PKG00263958-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Maternal and Child Health Bureau Division of Research

Maternal Child Health (MCH) Research Network on Promoting Healthy Weight among Children with Autism Spectrum Disorder and other Developmental

Disabilities

Funding Opportunity Number: HRSA-21-038 Funding Opportunity Type(s): New

Assistance Listings (CFDA) Number: 93.877

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2021

Application Due Date: February 3, 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: October 29, 2020

Jessica DiBari, PhD, MHS Acting Director/Health Scientist/Program Officer, Office of Epidemiology and Research, Division of Research Telephone: (301) 443-4690 Email: JDibari@hrsa.gov

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

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

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2021 Maternal and Child Health (MCH) Research Network on Promoting Healthy Weight (HW-RN) among Children with Autism Spectrum Disorder (ASD) and other Developmental Disabilities (DD). The purpose of the cooperative agreement outlined in this funding announcement is to establish and maintain an interdisciplinary research network (RN) of researchers and practitioners to lead and support coordinated research activities related to promoting healthy weight among children and youth with ASD/DD. For this competition, the target population of interest is broadened from the previous MCH HW-RN competition to include both overweight/obese and underweight children and an increased emphasis on the inclusion of underserved populations in the proposed research studies.1 The HW-RN will build research capacity to determine appropriate evidence-based practices for the prevention and treatment of overweight/obesity and underweight among children with ASD/DD. The use of technology to spark innovation in the field is encouraged.

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: MCH Research Network on Promoting

Healthy Weight among Children with Autism Spectrum Disorder and other Developmental Disabilities

Funding Opportunity Number: HRSA-21-038 Due Date for Applications: February 3, 2021 Anticipated Total Annual Available FY 2021 Funding:

$250,000

Estimated Number and Type of Award(s): One cooperative agreement Estimated Award Amount: Up to $250,000 per year subject to the availability of appropriated funds Cost Sharing/Match Required: No Period of Performance: July 1, 2021 through June 30, 2026

(5 years)

1 The Department of Health and Human Services (HHS) characterizes underserved, vulnerable, and special needs populations as communities that include members of minority populations or individuals who have experienced health disparities. For this announcement, underserved populations include low-income, racial/ethnic minorities, immigrant, female, tribal, the geographically remote, and other groups that are not already well represented in current pediatric research.

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

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

Application Guide

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

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Wednesday, November 18, 2020 Time: 12-1 p.m. ET Call-In Number: 1-800-857-5051 Participant Code: 5940173 Weblink: https://hrsa.connectsolutions.com/hwrn/ Playback Number: 1-888-566-0502 Passcode: 111820 http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf https://hrsa.connectsolutions.com/hwrn/

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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

3. ASSESSM ENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIV E AND NATIONAL POLICY REQUIREM ENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: RELEVANT WEBSITES

APPENDIX B: KEY TERMS FOR PROJECT ABSTRACTS

APPENDIX C: APPLICATION COMPLETENESS CHECKLIST

APPENDIX D: LOGIC MODEL

APPENDIX E: WAYS TO DEMONSTRATE COLLABORATION PLAN

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 Maternal and Child Health (MCH) Research Network on Promoting Healthy Weight (HW-RN) among Children with Autism Spectrum Disorder (ASD) and other Developmental Disabilities (DD) program. For this competition, the target population of interest is broadened from the previous MCH HW-RN competition to include both overweight/obese and underweight children, and an increased emphasis on the inclusion of underserved populations in the proposed research studies.2 The following lists HW-RN goals and objectives (specific applicant activities are described in the Network Coordinating Center Activities section):

• Infrastructure Development o Establish and maintain a national interdisciplinary research network to lead and support coordinated research activities related to promoting healthy weight among children and youth with ASD/DD across underserved populations.

