PKG00264936-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Maternal and Child Health Bureau Office of Epidemiology and Research

Autism Secondary Data Analysis Research Program

Funding Opportunity Number: HRSA-21-052 Funding Opportunity Type(s): New

Assistance Listings (CFDA) Number: 93.877

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2021

Application Due Date: April 12, 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 12, 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 Secondary Data Analysis Research (SDAR) Program.

The purpose of these grants is to support applied Maternal and Child Health (MCH) research that exclusively utilizes secondary analyses of existing national databases and/or administrative records to determine the evidence-based practices for interventions to improve the physical and behavioral health of children and adolescents with Autism Spectrum Disorder (ASD) and other Developmental Disabilities (DD) across the lifespan, with a focus on addressing the needs of underserved populations for whom there is limited evidence of the effectiveness of interventions, and limited access to screening, diagnosis, and treatment for ASD/DD.1 HRSA supports programs to improve the quality of care for those diagnosed with ASD/DD through education, early detection, and intervention.

Funding Opportunity Title: Autism Secondary Data Analysis

Research (SDAR) Program Funding Opportunity Number: HRSA-21-052 Due Date for Applications: April 12, 2021 Anticipated Total Annual Available FY 2021 Funding:

$400,000

Estimated Number and Type of Award(s): Up to 4 grants Estimated Award Amount: Up to $100,000 per grant per year, subject to the availability of appropriated funds

Cost Sharing/Match Required: No Period of Performance: September 1, 2021 through August 31, 2022 (1 year) 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.

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 announcement, underserved populations include low-income, racial/ethnic minorities, immigrant, female, tribal, the geographically remote, and other groups that are not already well represented in current pediatric research.

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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.

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Thursday, January 21, 2021 Time: 2– 3 p.m. ET Call-In Number: 1-888-917-8041 Participant Code: 4138140

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

Playback Number: 1-866-358-4518 Passcode: 42221 Available until: April 22, 2021 http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf https://hrsa.connectsolutions.com/autism_sdar/

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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 (20 page limit)

iii. Budget -- CORRESPONDS TO SECTION V’S REVIEW CRITERION 6: SUPPORT

REQUESTED

iv. Budget Justification Narrative -- CORRESPONDS TO SECTION V’S REVIEW

CRITERION 6: SUPPORT REQUESTED

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 MANAGEM ENT (SAM)

4. SUBMISSION DATES AND TIM ES

5. INTERGOV ERNM ENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSM ENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIV E AND NATIONAL POLICY REQUIREM ENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: RELEVANT WEBSITES

APPENDIX B: KEY TERMS FOR PROJECT ABSTRACTS

APPENDIX C: APPLICATION COMPLETENESS CHECKLIST

APPENDIX D: LOGIC MODEL

APPENDIX E: FREQUENTLY ASKED QUESTIONS (FAQS) ABOUT THE AUTISM

SECONDARY DATA ANALYSIS RESEARCH (SDAR) PROGRAM

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Autism Secondary Data Analysis Research (SDAR) Program. This program supports applied Maternal and Child Health (MCH) research that exclusively utilizes the secondary analysis of existing national databases and/or administrative records to determine the evidence-based practices for interventions to improve the physical and behavioral health of children and adolescents with Autism Spectrum Disorder (ASD) and other Developmental Disabilities (DD), Programs should address ASD/DD across the lifespan, with a focus on addressing the needs of underserved populations for whom there is limited evidence of the effectiveness of interventions, and limited access to screening, diagnosis, and treatment for ASD/DD.2

HRSA supports programs to improve the quality of care for those diagnosed with ASD/DD through education, early detection, and intervention. More specifically, the Autism SDAR program accelerates the pace of research by providing researchers with the opportunity to pose new research questions, test hypotheses, challenge existing paradigms or clinical practices, and explore the feasibility of interventions using existing data sets. The use of existing data sets helps researchers obtain results more efficiently, at a lower cost. Innovative methods (e.g., meta-analyses) and secondary analysis of existing national databases and/or administrative records are encouraged (e.g., National Survey of Children’s Health (HRSA), National Database for Autism Research (National Institutes of Health (NIH)), Medicaid (Centers for Medicare and Medicaid Services), National Health Interview Survey (Centers for Disease Control and Prevention (CDC)) and Mental Health Research Network Database (NIH)).

