MCHB HRSA-22-087 (UJ5) Emergency Medical Services for Children Data Center_Final.pdf

U.S. Department of Health and Human Services

Maternal and Child Health Bureau

Division of Child, Adolescent, and Family Health

Emergency Medical Services for Children Data Center

Funding Opportunity Number: HRSA-22-087

Funding Opportunity Type(s): Competing Continuation, New

Assistance Listings (AL/CFDA) Number: 93.127

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: January 18, 2022 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 may take up to 1 month to complete.

Issuance Date: October 19, 2021

Patricia L. Fanflik, PhD Health Scientist, Emergency Medical Services for Children Telephone: (301)-443-2564 Email: PFanflik@HRSA.gov

See Section VII for a complete list of agency contacts.

Authority: 42 U.S.C. § 300w-9 (Title XIX, § 1910 of the Public Health Service Act) https://nih.sharepoint.com/sites/hrsa-dynamics/nofo_nofoguidancedocument/PFanflik@HRSA.gov

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EXECUTIVE SUMMARY

508 Compliance Disclaimer Note: Persons using assistive technology may not be able to fully access information in this file. For assistance, please email or call one of the HRSA staff above in Section VII.

Agency Contacts.

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2022 Emergency Medical Services for Children (EMSC) Data Center. The purpose of this program is to support activities that demonstrate expansion and improvement in the delivery of high-quality emergency services for all children throughout our nation. The recipient will achieve this purpose by serving as a central data coordinating center that (1) provides support for large multi-center randomized clinical research trials focused on emergency medical services for children; (2) collects and provides annual surveillance on national performance measures that meaningfully describe the EMSC Program’s impact in 59 states and jurisdictions; and (3) collaborates with national partners to coordinate and support national data collection efforts to assess the readiness of prehospital and hospital emergency systems to care for children.

Also in this notice is the opportunity to apply for additional funding to build capacity to advance EMSC data integration and dissemination. Applying for the EDC Supplemental funding is optional.

Funding Opportunity Title: Emergency Medical Services for Children Data Center (EDC)

Funding Opportunity Number: HRSA-22-087

Due Date for Applications: January17, 2022

Anticipated Total Annual Available FY 2022 Funding:

EDC: $3,200,000

EDC Supplement (optional): Up to $500,000 may be available each year

Estimated Number and Type of Award(s): EDC: Up to one (1) cooperative agreement

EDC Supplement (optional): Up to one

(1) supplement per year, pending availability of funds.

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Estimated Annual Award Amount: EDC: Up to $3,200,000 per year based on listed criteria subject to the availability of appropriated funds.

EDC Supplement (optional): Annual supplement, up to $500,000, dependent on the availability of funds each year.

May be awarded in any of the 4 budget years for a funding period of one (1) year.

Cost Sharing/Match Required: No

Period of Performance: EDC: July 1, 22 through June 30, 2026 (4 years)

EDC Supplement (optional): 1-year one-time supplement with the July 1, 2022 through June 30, 2026 period of performance

Eligible Applicants: State governments and accredited schools of medicine. 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 Application Guide, available online, except where instructed in this NOFO to do otherwise.

Technical Assistance HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Thursday, November 4, 2021 Time: 3 – 4 p.m. ET Call-In Number: 1-833-568-8864 Participant Code: 36697355 Weblink: https://hrsa-gov.zoomgov.com/j/1613682452?pwd=TWxRQWV2VDFPRlpxdFdNUkNEMWhx dz09 http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa-gov.zoomgov.com/j/1613682452?pwd=TWxRQWV2VDFPRlpxdFdNUkNEMWhxdz09 https://hrsa-gov.zoomgov.com/j/1613682452?pwd=TWxRQWV2VDFPRlpxdFdNUkNEMWhxdz09 https://hrsa-gov.zoomgov.com/j/1613682452?pwd=TWxRQWV2VDFPRlpxdFdNUkNEMWhxdz09

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HRSA will record the webinar and make it available at:

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

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 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 MANAGEMENT (SAM)

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX: 1

APPENDIX 2:

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Emergency Medical Services for Children (EMSC) Data Center. The purpose of this program is to support activities that demonstrate expansion and improvement in the delivery of high-quality emergency services for all children throughout our nation by:

1) Providing independent, comprehensive research support for large multi-center randomized clinical trials and other types of clinical research conducted by and associated with the Pediatric Emergency Care Applied Research Network

(PECARN);

2) Enhancing and collecting performance measure data that align with the combined efforts of the EMSC State Partnership (SP) and the EMSC Innovation and Improvement Center (EIIC) to expand and improve EMSC in states/jurisdictions; and

3) Collaborating with national partners to coordinate and support nationally representative data collection efforts to assess the expansion of prehospital and hospital pediatric readiness initiatives.

