PKG00265017-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Maternal and Child Health Bureau Office of Epidemiology and Research

Autism Field-Initiated Innovative Research Studies Program

(Autism-FIRST)

Funding Opportunity Number: HRSA-21-053 Funding Opportunity Type(s): New

Assistance Listings (CFDA) Number: 93.877

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2021

Application Due Date: April 15, 2021

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, including SAM.gov and Grants.gov, may take up to 1 month to complete.

Issuance Date: January 15, 2021

Sylvia Sosa, MSc Program Officer Division of Research, Office of Epidemiology and Research Telephone: (301) 443-2259 Email: ssosa@hrsa.gov

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

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA), is accepting applications for the fiscal year (FY) 2021 Autism Field-Initiated Innovative Research Studies (Autism- FIRST) Program. 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 spectrum disorders and other developmental disabilities (ASD/DD) across the lifespan. Research should include a special focus on addressing the needs of underserved populations and, as appropriate, engage families. HRSA supports programs to improve the quality of care for those diagnosed with ASD/DD through education, early detection, and intervention, with the goal of optimizing development and promoting health and well-being for children, adolescents, and young adults with ASD/DD.

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

Funding Opportunity Number: HRSA-21-053

Due Date for Applications: April 15, 2021

Anticipated Total Annual Available FY 2021 Funding:

$600,000

Estimated Number and Type of Award(s):

Up to two (2) grants

Estimated Award Amount: Up to $300,000 total cost per year subject to the availability of appropriated funds

Cost Sharing/Match Required: No

Period of Performance: September 1, 2021 through August 31, 2024 (3 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.

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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. A short video explaining the Application Guide is available at http://www.hrsa.gov/grants/apply/applicationguide/.

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Friday, January 22, 2021 Time: 2 – 3 p.m. ET Call-In Number: 1-888-381-5770 Participant Code: 3734558

Weblink: https://hrsa.connectsolutions.com/autismfirstwebinar/

Instant replay:

Call-In Number: 866-430-4730 Passcode: 42321 Available until: April 23, 2021

In an attempt to most effectively utilize our TA webinar time, if you have questions about the NOFO, please send them beforehand via email to ssosa@hrsa.gov. We will compile and address these questions during the TA webinar.

HRSA will record the webinar and make it available at:

https://mchb.hrsa.gov/fundingopportunities/default.aspx http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/ https://hrsa.connectsolutions.com/autismfirstwebinar/ https://mchb.hrsa.gov/fundingopportunities/default.aspx

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AW ARD

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 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 AND OTHER PRE-AW ARD ACTIVITIES

VI. AWARD ADMINISTRATION INFORMATION

1. AW ARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: RELEVANT PUBLICLY AVAILABLE WEBSITES

APPENDIX B: KEY TERMS FOR PROJECT ABSTRACTS

APPENDIX C: APPLICATION COMPLETENESS CHECKLIST

APPENDIX D: LOGIC MODELS

APPENDIX E: FREQUENTLY ASKED QUESTIONS (FAQS)

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I. Program Funding Opportunity Description

1. Purpose

The Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB)’s Office of Epidemiology and Research is accepting applications for the fiscal year (FY) 2021 Autism Field-Initiated Innovative Research Studies (Autism- FIRST) Program. The purpose of this program is to support empirical research that advances the evidence base on interventions designed to improve the health of children, adolescents, and young adults with autism spectrum disorders and other developmental disabilities (ASD/DD) across the lifespan. Because racial and ethnic disparities exist in the early screening and diagnosis of ASD/DD, the Autism-FIRST Program has a special focus on addressing the needs of underserved populations, such as low-income, racial/ethnic minorities, individuals living in rural areas and, in the case of ASD/DD populations, girls and young women, who are often under identified with regard to ASD, particularly at the higher functioning end.1 The Autism-FIRST program supports research studies that address critical issues surrounding the health and well-being of underserved children, adolescents, and young adults with ASD/DD up to the age of 26, and their families, recognizing that the first 25 years of life help lay the foundation for health and well-being across the lifespan.