The Autism SDAR program’s goals and objectives are to:

• Generate new evidence to address the needs of underserved ASD/DD populations3 for whom there is limited evidence of the effectiveness of interventions, and limited access to screening, diagnosis, and treatment for ASD/DD;

• Contribute to a broad public health impact by improving patient engagement and care delivery through studies that are generalizable and replicable across underserved ASD/DD populations;

• Develop and implement a plan to disseminate applied and/or translational research through at least two peer-reviewed research articles related to the project (e.g., findings on research planning, participant recruitment, methods, implementation and/or research challenges, preliminary or unexpected research findings, in addition to final research findings) and to scientific, professional, lay audiences, and federal partners.

2 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 announcement, underserved populations include low-income, racial/ethnic minorities, immigrant, female, tribal, the geographically remote, and other groups that are not already well represented in current pediatric research.

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2. Background

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

ASD is a complex neurodevelopmental disorder, and individuals with this condition may experience core behavioral challenges with social interactions and communication, as well as restrictive and repetitive behaviors, which can be lifelong and pervasive.4

Children and adolescents with ASD/DD also have greater health service needs, which can place a significant financial and emotional burden on their families.5 Additionally, 83 percent of children with ASD have at least one co-occurring non-ASD/DD condition.6 Children and adolescents with ASD also experience more physical health problems than neuro-typical individuals, including seizures, sleep problems, gastrointestinal disorders, nutritional deficiencies, and metabolic conditions.7,8,9 Consequently, these children and adolescents have greater health service needs, which can place a significant financial and emotional burden on their families.5 Children and adolescents with ASD/DD from underserved populations encounter persistent disparities in screening, diagnosis, and health service access, increasing their vulnerability to adverse physical and behavioral outcomes across the lifespan.10,11

A comprehensive picture of ASD among children in the U.S is best understood by examining two key estimates of ASD prevalence12. The Centers for Disease Control

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

5 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.

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 Coury D. Medical treatment of autism spectrum disorders. Curr Opin Neurol. 2010;23(2):131-136.

8 Lavelle TA, Weinstein MC, Newhouse JP, Munir K, Kuhlthau KA, Prosser LA. Economic burden of childhood autism spectrum disorders. Pediatrics. 2014;133(3):e520-9.

9 Doshi-Velez F, Ge Y, Kohane I. Comorbidity clusters in autism spectrum disorders: an electronic health record time-series analysis. Pediatrics. 2014;133(1):e54–e63. doi:10.1542/peds.2013-0819 10 Zuckerman KE, Lindly OJ, Reyes NM, Chavez AE, Macias K, Smith KN, Reynolds A. Disparities in diagnosis and treatment of autism in Latino and non-Latino white families. Pediatrics. 2017; 139(5):e20163010.

11 Bishop-Fitzpatrick L, Kind AJH. A scoping review of health disparities in autism spectrum disorder. J Autism Dev Disord.

2017;47(11):3380-3391.

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

https://www.ncbi.nlm.nih.gov/pubmed/28756549

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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.13 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.14 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. Furthermore, even though children can be diagnosed as early as age 2, on average, children identified with ASD were not diagnosed until after age four.15 Although 2016 Autism and Developmental Disabilities Monitoring Network (ADDM) data suggest no overall difference in ASD prevalence between 8-year-old Black and White children, there were disparities for Black children in early evaluation and diagnosis of ASD. Hispanic children were identified as having ASD less frequently than White or Black children.16 The impact of these disparities on health outcomes may be compounded by other social determinants of health (SDOH) across the lifespan;

conditions in which people are born, grow, live, work, and age.17 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.

