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 the cost of 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

The purpose of this FOA is to request applications to develop, implement, evaluate, and disseminate strategies to improve the management of opioid use and opioid use disorder (OUD) in older adults in primary care settings.

For the purposes of this FOA, the following definitions apply:

Management of Opioid Use: Processes or activities to support the spectrum of care needed to: prevent potentially inappropriate prescribing and opioid misuse while ensuring the need for effective pain management is addressed; appropriately prescribe opioids when indicated; manage the care of opioid users to prevent adverse events and misuse; treat OUD when present. Specific activities or tools might include, but would not be limited to, strategies to address needs and challenges associated with the following types of activities:

• For patients for whom prescription of opioids may be considered (e.g., for pain management):
• Use of shared decision-making to support patient involvement in assessment of risk and benefits of treatment options (allow the physician and patient to jointly decide how the risks/benefits of opioids and other pain treatments align with their goals of care, and set realistic pain management expectations)
• Use of multi-modal pain management approaches
• Use of risk mitigation strategies (e.g., time limited prescribing; developing plan for tapering and discontinuation of prescription at the time of initial prescribing as appropriate; naloxone distribution; prescribing medication for OUD if appropriate)
• Use of other strategies to guide prescribing that mitigate risk for misuse or development of OUD
• For patients who are currently prescribed opioids for acute or chronic pain:
• Assessing whether opioid treatment is effective and whether the dose and duration is optimal
• Use of shared decision-making to support patient involvement in assessment of risk and benefits of other available treatment options
• Monitoring opioid use and identifying risk factors to prevent adverse events, misuse, diversion, or OUD.
• Determining whether tapering is appropriate and, if so, tapering and ensuring effective multimodal pain management
• Identification of the presence of opioid misuse or OUD in older adults, whether on prescription opioid therapy or not, and providing effective treatment. Identification of OUD should be based on careful assessment of validated criteria (i.e. using a Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID) or Mini International Neuropsychiatric Interview (MINI) or other instrument to assess all symptoms).

Medication-assisted treatment: (MAT; also referred to as Medications for Opioid Use Disorder, or MOUD) is the use of FDA-approved medications in combination with counseling and behavioral therapies to provide a whole-patient approach to the treatment of OUD.

Older Adults: While older adults are typically defined to be persons aged 65 or older, AHRQ recognizes the potential limitations with this arbitrary definition and invites applicants to define the term older adults as they see appropriate for meeting the objectives of this FOA, if they provide a clear and convincing reason for why the different definition is will be more effective for meeting the objectives of the FOA.

Opioid Misuse: Taking prescription opioids in a manner or for a purpose other than what they were prescribed for.

Opioid Use Disorder (OUD): Problematic pattern of opioid use leading to clinically significant impairment or distress (American Psychiatric Association, 2013). It may be characterized by physical effects (e.g., tolerance and withdrawal); difficulty reducing use; risky use behaviors; failure to fulfill obligations; and social problems. (Providers Clinical Support System, 2017). OUD occurs when the recurrent use of illegal or prescription opioids causes clinically significant impairment, including health problems, disability, and failure to meet major responsibilities at work, school, or home. Physical dependence alone is not opioid use disorder.).

Opioid related outcomes: Patient outcomes affected by opioid use. These include mortality, hospitalization or emergency care due to illegal or prescription opioids, rates of potentially inappropriate opioid prescribing, adverse events from opioid use, rates of opioid misuse, OUD, and rates of co-occurring mental disorders (e.g. depression, suicidal ideation).

Primary Care: AHRQ defines primary care as the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, including prevention and health promotion, developing a sustained partnership with patients, and practicing in the context of family and community.

Primary Care Practices: Primary care practices are health care organizations that are dedicated to providing primary care and where care is delivered by clinicians such as family medicine physicians, general internal medicine physicians, general practice physicians, general pediatric physicians, geriatrician physicians, nurse practitioners, and physician assistants.

Quality Improvement: Quality improvement (QI) is the action of systematically improving the process by which care is delivered to patients. Processes have characteristics that can be measured, analyzed, improved, and controlled. QI entails continuous efforts to achieve stable and predictable process results, that is, to reduce process variation and improve the outcomes of these processes both for patients and the health care organization and system. Achieving sustained QI requires commitment from the entire organization, particularly from top-level management.