A focus on underserved populations is consistent with HRSA’s mission as an agency that promotes access to equitable and coordinated health and health care delivery services. A focus on children, adolescents, and young adults up to the age of 26 is consistent with the mission of the Maternal and Child Health Bureau (MCHB) and the populations it serves. The Autism-FIRST’s program’s goals and objectives are to:

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

ASD/DD;

• Contribute to the broad public health impact to improve health and service delivery services through studies that are generalizable and replicable for underserved ASD/DD populations; and

• Conduct and disseminate findings from applied and/or translational research on critical and emerging ASD/DD issues using a research design focused on collection of primary data among underserved populations, with a special focus on underserved populations and children, adolescents, and young adults up to the age of 26. Examples of autism intervention research topics of interest to HRSA’s MCHB include, but are not limited to, developing and testing ways to:

o Improve access to supports and services among underserved

1 The Department of Health and Human Services (HHS) characterizes underserved, vulnerable, and special needs populations as communities that include members of minority populations or individuals who have experienced health disparities. For this funding opportunity, under-resourced/underserved populations include low-income, racial/ethnic minorities, immigrants, tribal, geographically remote, and other groups that are not already well-represented in current pediatric research. https://marketplace.cms.gov/technical-assistance-resources/training-materials/vulnerable-and-underserved-populations.pdf, accessed 11/23/2020 https://marketplace.cms.gov/technical-assistance-resources/training-materials/vulnerable-and-underserved-populations.pdf https://marketplace.cms.gov/technical-assistance-resources/training-materials/vulnerable-and-underserved-populations.pdf

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populations of children, adolescents, and young adults with ASD/DD and their families;

o Effectively tailor services, supports, and interventions to individual and family strengths, needs, and challenges, recognizing the heterogeneity with which ASD/DD manifests itself across children, adolescents, and young adults with ASD/DD and their families;

o Facilitate the transition into adulthood, including continuity in health care and other supports and services associated with optimal transitions and laying the foundation for improved health and well-being across the lifespan;

o Improve the coordination of care across different aspects of the medical home, and/or across multiple sectors (e.g., health, school) that affect the lives of children, adolescents, and young adults with ASD/DD and their families; and o Identify services and supports that mediate or moderate relations between family stresses and outcomes for children, adolescents, and young adults with ASD/DD.

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)). In carrying out these provisions, HRSA supports various programs to improve the quality of care for those who have, or are at risk for developing ASD/DD through education, early detection, and intervention. Specifically, these programs are designed to:

• Increase awareness of ASD/DD;

• Reduce barriers to screening and diagnosis;

• Support research on evidence-based interventions for individuals with

ASD/DD;

• Promote guideline development for interventions; and

• Train professionals to utilize valid screening tools to diagnose and provide research-informed interventions, through an interdisciplinary approach that focuses on specific issues for children and adolescents who are not receiving an early diagnosis and subsequent interventions.

The Autism CARES Act of 2019 emphasizes improving health outcomes and the well-being of individuals with ASD/DD across the lifespan.

A comprehensive picture of ASD among children in the U.S is best understood by examining two key estimates of ASD prevalence2. 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

2 Kogan, et al. (2018) The Prevalence of Parent-Reported Autism Spectrum Disorder Among US Children. Pediatrics 142(6).

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children have ASD.3 Parent-reported data from the 2016 National Survey of Children’s Health, a study published in 2018, documented that one in 40 children aged 3-17 years have a diagnosis of ASD.4 Estimates from these two systems reflect different years, 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 ASD among children in the U.S. ASD is a complex neurodevelopmental disorder, and individuals with this condition experience core behavioral challenges with social interactions, communication, as well as restrictive and repetitive behaviors, which can be lifelong and pervasive.5 Additionally, 83 percent of children with ASD have at least one co-occurring non-ASD condition.6 Children and adolescents with ASD also have greater health service needs, which can place a significant financial and emotional burden on their families.7

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 ASD/DD. Many gaps in research remain regarding effective interventions for their complex needs. Since racial and ethnic disparities exist in the early evaluation and diagnosis of ASD/DD, a particular focus on underserved populations is warranted.

The impact of racial and ethnic disparities in the early evaluation and diagnosis of ASD/DD may be compounded by other social determinants of health (SDOH) across the lifespan. SDOH are conditions in which people are born, grow, live, work, and age.8 SDOH include factors like socioeconomic status, 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.

