PKG00247259-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Maternal and Child Health Bureau Division of Child, Adolescent, and Family Health

Pediatric Emergency Care Applied Research Network (PECARN)

Funding Opportunity Number: HRSA-19-052

Funding Opportunity Type(s): Competing Continuation, New Catalog of Federal Domestic Assistance (CFDA) Number: 93.127

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2019

Application Due Date: March 8, 2019

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

HRSA will not approve deadline extensions for lack of registration.

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

Issuance Date: December 31, 2018

Diane Pilkey, RN MPH Nurse Consultant, EMSC Telephone: (301) 443-8927 Email: dpilkey@hrsa.gov

Authority: Public Health Service Act, Title XIX, Section 1910 (42 U.S.C. 300w-9).

mailto:dpilkey@hrsa.gov

HRSA-19-052 i

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2019 Emergency Medical Services for Children Pediatric Emergency Care Applied Research Network (PECARN) program. The purpose of this program is to establish and maintain a multi-institutional research network that conducts high-quality, rigorous studies using pooled samples of pediatric patients to determine optimal pediatric emergency care. This Program will demonstrate an effective 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 acute illnesses and injuries in children and youth in hospital emergency departments and prehospital Emergency Medical Services settings.

Funding Opportunity Title: Pediatric Emergency Care Applied

Research Network (PECARN) Funding Opportunity Number: HRSA-19-052 Due Date for Applications: March 8, 2019 Anticipated Total Annual Available FY 2019 Funding:

$4,950,000

Estimated Number and Type of Award(s): Up to seven cooperative agreements Estimated Award Amount: Up to $700,000 per year, subject to the availability of appropriated funds:

Category I: Six at $700,000 per year Category II: One at $700,000 per year

• A total of seven cooperative agreements at $700,000 each.

• Additionally, one site selected by the network as the PECARN Chair will receive an additional $50,000.

Cost Sharing/Match Required: No Period of Performance: September 1, 2019 through

August 31, 2023 (4 years) Eligible Applicants: Applications may be submitted by 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 at

HRSA-19-052 ii http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf, except where instructed in this NOFO to do otherwise.

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Tuesday January 8, 2019 Time: 2 p.m. ET Call-In Number: 1-866-917-4660 Participant Code: 68594605 Weblink: https://hrsa.connectsolutions.com/pecarn_nofo/

An archive recording of the call will be available within a week of the call at:

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

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa.connectsolutions.com/pecarn_nofo/ https://mchb.hrsa.gov/fundingopportunities/

HRSA-19-052 1

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 AND

SYSTEM FOR AWARD MANAGEMENT

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK AND OTHER PRE-AWARD ACTIVITIES

4. ANTICIPATED ANNOUNCEMENT AND AWARD DATES

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX - ADDITIONAL PECARN BACKGROUND

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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) Pediatric Emergency Care Applied Research Network (PECARN) Program, hereafter referred to as PECARN. The purpose of this program is to establish and maintain a multi-institutional research network that conducts high-quality, rigorous studies using pooled samples of pediatric patients to determine optimal pediatric emergency care.

Goal This Program will demonstrate an effective 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 acute illnesses and injuries in children and youth in hospital emergency departments (EDs) and prehospital Emergency Medical Services (EMS)1 settings.

PECARN studies that identify effective clinical practice directly inform efforts to spread and standardize the delivery of optimal pediatric emergency medicine across the nation, ultimately improving survival and health outcomes among children.

PECARN will consist of seven research nodes, as well as a Data Coordinating Center (DCC) (the DCC is funded by HRSA through a separate cooperative agreement). This NOFO solicits applications for the seven research node cooperative agreements. There are two categories of award. You may only apply for one category.2

• Category 1 (Research Nodes): Six awards at $700,000 each. Each recipient of Category 1 funding will develop and maintain a group of three EDs and one co-located EMS agency, 3 resulting in a total of 18 EDs and 6 EMS agencies supported through this funding opportunity. Together these recipients will collectively conduct research and disseminate findings on the efficacy of treatment and management of acute illnesses and injuries in children.

• Category 2 (EMS Research Node): One award at $700,000. This recipient will develop and maintain a network of three multi-state EMS agencies and provide leadership to and coordinate the six EMS agencies from Category 1 in an EMS Consortium to design and conduct multi-site prehospital EMS research across all nine EMS agencies.

Please see Section II: Award Information for the list of specific expectations of recipients.

