PKG00245777-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Maternal and Child Health Bureau Office of Epidemiology and Research, Division of Research

R41: Autism Secondary Data Analysis Research Program

Funding Opportunity Number: HRSA-19-090

Funding Opportunity Type(s): Initial: New, Resubmission Catalog of Federal Domestic Assistance (CFDA) Number: 93.877

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2019

Application Due Date: January 22, 2019

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: October 25, 2018

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

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

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for fiscal year (FY) 2019 R41: Autism Secondary Data Analysis Research (SDAR) Program. The purpose of this program is to improve the physical and behavioral health of children and adolescents with autism spectrum disorder (ASD) and other developmental disabilities (DD) by (1) reviewing and evaluating the effectiveness of ASD/DD interventions and (2) assessing disparities in access to ASD/DD screening, diagnosis and treatment through 1-year grants for secondary analyses of existing publicly available and accessible national datasets and/or administrative records.

Funding Opportunity Title: R41: Autism Secondary Data Analysis

Research Program Funding Opportunity Number: HRSA-19-090 Due Date for Applications: January 22, 2019 Anticipated Total Annual Available FY 2019 Funding:

$400,000

Estimated Number and Type of Award(s): Up to four grants Estimated Award Amount: Up to $100,000 Cost Sharing/Match Required: No Period of Performance: September 1, 2019 through

August 31, 2020 (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.

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.

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Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Monday, November 5, 2018 Time: 2:00 pm – 3:30 pm ET Call-In Number: 1- 888-566-5772 Participant Code: 4176887 Weblink: https://hrsa.connectsolutions.com/r41_autism_nofo_ta Playback Number: 1- 888-562-7630 Passcode: 2259

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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

iii. Budget

iv. Budget Justification Narrative

v. Program-Specific Forms

3. DUN AND BRADSTREET DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER AND

SYSTEM FOR AWARD MANAGEMENT

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-AWARD ACTIVITIES

4. ANTICIPATED ANNOUNCEMENT AND AWARD DATES

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: KEY TERMS FOR PROJECT ABSTRACTS

APPENDIX B: FREQUENTLY ASKED QUESTIONS (FAQS) ABOUT THE R41 AUTISM

SECONDARY DATA ANALYSIS RESEARCH (SDAR) PROGRAM

APPENDIX C: GRANT APPLICATION COMPLETENESS CHECKLIST

HRSA-19-090 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the R41 Autism Secondary Data Analysis Research (SDAR) Program, previously referred to as the R40 Autism Secondary Data Analysis Studies (SDAS) Program. The Autism SDAR Program supports secondary data analysis of existing publicly available and accessible national databases and/or administrative records1 to advance best practices and determine the evidence-based practices for interventions that improve the physical and behavioral health of children and adolescents with autism spectrum disorder (ASD) and other developmental disabilities (DD), referred to as ASD/DD.

The 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 determine pathways and the feasibility of interventions using existing data sets. This is more efficient and cost-effective than conducting primary data collection, which is both costly and time-consuming.

Findings from the research supported by the program are expected to:

• Generate new evidence to address the needs of underserved populations2 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 patient engagement and care delivery through studies that are generalizable and replicable for the targeted ASD/DD populations through dissemination activities. These may include development and publication of several peer-reviewed manuscripts as well as conference presentations, newsletter articles, webcasts, fact sheets, infographics, policy briefs, websites, and social media posts, as appropriate, clearly indicating the number of peer-reviewed and other publications that will be produced from the proposed project; and

• Address the following U.S. Department of Health and Human Services’ (HHS) and Health Resources and Services Administration (HRSA) priority areas as they relate to ASD/DD populations and align with the research and surveillance activities identified in the Autism Cares Act of 2014:3 o Combatting the opioid crisis, o Bringing down the high cost of prescription drugs, o Addressing the cost and availability of health insurance, o Implementing value-based care delivery and quality improvement initiatives, 1 In this NOFO, the terms publicly available and accessible are used to refer national datasets and/or administrative records that any researcher can access before or within the project period.

2 Underserved populations include low-income, racial/ethnic minorities, immigrant, female, the geographically remote and other groups that are not already well represented in current research on children and adolescents with ASD/DD.

3 https://www.hrsa.gov/opioids https://www.hrsa.gov/opioids

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o Targeting the health workforce need, o Enhancing access to mental health services, and o Reducing childhood obesity and maternal mortality.

HRSA expects each Autism SDAR award recipient to complete the following major activities:

• Conduct applied or translational research on critical and emerging ASD/DD issues through appropriate secondary data analyses of existing national databases and/or administrative records, that are aligned with research goals;

• Write and publish several peer-reviewed research articles about your project.

