PKG00257682-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Maternal and Child Health Bureau Office of Epidemiology and Research

Maternal and Child Health Research Network Program

UT2 Autism Intervention Research Network on Physical Health (AIR-P)

Funding Opportunity Number: HRSA-20-054

Funding Opportunity Type(s): New Assistance Listings (CFDA) Number: 93.877

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2020

Application Due Date: April 13, 2020

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 13, 2020

Jessica DiBari, Ph.D., M.H.S. and Melissa Jenssen, B.S.

Program Officers Division of Research, Office of Epidemiology and Research Telephone: (301) 443-4690 and (301) 945-3933 Email: jdibari@hrsa.gov and mjenssen@hrsa.gov

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

HRSA-20-054 i

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2020 UT2 Autism Intervention Research Network on Physical Health (AIR-P) Program. The purpose of this program is to establish and maintain an interdisciplinary, multicenter research forum for scientific collaboration and infrastructure building. This Research Network will provide national leadership in research to advance the evidence base on effective interventions for children and adolescents with autism spectrum disorder and other developmental disabilities (ASD/DD) as they transition to adulthood across the lifespan, with a focus on addressing physical health and well-being.

Funding Opportunity Title: UT2 Autism Intervention Research

Network on Physical Health (AIR-P) Funding Opportunity Number: HRSA-20-054 Due Date for Applications: April 13, 2020 Anticipated Total Annual Available FY 2020 Funding:

$3,000,000

Estimated Number and Type of Award(s): Up to one cooperative agreement Estimated Award Amount: Up to $3,000,000 total cost per year dependent on the availability of appropriated funds

Cost Sharing/Match Required: No Period of Performance: September 1, 2020 through

August 31, 2025 (5 years)

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

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

HRSA-20-054 ii

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Research and Related (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 23, 2020 Time: 1–2 p.m. ET Call-In Number: 1-800-369-1830 Participant Code: 4796126 Weblink: https://hrsa.connectsolutions.com/autism_intervention_research/

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

HRSA will record the webinar and make it available at:

https://mchb.hrsa.gov/fundingopportunities/default.aspx http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf https://hrsa.connectsolutions.com/autism_intervention_research/ mailto:jdibari@hrsa.gov mailto:mjenssen@hrsa.gov https://mchb.hrsa.gov/fundingopportunities/default.aspx

HRSA-20-054 iii

Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Justification Narrative

v. Program-Specific Forms

vi. Attachments

3. DUN AND BRADSTREET DATA UNIVERSAL NUMBERING SYSTEM 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

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

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 MODELS

APPENDIX E: FREQUENTLY ASKED QUESTIONS (FAQS)

HRSA-20-054 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the UT2 Autism Intervention Research Network on Physical Health (AIR-P) Program. The purpose of this program is to establish and maintain an interdisciplinary, multicenter research platform for scientific collaboration and infrastructure building. The Research Network will provide national leadership in research to advance the evidence base on effective interventions1 for children and adolescents with autism spectrum disorder and other developmental disabilities (ASD/DD), with a focus on addressing physical health and well-being across the lifespan. Physical health may include, but is not limited to, medical, dental, visual, nutrition, and speech/hearing components.

The Research Network will determine the evidence-based practices for interventions to improve the physical health of individuals with ASD/DD across the lifespan, develop guidelines for those interventions, and disseminate information related to such research and guidelines as authorized by the Autism Collaboration, Accountability, Research, Education, and Support Act of 2019 (Autism CARES Act).

ASD/DD initiatives focused on behavioral health will not be considered for this notice of funding opportunity (NOFO). A separate NOFO is available for the Autism Intervention Research Network on Behavioral Health (AIR-B) Program (Funding opportunity number

HRSA-20-055).

The Research Network will:

• Lead, promote, and coordinate national research activities to improve the physical health and well-being of children and adolescents with ASD/DD as they transition to adulthood across the lifespan, especially those from underserved populations with limited access to effective ASD/DD treatments;2,3

• Develop and maintain an infrastructure to support the design of a portfolio of an interdisciplinary research focuses on fostering the implementation of multi-site intervention research studies, translating research to policy and practice;

• Provide an environment for mentoring and training the next generation of diverse clinical and non-clinical researchers in applied and translational autism research and practice;4

1 For the purpose of this NOFO, an “intervention” is defined as a manipulation of the subject or subject’s environment to modify one or more health-related biomedical or behavioral processes and/or endpoints or outcomes for children and adolescents with ASD/DD.

