PKG00264010-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Maternal and Child Health Bureau Office of Epidemiology and Research Autism Research Network Program

UT5 Developmental Behavioral Pediatrics Research Network (DBPNet)

Funding Opportunity Number: HRSA-21-039 Funding Opportunity Type(s): New

Assistance Listings (CFDA) Number: 93.877

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2021

Application Due Date: February 2, 2021

Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

Registration in all systems, including SAM.gov and Grants.gov, may take up to 1 month to complete.

Issuance Date: November 4, 2020

Maura Maloney, PhD, MS Program Officer, Office of Epidemiology and Research, Division of Research Telephone: (301) 443-1087 Email: MMaloney@hrsa.gov

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

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2021 UT5 Developmental Behavioral Pediatrics Research Network (DBPNet). The purpose of this program is to establish and maintain a national, multi-site, collaborative research network for scientific collaboration and infrastructure building. This Research Network will provide national leadership in research to advance the evidence base in the developmental, behavioral, and psychosocial aspects of pediatric care to improve clinical services and health and related outcomes for children and adolescents with autism spectrum disorder (ASD) and other developmental disabilities across the lifespan.

The FY 2021 President’s Budget does not request funding for this program. This notice is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately. You should note that this program may be cancelled prior to award.

Funding Opportunity Title: UT5 Developmental Behavioral Pediatrics

Research Network (DBPNet) Funding Opportunity Number: HRSA-21-039 Due Date for Applications: February 2, 2021 Anticipated Total Annual Available FY 2021 Funding:

$275,000

Estimated Number and Type of Award(s): One cooperative agreement Estimated Award Amount: Up to $275,000 per year subject to the availability of appropriated funds Cost Sharing/Match Required: No Period of Performance: September 1, 2021 through

August 31, 2026 (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.

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Application Guide

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

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Tuesday, November 17, 2020 Time: 3–4:30 p.m. ET Call-In Number: 1-888-972-9684 Participant Code: 5781321 Weblink: https://hrsa.connectsolutions.com/fy21_dbpnet_ta/ In order to access the webinar, please use the “Guest” option, type your name in the field, and press “Enter Room.”

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

HRSA will record the webinar and make it available approximately 2 weeks after the webinar at:

https://mchb.hrsa.gov/fundingopportunities/default.aspx.

http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf https://hrsa.connectsolutions.com/fy21_dbpnet_ta/ mailto:mmaloney@hrsa.gov https://mchb.hrsa.gov/fundingopportunities/default.aspx

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Justification Narrative

v. Program-Specific Forms

vi. Attachments

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

TO THE UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEM ENT (SAM)

4. SUBMISSION DATES AND TIM ES

5. INTERGOV ERNM ENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIV E AND NATIONAL POLICY REQUIREM ENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: RELEVANT WEBSITES

APPENDIX B: KEY TERMS FOR PROJECT ABSTRACTS

APPENDIX C: APPLICATION COMPLETENESS CHECKLIST

APPENDIX D: LOGIC MODELS

APPENDIX E: COLLABORATION PLAN GUIDANCE

APPENDIX F: FREQUENTLY ASKED QUESTIONS (FAQS)

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the UT5 Developmental Behavioral Pediatrics Research Network (DBPNet) Program. The purpose of this program is to establish and maintain a national, multi-site, collaborative research network for scientific collaboration and infrastructure building. This Research Network will provide national leadership in research to advance the evidence base in the developmental, behavioral, and psychosocial aspects of pediatric care to improve clinical services and health and related outcomes for children and adolescents with autism spectrum disorder and other developmental disabilities (ASD/DD) across the lifespan. It will work to develop effective interventions1 in clinical services and to improve health and related outcomes for children and adolescents with autism spectrum disorder and other developmental disabilities (ASD/DD).