This work will support the EMSC Program’s efforts to reduce disparities in access to high quality pediatric emergency services and improve health equity in care across the continuum of emergency medical services for children. Also provided for in this notice is the opportunity to apply for the EDC Supplement funding to support building capacity to advance EMSC data integration and dissemination activities. Applying for the EDC Supplement is optional. For additional information on the EDC Supplement, please refer to Appendix 1: Description of the EDC Supplemental Funding.

Program Objectives

1) Provide independent, comprehensive research support for large multi-center randomized clinical trials and other types of clinical research related to improving and expanding emergency medical services for children conducted by and associated with PECARN. Specific activities will include:

• Coordinating research activities to include developing multi-center research protocols; managing single institutional review board policies;

delivering implementation training for clinical studies; providing statistical support and analysis; creating data transfer and management tools; preparing and participating in manuscript development and tracking; supporting ancillary study activities; and participating in executive, steering, and subcommittees;

• Expanding the impact of PECARN's research data and data registries by de-identifying PECARN data and creating a series of public use datasets that are maintained and made available for three years after the date that the last patient completes the study and follow-up;

supporting the expansion of the PECARN data registry; optimizing

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access to PECARN research data and data registries for clinical and health services research; developing PECARN's capacity to link or collaborate with other research networks; increasing alignment with national-level pediatric readiness efforts by assessing and promoting the uptake of PECARN-developed decision rules and evidence-based practices in community Emergency Departments (ED); and strengthening research that focuses on understanding and addressing health inequities in EMSC; and

• Providing rapid analyses of federally supported datasets and registries (e.g., PECARN’s multicenter electronic health record registry of pediatric emergency care) on issues related to public health emergencies and emerging needs to inform MCHB's public health responses.

2) Enhance and collect performance measure data that align with the EMSC SP and the EIIC’s1 combined efforts to expand and improve EMSC care in states and jurisdictions.

• Provide technical assistance (TA) for data collection and program evaluation that will enable EMSC SP recipients to collect data which measures EMS agencies’ ability to care for children and provide regular assessments of progress in key aspects of prehospital pediatric readiness statewide;

• Develop and implement the annual and/or biannual collection of state and nationally representative data on prehospital and hospital EMSC performance measures;

• Provide access to data that supports effective quality improvement (QI) strategies to increase prehospital EMS and EDs’ capacity in their state.

3) Collaborate with national partners to coordinate and support nationally representative data collection efforts to assess the expansion of prehospital and hospital pediatric readiness initiatives.

• Coordinate with national partners to develop, expand, and maintain data collection methods and portals which enhance the National Pediatric Readiness Project2 and the National Prehospital Pediatric Readiness Project;3

• Develop and maintain web-based data collection portals to provide timely program feedback on prehospital EMS and EDs’ degree of pediatric readiness; and

1 Visit the EIIC website to learn about their work at https://emscimprovement.center/.

2 To learn more at the National Pediatric Readiness Project, please visit:

https://emscimprovement.center/domains/pediatric-readiness-project/ 3 To learn more about the National Prehospital Pediatric Readiness Project, please visit:

https://emscimprovement.center/domains/prehospital-care/prehospital-pediatric-readiness/

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• Provide access to data that supports effective QI strategies to increase prehospital EMS and EDs’ capacity to provide up-to-date, evidence-based pediatric emergency services.

Also in this notice is the opportunity to apply for additional funding to support building capacity to advance EMSC data integration and dissemination. Specifically, the additional funds should help with improving and expanding database development, maintenance, and integration using cost effective, reliable, cutting-edge technologies to facilitate annual or biannual data collection, data analyses and information sharing for dissemination. Applying for the EDC Supplement is optional.