The Autism SDAR Program is the only federal program that supports foundational applied research through analysis of existing national databases and/or administrative records to evaluate inequalities in access to screening, diagnosis, and treatment and to identify effective ASD/DD interventions. The MCH Research Program in HRSA’s Maternal and Child Health Bureau’s Office of Epidemiology and Research administers the Autism SDAR Program. The Program has supported groundbreaking studies that have influenced clinical practice, organization and delivery of health care services, delivery of preventive care, and early intervention(s) for MCH populations, including children with special health care needs. Prior Autism SDAR recipients published an average of two peer-reviewed scholarly papers per grant totaling approximately 23 articles by the 12 funded recipients. These articles have been cited 422 times. Autism SDAR recipients have also delivered 44 scientific conference presentations. More information about the Autism SDAR Program, funded projects, and current activities can be found at http://www.mchb.hrsa.gov/research.

13 Autism and Developmental Disabilities Monitoring Network (2016 data) (http://www.cdc.gov/ncbddd/autism/data.html) 14 Kogan, et al. (2018) The Prevalence of Parent-Reported Autism Spectrum Disorder Among US Children. Pediatrics 142(6).

15 National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention. (2019) Spotlight On: Delay Between First Concern to Accessing Services 16 Maenner et al. (2020) Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years — Autism and Developmental Disabil ities Monitoring Network, 11 Sites, United States, 2016. MMWR Surveillance Summary, 69(4).

17 Wiggins LD, Durkin M, Esler A, Lee LC, Zahorodny W, Rice C, Yeargin-Allsopp M, Dowling NF, Hall-Lande J, Morrier MJ, Christensen D, Shenouda J, Baio J.

Disparities in Documented Diagnoses of Autism Spectrum Disorder Based on Demographic, Individual, and Service Factors. Autism Res. 2019 Dec 23. [PMID: 31868321] http://www.mchb.hrsa.gov/research http://www.cdc.gov/ncbddd/autism/data.html https://www.ncbi.nlm.nih.gov/pubmed/31868321

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For additional details, please see Appendix A.

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 estimates approximately $400,000 to be available annually to fund four (4) recipients. The actual amount available will not be determined until enactment of the final FY 2021 federal appropriation. You may apply for a ceiling amount of up to $100,000 total cost (includes both direct and indirect, facilities and administrative costs).

The period of performance is September 1, 2021 through August 31, 2022 (1 year).

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 program.

3. Other

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.

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.

If for any reason (including submitting to the wrong funding opportunity number or making corrections/updates) an application is submitted more than once prior to the http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

HRSA-21-052 5

application due date, 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 SDAR 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)18 on more than one application for the HRSA-21-052 competition;

• In order to diversify our research grant portfolio, and ensure that investigators devote adequate time and expertise to funded research programs, a current PD/PI of an active HRSA/MCHB Research award can serve for no more than 10 percent time on a new proposal;

• Applications must propose secondary analysis of existing national datasets and/or administrative records;

• All secondary analyses, including those that involve the linkage of multiple datasets, cannot exceed 1 year in length; and

• Projects that include the collection of biological specimens will not be considered, as this program funds only applied or translational research on ASD/DD populations and allows secondary analysis of existing national databases and administrative data.

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.

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 notice of funding opportunity (NOFO) following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

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

https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html

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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, 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.

Application Page Limit The total size of all uploaded files included in the page limit may not exceed the equivalent of 60 pages when printed by HRSA. The page limit includes a 20-page limitation for the narrative section, and 6-page limitation for the Methodology/Research Strategy methodology section; which includes Significance, Innovation, and Approach.

All sections combined contribute to the 60-page total limit, including the abstract, project and budget narratives, attachments including biographical sketches (biosketches), and letters of commitment and support required in HRSA’s SF-424 R&R Application Guide 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 60-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. Please be aware that this form does count against the page limit.

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 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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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-21-052, 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 6 PAGES as part of the 60-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.

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: 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 See Section 4.1.ix of HRSA’s SF-424 R&R Application Guide.

ii. Project Narrative (20 page limit) This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, 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:

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

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A. SPECIFIC AIMS – CORRESPONDS TO SECTION V’S REVIEW CRITERIA #1

NEED AND #2 RESPONSE

Provide a brief introduction and overview of the proposed research project. The purpose of this section is to provide a compelling explanation of your project for the reviewers to clearly understand the scientific value of the proposed study.

1) NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion #1 NEED

This section outlines the unmet needs of the targeted population that the proposed project will address, and should help reviewers understand how the targeted population will benefit from the proposed project.

• Briefly describe the target population(s) (including age ranges, race/ethnicity, gender/sex and other demographic information) and its unmet health needs.

• As appropriate, include SDOH and health inequalities impacting the population that the current project will address.

2) SIGNIFICANCE -- Corresponds to Section V’s Review Criterion #2 RESPONSE

• Describe the background literature, and explain how it is pertinent to and provides rationale for the proposed research objectives.

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

• Indicate the relevance of the problem to children and adolescents with ASD/DD and their families.

• Identify how findings may be applied to the field to improve care and/or the ways that services are organized and delivered.

3) GOALS AND HYPOTHESES-- Corresponds to Section V’s Review Criterion #2

RESPONSE

Goals and Objectives

• State clearly and succinctly the specific research objectives. This includes addressing any critical barriers to progress in the field.

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

Hypotheses and Specification of Variables

• Clearly and logically, present the specific questions that the study will answer and link to unmet target population needs. Include hypotheses and provide justifications. Ensure scientific approach is thoughtful and logical.

• Present a summary table of the variables, classified as independent, intervening, mediating, moderating, and dependent, etc., the measures you

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will employ as indicators for these variables, and the units and levels of measurement of the indicators.

• If possible, construct and present a model or graphical representation of the set of relationships held to be operative among the variables. Ensure alignment throughout the graphic analytic model (if included), the table of variables, the statement of hypotheses, and the plan for data analysis.

B. METHODOLOGY/RESEARCH STRATEGY -- Corresponds to Section V’s Review Criteria #3 EVALUATIVE MEASURES and #4 IMPACT

Organize the Methodology/Research Strategy section in the specified order using the instructions provided below. Start each section with the appropriate section heading – Work Plan/Approach and Scientific Innovation. Cite published experimental details and provide the full reference in the Bibliography and References Cited section.

The Methodology/Research Strategy section (Work Plan and Scientific Innovation) is limited to six pages in length. If you do not adhere to this page limit for this section of your narrative, your application will be deemed non-responsive to the NOFO and marked ineligible for review.

1) WORK PLAN -- Corresponds to Section V’s Review Criterion #3 Evaluative Measures

• Study Design: Describe the overall study design, strategy, methodology, and analyses you will use to accomplish the specific aims of the project. Include the following information:

o Information regarding the database(s) you propose to use; written confirmation of the availability of the database for the proposed study should be included in Attachment 4. Describe how access will be gained to any confidential files, if utilized, in the proposed analyses;

o Information regarding the linkage of multiple datasets; data linkage activities among multiple datasets should be included within the overall study design portion of the Work Plan;

o The data collection procedures used for the database(s) or administrative record(s) and instrumentation as appropriate;

o The study sample, including demographic information (e.g., age, racial/ethnic background, socioeconomic status, geographic location);

o The eligibility inclusion/exclusion criteria for the database(s) and/or administrative record(s);

o Issues regarding sampling design and randomization as appropriate;

o Estimated study sample response rates, nonresponse bias analyses, and power analyses as appropriate;

o Strategies that the database(s) utilized for participant recruitment;

o The reliability and validity of instruments (psychometric properties); and o Methods to collect, analyze, and interpret the data, as well as any resource sharing plans as appropriate.

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

2) SCIENTIFIC INNOVATION AND IMPORTANCE -- Corresponds to Section V’s Review Criterion #4 Impact

• Explain how the proposed project will advance scientific knowledge and the limited availability of evidence, and improve technical capability and/or clinical practice.

• Describe the impact that the results of the proposed research will exert 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, or analyses used, and any advantage over existing methodologies, or policies.

• Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or policies that will be changed if the proposed aims are achieved through this secondary data analysis project.

• Describe how current concepts, methods, technologies, treatments, services, policies, or preventive interventions will be changed if the proposed aims are achieved through this secondary data analysis project.

