism Coordinating Committee (IACC) names research on adult outcomes and services, including the transition to adulthood, as one of its seven major research topics in its strategic plan for autism spectrum disorder 2018-2019 update.18 Research on addressing the unique needs of underserved communities that are not already well-represented in research on youth with ASD is particularly needed.

9 Vohra, R, Madhavan, S, Sambamoorthi, U, St Peter, C. Access to services, quality of care, and family impact for children with autism, other developmental disabilities, and other mental health conditions. Autism, 2014; 18(7):815-26.

10 Mandell, DS, Wiggins, LD, Carpenter, LA, Daniels, J, et al. (2009). Racial/ethnic disparities in the identification of children with autism spectrum disorders. American Journal of Public Health, 99(3), 493–498.

11 National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention. Spotlight On Closing the Racial and Ethnic Gaps in the Identification of Autism Spectrum Disorder. Available from:

https://www.cdc.gov/ncbddd/autism/addm-community-report/spotlight-on-closing-racial-gaps.html 12 Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care; Smedley BD, Stith AY, Nelson AR, editors. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington (DC):

National Academies Press (US); 2003. 1, Introduction and Literature Review.

13 U.S. Department of Health and Human Services. Report to Congress: Young Adults and Transitioning Youth with Autism Spectrum Disorder. October 2017. Retrieved 11/12/2020 from the U.S. Department of Health and Human Services website:

https://www.hhs.gov/sites/default/files/2017AutismReport.pdf 14 Wilens TE, Rosenbaum JF. Transitional age youth: A new frontier in child and adolescent psychiatry. J Amer Acad Psych. 2013 Sept;52(9):887–90. DOI: http://dx.doi.org/10.1016/j.jaac.2013.04.020.

15 The Child and Adolescent Health Measurement Initiative, Johns Hopkins Bloomberg School of Public Health. (2016.) Experience Matters: A View into the Health and Well-being of US Children and Families with Autism Spectrum Disorder (ASD). Retrieved 11/12/2020 from http://childhealthdata.org/docs/default-source/cahmi/asdchartbookfinal.pdf?sfvrsn=2 16 Shattuck PT, Narendorf SC, Cooper B, Sterzing PR, Wagner M, Taylor JL. Postsecondary education and employment among youth with an autism spectrum disorder. Pediatrics. 2012;129(6):1042–1049.

17 Roux, Anne M., Shattuck, Paul T., Rast, Jessica E., Rava, Julianna A., and Anderson, Kristy, A. National Autism Indicators Report: Transition into Young Adulthood. Philadelphia, PA: Life Course Outcomes Research Program, A.J. Drexel Autism Institute, Drexel University, 2015. Available from: https://drexel.edu/autismoutcomes/publications-and-reports/publications/National-Autism- Indicators-Report-Transition-to-Adulthood/ 18 National Institutes of Health, Office of Autism Research Coordination. Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorder: 2018-2019 Update. Available from: https://iacc.hhs.gov/publications/strategic-plan/2019/strategic_plan_2019.pdf?version=3 https://www.cdc.gov/ncbddd/autism/addm-community-report/spotlight-on-closing-racial-gaps.html https://drexel.edu/autismoutcomes/publications-and-reports/publications/National-Autism-Indicators-Report-Transition-to-Adulthood/ https://drexel.edu/autismoutcomes/publications-and-reports/publications/National-Autism-Indicators-Report-Transition-to-Adulthood/ https://iacc.hhs.gov/publications/strategic-plan/2019/strategic_plan_2019.pdf?version=3 https://iacc.hhs.gov/publications/strategic-plan/2019/strategic_plan_2019.pdf?version=3

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MCHB’s Strategic Plan

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 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

Research findings from the Autism SIIPs address MCHB’s goals 1, 2, and 4, and also advance the evidence base for health care providers, other practitioners, researchers, policy makers, public health systems, Title V Block Grant programs, and the MCH community.

To learn more about MCHB and the bureau’s strategic plan, visit https://mchb.hrsa.gov/about.

Equity

MCHB is committed to promoting equity in health programs for mothers, children, and families. As such, we encourage applicants to develop programs that intend to reach underserved communities and improve equity among all communities.