2. Background

About MCHB and Strategic Plan

The Maternal and Child Health Bureau (MCHB) administers programs with focus areas in maternal and women’s health, adolescent and young adult health, perinatal and infant health, child health, and children with special health care needs. To achieve its mission of improving the health and well-being of America’s mothers, children, and families, MCHB is implementing a strategic plan that includes the following four goals:

Goal 1: Assure access to high quality and equitable health services to optimize health and well-being for all MCH populations

Goal 2: Achieve health equity for MCH populations

Goal 3: Strengthen public health capacity and workforce for MCH

Goal 4: Maximize impact through leadership, partnership, and stewardship

This program addresses MCHB Goals 1 and 2 by working to:

• Monitor and improve equitable access to a continuum of high-quality emergency medical services for children that address medical and social determinants of health across the life course;

• Strengthen state- and community-based comprehensive systems of emergency medical care for children that equitably improve well-being;

• Collect and use data on race, ethnicity, culture, language, income, disability status, health status, gender, sexual orientation, geographic location, or other factors to measure and address disparities and advance equity for children in their access and outcomes; and

• Leverage MCHB resources to improve access to emergency care services for health of all children that are marginalized, including those affected by racism and ableism.

To learn more about MCHB and the bureau’s strategic plan, visit https://mchb.hrsa.gov/about.

Health Equity Definition of Equity: The consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have https://mchb.hrsa.gov/about

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been denied such treatment, such as Black, Latino, Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons;

persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.4 MCHB is committed to promoting equity in health programs for mothers, children, and families. As such, the definition of equity provides a foundation for the development of programs that intend to reach underserved communities and improve equity among all communities.

Comprehensive Research Support for EMSC PECARN

Emergency Medical Services for Children Data Center (EDC) is authorized by the Public Health Service Act, Title XIX, 1910 (42 U.S.C. 300w-9). The EDC is administered by the Emergency Medical Services for Children (EMSC) Program within the Maternal and Child Health Bureau (MCHB) Division of Child, Adolescent, and Family Health.

MCHB is part of the Health Resources and Services Administration, an operating division of the U.S. Department of Health and Human Services.

The EMSC Program was established in 1984 to expand and improve emergency medical services for children, in response to a growing recognition that children have unique needs in emergencies -- needs that vary from those of adults due to physiological, developmental, and psychological differences. The EMSC Program aims to ensure that all of the nation’s children have access to high quality, evidence-based pediatric emergency care through a portfolio that consists of five individual inter-related programs (PECARN, SP, Targeted Issues, EIIC, and the EDC). These programs work to ensure that both prehospital EMS systems and EDs incorporate the most effective and appropriate pediatric clinical care, processes, equipment, and knowledge to treat and manage pediatric patients who experience trauma or medical emergencies.

The HRSA EMSC PECARN supports the research network infrastructure that enables pediatric emergency care researchers to address gaps in clinical evidence by collaboratively designing, conducting, and disseminating research that improves the treatment and management of children and youth in prehospital EMS and hospital EDs settings. PECARN research aims to address pediatric emergency care challenges by conducting studies that require multi-site randomized control trials. Results of these studies inform clinical care guidelines and practice. To ensure data collected by PECARN studies are made available to the public, the EDC is required to de-identify PECARN data and create a series of public use datasets that are maintained and available for 3 years after the date when the last patient completes the study and follow-

up. Current PECARN cooperative agreement recipients provide the EDC with final study data according to schedules developed and approved by the PECARN Steering Committee. The current grant cycle of PECARN research node recipients includes 7

4 Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, 86 FR 7009, at § 2(a) (Jan. 20, 2021), https://www.govinfo.gov/content/pkg/FR- 2021-01-25/pdf/2021-01753.pdf.

https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf

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research nodes that together include 18 EDs and 9 prehospital EMS agencies.5 To date, PECARN and the EDC have implemented 74 multi-institutional clinical studies, enrolling more than 143,000 children, resulting in more than 190 peer-reviewed journal articles and 21 public use datasets to enable future pediatric emergency care research and innovation. In the new funding period, the EDC will provide comprehensive research support for PECARN; expand the impact of PECARN’s research; strengthen health equity research; and modernize federally supported datasets to inform emerging public health needs. For additional background information on the relationship between the EDC and PECARN, please refer to Appendix 2: Additional Background on the Relationship between the EDC and PECARN.