The Research Network will:

• Lead, promote, and coordinate national research activities to improve the health and well-being of children and adolescents with ASD/DD, especially those from underserved2 populations who may have limited access to effective ASD/DD treatments;3

• Develop and maintain an infrastructure to support the design of a portfolio of interdisciplinary research that focuses on fostering the implementation of multi-site intervention research studies, translating research to policy and practice that meets the needs of all children (including those traditionally underserved);

• Coordinate a plan to enhance the research training and mentorship of diverse emerging investigators from traditionally underserved backgrounds through the use of innovative mentorship/research experiences and manuscript development;4 and

• Address, where applicable, U.S. Department of Health and Human Services’ (HHS) and Health Resources and Services Administration’s (HRSA) priorities, namely, mental health and telehealth.

For cooperative agreement activities, please see Project Narrative Section III.

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 l imited 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. Source: National Institutes of Health, Office of Extramural Research Frequently Asked Questions:

NIH clinical trial definition. Available at: https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5226. Accessed June 25, 2020.

2 In this NOFO, underserved populations include low-income, racial/ethnic minorities, immigrants, females, 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. Proposals should not duplicate the aims of this separate investment.

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

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2. Background

This program is authorized by 42 U.S.C. § 280i-1(f) (Title III, § 399BB(f) of the Public Health Service Act, as amended by the Autism Collaboration, Accountability, Research, Education, and Support Act of 2019 (Autism CARES Act) (P.L. 116-60)).

The need for more providers to care for children with, or at risk for, ASD/DD is evident by the high incidence of autism in the United States. A comprehensive picture of ASD among children in the United States is best understood by examining two key estimates of ASD prevalence5. According to a study using medical and education records in select communities in the United States, approximately 1 in 54 children have ASD,6 while parent-reported data from the 2016 National Survey of Children’s Health documented that 1 in 40 children aged 3–17 years have a diagnosis of ASD.7 Children and adolescents with ASD/DD have greater health service needs, which can place a significant financial and emotional burden on their families.5

Developmental behavioral pediatric (DBP) providers are trained to consider both the medical and psychosocial aspects of children’s and adolescents’ developmental and behavioral needs. They evaluate and treat children and adolescents with some of the most prevalent and chronic conditions including ASD, attention deficit hyperactivity disorder (ADHD), developmental delays, learning disorders, and behavioral/conduct disorders. Despite the increase in the prevalence of developmental behavioral conditions among children, the involvement of DBPs in research has been limited. This may contribute to the fact that few evidence-based assessments or interventions specific to the field havebeen developed. To date, the Society for Developmental Behavioral Pediatrics, the professional society for DBPs, has established one clinical practice guideline. Assessments and management guidelines created by DBPs are critical to ensuring that every provider who treats a child with ASD/DD has access to resources to provide evidence-informed optimal care. These guidelines are especially significant in light of the DBP workforce shortage. The need for DBP providers has outpaced the current workforce, resulting in over 50% of DBPs reporting that patients wait ≥8 weeks to get an initial appointment.8 There is a dire need to improve access to quality care and treatment for children and adolescents with ASD/DD. This is especially critical to those from underserved populations. These populations encounter persistent disparities in screening, diagnosis, and service access that increases their vulnerability for adverse health outcomes across the lifespan.9,10 Research Networks are needed to coordinate and provide infrastructure for national DBP research activities and by design may be an effective mechanism for addressing disparities.9,11

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

6 Autism and Developmental Disabilities Monitoring Network (2016 data) (http://www.cdc.gov/ncbddd/autism/data.html) 7 Kogan, et al. (2018) The Prevalence of Parent-Reported Autism Spectrum Disorder Among US Children. Pediatrics 142(6).

8 Bridgemohan C, N Bauer, B Nielsen, A DeBattista, H Ruch-Ross, L Paul, N Roizen. A workforce survey on developmental behavioral pediatrics. Pediatrics 2018; 141 (3): e20172164.

9 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.

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

2017;47(11):3380-3391.