Examples include, but are not limited to, delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior(s) (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies;

and diagnostic strategies. A manipulation or task would be regarded as an intervention if it is used to modify a health-related biomedical or behavioral outcome. A manipulation or task used expressly for measurement, and not modification, would not be considered as an intervention. National Institutes of Health, Office of Extramural Research. Frequently Asked Questions: NIH clinical trial definition. Available at: https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5226. Accessed August 27, 2019.

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

3 The Health Resources and Services Administration’s Maternal and Child Health Bureau also funds the Autism Transitions Research Project, please see https://mchb.hrsa.gov/research/project_info.asp?ID=318.

4 Consistent with HRSA’s mission, training and mentoring of diverse emerging investigators fosters the development of a pipeline of ASD/DD researchers who are critical in promoting the sustainability of autism research and the work of the network.

https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5226 https://mchb.hrsa.gov/research/project_info.asp?ID=318

HRSA-20-054 2

• Address, where applicable, the U.S. Department of Health and Human Services’ (HHS) and Health Resources and Services Administration (HRSA) priorities, namely, mental health, opioid use disorder, prescription drug pricing, maternal health, and telehealth; and

• Indicate how study findings will further develop the evidence base, where relevant for this program and in alignment with the research and surveillance activities identified in the Autism CARES Act.

For cooperative agreement activities please see Project Narrative Section IV.

2. Background

This program is authorized by the Public Health Service Act, § 399BB(f) (42 U.S.C. § 280i-1(f)), as amended. The Research Network is a national multi-site, Research Network focused on building the evidence base for physical health intervention research for children and adolescents with ASD/DD. The Research Network provides national leadership by engaging researchers, practitioners, policymakers and consumers in collaborative, innovative, and multidisciplinary research projects.

Approximately 1 in 40 children in the United States is diagnosed with ASD.5 ASD is a complex neurodevelopmental disorder.6 Additionally, 83 percent of children with ASD have at least one co-occurring non-ASD DD.5 Children and adolescents with ASD experience more physical health problems than those who are typically developing, including seizures, sleep problems, gastrointestinal disorders, nutritional deficiencies, and metabolic conditions.7,8,9 Consequently, these children and adolescents have greater health services needs which can place a significant financial and emotional burden on their families.5 Children and adolescents with ASD/DD (including those transitioning to adulthood) from underserved populations encounter persistent disparities in screening, diagnosis, and health service access increasing their vulnerability to adverse health outcomes across the lifespan.10,11 Given the limited number of evidence-based interventions for improving the physical health of children and adolescents with ASD/DD as they transition to adulthood across the lifespan, especially those from underserved populations, Research Networks are needed to coordinate and provide infrastructure for national autism research activities.10,12

5 Kogan, MD, Vladutiu, CJ, Schieve, LA, et al. The prevalence of parent-reported autism spectrum disorder among US children. 2018, Pediatrics, 142(6), e20174161.

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

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 2017 Report to Congress. Young Adults and Transitioning Youth with Autism Spectrum Disorder. Available at:

https://iacc.hhs.gov/publications/report-to-congress/2017/report_to_congress_2017.pdf. Accessed on November 8, 2019.

https://www.govtrack.us/congress/bills/113/hr4631/text https://www.ncbi.nlm.nih.gov/pubmed/28756549 https://iacc.hhs.gov/publications/report-to-congress/2017/report_to_congress_2017.pdf

HRSA-20-054 3

Autism CARES Act

In carrying out the provisions of the Autism CARES Act, HRSA supports programs to improve the quality of care for 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 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.

HRSA supports four program areas in accordance with the above activities:

• Training for Professionals,

• Autism Research Programs,

• Autism Policy Programs, and

• National Evaluation.