In response to this need, the Autism CARES Act of 2019 reauthorized research, surveillance, and education activities related to ASD/DD. The MCHB Division of Research within the Office of Epidemiology and Research supports applied and translational research and research networks relating to MCH services, including services for children, adolescents, and young adults with ASD/DD. Research projects address critical MCH research questions focused on public health systems and infrastructure, health disparities, quality of care, and promoting the health and well-being of MCH populations -- issues which also support the goals of HRSA. Emphasis is placed on projects that show promise of substantial contribution to the advancement of the current knowledge pool, and improvements in health and health services when applied in states and communities.

3 Autism and Developmental Disabilities Monitoring Network (2016 data) (http://www.cdc.gov/ncbddd/autism/data.html) 4 Kogan, et al. (2018) The Prevalence of Parent-Reported Autism Spectrum Disorder Among US Children. Pediatrics 142(6).

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

6 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.

7 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.

8 Social determinants of health (SDOH) are the conditions in the environments where people are born, l ive, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.

https://health.gov/healthypeople/objectives-and-data/social-determinants-health, accessed 11/23/20.

http://www.cdc.gov/ncbddd/autism/data.html https://health.gov/healthypeople/objectives-and-data/social-determinants-health

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The Autism-FIRST Program supports research on interventions for individuals with ASD/DD. Advancing the health and well-being of underserved children, adolescents, and young adults with ASD/DD and their families requires the application of new knowledge, evidence, and data. There is an additional need to examine how the systems and services to support underserved children, adolescents, and young adults with ASD/DD may fall short with regard to equitable and coordinated access for families.

The FY21 Autism-FIRST Program aligns with the Autism CARES Act of 2019 requesting applied and translational research that will develop and test new interventions and effective services in order to help improve the health and well-being of underserved children, adolescents, and young adults with ASD/DD across the lifespan.

Funding associated with these awards is intended to support the conduct of empirical research that will result in the following:

• Advancement of the current knowledge base through the development and testing of new and innovative investigator-initiated services and interventions designed to improve health and well-being across the lifespan for underserved children, adolescents, and young adults with ASD/DD and their families, as evidenced by the publication of study findings in peer-reviewed journals; and

• Facilitation of research findings into practice through the dissemination of information, reports, and/or award project outputs to key target audiences, including researchers, providers, State Title V and children with special health care needs programs, and other programs serving the populations targeted by the proposed research study, as well as policymakers, families, and the general public.

Autism-FIRST projects have been awarded across a variety of topics related to improving services and care for children, adolescents, and young adults with ASD/DD and their families.

For more information about MCHB’s autism programs, please see https://mchb.hrsa.gov/maternal-child-health-initiatives/autism. For more information about the MCH Research Program, visit our website:

http://www.mchb.hrsa.gov/research.

A list of Frequently Asked Questions (FAQs) about applying to our programs can be found in Appendix E of this NOFO.

II. Award Information

1. Type of Application and Award

Type(s) of applications sought: New

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA expects approximately $600,000 to be available annually to fund two (2) recipients. You may apply for a ceiling amount of up to $300,000 per year, which https://mchb.hrsa.gov/maternal-child-health-initiatives/autism http://www.mchb.hrsa.gov/research

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includes both direct and indirect costs. The period of performance is September 1, 2021 through August 31, 2024 (3 years). Funding beyond the first year is subject to the availability of appropriated funds for the Autism FIRST program in subsequent fiscal years, satisfactory recipient performance, 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.

2. Cost Sharing/Matching Cost sharing/matching is not required for this notice.

3. Other HRSA will consider any application that exceeds the ceiling amount of $300,000 per year total costs to be 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 to be non-responsive and will not consider it for funding under this notice.

NOTE: Multiple applications from an organization are allowable. Multiple applications from an organization with the same DUNS number are allowable if the applications propose separate and distinct projects. For example, different investigators (or research teams) from the same institution can apply for the same funding opportunity.

Please make sure you submit your application to the correct NOFO number:

HRSA-21-053 Autism-FIRST program. Applications submitted to the wrong competition will be deemed nonresponsive.

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.

Due to funding limitations and in order to diversify the Autism-FIRST Program portfolio, the following additional application responsiveness criteria apply. All applications that do not comply with these requirements will be deemed non-responsive and will not be considered for funding under this notice. For this NOFO:

• An individual cannot be named as the project director (PD) or principal investigator (PI) on more than one application to this competition.