Developing Performance Measures for EMSC SP and EIIC

The EDC supports the development and collection of EMSC performance measurement data to better assess the EMSC Program’s progress toward expanding and improving EMSC across the states and jurisdictions. In 2017, the EDC published the EMS for Children Performance Measures Implementation Manual for State Partnership Grantees. The purpose of the implementation manual was to provide EMSC SP recipients a “roadmap to improve the ease, accuracy, and consistency of data collection and reporting for their performance measures.”6 The EDC supported the national data collection of nine (9) EMSC National Performance Measures, which captured improvements in pediatric care across prehospital EMS and hospital EDs, and EMSC Program sustainability. In the new funding period, the EDC will continue to improve the quality and timeliness of meaningful performance measures, provide technical assistance for performance measures data collection, implement annual or biannual data collection, and support assessments of QI strategies.

Advancing Pediatric Emergency Readiness

The HRSA EMSC Program collaborates with multidisciplinary partners to support the National Pediatric Readiness Project (NPRP), a national QI initiative to ensure that all U.S. EDs have the essential guidelines and resources in place to provide effective emergency care to children. In 2013, the EDC provided support to the NPRP to launch a web-based assessment of all EDs in the U.S. to assess their progress in implementing the national pediatric readiness guidelines, outlined in the 2009 Joint Policy Statement, “Guidelines for Care of Children in the Emergency Department.” Over 4,000 (83%) hospital EDs responded. Of those responding, 69% of EDs reported treating less than 14 children per day and had an average pediatric readiness score of 69 out of a possible 100 points.7 A second national NPRP assessment of U.S. EDs, based on the updated 2018 Joint Policy Statement titled, “Pediatric Preparedness in the

5 Visit the PECARN website to understand the structure of the PECARN network and to learn about past and present studies at http://www.pecarn.org.

6 More information can be found at:

https://www.nedarc.org/performanceMeasures/documents/EMS%20Perf%20Measures%20Manual%20Web_0217.pdf 7 Gausche-Hill M, Ely M, Schmuhl P, et al. A National Assessment of Pediatric Readiness of Emergency Departments. JAMA Pediatr. 2015;169(6):527–534. doi:10.1001/jamapediatrics.2015.138 http://www.pecarn.org/ https://www.nedarc.org/performanceMeasures/documents/EMS%20Perf%20Measures%20Manual%20Web_0217.pdf

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Emergency Department,”8 was conducted in 2021. The results of this assessment will provide data to further advance QI efforts to improve pediatric emergency care.

In 2019, the HRSA EMSC Program convened national and federal partners to develop and implement pediatric readiness in the prehospital setting, which launched the National Prehospital Pediatric Readiness Project (NPPRP).9 The NPPRP is a national initiative established to address gaps in prehospital EMS based on the 2020 joint-policy statement technical report entitled, “Pediatric Readiness in Emergency Medical Services Systems.”10 The joint policy statement highlights key approaches to improving prehospital EMS for children, including increasing the number of agencies that have a pediatric champion; ensuring ambulances have appropriate pediatric equipment and medications; providing routine pediatric emergency care education and training;

developing quality improvement initiatives and strategies based on pediatric-specific guidelines; and integrating EMS physician medical oversight in prehospital EMS systems.11 In addition to supporting educational tools, the NPPRP partners are developing and planning the implementation of a national assessment of pediatric readiness in prehospital EMS agencies.12

In the new period of performance, the EDC will identify and implement innovative approaches to assess the improvements in pediatric readiness in prehospital EMS systems and hospital EDs across the nation.

II. Award Information

1. Type of Application and Award

Type(s) of applications sought: Competing Continuation, 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.

HRSA program involvement will include:

8 Remick K, Gausche-Hill M, Joseph MM, Brown K, Snow SK, Wright JL; American Academy of Pediatrics Committee on Pediatric Emergency medicine and Section on Surgery; American College of Emergency Physicians Pediatric Emergency Medicine Committee; Emergency Nurses Association Pediatric Committee. Pediatric Preparedness in the Emergency Department. Pediatrics. 2018;142(5):e20182459 9 More Information can be found at: https://emscimprovement.center/domains/prehospital-care/prehospital-pediatric-readiness/ 10 Owusu-Ansah S, Moore B, Shah MI, et al. AAP Committee on Pediatric Emergency Medicine. Section on Emergency Medicine, AAP EMS Subcommittee, Section on Surgery. Pediatric Readiness in Emergency Medical Services Systems. Pediatrics. 2020;145(1): e20193308 11 American Academy of Pediatrics, Committee on Pediatric Emergency Medicine American College of Emergency Physicians, Emergency Medical Services Committee Emergency Nurses Association, Pediatric Committee National Association of Emergency Medical Services Physicians, Standards and Clinical Practice Committee National Association of Emergency Medical Technicians, Emergency Pediatric Care Committee. Policy statement: pediatric readiness in emergency medical services systems. Pediatrics. 2019;145(1):e20193307 12 For more information, Please visit: https://emscimprovement.center/domains/prehospital-care/prehospital-pediatric-readiness/

