It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants 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/foaguidance/index.html. Applicants who propose the use of identifiable CMS data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for this data. 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

The purpose of this FOA is to invite applications to promote health equity and improve the health of individuals and populations at risk for suboptimal health outcomes through the use of primary care and community interventions that address chronic conditions, including prevention and management of multiple chronic conditions. This is to be accomplished by developing data resources, applying health services research methodologies and presenting data analytics to primary care providers, health care delivery systems, public health departments, and/or community organizations to help them address social determinants of health (SDOH) and contribute to the delivery of whole person, 360-degree care that meets physical, behavioral, and oral health, as well as social services, needs.

DEFINITIONS OF KEY TERMS

For the purposes of the Funding Opportunity Announcement, we use the following definitions.

Data analytics techniques, processes, algorithms, and tools to analyze large data sets to draw inferences and insights from disparate data sources. Examples include: data aggregation, data queries, predictive analytics, data mining, risk stratification and scoring, machine learning, natural language processing, and other artificial intelligence (AI) techniques. Data analytics requires an information technology infrastructure (i.e., the data and analytic platform) for collecting and housing the data and analytic tools.

A patient navigator a professional who focuses on the needs of individual patients. Navigators help guide people through health care and social systems and work to overcome obstacles to receiving required care and/or optimizing health and well-being. Patient navigators can include: health care navigators, community health workers, promoters, care managers, care coordinators, case managers, and others.

At-risk individuals individuals who are at high risk of poor health outcomes because of their poor access to health care, disabilities, education, employment/occupation, income/poverty, race/ethnicity, gender identity/sex, sexual orientation, language preference and English proficiency, Veteran’s status, insurance status, housing status, material security (food, clothing, utilities), exposure to discrimination or violence, family and social support, exposure to toxins, refugee status, incarceration history, or history of trauma.

At-risk communities communities that have a high prevalence of chronic disease, high economic, health, social, and/or environmental burdens, and a population that suffers from poor health outcomes.

Primary care providers organizations that include practices, clinics, academic health centers, and other non-emergency settings where primary care clinicians (such as family medicine physicians, general internal medicine physicians, general practice physicians, general pediatric physicians, geriatrician physicians, nurse practitioners, and physician assistants) deliver health care and coordinate specialty and other care.

Secondary data includes administrative data (e.g., claims, hospital discharge), survey data (e.g., national and state health and social service surveys, patient experience surveys), social determinants of health data (e.g., community needs assessments, Census data), and data on community resources (e.g., Area Health Resource Files, 2-1-1 databases, Robert Wood Johnson Foundation 500 Cities or Community Health Rankings databases). See Federal Data Sources for a partial list of publicly available secondary data sets.

Social determinants of health (SDOH) defined by Healthy People 2020 as the, conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. At a community level, data on social determinants of health can include: social and economic factors (e.g., education, employment/occupation, linguistic isolation, social cohesion, social capital, stressors such as crime/safety/violence and discrimination, income/poverty, race/ethnicity, gender identity/sex, sexual orientation), physical infrastructure of the community (e.g., housing, transportation, food access, parks, air and water quality, hazardous waste), health and health behaviors of the community, culture of health care in the community (e.g., view of health care and prevention, health promotion initiatives, health care laws), access to care (e.g., distance to and availability of physicians, clinics, hospitals, community health centers, health care services/interventions, and pharmacies in the community, ability to pay for health services including insurance and cost of care), quality of care (e.g., hospitals, community).

Whole-person, 360-degree care the coordination of interventions and services that address physical, behavioral, and oral health, intellectual/developmental disabilities, and social services in a person-centered manner, with the goals of improved health outcomes and more efficient and effective use of resources in the context of people’s lives and the communities they live in.

BACKGROUND

According to the Centers for Disease Control (CDC), sixty percent of adults in the United States have a chronic condition, such as hypertension, depression, or diabetes. More than one in four adults, and over two out of three older adults, are estimated to have at least two chronic physical and/or behavioral health conditions. Many of the same risk factors contribute to common chronic conditions, which in turn lead to impaired functional status and disability. Chronic conditions are the leading cause of disability, death, and health care costs. Much of the high burden of illness due to chronic illness and associated disability is preventable. Furthermore, these burdens are not equally distributed. Considerable evidence demonstrates there is a relationship between social determinants of health (SDOH) and poor health outcomes (e.g., mortality, acute and chronic disease, disability). Race, socioeconomic status, and place of residence are key determinants of health and life expectancy and result in profound disparities and inequities.