• A current PD/PI of an active HRSA/MCHB Research award can serve for no https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

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more than 10 percent time on a new proposal;

• Applications that overlap in period of performance with a currently funded

HRSA/MCHB Research project by the same PD/PI will not be considered for funding (i.e., a PD/PI cannot have two (2) HRSA/MCHB Research awards in effect simultaneously). A 1-year no-cost extension counts as part of the total period of performance during which an overlap in period of performance is not allowed.

• A recipient who currently has or in the past has had a HRSA/MCHB Research award cannot apply for a new award to follow longitudinally the population used in their previous HRSA/MCHB award. This limitation applies for a period of 3 years. The following are acceptable, however:

Applications that include a longitudinal design within the proposed 3-year period of performance; and applications that involve collecting follow-up data on a population targeted in an award funded by another agency.

• All applications that request funding for this competition must involve the collection of primary data (i.e., original data that will be collected, compiled, and analyzed specifically for the proposed research project). Applications that focus on the analysis of secondary data (i.e., data that were previously collected by you or other investigators, institutions, or agencies) are not eligible for the multi-year HRSA-21-053 Autism-FIRST program, and will not be considered for funding.

• The applicant PD/PI is expected to spend a minimum of 10 percent effort on this project to ensure that sufficient time is allocated and devoted to conducting the proposed study.

Additionally, a student/trainee receiving support from grant funds must be a citizen of the United States or a foreign national having in his/her possession a visa permitting permanent residence in the United States, or a non-citizen national.

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 NOFO following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for each NOFO you are reviewing or preparing in the workspace application package 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

Section 4 of HRSA’s SF-424 R&R Application Guide provides instructions for the budget, budget justification, staffing plan and personnel requirements, assurances, https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/ https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

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certifications, and abstract. You must submit the information outlined in the 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 SF-424 R&R Application Guide for the Application Completeness Checklist (also Appendix C of this application).

Application Page Limit 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 abstract, project and budget narratives, attachments including biographical sketches (biosketches), and letters of commitment and support required in HRSA’s and this NOFO.

Biographical sketches for any key employed personnel that will be assigned to work on the proposed project must be attached to RESEARCH & RELATED Senior/Key Person Profile (OMB Number 4040-0001) found in the application package on Grants.gov. Due to the HRSA 80-page limit, it is recommended that all biographical sketches are no more than five pages in length and must follow the HRSA font/margin requirements. For details on how to format the biographical sketch visit:

https://mchb.hrsa.gov/research/documents/FORM-Biographical-Sketch-for-Research- Grant-Applicants-Jan2020-2023.docx.

Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. However, biographical sketch OMB forms do count in the page limitation. Please note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-21-053 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.

Please note that the Methodology/Research Strategy of the application narrative is STRICTLY LIMITED TO 12 PAGES as part of the 80-page limit. If you do not adhere to this page limit, your application will be deemed non-responsive to the NOFO and marked ineligible for review.

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

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 https://mchb.hrsa.gov/research/documents/FORM-Biographical-Sketch-for-Research-Grant-Applicants-Jan2020-2023.docx https://mchb.hrsa.gov/research/documents/FORM-Biographical-Sketch-for-Research-Grant-Applicants-Jan2020-2023.docx

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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. 3321).

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachment 8: Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 R&R Application Guide for additional information on this and other 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), please include the following:

i. Project Abstract See Section 4.1.ix of HRSA’s SF-424 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, please prepare this to be clear, accurate, concise, and without referring to other parts of the application. Briefly state the principal needs and problem, goals, proposed activities including underserved target population(s), planned coordination, anticipated products, and plans for evaluation.

Abstract content: The following describes the different suggested section headers (capitalized) and content. The abstract should not exceed one page in length.

• FUNDING OPPORTUNITY NUMBER: HRSA-21-053

• FUNDING OPPORTUNITY TITLE: Autism-FIRST program

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

• GOAL(S) AND OBJECTIVES: Include the major goal(s) and objectives for the period of performance listed in your proposal. 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 underserved population(s) addressed, and comment on innovations in the proposed plan.

• COORDINATION: Describe the coordination planned with, and participation of, any 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.

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

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

• EVALUATION: Briefly describe the evaluation methods you will use 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.

ii. Project Narrative This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, self-explanatory and well organized so that reviewers can understand the proposed project.