The United States is in the midst of an unprecedented opioid crisis that is affecting people from all walks of life. Regulators and policy makers have initiated many activities to curb the crisis, but relatively little attention has been paid to the growing toll of opioid use, opioid misuse, and OUD in older adults. Between 2010 and 2015, the rate of opioid-related inpatient stays and Emergency Department (ED) visits increased for people 65 years old or older by 34% and 74% respectively. This includes older adults who experienced common side effects from opioids such as constipation, confusion, nausea, falls, etc., as well as overdoses.[i]

The opioid crisis in older adults is strongly related to challenges in prescription opioid management in this population. Older adults have a high prevalence of chronic pain. Pain is linked to disability and loss of function, reduced mobility, falls, depression, anxiety, sleep disorder, social isolation, and also to suicide and suicidal ideation.[ii] Until recently, chronic pain in older adults was often treated primarily with long-term opioid prescriptions. In 2016, a third of the more than 40 million Americans enrolled in Medicare Part D received prescription opioids and a substantial number received higher doses than recommended for prolonged periods of time. However, for some chronic conditions there is little evidence that opioids are effective or there is evidence that other treatments are as effective and safer.[iii],[iv],[v] A comprehensive, person-centered, approach to pain management in older adults that includes opioids, other medications, and complementary and integrative care could both improve pain control and function, and at the same time reduce the harms of unnecessary opioid exposure.[vi]

Older adults are especially vulnerable to developing adverse events from opioids use, making safe prescribing more challenging even when opioids are an appropriate therapeutic choice. Biological changes associated with aging complicate management of opioids. Changes in metabolism in older adults enhance their risk of serious side effects such as overdose, dizziness, and/or delirium.[vii],[viii] Older adults often have multiple chronic conditions and take multiple medications that increase risk of side effects due to drug-disease and drug-drug interactions.[ix],[x] For example, older adults are at higher risk for falls when opioids are co-administered with other medications that affect the central nervous system or when the person is frail and has had previous episodes of delirium.[xi][xii]

Identifying adverse effects due to opioid use, misuse or abuse is complicated further by factors such as co-occurring disorders that can mimic the effects of opioid use. There is also a risk of attributing clinical findings in older adults (e.g., personality changes, dementia, falls/balance problems, difficulty sleeping, and heart problems) to other conditions that are also common with age. If adverse events due to opioid prescriptions are identified, finding appropriate alternatives for pain management can be challenging if other pharmacologic options (such e.g. NSAIDS, gabapentin) are contraindicated or mobility issues limit access to other therapeutic options. It can also be difficult to treat pain in persons with cognitive disorders (e.g. dementia, delirium, intellectual disabilities) where communication challenges exist.

Diagnosis of substance use disorders is also more complicated in older adults. The first wave of the "baby boom" generation turned 65 years old in 2011, comprising about thirty percent of the total US population. Historically older adults have not experienced high rates of SUDS; but there is some evidence these conditions have been under-diagnosed in older adults for many years. There is a strong need for a better understanding of how SUDs, including OUD, and the intersection of care for acute and chronic pain are impacting this population. Clinicians may not associate substance use disorders with older adults or they may be inadequately trained in the identification and treatment of opioid misuse and OUD among older adults, and hence may not monitor for the signs of OUD or co-occurring SUDs in this population. Symptoms of OUD may be masked as part of the aging process or confused with other common diseases such as depression or dementia. Similarly, older persons may not seek help because they may not be aware that prescribed drugs can create dependence, or that treatment is available for OUD. Stigma is also an issue. Older patients may not report their concerns about their opioid use for fear of being labeled a drug seeker or addicted. Substance use disorder treatment centers or programs are often designed to engage younger adults, which may present additional barriers.

Successfully optimizing the prescribing and use of opioids in older adults will require addressing the issue at many points along the care continuum where older adults may need a specialized approach to pain care. Primary care should be central to this effort, although proposals are encouraged to integrate other settings, such as ambulatory, emergency and perioperative care. Evidence-based tools and resources will be needed to adapt guidelines for this population, and effective ways to integrate these tools into the workflow of primary care clinicians and care teams. Primary care providers need innovative models, supports, tools and implementation strategies that are feasible to adopt and incorporated into practice workflow. Effective strategies will incorporate existing tools, such as the electronic health record, as well as other options such as team-based approaches, patient/caregiver engagement in decision making, and use of community-based resources. While some evidence-based guidelines are available, the development of tools and processes adapted for older adults and strategies to integrate them into primary care workflows is still in the early stages. There is a gap in existing research focusing on clinic and system level interventions to inform management of opioids in older adults. Therefore, AHRQ is interested in developing, testing, and disseminating interrelated strategies that allow primary care practices to optimize pain management in their older adult patients, and to prescribe and monitor appropriate opioid use to minimize adverse events and OUD risk. These strategies should build on evidence-based guidelines and, where possible, tested tools.

The goal of this FOA is to fund projects that develop, implement, evaluate, and disseminate strategies allowing primary care practices to optimize pain management in their older adult patients, prescribe and monitor appropriate opioid use so as to minimize adverse events and addiction risk, and identify and treat OUD. These strategies should build on evidence-based guidelines and, where possible, tested tools. AHRQ is seeking applications that focus primarily on primary care, although other settings may be incorporated into the project as part of the continuum of care for patients based within a primary care setting. AHRQ is not seeking applications that address populations other than older adults or that take place exclusively in settings other than primary care (e.g., emergency departments, assisted living or nursing homes, specialty settings). Applications that focus on other patient populations or primarily on other care settings will not undergo peer review.