HRSA-22-086 (ALDP) aims to understand early life determinants of ASD/DD through prospective birth cohort studies and HRSA-22-099 (ATRP) aims to investigate social, economic, and physical determinants and risk factors associated with healthy life outcomes among adolescents and young adults with ASD who are transitioning to adulthood. Since racial and ethnic disparities exist in the early evaluation, diagnosis and receipt of services by children and young adults with ASD/DD, a focus on underserved racial and ethnic minority populations is particularly warranted.

II. Award Information

1. Type of Application and Award

Type of applications sought: New https://mchb.hrsa.gov/about

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Funding for HRSA-22-086: ALDP and funding for HRSA-22-099: ATRP will each be provided in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where HRSA anticipates substantial involvement with the recipient during performance of the contemplated project.

HRSA program involvement for awards made under both HRSA-22-086 (ALDP) and HRSA-22-099 (ATRP) will include:

• Assurance of the availability of HRSA/MCHB personnel or designees to participate in the planning and development of all phases of the activity;

• Review of policies and procedures established for carrying out project activities;

• Participation in meetings and regular communications with the award recipient to review mutually agreed upon goals and objectives and to assess progress;

• Facilitation of effective communication and accountability to HRSA/MCHB regarding the project, with special attention to new program initiatives and policy development that have the potential to advance the utility of the project;

• Assistance in establishing and maintaining federal interagency and inter-organizational contacts necessary to carry out the project;

• Review of documents such as operating procedures, authorship guidelines, and manuscripts, prior to submitting to peer-reviewed journals, etc.; and

• Participation in project activities such as meetings, webinars, presentations, publications, and other forms of disseminating information regarding project results and activities.

The HRSA-22-086 (ALDP) and HRSA-22-099 (ATRP) cooperative agreement recipients’ responsibilities will include:

• Identifying gaps, and developing and/or updating a research agenda for scientific studies;

• Leveraging external funds to advance and implement critical research that will address identified gaps and promote the research agenda;

• Planning and implementation of research studies on priority, emerging, and underdeveloped research areas in ASD/DD, with a special focus on addressing the needs of underserved communities;

• Disseminating critical information and fostering continued education activities on its research findings to inform researchers, practitioners, policy makers, adolescents and young adults and their families, educators, the public, and other stakeholders through at least three peer-reviewed publications per year;

• Participating in a two-day meeting organized by MCHB for its award recipients.

This meeting may be held virtually or take place in the Washington, DC area, and will be an opportunity to share best practices, disseminate results, and discuss research priorities with MCHB leadership, staff, and stakeholders;

• Coordinating at least one annual leadership meeting;

HRSA-22-086: ALDP and HRSA-22-099: ATRP 7

• Collaborating with pertinent partners, such as other MCHB Programs; Title V Maternal and Child Health Services Block Grant Program; MCH Research Network grant recipients (available at: https://mchb.hrsa.gov/research); and community organizations;

• Attending virtual meetings with MCHB and other award recipients, as needed;

• Providing an electronic copy of any products supported by award funds

(including guidelines, assessment tools, publications, books, pamphlets, PowerPoint presentations, curricula, videos, etc.) to be made available to the general public and shared with the project officer(s);

• Developing a schedule for recurring meetings to ensure on-going communication with the HRSA/MCHB Project Officer(s); and

• Presenting (virtually) select project accomplishments to MCHB at the end of the period of performance.

2. Summary of Funding

HRSA estimates approximately $500,000 to be available annually to fund one (1) recipient for HRSA-22-086: ALDP and approximately $500,000 to be available annually to fund one (1) recipient for HRSA-22-099: ATRP. The actual amount available will not be determined until enactment of the final FY 2022 federal appropriation. You may apply for a ceiling amount of up to $500,000 total cost (includes both direct and indirect, facilities and administrative costs) per program, per year.

The period of performance for each competition is September 1, 2022 through August 31, 2027 (five (5) years). Funding beyond the first year is subject to the availability of appropriated funds for HRSA-22-086: ALDP and HRSA-22-099: ATRP in subsequent fiscal years, satisfactory progress, and a decision that continued funding is in the best interest of the Federal Government.

All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 CFR part 75.