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

The HRSA Maternal and Child Health Research Network Program

The HRSA Maternal and Child Health (MCH) Research Network Program administered by the Division of Research in MCHB’s Office of Epidemiology and Research supports the establishment and maintenance of interdisciplinary, multi-site, collaborative, national Research Networks that lead, promote, and coordinate national research activities on both broad and specific MCH topics. As of June 2019, HRSA MCH Research Networks have contributed to improving the lives and health of MCH populations by:

• Enrolling and serving approximately 3.9 million participants in research studies;

• Publishing 837 peer-reviewed articles in leading scholarly journals; and

• Developing and placing 84 clinical guidelines, tools, and toolkits collectively in the hands of over 260,000 practitioners and families.

Functions

The following describes multiple aspects of the Research Network that you should consider in the development of your application:

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

HRSA-20-054 4

Organization and Functions

The Research Network will consist of a Network Coordinating Center (NCC) and multiple Collaborating Research Entities/Sites (CREs). 13 The NCC is the administrative center of the Research Network, providing leadership and maintaining a partnership, with its CREs. An example of this structure is depicted in the following diagram:

Research Network Organizational Structure with the NCC

The NCC will be located at the principal investigator’s (PI) institution, which is the recipient of the cooperative agreement. The NCC provides the core administrative and operational functions that include the following:

1) Support the Research Network infrastructure for partnership among CREs;

13 This structure ensures that all Research Network activities encompass a general approach to address population needs to accelerate, upstream, together. Accelerate: An acknowledgement that although progress has been made in a variety of areas, much remains to be done. Research Networks must continue to innovate, grow the evidence base, and strive to address health disparities in maternal and child health by considering ways to reduce the gap between populations—whether those are defined by race, place, age, or gender. Upstream: A consideration of the social determinants of health—a broader and expansive way of looking at contributors to health beyond health care. Research Networks must think about primary prevention, but recognize the importance of secondary and tertiary prevention for some MCH populations. Together: A need to strategically engage stakeholders who understand the needs and priorities of the maternal and child health population. Research Networks must collaboratively develop solutions to the current and emerging health and development challenges. Available at: http://familyvoices.org/wp-content/uploads/2019/05/Warren-2019.05.09-MCHB-Presentation-to-Family-Voices_c.pdf.

14 The recipient is expected to participate in the national evaluation of HRSA/MCHB’s Autism CARES Act programs and will receive more information at the time of award.

http://familyvoices.org/wp-content/uploads/2019/05/Warren-2019.05.09-MCHB-Presentation-to-Family-Voices_c.pdf http://familyvoices.org/wp-content/uploads/2019/05/Warren-2019.05.09-MCHB-Presentation-to-Family-Voices_c.pdf

HRSA-20-054 5

2) Facilitate the process for the development, selection, implementation, and oversight of scientific research studies;

3) Coordinate a plan to enhance the research training and mentorship of diverse emerging investigators through the use of innovative mentorship/research experiences and manuscript development;

4) Coordinate the dissemination of findings to health professionals, researchers, policymakers, family members, and the greater public;

5) Establish and foster partnerships with programs and organizations serving underserved populations, and recruit study participants from these populations;

6) Establish a plan to ensure parent, family and/or consumer involvement and input in Research Network activities; and

7) Collaborate with pertinent partners, including the other HRSA-supported Autism CARES Act Programs (available here: https://mchb.hrsa.gov/maternal-child-health-initiatives/autism) and MCH Research Network recipients which are available here: https://mchb.hrsa.gov/research.

Research Network Advisory Board or Committee

The Research Network Advisory Board or Steering Committee will be comprised of representatives of the CREs and HRSA/MCHB. The PI will serve as Chair of the Research Network Advisory Board or Steering Committee. All major scientific decisions (e.g., study designs and policies) are determined by majority vote of the Research Network Advisory Board or Steering Committee. All participating CREs must agree to abide by these approved decisions. The Research Network Advisory Board or Steering Committee will meet monthly by telephone or other online platforms, and in person at least once a year in the Washington, D.C. area. The PI will meet annually with HRSA/MCHB leadership and other key stakeholders including, but not limited to: Title V directors, clinical interest groups, state and local education districts, Centers for Medicare and Medicaid Services, and Department of Education agencies, as applicable, to brief them on the existence and progress of the Research Network and to leverage their networks for translating Research Network findings into practice and policy.

