PKG00258262-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Office of Rural Health Policy

Telehealth Focused Rural Health Research Center Program

Funding Opportunity Number: HRSA-20-023

Funding Opportunity Types: New, Competing Continuation Assistance Listings (CFDA) Number: 93.155

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2020

Application Due Date: May 1, 2020

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

HRSA will not approve deadline extensions for lack of registration.

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

Issuance Date: February 11, 2020

Jennifer Burges Research Coordinator, Federal Office of Rural Health Policy Telephone: (301) 945-3985 Email: jburges@hrsa.gov

Authority: Social Security Act, Title VII, §711(b) (42 U.S.C. 912(b)), as amended.

mailto:jburges@hrsa.gov

HRSA-20-023 i

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for fiscal year (FY) 2020 Telehealth Focused Rural Health Research Center Program (TF RHRC Program). The purpose of this program is to conduct and maintain a thorough and comprehensive evaluation of nationwide telehealth investments in rural areas and populations and conduct clinically informed and policy-relevant research to expand the evidence base for rural telehealth services.

Funding Opportunity Title: Telehealth Focused Rural Health

Research Center Program

Funding Opportunity Number: HRSA-20-023 Due Date for Applications: May 1, 2020 Anticipated Total Annual Available FY 2020 Funding:

$1,900,000

Estimated Number and Type of Award: Up to two cooperative agreements:

one for an evidence-focused research center and one for an evaluation-focused research center

Estimated Award Amount: Up to $950,000 per year subject to the availability of appropriated funds

Cost Sharing/Match Required: No Period of Performance: September 1, 2020 through August 31, 2024 (4 years) Eligible Applicants: Eligible applicants include public and nonprofit entities. Faith-based and community-based organizations, tribes, and tribal organizations are eligible to apply.

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

Application Guide

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

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

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Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Friday, February 28, 2020 Time: 1 – 2 p.m. ET Call-In Number: 1-888-324-8125 Participant Code: 4438375 Weblink: https://hrsa.connectsolutions.com/trcp/ Playback Number: 1-800-685-7910 Passcode: 22820 https://hrsa.connectsolutions.com/trcp/

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Justification Narrative

v. 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

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

HRSA-20-023 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Telehealth Focused Rural Health Research Center (TF RHRC) Program. This NOFO will fund two Telehealth Focused Rural Health Research Centers, one evaluation-focused and one evidence-focused.

The purpose of the evaluation-focused TF RHRC is to conduct and maintain a thorough and comprehensive evaluation of nationwide telehealth investments in rural areas and populations. This comprehensive evaluation will explore the impact of telehealth investments on rural areas and populations, to include an assessment of access, cost, experience, and effectiveness for patients and providers. This research will assist decision-makers at the federal, state and local levels by examining the impact of investments of telehealth services in rural communities on access to health care, population health/health indicators, health care spending (both for payers and for the patients receiving the services), quality of care, value based care, workforce, business strategy, and clinical delivery of care. By evaluating the impact of investments in rural telehealth services, the evaluation-focused TF RHRC will directly inform improvements in health care access and population health for rural America.

The purpose of the evidence-focused TF RHRC is to conduct clinically informed and policy-relevant health services research to expand the evidence base for rural telehealth services. This research will assist rural health providers and decision-makers at the federal, state and local levels by examining the impact of telehealth services in rural communities on access to health care, population health/health indicators, health care spending (both for payers and for the patients receiving the services), quality of care, value based care, and clinical delivery of care. The research may also assess the comparative effectiveness of specific telehealth services relative to in-person services in the same clinical area, examine the impact of health care policies on the provision of telehealth services, and analyze the cost effectiveness of telehealth services. Potential areas of interest include tele-emergency services, tele-behavioral health services (including substance use treatment services), and remote patient monitoring. By contributing to the evidence base for rural telehealth services, this evidence-focused TF RHRC will directly inform improvements in health care access and population health for rural America.

The recipients will conduct policy-oriented health services research, update trend analyses and existing research, and conduct necessary literature reviews on rural issues and synthesize the issues into publically available policy briefs that are easy to understand by a non-technical audience. In addition to primary and secondary research, the applicant must be willing and able to conduct literature syntheses, develop evaluation or performance measures, and update existing research to produce timely and relevant information. The Federal Office of Rural Health Policy (FORHP) and the recipients will negotiate the ratio of original research to other needed projects.