11 2017 Report to Congress. Young Adults and Transitioning Youth with Autism Spectrum Disorder. Available athttps://iacc.hhs.gov/publications/report-to-congress/2017/report_to_congress_2017.pdf. Accessed on November 8, 2019.

http://www.cdc.gov/ncbddd/autism/data.html https://www.ncbi.nlm.nih.gov/pubmed/28756549 https://iacc.hhs.gov/publications/report-to-congress/2017/report_to_congress_2017.pdf

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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,

• State Systems 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 Maternal and Child Health Bureau’s (MCHB) Office of Epidemiology and Research, supports the establishment and maintenance of interdisciplinary, national, multi-site, collaborative Research Networks that lead, promote, and coordinate national research activities on both broad and specific MCH topics. In 2019, HRSA MCH Research Networks contributed to improving the lives and health of MCH populations by:

• Enrolling approximately 14,000 participants and utilizing data on an additional 10 million participants in secondary data analyses in 124 research studies;

• Publishing 155 peer-reviewed articles in leading scholarly journals; and

• Developing and distributing 63 clinical guidelines, tools, or toolkits collectively to service providers and families.

Research Network Organization and Functions The following describes the expectations for a Research Network:

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

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Organization and Functions The Research Network will consist of a Network Coordinating Center (NCC) and multiple Collaborating Research Entities/Sites (CREs).12 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 project director/principal investigator’s (PD/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;

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 other MCHB recipients, 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;

12 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. RNs must continue to innovate, grow the evidence base, and strive to address health disparities in MCH 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. RNs 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 MCH population. RNs must collaboratively develop solutions to current and emerging health and development challenges.

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6) Establish and implement a plan to ensure parent, family and/or consumer involvement across populations including underserved populations in Research Network activities and;

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

For cooperative agreement activities, please see Project Narrative Section III.

Research Network Advisory Board or Steering Committee

The Research Network Advisory Board or Steering Committee will be comprised of representatives of the CREs, HRSA/MCHB, and new to this competition at least two community members (e.g., a family advocate). The PI will serve as Chair of the 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, if possible. The PI will meet annually with HRSA/MCHB leadership and other key stakeholder organizations, such as Title V MCH Services Block Grant programs, clinical interest groups, state and local education districts, and federal partners, such as the HHS Centers for Medicare and Medicaid Services, and U.S.

Department of Education agencies, as applicable, to brief them on the existence and progress of the Research Network and to engage them in 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.13

13 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),%20other%20MCHB%20recipients,%20Title%20V%20recipients,%20a https://mchb.hrsa.gov/maternal-child-health-initiatives/autism),%20other%20MCHB%20recipients,%20Title%20V%20recipients,%20a https://mchb.hrsa.gov/research

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II. Award Information

1. Type of Application and Award

Type(s) of applications sought: New

HRSA will provide funding in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where HRSA anticipates substantial involvement with the recipient during performance of the contemplated project.

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

1) Establishing and maintaining an interdisciplinary, multi-site, national Research Network to determine evidence-based practices for interventions in clinical services and health and related outcomes for children and adolescents with ASD/DD 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) that address inequities in developmental behavioral health interventions and treatment in individuals with ASD/DD;

3) New to this competition: Establishing partnerships with programs serving underserved populations and recruiting study participants from these populations, such as HRSA’s Health Center Program or Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program;

4) Providing a research environment that supports the professional development and mentorship of diverse emerging investigators in the field of developmental behavioral pediatric health intervention research for ASD/DD, that includes

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researchers representing underserved populations to ensure diversity among new trainees;

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 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 protocols;

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

9) Collaborating with the other HRSA-supported Autism CARES Act Programs, Title V recipients, and MCH Research Network recipients 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 $275,000 to be available annually to fund one recipient.

The actual amount available will not be determined until enactment of the final FY 2021 federal appropriation. You may apply for a ceiling amount of up to $275,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The FY 2021 President’s Budget does not request funding for this program. This program notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately.