1 NHTSA Office of EMS (n.d.).What is EMS? Retrieved October 18, 2018 at https://www.ems.gov/whatisems.html 2 Multiple applications from an organization with the same Dun and Bradstreet Data Universal Numbering System (DUNS) number are not allowable. See Section IV: Application and Submission Information.

3 Located within the catchment area of one of the participating Emergency Departments https://mchb.hrsa.gov/fundingopportunities/?id=fca6e519-82ea-4bf8-b481-1267b651e776 https://www.ems.gov/whatisems.html

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Activities The PECARN network has four overarching activities that apply to both Categories unless otherwise indicated:

1) Conduct high priority, high-impact EMSC research using rigorous study designs and methodologies via a network of multi-site ED and prehospital EMS settings.

Studies will be supported by a network organizational structure that ensures efficiency, productivity, fidelity of study implementation, and provides the ability to:

a) Develop research studies;

b) Obtain extramural funding for research studies;

c) Conduct multi-site clinical studies;

d) Publish and disseminate results of research studies; and

e) Develop early stage investigators4 in the area of pediatric emergency medicine and ensure that these investigators are submitting research proposals to PECARN.

2) Establish and maintain a data infrastructure within the network and each site to ensure data are available for research and knowledge translation activities. Note:

Category 1 applicants can choose either or both options below (Option A and/or B). Category 2 applicants must choose option A.

a) Option A: Link patient encounter data between at least one participating prehospital EMS agency and their associated hospital systems which will allow studies of both prehospital and hospital clinical care and associated health outcomes;

b) Option B: Identify at least one Hospital Emergency Department Affiliate to participate in the ED Data Registry managed by the DCC.

3) Develop and implement two network-wide plans that include both prehospital EMS and hospital research: (1) research priorities to help guide selection of study concepts, and (2) dissemination activities to facilitate translation of research results to clinical practice and to the stakeholder community.

4) Foster collaboration among ED and EMS personnel, nurses, practitioners, and researchers to expand research opportunities and ensure implementation of research findings.

2. Background

The EMSC Program is authorized by the Public Health Service Act, Title XIX, Section 1910 (42 U.S.C. 300w-9). The program works to ensure that all children and adolescents receive appropriate emergency medical care, no matter where they live, attend school, or travel. Legislation first passed by Congress in 1984 authorized the use of federal funds to expand and improve emergency medical services for children.

In 2015, an estimated 34 million children sought care in EDs in the United States, representing about a quarter of all ED visits.5 The majority of pediatric ED visits occur

4 For example, see https://grants.nih.gov/policy/early-investigators/index.htm 5 Whitfill T, Auerbach M, Scherzer DJ, Shi J, Xiang H, Stanley RM. Emergency Care for Children in the United States: Epidemiology and Trends Over Time. The Journal of Emergency Medicine. 2018 May 21,

pp. 1-12.

https://grants.nih.gov/policy/early-investigators/index.htm

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in community hospitals where fewer than 15 pediatric patients are seen a day. In addition, less than 10 percent of prehospital EMS patient encounters are for pediatric patients.6 When children experience an injury or critical illness requiring emergency care, the delivery of appropriate, effective clinical care is essential to improve survival and subsequent health outcomes. However, because most institutions treat children far less frequently than adults and because children have unique medical needs requiring specialized equipment and other resources,7 research to define appropriate and effective care in the pediatric emergency medicine setting can be challenging. In particular, single institutions often do not treat a sufficient volume and variety of pediatric patients, especially those experiencing the same medical or trauma emergency, to derive conclusive results on the best course of treatment.

HRSA launched the PECARN program in 2001 to overcome these challenges, enabling recipients to collaborate across institutions and obtain the diverse, representative sample sizes needed to produce scientific evidence on effective, high quality care.

Since 2001, HRSA has sustained funding for the PECARN program while modifying the design to encompass prehospital EMS research.

PECARN Structure and Function

PECARN is an established research network with preexisting structures, policies, and procedures that will continue to apply to recipients of these new cooperative agreements. You need to understand the structures, functions, and activities of PECARN to verify that your proposed activities are in alignment with these policies and procedures. Network success is dependent on full participation of all recipients in functioning collaboratively and contributing to all aspects of network operations. The information below describes the PECARN Research nodes which will be funded through this NOFO, as well as the roles of the EMSC DCC and PECARN Committees.

Research Nodes The Research Node is the operational unit of PECARN. There are two categories of Research Nodes, each of which consists of a Research Node Center (RNC) and affiliates. The RNC is the recipient for this NOFO and provides administration and operations support as well as scientific leadership and management of studies in their node.