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The Agency for Healthcare Research and Quality (AHRQ) defines the term “health services research” as research that examines “how people get access to health care, how much care costs, and what happens to patients as a result of this care.” The main goals of health services research are to “identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors, and improve patient safety.”1

The TF RHRC Program provides support for two (2) four-year research centers with a concentration on telehealth (one with a focus on evidence and one with a focus on evaluation) specifically to provide infrastructure to support telehealth services researchers as they explore the complexities of telehealth issues. Research funded under these cooperative agreements will be publically available on the Rural Health Research Gateway https://www.ruralhealthresearch.org/).

These cooperative agreements do not support biomedical research or the delivery of health care services.

2. Background

This program is authorized by Section 711(b) of the Social Security Act (42 U.S.C.

912(b)), as amended. The Health Resources and Services Administration’s (HRSA’s) FORHP is the focal point for rural health activities within the Department of Health and Human Services (HHS). FORHP is statutorily required to advise the Secretary on the effects of current policies and proposed statutory, regulatory, administrative and budgetary changes in Medicare and Medicaid programs on the financial viability of small rural hospitals; the ability of rural areas to attract and retain physicians and other health professions; and access to and the quality of health care in rural areas. For additional information about FORHP, please see http://www.hrsa.gov/ruralhealth/index.html.

Located within FORHP is the Office for the Advancement of Telehealth (OAT), which promotes the use of telehealth technologies for health care delivery, education, and health information services. Telehealth is especially critical in rural and other remote areas that lack sufficient health care services, including specialty care. For additional information about OAT, please see https://www.hrsa.gov/rural-health/telehealth/index.html.

FORHP accomplishes its mission through a broad range of policy and program activities. The TF RHRC program focuses on informing FORHP’s policy role and programmatic areas with a nation-wide evidence base to inform policy and programs for telehealth. This includes informing the development of OAT’s programs, such as the Telehealth Network Grant Program. Policy-relevant research is useful because it enhances knowledge about rural health and rural health services, including telehealth services. In addition, telehealth focused rural health services research addresses critical concerns facing rural communities in their efforts to secure adequate, affordable, and high-quality health services. Research findings inform a wide audience of national, 1 Agency for Healthcare Research and Quality. What is Health Services Research? Agency for Healthcare Research and Quality, 2002. [Online] http://www.hrsa.gov/ruralhealth/index.html https://www.hrsa.gov/rural-health/telehealth/index.html https://www.hrsa.gov/rural-health/telehealth/index.html

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state, and local decision-makers about the health issues in rural communities and are instrumental in bridging gaps between policy and program needs.

II. Award Information

1. Type of Application and Award

Types of applications sought: New, Competing Continuation

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

HRSA program involvement will include:

• Participating in the planning and development of the TF RHRC’s annual research portfolio and the final selection of projects (typically 4-5 per year);

• Reviewing/commenting on the TF RHRC’s project design and methodology in the research proposals;

• Reviewing the TF RHRC’s products including the methodology, analysis, results, policy implications, format and tone prior to public dissemination;

• Participating, as appropriate, in the planning and implementation of any meetings, training activities or workgroups conducted during the period of performance; and

• Providing consultation with the TF RHRC to design dissemination strategies of its projects and findings to multiple audiences interested in rural health issues in the form of policy briefs, journal manuscripts, chart books, presentations to policy makers, responses to health policy programs and experts, and presentations at national, state, and regional conferences.

