hrsa-25-044 and hrsa-25-045_final.pdf

Office for the Advancement of Telehealth (OAT)

Notice of Funding Opportunity

Application due April 15, 2025

Telehealth Rapid Response Center (HRSA-25-044) and Telehealth Research Center (HRSA-25-045) Opportunity number: HRSA-25-044 and HRSA-25-045

Modified on 1/28/25

Updated TA Webinar information

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic Information 5

Eligibility 7

Program description 9

Award information 12

Step 2: Get Ready to Apply 16

Get registered 17

Find the application package 17

Application writing help 17

Step 3: Prepare Your Application 19

Application contents and format 20

Step 4: Learn About Review and Award 39

Application Review 40

Selection process 49

Award notices 49

Step 5: Submit Your Application 50

Application submission and deadlines 51

Application checklist 53

Step 6: Learn What Happens After Award 55

Post-award requirements and administration 56

Contacts and Support 60

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks)

You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days)

You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date

Applications are due by 11:59 p.m. Eastern Time on April 15, 2025.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

Jump to a step

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic Information 5

Eligibility 7

Program description 9

Award information 12

Basic Information Health Resources and Services Administration (HRSA)

Office for the Advancement of Telehealth (OAT)

Policy and Research Team

Have questions?

Go to Contacts and Support.

Key facts Opportunity name:

Telehealth Rapid Response Center (HRSA-25-044) and Telehealth Research Center

(HRSA-25-045)

Opportunity number:

HRSA-25-044 and

HRSA-25-045

Announcement version:

Modification #1

Federal Assistance Listing Number: 93.211

Statutory authority:

42 U.S.C. § 254c -14 (§ 330I of the Public Health Service Act)

Key dates NOFO issue date: January 17, 2025

Informational webinar:

See Webinar Section

Application deadline: April 15, 2025

Expected award date is by:

August 1, 2025

Expected start date:

September 1, 2025

See other submissions for other time frames that may apply to this NOFO.

Summary The Health Resources and Services Administration (HRSA) is accepting FY2025 applications for the Telehealth Rapid Response Center (HRSA-25-044) and the Telehealth Research Center (HRSA-25-045).

This funding opportunity aims to support activities to expand the evidence base to inform policy and programs for telehealth services in underserved populations in the United States.

The two announcements under this funding opportunity are as follows:

• The Telehealth Rapid Response Center (HRSA-25-044) will conduct rapid telehealth data analyses and short-term, issue-specific telehealth research studies to provide stakeholders and the public with resources to understand the impact of telehealth policies and regulations. It will also provide information to improve telehealth access for underserved populations in the United States.

• The Telehealth Research Center (HRSA-25-045) will conduct clinically informed and policy-relevant health services research to expand the evidence base for telehealth services.

Funding details Application types: New, Competing Continuation

Expected total available funding in FY2025:

• $950,000 for HRSA-25-044

• $950,000 for HRSA-25-045

Expected number and type of awards: 1 cooperative agreement per funding announcement.

Funding range per award:

• $950,000 cooperative agreement for HRSA-25-044

• $950,000 cooperative agreement for HRSA-25-045

We plan to fund awards in five 12-month budget periods for a total 5-year period of performance from September 1, 2025, to August 31, 2030.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 5 https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&req=granuleid%3AUSC-prelim-title42-section254c-14&f=treesort&num=0&saved=%7CKHRpdGxlOjQyIHNlY3Rpb246MjU0YyBlZGl0aW9uOnByZWxpbSkgT1IgKGdyYW51bGVpZDpVU0MtcHJlbGltLXRpdGxlNDItc2VjdGlvbjI1NGMp%7CdHJlZXNvcnQ%3D%7C%7C0%7Cfalse%7Cprelim

The program and awards depend on the appropriation of funds and are subject to change based on the availability and amount of appropriations. This NOFO is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately. You should note that this NOFO may be modified based on the availability and amount of appropriations.

Step 1: Review the Opportunity 6

Eligibility Who can apply All domestic* public or private, non-profit, and for-profit entities are eligible to apply.