Primary care is the cornerstone of primary prevention for chronic conditions and where many chronic conditions are managed. The complexity and fragmentation of medical, dental, behavioral, and social services, however, often prevents individuals from getting the comprehensive support they need. Primary care settings therefore can benefit from understanding both community-level SDOH as well as the individual social risk factors that affect each patient in order to deliver comprehensive care that includes medical (e.g., primary prevention, self-management support), behavioral (e.g., mental health, substance use), and social services. Practices can develop relationships with public health, community service organizations, and other sectors to address SDOH (including housing, food, transportation, clean water) and other critical health needs including dental services (e.g., primary prevention, oral health education).

The community and context in which people live can have a powerful positive or negative effect on health outcomes. Overcoming socioeconomic adversities can be as important as health care services in preventing chronic disease and reducing its negative impact. By expanding data capacity, this project enables research and analysis that helps communities including state and local public health agencies, social service and community organizations take actions to address SDOH disparities.

Better understanding of patterns of chronic illness at the community level, community-specific modifiable risk factors, and clinical and community resources, help with the characterization of SDOH and other risk factors that contribute to disease. Similarly, better understanding of the context in which people live their lives and receive care contributes to the identification and reduction of health inequities. Primary care clinicians, working with teams that may include patient navigators, have a vital role in assessing and acting upon SDOH to improve health outcomes.

OBJECTIVES

AHRQ’s goal is to promote health equity and improve the health of individuals and populations at risk for suboptimal health outcomes through the use of primary care and community interventions that address chronic conditions, particularly multiple chronic conditions, and functional status. This is to be accomplished by supplying data analytics to providers of primary care, health care delivery systems, public health departments, and/or community organizations to help them address SDOH and contribute to the delivery of whole person, 360-degree care that meets physical, behavioral, and oral health, as well as social services, needs.

This FOA seeks to harness the power of data to improve individual and community health among those at greatest risk for preventable adverse health outcomes. Applications submitted to this FOA will propose to use data analytics to enable primary care providers to better prevent and manage chronic illness, including multiple chronic conditions, and to support public health and community organizations to use local SDOH information in planning for and addressing the health needs of at-risk individuals and communities. Applicants can propose to focus on data analytics to inform: 1) primary care interventions, and/or 2) community interventions. The following describes the two types of interventions.

Primary Care Interventions

Applicants targeting primary care interventions should propose to develop easy-to-access data, analyses, analytic tools, and/or data-driven protocols aimed at enabling primary care providers to manage patients at high risk for preventable disease or disease progression. The recent report from the National Academy of Medicine, The Future of Health Services Research, provides examples of using predictive analytics and integrating large databases to improve primary care delivery to high-need populations. The report describes a project that used clinical, claims, SDOH data to characterize high-need, high-cost patients. They developed a social vulnerability index that is being translated into an actionable algorithm that health systems can run on their health information systems to help target effective interventions at the patient-level. One such intervention is the use of patient navigators, often embedded in a health care delivery organization, who can help patients negotiate the various systems to ensure patients receive the full array of needed services. Another example is the creation of a primary care data dashboard that imports SDOH data into health information systems so that practices can make better population health management decisions.

Alternatively, the data and analytic platform could be used to inform primary care providers' participation in community interventions that benefit the providers' entire patient population. For example, community SDOH data could be used to: 1) prioritize which specific SDOH the community should tackle first (e.g., preserving affordable housing, organizing recreational activities for socially isolated individuals, establishing farmers markets, improving air quality), or 2) geographically target high-need locations for forming community partnerships (e.g., with public health, social services).