The cooperative agreement recipient’s responsibilities will include:

• Adherence to HRSA guidelines pertaining to acknowledgement and disclaimer on all products produced by HRSA award funds;

• Adherence to Section 508 of the Rehabilitation Act of 1973, as amended;

• Participating in the planning and development of the TF RHRC’s annual research portfolio and the final selection of research projects;

• Responding to FORHP requests (including execution of short-term qualitative or quantitative analyses to assist in informing emerging policy questions), comments and questions within a timely manner;

• Coordinating and providing regular updates on research progress and/or preliminary findings;

• Conducting policy-relevant health services research on telehealth issues and synthesizing the results into reports easily understood by a non-technical policy audience;

• Updating preexisting research that has become outdated where advised by

FORHP;

• Conducting literature reviews and syntheses when advised by FORHP;

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• Sharing research findings (e.g., policy briefs, chart books, etc.) for FORHP review by work plan guidelines;

• Submission of all finalized research findings to the Rural Health Research Gateway; (https://www.ruralhealthresearch.org/) and TF RHRC websites for publication;

• Designing and implementing dissemination strategies of the TF RHRC’s research results to multiple audiences interested in rural health issues in the form of policy briefs, journal manuscripts, presentations to policy makers, responses to health policy programs and experts, and presentations at national, state, and regional conferences; and

• Attending and presenting research at annual Rural Health Research Center (RHRC) meetings, including in fall 2020.

2. Summary of Funding

HRSA expects approximately $1,900,000 to be available annually to fund two recipients. You may apply for a ceiling amount of up to $950,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The period of performance is September 1, 2020 through August 31, 2024 (4 years). Funding beyond the first year is subject to the availability of appropriated funds for the Telehealth Focused Rural Health Research Center Program (TF RHRC) 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 domestic public or private, non-profit entities. Domestic faith-based and community-based organizations, tribes, and tribal organizations are also eligible to apply.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

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

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

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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Applicants may only apply for one type of TF RHRC: evaluation-focused or evidence-focused. The applicant must specify the type of award for consideration on line 15 of the SF-424 and also state the type of award clearly in the Project Abstract.

NOTE: Multiple applications from an organization 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 Research and Related (R&R) workspace application package associated with this notice of funding opportunity (NOFO) following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

The NOFO is also known as “Instructions” on Grants.gov. You must provide your email address when reviewing or preparing the workspace application package in order to receive notifications including modifications and/or republications of the NOFO on Grants.gov before its closing date. Responding to an earlier version of a modified notice may result in a less competitive or ineligible application. Please note you are ultimately responsible for reviewing the For Applicants page for all information relevant to desired opportunities.

2. Content and Form of Application Submission

Section 4 of HRSA’s SF-424 R&R Application Guide provides instructions for the budget, budget justification, staffing plan and personnel requirements, assurances, certifications, and abstract. You must submit the information outlined in the R&R Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 R&R Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the SF-424 R&R Application Guide for the Application Completeness Checklist.

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

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Application Page Limit The total size of all uploaded files may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments including biographical sketches (biosketches), and letters of commitment and support required in HRSA’s SF-424 R&R Application Guide and this NOFO.

Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Biographical sketches do count in the page limitation.

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

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

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachment 6: Other Relevant Documents.

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

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 R&R Application Guide (including the budget, budget justification, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract See Section 4.1.ix of HRSA’s SF-424 R&R Application Guide. The project abstract must be single-spaced and limited to one page in length. In addition to the requirements in the application guide, applicants must designate whether they are applying for the evaluation-focused TF RHRC or the evidence-focused TF

RHRC.

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

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

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

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INTRODUCTION -- Corresponds to Section V’s Review Criteria 1 (Need) Describe the current and emerging national health policy trends that can affect the provision of telehealth services in rural communities and describe how policy-relevant telehealth research aligns with FORHP’s charge as specified in Section 711 of the Social Security Act.2 Describe the unique dynamics affecting rural populations compared to urban populations from the patient, provider and payer perspectives.

NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criteria 1 (Need) Describe the gaps in the research/evidence base for, or evaluations of, rural telehealth services that this funding opportunity can address. Explain how your proposed research and/or evaluation studies satisfy the need for a nationwide evaluation of telehealth services or will expand the telehealth evidence base and inform rural health policy, particularly as it relates to FORHP’s Section 711 charge.

METHODOLOGY -- Corresponds to Section V’s Review Criteria 2 (Response) and 4 (Impact) This section you must provide specific information about five proposed research projects for the first budget period (September 1, 2020 to August 31, 2021). It is expected that all research products proposed for the first year will be completed within the 12 month budget period. The proposed projects must align with FORHP’s Section 711 charge and either address (aligning with the type of TF RHRC you are applying for) the approach to a comprehensive nationwide evaluation of telehealth investments in rural areas or contribute to the existing evidence base of policy-relevant telehealth research and address the Purpose described on page 1. The evaluation TF RHRC should describe how the proposed individual research projects will build on each other to produce a comprehensive evaluation of nationwide telehealth investments.