Types of eligible organizations These types of domestic* organizations may apply:

• Public institutions of higher education

• Private institutions of higher education

• Non-profits with or without a 501(c)(3) IRS status

• For-profit organizations, including small businesses

• State, county, city, township, and special district governments, including the District of Columbia, domestic territories, and freely associated states

• Independent school districts

• Native American tribal governments

• Native American tribal organizations

*“Domestic” means the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

Individuals are not eligible applicants under this NOFO.

Completeness and responsiveness criteria We will review your application to make sure it meets these basic requirements to move forward in the competition.

We will not consider an application that:

• Is from an organization that does not meet all eligibility criteria.

• Requests funding above the award ceiling shown in the funding range.

• Is submitted after the deadline.

Application limits You may not submit more than one application per announcement number. If you submit more than one application per announcement number, we will only accept the last on-time submission.

Step 1: Review the Opportunity 7

Cost sharing This program has no cost-sharing requirement. If you choose to share in the costs of the project, we will not consider it during merit review. We will hold you accountable for any funds you add, including through reporting.

Step 1: Review the Opportunity 8

Program description Purpose This notice announces the opportunity to apply for funding for the Telehealth Rapid Response Center (HRSA-25-044) and the Telehealth Research Center (HRSA-25-045).

The purpose of this program is to fund research that expands the evidence base to inform policy and programs for telehealth services in underserved populations in the United States.

The research supported through this program will inform providers, policymakers, and telehealth stakeholders on the latest trends and data impacting telehealth disparities and access, telehealth providers, flexibilities for telehealth care, and continued services for telehealth utilization in various specialties and via different modalities.

We will award one cooperative agreement for each of the following opportunities:

• The Telehealth Rapid Response Center funded under HRSA-25-044 is responsible for conducting rapid data analyses and short-term issue-specific telehealth research studies. It will provide stakeholders and the public with resources to understand the impact of telehealth policies and regulations as well as provide information that will improve telehealth access to underserved populations in the United States.

• The Telehealth Research Center funded under HRSA-25-045 is responsible for conducting clinically informed and evidence-based research. The Telehealth Research Center plays a key role in helping to expand the evidence base for telehealth services and address gaps in knowledge for effectiveness, costs, and delivery, including the use of telehealth technology. This center will also conduct and maintain a comprehensive evaluation of nationwide telehealth investments in rural and underserved areas and populations. This research will help health providers and decision-makers at the local, state and federal levels by examining the impact of telehealth services in rural and underserved communities on access to health care, population health/health indicator, health care spending (both for payers and for the patients receiving the services), quality of care, value-based care, and clinical delivery of care.

You must apply to the correct opportunity number.

IMPORTANT: If you are applying for both opportunities, you must submit a separate application for each.

Step 1: Review the Opportunity 9

Background HRSA’s Office for the Advancement of Telehealth (OAT) supports the advancement of telehealth by improving access to quality health care through integrated telehealth services.

The office plays a key role in advising HRSA, the U.S. Department of Health and Human Services (HHS), policymakers, and other telehealth stakeholders on a range of telehealth topics. This effort includes managing Telehealth.hhs.gov on behalf of HHS and keeping it updated with the most relevant information and resources for stakeholders as telehealth becomes more integrated into health care.

This notice provides funding for recipients to respond to emerging topics as telehealth continues to evolve and promptly provide critical information to patients, providers, policymakers, researchers, and other stakeholders.

Program requirements and expectations Telehealth Rapid Response Center The Telehealth Rapid Response Center funded under HRSA-25-044 will:

• Produce at least 4 high-quality studies each award year on an expedited time frame (for example, 1 to 3 months) for current and emerging telehealth issues for various audiences, and that cannot be accommodated by the Telehealth Research Center.

• Have access to and maintain a repository of national data sets that include telehealth and telehealth-related variables, such as remote patient monitoring.

These datasets will be current, cleaned, and geocoded. They include, but are not limited to, HHS data from the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS) (for example, Medicare and Medicaid files), and HRSA, as well as health care professional association data sets. You will be expected to share access to data sources for any data used to produce final deliverables with your OAT project officer.

• Staff a rapid response data analysis team capable of responding, within 5 to 10 business days, to an estimated 1 to 2 data analysis requests per month from telehealth stakeholders. Compile, analyze, and evaluate data to enhance knowledge about the impact of national telehealth care policies.

• Share data analyses and short-term, issue-specific research briefs for HRSA review by work plan guidelines.