Community Interventions

Applicants targeting community interventions should propose to use their data and analytics to better understand patterns of chronic disease, SDOH, and community resources and services. For example, applicants could consider use of hot spotting methods to identify geographic areas of higher rates of uncontrolled diabetes that community planners could use to allocate outreach workers, develop safe exercise spaces, and introduce healthy eating education. Alternatively, applicants might discover a high prevalence of depression and poor eating habits among elderly women with residential and social isolation. Equipped with that data, community planners could develop recreational and nutritional outreach programs. Another example of using data analytics to inform a community intervention would be a data platform that outreach workers, police, and the public could access with mobile devices to identify in real time available shelter beds, nearby food pantries, or other services to address SDOH. Data collected about inquiries that measured unmet needs could guide expansion plans for housing and hunger programs. Data on community levels of stress due to discrimination could inform the provision of cultural sensitivity training of police, case workers, and other service providers.

Aligning health care and community interventions could greatly improve individual and community health outcomes. For example, primary care interventions that coordinate transportation assistance with community transit access programs or community interventions that connect at-risk individuals with health delivery systems to advance whole-person 360-degree care. Applications targeting community interventions should address their connection with health care organizations (e.g., primary care, hospitals, integrated health systems) and how they could access and use these data

APPLICATION REQUIREMENTS

To foster enduring relationships between the grantee and stakeholders in the selected geographic region, applicants must be located in same state as the geographic region they have selected. If a region crosses state borders, the applicant may be located in any of the area's states, as long as the portion of the area in that state is not trivial. A targeted region does not have to be contiguous, but applicants should provide a convincing rationale as to why the non-contiguous areas present a coherent region.

Applicants must plan for up to three project team members, including but not limited to the PI and coinvestigators from partner organizations, to attend a 1 -day meeting in Washington DC each year of the three-year grant.

Applicants should:

1. Address the needs of at-risk individuals and communities in a defined geographic region. Applicants must define a geographic region within which they will test their user-centered interface. Applicants should select a region where their proposed activities are likely to reduce health inequities. AHRQ is particularly interested in reducing racial/ethnic and socioeconomic (SES) disparities.

2. Identify and obtain data to import, analyze, and display, including data on chronic disease risk factors and prevalence, SDOH, and community services. Secondary data may be principally used. However, those data may link to or inform the collection of person-specific data by primary care or community providers. AHRQ encourages applicants to consider a variety of data sources that address region-specific community health for chronic diseases, including but not limited to Federal, state, and local data. It will be important that applicants be able to obtain access to data sources expeditiously.

Federal datasets that applicants can consider include but are not limited to:

• AHRQ’s Healthcare Cost and Utilization Project (HCUP), which includes State Inpatient Databases (SID), a set of longitudinal State-specific hospital inpatient databases. To learn more about the SID and how to obtain the SID, visit: www.hcup-us.ahrq.gov/sidoverview.jsp.
• AHRQ’s Medical Expenditure Panel Survey (MEPS) is a set of large-scale surveys of families and individuals, their medical providers, and employers across the United States. For more information and to access data files, visit: https://meps.ahrq.gov/mepsweb/.
• AHRQ uses a number of publicly available data sources that contain SDOH information. For a comprehensive list of SDOH databases, visit: https://www.ahrq.gov/topics/social-determinants-health.html.
• Centers for Medicare and Medicaid Services (CMS) releases a number de-identified, summarized Public Use Files (PUF). To locate relevant PUFs, visit: https://dnav.cms.gov/.
• CMS makes Limited Data Set (LDS) files available to approved researchers under a Data Use Agreement. LDS files contain beneficiary identifiable protected health information, but exclude direct identifiers specified in HIPAA. For more information about the process for requesting LDS files and the fees associated with accessing these files, visit: https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/index.html.
• CMS makes research identifiable files (RIFs) available to approved researchers under a Data Use Agreement. RIFs contain protected health information (PHI) and/or personally identifiable information (PII) and CMS is committed to ensuring this information is protected. For more information about the process for requesting RIFs and the fees associated with accessing these files, visit the CMS Research Data Assistance Center (ResDAC) at: https://www.resdac.org/.

Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System (BRFSS) collects state data about U.S. residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services. Find more information at: www.cdc.gov/brfss/index.html.