FORHP acknowledges that some research topics in telehealth may face challenges in terms of assessing comparative clinical effectiveness (e.g., identifying relevant comparison populations). This may limit the scope of some studies to particular states where data exist to conduct these types of studies (i.e., states where Medicaid covers telehealth services) or specific populations (i.e., Medicare population).

Present five research proposals using the format outlined below. Limit each research proposal to a maximum of six pages.

Proposal Summary

a. Project title

b. Principal Investigator information (name, degree, telephone number, email address)

c. Two sentence project description

2 https://www.ssa.gov/OP_Home/ssact/title07/0711.htm

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Research Proposal

a. Project title

b. Statement of the problem/issue and policy relevance:

Clearly state the purpose of the research or evaluation. Identify the gaps in existing knowledge that the research is intended to fill. State the relevance of the research and its implications for rural health policy from the perspectives of national, state and local stakeholders and policy makers.

c. Geographic Coverage:

Describe the geographic coverage and any sub-populations of focus for the research and assess how generalizable the results will be for informing policy-making. Indicate how you will define rurality.

d. Hypotheses, Design/Methods and Analysis:

State the hypothesis(es) or research/evaluation questions for the research project. Thoroughly describe the project design you will use to accomplish the specific aims of the proposed study (quantitative or mixed methods). All studies should have some quantitative component and qualitative work should not be the foundation for a study. Include a discussion of any anticipated limitations of the study design.

e. Data Sources:

Identify and describe the data sources. Include information on data availability, acquisition cost, and a time schedule for obtaining and preparing the data for analysis. If you are proposing to use primary data discuss the data collection plan including sampling methods, sample size estimates, expected response rate, etc. It is the responsibility of the applicant to obtain reliable and accurate data, HRSA does not provide this.

f. Human Subjects Research:

i. Are human subjects involved? If you are planning activities involving human subjects at any time during the proposed research project, indicate YES even if the proposed project is exempt from Regulations for the Protection of Human Subjects. Indicate NO if you are not planning any activities involving human subjects and skip to the Staff Qualifications and Staff-loading Chart section of the NOFO.

ii. If the answer is YES, indicate if the Institutional Review Board (IRB) review is pending. Provide the approval date if you received IRB approval.

iii. If exempt from IRB approval, enter the exemption numbers and a short description corresponding to one or more of the exemption categories. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101(b) for a list of the six categories of research that qualify for exemption from coverage by the regulations as defined in the Common Rule for the Protection of Human Subjects.

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101(b)

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iv. For the Human Subject Assurance Number provide the IRB approval number or the approved Federal Wide Assurance (FWA), Multiple Project Assurance (MPA), Single Project Assurance (SPA) or Cooperative Project Assurance Number (CPA) that the applicant has on file with the Office of Human Research Protections, if available.

v. If you have not yet been reviewed by IRB and you believe your research is exempt, provide a justification for the exemption(s) with sufficient information about involvement of human subjects to allow a tentative conclusion by HRSA staff that the claimed exemption(s) seems appropriate.

NOTE: Non-exempt research involving human subjects cannot be conducted under a HHS-sponsored award unless your organization provides verification of the justification of the exemption per HHS regulations. Documentation of IRB review when it is completed and its exemption or approval must be sent to the Project Officer. This IRB certification must include the grant number, the title of the project, name of the appropriate IRB that has reviewed and exempted or approved the proposed activity, name of the principal investigator/program director, date of IRB exemption or approval, and appropriate signatures.

g. Staff-loading Chart:

Identify the project leader and other senior staff involvement. Include a Staff-loading Chart that presents the number of hours devoted to the project for each staff member and the total number of hours for each activity (e.g., data cleaning, mapping, analysis). Indicate the relevant expertise and experience of the staff.

h. Timetable:

Provide a schedule for the project work. Deliverable due dates for each project should be included. Gantt charts are not necessary. Dates should reflect time required for data acquisition, IRB approval, etc.

i. Literature Citations:

Provide citations to published literature relevant to this proposal.