The period of performance is September 1, 2021 through August 31, 2026 (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 not to the research rate, nor the education/training program rate. Those applicants without an established indirect cost rate for “other sponsored 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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programs” may only request 10 percent of salaries and wages, and must request an “other sponsored programs” rate from Cost Allocation Services (CAS).

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.

HRSA will not consider any application that does not adhere to the 1” margin guidelines specified in HRSA’s SF-424 Research and Related (R&R) Application Guide.

NOTE: Multiple applications from an organization are allowable. In order to diversify the HRSA/MCHB research award portfolio, an individual cannot serve as the project director/principal investigator (PD/PI) on more than one active HRSA MCH Research Network. New to this competition, the PD/PI is expected to commit a minimum percent effort of 20 percent on this project to justify their commitments to the project. To foster interdisciplinary collaboration and increase opportunities for mentorship for emerging MCH researchers, a PD/PI on an active HRSA MCH research grant is encouraged to commit 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. This policy does not apply to PD/PIs on grants from other agencies. However, if selected for funding, the new recipient will

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need to verify that percent effort across all federally-funded grants does not exceed 100 percent.

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

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

2. Content and Form of Application Submission

Section 4 of HRSA’s SF-424 R&R Application Guide provides instructions for the budget, budget justification, staffing plan and personnel requirements, assurances, 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.

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

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Application Page Limit The total size of all uploaded files included in the page limit may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments including biographical sketches (biosketches), and letters of commitment and support required in HRSA’s 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. Please note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-21-039, it may count against the page limit. Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. It is important to take appropriate measures to ensure your application does not exceed the specified page limit.

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

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

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

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

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachments 7–15: Other Relevant Documents.

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

Temporary Reassignment of State and Local Personnel during a Public Health Emergency

Section 319(e) of the Public Health Service (PHS) Act provides the Secretary of the Department of Health and Human Services (HHS) with discretion upon request by a state or tribal organization to authorize the temporary reassignment of state, tribal, and local personnel during a declared federal public health emergency. The temporary reassignment provision is applicable to state, tribal, and local public health department or agency personnel whose positions are funded, in full or part, under PHS programs and allows such personnel to immediately respond to the public health emergency in the affected jurisdiction. Funds provided under the award may be used to support personnel who are temporarily reassigned in accordance with § 319(e). Please reference detailed information available on the HHS Office of the Assistant Secretary for Preparedness (ASPR) website via http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx.

http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx

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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-21-039

• FUNDING OPPORTUNITY TITLE: UT5 Developmental Behavioral Pediatric

Research Network (DBPNet)

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

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

• PROPOSED ACTIVITIES AND TARGET POPULATION(S): Describe the programs and activities used to attain the objectives, the 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 http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

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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 developmental behavioral health of individuals with ASD/DD;

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

• Knowledge and identification of the needs and issues for children and adolescents with ASD/DD, especially those from underserved populations;

• How proposed interdisciplinary research studies may fill gaps in research and advance the field of developmental behavioral pediatrics; and

• How the national, multi-site, collaborative research network may address identified needs of children and adolescents with ASD/DD, including those of 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 goals and objectives that address the major Research Network activities listed in the Purpose section of this notice. Specific objectives should be succinctly stated and innovative, and direct attention to the scope of expected activities listed.

Objectives should be specific, measurable, achievable, realistic, time-bound (SMART), and tied to a distinct project goal;

• A detailed plan for completing several intervention studies in consultation with HRSA/MCHB, including studies on emerging topics affecting children and adolescents with ASD/DD, especially those from underserved populations;

• The process for developing an integrated Research Network and a plan of proposed activities showing progressive implementation to ensure national level activities 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;

• A description of how proposed activities will build upon ongoing

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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. 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 4). 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 includes: patient population characteristics for individuals with ASD/DD; average patient numbers; types of ASD/DD-related treatments, interventions, or services currently delivered; and characteristics and structure of staff. Include letters of agreement from CRE sites in Attachment 1. 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, please refer to Appendix E: Collaboration Plan Guidance.