• Network Activities o Plan HW-RN activities and research designed to improve and promote healthy weight through the prevention and treatment of overweight/obesity and underweight among children and youth with ASD/DD. Such activities and research will address the needs of underserved populations. Research activities will be responsive to the cultural and linguistic needs of special populations, and services should be family-centered and accessible to consumers. We encourage studies on the use of technology (e.g., innovative interactive technologies, wearable digital devices) to overcome some of the social and environmental barriers to physical activity that children with ASD/DD face. We also encourage partnerships with minority-represented community level organizations such as Historically Black Colleges and Universities (HBCUs) and family-led organizations that can advocate for and connect with underserved populations. Applications must include letters of support (Attachment 1).

o Address HRSA's 2019-2022 Strategic Plan (sub-objectives 1.2.3, 2.2.2, and 3.1.4) by engaging researchers, clinicians, underserved populations, families of individuals with ASD/DD, self-advocates, community members, and policymakers to translate research findings into a variety of resources (e.g., guidelines, toolkits) for use in clinical practice or community settings.

o Provide an environment for mentoring and training the next generation of researchers in applied and translational autism research and practice.

2 The Department of Health and Human Services (HHS) characterizes underserved, vulnerable, and special needs populations as communities that include members of minority populations or individuals who have experienced health disparities. For this announcement, underserved populations include low-income, racial/ethnic minorities, immigrant, female, tribal, the geographically remote, and other groups that are not already well represented in current pediatric research.

https://www.hrsa.gov/about/strategic-plan/index.html

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• Dissemination o Maintain a HW-RN website to disseminate research findings, guidelines, tools, study protocols and toolkits, generate interest in the HW-RN, and expand HW-RN membership.

o Develop and implement a plan to disseminate HW-RN findings through at least three peer-reviewed publications per study, at least two webinars, annual HW-RN meetings, and other related activities.

• Translational Research o Identify opportunities to include findings from research on children or adolescents with ASD/DD in the design and implementation of ongoing large state-wide or national programs.

• Expansion Efforts o Collaborate with other MCHB research networks.

o Leverage external funds to advance and implement critical research that will address identified gaps and promote the HW-RN research agenda.

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 Suport Act of 2019 (Autism CARES Act) (P.L. 116-60). The Research Network on Promoting Healthy Weight aims to build the evidence base for interventions and promote healthy weight among children and adolescents with ASD/DD. The Network provides national leadership by engaging researchers, practitioners, policymakers, and consumers across multiple sites to collaborate on innovative multidisciplinary research projects.

A comprehensive picture of ASD among children in the U.S is best understood by examining two key estimates of ASD prevalence.3 The Centers for Disease Control and Prevention used population-based ASD prevalence estimates for U.S. children reported from the Autism Developmental Disabilities Monitoring Network (ADDM) – a surveillance system in local population-based areas in which ASD cases are identified through education and health records review – to report that approximately 1 in 54 children have ASD.4 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.5 Estimates from these two systems reflect different years, populations (11 local U.S.

populations versus the entire U.S.), and ages of children (children aged 8 years in ADDM versus 3–17 years in NSCH) and contribute unique information, that when combined, help form a comprehensive picture of ASD among children in the U.S. ASD is a complex neurodevelopmental disorder, and individuals with this condition experience core behavioral challenges with social interactions, communication, as well

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

4 Autism and Developmental Disabilities Monitoring Network (2016 data) (http://www.cdc.gov/ncbddd/autism/data.html) 5 Kogan, et al. (2018) The Prevalence of Parent-Reported Autism Spectrum Disorder Among US Children. Pediatrics 142(6).

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

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as restrictive and repetitive behaviors, which can be lifelong and pervasive.6

Additionally, 83 percent of children with ASD have at least one co-occurring non- ASD/DD condition.7 Children and adolescents with ASD/DD also have greater health service needs, which can place a significant financial and emotional burden on their families.8

Although there has been a great deal of attention to childhood obesity, very little research has focused on the obesity risk among children with ASD/DD. A study using data from the National Survey of Children’s Health reported that children with ASD were 42 percent more likely to be obese than children without ASD.9 This population faces unique needs and challenges that may increase their risk of obesity and poor nutrition.

Impaired motor and social skills may result in lower levels of physical activity, which is often associated with higher screen time compared to children without ASD/DD.

Additionally, psychotropic medications often used to treat children and adults with ASD/DD with irritability, aggression, and behavioral disturbances have been shown to be associated with significant weight gain10 and metabolic syndrome.11

Food selectivity also appears to be a significant problem in children with ASD/DD, though only a few empirical studies have focused on underweight children with ASD/DD. Some children with ASD/DD are highly selective eaters with aversions to specific textures, colors, smells, and temperatures. Their diets are often characterized by a lack of variety and may be associated with inadequate nutrient intake, which has implications for child health.12

Further research is needed to explore mediators to food selectivity such as behavior problems, parental preferences and family mealtimes.13 Additionally, research is needed to understand the disproportionate impact of under- and overweight status among underserved children with ASD/DD.