Data Collection and Management

The NCC will facilitate data gathering, data management training, and data quality assurance according to developed protocol. CREs must follow the Research Network policies and procedures to (1) monitor adverse events; (2) report data and other information to the NCC; (3) ensure good clinical practice or other applicable regulatory requirements; and (4) participate in the national evaluation of HRSA/MCHB’s Autism CARES Act programs. 14

14 The recipient is expected to participate in the national evaluation of HRSA/MCHB’s Autism CARES Act programs and will receive more information at the time of award.

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

HRSA-20-054 6

II. Award Information

1. Type of Application and Award

Types of applications sought: New

HRSA will provide funding in the form of a cooperative agreement. A cooperative agreement, as opposed to a grant, is an award instrument of financial assistance in which substantial involvement is anticipated between HRSA and the recipient during performance of the contemplated project.

In addition to the usual monitoring and technical assistance provided under the cooperative agreement, HRSA Program responsibilities shall include:

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

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

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

4) Facilitation of effective communication and accountability to HRSA/MCHB regarding the project, with special attention to new program initiatives and policy developments that have the potential to advance the utility of the Research Network;

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

6) Review of all documents and products prior to submission for publication or public dissemination;

7) Identification of emerging research issues or agency priority topics that warrant new Research Network research studies; and

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

The cooperative agreement recipient’s responsibilities shall include:

1) Establishing and maintaining an interdisciplinary, multicenter Research Network to determine evidence-based practices for interventions to improve the physical health of children and adolescents with ASD/DD as they transition to adulthood across the lifespan;

2) Designing and implementing multi-site research protocols to develop evidence-based practices for interventions (including innovative models for reaching underserved populations), address disparities in physical health interventions, and treatment of individuals with ASD/DD;

3) Establishing partnerships with programs serving underserved populations and recruiting study participants from these populations, such as HRSA’s Health Center Program or the MIECHV Program;

HRSA-20-054 7

4) Providing a research environment that supports the professional development and mentorship of diverse emerging investigators in the field of physical health intervention research for ASD/DD;

5) Developing and instituting a plan to ensure dissemination of Research Network findings via peer-reviewed publications, and other formats (e.g., presentations, tools, guidelines) to diverse stakeholders in order to increase the evidence base and accelerate the adoption of effective interventions into practice and care;

6) Developing and implementing procedures to store and share, after a 3-year embargo period, de-identified data with interested members of the research community in a manner that protects the privacy of participants and providers while enabling the full utilization of those data to improve the health and well-being of the population;

7) Leveraging Research Network capacity to compete for grant opportunities from other federal and private sources to bolster support and more strongly extend implementation of Research Network research protocols;

8) Providing an electronic copy of any products supported by award funds (including guidelines, assessment tools, publications, books, pamphlets, PowerPoint presentations, curricula, videos, etc.) to be made available to the general public and to the MCH Research Program; and

9) Collaborating with the other HRSA-supported Autism CARES Act Programs to ensure synergy, sharing of information, avoidance of duplication, and to promote the translation of findings into practice.

2. Summary of Funding

HRSA estimates approximately $3,000,000 to be available annually to fund one recipient. The actual amount available will not be determined until enactment of the final FY 2020 federal appropriation. You may apply for a ceiling amount of up to $3,000,000 total cost (includes both direct and indirect, facilities and administrative costs) per year.

The period of performance is September 1, 2020 through August 31, 2025 (5 years).

Funding beyond the first year is subject to the availability of appropriated funds for the Research Network in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government.

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

Please note that if indirect costs are requested, the applicant must submit a copy of the latest negotiated rate agreement. This project supports an infrastructure from which to conduct research, but is not a research project in and of itself, therefore, it is not eligible for research indirect rates. The indirect costs rate refers to the "Other Sponsored Program/Activities" rate and to neither the research rate, nor the education/training program rate. Those applicants without an established indirect cost rate for “other sponsored programs” may only request 10 percent of salaries and wages, and must request an “other sponsored programs” rate from Cost Allocation Services (CAS).

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

HRSA-20-054 8

Direct cost amounts for equipment (capital expenditures), tuition and fees, and contracts in excess of $25,000 are excluded from the actual direct cost base for purposes of this calculation.

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.