Category 1 (6 Research Nodes)

Category 2 (1 EMS Research Node)

Category 1: Each of the six Category 1 Research Node awards will consist of a Research Node Center (RNC), three Hospital Emergency Department Affiliates

6 Data from the National Emergency Medical Services Information System (NEMSIS).

7 Institute of Medicine Committee on the Future of Emergency Care in the US. Emergency care for children: growing pains. Washington, DC: National Academy Press; 2007.

http://www.pecarn.org/

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(HEDAs) and an EMS affiliate. The RNC is co-located at one of the three HEDAs. The EMS affiliate must be within the catchment or service area of one of the HEDAs in order to promote linkage of prehospital and ED data systems to follow outcomes for patient encounters. The RNC has primary responsibility for:

• Establishing and maintaining a Research Node infrastructure;

• Building partnerships with the HEDAs and the EMS affiliate; and

• Providing the HEDAs and EMS affiliate with administration and operations support, communications, and quality assurance.

Category 2: The Category 2 EMS Research Node consists of a prehospital EMS Research Node Center (E-RNC) that includes three EMS affiliates in separate states.

The E-RNC has primary responsibility for:

• Establishing and maintaining a Research Node infrastructure;

• Building partnerships with the three EMS affiliates;

• Providing the three EMS affiliates with administration and operations support, communications, and quality assurance; and

• Providing prehospital research leadership and coordination across the six EMS affiliates of the Category 1 recipients, forming one prehospital EMS Research Consortium within PECARN.

Outcomes PECARN progress and impact will be assessed using the program outcomes and indicators below. Each applicant to this NOFO will propose quantifiable targets to achieve by the end of the period of performance (August 31, 2023) for each of the below listed indicators. Applicants may also propose additional outcomes and/or indicators.

Program Outcomes Quantifiable Indicators of Success Improved infrastructure for conducting high quality research on pediatric emergency care

# of studies implemented within each Hospital Emergency Department Affiliate and the prehospital EMS agency sites

Average # of days between IRB approval and first study participant enrollment at study sites

Average # of months from last patient enrollment to submitted manuscript(s) of study results

Increased number of studies designed and implemented, including studies that aim to identify and spread effective and appropriate clinical practices

# of research concepts proposed to the PECARN Steering Committee

# of protocols approved by the PECARN Steering Committee

Strengthened pipeline of extramural research funding for pediatric emergency medicine

# and percent of PECARN-approved study concepts receiving external grant funding

Improved volume and power of research findings due to data linkages

# of studies initiated using linked data between prehospital EMS and hospital settings

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# of Research Nodes submitting data to the PECARN data registry

# of studies initiated using data from the PECARN data registry

Strengthened pipeline of researchers in pediatric emergency medicine

# of submitted research concepts submitted by future investigators and non-Principal Investigators

Expanded evidence base on effective and appropriate clinical care in pediatric emergency medicine

# of manuscripts submitted to peer reviewed journals

# of publications cited as evidence within clinical practice guidelines published by pediatric emergency and medical care leadership organizations8

Increased dissemination and translation of PECARN research findings

# of scientific presentations at continuing education conferences for practicing prehospital EMS and hospital clinicians

# of educational outreach activities to help the EMSC grantee network translate research findings into practice

EMSC Data Coordinating Center (DCC) HRSA has established a central DCC under a separate cooperative agreement to provide PECARN Research Nodes funded under this NOFO with data collection and management, quality assurance, statistical analyses, and coordination of select PECARN activities. It also serves as a central repository for PECARN generated data, as well as a PECARN data registry housing ED data from participating Research Nodes. DCC activities are described in this NOFO at:

https://mchb.hrsa.gov/fundingopportunities/?id=fca6e519-82ea-4bf8-b481- 1267b651e776

The purpose of the DCC is to assist the network in conducting multi-center clinical studies and provide information to assist HRSA in ensuring the efficiency and productivity of the network. All RNCs, HEDAs and EMS affiliates will cooperate with the DCC throughout the funding period to enable study monitoring and assure regulatory compliance and adherence to good clinical practices in all studies. In addition, they will cooperate with the DCC by implementing PECARN-wide data standards for collection and analysis of data generated under PECARN, and provide the DCC with timely data for purposes of monitoring the safety and progress of studies conducted under PECARN. Research Nodes will provide the DCC final study data according to schedules developed and approved by the Steering Committee. Study data collected by PECARN studies will be shared via a de-identified public use dataset will be made available by the DCC 3 years after the last patient completes the study and any follow-

up. The purpose is to ensure further use and dissemination of research. See the Appendix for additional information on Site Monitoring Reporting to the DCC.