III. Eligibility Information

1. Eligible Applicants

Eligible applicants include any domestic public or private entity, including research centers or networks. Domestic faith-based and community-based organizations, tribes, and tribal organizations are eligible to apply.

https://mchb.hrsa.gov/maternal-child-health-initiatives/title-v-maternal-and-child-health-services-block-grant-program https://mchb.hrsa.gov/maternal-child-health-initiatives/title-v-maternal-and-child-health-services-block-grant-program https://mchb.hrsa.gov/research http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

HRSA-22-086: ALDP and HRSA-22-099: ATRP 8

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

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

• HRSA will consider any application that exceeds the ceiling amount non-responsive and will not consider it for funding under this notice.

• HRSA will consider any application that fails to satisfy the deadline requirements referenced in Section IV.4 non-responsive and will not consider it for funding under this notice.

• The Methods section of the Project Narrative is limited to 12 pages in length.

Applications that exceed this 12-page limit for the Methods section will be deemed non-responsive and will not be considered for funding under this notice.

Applications must also adhere to the 1” margin guidelines specified in HRSA’s SF-424 Research and Related (R&R) Application Guide.

NOTE: Multiple applications from an organization with the same DUNS number or Unique Entity Identifier (UEI) are allowable if the applications propose separate and distinct projects.

Your organization can apply to both HRSA-22-086 (ALDP) and HRSA-22- 099 (ATRP);

however, if applying to both funding opportunities listed in this NOFO, two separate applications are required. HRSA will not consider funding applicants that submit a combined application for both funding opportunities. Please make sure you submit your application to the correct funding opportunity number. Applications submitted to the wrong competition will be deemed nonresponsive.

In order to diversify the HRSA/MCHB research funding portfolio, an individual cannot serve as the project director/principal investigator (PD/PI) on both HRSA-22-086 (ALDP) and HRSA-22-099 (ATRP) or more than one existing HRSA/MCHB/OER/DoR grant/cooperative agreement. In general, the NOFO does not specify any minimum or maximum time requirement for the PD/PI, but we expect the PD/PI to dedicate a minimum of 20 percent effort on this project to justify their commitments to the project.

In addition, a PD/PI on another HRSA MCH research grant is allowed up to 10 percent effort as a co-investigator. If selected for funding, the recipient will need to verify that percent effort across all federally-funded programs does not exceed 100 percent. The application can include co-investigators as key personnel on the project. HRSA allows one PD/PI to be named on the cover page of the SF-424 R&R application, who will serve as the key point of contact.

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

HRSA-22-086: ALDP and HRSA-22-099: ATRP 9

HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, prior to the Grants.gov application due date as the final and only acceptable application.

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 Research and Related (R&R) workspace application package associated with this notice of funding opportunity (NOFO) following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

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 2.0 in workspace to complete the Project Abstract Summary.

See Section IV.2.i Project Abstract for content information.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-22-086: ALDP or HRSA-22-099: ATRP in order to receive notifications including modifications, clarifications, and/or republications of the NOFO on Grants.gov. You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. You are ultimately responsible for reviewing the For Applicants page for all information relevant to this NOFO.

2. Content and Form of Application Submission

Application Format Requirements Section 4 of HRSA’s SF-424 R&R Application Guide provides general instructions for the budget, budget justification, staffing plan and personnel requirements, assurances, certifications, etc. You must submit the information outlined in the HRSA SF-424 R&R Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 R&R Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the HRSA SF-424 R&R Application Guide for the Application Completeness Checklist, as well as the checklist provided in Appendix A.

https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

HRSA-22-086: ALDP and HRSA-22-099: ATRP 10

Application Page Limitation

The total size of all uploaded files included in the page limit may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the project and budget narratives, and attachments required in HRSA’s SF-424 R&R Application Guide and this NOFO. The Methods section of the Project Narrative is limited to 12 pages in length. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Please note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-22-086: ALDP and HRSA-22-099: ATRP, it may count against the page limit. Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit.

Applications must be complete, within the specified page limit, and validated by Grants.gov under the correct funding opportunity number prior to the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. § 3354).

3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachment: Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 R&R Application Guide for additional information on all certifications.

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 R&R Application Guide (including the budget, budget justification, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract Use the Standard OMB-approved Project Abstract Summary Form 2.0 that is included in the workspace application package. Do not upload the abstract as an attachment or it will count toward the page limitation. See Form Alert in Section IV.1 Application Package. Please use the guidance below. It is most current and differs slightly from that in Section 4.1.ix of HRSA’s SF-424 R&R Application Guide.

http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf 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 http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

HRSA-22-086: ALDP and HRSA-22-099: ATRP 11

Provide a summary of the application in the Project Abstract box of the Project Abstract Summary Form using 4,000 characters or less. Because the abstract is often distributed to provide information to the public and Congress, prepare this so that it is clear, accurate, concise, and without reference to other parts of the application. It must include a brief description of the proposed project including the needs to be addressed, the proposed services, and the population group(s) to be served. If the application is funded, your project abstract information (as submitted) will be made available to public websites and/or databases including USAspending.gov.