• Health Resources and Services Administration’s Area Health Resource Files include data on Health Care Professions, Health Facilities, Population Characteristics, Economics, Health Professions Training, Hospital Utilization, Hospital Expenditures, and Environment at the county, state and national levels. To query or download data, go to https://data.hrsa.gov/.
• National Center for Health Statistics (NCHS) offers a number of downloadable data sets, including National Health and Nutrition Examination Survey (NHANES), National Health Care Surveys, National Vital Statistics System (NVSS), National Health Interview Survey (NHIS), and Longitudinal Studies of Aging (LSOA). For more information, visit: www.cdc.gov/nchs/data_access/ftp_data.htm.
• The U.S. Bureau of the Census fields the American Community Survey, available at: https://www.census.gov/programs-surveys/acs/
• Information about other Federal and State data sets can be found at www.HealthData.gov.

3. Adapt or build a data and analytic platform that integrates data from multiple sources and select data analytic methods. AHRQ encourages applicants to consider combining SDOH and other data with electronic health record (EHR) data and use advanced data analysis techniques to better inform individual and population health and chronic disease management in primary care in the targeted region.

Applicants are encouraged to consider existing primary care data analytic initiatives, including but not limited to, models from the CMS:

• The Comprehensive Primary Care Plus (CPC+) model, the CPC+ data feedback tool that provides an interactive aligned beneficiary and population health data analytic tool for care improvement. The CPC+ data feedback tool is only available to CPC+ practice participants and business associates. More information about CPC+ is available at https://innovation.cms.gov/initiatives/comprehensive-primary-care-initiative/.
• The Accountable Health Communities Model that promotes clinical-community collaboration through screening to identify unmet health-related social needs, providing navigation services to assist with accessing community services, encouraging alignment between clinical and community services.
• Integrated Care for Kids (InCK) Model, which will support states and local providers to conduct early identification and treatment of children with health-related needs across settings. Medicaid agencies provide population-level data for the geographic service area, supporting the development of information sharing arrangements and infrastructure, working to align support for the model across child-focused state agencies.

4. Partner with stakeholders (e.g., primary care providers, health care delivery organizations, state departments of health, community service organizations) who will use the data and analytic products. AHRQ encourages applicants to have extensive experience in working in partnership with primary care and/or community stakeholders, including but not limited to state and/or local departments of health and other sectors (e.g., social services, housing, education) that address SDOH.

5. Perform analyses to inform chronic disease prevention and management, including of multiple chronic conditions. AHRQ is not seeking more studies to further quantify health inequities and their consequences. Analyses should inform primary care and/or community interventions, including patient navigators to improve the health and well-being of individuals and communities at greatest risk for preventable adverse health outcomes, and reduce the incidence and severity of chronic diseases.

6. Design and test a user-centered interface (e.g., dashboard) to present data analytics to stakeholders and/or integrate with existing information systems. For primary care interventions: Applicants are encouraged to consider how such a data and analytic platform could interface with primary care health information systems (e.g., electronic health records (EHRs), registries), and other existing data feedback tools for primary care. Applicants must plan to test their user-centered interface in the targeted region with primary care providers and/or community organizations and validate its ability to inform primary care and/or community interventions.

7. Conduct an evaluation examining whether data analytics provided to stakeholders informed interventions to improve whole-person care for individuals and communities at risk.

8. Disseminate information and tools required for replication (e.g., database artifacts, data types used, description of platform and data analytics used, models, algorithms, application program interfaces, graphical user interface), as well as findings and insights from the project. Successful projects should be easily replicated. Applicants must plan to cooperate with AHRQ and its contractors on dissemination activities.

These projects are authorized by 42 U.S.C. 299a(7) and (8), 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 health promotion and disease prevention, including database development.

All applications submitted and AHRQ grants made in response to this FOA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), the HHS Grants Policy Statement (see http://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 AHRQ 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)

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

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

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 grantee 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.

Applicant Organizations

Applicant 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (https://www.sam.gov/portal/SAM/#1) (formerly CCR) Applicants 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order 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.

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. See also AHRQ's NOT-HS-16-018 related to Multiple PD/PI via https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this RFA, 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.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-18-197 ).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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 staff estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants 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, with a Subject line of Letter of Intent to Submit Application to Data Analytics and Population Health FOA to _____, should be emailed to: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed unless otherwise noted in this FOA.

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

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. 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. Applicants 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.