Articles could include findings on research planning, participant recruitment, methods, implementation and/or research challenges, preliminary or unexpected research findings, in addition to final research findings. It is expected that the project will produce and publish several peer-reviewed publications, but no less than two. Please clearly indicate the number of peer-reviewed publications proposed;

• Distribute research findings and products to scientific, professional, and lay audiences, including HRSA and other HHS agencies; and

• Report target population study sample with regards to diversity (i.e., ethnicity, race, gender/sex, geographic location, and socioeconomic status).

Innovative secondary use of existing data from national datasets, administrative records and other publicly available datasets from a variety of sources (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)) is encouraged. Innovative methods such as meta-analysis are also encouraged.

2. Background

This program is authorized by the Public Health Service Act, § 399BB(f) (42 U.S.C. § 280i-1(f)), as amended.

ASD is a developmental disorder that can cause significant physical and behavioral health challenges (e.g., unhealthy weight, difficulty communicating, etc.). The CDC estimates that 1 in every 59 children in the United States meets ASD diagnostic criteria4. In response to this public health need, the Autism CARES Act of 2014 reauthorized research, surveillance, and education activities related to ASD/DD.

Specifically, the Autism SDAR Program addresses the critical need that exists for research on the barriers to screening, diagnosis, and receipt of evidence-based interventions for underserved populations of children and adolescents with ASD/DD.

4 U.S. Centers for Disease Control and Prevention, Autism Spectrum Disorder (ASD), Data & Statistics Prevalence. https://www.cdc.gov/ncbddd/autism/data.html.

https://www.cdc.gov/ncbddd/autism/data.html

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The Autism SDAR Program is the only federal program supporting 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 establish potential pathways for effective ASD/DD interventions.

The Maternal and Child Health (MCH) Research Program in HRSA/Maternal and Child Health Bureau’s Office of Epidemiology and Research, administers the Autism SDAR Program. The MCH Research Program has supported groundbreaking studies that have significantly 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. The 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.

Autism CARES Act of 2014

In carrying out the provisions of the Autism CARES Act, HRSA supports programs to improve the quality of care among those diagnosed with ASD/DD through education, early detection, and intervention. Specifically, these activities are designed to:

• 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 to provide research-informed interventions through an interdisciplinary approach that will also focus on specific issues for children who are not receiving an early diagnosis and subsequent interventions.

The four program areas supported by HRSA include (1) Training for Professionals,

(2) Autism Research Programs (3) Autism Policy Programs and (4) National Evaluation.

For additional details, please see https://mchb.hrsa.gov/maternal-child-health-initiatives/autism.

http://www.mchb.hrsa.gov/research https://mchb.hrsa.gov/maternal-child-health-initiatives/autism https://mchb.hrsa.gov/maternal-child-health-initiatives/autism

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II. Award Information

1. Type of Application and Award

Type(s) of applications sought: New, Resubmission5

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA expects approximately $400,000 to be available to fund four recipients for 1 year.

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, 2019 through August 31, 2020 (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.

5 A resubmission is a subsequent application from the same investigator for a revised proposal following an earlier unsuccessful application and review.

http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

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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 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)6 on more than one application for the HRSA-19-090 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 to analyze publicly available and accessible longitudinal data7 are allowed;

• Analysis of secondary data previously collected by the applicant PD/PI will not be considered for funding;

• Applications cannot propose to analyze linked datasets where one of the datasets proposed for analysis is not publicly available and accessible as all proposed datasets must be publicly available and accessible;

• Applications must propose the use of existing publicly available and accessible 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 the use of existing databases and administrative data.

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. If you’re reading this notice of funding opportunity (NOFO) (also known as “Instructions” on Grants.gov) and reviewing or preparing the workspace application package, you will automatically be notified in the

6HRSA 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.

7In this NOFO, the term dataset refers to both national datasets and administrative data.

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

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event HRSA changes and/or republishes the NOFO on Grants.gov before its closing date. Responding to an earlier version of a modified notice may result in a less competitive or ineligible application. Please note you are ultimately responsible for reviewing the For Applicants page for all information relevant to desired opportunities.

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 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 SF-424 R&R Application Guide and this NOFO.

Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Biographical sketches do count in the page limitation.

Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. We strongly urge you 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 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 to be considered under this notice.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) The prospective recipient certifies, by submission of this proposal, that neither it nor its principals is 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).

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

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3) Where the prospective recipient is unable to attest to the statements in this certification, an explanation shall be included in an 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 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:

A. INTRODUCTION – (for resubmission only)

Note: For resubmissions, mark the application as “Resubmission” for item #8 “Type of Application” on the first page of the SF-424 R&R.

For a resubmission of a previously reviewed proposal, begin the Introduction by specifying that it is a resubmission; state the application/tracking number of the prior submission, its title, and HRSA notice number of the prior submission. Example:

This is a resubmission of application #, ‘Determinants of Racial Disparities in Access to Screening Services for Autism,’ that was submitted for HRSA-15-032.