Applicants must:

1. Convene a team with the expertise and experience to achieve the goals of this FOA. The project team should have existing strong relationships with primary care practices, expertise in pain management, OUD, and geriatrics, experience with implementing quality improvement in primary care practices, and experience in disseminating and implementing findings from patient centered outcome research (PCOR).

2. Identify either a health system which provides primary care, or a network of primary care practices which care for older adults, and provide preliminary data to suggest that pain and opioid management in this population is suboptimal. Data might include, for example, hospitalizations rates related to opioids, lack of systems for assessing or monitoring opioid use, lack of procedures for multimodal pain or OUD management, etc. Applications are encouraged to consider including other settings, such as ambulatory, emergency and perioperative, as well as building networks with social services as part of the care transformation model, as long as the intervention is centered in primary care. Applications should include the influence of social risk and organizational factors in the development, implementation, and dissemination of strategies to improve the management of opioid use and OUD in older adults, as appropriate. Applications are also encouraged to select practices that include diverse populations in terms of socio-economic status, gender, race/ethnicity, and geography (including rurality). Descriptions of proposed implementation sites must include:

• estimates of the number and percentage of older adults cared for;
• opioid-related harm and adverse events resulting from opioid-misuse by older adults;
• current treatment of Opioid Use Disorder (OUD) among older adults

If the cohort of practices to be recruited does not meet the above criteria (e.g., data demonstrating suboptimal pain and opioid management), the applicant must explain how the proposed intervention would lead to additional improvements.

3. Provide a preliminary assessment of the extent to which current efforts to improve pain management and optimize opioid use in the study practices specifically address older adults. Applicants should provide a description of any federal or state (SUD/OUD) funding that they currently receive and a description of how they will avoid duplication/overlapping of effort, science and/or budgetary items of costs across awards.

4. Develop a comprehensive model or models for improving the management of pain, opioid use and OUD for older adults in those primary care practices, in the context of person-centered management that acknowledges multiple chronic conditions as well as social risk factors.[xiii] Management includes the entire continuum of care, from appropriate treatment for acute and chronic pain that includes a consideration of the full range of treatment modalities, through optimal management of opioids when indicated, monitoring and management of adverse events, misuse, OUD, and tapering with shared decision making when appropriate. Proposed projects should consider all stages of management, although the intensity of intervention may vary by management stage, and should plan for sustainability. The project should integrate Department of Health and Human Services guideline recommendations (e.g., Centers for Disease Control and Prevention, National Institutes of Health), findings from other relevant AHRQ projects related to opioids and pain management (https://www.ahrq.gov/opioids/index.html), and use evidence-based approaches where possible. AHRQ is interested in approaches that include Learning Health System models, shared decision-making (SDM), safe prescribing and risk mitigation practices, multimodal pain therapy for patients, leveraging existing health information technology or electronic health record systems, and adapting to meet the needs of specific populations of older adults. Models that engage relevant community-based organization(s) who serve older adults are also of interest.

5. To further support development of the science, we encourage use of innovative methods and study designs in answering the intended research questions that advance our understanding of implementation. Mixed methods designs that include integrative approaches to examine qualitative and quantitative results together are encouraged. Innovative study designs such as agile and adaptive designs that address complexity are also encouraged. These are offered as examples and not prescriptive of specific methods. Resources on implementation strategies are available.[xiv], [xv], [xvi],^[xvii]

6. Plan to recruit and engage at least 25 primary care practices, and provide necessary training and support to clinicians and practices in implementing the model. The practices selected must serve a sufficient number of relevant patients (i.e. older adults, older adults with chronic pain, and older adults using opioids) for interpretable evaluation results.

7. Plan for a robust, multi-level intervention evaluation that will examine the effectiveness of the implemented model to improve opioid-related outcomes and pain outcomes among older adults while maintaining or improving other important measures of health and well-being. The evaluation should also describe the experience of primary care physicians and staff members in implementing the model, and lessons learned for implementation.

8. Propose a dissemination plan (including a notification to AHRQ and the AHRQ Office of Communications) of any related publications or events.

9. Provide a project timeline showing the major scheduled activities and milestones for the project, including:

• Start-up activities (e.g., hiring and training staff)
• Recruitment of primary care practices
• Implementation initiation and completion
• Evaluation plan
• Dissemination and Sustainability Plan

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

These projects are authorized by 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 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/SAM/) (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.