8 Examples of such organizations include the American Academy of Pediatrics (AAP), Emergency Nurses Association (ENA), American College of Emergency Physicians (ACEP), National Association of EMS Physicians (NAEMSP), and National Association of State EMS Officials (NASEMSO).

http://www.pecarn.org/coordinatingCenter/

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PECARN Committees The RNCs, HEDAs, and EMS affiliates are expected to participate in PECARN Committees as described below.

Executive Committee: This committee consists of Principal Investigators (PIs) of the research nodes (known as the nodal PI), the PI of the DCC, and the HRSA Project Officer. The HRSA Project Officer is a liaison with the Executive Committee and reviews all decisions to ensure they fall within the scope of this cooperative agreement.

Steering Committee: This committee constitutes the primary governing body of PECARN. The voting membership of the committee consists of the PIs of each Research Node, the PI of the DCC, the HRSA Project Officer, and representatives from HEDAs and EMS affiliates. The Steering Committee is responsible for overseeing the scientific aspects of the network. The HRSA Project Officer reviews and concurs with committee decisions. The committee typically meets in person at least two times a year and may hold additional in-person meetings as needed. At least one meeting will be in the Washington, DC metro area and another meeting will be in a major U.S. city. The committee will also meet a minimum of three times virtually each year, and timing of the meetings will correspond to the needs of extramural grant development and submission.

PECARN Chairperson PECARN recipients identify a new Steering Committee Chairperson every 3 years to lead the Network and serve as a liaison to HRSA. The recipient that houses/supports the individual selected to be Chair will be awarded an additional $50,000 annually to support the specific activities listed in the Appendix.

Section II (Award Information 1) of this NOFO provides additional details on required roles and responsibilities of HRSA, the RNCs, HEDAs, and participating EMS affiliate sites for this application.

PECARN Results to Date PECARN has the capacity to answer long-standing, important clinical questions in pediatric emergency medicine, largely due to its ability to conduct randomized controlled trials and clinical studies on a large scale. PECARN has leveraged the analytical power of the HRSA-supported network infrastructure to seek research funding from entities like the National Institutes of Health, experiencing a 70 percent success rate for all external grant proposals. Since its inception, PECARN has implemented 34 multi-center research studies and published more than 140 peer-reviewed publications and 140 abstracts for conference presentations. In addition, more than 117,000 children have been enrolled in PECARN studies.

PECARN studies have increased provider knowledge and resulted in practice change.

For example, the PECARN Head Injury study9 resulted in a clinical decision rule designed to accurately identify children at very low risk of brain injury after head trauma.

9 Kuppermann N1, Holmes JF, Dayan PS, et.al. Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma:

a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70

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This finding changed practice and reduced unnecessary radiation exposure for children.10,11,12

Other questions that PECARN studies have answered include:13

• Do steroids work for children with bronchiolitis?

• When can CT scans for children be avoided after head injury?

• When can CT scans be avoided after abdominal injuries?

• Can RNA technology be used to determine whether infants with fever have a bacterial or viral infection?

• What is the best treatment for children with Status Epilepticus?

• Is it safe to give children with Diabetic Ketoacidosis intravenous fluids?

Additional Background

• More information about PECARN is available at http://www.pecarn.org.

• All participating Research Nodes, HEDAs, and EMS affiliates must agree to abide by

PECARN study protocols and PECARN policies and procedures available at:

http://www.pecarn.org/helpfulResources/documents/Approved%20PECARN%20Poli cies%2008.07.18.pdf.

• PECARN has developed a logic model illustrating the relationships between network activities and goals available at:

http://pecarn.org/helpfulResources/documents/PECARN_Logic%20Model%2008.08.

18.pdf

• The Appendix includes additional information about PECARN functions and reporting requirements.

PECARN should prioritize studies in critical illness or trauma that are likely to have a high impact on the clinical care and health outcomes for children, and/or studies of rare events requiring pooling of samples from multi-center research sites. Examples of these study topics would include shock, sepsis, seizure, respiratory illness, cardiac arrest, and behavioral health. Applicants should also remember the emphasis that HRSA is placing on opioid and substance use disorder, and applications featuring studies in this space would also be welcomed. Building on the history of PECARN, HRSA is introducing changes in this Notice designed to more effectively demonstrate how the Network can fill gaps in the clinical evidence needed to define optimal pediatric emergency care and ultimately improve survival and health outcomes of children who require emergency care.