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:

The research strategy section of the application is limited to 20 total pages. Applications with a Research Strategy section that exceeds 20 pages will not undergo peer review.

The research strategy should describe, but is not limited to, the following:

• Target Region
• Project Team, Organization, and Management
• Stakeholder Collaboration Plan
• Data and Analytic Plan
• Sustainment and Dissemination Plan
• Appendix

Section 1: Target Region

This section should:

• Define a geographic region that has a high prevalence of chronic disease and within which grantees will test their user-centered interface.
• Include descriptions of the: 1) population of at-risk individuals, 2) the primary care and community infrastructure to serve at-risk individuals, and 3) the SDOH they face.
• Explain how targeting this region and this population will reduce inequities in health care and health outcomes.

Section 2: Project Team, Organization, and Management

This section should:

• Describe the structure and members of the project team, and the roles of team members in the project, including:
• The proposed leadership and governance structure for the project, the roles and responsibilities of each organization, and how collaboration and coordination of all participating organizations, institutions or other entities will be ensured.
• Any history of working together and previous successful joint projects.
• The resources and expertise that each organization and all key personnel bring to the project that would support the goals of this initiative
• Provide a project timeline showing the major scheduled activities and milestones for the project and how they will be completed in three years.

Section 3: Stakeholder Partnership Plan

This section should:

• Describe their relationships with community partners, such as primary care providers, local, state, and/or regional organizations (e.g., departments of public health, community service providers, primary care associations, health care delivery systems, health information exchanges). AHRQ encourages applicants to recruit community partners willing to make financial or in-kind contributions to this project, which will give them a stake in its success.
• Explain how they will use user-centered design principles, including but not limited to substantial involvement of users (e.g., primary care providers, community organizations) throughout the design process, to ensure that the data and analytic tools are both useful and easy-to-use.
• Tell how they will get input from individuals with chronic disease and their families to understand and act upon their preferences and priorities for improving the health and well-being of individuals with or at risk of chronic disease, including those with multiple chronic conditions.

Section 4: Data Analytic and Testing Plan

Applicants must describe a plan to develop and test the use of data analytics to inform interventions to prevent and/or manage chronic disease.

This section should describe:

• The data and analytic platform they will adapt or develop.
• The data sources that will be used. Applicants must demonstrate that they will be able to obtain access to those sources expeditiously.
• The analytic methods that will be used.
• How the data, data analysis, and analytic tools will inform primary care and/or community interventions to prevent disease before it occurs or progresses, taking into account SDOH. The plan will describe how the applicants will ensure that the right data is provided to the right people, in the right format, using the right channel, at the right time.
• Plans for developing and testing the user-centered interface in the targeted region with primary care providers and/or community organizations and validating its ability to inform primary care and/or community interventions.
• The evaluation plan to examine whether data analytics provided to stakeholders informed interventions to improve whole-person care for individuals and populations at risk.

Section 5: Sustainment and Dissemination Plan

This section should describe:

• What effects from this project could last beyond the grant period and how they would be sustained.
• How the project could be replicated easily in other regions.
• Plans for sharing project findings and insights into data analytics and the role it can play in addressing SDOH and health inequities. This should address dissemination to multiple stakeholder groups and should not be limited to peer-reviewed publications and conference presentations at the end of the project.
• Plans to disseminate information and tools required for replication (e.g., database artifacts, data types used, description of platform and data analytics used, models, algorithms, application program interfaces, graphical user interface).
• How the applicant will cooperate with AHRQ and its contractors on dissemination activities.

Resource Sharing Plan: Individuals 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:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

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

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-18-126

Special instructions for this FOA:

• Include in the Appendix letters of commitment from all organizations that are part of the project team.
• Include in the Appendix letters of support from organizations that have agreed to participate in and collaborate as part of the proposed project to document the strength of already established partnerships and/or intention to partner for the purposes of this project. Letters of support, recommendation, or endorsement from any entity or individual who is not directly participating in the proposed project should NOT be included. These types of letters may impede the review and/or selection process.

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 with the following additional instructions:

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). A Delayed Onset study is one in which human subjects research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application.

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

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

Part I. Overview Information contains information about Key Dates and times. Applicants 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). Applicants 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.

Applicants 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.

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number 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 Avoiding Common Errors for avoiding common errors.

The applicant should pay particular attention to the SF424 (R&) application guide instructions concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH and for responsiveness by AHRQ. Applications that are incomplete will not be reviewed.

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, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Applicants are required to follow the instructions for post-submission materials, as described in see NOT-OD-18-197. Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups, minority groups, women, children, the elderly, and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. 42 USC 299(c). Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. 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-03-010.html. Applicants under this FOA should consider and discuss including priority populations in the 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.

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. Applicants 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, applicants 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 grantees under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee 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 grantees 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 Federal purposes, and to authorize others to do so. In accordance with AHRQ's research dissemination mandate, such products and materials will be made available to the public and the health care community. AHRQ purposes may include but are not limited to making project materials, databases, results, and algorithms available for verification or replication by other researchers. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ requests that grantees 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 [email protected] at least four to six weeks in advance of the journal’s expected publication date.

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

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.

AHRQ's priority areas of focus are:

• Research to improve health care patient safety.
• Harnessing data and technology to improve health care quality and patient outcomes and to provide a 360-degree view of the patient.
• Research to increase accessibility and affordability of health care by examining innovative market approaches to care delivery and financing.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific 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 scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

• Is the proposed project likely to result in data analytics that supports: 1) primary care interventions to improve chronic disease prevention and management for at-risk individuals and populations served, and/or 2) community interventions that help community agencies and organizations address the SDOH and other factors that cause and exacerbate chronic disease?
• For primary care interventions: Is the proposed project likely to lead to sustainable improvements in the way primary care providers care for individuals and populations with or at risk of chronic disease, or reduce risks for their entire population of patients?
• For community interventions: Is the proposed project likely to lead to sustained activity by community partners (e.g., local, state, and/or regional organizations, such as departments of public health, community service providers, primary care, health information exchanges) to reduce risk factors for chronic illness in the community? Has the connection with and use by health care organizations been described?
• How easy will it be to replicate the project in other regions?
• Is the proposed project likely to lead to data-driven primary care or community interventions that reduce health inequities?
• Would it be possible to scale up the products from this project to benefit a substantial portion of at-risk individuals and communities in the U.S.?

• Does the project team, including the PD(s)/PI(s), team members, and collaborating organizations, have the appropriate training, skills, experience, and resources to carry out the work successfully? Do they have complementary and integrated expertise?
• Are the governance structure and leadership for the project and the roles and responsibilities of each participating organization clearly described and appropriate?
• Do partnerships and collaborations already exist? Have partnerships important to the success of the project been formed? Are the letters of support strong and convincing? Are processes and mechanisms to support collaboration and coordination among all participating organizations clearly identified and likely to be effective?
• Are the total hours described for all key personnel appropriate to the level of effort required for the performance of their responsibilities?

• How innovative is the proposed approach to providing data analytics? Does the application apply state-of-the-art approaches to new populations or communities?
• How well do the proposed data analytics support novel approaches to improve chronic disease prevention and management for individuals and communities at risk for suboptimal health outcomes?
• Are there innovative partnerships that could serve as a model for other at-risk communities seeking to achieve the same aims?
• How likely is it that the proposed innovations will be successful within the time and budget proposed?

• Are the overall strategy and methods well-reasoned and appropriate to accomplish the specific aims of the project?
• Have the applicants presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Is the applicant's Stakeholder Partnership Plan appropriate and realistic?
• Are there any signs that the partnerships are not stable?
• Is the plan to get input from individuals with chronic disease and their families appropriate and realistic?
• Is the applicant’s Data and Analytic Plan for each of the following appropriate and realistic?
• Data and analytic platform.
• Data sources: Are they using the right data? Have they demonstrated they can access the data in a timely manner?
• Analytic methods.
• Plans for developing and testing the user-centered interface. Are the right people testing the interface? Is it likely that the testing will be implemented as planned? Is the scope of the testing sufficient to validate the interface? Is it likely that the interface will be both useful and easy-to-use?
• Evaluation plan. Is it likely that they will be able to tell whether data analytics provided to stakeholders informed primary care and/or community interventions to improve whole-person care for at-risk individuals and communities?
• Is the applicant’s Sustainment and Dissemination Plan appropriate and realistic?
• Is it likely that effects from this project will be sustained?
• Is it likely that the findings and insights into data analytics, as well as information and tools necessary for replication, will be shared with multiple stakeholder groups?
• Are the proposed innovative methods of dissemination (i.e., other than peer-reviewed publications and conference presentations) likely to be effective?
• Has the applicant committed to cooperate with AHRQ and its contractors on dissemination activities?
• Is the project likely to inform primary care and/or community interventions to prevent disease before it occurs or progresses, taking into account SDOH?
• Has the applicant adequately described how particularly risky aspects of the project will be managed? Are potential problems, alternative strategies, and benchmarks for success presented?
• Is the timeline realistic?