Additional Considerations and Requirements:

Post award, projects will be defined collaboratively between the successful applicants and HRSA. This process may include additional input from HRSA on alternative proposals and/or suggested proposal modifications depending on policy needs at that time and/or emerging HRSA/HHS priorities.

You must avoid duplication with research that is already underway or recently completed by querying the Rural Health Research Gateway. Competing continuation applicants must propose research projects that are not duplicative of past projects but they may propose projects that build on or update previously funded work. Post award, the successful applicant will work with FORHP to ensure that work is not duplicative of work conducted by the Telehealth Resource Centers, the Center for Connected Health Policy, the Telehealth Centers of Excellence, or through other federally-supported initiatives.

https://www.ruralhealthresearch.org/ https://www.telehealthresourcecenter.org/ https://www.telehealthresourcecenter.org/ https://www.cchpca.org/ https://www.hrsa.gov/library/forhp?page=1 https://www.hrsa.gov/library/forhp?page=1

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WORK PLAN -- Corresponds to Section V’s Review Criteria 2 (Response) and 4

(Impact) Describe the activities or steps proposed to complete the research and dissemination plan. This discussion must include the following:

1. Explanation of quality control processes, including data quality and the quality of the written products produced under this cooperative agreement.

Including plan to comply with the Section 508 of the Rehabilitation Act of 1973, as amended.

2. Project management plan that will ensure each funded activity stays on track throughout the first 12 month budget period.

3. A general work plan for budget periods two through four. This SHOULD NOT include specific research projects that will be conducted during those years but should highlight activities that will span all four years of the period of performance.

4. Plan for the Principal Investigator to review all draft reports to assure their policy-relevance, quality and readability.

5. Plan for disseminating the research findings (e.g., policy briefs) produced under this cooperative agreement. At minimum, this plan should include strategy to:

a. Develop and maintain a website dedicated to FORHP funded research that will house completed research projects.

b. Provide the Rural Health Research Gateway with links to completed research products housed on the TF RHRC’s individual website.

c. Alerting users to new research products through multiple channels of communication and targeting dissemination to State Offices of Rural Health, policy makers, and other relevant rural and telehealth stakeholders.

RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criteria 2 (Response) Discuss challenges (e.g., data authorization, accessibility, cost, etc.) that are likely to encounter in designing and implementing the research projects proposed in the Methodology section as well as activities described in the Work Plan. Explain the approaches that you will use to resolve these challenges. In particular, include a discussion about challenges and resolutions for primary data collection outside of your organization/your parent organization.

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EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to Section V’s Review Criteria 3 (Evaluative Measures) This section should include the following:

1. Your plan for reporting the number of times that each research or evaluation product posted on the TF RHRC’s website is accessed and/or downloaded as well as your plan to track journal citations, conference presentations and posters, speaking engagements (including webinars) and press inquiries/communications.

2. A detailed plan for notifying HRSA prior to any public release of data directly or indirectly funded by HRSA (for instance, a courtesy copy of manuscripts submitted to HRSA prior to journal acceptance, advance notice of a presentation at a conference and any accompanying slides or materials, etc.).

3. Your plan for measuring the broader impact of their research findings.

4. A tracking method that allows you to respond to an urgent HRSA request for data within a timely manner.

5. Your plan for self-monitoring progress on each of the research studies throughout each budget period.

FORHP will collect these measures annually within the Non-Competing Continuation Application as well as 30 days after the end of the program year.

This may not be a comprehensive list of all the necessary tracking measures, and additional elements may be included within the Notice of Award.

ORGANIZATIONAL INFORMATION -- Corresponds to Section V’s Review Criteria 5 (Resources/Capabilities) This section should describe your expertise and experience conducting clinically informed and policy-relevant health services research to expand the evidence base for rural telehealth services as well as your organization’s structure and staffing plan.