Abstract content: The following describes the section headers and content.

• Funding opportunity number: HRSA-22-086: ALDP or HRSA-22-099: ATRP

• Applicant Name: XXX

• Descriptive Title of Applicant’s Project: XXX

• Project Abstract

Provide the information below in the Project Abstract field (4,000 characters or less):

• Problem: Briefly state the principal needs and problems that are addressed by the project.

• 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 activities and target population(s): Describe the programs and activities used to attain the objectives, the study population(s) addressed, and comment on innovations and other characteristics of the proposed plan.

• Coordination: Describe the coordination planned with, and participation of appropriate national, regional, state, and/or local health agencies, interdisciplinary professional groups and providers, and/or organizations that function as stakeholders or partners in the proposed project.

• Products: Provide a brief description of the anticipated products, including modes of dissemination of project activities and findings.

• 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: From Appendix B select: (a) significant content terms that describe your project (maximum of 10 content terms), (b) targeted populations (select all that apply), and (c) age ranges (select all that apply), and include at the end of your abstract.

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, the table below provides a crosswalk between the narrative language and where each section falls within the review criteria. Any forms or attachments referenced in a narrative section may be considered during the objective review.

http://www.usaspending.gov/

HRSA-22-086: ALDP and HRSA-22-099: ATRP 12

Narrative Section Review Criteria

Background and Significance

(1) Need

(2) Response

(4) Impact

Specific Goals and Objectives

(2) Response

(4) Impact

(5) Resources/Capabilities

Project Design: Methods and Evaluation

(2) Response

(3) Approach

(4) Impact

(5) Resources/Capabilities

(7) Program Assurances

Plan and Schedule of Implementation, and Capability of Applicant

(3) Approach

(4) Impact

(5) Resources/Capabilities

(6) Support Requested

(7) Program Assurances

Budget and Budget Justification Narrative

(6) Support Requested – the budget section should include sufficient justification to allow reviewers to determine the reasonableness of the support requested.

ii. Project Narrative This section provides a comprehensive description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and organized in alignment with the sections and format below so that reviewers can understand the proposed project.

Successful applications will contain the information below. Please use the following section headers for the narrative:

BACKGROUND AND SIGNIFICANCE -- CORRESPONDS TO SECTION V’S

REVIEW CRITERIA #1 NEED, #2 RESPONSE, AND #4 IMPACT

• Describe the background literature, with focus on its pertinence to and rationale for the current research problem;

• Demonstrate knowledge and understanding of gaps in the existing research/literature;

• Write a statement of the research problem and indicate the problem’s relevance to the health and well-being of children, adolescents, and their families;

• Identify how the envisioned research findings may be applied to improve the health and well-being or health care of this population and/or the ways that services are organized and delivered;

HRSA-22-086: ALDP and HRSA-22-099: ATRP 13

• Describe how interdisciplinary research studies can fill the gaps in research and advance the autism field; and

• Describe how the proposed project can address the identified needs, including those of underserved communities.

• For HRSA-22-086: ALDP Demonstrate within the narrative an understanding of the early life determinants of ASD/DD; and Indicate how the proposed research can contribute to our understanding of the etiology of ASD/DD and contribute to the development of a predictive model.

• For HRSA-22-099: ATRP Demonstrate awareness of the recommendation within the 2017

Report to Congress on Young Adults and Transitioning Youth with ASD;19 and

Address the critical need for ASD transitions research that examines the influence of the social environment and not just individual-level factors.

SPECIFIC GOALS AND OBJECTIVES -- CORRESPONDS TO SECTION V’S

REVIEW CRITERIA #2 RESPONSE, #4 IMPACT, AND #5

RESOURCES/CAPABILITIES

• Include three to five topical areas of investigation within the Project Narrative;

• Include a numbered list of goals and objectives to be accomplished during the period of performance that address the project activities listed in the Purpose section of this notice. Specific objectives should be succinctly stated and innovative, and direct attention to the scope of expected activities listed. Objectives should be specific, measurable, achievable, realistic, time- bound (SMART), and tied to a distinct project goal;

• Include a detailed plan for completing studies in consultation with HRSA/MCHB, focusing on children and families from underserved backgrounds.