These changes include:

• Fully integrating a multi-state EMS Research Node to lead the EMS research within

PECARN to strengthen the PECARN research in the prehospital EMS setting.

• Adding a focus on improving data systems and linkages to allow for ongoing assessment and research, information on health outcomes, and to promote translation of studies to clinical practice.

10 Dayan PS, Ballard DW, Tham E, et.al. Use of Traumatic Brain Injury Prediction Rules With Clinical Decision Support. Pediatrics. 2017 Apr;139(4). e2 0162709 11 For more information, see: https://www.mdcalc.com/pecarn-pediatric-head-injury-trauma-algorithm 12 Jennings RM, Burtner JJ, Pellicer JF, et.al. Reducing Head CT Use for Children With Head Injuries in a Community Emergency Department. Pediatrics. 2017 Apr;139(4);.2016-1349.

13 Information on PECARN and publications can be found at: http://www.pecarn.org/ http://www.pecarn.org/ http://www.pecarn.org/helpfulResources/documents/Approved%20PECARN%20Policies%2008.07.18.pdf http://www.pecarn.org/helpfulResources/documents/Approved%20PECARN%20Policies%2008.07.18.pdf http://pecarn.org/helpfulResources/documents/PECARN_Logic%20Model%2008.08.18.pdf http://pecarn.org/helpfulResources/documents/PECARN_Logic%20Model%2008.08.18.pdf https://www.mdcalc.com/pecarn-pediatric-head-injury-trauma-algorithm http://www.pecarn.org/

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II. Award Information

1. Type of Application and Award

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

Funding will be provided in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where substantial involvement is anticipated between HRSA and the recipient during performance of the contemplated project.

HRSA program involvement will include:

1) Assuring the availability of HRSA personnel to participate in the planning and development of all phases of PECARN;

2) Participating in, including the planning of, meetings conducted during the period of the cooperative agreement including, but not limited to, Executive Committee and Steering Committee meetings;

3) Reviewing meeting agendas and network policies and procedures established for conducting project activities;

4) Reviewing research concepts, protocols, or award submissions prior to their consideration before the full Steering Committee;

5) Facilitating and monitoring recipients’ compliance with NOFO requirements and participating in periodic meetings and/or communications with recipients to assess progress;

6) Participating, as appropriate, in the dissemination of research findings, best practices, and lessons learned from the project; and

7) Facilitating effective collaborative relationships with federal and state agencies, HRSA-funded grants, and other entities relevant to the project’s mission.

The cooperative agreement recipient’s responsibilities will include:

1) The Research Node Centers will establish written agreements with their HEDAs and

EMS affiliates that include, at a minimum:

a. A statement of work defining the goals and objectives of the projects to be undertaken through this cooperative agreement;

b. A budget for support of the projects that clearly identifies the personnel, equipment, materials, and other costs required to successfully conduct high quality work according to the requirements of specific PECARN protocols and policies;

c. Financial and program reporting requirements, including access to data and materials, to facilitate PECARN operations and project oversight and monitoring;

d. A requirement that each HEDA have a designated lead investigator and each EMS affiliate have a lead scientific advisor (Category 1) or investigator (Category

2) who agrees to fully cooperate with the Steering Committee, DCC, and HRSA to assure proper implementation of PECARN studies;

e. A plan for nodal communication and quality assurance;

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f. For Category 1 recipients, a requirement that the catchment area of the EMS affiliate must be within the catchment area of at least one of the HEDAs and that the EMS affiliate leadership such as the Medical Director is involved; and

g. A description of resources provided pertaining to:

1. Staffing and training needed to implement a study protocol;

2. A training and monitoring system to ensure protocol-specific requirements;

3. Additional assistance such as quality control to ensure the successful completion of the scientific goals of the research project.