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.

Describe the methodology for accomplishing the work of the Research Network and each of its distinct objectives. Provide 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 goal and objective. List and discuss anticipated obstacles that may be encountered and indicate how these will be overcome.

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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 of children and adolescents with ASD/DD, and the greater public. Include:

• Peer-reviewed publications: It is expected that the Research Network will produce at least three 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: It is expected that the Research Network will maintain a public Research Network website to disseminate research findings, generate interest in the Research Network, and expand Research Network membership;

• Research acceleration: It is expected that the Research Network will 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; and

• Stakeholder engagement: It is expected that the Research Network will showcase 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 the 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 performance management 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, HRSA-21-039 15 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 studies 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. Research Network Activities:

For this cooperative agreement the recipient will perform the activities listed below.

• 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 developmental behavioral pediatrics in accordance with the objectives and functions outlined in this NOFO;

• 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 (including non-physician providers), academics, national experts, research entities, and family members, including those from underserved populations, in accordance with the guidance outlined in this NOFO;

• 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 developmental behavioral pediatrics;

• Design, implement, and complete several multi-site intervention research studies clearly identifying the number of studies and how they address disparities in screening, diagnosis, and access to services for children and adolescents with ASD/DD, including innovative models serving underserved populations;

• Develop a plan for the design and implementation of multi-site intervention research studies addressing emerging issues affecting the developmental and behavioral health of children and adolescents with ASD/DD especially those from underserved populations, in consultation with HRSA/MCHB leadership;

• Recruit research participants from underserved populations in order to address gaps in the field and provide regular updates on progress to

HRSA/MCHB;

• Develop and foster partnerships with several programs serving underserved populations (e.g., HRSA Health Center Program, MIECHV);

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• Engage key audiences such as policymakers; researchers; school systems; health professionals; families; community members; and state, tribal, territorial, and local agencies that support underserved children and adolescents with ASD/DD to advance the translation of research into practice;

• Develop and evaluate resources such as guidelines, tools, or toolkits for use in clinical practice or intervention-based research in communities;

• Train and mentor diverse emerging investigators in developmental behavioral pediatric research;

• Develop and maintain a public website for engaging multiple stakeholders;

• Schedule monthly and ad hoc meetings with the HRSA project officer to ensure ongoing communication and collaboration;

• Ensure challenges and barriers to completing proposed activities and achieving goals are discussed with HRSA project officer in a timely manner;

• Coordinate monthly virtual meetings with the Research Network Advisory Board or Steering Committee and at least one in person meeting annually;

• Meet annually with HRSA/MCHB leadership and other key stakeholders;

and

• Disseminate information on Research Network activities and research findings to a broad audience including researchers, health professionals, policymakers, educators, community members, and families.

Consistent with HRSA’s mission to improve access to quality services for underserved populations, the Research Network should ensure that its activities will be responsive to the cultural and linguistic needs of underserved populations such as partnering with programs that serve these populations in Research Network activities. These services should be family-centered, accessible to consumers, and reflect the needs of the populations described above.

SECTION IV – PLAN AND SCHEDULE OF IMPLEMENTATION, AND

CAPABILITY OF THE APPLICANT -- CORRESPONDS TO SECTION V’S

REVIEW CRITERIA #3 EVALUATIVE MEASURES, #4 IMPACT,

#5 RESOURCES/CAPABILITIES, #6 SUPPORT REQUESTED, AND # 7

PROGAM ASSURANCES.

Provide a description of the organizational plan for management of the project, including an explanation of the roles and responsibilities of interdisciplinary project personnel and collaborators. Provide a draft organizational chart as Attachment 3 describing the leadership structure of the Research Network demonstrating collaboration between the PI, co-investigators, and the CREs.

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