Describe your plan to collaborate with local health and community partners and/or HRSA programs; such as the Title V Maternal and Child Health Services Block Grant Program; MCH Research Network recipients (available at: https://mchb.hrsa.gov/research);

and for ATRP: HRSA-22-099 “Got Transition,” the MCHB-funded

19 U.S. Department of Health and Human Services. Report to Congress: Young Adults and Transitioning Youth with Autism Spectrum Disorder. October 2017. Retrieved 11/12/2020 from the U.S. Department of Health and Human Services website:

https://www.hhs.gov/sites/default/files/2017AutismReport.pdf https://www.hhs.gov/sites/default/files/2017AutismReport.pdf

HRSA-22-086: ALDP and HRSA-22-099: ATRP 14 national resource center on health care transition (available at:

https://www.gottransition.org/) in the development and implementation of research studies;

Describe your plan to disseminate findings among relevant health and community partners and other key stakeholders (e.g., HRSA’s Health Center Program or MCHB programs such as the MIECHV Program, Healthy Start Program, Family-to-Family Health Information Center Program, Title V Maternal and Child Health Services Block Grant Program, or ECCS Program); and

Describe how proposed activities will build upon ongoing efforts, and not be duplicative of existing funded efforts (including HRSA/MCHB projects; https://mchb.hrsa.gov/research).

• Demonstrate previous work related to the proposed project;

• Identify meaningful support and collaboration with key stakeholders and partners in planning, designing, implementing, and evaluating all activities. We encourage partnerships with programs serving underserved populations (e.g., HRSA’s Health Center Program;

MIECHV Program; Healthy Start Program, Family-to-Family Health Information Center Program, Title V Maternal and Child Health Services Block Grant Program, or ECCS Program). We also encourage partnerships with minority-serving institutions such as Historically Black Colleges and Universities (HBCU’s) and family-led organizations that can advocate for and connect with underserved communities; and

• Submit a logic model for designing and managing the project. The creation of a logic model is a requirement of the Autism SIIP Application, as described in the Attachment 1.

For HRSA-22-099: ATRP

• Develop a plan to partner with at least one additional site. Provide documentation (letters of agreement) of the site(s) that will collaborate to fulfill the goals and objectives of the project, with descriptions of the site’s characteristics, including patient population characteristics, average patient numbers, interventions, or services currently delivered, and characteristics and structure of staff. Include letters of agreement from site(s) in Attachment 2. The identified site(s) should demonstrate success in recruiting participants from underserved communities(s); and

• Conduct at least one study that advances the evidence base available on the social determinants and risk factors associated with healthy life outcomes (physical, mental/emotional/behavioral, social, and educational/occupational) among adolescents and young adults with ASD who are transitioning to adulthood.

https://www.gottransition.org/

HRSA-22-086: ALDP and HRSA-22-099: ATRP 15

To assist you in developing a plan for collaboration with programs serving underserved communities, please refer to Appendix C: Collaboration Plan Guidance.

PROJECT DESIGN: METHODS AND EVALUATION -- CORRESPONDS TO SECTION

V’S REVIEW CRITERIA #2 RESPONSE, #3 APPROACH, #4 IMPACT, #5

RESOURCES/CAPABILITIES, AND #7 PROGRAM ASSURANCES

A. Methods: This section has a strict 12-page limit.

Describe the methodology and provide sufficient technical detail to demonstrate the necessary steps to accomplish each objective and to convey to reviewers adequate information to assess the effectiveness and appropriateness of the proposed methodology. Indicate the specific methods that will be used to evaluate progress in meeting each objective. List and discuss anticipated obstacles that may be encountered and indicate how these will be overcome.

In addition, describe plans to disseminate findings to stakeholders, including health professionals, policymakers, family members, and the greater public. Discuss your plans for:

• Peer-reviewed publications: It is expected that HRSA-22-086: ALDP and HRSA-22-099: ATRP will each produce at least three peer-reviewed publications per year.

• Research acceleration: It is expected that HRSA-22-086: ALDP and HRSA-22- 099: ATRP will disseminate findings to help accelerate the synthesis, analysis, and translation of existing…