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

A. SPECIFIC AIMS -- Corresponds to Section V’s Review Criteria 1 Need and 2 Response

The applicant should 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 impetus behind the proposed study.

1) Needs Assessment (Corresponds to Section V’s Review Criterion 1 Need) This section outlines the unmet needs of the underserved population(s) that the proposed project will address, and should help reviewers understand how the targeted population will benefit from the proposed project.

• Briefly describe the underserved population(s) (including age ranges of children/youth) and its unmet health needs that the proposed study targets.

• As appropriate, include sociocultural determinants of health and health disparities impacting the population that the proposed project will address.

2) Significance – (Corresponds to Section V’s Review Criterion 2 Response)

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

• Explain the critical problem or barrier to progress in the field that the proposed project addresses.

• Indicate the relevance of the problem to the targeted population, and identify the envisioned application of findings to practice and/or the ways that services are organized and delivered.

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

• Clearly and succinctly state the specific objectives of the particular research proposed, for example, to test a stated hypothesis, create a novel intervention, solve a specific problem, challenge an existing paradigm or

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clinical practice, address a critical barrier to progress in the field, and/or develop new technology.

• Clearly and concisely summarize the expected outcome(s) and how these will address the unmet needs of the targeted population.

• Construct and present a logic model or graphical representation of the set of relationships held to be operative among the variables (see Attachment 3 and Appendix D for more detailed information on how to construct a logic model).

• Make sure that there is congruence among the associations depicted by the logic model or graphic model, the statement of hypotheses, and the plan for data analysis.

Do not use the Specific Aims section to circumvent the 12-page limit of the Methodology/ Research Strategy section.

B. METHODOLOGY/RESEARCH STRATEGY -- Corresponds to Section V’s Review Criteria: 3 Evaluative Measures, and 4 Impact

Organize the Methodology/Research Strategy section in order of instructions provided below. Start each section with the appropriate section heading – Work Plan/Approach and Scientific Innovation and Importance. Cite relevant publications in the Methodology/Research Strategy section and provide the full reference in the Bibliography and References Cited section.

The Methodology/Research Strategy section (Work Plan/Approach, Scientific Innovation and Importance) is limited to 12 pages in length. Applications that exceed this 12-page limit in the Methodology/ Research Strategy section will be deemed nonresponsive, and will not be considered for funding under this notice.

1) Work Plan/Approach (Corresponds to Section V’s Review Criterion 3 Evaluative Measures)

• Describe the overall study design, strategy, methodology, and analyses to be used to accomplish the specific aims of the proposed project.

• Describe the procedures for data collection and instrumentation as appropriate, including information/citations regarding the established validity of the instruments used if applicable.

• Describe the study population. Include demographic information on the participant population (i.e., targeted ages, expected racial/ethnic background and socioeconomic status, rural/urban, etc.).

• Describe eligibility inclusion/exclusion criteria.

• Address issues regarding sampling design and randomization as appropriate.

• Include expected targeted/planned enrollment number and power analyses as appropriate.

• Include a description of strategies for participant recruitment.

• Include how the data will be collected, analyzed, and interpreted as

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well as any resource sharing plans as appropriate.

• Assure cultural competence in the planning and implementation of the proposed research project.

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

• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in the ASD/DD field.

• Describe the impact that the results of the proposed research will have on the research field(s) involved.

• Explain how the application challenges and seeks to shift current research or clinical practice paradigms.

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

• Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, policies, or interventions.

• Describe how the concepts, methods, technologies, treatments, services, policies, or preventive interventions that drive the relevant field will be changed if the proposed aims are achieved.

PRELIMINARY STUDIES

Information regarding Preliminary Studies may be placed in Attachment 4. [Note that this attachment counts in the overall 80-page limit.]

BIBLIOGRAPHY AND REFERENCES CITED

The Bibliography/References cited may be placed between Section B, Methodology/Research Strategy, and Section C, Impact and Dissemination. It does not count in the 12-page limit for Section B, but does count in the overall 80-page limit.

C. IMPACT AND DISSEMINATION -- Corresponds to Section V’s Review Criterion 4 Impact

1) Public Health Impact

• Describe the public health impact that study results are likely to have.