• Will the scientific environment in which analytic work will be done contribute to the probability of success?
• Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?
• How much will the capacities, experience, expertise, and other resources of the applicant institution and participating organizations contribute to the project’s success? Does the application effectively leverage regional and local expertise?
• Has the applicant clearly defined and convincingly demonstrated that: 1) the target region is a at high risk of poor health outcomes, and 2) improving care to people with or at risk of chronic disease in this area has the potential to reduce health and health care inequities?
• Does the proposed project benefit from features of the area, such as recent or on-going health and health care initiatives, health information exchanges, clinical environments, community settings, and patient populations?
• Have potential environmental obstacles and the means for avoiding or mitigating their effects been identified?

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 six 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 six 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.

Degree of Responsiveness

Reviewers will assess how well the application addresses the purpose and objectives of this FOA. How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Budget and Period of Support

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.

Inclusion of Priority Populations

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.7 Other Submission Requirements ).

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.

Not applicable.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA 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 compete for available funds with all other recommended applications submitted in response to this FOA.

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 FOA.
• 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 Part 1 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 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, applicants 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).

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.

Awardees 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.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the OER Glossary link or the AHRQ web site at https://www.ahrq.gov/funding/grant-mgmt/index.html.

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award. As necessary, additional Terms and Conditions will be incorporated into the award statement.

A standard term and condition of award will be included in the Notice of Award (NOA) that states: in any grant-related activity in which family, marital, or household consideration are, by statute or regulation, relevant for purposes of determining beneficiary eligibility or participation, grantees must treat same-sex spouses, marriages, and households on the same terms as opposite-sex spouses, marriages, and households, respectively. By same-sex spouses, HHS means individuals of the same sex who have entered into marriages that are valid in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By same-sex marriages, HHS means marriages between two individuals validly entered into in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By marriage, HHS does not mean registered domestic partnerships, civil unions or similar formal relationships recognized under the law of the jurisdiction of celebration as something other than a marriage.

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research

For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please 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/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations.

For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53 .

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 Awardee 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 applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all AHRQ grants and cooperative agreements except fellowships.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award. Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual progress reports are due 3 months before the anniversary of the award. In addition to the annual progress report, recipients may be required to submit interim progress reports to AHRQ. If applicable, detailed instructions on additional reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). 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 4/30/2018, the annual FFR is due 9/30/2018 (90 days after the end of the calendar quarter of 6/30/2018).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer https://www.ahrq.gov/funding/grant-mgmt/closeout.html.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the HHS Grants Policy Statement (https://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 Appendix XII to 45 CFR Part 75, 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 the System for Award Management (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. The recipient 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 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (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: http://grants.nih.gov/support/ (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: [email protected]

General Grants Information (Questions regarding application processes and AHRQ grant resources)
Email: [email protected]

Brent Sandmeyer, MPH
Social Science Analyst
Agency for Healthcare Research and Quality
Phone: (301) 427-1441
Fax: (301) 427-1430
[email protected]

Celeste Torio, PhD, MPH
Scientific Review Officer
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations (OEREP)
Agency for Healthcare Research and Quality (AHRQ)
Email: [email protected]

Brian Campbell
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1266
Email: [email protected]

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. 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/fund/hhspolicy.htm.

This program is described in the Assistance Listings (formerly called Catalog of Federal Domestic Assistance, or CFDA ) 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 https://www.ahrq.gov/funding/policies/hhspolicy/index.html.