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

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

7 Levy SE, Giarelli E, Li-Ching L, Schieve LA, Kirby RS, Cuniff C, et al. Autism spectrum disorder and co-occurring developmental, psychiatric, and medical conditions among children in multiple populations of the United States. Journal of Developmental and Behavioral Pediatrics. 2010;31:267–275.

8 Vohra, R, Madhavan, S, Sambamoorthi, U, St Peter, C. Access to services, quality of care, and family impact for children with autism, other developmental disabilities, and other mental health conditions. Autism, 2014; 18(7):815-26.

9 Curtin C, Anderson SE, Must A, Bandini L. The prevalence of obesity in children with autism: A secondary data analysis using nationally representative data from the National Survey of Children's Health. BMC Pediatrics. 2010;10(1):11.

10 LeClerc, S. & Easley, D. (2015). Pharmacological Therapies for Autism Spectrum Disorder: A Review. P & T : a peer-reviewed journal for formulary management. 40. 389-97.

11 Posey DJ, & McDougle CJ. Use of atypical antipsychotics in autism. In: Hollander E, editor. Autism Spectrum Disorders. New York, New York: Marcel Dekker, Inc; 2003. pp. 247–264.

12 Cermak, S. A., Curtin, C., & Bandini, L. G. (2010). Food selectivity and sensory sensitivity in children with autism spectrum disorders. Journal of the American Dietetic Association, 110(2), 238–246.

13 Cermak, S. A., Curtin, C., & Bandini, L. G. (2010). Food selectivity and sensory sensitivity in children with autism spectrum disorders. Journal of the American Dietetic Association, 110(2), 238–246.

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

The HRSA Maternal and Child Health Research Network Program

The HRSA MCH Research Network Program administered by the Division of Research in the 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, support, 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 for 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.

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

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Research Network Organization and Functions

The following describes the expectations for a Research Network:

Organization and Functions The Research Network will consist of a Network Coordinating Center (NCC) and multiple Collaborating Research Entities/Sites (CREs).14 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:

14 This figure was designed for use in this NOFO. 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 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. 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 MCH population. Research Networks must collaboratively develop solutions to current and emerging health and development challenges.

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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;

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 HRSA/MCHB funded 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;

6) Establish 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 the other HRSA-supported Autism CARES Act Programs (available here: https://mchb.hrsa.gov/maternal-child-health-initiatives/autism), Title V Maternal and Child Health Services Block Grant recipients, and MCH Research Network recipients which are available here:

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

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 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 ideally in the Washington, D.C. area. The PI will meet annually with HRSA/MCHB leadership and other key stakeholder organizations, such as Title V Maternal and Child Health Services Block Grant programs, clinical interest groups, state and local education districts, and federal partners, such as the U.S. Health and Human Services 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 facilitate the translation of 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 https://mchb.hrsa.gov/maternal-child-health-initiatives/autism https://mchb.hrsa.gov/maternal-child-health-initiatives/autism https://mchb.hrsa.gov/research

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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.15

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 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 studies; and

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

The cooperative agreement recipient’s responsibilities will include:

1) Establishing and maintaining a national, multi-site, collaborative research network to lead and support coordinated research activities related to promoting healthy weight among children and youth with ASD/DD across underserved populations;

2) Designing and implementing multi-site research protocols to develop evidence-based practices for interventions (including innovative models for reaching underserved populations);

3) Establishing partnerships with programs serving underserved populations that can assist with recruiting research participants from underserved communities;

15 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.

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4) Recruiting study participants from these populations, such as HRSA’s Health Center Program or MCHB programs such as the Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) Program, Healthy Start Program, or Family-to-Family Health Information Center Program;

5) Providing a research environment that supports the professional development and mentorship of new investigators that includes researchers representing underserved populations, ensuring the diversity of new investigator trainees;

6) 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;

7) 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;

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

9) 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

10) Collaborating with the other HRSA-supported Autism CARES Act Programs, Title V Maternal and Child Health Services Block Grant, and other MCH Research Networks 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 $250,000 to be available annually to fund one (1) 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 $250,000 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 July 1, 2021 through June 30, 2026 (5 years). Funding beyond the first year is dependent on 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, you 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 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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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).