2) Responsibilities of the HEDAs and EMS affiliates include:

a. Initiating and participating in the development of concepts and protocols of observational studies and clinical trials to be conducted by the network;

b. Participating in research studies approved by the Steering Committee and education training programs required for each study protocol;

c. Enrolling adequate numbers of representatively diverse research participants required for studies;

d. Providing routine clinical care to patients participating in protocols and experimental/standard care in accordance with approved research protocols;

e. Maintaining patient records and essential documents required for each protocol and permit site monitors to examine those records;

f. Collecting clinical and laboratory data for research purposes, including biological specimens when indicated;

g. Adhering to all policies established by the RNC and the Steering Committee;

h. Collecting and submitting study data in a timely manner to the DCC in accordance with Steering Committee, HRSA, and DCC policies;

i. Agreeing to not report data prior to collaborative reporting by PECARN;

j. Possessing adequate information technology and systems supported by each site’s designated institutional staff;

k. Agreeing to multi-faceted site monitoring by representatives of its RNC, DCC, HRSA (or designees) for use of treatments, compliance with protocol specifications, quality control, accuracy of data recording, and completeness of reporting of adverse reactions to treatments;

l. Adhering to good clinical practice and other regulatory requirements concerning human subjects protections (including all federal, institutional, and PECARN defined policies and procedures);

m. Attending relevant PECARN meetings and participating in subcommittees and working groups;

n. Working cooperatively with HRSA, other recipients, and the DCC, and complying fully with all protocol requirements of each study;

o. For EMS affiliates, establishing data linkages between prehospital and HEDA hospital systems.

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3) Additional responsibilities of all recipients:

a. Participate in a national EMSC grantee meeting in (in Years 2 and 4) as described in the Section IV. Application and Submission Information/ iv. Budget narrative.

b. Work with the DCC to create a de-identified public use dataset from study data that will be available three (3) years after completion of all follow-up procedures for the final subject enrolled in the study.

c. Collaborate with the HRSA Project Officer and the DCC in the collection and reporting of ongoing Research Network impact data such as number of research studies, study enrollees, publications, investigators, and mentees.

2. Summary of Funding

HRSA expects approximately $4,950,000 to be available annually to fund a total of seven recipients (six in Category 1 and one in Category 2). You may apply for a ceiling amount of up to $700,000 total cost (includes both direct and indirect, facilities and administrative costs) per year or $750,000 if you wish to be considered as the PECARN Chairperson. If you are interested in being considered for the PECARN Chairperson supplement, include a statement in the application indicating this, along with a proposed budget narrative for the supplemental amount (up to $50,000 for direct and indirect costs). However, do not include this amount in your SF-424A nor the total requested amount.

The period of performance is September 1, 2019 through August 31, 2023 (4 years).

Funding beyond the first year is subject to the availability of appropriated funds for the EMSC Program 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.

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 section 799B(1)(A) of the Public Health Service Act (42 U.S.C. 295p(1)(A)).14

Pursuant to section 1910(a) of the PHS Act, no more than three awards under this authority may be made in a state (to a state or a school of medicine in such state).

HRSA will not provide funds to more than three award recipients within each state in a given fiscal year. HRSA will make competitive awards under this NOFO in accordance with the rank order established by the objective review committee, but if awarding funds to the next ranking applicant would result in a fourth award to any state, HRSA will skip

14 See definition at: https://www.law.cornell.edu/uscode/text/42/295p http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75 https://www.law.cornell.edu/uscode/text/42/295p

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that applicant and make the award to the next eligible applicant, ensuring compliance with this statutory restriction.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA will consider any application that exceeds the ceiling amount non-responsive and will not consider it for funding under this notice.

HRSA will consider any application that fails to satisfy the deadline requirements referenced in Section IV.4 non-responsive and will not consider it for funding under this notice.

NOTE: Multiple applications from an organization with the same DUNS number are not allowable.

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 NOFO following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

If you’re reading this notice of funding opportunity (NOFO) (also known as “Instructions” on Grants.gov) and reviewing or preparing the workspace application package, you will automatically be notified in the event HRSA changes and/or republishes the NOFO on Grants.gov before its closing date. Responding to an earlier version of a modified notice may result in a less competitive or ineligible application. Please note you are ultimately responsible for reviewing the For Applicants page for all information relevant to desired opportunities.

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

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2. Content and Form of Application Submission

Section 4 of HRSA’s SF-424 Application Guide provides instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract. You must submit the information outlined in the 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 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 Application Guide for the Application Completeness Checklist.

Application Page Limit The total size of all uploaded files may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. We strongly urge you to take appropriate measures to ensure your application does not exceed the specified page limit.

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

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) The prospective recipient certifies, by submission of this proposal, that neither it nor its principals is presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

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

3) Where the prospective recipient is unable to attest to the statements in this certification, an explanation shall be included as an Attachment: 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 See Section 4.1.ix of HRSA’s SF-424 Application Guide. Include the information requested at the top of the abstract. Clearly indicate Category 1 or Category 2.