• Respond to the OAT Research Coordinator’s comments, questions, and requests within 5 to 10 business days.

Step 1: Review the Opportunity 10

• Design and implement strategies to distribute rapid response and issue-specific research products to multiple audiences interested in telehealth issues.

• Distribute research findings as a tool to inform the public, including national, state, and local policymakers, state-based entities, or individual safety-net health care providers. Dissemination products may include policy briefs, invited presentations, responses to inquiries from health policy programs and health policy researchers, webinars, presentations at national, regional, state, and local conferences, the telehealth.hhs.gov website, and other appropriate vehicles for sharing rigorous, policy-oriented research.

• Respond to other data requests to help telehealth stakeholders find and use existing research and analysis products. Requests may be a variety of products that may include short reports, memoranda, tables, or other products.

Telehealth Research Center The Telehealth Research Center funded under HRSA-25-045 will:

• Conduct five clinically informed and policy-relevant health services research projects, each over a 1-year period, to expand the evidence base for telehealth services in rural and underserved populations in the United States. Synthesize the results into reports or other work products developed for both technical and non-technical audiences.

• Assess the comparative effectiveness of specific telehealth services relative to in-person or hybrid 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.

• Publish the outcomes of telehealth research findings in peer-reviewed journals.

• Update preexisting research that has become outdated.

• Publish telehealth research findings in peer-reviewed journals.

Step 1: Review the Opportunity 11

Award information Cooperative agreement terms Our responsibilities Aside from monitoring and technical assistance, we also get involved in these ways:

• Make available experienced HRSA OAT personnel to support and provide consultation in the design, planning, development, or delivery of cooperative agreement activities and materials.

• Ensure cooperative agreement activities build upon progress, success, and lessons learned by providing access to materials and information from previous work in this area.

• Coordinate communication and develop linkages with personnel from other federally funded programs, HRSA, and other federal agencies as needed.

• Provide ongoing monitoring and review of the design, development, direction, or delivery of cooperative agreement activities, including procedures, evaluation measures, and quality improvement efforts for accomplishing the goals of the cooperative agreement.

• Review and provide guidance on cooperative agreement materials and activities.

• Review methods for evaluating the process and outcome of cooperative agreement activities and using findings to inform future work.

• Provide consultation and support the dissemination of cooperative agreement activities, progress, and results, like formal or informal presentations to internal and external stakeholders, presentations at national or regional conferences.

Dissemination products may include policy briefs, research briefs, invited presentations, responses to inquiries from health policy programs and health policy researchers, webinars, presentations at national, regional, state, and local conferences, and other appropriate vehicles for sharing rigorous, policy-oriented research.

• Consult in the planning and development of the recipient’s research portfolio.

• Review, and, if necessary, provide guidance on each plan and methodologies presented in the research proposals.

• Review work products, including each study’s methodology, analysis, results, policy implications, and format, before public dissemination.

Step 1: Review the Opportunity 12

• Participate, as appropriate, in meetings, training activities, or workgroups conducted during the project period.

• Host monthly calls with all of the key staff on the project.

Your responsibilities You must follow all relevant laws and policies. Your other responsibilities will include:

• Adherence to HRSA guidelines about the acknowledgment of and disclaimer on all products produced by HRSA award funds, per Section 5.1 of the R&R Application Guide (Acknowledgement of Federal Funding).

• Provide a conflict-of-interest statement (COI) disclosing any potential COI supported by a federal award and what measures will be taken to resolve the potential COI. Review HRSA’s COI policy.

• Establish and maintain effective working relationships with other HRSA-funded recipients, as well as with telehealth policy stakeholders.

• Participate in any requested meetings related to the planning and development of your research portfolio.

• Submit research study proposals with relevant timelines and milestones to the OAT Research Coordinator for review.

• Participate in the planning and development of the annual project portfolio.

• Submit work products (for example, abstracts, 2-page briefs, full policy briefs, reports, manuscripts, monographs and other items) for OAT review, within the time specified in the requests.

• Implement and maintain a publicly available website with information about current OAT projects funded under this cooperative agreement and completed work products. Your website must also include the acknowledgment and disclaimer information required on all products supported by HHS award funds.

• Attend and present at periodic HRSA and OAT Program meetings.

• Participate in monthly conference calls with OAT staff and periodically other stakeholders.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13 https://www.hrsa.gov/grants/standard-terms/conflict-interest-policy#recipient

Funding policies and limitations Policies

• We will only make awards if this program receives funding. If Congress appropriates funds for this purpose, we will move forward with the review and award process.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting the project’s objectives.

◦ A decision that continued funding is in the government’s best interest.

• If we receive more funding for this program, we may:

◦ Fund more applicants from the rank order list.

◦ Extend the period of performance.

◦ Award supplemental funding.

General limitations

• For guidance on some types of costs we do not allow or restrict, see Project

Budget Information in Section 3.1.4 of the R&R Application Guide. You can also see 45 CFR part 75, General Provisions for Selected Items of Cost.

• You cannot earn profit from the federal award. See 45 CFR 75.400(g).

• Congress’s current appropriations act includes a salary limitation, which applies to this program. As of January 2025, the salary rate limitation is $225,700. This limitation may be updated.

See Manage Your Grant for other information on costs and financial management.

Indirect costs Indirect costs are costs you charge across more than one project that cannot be easily separated by project. For example, this could include utilities for a building that supports multiple projects.

To charge indirect costs you can select one of two methods:

Method 1 — Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency.

Method 2 — De minimis rate. Per 2 CFR 200.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. If you choose

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 14 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=15 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75#75.400 https://www.hrsa.gov/grants/manage-your-grant https://www.ecfr.gov/current/title-2/section-200.414 this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is 15% of modified total direct costs (MTDC). See 2 CFR 200.1 for the definition of MTDC. You can use this rate indefinitely.

Program Income Program income is money earned as a result of your award-supported project activities. You must use those funds to add to approved project activities. Find more about program income at 45 CFR 75.307.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 15 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.307

Step 2:

Get Ready to Apply

In this step

Get registered 17

Find the application package 17

Application writing help 17

Get registered SAM.gov You must have an active account with SAM.gov to apply. This includes having a Unique Entity Identifier (UEI). SAM.gov registration can take several weeks. Begin that process today.

To register, go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist to find out what you’ll need to register.

When you register or update your SAM.gov registration, you must agree to the financial assistance general certifications and representations. You must agree to those for grants specifically, as opposed to contracts, because the two sets of agreements are different. You will have to maintain your registration throughout the life of any award.

Grants.gov You must also have an active account with Grants.gov. You can see step-by-step instructions at the Grants.gov Quick Start Guide for Applicants.

Find the application package The application package has all the forms you need to apply. You can find it online.

Go to Grants Search at Grants.gov and search for opportunity numbers HRSA-25-044 or

HRSA-25-045.

After you select the opportunity, we recommend that you click the Subscribe button to get updates.

Application writing help Visit HHS Tips for Preparing Grant Proposals.

Visit HRSA’s How to Prepare Your Application page for more guidance.

See Apply for a Grant for other help and resources.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 17 https://sam.gov/content/entity-registration https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/search-grants https://www.hhs.gov/grants-contracts/grants/get-ready-for-grants-management/tips-for-preparing-grant-proposals/index.html https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://www.hrsa.gov/grants/apply-for-a-grant

Join the webinar More information on this NOFO's webinar will be posted at a later date to the related documents tab here: HRSA-25-044 and HRSA-25-045.

We recommend you “Subscribe” to the NOFO on Grants.gov to receive updates when documents are posted.

The Webinar will be recorded.

Have questions? Go to Contacts and Support.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 18 https://www.grants.gov/search-results-detail/355859 https://www.grants.gov/search-results-detail/355860

Step 3:

Prepare Your Application

In this step

Application contents and format 20

Application contents and format Applications include five main components. This section includes guidance on each.

Application page limit: 60 pages

Submit your information in English and express budget figures using U.S. dollars.

Make sure you include each of these:

Components Submission format

Project abstract Use the Project Abstract Summary form

Project narrative Use the Research and Related Other Project Information form

Budget narrative Use the Research and Related Budget form

Attachments Enter each in the Attachments Form

Other required forms Upload using each required form

Required format You must format your narratives and attachments using our required formats for fonts, size, margins, etc. See the formatting guidelines in section 3.2 of the R&R Application Guide.

Project abstract Complete the information in the Project Abstract Summary form. Include a short description of your proposed project. Include the needs you plan to address, the proposed services, and the population groups you plan to serve. For more information, see section 3.1.2 of the R&R Application Guide.

Indicate the project title as either:

• “Telehealth Rapid Response Center HRSA-25-044” or

• “Telehealth Research Center HRSA-25-045”

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 20 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=1 https://www.hrsa.gov/sites/default/files/hrsa/grants/research-related-application-guide.pdf#page=1

Project narrative Use the Research and Related Other Project Information form to attach the project narrative.

In the project narrative, you will describe all aspects of your project. Project activities must comply with the nondiscrimination requirements.

Use the section headers and the order listed.

Introduction

• For HRSA-25-044 Telehealth Rapid Response Center, see merit review criterion 1:

Need

• For HRSA-25-045 Telehealth Research Center, see merit review criterion 1: Need

For both HRSA-25-044 and HRSA-25-045:

Briefly describe the purpose of your project.

Need

• For HRSA-25-044 Telehealth Rapid Response Center, see merit review criterion 1:

Need

• For HRSA-25-045 Telehealth Research Center, see merit review criterion 1: Need

For both HRSA-25-044 and HRSA-25-045:

• Describe current and emerging telehealth services and policy issues at the local, state, and federal levels. Use and cite demographic data from underserved and rural populations whenever possible.

• Describe the gaps in the research for telehealth services and policy for rural and underserved communities.

HRSA-25-044 Telehealth Rapid Response Center applicants should also:

• Discuss the need to assist health providers, policymakers, and other stakeholders by conducting rapid data analyses and research studies to understand the impact of current and proposed policies and regulations to provide information that will improve health care.

Step 3: Prepare Your Application 21

• Use and cite demographic data and publications using national datasets to support the information provided. This includes documents, briefs or publications from your organization or institute.

HRSA-25-045 Telehealth Research Center applicants should also:

• Demonstrate a strong understanding of the unique characteristics of rural/frontier communities, medically underserved people, historically marginalized groups/ individuals, and people with lower incomes from a health care service, payment, and provider point of view.

• Explain how your proposed clinically informed research will expand the telehealth evidence base to assist health providers and policymakers at the local, state, and federal levels to show the impact of telehealth services on rural and underserved communities, access to health care, population health/health indicators, health care spending, quality of care, value-based care, and clinical delivery of care.

• Use and cite demographic literature and peer-reviewed publications to support the information provided. This includes publications from your organization or institute.

Approach

• For HRSA-25-044 Telehealth Rapid Response Center, see merit review criterion 2:

Response

• For HRSA-25-045 Telehealth Research Center, see merit review criterion 2:

Response

For both HRSA-25-044 and HRSA-25-045:

• Tell us specific information about the proposed projects for the first budget year.

You should propose projects that would produce findings with a high likelihood of having meaningful applications that advance telehealth’s impact on health access and outcomes, and return on investment.

• As it makes sense, include strategies for sharing findings at conferences, webinars, or other events. Also, include strategies for outreach and collaboration efforts to involve stakeholders.

• Use this outline for research study proposals:

◦ Project title

◦ Principal investigator information (name and degree)

◦ Two-sentence project description

Step 3: Prepare Your Application 22

◦ Statement of the problem or 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 significance for telehealth policy and clinical outcomes from the perspectives of national, state, and local stakeholders and policymakers.

◦ Geographic coverage: Describe the geographic coverage and any subpopulations of focus for the research. Assess how generalizable the results will be for informing policymaking and telehealth access. Indicate how you will define rurality, if it applies.

◦ Overview of research questions: State the hypotheses or research and evaluation questions for the research project.

◦ Research design, outcomes, analysis: 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. Qualitative work should not be the foundation for a study.

Include a discussion of any anticipated limitations of the study design.

◦ Data sources: Identify and describe the data sources. 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 your responsibility to obtain reliable and accurate data. HRSA will not provide data.

◦ Human subjects research: 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-loading chart section.

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

▪ If exempt from IRB approval, enter the exemption numbers and a short description corresponding to one or more of the exemption categories.

See 45 CFR 46 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. 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 you have on file with the Office of Human Research Protections, if available.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 23 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101(b)

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

▪ Non-exempt research involving human subjects cannot be conducted under an 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, the name of the appropriate IRB that has reviewed and exempted or approved the proposed activity, the name of the principal investigator/program director, date of IRB exemption or approval, and appropriate signatures.

◦ 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 (such as data cleaning, mapping, analysis, and so on).

Indicate the relevant expertise and experience of the staff.

◦ Literature citations: Provide citations to published literature relevant to this proposal.

Telehealth Rapid Response Center HRSA-25-044 applicants should also:

• Provide a detailed explanation of your proposed approach to staff a rapid response data analysis team. This team should be capable of responding within 5 to 10 business days to an estimated one to two data analysis requests per month from telehealth stakeholders.

• Provide a detailed strategy that includes (but is not limited to):

◦ A description of your access to national datasets that include telehealth variables and are current, cleaned, and geocoded, with the ability to have a rural-urban comparison within the dataset.

◦ Your approach to maintain a repository of telehealth and telehealth policy-relevant datasets that are current, cleaned, and geocoded.

◦ A plan to provide the public with a vehicle for performing data analyses and interpretation related to time-sensitive and significant telehealth policy issues or questions to understand the impact of policies and regulations and to provide information to improve health care in underserved areas.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 24 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.101(b)

◦ A process to determine the feasibility of responding to telehealth stakeholders’ requests, including the feasibility of conducting the data analyses and the broader public benefit of conducting the analyses.

◦ A process for sharing the results of the analyses with the public on time and using existing research and analysis products produced under this cooperative agreement.

• Describe the detailed approach to conducting short-term issue-specific telehealth research studies you propose to conduct in the first budget year. Proposed projects should aim to produce policy-relevant briefs or reports with a high likelihood of being applied in meaningful ways to improve health care among underserved populations. These projects should aim to improve the understanding of the effects of current or proposed telehealth policy changes relating to telehealth flexibilities, reimbursement, licensure, prescribing controlled substances, and telehealth services for safety-net providers, such as Federally Qualified Health Centers, Rural Health Clinics, Critical Access Hospitals, Ryan White Clinics, Certified Community Behavioral Health Clinics.

• Present a minimum of 4 short-term research proposals using the format outlined.

Telehealth Research Center HRSA-25-045 applicants should also:

• Describe specific information about 5 telehealth-focused research projects for the first budget year.

• Include information on data availability, acquisition cost, and a schedule for obtaining and preparing the data for analysis.

• Your proposals should be national in scope. OAT acknowledges that some research topics in telehealth may be limited in scope to particular states or specific populations (such as Medicaid-focused studies or Medicare populations).

• Present 5 telehealth-focused research proposals using the format outlined. At a minimum, we expect one manuscript to be submitted to a peer-reviewed journal for each project. If you are a competing continuation applicant, you must propose research projects that are not duplicative of past projects — but you can propose projects that build on or update previously funded work.

Step 3: Prepare Your Application 25

High-level work plan

• For HRSA-25-044 Telehealth Rapid Response Center, see merit review criteria 2:

Response and criteria 4: Impact

• For HRSA-25-045 Telehealth Research Center, see merit review criteria 2:

Response and criteria 4: Impact

For both HRSA-25-044 and HRSA-25-045:

• Describe how you’ll successfully produce manuscripts, policy briefs, and other reports for the first year of performance.

• Provide a timeline that includes each activity and identifies who is responsible for each. Deliverable due dates for each project should be included. Gantt charts are not necessary.

• Include a plan to distribute reports, products, or project outputs to target audiences. You will be expected to coordinate with OAT regarding the process to distribute products.

• Develop and maintain a website dedicated to OAT-funded research that will house completed research projects.

• Plan to comply with Section 508 of the Rehabilitation Act of 1973, as amended.

• Include goals in the work plan for the entire proposed 5-year period of performance.

• Include your detailed work plan in your Attachments.

Telehealth Rapid Response Center HRSA-25-044 applicants should also:

• Plan for publicly distributing the results from any rapid response data analyses or issue-specific research studies. Products produced may be shared at telehealth.HHS.gov.

Telehealth Research Center HRSA-25-045 applicants should also:

• Consider the time required for data acquisition, IRB approval, etc. and reflect this in deliverable due dates.

• Plan for publicly distributing the research deliverables produced under this cooperative agreement. Publications will be shared at telehealth.HHS.gov.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 26 https://telehealth.hhs.gov/ https://telehealth.hhs.gov/

Resolving challenges

• For HRSA-25-044 Telehealth Rapid Response Center, see merit review criteria 2:

Response and criteria 4: Impact

• For HRSA-25-045 Telehealth Research Center, see merit review criteria 2:

Response and criteria 4: Impact

For both HRSA-25-044 and HRSA-25-045:

Discuss possible challenges you may face in designing and carrying out the activities in the Approach section and in your work plan. Explain how you’ll resolve them.

Performance reporting and evaluation

• For HRSA-25-044 Telehealth Rapid Response Center, see merit review criteria 3:

Performance reporting and evaluation

• For HRSA-25-045 Telehealth Research Center, see merit review criteria 3:

Performance reporting and evaluation

For both HRSA-25-044 and HRSA-25-045:

• Describe your plan for reporting the number of times that each research or rapid response product posted on the website is accessed or downloaded as well as your plan to track journal citations, conference presentations and posters, speaking engagements (including webinars), and press inquiries or communications. We will collect these measures annually.

• Describe how you will manage and securely store data.

• Describe quality control processes, including the quality of the written products produced under this cooperative agreement. This should include a plan for the principal investigator to review all draft reports to check their quality and readability.

• Describe your plan for self-monitoring progress on each of the research studies throughout each budget period.

• Explain how you will assess whether your distribution plan is effective, whether the results are national in scope, and the extent of potential replication.

Step 3: Prepare Your Application 27

Telehealth Research Center HRSA-25-045 applicants should also:

• Describe the evaluation capacity of your organization and staff to evaluate programs, including your relevant experience, skills, and knowledge. OAT may request program evaluation studies of telehealth investments in rural and underserved areas and populations. This comprehensive evaluation will explore the impact of telehealth investments on rural and underserved areas and populations, to include an assessment of access, cost, experience, and effectiveness for patients and providers. Evaluations must follow the HHS Evaluation Policy, as well as the standards and best practices described in OMB Memorandum M-20-12.

See Reporting for more information.

Organizational information

• For HRSA-25-044 Telehealth Rapid Response Center, see merit review criterion 5:

Resources and capabilities

• For HRSA-25-045 Telehealth Research Center, see merit review criterion 5:

Resources and capabilities

For both HRSA-25-044 and HRSA-25-045:

• Briefly describe your mission, structure, and the scope of your current activities.

Explain how they support your ability to carry out the program requirements. Use attachment 4 to include a project organization chart.

• Discuss how you’ll follow the approved plan, account for federal funds, and record all costs to avoid audit findings.

• Provide a conflict-of-interest statement (COI) disclosing any potential COI supported by a federal award and what measures will be taken to resolve the potential COI. View HRSA’s COI policy.

• Include a staffing plan and job descriptions for key faculty and staff in Attachment 2.

• Describe the organizations you will partner with to fulfill the program goals and meet the objectives. Include key agreements and letters of support in Attachment 3.

• Include biographical sketches for Senior and core staff using the Research & Related Senior/Key Person Profile form. See Other required forms.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 28 https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//200386/hhs-evaluation-policy.pdf https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//200386/hhs-evaluation-policy.pdf https://www.whitehouse.gov/wp-content/uploads/2020/03/M-20-12.pdf https://www.whitehouse.gov/wp-content/uploads/2020/03/M-20-12.pdf https://www.hrsa.gov/grants/standard-terms/conflict-interest-policy#recipient

Telehealth Rapid Response Center HRSA-25-044 applicants should also:

• Describe your expertise in responding to and conducting rapid response data analyses (5 to 10 business days) and short-term, issue-specific research studies.

• Demonstrate your program’s significant past experience conducting similar work (from any funder). Include specific examples of:

◦ Past publications or analyses that were national in scope and were completed in a 1-to-3-month period.

◦ Past rapid data analyses of complex national data sets that were completed in 5 to 10 business days.

◦ Communicating complex public telehealth policy issues and data analyses to varied audiences in ways that identify key telehealth access and reimbursement concerns.

• Demonstrate your organization’s access to and substantial experience working with large, national data sets, including, but not limited to, data from AHRQ, Census Bureau, CDC, CMS, HRSA, health care professional associations like the American Hospital Association, and so on.

• Describe the library of data sets you currently maintain that will support the request for rapid response telehealth data analysis.

• Include the following staff:

◦ Principal investigator (i.e., the project director)

◦ Deputy principal investigator (i.e., the deputy project director)

◦ Core data analysis team

◦ Core research team

◦ Technical writer/editor

◦ Project manager

Step 3: Prepare Your Application 29

Except for the principal investigator and the deputy principal investigator, multiple staff roles may be filled by the same person (a member of the core research staff can also fill the role of the project manager).

However, staff can’t duplicate FTE and responsibilities across other OAT funded programs. In addition, a co-principal investigator is not permitted.

• Describe the following for the principal investigator:

◦ Evidence of successfully managing a rapid response research team as well as conducting and disseminating telehealth-focused research and rapid data analysis (including at least eight years of work experience in telehealth-focused health services research, or comparable experience).

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

HRSA recommends that the principal investigator devote at least 25 percent of their time to the Telehealth Rapid Response Center. They will lead the development and realization of the Telehealth Rapid Response Center portfolio.

They are responsible for the administrative aspects of the Telehealth Rapid Response Center and reviewing all draft research products.

HRSA strongly suggests that the principal investigator have a substantial number of telehealth publications that focus on underserved populations, a minimum of 8 years of work experience specific to underserved populations, telehealth-focused health services research, and a medical or doctoral degree.

• Describe the following for the deputy principal investigator:

◦ Experience, including roles and responsibilities in organizational lines of authority, conducting and disseminating policy-relevant health research or evaluation for underserved populations.

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

◦ Process to assume the duties of the principal investigator when the principal investigator is on short-term and extended leave (like a vacation or a sabbatical).

HRSA recommends that the deputy principal investigator devote at least 20 percent of their time to the proposed Telehealth Research Center.

Step 3: Prepare Your Application 30

• The core data analysis staff should be multi-disciplinary and have the educational and professional experience necessary to conduct data analysis to meet program goals. This includes gathering data from a variety of resources, cleaning and filtering data, using statistical tools and analytical methods to explore and analyze data, identifying trends and relationships, data validation and interpreting skills, and data visualization skills.

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

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

Telehealth Research Center HRSA-25-045 applicants should also:

• Describe your capability (as evidenced by experience) to conduct and disseminate complex, clinically informed, or policy-relevant research studies in a 12-to-15-month period. You may demonstrate this past performance by describing work completed for any funder.

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

• Describe your organizational structure. You can apply on behalf of your organization alone or on behalf of a group of organizations, but you will remain responsible for research, supervision, administrative activities, and overall management of federal funds.

• Include the following staff:

◦ Principal investigator (i.e., the project director)

◦ Deputy principal investigator (i.e., the deputy project director)

◦ Core research team

◦ Technical writer/editor

◦ Project manager

Step 3: Prepare Your Application 31

Except for the principal investigator and the deputy principal investigator, multiple staff roles may be filled by the same person (a member of the core research staff can also fill the role of the project manager). Also, a co-principal investigator is not permitted.

• Describe the following for the principal investigator:

◦ Evidence of successfully managing a research or evaluation team as well as conducting and disseminating telehealth-focused health services research (including at least eight years of work experience in telehealth-focused health services research, or comparable experience).

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

HRSA recommends that the principal investigator devote at least 25 percent of his or her time to the Telehealth Research Center. The principal investigator can’t duplicate FTE and responsibilities across other OAT funded programs.

The principal investigator leads the development and realization of the Telehealth Research Center research portfolio. They are the lead investigator on at least two of your proposed research projects, responsible for the administrative aspects of the Telehealth Research Center and reviewing all draft research products.

HRSA strongly suggests that the principal investigator have a substantial number of telehealth publications that focus on underserved and rural populations, a minimum of eight years of work experience specific to rural and underserved populations, telehealth-focused health services research, and a medical or doctoral degree.

• Describe the following for the deputy principal investigator:

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

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

◦ Process to assume the duties of the principal investigator when the principal investigator is on short-term and extended leave (like a vacation or a sabbatical).

HRSA recommends that the deputy principal investigator devote at least 20 percent of his or her time to the proposed Telehealth Research Center.