• Describe the impact that the expected outcomes are likely to have on care delivery strategies involved and/or the health and well-being of the target population(s) that the study sample is drawn from.

• Describe the extent to which study results will be generalizable and replicable.

• Describe the extent to which study results will be regional or national in significance.

2) Publication and Dissemination Plan

• Autism-FIRST awardees will produce at least three (3) peer-reviewed publications per study. Describe how the dissemination plan will

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include at least three peer-reviewed publications.

• Reference relevant publications from any previous work.

• Describe a plan to advance the transfer of findings into practice by disseminating findings, reports, and/or award project outputs to key target audiences, including researchers, providers, State Title V and children with special health care needs programs and other program(s) serving MCH and ASD/DD populations, policymakers, families and the general public. In terms of communication channels, awardees may distribute research findings and information on project activities and findings through: targeted email messages, newsletter articles, conference presentations, webcasts, fact sheets, infographics, policy briefs, and website and social media posts, as appropriate.

D. ORGANIZATIONAL INFORMATION/ENVIRONMENT -- Corresponds to Section V’s Review Criterion 5 Resources/Capabilities

This information is used to assess the capability of the organizational resources available to perform the effort proposed. NOTE: The SF-424 R&R Table of Contents in HRSA’s SF-424 R&R Application Guide 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.

• Identify the facilities to be used (laboratory, clinical setting, computer lab, office, and/or other). If appropriate, indicate capacities available to the proposed study. Describe only those resources that are directly applicable to the proposed work.

• Describe how the scientific environment in which the research will be done, and/or useful collaborative arrangements that enhance the scientific environment in which the project will be conducted, contribute to the probability of its success (e.g., institutional support, physical and other resources, and intellectual environment).

• For Early Stage Investigators (defined as up to 7 years following attainment of the field-relevant doctoral degree), describe institutional investment in the success of the investigator; examples of such investment would be: resources for professional development, travel, training; collegial support such as career enrichment programs and availability of organized peer groups; logistical support such as administrative management and oversight and best practices training; and financial support such as protected time for research with salary support.

• If there are multiple performance sites, describe the resources available at each site.

Qualifications of Research Team’s Key Personnel

• The qualifications of the research team’s key personnel are assessed as part of Section V’s Review Criterion 5 Resources/Capabilities. To assess the qualifications of the research team’s key personnel, the

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following items are used: (a) Preliminary Studies in Attachment 4; (b) Staffing Plan in Budget Narrative; and (c) Biographical Sketches of key personnel.

• Include biographical sketches for persons occupying key positions. In the event that a biographical sketch is included for an identified individual who is not yet hired, please include a letter of commitment from that person with the biographical sketch. Please use the MCHB biographical sketch form found here:

https://mchb.hrsa.gov/research/documents/FORM-Biographical- Sketch-for-Research-Grant-Applicants-Jan2020-2023.docx. Please note that even though the document has an OMB clearance number, it’s not a standard form and your response counts against the page limit. The biographical sketch may not exceed five pages per person. This OMB form can be attached to RESEARCH & RELATED Senior/Key Person Profile (OMB Number 4040-0001) found in the application package on grants.gov.

• Do not confuse “Research Support” with “Other Support.” Though they sound similar, these parts of the application are very different.

As part of the biographical sketch section of the application, “Research Support” highlights your accomplishments, and those of your colleagues, as scientists. This information will be used by the reviewers in the assessment of each individual’s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. In contrast, “Other Support” information is required for all applications that are selected to receive funding awards. HRSA staff will request complete and up-to-date “other support” information from you after peer review. This information will be used to check that the proposed research has not already been federally-funded.

E. FEASIBILITY -- Corresponds to Section V’s Review Criterion 7 Program Assurances

Proposed Sequence or Timetable

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

Resolution of Challenges

• Discuss any challenges that are likely to be encountered in designing and implementing the research activities described in the Work Plan/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.

https://mchb.hrsa.gov/research/documents/FORM-Biographical-Sketch-for-Research-Grant-Applicants-Jan2020-2023.docx https://mchb.hrsa.gov/research/documents/FORM-Biographical-Sketch-for-Research-Grant-Applicants-Jan2020-2023.docx

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

• Discuss the feasibility of reaching targeted/planned enrollment levels.

• Establish feasibility by describing any strategies that will be used to address the management of any high-risk aspects of the proposed work.

F. EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to Section V’s Review Criterion 7 Program Assurances

• Describe a plan for performance evaluation (evaluating project progress towards its specific aims) that will contribute to continuous quality improvement of project efforts. The project performance evaluation should reflect the Specific Aims described in Section B above, as well as the specific timeline goals set in the Proposed Sequence or Timetable under Section F Feasibility above (e.g., all staff identified and trained by month 4, data collection begun by month 6, etc.). The purpose is to monitor ongoing processes and the progress towards the aims and objectives of the project.

G.HUMAN SUBJECTS Protections -- Corresponds to Section V’s Review Criterion 7 Program Assurances

• If human subjects are involved, the project should be in compliance 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).

Please refer to instructions provided in HRSA’s SF-424 R&R Application Guide Appendix: Supplemental Instructions for Preparing 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.

• This section is required for applicants answering “yes” to the question “Are human subjects involved?” on the R&R Other Project Information form. If the answer is “No” to the question but the proposed research involves human specimens and/or data from subjects, you must provide a justification in this section for the claim that no human subjects are involved.

• Discuss plans to seek Institutional Review Board (IRB) approval. IRB approval is not required at the time of application submission, but must be received prior to initiation of any activities involving human subjects. Do not use the protection of human subjects section to circumvent the page limits of the Research Strategy.

If appropriate, describe any procedures, situations, or materials that may be hazardous to personnel, and precautions to be exercised.

H. TARGETED/PLANNED ENROLLMENT -- Corresponds to Section V’s Review Criterion 7 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

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Program Assurances

Provide details about the targeted/planned enrollment for the proposed study.

Information should include targeted/planned enrollment totals by:

• Ethnic Category (Hispanic Heritage): “Hispanic or Latino” or “Not Hispanic or Latino”

• Gender distribution within each Ethnic Category (Hispanic Heritage)

• Total planned enrollment by Ethnic Category (Hispanic Heritage)

• Racial Categories

• American Indian/Alaska Native

• Asian

• Native Hawaiian or Other Pacific Islander

• Black or African American

• White

• More than One Race

• Gender distribution within each racial category

• Total planned enrollment by racial category

• The “Ethnic Category (Hispanic Heritage): Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects”. Also list any proposed racial/ethnic subpopulations, if applicable.

• The “Total Planned Enrollment” means the number of subjects that are expected to be enrolled during the entire period of the proposed study and are needed to evaluate the research question. The “Total Planned Enrollment” will be reported in two ways in the table: by self-reported “Ethnic Category (Hispanic Heritage)” and by self-reported “Racial Categories.”

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).

iii. Budget The directions offered in the SF-424 R&R Application Guide may differ from those offered by Grants.gov. Follow the instructions included in the R&R Application Guide and the additional budget instructions provided below. A budget that follows the R&R Application Guide will ensure that, if HRSA selects the application for funding, you will have a well-organized plan, and by carefully following the approved plan can avoid audit issues during the implementation phase.

Reminder: The Total Project or Program Costs are the total allowable costs (inclusive of direct and indirect costs) you incur to carry out a HRSA-supported project or activity. Total project or program costs include costs charged to the award and costs borne by the recipient to satisfy a matching or cost-sharing requirement, as applicable.

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The maximum number of budget periods allowed is three. A budget period represents 12 months of project effort.

In addition, the HRSA-21-053 Autism-FIRST program requires the following:

The budget should reflect the travel expenses associated with participating in the HRSA MCHB Autism CARES recipients’ meeting, which is expected to be held in person in the Washington, D.C. metropolitan area in 2023. Sufficient funds must be set aside for the PI to attend this meeting. [Note: meeting may be virtual depending on COVID or other restrictions.]

NOTE: Travel outside of the United States is not supported.

The Consolidated Appropriations Act, 2021(P.L. 116-260), Division H, § 2.02 states, “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. . . .” See Section 4.1.iv Budget – Salary Limitation of HRSA’s SF-424 R&R Application Guide for additional information. Note that these or other salary limitations may apply in the following fiscal years, as required by law.

iv. Budget Narrative See Section 4.1.v of HRSA’s SF-424 R&R Application Guide.

In addition, the Autism FIRST program requires the position descriptions (roles, responsibilities, and qualifications of proposed project…