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

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Prepare the abstract so that it is clear, accurate, concise and without reference to other parts of the application because it is often distributed to provide information to the public and Congress. Briefly state the problem, goals and objectives, proposed activities, coordination, anticipated products and plans for evaluation.

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. Unless otherwise stated, the narrative elements described below apply to both Category 1 and Category 2.

Successful applications will include the information below. Please use the following section headers for the narrative:

Section I. Background and Significance Section II. Goals and Objectives Section III. Project Design: Methods and Evaluation Section IV. Capability of RNC, HEDAs, and EMS Affiliate Section V. Organizational Information

Section I – Background and Significance –Corresponds to Section V’s Review Criterion #1 Need

• Identify needs, challenges, and gaps in conducting pediatric emergency care research in both ED and prehospital EMS sites, and of using evidence-based research to improve the care of children.

• Provide an assessment of high priority research needs in pediatric emergency care, the current literature available to inform those study designs, and the opportunities for multi-site research studies to address these needs and advance the field.

• Demonstrate a thorough knowledge and understanding of multi-site pediatric emergency care research across the EMS continuum and in ED and/or prehospital EMS agency settings.

Section II – Goals and Objectives –Corresponds to Section V’s Review Criteria # 2 Response, #3 Evaluative Measures and #4 Impact This section of the narrative must include:

• A numbered list of the proposed goals and objectives to be accomplished by your research node during the funding period that address the major network goals, activities and expectations described in this NOFO in Sections 1: Program Funding Opportunity Description and Section 2: Award Information. Objectives should be SMART (specific, measurable, attainable, realistic, and time-bound).

• Targets for each of the indicators listed in the table in the Purpose section of this

NOFO.

• A description of activities and steps to achieve each of the project goals.

• An implementation schedule/timeline for the activities presented in a succinct manner, with a brief listing of responsible staff, specific milestones, and expected outcomes.

• Although you are not required to submit a logic model with your application, you should review the PECARN logic model

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(http://www.pecarn.org/helpfulResources/documents/PECARN_Logic%20Model% 2008.08.18.pdf ). Goals and objectives should be consistent with this logic model.

Section III – Project Design: Methods and Evaluation –Corresponds to Section V’s Review Criteria # 2 Response, # 3 Evaluative Measures, and #4 Impact.

A. Methods:

• Provide detailed descriptions of the methodology for accomplishing each of the specific goals, objectives, and activities.

• Describe how the health providers and/or researchers will function in partnership with the network in terms of study origination, design, execution, and administration.

• Describe plans to ensure clear roles, effective communication, and quality assurance across the node.

• Describe how prehospital to hospital data linkages will be established, and whether you plan to participate in the PECARN ED data registry, including the availability of adequate IT support, data use agreements, data storage, and allocated expertise and agreements.

• Describe plans and processes for engaging stakeholders (ED providers, EMS agencies, and other providers across the EMS continuum) in order to broaden the scope of Network research.

• Describe the process for generating and reviewing research ideas generated by the Research Node.

• Describe how research findings will be disseminated and adopted into clinical practice across the EMS care continuum.

• Include two Research Concepts as Attachment 3. A key aspect of successful participation in PECARN is the ability to generate research ideas and proposals.

To demonstrate the ability to generate such ideas, two concept proposals must be submitted. At least one of these proposals must describe knowledge translation project that tests effective mechanisms to spread uptake of new clinical evidence into widespread practice. One concept proposal should be for the prehospital setting. These concept proposals should be no more than two pages each in length and address the following; (1) The topic’s significance, including how results will be readily applicable to improving clinical care; (2) Specific objectives; (3) Methods (study design, statistical sampling frame, and plan for evaluation); and (4) Funding Plan (identify potential plans to attain extramural funding for research projects). Note: These concept proposals are a demonstration of ability only. Implementation of these ideas will need to follow applicable PECARN bylaws.

B. Evaluation:

• Describe a plan for monitoring and evaluation that includes monitoring nodal processes and the progress towards achieving the project’s goals and objectives.

This plan should also address the success of the RNC, HEDA sites, and EMS affiliate in enrolling patients in studies, contributing new research ideas to PECARN, writing grants to acquire extramural funding for specific PECARN studies, and timely publication of research findings.

http://www.pecarn.org/helpfulResources/documents/PECARN_Logic%20Model%2008.08.18.pdf http://www.pecarn.org/helpfulResources/documents/PECARN_Logic%20Model%2008.08.18.pdf

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• Discuss how the RNC will monitor HEDA and EMS affiliate site performance and include plans for assisting sites experiencing challenges or that do not meet performance targets.