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

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

NOTE: Multiple applications from an organization are allowable. In order to diversify the HRSA/MCHB research grant portfolio, an individual cannot serve as the project director (PD) or PI on more than one active HRSA MCH Research Network. To foster interdisciplinary collaboration and increase opportunities for mentorship for emerging MCH researchers, a PD/PI on an active HRSA MCH research grant is expected to serve for no more than 10 percent effort as a co-investigator on an existing HRSA MCH research grant. HRSA allows one PD/PI to be named on the cover page of the SF-424 R&R application, who will serve as the key point of contact. The application can include co-investigators as key personnel on the project. It does not apply to being a PI on grants from other agencies. However, if selected for funding, the new recipient will need to verify that percent effort across all federally-funded grants does not exceed 100 percent.

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

HRSA-20-054, the UT2 AIR-P Research competition. Applications submitted to the wrong competition will be deemed nonresponsive and will not be considered for funding under this notice.

HRSA-20-054 9

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.

IV. Application and Submission Information

1. Address to Request Application Package

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

The NOFO is also known as “Instructions” on Grants.gov. You must provide your email address when reviewing or preparing the workspace application package in order to receive notifications including modifications and/or republications of 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, and letters of commitment and support required in HRSA’s SF-424 R&R Application Guide and this NOFO. Standard Office of Management and Budget (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 do not https://www.grants.gov/ https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/ https://www.grants.gov/ 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

HRSA-20-054 10

count in the page limit. We strongly urge you to take appropriate measures to ensure your application does not exceed the specified page limit.

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

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

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

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. 3321).

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

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

Include the information requested at the top of the abstract. Because the abstract is often distributed to provide information to the public and Congress, please prepare this to be clear, accurate, concise, and without referring to other parts of the application. Briefly state the principal needs and problem, goals, proposed activities including target population(s), planned coordination, anticipated products, and plans for evaluation.

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

• FUNDING OPPORTUNITY NUMBER: HRSA-20-054

• FUNDING OPPORTUNITY TITLE: UT2 Autism Intervention Research Network on Physical Health (AIR-P)

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

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

HRSA-20-054 11

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

• PROPOSED ACTIVITIES AND TARGET POPULATION(S): Describe the programs and activities used to attain the objectives, the target population(s) addressed, and comment on innovations and other characteristics of the proposed plan.

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

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

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

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

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:

SECTION I – BACKGROUND AND SIGNIFICANCE -- CORRESPONDS TO

SECTION V’S REVIEW CRITERIA #1 NEED, #2 RESPONSE, AND #4

IMPACT

Demonstrate/Include the following:

• A thorough knowledge and understanding of the gaps in evidence-based practices for interventions to improve the physical health of individuals with ASD/DD;

• Critical evaluation of the national significance of this Research Network;

• Knowledge and identification of the physical health needs and issues for children and adolescents with ASD/DD as they transition to adulthood across the lifespan, especially those from underserved

HRSA-20-054 12

populations;

• How proposed interdisciplinary research studies may fill gaps in research and advance the field of physical health of children with ASD/DD; and

• How the interdisciplinary, national, multi-site Research Network may address the identified needs of children and adolescents (including those transitioning to adulthood) with ASD/DD from underserved populations.

SECTION II – SPECIFIC GOALS AND OBJECTIVES -- CORRESPONDS TO

SECTION V’S REVIEW CRITERIA #2 RESPONSE, #4 IMPACT, AND #5

RESOURCES/CAPABILITIES

Include the following:

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

• A detailed plan for completing several intervention studies, including studies on emerging physical health topics affecting children and adolescents with ASD/DD as they transition to adulthood across the lifespan, especially those from underserved populations, in consultation with HRSA/MCHB stakeholders;

• The process for developing an integrated Research Network and a plan of proposed activities showing progressive implementation to ensure national reach during the 5-year period of performance;

• A description of the activities or steps that will be used to achieve each of the project goals. Please provide a timeline that includes each activity and identifies responsible staff;

• A description of how proposed activities will build upon ongoing efforts, and not be duplicative of existing funded efforts (including HRSA/MCHB and Autism CARES Act projects). As appropriate, identification of meaningful support and collaboration with key stakeholders and partners in planning, designing, and implementing all activities; and

• A logic model utilized for designing and managing the project in this section of the narrative. A logic model is a one-page diagram that presents the conceptual framework for a proposed project and explains the links among program elements. The creation of a logic model is a requirement of the Research Network Application, as described in the Attachments Section of this NOFO (Attachment 5).