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• Participating in the planning and scheduling of meetings conducted during the period of the cooperative agreement;

• Participating in regular meetings and communications with the recipients to assess progress;

• Providing clearance of the planning, development, implementation, and evaluation of products and tools funded under this cooperative agreement;

• Participating in the design, direction, and evaluation of innovative activities;

• Facilitating efforts in the provision of technical support and training/education to specified individuals;

• Reviewing procedures to be established for ongoing monitoring and successful accomplishment of the scope of work proposed;

• Supporting the identification and engagement of federal and state contacts and professional and national organizations with whom the recipient will be asked to develop cooperative and collaborative relationships;

• Co-leading evaluative meetings dedicated to the ongoing development, evolution, refinement, and/or retirement of EMSC performance measures;

• Providing review and advisory input of any draft and final publications, audiovisuals, and other materials produced under the auspices of this cooperative agreement; and

• Reviewing and considering for approval all travel for meetings and conferences.

The cooperative agreement recipient’s responsibilities will include:

• Establishing bi-monthly check-ins with EDC leadership, with ad-hoc meetings as needed with federal EMSC Program staff. At least two meetings must be in-person each year, if permissible and safe;

• Responding in a timely and flexible manner to collaborating on short-term, long-term, and ongoing projects as well to rapid-response requests, to be determined by HRSA staff on a case-by-case basis;

• Providing summary de-identified aggregate data to the federal Project Officer (PO), including data on emergent issues if requested;

• Consulting with federal Project Officer regarding the selection and hiring of new key project staff;

• Consulting with the PO when planning and implementing new activities;

• Consulting with the PO when scheduling any meetings, including project advisory/Steering Committee meetings, that pertain to the scope of work and at which the PO’s attendance would be appropriate (as determined by the PO);

• Providing the PO with adequate time and opportunity to review, provide advisory input, and approve at the program level, any publications, audiovisuals, and other materials produced, as well as meetings planned, under the auspices of this cooperative agreement (such review should start as part of concept development and include a review of drafts and final products);

• Providing the PO with an electronic copy of, or electronic access to, each product developed under the auspices of this project;

• Ensuring that all products developed or produced, either partially or in full, under the auspices of this cooperative agreement are fully accessible and available for free to members of the public;

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• Consulting with and coordinating attendance at national meetings or conferences with the PO to keep informed of and involved in initiatives of national significance to the EDC and its recipients;

• Co-leading, with the federal program staff, evaluative meetings dedicated to the ongoing development, evolution, refinement, and/or retirement of EMSC performance measures;

• Providing technical expert guidance, such as survey methodology, data analytics, framing, and visualization, for annual and/or biannual performance measure data;

• Participating in the planning of and providing technical support during EMSC grant recipient site visits or other meetings as requested;

• Seeking prior approval for all travel to ensure coordination with other EMSC award recipient activities;

• Submitting a quarterly travel schedule with all planned travel (due 30 days before the start of each quarter), format to be determined in partnership with the PO;

• Acknowledging that HRSA/MCHB has full access rights to all data generated under this cooperative agreement and that the government has a royalty-free, nonexclusive, and irrevocable license to reproduce, publish, or otherwise use any products derived from activities conducted under this cooperative agreement;

and

• Assuring seamless transfer of all web-based and non-web-based materials developed and stored throughout this cooperative agreement within 90 days of the project period expiration.

HRSA/MCHB and the recipient have a joint responsibility to develop a plan of action for issues to be addressed during the period of performance. The plan will include the sequence in which the issues will be addressed, what approaches and strategies will be used to address them, and how relevant information will be transmitted to specified target audiences and used to enhance project activities and advance the EDC.

2. Summary of Funding

HRSA estimates approximately $3,200,000 to be available annually to fund one recipient. The actual amount available will not be determined until enactment of the final FY 2022 federal appropriation.