C. IMPACT AND DISSEMINATION – CORRESPONDS TO SECTION V’S REVIEW

CRITERION #4 IMPACT

Public Health Impact

• Describe the impact that the expected outcomes are likely to have on patient engagement, care delivery strategies involved and/or the physical and behavioral health of targeted ASD/DD populations.

• Peer-reviewed publications: It is expected your project will produce at least two peer-reviewed publications. Clearly indicate the number and focus area of your proposed peer-reviewed publications.

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

• Describe how the proposed study contributes to broad public health impact.

Publication and Dissemination Plan

Provide a publication action plan that includes:

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• How you will publish several peer-reviewed articles describing outcomes, results, and challenges of your research project.

• Describe how you will facilitate the transfer of findings into practice by disseminating findings, reports, and/or project outputs to key target audiences, including scientific, professional, lay audiences, and federal partners.

Examples of how past recipients have disseminated research findings and information on project activities include email messages, newsletter articles, conference presentations, webcasts, fact sheets, infographics, policy briefs, and website and social media posts.

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 and personnel resources available to perform the effort proposed. NOTE: The SF-424 R&R Table of Contents Page refers to Environment as “Facilities & Other Resources.” This section on “Environment” can be included as an attachment in the Other Project Information Form, box 10, or included as part of the research narrative.

Organizational Facilities and Other Resources

• Identify the facilities you will use (laboratory, clinical setting, computer lab, office, and/or other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work.

• Describe how you will collaborate with pertinent partners, such as other HRSA-supported Autism CARES Act Programs (available here:

https://mchb.hrsa.gov/maternal-child-health-initiatives/autism), Title V grantees, and MCH Research Network recipients which are available here:

https://mchb.hrsa.gov/research.

• Discuss ways in which the proposed study will benefit from the unique features of the scientific environment or target population.

• For Early Stage Investigators19, describe institutional investment in the success of the research project and success of the investigator in obtaining funding.

Examples may include laboratory space sufficient for project needs, collegial support such as the availability of organized peer groups, logistical support such as administrative management and oversight, and financial support such as protected time for research with salary support.

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

19 A Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial independent research award. https://grants.nih.gov/policy/early-investigators/index.htm https://grants.nih.gov/policy/early-investigators/index.htm

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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 and research strategy, the following items are used: (a) Preliminary Studies in Section C.

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

• Biographical sketches should follow the instructions provided below. When applicable, biographical sketches should include training, language fluency and experience working with culturally and linguistically diverse study populations.

• It is encouraged that you use the MCHB biographical sketch form found here:

https://mchb.hrsa.gov/research/documents/FORM-Biographical-Sketch-for- Research-Grant-Applicants-Jan2020-2023.docx. NOTE: The biographical sketch form counts against your total page limitation and may not exceed five pages per person.

Professional Information: At the top of page one, include Name, Position Title, and Education/Training including: institution and location, degree, month/year degree attained, field of study. Then complete sections as described below:

A. Ethnicity Data: Provide ethnicity data for the Principal Investigator and all key staff according to the included chart on the MCHB Biographical sketch form to catalogue diversity among research staff.

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

B. Personal Statement Briefly describe why you are well suited for your role(s) in the project described in this application. The relevant factors may include:

aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and your past performance in this or related fields (you may mention specific contributions to science that are not included in Section C). You may also identify up to four peer-reviewed publications that specifically highlight your experience and qualifications for this project. If you wish to explain impediments to your past productivity, you may include a description of factors such as family care responsibilities, illness, disability, and/or active duty military service.

C. Positions and Honors List in chronological order previous positions, concluding with the present position. List relevant honors. Include present membership on any Federal Government public advisory committee.

D. Contribution to Science Briefly describe one to three of your most significant contributions to science. For each contribution, indicate the historical background that frames the scientific problem, the central finding(s), the influence of the finding(s) on the progress of science or the application of those finding(s) to 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 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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health or technology, and your specific role in the described work. For each of these contributions, reference up to four peer-reviewed publications or other non-publication research products (can include audio or video products, patents, data and research materials, databases, educational aids or curricula, instruments or equipment, models, protocols, and software or NetWare) that are relevant to the described contribution. The description of each contribution should be no longer than half a page, including figures and citations.