• Describe potential problems and challenges that may arise in this project, and propose mechanisms for collaborative resolution among the Research Node participants.

Section IV – Capability of RNC, HEDAs, and EMS Affiliate Sites –Corresponds to Section V’s Review Criteria #2 Response and #5 Resources/Capabilities

A significant portion of the review criteria is focused on the ability to demonstrate historic success with conducting pediatric emergency medicine research and enrolling patients in interventional and observational studies. Applications must address the following:

• Document previous experience and demonstrable success in pediatric emergency care research and in enrolling patients in the ED and prehospital EMS settings in both randomized intervention trials and observational studies.

• Describe the availability of necessary infrastructure and staff with relevant experience to support both ED and prehospital research.

• Include letters of commitment from participating HEDAs and EMS Affiliates (Attachment 1)

• Include notation of access to an Institutional Review Board (IRB) or a Central IRB and experience with exemptions from informed consent. Describe procedures for obtaining IRB approval for PECARN research protocols.

Include specific information on the frequency of IRB meetings and typical review times for study protocols at each HEDA site. Historical information for the amount of time needed to obtain IRB approval for the studies described above should be included.

• Highlight experience establishing electronic data collection system and data linkages for prehospital and hospital systems and with providing data to an ED Data Registry.

• For EMS affiliates, describe involvement of EMS affiliate leadership and the Medical Director in this collaboration. A Letter of Support should be included.

• Describe the proposed catchment areas covered by the HEDAs and the EMS affiliates. Explain how they will support research focused on improving care and outcomes across the EMS care continuum.

• Provide additional demographic data for the sites as described below:

Category 1: The following information must be included for each HEDA site:

1) Total number of pediatric ED visits at the HEDA site.

2) Characteristics of pediatric ED visits (demographics, percent trauma versus medical and other available statistics such as types of conditions).

3) Structure of each HEDA site that facilitates ED research (for example, resources available at the site such as electronic health records, presence of trained research personnel, trauma center designation, etc. that create a conducive environment to conduct research).

4) List of ED-based studies that the HEDA site has participated in during the past 5 years that enrolled pediatric patients. For each study, provide a table that includes the following information:

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a. Brief description of the study including study type (interventional versus observational);

b. Number of patients enrolled at the HEDA site. For multi-center studies:

Percent of patients enrolled at the HEDA site (i.e., number of patients enrolled at the site divided by total patients enrolled across all sites).

5) Qualifications and experience of the HEDA PI (including the RNC PI if he/she is serving as the HEDA PI). The following specific items should be included (can be included in the biosketches- Attachment 2):

a. Major publications of the HEDA PI that involved a pediatric emergency medicine research study. Highlight noteworthy publications.

b. Noteworthy grants/contracts obtained by the HEDA PI to conduct pediatric emergency medicine studies.

Category 1 and Category 2: The following information must be included for each EMS affiliate site:

1) EMS agency demographics (total population served, total population under age

21, square miles in catchment area, number of annual EMS calls, number and percent of annual pediatric calls, types of conditions, highest level of care, number of paramedics).

2) Structure of each EMS affiliate site that facilitates EMS research.

3) List of EMS-based studies that the site has participated in during the past 5 years that enrolled pediatric patients. For each study, provide a table that includes the following information:

a. Brief description of the study including study type;

b. Number of patients enrolled at the EMS site. For multi-center studies, include percent of total patients enrolled at the EMS site (i.e., number of patients enrolled at the site divided by total patients enrolled across all sites).

4) Involvement in data collection and analysis (including activities related to quality improvement as well as research studies).

5) Qualifications and experience of the EMS affiliate scientific advisor (Category

1) or EMS Affiliate PI (Category 2), including major publications or grants to conduct pediatric emergency care research.

Section V: – Organizational Information–Corresponds to Section V’s Review Criterion # 5 Resources/Capabilities

• Provide a description of the organizational plan for management of the project, including an explanation of the roles and responsibilities of project personnel, project collaborators, and consultants.

• Include an organizational chart (Attachment 4) that describes the functional structure of the Research Node Center, HEDAs, and EMS affiliate personnel.

• Describe the Research Node operation and the relationship between the research, clinical practices, and administrative functional units within the…