You may apply for a ceiling amount of up to $3,200,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. 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, 2022 through June 30, 2026 (4 years). Funding beyond the first year is subject to the availability of appropriated funds for the EDC in subsequent fiscal years, satisfactory progress, 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.

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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In addition, up to $500,000 per year may be available annually to fund one (1) EDC optional supplement to support building capacity to advance EMSC data integration and dissemination described in Attachment 7. In this application, you may apply for a ceiling amount of up to $500,000 total costs (includes both direct and indirect, facilities and administrative costs) to be awarded through this supplement opportunity. The recipient may be awarded a one-time, 1-year supplement during 1 of the 4 budget years. The actual amount available will not be determined until the enactment of the final FY 2022 federal appropriation and appropriation going forward until 2026.

Base funding opportunity under this NOFO

Type of Award Estimated Number of Awards Estimated Funding of Award Per Year

Total Program Funds/Year

Emergency Medical Services for Children Data Center

1 $3,200,000 $3,200,000

Optional supplemental funding opportunity under this NOFO

Type of Award Estimated Number of Awards

Estimated $ of Award

Total Program Funds/Year

Optional EDC Supplement

1 recipient per year Recipient may receive a one-time award of up to $500,000 once in any of the 4 budget periods.

Up to $500,000 per year pending availability of funds.

See HRSA Grants Policy Bulletin 2017-03 Indirect Cost Rate Agreements in the NOFO.

III. Eligibility Information

1. Eligible Applicants

Eligible applicants include state governments and accredited schools of medicine in states and jurisdictions. The term “school of medicine” for the purpose of this funding opportunity (and under 42 U.S.C. 300w-9(c) has the same meaning as set forth in § 799B(1)(A) of the Public Health Service Act (42 U.S.C. 295p(1)(A)).13 The term “state” for the purpose of this funding opportunity includes, in addition to the several states, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the

13 See definition at: https://www.law.cornell.edu/uscode/text/42/295p https://sharepoint.hrsa.gov/ofam/dgp/PolicySOP/Grants%20Policy%20Bulletin%202017-03%20Indirect%20Cost%20Rate%20Agreements%20in%20the%20NOFO.pdf

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Pacific Islands.

Per legislation, only three EMSC grant awards per state may be awarded to each state during any fiscal year.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA may not consider an application for funding if it contains any of the non-responsive criteria below:

• Exceeds the ceiling amount

• Fails to satisfy the deadline requirements referenced in Section IV.4

NOTE: Multiple applications from an organization are not allowable.

HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, before 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 Grants.gov: HOW TO

APPLY FOR GRANTS.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-22-087 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

Application Format Requirements Section 4 of HRSA’s SF-424 Application Guide provides general instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, etc. You must submit the information outlined in the HRSA SF-424 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 Application Guide except where instructed in the NOFO to do otherwise. You must https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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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 HRSA SF-424 Application Guide for the Application Completeness Checklist.

Application Page Limitation The total size of all uploaded files included in the page limit may not exceed the number of pages listed in the table below when printed by HRSA.

EDC Base Award 80 pages

EDC Supplement (Optional as Attachment 7) 10 additional pages

The page limit for the EDC includes the project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO.

Please note: Effective April 22, 2021, the abstract is no longer an attachment that counts in the page limit. The abstract is the standard form "Project Abstract Summary.”

Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-22-087, 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.

Any application exceeding the page limit of 80 pages total for the EDC base award application, and 90 pages if applying for the supplemental funding will not be read, evaluated, or considered for funding.

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

The page limit for the supplement includes the project narrative, budget narrative, and any other descriptive information. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit.

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).

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371

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3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachment 8-15: Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 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 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract Use the Standard OMB-approved Project Abstract Summary Form 2.0 that is included in the workspace application package. Do not upload the abstract as an attachment or it will count toward the page limitation. For information required in the Project Abstract Summary Form, see Section 4.1.ix of HRSA’s SF-424 Application Guide.

Place the following at the top of the abstract:

Address Project Director Name Contact Phone Numbers (Voice, Fax) Email Address Website Address, if applicable

For abstract information content, include the following:

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

• GOAL(S) AND OBJECTIVES: Identify the major goal(s) and objectives for the 4-year period of performance. METHODOLOGY: Describe the activities used to attain the objectives.