There is no limitation to the amount of time lapsed from initial submission of an application to resubmission.

The following requirements pertain to a resubmission:

• Resubmitted applications will not be reviewed by the prior reviewers/review panel;

• The PD/PI must make significant changes to the application;

• This section must summarize the substantial additions, deletions, and changes to the application. It must also include a response to the issues and criticism raised in the Summary Statement of the previous application.

• The Introduction should not exceed three pages in length; and The substantial scientific changes must be marked in the text of the application by bracketing, indenting, or changing the typography. Do not underline or shade the changes. Deleted sections should be described but not marked as deletions. If the http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

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changes are so extensive that essentially all of the text would be marked, explain this in the Introduction. The Preliminary Studies/Progress Report section should incorporate work completed since the prior version of the application was submitted.

Resubmissions must address all of the current NOFO requirements.

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

NEED AND #2 RESPONSE

1) Needs Assessment -- Corresponds to Section V’s Review Criterion #1 Need This section outlines the unmet needs of the targeted population that the current 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 and other demographic information) and its unmet health needs

• As appropriate, include sociocultural determinants of health 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, with focus on its pertinence to and rationale for the current 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 children and adolescents with ASD/DD and their families; 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

Goals and Objectives

• State clearly and succinctly the specific research objectives, identify new research questions, test hypotheses, determine pathways and feasibility of interventions, challenge an existing paradigm or clinical practice, or address a critical barrier to progress in the field.

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

Hypotheses and Specification of Variables

• Clearly and logically, present the specific questions that the study will answer and link to your program need. These should include not only predictions as to findings (hypotheses) but also justifications for the predictions. Ensure scientific approach is thoughtful and logical.

• Present a summary table of the variables, classified as independent, intervening, mediating, moderating, and dependent, etc. specifying the nature of the variables, the measures you will employ as indicators for these variables, and the units and levels of measurement of the indicators.

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• If possible, construct and present a model or graphical representation of the set of relationships held to be operative among the variables.

• Ensure congruence among the associations depicted by the graphic analytic model (if included), the table of variables, the statement of hypotheses, and the plan for data analysis.

C. 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 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 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/Approach-- Corresponds to Section V's Review Criterion #3 Evaluative Measures

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

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

o The study sample. Include demographic information on the participant population (i.e., ages, racial/ethnic background and socioeconomic status, geographic location, etc.);

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);

o Methods to collect, analyze, and interpret the data, as well as any resource sharing plans as appropriate; and

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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.

Preliminary Studies: Include information on preliminary studies as part of the Section (1) Work Plan/Approach section. Use this section to 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 -- 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 the concepts, methods, technologies, treatments, services, policies, or preventive interventions that drive this field will be changed if the proposed aims are achieved through this secondary data analysis project.

D. 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.

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

• Describe how the proposed study specifically addresses issues with expected broad public health impact.

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Publication and Dissemination Plan

• Your “publication action plan” should include information on:

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

o How you will advance the transfer of findings into practice by disseminating findings, reports, and/or project outputs to key target audiences, including scientific, professional, and lay audiences. Recipients will have implemented their plan to advance the transfer of findings into practice by the end of the period of performance, including dissemination to HRSA and other HHS agencies. In terms of communication channels, recipients 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.

E. RESOURCES AND CAPABILITIES -- 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 the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport). In describing the scientific environment in which the work will be done, discuss ways in which the proposed study will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements.

• For Early Stage Investigators, describe institutional investment in the success of the investigator; examples of such investment include provision of resources such as laboratory space sufficient to 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 the resources available at each site.

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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, 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 format described below. When applicable, biographical sketches should include training, language fluency and experience working with the culturally and linguistically diverse populations served by their programs.

NOTE: The biographical sketch may not exceed five pages per person. Follow the formats and instructions below.

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. 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 active duty military service.

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

C. Contribution to Science Briefly describe up to five 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 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.

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D. 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 key person identified on the biographical sketch. Do not include number of person months or direct costs.

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.

F. FEASABILITY – 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. Examples include staff training, putting culturally/linguistically competent project staff in place quickly, etc.

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

• Discuss the feasibility of obtaining the dataset or administrative record, including access to most-recent dataset or administrative record(s) if multiple years exist.

• Describe any strategy to establish the feasibility of the proposed work, and to address the management of any high-risk aspects of the proposed work.

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

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G. 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 analysis begun by month 6, etc.). The purpose is to monitor ongoing processes and the progress towards the aims and objectives of the project.