1. Organizational Structure of the Proposed TF RHRC

The proposed TF RHRC must be a single entity or a consortium of organizations with a primary entity responsible for research, supervision, administrative activities and overall management of federal funds. The TF RHRC must have its own identity including name, organizational structure, and dedicated website but may be located in a larger organizational entity. This discussion should include at minimum:

a. The identity of the proposed TF RHRC as an entity and its relationship to its parent organization (if applicable). If your proposed research center has multiple sites or is a consortium, you must provide this information for each component.

b. Relevant resources (e.g., personnel, computer facilities, dedicated office space, technical or analytic support) that will support the TF RHRC in conducting the proposed research or evaluation.

c. Description of the library of data sets currently maintained by the applicant that will support rural health research or evaluation, including information on the types of geo-codes on files for different definitions of rural. Indicate any plans for purchasing data sets to keep these libraries

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up to date. You must provide rural relevant examples (one example at the minimum) of demonstrated experience working with each data set listed. Additionally, you must provide proof that you have access to the geographic variables necessary to conduct rural/urban research or evaluation.

2. Staffing Plan and Personnel Requirements

You must present a staffing plan and provide a justification for that plan that includes education, experience qualifications, and rationale for time requested for each staff position. Staff of the TF RHRC must include:

a. Principal Investigator (i.e., the Project Director)

b. Deputy Principal Investigator (i.e., the Deputy Project Director)

c. Core Research Staff

d. Technical Writer/Editor

e. Project Manager

With the exception of the Principal Investigator and the Deputy Principal Investigator, multiple staff roles may be filled by the same person (i.e., a member of the core research staff can also fill the role of the project manager).

Include a Staff-loading Chart that presents the number of hours of FTE devoted to the proposed TF RHRC for each staff member and the total number of hours or FTE for all staff members (Attachment 1). You must provide position descriptions that include the roles, responsibilities (Attachment 2), and qualifications of proposed project staff (Attachment 3).

The principal investigator is expected to devote at least 25 percent of his or her time to the TF RHRC. The principal investigator leads the development and realization of the TF RHRC’s research portfolio and is the lead investigator on at least two of your proposed research projects. The principal investigator is responsible for the administrative aspects of the TF RHRC and reviewing all draft research products. The principal investigator should also have a substantial number of telehealth publications that focus on rural populations, a minimum of ten years of work experience specific to rural, policy relevant, telehealth focused health services research, and a doctoral degree.

Describe the following regarding the Principal Investigator: (Note: A co-principal investigator is not permitted)

a. Evidence of successfully managing a research or evaluation team as well as conducting and disseminating policy relevant telehealth focused health services research (including at least 8 years of work experience in telehealth focused health services research)

b. Experience informing/educating national, state, and community decision-makers about health and access issues for rural populations.

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The Deputy Principal Investigator is expected to devote at least 20 percent of his/her time to the proposed TF RHRC. Describe the following regarding the Deputy Principal Investigator:

a. Experience, including roles and responsibilities in organizational lines of authority, conducting and disseminating policy relevant rural health research or evaluation.

c. Experience informing/educating national, state, and community decision-makers about health and access issues for rural populations.

d. Process to assume the duties of the Principal Investigator when the Principal Investigator is on short-term (e.g., vacation) and extended (e.g., sabbatical) leave.

The core research staff should be multi-disciplinary and have the educational and professional experience necessary to conduct research proposed by the TF RHRC. This may include both social science (sociology, epidemiology, demography, economics, organizational behavior, statistics, public health, political science and/or geography) and clinical backgrounds. Describe the following:

a. How the disciplines of the core research or evaluation staff are related to the proposed work of the TF RHRC; and/or

b. The implementation and execution of a rural telehealth services research or evaluation project or the dissemination of policy-relevant research.

An editor or technical writer must also be included on staff whose main/partial responsibility should be to review drafts of studies prior to FORHP submission for review to ensure high quality. Identify this individual in the line item budget.

A project manager will be responsible for tracking the progress of each research project from inception to completion. The project manager should be able to provide information to FORHP staff on the status of each research project. This individual may also fill another role (i.e., Deputy Director or Administrative Assistant) in the proposed TF RHRC. Identify this individual in the line item budget.

3. Ability to Complete Research Projects in a Timely Manner You must demonstrate the capability (as evidenced by past performance) to conduct and disseminate complex, policy-relevant research studies in a 12-15 month period. You may demonstrate this past performance by describing work completed for any funder.