HRSA-20-054 13

HRSA’s expectations and goals for the Research Network logic model is further illustrated in Appendix D of this NOFO.

Provide documentation (letters of agreement) of participation of CREs that will collaborate to fulfill the goals and objectives of the Research Network, with descriptions of each CRE’s characteristics that include patient population characteristics for individuals with ASD/DD, average patient numbers, types of ASD/DD-related treatments, interventions or services currently delivered, as well as characteristics and structure of staff. Include letters of agreement from CRE sites in Attachment 2. It is expected that at least six CREs will work in collaboration with partnering programs and should demonstrate success in recruiting from underserved population(s) with limited access to services, and/or other underserved populations as defined by your organization.

To assist you in demonstrating a plan for collaboration with programs serving underserved populations, this section describes the expected documentation that would demonstrate commitment of both your organization and the partnering programs. Examples of collaboration with HRSA’s Health Center Program and the MIECHV Program are given. For collaboration with other non-federal programs, you should provide similar documentation.

• The HRSA Health Center Program: Submit a letter of agreement from a Primary Care Association (PCA) that will serve as the mediator for research involving recruitment from Health Centers. The PCA will document a commitment to working with your organization in identifying Health Centers that demonstrate the patient population needed to support Research Network research endeavors.

They will support staff leadership and commitment to the project and collaboration with your organization to fulfill the purpose of the Research Network program.

The PCA will facilitate the arrangements between your organization and the Health Centers.

• Link to find Primary Care Associations:

https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/ncapca/associatio ns.html

• Establish subcontract arrangements between your organization and Health Centers identified by the PCA for Research Network participation that will provide funding for Health Center Program liaison(s), such as a research project coordinator. The Health Center Program liaison will facilitate the research coordination and recruitment of Health Center patients for Research Network research studies.

• The HRSA MIECHV Program: Submit a letter of agreement from a MIECHV State Program that will facilitate connections with MIECHV local implementing agencies (LIAs). The MIECHV State Program must document a commitment to https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/ncapca/associations.html https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/ncapca/associations.html https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/ncapca/associations.html https://mchb.hrsa.gov/maternal-child-health-initiatives/home-visiting/fy19-awards

HRSA-20-054 14

working with your organization in the identification of LIAs that demonstrate the patient population needed to support Research Network research endeavors.

They will support staff leadership and commitment to the project and collaboration with your organization to fulfill the purpose of the Research Network program.

The MIECHV State Program will facilitate arrangements between your organization and the MIECHV LIAs.

• Link to find MIECHV State Programs: https://mchb.hrsa.gov/maternal-child-health-initiatives/home-visiting/fy18-home-visiting-awards

• Establish subcontract arrangements between your organization and the MIECHV LIAs that will provide funding for a LIA liaison. The LIA liaison will facilitate the research coordination and recruitment of participants served by the MIECHV LIAs for Research Network research studies.

Responsibility of the NCC overseeing the CREs: Address how the Research Network will manage CRE or sites. The Research Network provides the CREs with guidance to ensure:

• Staff and training needed for the CREs to implement a study protocol and participate in Research Network activities;

• A data acquisition system to collect intake, treatment, and outcome data for all study participants, according to protocol-specific requirements; and

• Additional support such as quality control to ensure the successful completion of the scientific goals of a research project and other Research Network activities. You should include budgets for CRE travel support to Research Network meetings in your applications.

Responsibility of Each CRE Site: Each CRE should, as appropriate, in conducting studies and participating in Research Network activities:

• Describe a plan to establish and sustain the CREs;

• Participate in Research Network subcommittees and agree to attend

Research Network monthly teleconferences and in-person meetings;

• Participate in the development of concept and protocol of observational and clinical trial studies to be conducted by the Research Network;

• Agree to participate in observational studies and clinical trials, including subject enrollment, data collection, patient record maintenance, adherence to good clinical practice, compliance with protocol requirements, randomization methods for assignment of patients to experimental or control groups or randomization of care delivered to different conditions;

• Participate in Research Network activities that enhance the research training and mentorship of junior/new investigators; and, https://mchb.hrsa.gov/maternal-child-health-initiatives/home-visiting/fy18-home-visiting-awards https://mchb.hrsa.gov/maternal-child-health-initiatives/home-visiting/fy18-home-visiting-awards

HRSA-20-054 15

• Participate in the translation of critical Research Network findings to practice settings and educational training that will result in advancing and strengthening the evidence base on ASD/DD physical health research and other related outcomes.