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 grant portfolio, an individual cannot serve as the project director/principal investigator (PD/PI) on more than one active HRSA/MCH Research Network.

The NOFO does not specify any minimum or maximum time requirement for the PD/PI, however, the PD/PI is expected to dedicate a minimum of 20 percent effort on this project to justify commitment to the project. To foster interdisciplinary collaboration and increase opportunities for mentorship for emerging MCH researchers, a PD/PI on an

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active HRSA/MCH research grant is allowed up to 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 PIs on programs funded by other federal agencies. However, if selected for funding, the new recipient must verify that percent effort across all federally-funded programs 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 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.

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 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

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(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-21-038, it may count against the page limit. Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit.

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

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

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

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

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachment(s) 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.

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, be clear, accurate, concise, and do not refer 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-21-038

• FUNDING OPPORTUNITY TITLE: MCH Research Network on Promoting

Healthy Weight among Children with Autism Spectrum Disorder and other Developmental Disabilities (HW-RN) http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf https://www.grants.gov/ http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

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• 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 you will use to assess program outcomes as well as the effectiveness and efficiency of the project in attaining goals and objectives.

• KEY TERMS: From Appendix B select: a maximum of ten (10) significant content terms that describe your project, and as many targeted populations and age ranges that apply. Include the selected (a) content terms, (b) populations, and (c) age ranges targeted 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 interdisciplinary research related to prevention and treatment of overweight/obesity and underweight among children and youth with ASD/DD;

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

• Knowledge and identification of needs and challenges in promoting healthy weight through evidence-based prevention and treatment of overweight/obesity and underweight among children and youth with

ASD/DD;

• How proposed interdisciplinary research studies may fill gaps in research and advance the field; and

• How the interdisciplinary, national, multi-site Research Network may

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identify and address the 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 to be accomplished during the period of performance 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 as they transition to adulthood, especially those from underserved populations;

• A detailed plan for engaging and including underserved populations in research activities;

• 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. 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 include: 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 are identified in the application and the CREs should demonstrate success in recruiting from underserved population(s) with limited access to services, and/or other underserved populations as defined by your organization.

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To assist you in demonstrating a plan for collaboration with programs serving underserved populations, please refer to Appendix E: Ways to Demonstrate Collaboration Plan.

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 you will use to evaluate progress in each objective. 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 goals and objectives. 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

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• 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 you will be use 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, describe the data collection strategies you will use 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 participants in research studies from underserved populations.

C. Network Coordinating Center Activities:

For this cooperative agreement, you will perform the activities listed below.

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 promoting the healthy weight of children and adolescents with ASD/DD as they transition to adulthood, 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.

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Research Network Activities:

• Research network activities should:

• In consultation with HRSA/MCHB leadership, design, implement, and complete several multi-site intervention research studies designed to promote healthy weight among children and youth with ASD/DD, especially those from underserved populations. The applicant should consider adapting an existing successful program for children and youth from the general population or selected subgroups and tailor it for application to children and youth with ASD/DD;

• Address the needs of underserved populations, such as low-income, racial/ethnic minorities, immigrants, individuals who have limited access to services, and/or other underserved populations;

• Engage family members, including those of diverse racial/ethnic and underserved communities, 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 promoting healthy weight among children and youth with ASD/DD;

• Build upon existing knowledge by conducting data analyses using existing large or population-based datasets and/or health records to improve the knowledge about the prevalence of overweight/obesity and underweight, key risk factors, and related chronic and secondary health conditions among children and youth with ASD/DD;

• Conduct formative work through surveys or literature reviews to understand the biopsychosocial barriers/facilitators to achieving healthy weight among children with ASD/DD, such as their perspectives and experiences on excessive body weight; barriers to physical activity and healthy eating; psychological, biological, medical, social, and environmental influences on obesity and obesity-related health behaviors;

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

• Develop and implement a dissemination plan for communicating research findings to diverse stakeholders;

• 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 across the lifespan 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;

• Develop and implement strategies to sustain the Research Network infrastructure;

• Train and mentor diverse emerging investigators; and

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