4. Ability to Collect and Validate Primary Data From Outside Your Organization

You must demonstrate the capability (as evidenced by past performance) to collect and validate primary data collected from entities outside of your organization/your parent organization (e.g., a cohort of HRSA award recipients or a cohort of rural hospitals). You may demonstrate this past performance by describing work completed for any funder.

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5. OPTIONAL: Expert Work Group The applicant may choose to appoint and convene an Expert Work Group (EWG) comprised of national and regional experts in its proposed area(s) of concentration. The EWG may meet with the RHRC virtually or in-person;

however, no more than $7,000 of the annual budget may be spent on this activity (including travel, per diem and honorarium). Note: The EWG is not a requirement. HRSA leaves it to the discretion of each applicant to decide whether or not an EWG will strengthen its products.

NARRATIVE GUIDANCE

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

Narrative Section Review Criteria Introduction (1) Need

Needs Assessment (1) Need

Methodology (2) Response and (4) Impact

Work Plan (2) Response and (4) Impact

Resolution of Challenges (2) Response

Evaluation and Technical Support Capacity

(3) Evaluative Measures

Organizational Information (5) Resources/Capabilities

Budget and Budget Narrative

(6) Support Requested – the budget section should include sufficient justification to allow reviewers to determine the reasonableness of the support requested.

iii. Budget See Section 4.1.iv of HRSA’s SF-424 R&R Application Guide. Please note: the directions offered in the SF-424 R&R Application Guide may differ from those offered by Grants.gov. Follow the instructions included in the R&R Application Guide and the additional budget instructions provided below. A budget that follows the R&R Application Guide will ensure that, if HRSA selects the application for funding, you will have a well-organized plan, and by carefully following the approved plan can avoid audit issues during the implementation phase.

Reminder: The Total Project or Program Costs are the total allowable costs (inclusive of direct and indirect costs) incurred by the recipient to carry out a -HRSA-supported project or activity. Total project or program costs include costs charged to the award and costs borne by the recipient to satisfy a matching or cost-sharing requirement, as applicable.

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In addition, the Telehealth Focused Rural Health Research Center Program requires the following:

The maximum yearly budget for a TF RHRC award is $950,000. After an award has been made, the final projects will be chosen in consultation with FORHP and may include emerging priorities from FORHP, HRSA, and HHS; award recipients will be required to revise and resubmit finalized budgets. FORHP will work collaboratively with successful applicants post award to address any potential budget issues that arise during the project proposal selection process. Successful applicants may be asked to submit individual budgets for each project proposal post award to aid in this process.

No more than $7,000 of an award recipient’s annual budget may be spent on the optional Expert Work Group (EWG), including travel, per diem and honorarium.

The Further Consolidated Appropriations Act, 2020 (P.L. 116-194), Division A, § 202 states, “None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II.” See Section 4.1.iv Budget – Salary Limitation of HRSA’s SF-424 Application Guide for additional information. Note that these or other salary limitations may apply in the following FY, as required by law.

iv. Budget Justification Narrative See Section 4.1.v of HRSA’s SF-424 R&R Application Guide.

v. Attachments Provide the following items in the order specified below to complete the content of the application. Unless otherwise noted, attachments count toward the application page limit. Indirect cost rate agreements and proof of non-profit status (if applicable) will not count toward the page limit. You must clearly label each attachment.

Attachment 1: Staffing Plan (Staff-loading Chart) (see Section 4.1.vi. of HRSA’s SF- 424 R&R Application Guide)

Attachment 2: Position Descriptions (see Section 4.1.vi. of HRSA’s SF-424 R&R Application Guide)

Attachment 3: Biographical Sketches (see Section 4.1.vi. of HRSA’s SF-424 R&R Application Guide)

Biographical sketches should include the following information: name, position title, education/training, personal statement, positions/honors, contributions to science, and additional research support. In the personal statement you may wish to briefly describe why you are well-suited for your role(s) in this project.

Relevant factors may include: aspects of your training; your previous work on this specific topic or related topics; your technical expertise; and/or your past performance in this or related fields. In the contributions to science you may wish to briefly describe up to three of your most significant contributions to science. In the additional research support you may wish to list ongoing and completed 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/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf

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research projects from the past four years that you want to draw attention to describing the overall goals of the projects and your responsibilities. The biographical sketches should not exceed two pages in length.