SECTION III – PROJECT DESIGN: METHODS AND EVALUATION --

CORRESPONDS TO SECTION V’S REVIEW CRITERIA #2 RESPONSE,

#3 EVALUATIVE MEASURES, #4 IMPACT, #5 RESOURCES/CAPABILITIES, AND #7

PROGRAM ASSURANCES

A. Methods:

This section has a strict 12-page limit.

Provide detailed descriptions of the methodology for accomplishing the work of the Research Network and each of its distinct objectives. Include sufficient technical detail to demonstrate the necessary steps to accomplish each objective and to convey to reviewers adequate information to assess the methodology.

Indicate the specific methods that will be used to evaluate progress in each activity area. List and discuss anticipated obstacles that may be encountered and indicate how these will be overcome.

It is important that you describe how the interdisciplinary team will function in true partnership/collaboration within the Research Network to accomplish their objectives and meet their goals. Anticipate potential problems and challenges that may arise in this process, and propose mechanisms for collaborative resolution.

Successful participation in the Research Network includes the ability to work collaboratively to achieve the goals of the Research Network, address challenges, and fulfill commitments to the project as indicated in the proposal and Letters of Agreement.

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

These include:

• Peer-reviewed publications: It is expected that the Research Network will produce at least four peer-reviewed publications per year. In addition, it is expected that a new or updated national research agenda for the Research Network will be published in a peer-reviewed journal;

• Research Network website: Maintain a public Research Network website to disseminate research findings, generate interest in the Research Network, and expand Research Network membership;

HRSA-20-054 16

• Research acceleration: Disseminate findings to help accelerate the synthesis, analysis, and translation of existing and future knowledge so that it can be applied to practice and policy at the state and national levels;

• Stakeholder engagement: Showcasing informational products and educational opportunities, including webinars, website material, plenary sessions, abstracts, conference presentations, annual Research Network meetings, and consumer materials, etc.

B. Evaluation:

Describe a plan for program performance evaluation that will contribute to continuous quality improvement. The program performance evaluation should monitor ongoing processes and progress towards the goals and objectives of the project.

Indicate the specific methods that will be used to evaluate progress in each activity area. List and discuss anticipated obstacles to implementing the program performance evaluation that may be encountered and describe plans to overcome these obstacles.

Describe the systems, processes, and staff that will support the organization's performance management requirements through effective tracking of performance outcomes, including a description of how the organization will collect and manage data (e.g., assigned skilled staff, data management software) in a way that allows for accurate and timely reporting of performance outcomes. As appropriate, describe the data collection strategies that will be used to collect, analyze, and track data to measure progress and impact/outcomes with different sociocultural groups (e.g., race, ethnicity, language, rural versus urban, socioeconomic, gender), and explain how the data will be used to inform program development and service delivery.

Describe a plan to recruit diverse participants in research with the target of including at least 60 percent of Research Network study participants from underserved populations.

For each described objective, include an evaluation measure. The evaluation measure should be SMART with a timeline for evaluation and should be presented consistent with the plan and schedule of implementation of the goals and objectives.

C. Cooperative Agreement Activities:

Infrastructure Development:

• Develop and maintain a national Research Network of research entities from across the country that will collaborate to advance and strengthen the evidence base for improving the physical health of children and

HRSA-20-054 17

adolescents with ASD/DD as they transition to adulthood across the lifespan, in accordance with the objectives and functions outlined in this NOFO; and

• Establish an interdisciplinary Research Network Advisory Board or Steering Committee comprised of a broad representation of diverse key stakeholders, including but not limited to, health professionals, national experts, research entities, and family members, including those from underserved populations, in accordance with the guidance outlined in this NOFO.

Research Network Activities:

• Create an interdisciplinary Research Network for autism intervention research on physical health of children and adolescents with ASD/DD as they transition to adulthood across the lifespan;

• Engage family members in the planning, design, and implementation of Research Network studies;

• Conceptualize or update and publish, in a peer-reviewed journal, a national research agenda for ASD/DD intervention research on physical health;

• Design, implement, and complete several multi-site intervention research studies, clearly identifying the number of studies and how they…