E. Research Support List both selected ongoing and completed research projects for the past 3 years (federal or non-federally-supported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the person identified on the biographical sketch.

Do not confuse “Research Support” with “Other Support.” Although they sound similar, these parts of the application are very different. As part of the biosketch 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 an award to show other sources of federal grant support for the applicant. 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

This section addresses questions around project feasibility. Provide assurance that the research team will conduct the study as designed. Once funded, it is critical that the recipient implements and completes the study as proposed and approved.

Proposed Sequence or Timetable

• Provide a sequence or timetable for the project that includes the 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. Discuss alternative strategies should any of these potential challenges arise. Examples include:

o Staff training, putting culturally/linguistically competent project staff in place quickly, etc.

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o The feasibility of obtaining the dataset or administrative record within the required timeline to complete the tasks, including access to most-recent dataset or administrative record(s) if multiple years exist.

o The feasibility of completing the proposed work within the timeline provided.

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 achieving 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 E Feasibility above (e.g., all staff identified and trained by month 4, data analysis begun by month 6, etc.).

The purpose is to monitor ongoing processes and the progress towards the aims and objectives of the project.

G. PROTECTION OF HUMAN SUBJECTS, DATA AVAILABILITY AND DIVERSITY

OF DATABASE SAMPLE – CORRESPONDS TO SECTION V’S REVIEW CRITERION

#7 PROGRAM ASSURANCES

Protection of Human Subjects

Human Subjects Protection:

Federal regulations (45 CFR part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. If you anticipate research involving human subjects, you must meet the requirements of the HHS regulations to protect human subjects from research risks.

• Please refer to instructions provided in HRSA’s SF-424 R&R Application Guide, Appendix Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan and Human Subjects Research Policy for specific instructions on preparing the human subjects section of the application.

• Please refer to HRSA’s SF-424 R&R Application Guide to determine if you are required to hold a Federal Wide Assurance (FWA) of compliance from the Office of Human Research Protections (OHRP) prior to award. You must provide your Human Subject Assurance Number (from the FWA) in the application. If you do not have an assurance, you must indicate in the application that you will obtain one from OHRP prior to award.

• In addition, you must meet the requirements of the HHS regulations for the protection of human subjects from research risks, including the following: (1) discuss plans to seek IRB approval or exemption; (2) develop all required documentation for submission of research protocol to IRB; (3) communicate with IRB regarding the research protocol; (4) communicate about IRB’s decision and any IRB subsequent issues with HRSA.

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

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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 Methods portion of the Project Narrative section.

This section is required if you answer “yes” to the question: “Are human subjects involved?” on the R&R Other Project Information form. If the answer is “No” to the HRSA-21-052 question but the proposed research involves data from human subjects, you must provide a justification in this section for the claim that no human subjects are involved.

• 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 the Protection of Human Subjects Section of the Research Plan and Human Subjects Research Policy for specific instructions on preparing the human subjects section of the application.

• Discuss plans to seek Institutional Review Board (IRB) approval or exemption.

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 Methodology/Research Strategy section.

Data Availability and Diversity of Database Sample

Provide details about the diversity of the sample selected for the study/analysis.

Information should include study sample totals by:

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

• Gender/sex distribution within each Ethnic Category (Hispanic Heritage)

• Total distribution by Ethnic Category (Hispanic Heritage)

2) Racial Categories

• American Indian/Alaska Native

• Asian

• Native Hawaiian or Other Pacific Islander

• Black or African American

• White

• More than One Race

• Gender/sex distribution within each racial category

• Total sample by racial category

3) Socioeconomic status20

20 Socioeconomic status can be determined by a family's income level, education level, and occupational status. Despite the differences in definition betw een poverty and socioeconomic status, researchers agree that there

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4) Geographic Location

• Urban

• Rural

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

“Racial Categories: Total Sample.” Also, list any proposed racial/ethnic subpopulations, if applicable.

• The “Total Sample” means the number of subjects in the dataset that will be used to evaluate the research question. They 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 analytic plan will reflect an understanding and valuing of the culture of the target population.

• Provide written confirmation that the proposed data that will be used for the Autism…