• COORDINATION: Describe the coordination planned with appropriate national, regional, state, and/or local partners to implement the proposed project. POPULATION: Briefly describe the population group(s) to be served.

• EVALUATION: Briefly describe the evaluation methods that will assess program outcomes and the effectiveness and efficiency of the project in attaining goals and objectives.

• ANNOTATION: Provide a three- to five-sentence description that identifies the project’s purpose, the needs and problems that are addressed, the goals and objectives of the project, the activities that will be used to attain the goals, and the materials that will be developed.

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, the table below provides a crosswalk between the narrative language and where each section falls within the review criteria. Any forms or attachments referenced in a narrative section may be considered during the objective review.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need

Methodology (2) Response

Work Plan (2) Response

Resolution of Challenges (2) Response

Evaluation and Technical Support Capacity

(3) Evaluative Measures and (4) Impact

(5) Resources/Capabilities

Organizational Information (5) Resources/Capabilities

Budget and Budget Narrative (6) Support Requested

ii. Project Narrative This section provides a comprehensive description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and organized in alignment with the sections and format below so that reviewers can understand the proposed project.

Use the following section headers for the narrative:

INTRODUCTION -- Corresponds to Section V’s Review Criterion 1 Need

Briefly describe the purpose of the proposed project that is consistent with Section I: Purpose of this NOFO.

Provide an overview of how the project will accomplish the following:

• Provide independent, comprehensive research support for large multi-center randomized clinical trials and other types of clinical research associated with the PECARN;

• Enhance and collect performance measure data that measure the EMSC SP and the EIIC's combined efforts to expand and improve EMSC care in states/jurisdictions; and

• Collaborate with national partners to coordinate and support nationally representative data collection efforts to assess the expansion of prehospital and hospital pediatric readiness initiatives.

NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion 1 Need

The needs assessment should help reviewers understand the need for the EDC and should exhibit an expert understanding of the EDC processes, needs, and the activities/tasks included in this cooperative agreement as well as the expected outcomes.

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• Briefly describe the need to provide support to and coordination of the PECARN, EMSC SP, and EIIC programs, and national partners working to advance pediatric readiness and the delivery of equitable and quality pediatric emergency care that is consistent with specific activities described in Section I.

Describe the significance of the project in terms of its potential impact for improving EMSC nationally, with a focus on data collection, analysis and utilization.

• Briefly discuss any relevant barriers in the field of pediatric emergency care that the project intends to overcome. This section should help reviewers understand the:

o role of the EDC in a research network;

o role of the EDC in supporting ongoing program evaluation, specifically the EMSC Program performance measures and data system support;

o role of the EDC in prehospital and hospital pediatric readiness initiatives;

o issues, including inequities, related to pediatric emergency care services and research (including issues related to human subjects protections and single institutional review board policies and procedures);

o data collection and analysis including natural language processing and machine learning approaches and the technical support personnel to implement these approaches;

o general infrastructure and technological support needs of the EDC (e.g., software/hardware to ensure secure transmission and storage of protected health information), and cutting edge data collection and analysis (e.g., natural language processing and machine learning approaches).

METHODOLOGY -- Corresponds to Section V’s Review Criterion 2 Response

Propose clear and feasible methods including goals and objectives to meet the expectations described in this NOFO. Objectives should be specific, measurable, achievable, relevant, and time-bound (SMART) and align with the objectives in this NOFO. Describe how the proposed project will address the public health need and incorporate a health equity lens in the activities of this program.

Ensure the following core objectives and activities are integrated into the proposal.

Objective 1: Provide independent, comprehensive research support for large multi-center randomized clinical trials and other types of clinical research associated with PECARN. Specific activities are detailed below.

Coordinate PECARN Research Activities:

• Support the development of multi-center research protocols that have been approved by the PECARN Steering or Executive Committees;

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• Support the development of operational and procedural manuals, protocols, and forms; quality control systems, data collection modules, and an electronic communications system for research nodes and their respective Hospital Emergency Department Affiliates or Emergency Medical Services Affiliates;

• Provide training for research nodes and their respective Hospital Emergency Department Affiliates for standardization of PECARN study protocols across sites;

• Manage single institutional review board policies, activities, and implementation;

• Coordinate and support Data Safety Monitoring Boards;

• Ensure network-wide compliance with human subject protections;