H. 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 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 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” o Gender/sex distribution within each Ethnic Category (Hispanic Heritage) o Total distribution by Ethnic Category (Hispanic Heritage) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

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

3) Socioeconomic status

4) Geographic Location o Urban o 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 SDAR project are available to the investigator, including information such as name of dataset, year of dataset, and date of data availability, and correspondence from the organization overseeing the dataset.

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, this table provides a crosswalk between the narrative language and where each section falls within the review criteria.

Narrative Section Review Criteria Points

A. Introduction (for resubmission only) Not Applicable--For Resubmissions Only N/A

B. Specific Aims: 1) Needs Assessment (1) Need 10

B. Specific Aims: 2) Significance (2) Response 20 B. Specific Aims: 3) Goals and

Hypotheses (2) Response

C. Methodology/Research Strategy:

1) Work Plan/Approach (3) Evaluative Measures 20

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C. Methodology/Research Strategy:

2) Scientific Innovation (4) Impact

D. Impact and Dissemination (4) Impact

E. Resources and Capabilities (5) Resources/Capabilities 10

Budget and Budget Justification (below) (6) Support Requested 10

F. Feasibility (7) Program Assurances

G. Evaluation and Technical Support

Capacity (7) Program Assurances

H. Protection of Human Subjects, Data Availability and Diversity of Database Sample

(7) Program Assurances

Total Points 100

iii. Budget See Section 4.1.iv of HRSA’s SF-424 R&R Application Guide. Please note: 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) incurred by the recipient 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.

The Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L. 115-245), Division B, § 202 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 FY, as required by law.

iv. Budget Justification Narrative

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

In addition, the Autism SDAR Program requires the following:

Within Personnel Costs, include the staffing plan by providing position descriptions (roles, responsibilities, and qualifications of proposed project staff) in the “Budget Justification” section that you will add to SF-424 R&R Budget Period – Section F – K Form, Box K. This staffing plan should describe the complementary and integrated http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

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expertise of the investigators and show that the leadership approach, governance and organizational structure are appropriate for the project. The staffing plan should reflect the commitment of the research team in conducting and completing the study.

(NOTE: A current PD/PI of an Autism FIRST or Autism SDAR Program award can serve for no more than 10 percent time on a new proposal in a capacity other than as Principal Investigator.) Copies of biographical sketches for all senior/key personnel and other significant contributors must also be submitted as an attached file to each SF-424 R&R Senior/Key Person Profile.

v. Program-Specific Forms Program-specific forms are not required for application.

vi. Attachments

Provide the following items in the order specified below to complete the content of the application. Unless otherwise noted, attachments count toward the application page limit. Indirect cost rate agreements (if applicable) will not count toward the page limit. You must clearly label each attachment.

Attachment 1: Letters of Agreement/Letters of Support

Provide any documents that describe working relationships between your agency and other agencies and programs cited in the proposal, including letters of agreement for use of datasets and/or administrative records for secondary data analysis. Documents that confirm actual or pending contractual agreements should clearly describe the roles of the subcontractors and any deliverables.

Include only letters of support that specifically indicate a commitment to the project/program (in-kind services, dollars, staff, space, equipment, etc.). Letters of agreement and letters of support must be dated.

Attachment 2: Key Publications or Condensed Citations with Abstracts

A list of citations for key publications by the key personnel that are relevant to the proposal can be included. Do not include unpublished theses, or abstracts/ manuscripts submitted (but not yet accepted) for publication. In consideration of the 80-page limitation, a list of citations only may be included.

Attachment 3: Surveys, Questionnaires, Data Collection Instruments, Clinical Protocols

Surveys, questionnaires, other data collection instruments, clinical protocols and informed consent documents may be submitted as an attachment as necessary, keeping in mind that these count in the 80-page limitation.

Attachment 4: 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.

Attachment 5: Explanation on Delinquent Federal Debt, if applicable Attachments 6 -15: Other Relevant Documents

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3. Dun and Bradstreet Data Universal Numbering System (DUNS) Number and System for Award Management

You must obtain a valid DUNS number, also known as the Unique Entity Identifier, for your organization/agency and provide that number in the application. You must also register with the System for Award Management (SAM) and continue to maintain active SAM registration with current information at all times during which you have an active federal award or an application or plan under consideration by an agency (unless the applicant is an individual or federal agency that is exempted from those requirements under 2 CFR § 25.110(b) or (c), or has an exception approved by the agency under 2 CFR § 25.110(d)).

HRSA may not make an award to an applicant until the applicant has complied with all applicable DUNS and SAM requirements and, if an applicant has not fully complied with the requirements by the time HRSA is ready to make an award, HRSA may determine that the applicant is not qualified to receive an award and use that determination as the basis for making an award to another applicant.

If you have already completed Grants.gov registration for HRSA or another federal agency, confirm that it is still active and that the Authorized Organization Representative (AOR) has been approved.

The Grants.gov registration process requires information in three separate systems: