It is critical that recipients follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Recipients must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/nofoguidance/index.html.

When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose & Objectives: Expanding Access and Improving Long COVID Care

This NOFO will support existing, multidisciplinary Long COVID clinics in the United States in developing and implementing new or improved care delivery models that enhance access to care and quality of care for people with Long COVID, particularly underserved, rural, vulnerable, or minority populations that are disproportionately impacted by the effects of Long COVID. This NOFO will only support expansion of existing clinics (including establishment of new satellite clinics), and not the development of new, independent Long COVID clinics. AHRQ funding is intended to supplement, not displace, current sources of funding (e.g., insurance reimbursement) for care and services provided.

Proposed new or improved models must deliver comprehensive, coordinated, person-centered, and timely care to people with Long COVID, collaborating with primary care and specialty clinicians and social service providers to optimally integrate Long COVID care with any services for co-existing illnesses and social risk factors. Applicants can propose models focused on specific populations, such as pediatrics, older adults, or underserved, rural, vulnerable or minority populations. For examples of Long COVID care model elements and management guidelines, please refer to resources such as the HHS Health+ Long COVID Human-Centered Design Report [1] and CDC s guidance for management of post-COVID conditions.[2]

Applicants must use funds for primary care practitioner education, support, and engagement to expand primary care capacity for Long COVID care.

Key Definitions for this NOFO

Long COVID: Long COVID is broadly defined as signs, symptoms, and conditions that continue or develop after initial COVID-19 or SARS-CoV-2 infection. The signs, symptoms, and conditions are present four weeks or more after the initial phase of infection; may be multisystemic; and may present with a relapsing remitting pattern and progression or worsening over time, with the possibility of severe and life-threatening events even months or years after infection. Long COVID is not one condition. It represents many potentially overlapping entities, likely with different biological causes and different sets of risk factors and outcomes. [3]

There are other working definitions of Long COVID, such as the one from the World Health Organization[4] and other terms used to describe Long COVID, such as post COVID-19 condition, Long-haul COVID, post-acute COVID-19, post-acute sequelae of SARS CoV-2 infection (PASC), Long-term effects of COVID, and chronic COVID. Terms and definitions for these conditions have evolved since the beginning of the pandemic and will continue to evolve as we learn more about the symptoms and conditions associated with Long COVID.[5] Additional information about Long COVID is available at COVID.gov/longcovid [6] and Post-COVID Conditions: Information for Healthcare Providers (cdc.gov).[2]

Multidisciplinary Long COVID Clinics: Outpatient care centers or clinics established to identify people with Long COVID and deliver multidisciplinary health care services, such as screening for disease outcomes, rehabilitation, care coordination and management, and targeted specialist referrals. Multidisciplinary teams are from a broad range of specialties and focus on addressing the issues of COVID-19 recovery. Other terms used to refer to Long COVID clinics include Post-COVID Care Centers, Post-COVID Recovery Clinics, and Comprehensive COVID-19 Centers. (Definition adapted from the U.S. Department of Health and Human Services (HHS) Health+ Long COVID Human-Centered Design Report.[1]) Long COVID clinics are not necessarily distinct physical entities and clinicians and other staff may or may not be co-located. See additional description of Long COVID clinics under Background on Long COVID Clinics below.

Background on Long COVID

Long COVID is a chronic condition in which people continue to experience persistent, varying, and potentially disabling health impacts after the acute COVID-19 illness. While estimates vary, up to one-third of people with COVID-19 experience Long COVID, with estimates being much higher in females; transgender and bisexual people; people without a college degree, particularly those without a high school diploma; and people with a disability.[7] Further, many minority and at-risk populations for Long COVID face barriers that can worsen the impact of Long COVID on their lives and complicate their recovery. Examples of such barriers include difficulty with healthcare access, communication, and Internet accessibility; lack of health insurance; lower health literacy; greater difficulty using patient portals and telemedicine; and greater medical and social vulnerabilities.[8-10]

Background on Long COVID Clinics

Dedicated outpatient Long COVID clinics have emerged across the nation to provide coordinated, multidisciplinary care that meets the complex, diverse, multi-system, and specialized needs of people with Long COVID. Several Long COVID clinic models exist, with common elements including care coordination and access to multidisciplinary care.[8, 11-15] While filling a critical need, Long COVID clinics face significant challenges such as staffing shortages, long patient waitlists, lack of funding or reimbursement for some services, lack of clear treatment protocols, limited capacity to provide timely, comprehensive, coordinated and person-centered care, and limited clinician knowledge and training in Long COVID management. Further, people with Long COVID experience access barriers and delayed care due to the limited number or capacity of Long COVID clinics and specialists, concentration of clinics in academic centers and urban areas, late recognition of Long COVID symptoms by clinicians, and delayed referral to Long COVID clinics or appropriate specialists for care.

Examples of Activities Responsive to this NOFO

There are many opportunity areas for improving Long COVID care delivery that may be proposed for this NOFO. Applications should focus on addressing key challenges facing Long COVID clinics and people with Long COVID, particularly underserved, rural, vulnerable, or minority populations. Below are some examples of activities that would be responsive to this NOFO. Applicants can propose other activities not listed below.

Examples of Strategies to Increase Access and Serve More People with Long COVID:

• Increasing staffing to increase clinic capacity and shorten wait times for patient intake and follow-up appointments (e.g., by adding trained clinicians or by training clinicians within the health system in Long COVID management)
• Expanding services to new regions and/or populations, particularly underserved, rural, vulnerable, or minority populations, through telehealth, satellite or mobile clinics, clinician-to-clinician consultative services (e.g., e-consults), in-home services, partnerships with rural clinicians, language assistance (e.g., through certified medical interpreters), lengthening hours of operation, or other strategies

Examples of Strategies to Make Long COVID Care More Comprehensive, Coordinated, and Person-Centered:

• Increased time and standardized processes for patient intake to facilitate comprehensive assessment, shared decision-making,[16] person-centered care planning, education, and standardized data collection
• Adding or expanding specialty services (e.g., behavioral health, rehabilitation services) accessible within the health system or by referral to external clinicians
• Adding or expanding non-clinical, professional services such as social work, case management, or peer-to-peer support by community health workers
• Establishing or improving referral relationships and processes with community-based organizations to help people with Long COVID, families, and caregivers access local, state, or federal support services and programs
• Establishing or improving the clinic’s support programs and resources for people with Long COVID, families, and caregivers, such as through support groups, easy-to-understand educational resources in multiple languages, and self-management tools
• Transferring care back to the primary care and/or specialty clinician(s) at the time of patient discharge, e.g., through clinician-to-clinician warm handoffs
• Adding bilingual clinicians to provide patient-physician language-concordant services
• Providing staff training on Long COVID management, strategies for working with diverse populations, or shared decision-making
• Implementing shared or collaborative care models to integrate Long COVID care with care for co-existing conditions by primary care clinicians or specialists
• Improving health information systems to facilitate care coordination and tracking of patient outcomes
• Incorporating complementary and alternative medicine therapies, if supporting evidence exists in the Long COVID population or if the applicant can justify appropriateness based on evidence in other patient populations

Examples of Strategies for Primary Care Education and Support:

• Education, training, and consultative services for primary care practices (e.g., Project ECHO-like models, webinars, clinician education materials, train-the-trainer models), particularly in underserved areas, safety-net systems, and regions with high Long COVID rates, to increase primary care clinicians ability to identify, manage, and refer patients with Long COVID
• Establishment of an e-consult system to provide asynchronous clinical and care management support to primary care clinicians from Long COVID clinic staff

Overview of NOFO Requirements

1. Required Care Delivery Model Components

Proposed models must provide comprehensive, coordinated, person-centered care that, at a minimum, includes:

• Holistic assessment of a person’s physical, behavioral, functional, and social needs, including co-existing conditions, associated treatments, and social supports
• Shared decision-making and person-centered care planning that incorporate patients values, goals, preferences, and circumstances into treatment prioritization, decisions, and delivery
• Multidisciplinary care, with access or referral to a variety of specialists, including behavioral health clinicians, and social service providers to address social risks
• Communication and care coordination across the patient’s entire care team, which may include primary care clinicians, specialists, rehabilitation clinicians, social service providers, patients, families, and caregivers, with particular attention to providing integrated care, avoiding conflicting treatments, ensuring medication reconciliation, and minimizing patient and caregiver burden
• Partnerships with community-based organizations to help people with Long COVID, families, and caregivers access social support services
• Strategies to promote health equity, reduce disparities, and identify and support populations most impacted by Long COVID
• Strategies to address health literacy[17]
• Strategies to identify and implement the latest evidence and best practices in Long COVID management

2. Applicants must engage in activities to support the primary care community in identification, management, and referral of people with Long COVID through education, consultation, or other methods.

3. Applicants must conduct a mixed-methods evaluation of their project and report on the required performance measures listed in the Evaluation Approach section below.

4. Required Participation in AHRQ’s Broader Initiative

Through a separate contract, AHRQ will operate a learning community for recipients, evaluate the overall initiative across recipients, and disseminate findings. Applicants must indicate a commitment to participate in these activities led by AHRQ and its contractor, including collaborating with other recipients. Applicants must describe strategies for engaging in these activities and build in corresponding resources in the application budget and personnel sections.

• Learning Community: A learning community will bring together recipients, contractor staff, and AHRQ to discuss progress, share best practices, identify common challenges, engage in problem solving, and learn from external experts. Applicants must commit to sharing care delivery model design, workflows, data collection plans, intake forms and other relevant tools; engage in peer-to-peer learning and knowledge sharing; and incorporate learnings into project implementation. Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and key implementation and evaluation personnel must participate in monthly learning community meetings and activities.
• Evaluation of Overall Initiative: Applicants must commit to collaborating with the contractor and other grantees for the cross-recipient evaluation, collecting harmonized cross-recipient metrics, sharing data with the contractor, and participating in qualitative data collection efforts, which may include site visits, interviews, focus groups, and other activities. Applicants should anticipate sharing the types of performance measures listed under the Evaluation Approach section below and collecting and sharing additional measures that the contractor may recommend.
• Dissemination: Applicants must commit to cooperating with AHRQ and its contractor in disseminating project information, including details about recipients care delivery models, implementation tools and evaluation findings, through conferences, publications, webinars, or other modes.

Required Application Elements

A. Description of Current Clinic

• Applicants must describe their current patient population, clinic characteristics, care delivery model, and challenges, including the below listed elements and any additional information necessary to fully understand whom the clinic serves and how care is currently delivered. If applicants do not have specific data on any required element, they must present best estimates (indicating that they are estimates) and describe their ability and plan to collect these elements, if funded.
• Current Patient Population
  • Sociodemographic profile of patients served to date (e.g., age, gender, race, ethnicity, insurance status)
  • Eligibility criteria for receiving clinic services (e.g., a confirmed COVID-19 diagnosis)
  • Numbers of patients served to date, trends in patient volume since the clinic was established, anticipated future patient volume, and number of patients on the waitlist
  • Extent of inclusion of those most affected by Long COVID in the clinic's service area and traditionally underserved or vulnerable populations
  • Any patient populations served, besides Long COVID
• Current Clinic Characteristics
  • Clinic origin, location, and structure (e.g., date established, whether clinicians are co-located, home department if within a health system, primary discipline responsible for overall care management, characteristics of parent organization or health system)
  • Number and level of effort of clinical and non-clinical staff, types of services provided, clinical disciplines and whether primary care clinicians are part of the team
  • Model or team structure and connection among clinicians (e.g., integrated team, shared or collaborative care model, consultative care model, referral model, or independent, autonomous practitioners)
  • Average wait times for seeing a new patient and for follow-up appointments
  • Hours and days of operation per week
  • Current clinic funding model (e.g., insurance reimbursement, institutional funds, grant support)
  • Any participation in Long COVID research studies/programs, federally funded demonstration projects, or patient referrals to Long COVID clinical trials
  • Any experience managing Federal grants or contracts
• Current Care Delivery Model
  • Primary referral sources and any referral requirements for receiving services in the clinic
  • Current approach to patient intake (e.g., length of initial visit, provider disciplines involved), shared decision-making, care planning, and general patient and caregiver support
  • Current approach to care coordination and communication across the entire care team, including the primary care clinician (if any), specialists, rehabilitation clinicians, other team members (e.g., social service providers), patient, family, and caregivers. Include referral and care coordination processes for services referred out to external clinicians and providers, including processes to ensure patient follow-through with referral.
  • Care delivery format (i.e., in-person or telehealth or both) for initial and follow-up visits
  • Types of technology used, if any (e.g., personal/remote patient monitoring devices, clinical decision support or algorithms)
  • Existing connections with primary care, behavioral health, community, social service, or other resources
• Current Challenges
  • Most significant gaps or barriers to delivering and accessing comprehensive, coordinated, person-centered, and timely care from both clinician and patient perspectives, overall and specific to underserved, rural, vulnerable, or minority populations identified by the applicant

B. Proposed Project Description

Applicants must describe their proposed goals, care model and associated implementation strategies, learning approach, and dissemination and evaluation strategies, including the elements listed below and any additional elements necessary to fully understand how grant funding will be used. While a meaningful evaluation plan is required, applicants must devote no more than 20% of total funding to evaluation activities.

• Goals and Significance
  • Specify project goals and target benchmarks for each goal.
  • Describe the target population and region, highlighting inclusion of underserved, rural, vulnerable, or minority populations and the need for additional Long COVID clinic capacity and resources in the region.
  • Describe how funding will be used to address identified care access and delivery gaps and barriers.
  • Discuss anticipated learnings that would help other Long COVID clinics to expand access to comprehensive, coordinated, and person-centered care, improve care delivery models, and prepare primary care clinicians to identify, refer, and care for people with Long COVID.
• Approach and Innovation
  • Implementation Strategies and Activities
    • Describe specific strategies and activities that will be used to achieve project goals. Provide a logic model or conceptual framework that clearly describes how proposed activities will lead to achieving project goals.
    • Describe the approach for implementing each required care delivery model component listed in the Overview of NOFO Requirements section, highlighting key strategies that will make care delivery more comprehensive, coordinated, person-centered, and timely.
    • Describe care coordination strategies, including how Long COVID care will be coordinated with any ongoing care for co-existing illnesses or social services.
    • Describe any special care delivery approaches for underserved, rural, vulnerable, or minority populations.
    • Describe any special care delivery approaches for older adults, people with complex needs (e.g., due to disability or multiple chronic conditions), and people with social risks.
    • Describe the approach to assessing patient readiness for discharge from the Long COVID clinic, criteria for discharge, and process for transferring care back to the primary care, referring, or other clinician(s).
    • Describe any new partnerships proposed (e.g., with primary care and specialty practices/clinicians, social service providers, and community-based organizations), characteristics of proposed partners and partnering organizations, and strategies for initiating and maintaining partnerships. Provide letters of support from partnering organizations or clinicians, where possible.
    • Describe how primary care practices and/or clinicians will be identified and engaged for education and support activities, and any specific efforts to reach practices and clinicians in underserved communities and/or those with limited resources.
    • Describe potential implementation challenges and mitigation strategies.
    • Highlight any innovative implementation approaches and mitigation strategies that may contribute to project success.
    • Include a timeline for grant activities with major milestones.
  • Learning Approach
    • Describe the approach to staying updated about the latest evidence on Long COVID and incorporating it into care delivery design and implementation strategies.
    • Describe how strategies will be adapted in response to changing evidence or internal evaluation findings to optimize care delivery design and implementation on an ongoing basis.
    • Describe the proposed approach to participating in the Learning Community facilitated by the AHRQ contractor, including engaging in peer-to-peer learning with other recipients and incorporating learnings into the applicant’s project.
• Dissemination Approach
  • Describe the plan for disseminating project learnings, including proposed dissemination topics, products, modes, channels, audiences, and timing for disseminating various products.
  • Describe the approach to collaborating with AHRQ’s contractor on dissemination activities.
• Evaluation Approach
  • Applicants must propose a mixed-methods, formative and summative evaluation approach that will allow the clinic to regularly track progress, identify need for changes and adapt implementation strategies throughout the period of support, identify challenges and facilitators to successful implementation and goal attainment, and assess overall project impact.
  • Describe the evaluation plan, including proposed data sources, data collection approaches, and data analyses to assess success of each project goal and strategy.
  • Describe the proposed approach to working with AHRQ’s contractor on the cross-recipient evaluation, including harmonizing measures across recipients. Applicants must assign an evaluation liaison (ideally the PD/PI) or dedicated evaluation lead) with expertise across the project to serve as a chief informant and coordinator with the contractor. This team member must have a minimum of 5% full-time equivalent (FTE) dedicated to evaluation liaison activities throughout the project.
  • Describe performance measures that will be used to evaluate progress toward goals. Where possible, data collection should support stratification by patient sociodemographic characteristics such as race/ethnicity, insurance status, education, language, and geography. At a minimum, applicants must track the measure domains and measures listed below. Applicants can propose additional measure domains or measures that are relevant to their projects.

Reach measures: Who was reached by the project?

• Number of patients directly served by grant-supported clinics
• Number of primary care clinicians and/or practices engaged by grant-supported clinics; stratify by type of engagement activity, if possible
• Timeline: Reach annual targets

Structure and Process measures: What strategies were implemented and how?

• Number and types of clinical and non-clinical personnel and services added
• Timeline: Services and personnel added within year 1 and sustained or adjusted throughout the period of support
• Costs and resources (personnel and non-personnel) associated with implementation
• Timeline: Report annually (if possible) and cumulative at 5 years

Impact measures: What was the impact of implemented strategies?

• Use of clinical specialties and services offered (e.g., percent of patients using each available service)
• Impact on patient accessibility (e.g., appointment wait times for the initial intake visit and for follow-up care recommended during the intake visit)
• Number of patients discharged from the Long COVID clinic, with the patient’s primary care and/or other current clinician(s) being notified of the discharge
• At least one patient-reported health outcome or experience of care measure
• Timeline: Data collected through year 5, reach targets

• Investigator(s) and Organization(s)
  • Describe the proposed leadership and governance structure for the project, key personnel roles, and their qualifications to perform assigned roles.
  • Identify the evaluation liaison for the external, contractor-led evaluation and describe their qualifications to provide meaningful input on cross-recipient evaluation strategies (e.g., methodology, harmonized cross-recipient metrics), represent the recipient’s perspective in communications across AHRQ, contractor, and recipient teams, and implement group recommendations in the recipient's individual project.
  • Highlight key features of the investigator team, clinic, and parent organization or health system (if any) that will contribute to the probability of success. In particular, highlight multidisciplinary expertise of the investigator team and expertise in understanding and addressing issues related to health equity, access to care, and disparities.
  • Describe organizational leadership support for the project and describe strategies for engaging with leadership to maintain such support.

See Section VIII. Other Information for award authorities and regulations.

These projects are being funded pursuant to 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

All applications submitted and AHRQ grants made in response to this NOFO are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75)), the HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally-recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the recipient and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement via https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf, may participate in projects as member of consortia or as subcontractors only.

Recipient Organizations

Recipient organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

• System for Award Management (SAM) Recipients must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one PD/PI account to submit an application.
• Grants.gov Recipients must have an active SAM registration to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Note: After January 25, 2022, all individuals listed on the R&R Senior/Key Person Profile (Expanded) Form are required to have an eRA Commons username (Commons ID). See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-109.html.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD(s)/PI(s) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for AHRQ support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple PD/PI Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum FTE (i.e., at least 8 hours per week) in each given year of the project. If any effort is in-kind, this should be explained in the budget justification, and a letter of support from an authorized institutional official is required.

This NOFO does not require cost sharing.

While there is no cost sharing requirement included in this NOFO, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

AHRQ will not accept duplicate or highly overlapping applications under review at the same time. This means that AHRQ will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that recipients follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective recipients are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Poonam Pardasaney, ScD, DPT, MS

Email: long-covid-rfa@ahrq.hhs.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

AHRQ encourages applicants to take advantage of a pre-application technical assistance (TA) conference call sponsored by AHRQ program staff. During the call, AHRQ program staff will summarize the purpose of this RFA and respond to questions about preparation of an application in response to the RFA. The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying.

The conference call will take place on May 1, 2023 at 1:00-2:00 PM Eastern time. To register to participate, please send an e-mail request to long-covid-rfa@ahrq.hhs.gov by April 26, 2023. Please include the phrase TA Call Registration: Implementing and Evaluating New Models for Delivering Comprehensive, Coordinated, Person-Centered Care to People with Long COVID in the subject line. All registrants will receive an email with the call-in information at least one business day before the conference call.

Participants are encouraged to submit questions via email prior to the conference call. Please submit up to five questions with your name and the name of your institution to long-covid-rfa@ahrq.hhs.gov by April 24, 2023. Please include the phrase TA Call Questions: Implementing and Evaluating New Models for Delivering Comprehensive, Coordinated, Person-Centered Care to People with Long COVID in the subject line. Questions of a similar topic and nature may be grouped together at the sole discretion of AHRQ staff. Notes from the conference call will be posted on AHRQ's website.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Budget Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process. Recipients applying for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

• Budget Allocation: Applicants must allocate no more than 20% of funding to evaluation activities.
• PI(s) Level of Effort: A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum FTE (i.e., at least 8 hours per week) in each given year of the project. If any effort is in-kind, this should be explained in the budget justification, and a letter of support from an authorized institutional official is required.
• Travel: Applicants must budget for up to two key personnel to travel to the Washington, DC area once each year to meet with AHRQ staff, other recipients, and any invited guests for a one- or two-day meeting.
• Evaluation liaison: Applicants must designate an evaluation liaison to collaborate with AHRQ and its contractor on all evaluation matters. The evaluation liaison must be designated as key personnel and have at least 5% FTE dedicated to evaluation liaison activities. If the PD(s)/PI(s) or other key personnel will serve in this role, FTE requirements are not cumulative (i.e., 20% FTE requirement for PD/PI could include this role).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Applicants must include the Required Application Elements described in Section I. Funding Opportunity Description. Applications that fail to include this information may not be accepted for review.

Resource Sharing Plan:

Applicants are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: Submission of a data management plan is required. AHRQ recipients are reminded to refer to NOT-HS-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy for additional information on how to incorporate their data management plan into the resource sharing plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions Do not use the Appendix to circumvent page limits.

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed. For details regarding IRB approval, recipients may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Recipient should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html).

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

The Federal awarding agency may not make a Federal award to an applicant until the applicant has complied with all applicable unique entity identifier and SAM requirements and, if an applicant has not fully complied with the requirements by the time the Federal awarding agency is ready to make a Federal award, the Federal awarding agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant.

Part I. Overview Information contains information about Key Dates and times. Recipients are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Recipients must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. AHRQ and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected, and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Recipients are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

Grant funds may NOT be used for the purchase of food of any kind (refreshments, meals, etc.). AHRQ will not award funds to support the cost of food.

These awards will not be made under expanded authorities; therefore, pre-award costs are not allowable without prior approval from AHRQ.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the UEI provided on the application is the same identifier used in the organization s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, AHRQ.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, recipients are generally notified of the review and funding assignment within eight (8) weeks.

Please be sure that you observe the total cost, project period, and page number limitations specified above for this NOFO. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

• Budget Allocation: Applicants must allocate no more than 20% of funding to evaluation activities.
• PI(s) Level of Effort: A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum FTE (i.e., at least 8 hours per week) in each given year of the project. If any effort is in-kind, this should be explained in the budget justification, and a letter of support from an authorized institutional official is required.
• Travel: Applicants must budget for up to two key personnel to travel to the Washington, DC area once each year to meet with AHRQ staff, other recipients, and any invited guests for a one- or two-day meeting.
• Evaluation liaison: Applicants must designate an evaluation liaison to collaborate with AHRQ and its contractor on all evaluation matters. The evaluation liaison must be designated as key personnel and have at least 5% FTE dedicated to evaluation liaison activities. If the PD(s)/PI(s) or other key personnel will serve in this role, FTE requirements are not cumulative (i.e., 20% FTE requirement for PD/PI could include this role).

Applicants are required to follow the instructions for post-submission materials, as described in

NOT-OD-23-066: Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: August/October 2023 Councils: Updates to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials and related, as applicable.

Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

AHRQ is committed to the inclusion of priority populations in health services research. The overall portfolio of health services research that AHRQ conducts and supports shall include the populations specifically named in AHRQ’s authorizing legislation: inner city; rural; low income; minority; women; children; elderly; and those with special health care needs, including those who have disabilities, need chronic care, or need end-of-life health care (42 U.S.C. 299(c)(1)). AHRQ also includes in its definition of priority populations those groups identified in Section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality (2021-01753.pdf (govinfo.gov).

AHRQ will broadly implement this inclusion policy across the research that AHRQ supports and conducts so that the portfolio of research is inclusive of all populations. AHRQ intends that these populations be included in studies such that the research design explicitly allows conduct of valid analyses. The policy applies to all grant applications. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-21-015.html. Recipients under this NOFO must consider and discuss including priority populations in research design as specified in this Notice.

Public Access to AHRQ-Funded Scientific Publications

Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications , which is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher’s date of publication.

AHRQ Data Management Plan Policy

Investigators should review the document titled AHRQ Data Management Plan (DMP) Policy, which is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html). This policy requires recipients for AHRQ new/competing grants and research contracts to include a DMP for managing, storing and disseminating the primary data, samples, physical collections, and other supporting materials created or gathered in the course of research funded by AHRQ, or state why data management is not possible, as a component of their grant application or research contract proposal.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Recipients who are planning to share data should describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ-supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute (42 USC 299c-3(d)). In the Human Subjects section of the application, recipients must describe procedures for ensuring the confidentiality of the identifying information to be collected (see NOT-HS-18-012: Confidentiality in AHRQ-Supported Research). The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine-readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by recipients under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The recipient should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ recipients may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on recipients to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ requests that recipients notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date.

Regulations applicable to AHRQ recipients concerning intangible rights and copyright can be found at 45 CFR 75.322.

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with HHS and other partners to make sure that the evidence is understood and used. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, National Institutes of Health, and for responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the project will expand access to comprehensive, coordinated, and person-centered care for people with Long COVID and better prepare the healthcare system for caring for people with Long COVID, in consideration of the scored review criteria and additional review criteria below.

Reviewers will consider each review criterion below in the determination of application merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major impact. For example, a project that by its nature is not innovative may be essential to expand access to comprehensive, coordinated, person-centered care for people with Long COVID.

• Does the proposed care delivery model effectively address the clinic's identified gaps, barriers, and/or patient access issues?
• Are target populations and/or regions clearly described, and do they include underserved, rural, vulnerable, or minority populations most impacted by the effects of Long COVID?
• Is the proposed care delivery model likely to result in meaningful, measurable improvements in access to comprehensive, coordinated, and person-centered care for people with Long COVID?
• Are target benchmarks for each goal feasible and appropriate, considering the proposed approach?
• Is the project (and proposed evaluation approach) likely to generate learnings that will better prepare the healthcare system to care for people with Long COVID?

• Are personnel roles and activities clearly described?
• Do the PD(s)/PI(s) and other key personnel have appropriate and complementary qualifications and levels of effort to successfully perform their assigned roles?
• Does the application propose a multidisciplinary investigator team that includes physicians and other clinicians (e.g., rehabilitation specialists, behavioral therapists)?
• Is the single PD/PI, or are the multiple PD(s)/PI(s) combined, devoting at least 20% annual FTE (i.e., at least 8 hours per week) in each given year of the project?
• Are the leadership approach, governance, and organizational structure (of the clinic and parent organization or health system, if any) appropriate for the project?
• Is the evaluation liaison for the external cross-recipient evaluation well-qualified for the role, and do they have at least 5% FTE dedicated to evaluation liaison activities?

• Does the application propose innovative strategies for model design and implementation, overcoming critical barriers and access issues, reaching underserved, rural, vulnerable, or minority populations, and/or maximizing primary care community reach and engagement?
• Does the application identify and adapt existing models and methods that are successful or promising in other patient populations with similar needs?

• Implementation Strategies and Activities
  • Does the application clearly describe the proposed goals, benchmarks, care delivery model, and strategies and activities to accomplish project goals and meet targets?
  • Does the logic model or conceptual framework clearly demonstrate how proposed activities will lead to achieving project goals?
  • Is the overall strategy well-reasoned, feasible, and appropriate to accomplish goals?
  • Does the application propose appropriate strategies to reach and serve underserved, rural, vulnerable, or minority populations?
  • Does the proposed care delivery model include all the components listed in the Required Care Delivery Model Components section and how strong is the proposed approach for each component?
  • How strong are the proposed partnerships and primary care practice/clinician engagement strategies? Are letters of support included for collaborating organizations and if so, do they indicate a high level of commitment and support?
  • Are potential implementation challenges identified and appropriate mitigation strategies proposed?
  • Are the proposed timeline and milestones appropriate and feasible?
• Learning Approach

Does the proposed learning approach support the following?

• Timely incorporation of the latest evidence and guidance into implementation strategies
• Timely adaptation of strategies, if indicated, based on new external evidence or internal evaluation findings
• Incorporation of knowledge gained from the Learning Community facilitated by the AHRQ contractor
• Dissemination Approach
  • Does the applicant propose appropriate dissemination topics, products, modes, channels, and audiences?
  • Does the dissemination approach support timely dissemination of project learnings?
• Evaluation Approach
  • Does the applicant propose a mixed-methods evaluation approach that will allow meaningful assessment of implementation success on an ongoing basis, and overall project success at the end of the period of support? Will it identify successes, challenges, barriers, and facilitators so the applicant can adapt approaches as needed?
  • Does the evaluation approach include the required reach, structure and process, and impact measure domains and measures?
  • Are the proposed data sources, data collection approaches, performance measures, and analytic approaches clearly described and appropriate to assess project success?
• Other
  • Has the applicant indicated a commitment to cooperate with AHRQ and its contractor on the Learning Community, cross-recipient evaluation, and dissemination activities? Has the applicant allocated appropriate resources for these activities?

• Does the application clearly describe the current clinic structure and operations? Do the organizational structure, staffing, resources, and experiences of the clinic and parent organization or health system (if any) contribute to the probability of success?
• Has the applicant demonstrated organizational leadership support for the project and described valid strategies for engaging with leadership to maintain that support?
• Does the clinic have existing partnerships with primary care, behavioral health, community and social resources or other collaborative arrangements that will contribute the probability of success?
• Does the clinic and/or parent organization or health system have experience managing Federal grants or contracts that will contribute to the probability of success?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

For details regarding IRB approval, recipients may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicants should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html).

Peer reviewers will assess the adequacy of plans to address the needs of AHRQ priority populations.

Peer reviewers must include their assessment of the proposed inclusion plan for priority populations in evaluating the overall scientific and technical merit of the application and assigning the impact score.

In evaluating the overall impact of the application, the review groups will:

• Evaluate the application for the presence or absence of the inclusion plan based on the proposed research objectives.
• Evaluate the adequacy of the proposed plan for the inclusion of priority populations.
• Evaluate the proposed justification for the exclusion of priority populations when a requirement for inclusion is described as inappropriate with respect to the purpose of the research.
• Evaluate the plans for outreach and recruitment of study participants, including priority populations, where appropriate.
• Evaluate the proposed plan for study design, execution and outcome assessments so that study results will be relevant to one or more priority populations, where appropriate.
• Assess the plan as being acceptable or unacceptable with regard to the appropriateness of the inclusion or exclusion of priority populations in the proposed research.

Reviewers will assess how well the application addresses the purpose and objectives of this NOFO and how responsive the application is to the NOFO criteria and requirements. Reviewers will also assess whether the application proposes to expand existing services offered by an established Long COVID clinic rather than create an entirely new, independent clinic.

The committee will evaluate whether the proposed budget is reasonable, and whether the requested period of support is appropriate in relation to the proposed research.

Not applicable

Not applicable

Not applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable, such as: Data Sharing Plan if applicable.

The reviewers will comment on whether the Data Management Plan is reasonable.

Not Applicable

Applications that are complete and responsive to the NOFO will be evaluated for scientific and technical merit, using the above Review Criteria, by an appropriate Scientific Review Group convened in accordance with standard AHRQ peer review procedures described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this NOFO will not be reviewed.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned based on established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO.

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the NOFO.
• Proposed approach to addressing health equity.
• Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Section I for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html).

If the application is under consideration for funding, AHRQ Division of Grants Management staff will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, recipients may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicants should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html).

If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the e-mail address designated by the recipient organization during the eRA Commons registration process.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Individual awards are based on the application submitted to, and as approved by, AHRQ and are subject to the AHRQ-specific terms and conditions identified in the NoA.

Any application awarded in response to this NOFO will be subject to the SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at

https://www.ahrq.gov/funding/grant-mgmt/index.html.

All AHRQ grant and cooperative agreement awards are subject to HHS Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75, HHS' Grants Policy Statement (http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

Potential recipients should be cognizant of the statutory and policy requirements for acknowledging HHS funding when issuing statements, press releases, publications, and other documents.

All recipients will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award and requires that recipients inform their employees in writing of employee whistleblower rights and protections under 41 U.S.C. 4712 in the predominant native language of the workforce.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

AHRQ regulatory procedures that pertain to suspension and termination are specified in 45 CFR 75.371 through 75.375.

There is a prohibition on certain telecommunications and video surveillance services or equipment that became effective on or after August 13, 2020.

Should you successfully compete for an award, recipients of federal financial assistance (FFA)

from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in

which you agree, as a condition of receiving the grant, to administer your programs in compliance

with federal civil rights laws that prohibit discrimination on the basis of race, color, national

origin, age, sex and disability, and agreeing to comply with federal conscience laws, where

applicable. This includes ensuring that entities take meaningful steps to provide meaningful access

to persons with limited English proficiency; and ensuring effective communication with persons

with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis

of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on

complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/forproviders/

provider-obligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/

nondiscrimination/index.html.

For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful

access to your programs or activities by limited English proficient individuals, see

https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-englishproficiency/

fact-sheet-guidance/index.html and https://www.lep.gov.

For information on your specific legal obligations for serving qualified individuals with

disabilities, including providing program access, reasonable modifications, and to provide

effective communication, see

http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

HHS funded health and education programs must be administered in an environment free of

sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/

index.html.

For guidance on administering your project in compliance with applicable federal religious

nondiscrimination laws and applicable federal conscience protection and associated antidiscrimination

laws, see https://www.hhs.gov/conscience/conscience-protections/index.html

and https://www.hhs.gov/conscience/religious-freedom/index.html.

• Contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at:
  • https://www.hhs.gov/ocr/index.html
  • or call 1-800-368-1019 or TDD 1-800-537-7697.
• Below are available HHS resources on Health Literacy:
  • Health.gov: Health Literate Care Model
  • AHRQ: Health Literacy Universal Precautions Toolkit

For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII. Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Recipient Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by recipients as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by recipients. This provision will apply to all AHRQ grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following Terms and Conditions will be incorporated into the award notice and will be provided to the grant recipient at the time of award.

Terms and Conditions of Cooperative Agreement Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and AHRQ grant administration policy statements. AHRQ will use these procedures in evaluating and administering this cooperative agreement.

The administrative and funding instrument used for this program is the cooperative agreement. A cooperative agreement is an "assistance" mechanism (rather than an "acquisition mechanism), in which substantial AHRQ programmatic involvement with the grantee is anticipated during the performance of the activities. Under a cooperative agreement, AHRQ's purpose is to support and stimulate recipients' activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and primary responsibility resides with the grant recipient and the PD(s)/PI(s) for the project as a whole, although specific tasks and activities may be shared between the grantee and AHRQ as described in the NOFO. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data sharing, data access and communications.

All cooperative activities that include significant government involvement will require prior approval by AHRQ.

Activities conducted under this award that involve the collection of information, e.g., conducting surveys or requesting responses to uniform questions from nine or more persons, establishments, or other entities, with certain exceptions, are currently required to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521). PRA review and approval is required in cooperative agreements if AHRQ has significant input or control over the data collection activity. Submissions for clearance under the PRA are through AHRQ and HHS. Therefore, impacted awardees should include PRA review and approval time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least six months from date of initial submission to AHRQ and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until awardees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found at Paperwork Reduction Act (PRA) of 1995 | Guidance Portal (hhs.gov).

Program Director/Principal Investigator (PD/PI) Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for conducting research in accordance with the terms and conditions of the NoA and cooperating with other key parties, including the AHRQ Program Official, AHRQ contractor, and other recipients.

The PD(s)/PI(s) must participate in monthly teleconferences with the program official and/or other AHRQ personnel as appropriate. The PD(s)/PI(s) and designated project staff must attend an annual one- or two-day meeting with AHRQ staff, AHRQ’s contractor, and other grant recipients, in-person in the Washington, DC area. At this meeting, PD(s)/PI(s), other project staff, the AHRQ contractor, and AHRQ will discuss progress on the work to date, identify common challenges, and engage in problem solving.

PD(s)/PI(s) and key implementation and evaluation personnel must participate in monthly learning community meetings and activities led by AHRQ’s contractor.

AHRQ Responsibilities

AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Cooperative activities are intended to strengthen individual projects and generate collaboration across projects. Specific cooperative aims and activities in carrying out individual projects may be shared among grant recipients and AHRQ program officials. AHRQ staff will provide advice and support to recipients and will assist in cooperative work of the project beyond the usual program stewardship for grants.

The AHRQ Program Official will maintain regular contact with the PD(s)/PI(s) to consult on key project decisions, help trouble-shoot barriers/challenges, and confirm that projects are proceeding according to timelines and plans. The Program Official, in coordination with the recipient and AHRQ contractor, will also disseminate project findings to research and policy audiences. Progress will be officially reviewed quarterly.

AHRQ will:

• Review the development of project timelines and plans and assess progress.
• Work closely with recipients and AHRQ's contractor to ensure harmonization of cross-recipient metrics for evaluation.
• Coordinate and facilitate collaboration and engagement with stakeholders.
• Facilitate the development of common frameworks, tool kits, and other products for implementation and evaluation activities.
• Facilitate conference calls and an annual meeting with grant recipients.
• Work closely with grant recipients, AHRQ's contractor(s), and other federal partners to ensure dissemination of products.
• Additionally, AHRQ program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Collaborative Responsibilities

Applicants must commit to collaborating with AHRQ, its contractor, and other recipients in the learning community, cross-recipient evaluation, and dissemination activities, as described in the section, "Overview of NOFO Requirements: Required Participation in AHRQ’s Broader Initiative".

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually, unless specified otherwise in the terms of the award.

For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html. If instructions on AHRQ's website are different from the RPPR Instructions, follow the instructions on AHRQ's website. Annual progress reports are due three months before the start date of the next budget period of the award.

In addition to the annual RPPR that is required of grants with multiple years of funding, awards under this NOFO carry the requirement to submit a Disparities Impact Statement as part of the RPPRs. Instructions on reporting requirements will be provided at the time of grant award. Conference calls with the AHRQ Program Official for the grant may also be required at the discretion of the Program Official.

Recipients are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually. AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2023, the annual FFR is due 9/30/2023 (90 days after the end of the calendar quarter of 6/30/2023).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 120 days of the project period end date. For further details regarding grant closeout requirements, refer to Post Award Grants Management | Agency for Healthcare Research and Quality (ahrq.gov).

AHRQ NOFOs outline intended research goals and objectives. Post-award, AHRQ will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the HHS Grants Policy Statement (http://www.ahrq.gov/funding/policies/hhspolicy/index.html) for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in SAM about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. Recipients must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Program planning and performance reporting requirements:

Recipient performance will be measured based on success in the following Program goals:

• Reach: Who was reached by the project?

Performance measures:

• Number of patients directly served by grant-supported clinics
• Number of primary care clinicians and/or practices engaged by grant-supported clinics; stratify by type of engagement activity, if possible
• Timeline: Reach annual targets
• Structure and Process: What strategies were implemented and how?

Performance measures:

• Number and types of clinical and non-clinical personnel and services added
  • Timeline: Services and personnel added within year 1 and sustained or adjusted throughout the period of support
• Costs and resources (personnel and non-personnel) associated with implementation
  • Timeline: Report annually (if possible) and cumulative at 5 years

• Impact: What was the impact of implemented strategies?

Performance measures:

• Use of clinical specialties and services offered (e.g., percent of patients using each available service)
• Impact on patient accessibility (e.g., appointment wait times for the initial intake visit and for follow-up care recommended during the intake visit)
• Number of patients discharged from the Long COVID clinic, with the patient’s primary care and/or other current clinicians being notified of the discharge
• At least one patient-reported health outcome or experience of care measure
• Timeline: Data collected through year 5, reach targets

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential recipients.

eRA Service Desk (for questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Poonam Pardasaney, ScD, DPT, MS
Center for Evidence and Practice Improvement
Division of Practice Improvement
Agency for Healthcare Research and Quality
Email: long-covid-rfa@ahrq.hhs.gov

Michele A. Calton, PhD
Scientific Review Officer
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
Email: michele.calton@ahrq.hhs.gov

Anna Caponiti
Division of Grants Management
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1402
Email: anna.caponiti@ahrq.hhs.gov

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices.

This program is described in the Assistance Listings (formerly called the Catalog of Federal Domestic Assistance) at http://www.cfda.gov and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

Awards are made under the authority of 42 USC 299 et seq., and in accordance with 45 CFR Part 75 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement (. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/funding/policies/hhspolicy/index.html)

1. Department of Health and Human Services, Office of the Assistant Secretary for Health. 2022. Health+ Long COVID Human-Centered Design Report, 200 Independence Ave SW, Washington, DC 20201. Available from: https://www.hhs.gov/sites/default/files/healthplus-long-covid-report.pdf.

2. Post-COVID Conditions: Information for Healthcare Providers. Centers for Disease Control and Prevention. [Cited 2023 January 26]; Available from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-conditions.html.

3. What is Long COVID? COVID.gov: An official website of the Department of Health and Human Services. [Cited 2023 January 26]; Available from: https://www.covid.gov/longcovid/definitions.

4. Post COVID-19 condition (Long COVID). World Health Organization. Available from: https://www.who.int/europe/news-room/fact-sheets/item/post-covid-19-condition.

5. National Academies of Sciences, Engineering, and Medicine. Examining the Working Definition for Long COVID. [Cited 2023 March 9]; Available from: https://www.nationalacademies.org/our-work/examining-the-working-definition-for-long-covid.

6. Long COVID. COVID.gov: An official website of the Department of Health and Human Services. [Cited 2023 March 10]; Available from: https://www.covid.gov/longcovid.

7. Long COVID: Household Pulse Survey. Centers for Disease Control and Prevention: National Center for Health Statistics. [Cited 2022 December 19]; Available from: https://www.cdc.gov/nchs/covid19/pulse/long-covid.htm.

8. Verduzco-Gutierrez, M., Estores, I. M., Graf, M. J. P., Barshikar, S., Cabrera, J. A., Chang, L. E., et al. Models of Care for Postacute COVID-19 Clinics: Experiences and a Practical Framework for Outpatient Physiatry Settings. Am J Phys Med Rehabil, 2021. 100(12): p. 1133-1139.

9. Verduzco-Gutierrez, M., Lara, A. M., Annaswamy, T. M. When Disparities and Disabilities Collide: Inequities during the COVID-19 Pandemic. PM R, 2021. 13(4): p. 412-414.

10. Annaswamy, T.M., Verduzco-Gutierrez, M., Frieden, L. Telemedicine barriers and challenges for persons with disabilities: COVID-19 and beyond. Disabil Health J, 2020. 13(4): p. 100973.

11. Morrow, A.K., Ng, R., Vargas, G., Jashar, D. T., Henning, E., Stinson, N., et al. Postacute/Long COVID in Pediatrics: Development of a Multidisciplinary Rehabilitation Clinic and Preliminary Case Series. Am J Phys Med Rehabil, 2021. 100(12): p. 1140-1147.

12. Lutchmansingh, D.D., Knauert, M. P., Antin-Ozerkis, D. E., Chupp, G., Cohn, L., Dela Cruz, C. et al. A Clinic Blueprint for Post-Coronavirus Disease 2019 RECOVERY: Learning From the Past, Looking to the Future. Chest, 2021. 159(3): p. 949-958.

13. Parker, A.M., Brigham, E., Connolly, B., McPeake, J., Agranovich, A. V., Kenes, M. T., et al. Addressing the post-acute sequelae of SARS-CoV-2 infection: a multidisciplinary model of care. Lancet Respir Med, 2021. 9(11): p. 1328-1341.

14. D cary, S., Dugas, M., Stefan, T., Langlois, L., Skidmore, B., Bh reur, A., et al. Care Models for Long COVID: A Rapid Systematic Review. 2021.

15. Decary, S., Dugas, M., Stefan, T., Langlois, L., Skidmore, B., Bh reur, A., et al. Care Models for Long COVID A Living Systematic Review. First Update December 2021. SPOR Evidence Alliance, COVID-END Network, 2021.

16. The SHARE Approach. Agency for Healthcare Research and Quality. [Cited 2023 February 7]; Available from: https://www.ahrq.gov/health-literacy/professional-training/shared-decision/index.html.

17. AHRQ Health Literacy Universal Precautions Toolkit. 2nd edition. Agency for Healthcare Research and Quality. [Cited 2023 February 7]; Available from: https://www.ahrq.gov/health-literacy/improve/precautions/index.html.