Attachment 4: Letters of Agreement, Memoranda of Understanding, and/or Description(s) of Proposed/Existing Contracts (project-specific)

Provide any documents that describe working relationships between your organization and other entities and programs cited in the proposal. Documents that confirm actual or pending contractual or other agreements should clearly describe the roles of the contractors and any deliverable. Make sure any letters of agreement are signed and dated.

Attachment 5: List of Published Journal Articles, Briefs, and Presentations Authored/Co-Authored by the Principal Investigator, Deputy Principal Investigator, and Key Personnel

Include all rural-relevant briefs, peer-reviewed journal articles, and other written materials and presentations at national, state, and regional conferences. For published materials include the full citation. For presentations include author(s), title, conference name, and date.

Attachments 6-15: Other Relevant Documents

Include here any other documents that are relevant to the application, including letters of support. Letters of support must be dated and specifically indicate a commitment to the project/program (e.g., in-kind services, dollars, staff, space, equipment, etc.).

3. Dun and Bradstreet Data Universal Numbering System (DUNS) Number and System for Award Management

You must obtain a valid DUNS number, also known as the Unique Entity Identifier, for your organization/agency and provide that number in the application. You must also register with the System for Award Management (SAM) and continue to maintain active SAM registration with current information at all times during which you have an active federal award or an application or plan under consideration by an agency (unless the applicant is an individual or federal agency that is exempted from those requirements under 2 CFR § 25.110(b) or (c), or has an exception approved by the agency under 2 CFR § 25.110(d)).

HRSA may not make an award to an applicant until the applicant has complied with all applicable DUNS and SAM requirements and, if an applicant has not fully complied with the requirements by the time HRSA is ready to make an award, HRSA may determine that the applicant is not qualified to receive an award and use that determination as the basis for making an award to another applicant.

If you have already completed Grants.gov registration for HRSA or another federal agency, confirm that it is still active and that the Authorized Organization Representative (AOR) has been approved.

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The Grants.gov registration process requires information in three separate systems:

• Dun and Bradstreet (http://www.dnb.com/duns-number.html)

• System for Award Management (SAM) (https://www.sam.gov)

• Grants.gov (http://www.grants.gov/)

For further details, see Section 3.1 of HRSA’s SF-424 R&R Application Guide.

SAM.GOV ALERT: For your SAM.gov registration, you must submit a notarized letter appointing the authorized Entity Administrator. The review process changed for the Federal Assistance community on June 11, 2018.

In accordance with the Federal Government’s efforts to reduce reporting burden for recipients of federal financial assistance, the general certification and representation requirements contained in the Standard Form 424B (SF-424B) – Assurances – Non- Construction Programs, and the Standard Form 424D (SF-424D) – Assurances – Construction Programs, have been standardized federal-wide. Effective January 1, 2020, the updated common certification and representation requirements will be stored and maintained within SAM. Organizations or individuals applying for federal financial assistance as of January 1, 2020, must validate the federally required common certifications and representations annually through SAM located at SAM.gov.

If you fail to allow ample time to complete registration with SAM or Grants.gov, you will not be eligible for a deadline extension or waiver of the electronic submission requirement.

4. Submission Dates and Times

Application Due Date The due date for applications under this NOFO is May 1, 2020 at 11:59 p.m.ET. HRSA suggests submitting applications to Grants.gov at least 3 calendar days before the deadline to allow for any unforeseen circumstances. See Section 8.2.5 – Summary of emails from Grants.gov of HRSA’s SF-424 R&R Application Guide for additional information.

5. Intergovernmental Review

The Telehealth Focused Rural Health Research Center Program is subject to the provisions of Executive Order 12372, as implemented by 45 CFR part 100.

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

http://www.dnb.com/duns-number.html https://www.sam.gov/ http://www.grants.gov/ http://www.hrsa.gov/grants/apply/applicationguide/sf424rrguidev2.pdf http://sam.gov/ https://www.fsd.gov/fsd-gov/answer.do?sysparm_kbid=d2e67885db0d5f00b3257d321f96194b&sysparm_search=kb0013183 https://www.sam.gov/

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6. Funding Restrictions

You may…