• Provide support and guidance for the regulatory functions and requirements associated with the study protocols, procedures, and Institutional Review Board (IRB) approval process including the Single IRB;

• Revise and maintain network policies and procedures that support the network’s mission and comply with federal rules and regulations in conjunction with the PECARN Nodal Principal Investigators and MCHB Project Officer or designee;

• Organize and conduct multi-site monitoring activities in conjunction with MCHB Project Officer or designee;

• Serve as a central resource for PECARN generated network data including creating data collection, transfer and management tools, data integration, and quality assurance;

• Provide statistical support and analysis of data for planned primary study analyses, and secondary analyses, that are approved by the PECARN Steering or Executive Committees;

• Assist in support of ancillary studies that have been approved by the PECARN Steering or Executive Committees;

• Assist in preparing abstracts for presentation at scientific meetings;

• Participate in the preparation of manuscripts and tracking for publication;

• Facilitate communication between EDC staff and other components of PECARN, including MCHB, Data Safety Monitoring Boards, and PECARN Research Node Centers and their respective Hospital Emergency Department Affiliates and Emergency Medical Services Affiliates;

• Provide an operational structure capable of coordinating EDC functions for several protocols simultaneously;

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• Provide MCHB and PECARN information on the efficiency and productivity of the network that includes metrics regarding concept development, grant submission, study implementation, and related manuscript publications; and

• Participate in executive, steering, and subcommittees, and as a voting member of the PECARN Executive Committee and PECARN Steering Committee.

Lead Dissemination of PECARN Studies:

• Expand the impact of PECARN’s research data and data registries;

• De-identify PECARN data and create a series of public use datasets that are available 3 years after the last patient completes the study and follow-up;

• Support the expansion of the PECARN data registry;

• Modernize data evaluation including developing partnerships or building capacity within the EDC to use natural language processing and/or machine learning;

• Provide rapid analyses of federally supported datasets on issues related to public health emergencies and emerging needs to inform MCHB's public health responses;

• Develop PECARN's capacity to link or collaborate with other research networks;

• Participate on the PECARN Dissemination working group;

• Increase alignment with national-level pediatric readiness efforts by assessing and promoting the uptake of PECARN-developed decision rules and evidence-based practices in community EDs; and

• Increase and strengthen research that focuses on understanding and addressing health inequities in EMSC.

Objective 2: Enhance and collect performance measure data that align with the EMSC SP program and the EIIC's combined efforts to expand and improve EMSC care in states and jurisdictions. The recipient will provide analytical support to EMSC grant recipients and national stakeholders to enhance and improve state data systems needed to advance the delivery of quality pediatric emergency care.

This includes providing statistical and data management technical assistance to EMSC grant recipients and researchers. Specific activities are detailed below.

Data-related TA to EMSC SP Recipients:

• Provide technical support to ensure that sufficient tools and TA are available for states to collect EMSC Program Performance Measures that are used to assess the ongoing quality of pediatric emergency care provided in prehospital and hospital settings; and

• Support learning communities among states to assist them in sharing lessons learned to improve data collection of EMSC performance measures through facilitated workshops, expert panels, and networking opportunities.

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Annual and/or Biannual Data Collection

• Assist HRSA/MCHB with ongoing development, refinement, and/or retirement of EMSC performance measures. The EDC plays a vital role in modifying and developing new measures that address care delivery gaps. This may include modifications to the accompanying guidance manual for EMSC program managers and a data dictionary for HRSA; and

• Facilitate and implement annual or biannual collection of state and nationally representative data on prehospital and hospital EMSC performance measures.

Effective QI Support

• Support states to collect, analyze, and utilize data to enhance and improve pediatric emergency care;

• Assist states in linking state performance data with other national data sets focused on emergency medical services in the prehospital and hospital setting;

and

• Disseminate results from EMSC SP performance measure assessment in the form of peer-reviewed articles for the field and general publications for the public.

Objective 3: Collaborate with national partners to coordinate and support nationally representative data collection efforts to assess the expansion of prehospital and hospital pediatric readiness initiatives. Specific activities are detailed below.

• Coordinate with national partners to develop, expand, and maintain data collection methods and portals which enhance the NPRP and the NPPR Projects;

• Develop and maintain web-based data collection portals to provide timely program feedback on prehospital EMS and EDs’ degree of pediatric readiness;

• Collaborate with EIIC and national partners to…