The PI must devote at least 20% full-time effort (i.e. at least 8 hours per week) in each given year of the project. If a multiple PI plan is proposed, one of the PIs must devote at least 20% full-time effort (i.e. at least 8 hours per week) in each given year of the project and any other PI(s) must devote at least 10% full-time effort (i.e. at least 4 hours per week) in each given year of the project. It is expected that a PI devoting at least 20% full-time effort will be designated as the contact PI for a multiple PI proposal.

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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.html).

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.

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 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 should be emailed to:

Elisabeth Kato
Center for Evidence and Practice Improvement/AHRQ
Telephone: 301-427-1568
Email: elisabeth.kato@@AHRQ.hhs.gov

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. 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 [January 21, 2020] at [1:00] pm Eastern Time. To register to participate in the conference call, please send an e-mail request to the Scientific/Research Contacts listed in Section VII. Agency Contacts by [January 16, 2020]. Please include the phrase [Registration: Improving Management of Opioids and Opioid Use Disorder (OUD) in Older Adults (R18)] 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 [[email protected]] by [January 16, 2020]. Please include the phrase Questions: Management of Opioids in Older Adults 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 the AHRQ website.

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 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:

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.

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).

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 more tips 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 via https://grants.nih.gov/grants/guide/notice-files/NOT-HS-18-012.html). 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.

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 available at https://www.ahrq.gov/funding/policies/foaguidance/index.html. As part of this mission, applications are submitted to AHRQ to support health services research which are evaluated for scientific and technical merit through the AHRQ peer review system.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer 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. Only the review criteria described below will be considered in the review process.

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, 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 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 improve the management of opioid use and opioid use disorder (OUD) in older adults in primary care settings, especially among socially at-risk older adults?
• Is the proposed project likely to result in dissemination and implementation of patient-centered models of care that improve outcomes related to pain and opioid use for older adults in primary care practices?
• Does the project address an important problem or a critical barrier to progress in the field?
• Is the prior research that serves as the key support for the proposed project rigorous?
• If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
• How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

• Are the proposed leadership and governance structure and collaboration and coordination plans appropriate to manage the project successfully?
• Does the team, including the PD(s)/PI(s), team members, and collaborating institutions, have the appropriate training, skills, experience, and resources to carry out the work successfully?
• Does the team have existing relationships with primary care practices (especially those that deal with a substantial segment of socially at-risk older adults) within the target region and an approach that ensures that the project can start quickly and deliver the proposed approach within the proposed timeline?
• If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
• If this is a single PI project, is the PI devoting at least 20% full-time effort in each given year of the project? If this is a multiple PI project, is at least one PI devoting at least 20% full-time effort in each given year and are all other PIs devoting at least 10% full-time effort in each given year of the project?
• Are letters of support included for collaborating organizations?
• Are the total hours described for all key personnel appropriate to the level of effort required for the performance of their responsibilities?

• Does the project identify innovative approaches for successful implementation?
• Does the project include innovative approaches to overcoming barriers and challenges (including socially at-risk factors?
• Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
• Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?
• Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

• Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
• Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
• Is the number of practices to be recruited reasonable given the approach? Is the practice recruitment plan realistic and how likely is the applicant to succeed in recruiting at least 25 primary care practices including practices with populations with significant/substantial social risks?
• If the cohort of practices to be recruited does not meet the criteria in the FOA (e.g., data demonstrating suboptimal pain and opioid management), does the application adequately explain how the proposed intervention would lead to additional improvements?
• Does the patient population served reflect the diversity within the region and the older adult populations most affected by opioid use and OUD? Does the patient population reflect areas of high levels of social risk?
• Will the project reach primary care practices that serve rural or underserved communities (especially those that have a high prevalence of socially at-risk patients?
• Is the approach to improving management of opioids in older adults, including specific strategies within the approach, feasible, evidence-based, and likely to lead to achievement of the project’s stated aims?
• Does the applicant delineate a clear theory, conceptual model, and/or logic model (i.e., the links between the problem, the approach, implementation, and expected outcomes) supporting the approach to practice improvement?
• Does the approach adequately address sustainability beyond the project time frame, including:
• What effects from this project could last beyond the project period and how they would be sustained?
• How the project could be replicated easily in other regions?
• Does the applicant clearly articulate a robust evaluation plan that will produce results that are meaningful and valid?
• Does the approach include an appropriate plan for identifying and selecting relevant findings and effective interventions and models for dissemination?
• Has the applicant demonstrated a commitment to undertake dissemination activities?
• How likely is the applicant to be able to complete the project within 36 months of award?

• How likely are the capacities, experience, expertise, and other resources of the applicant institution and participating organizations to contribute adequately to the project’s success?
• Does the environment include practices with a substantial number of socially at-risk individuals?
• Does the application effectively leverage regional and local expertise?
• Have potential environmental obstacles (e.g., political/interest group opposition; regulations) 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.

• How well does the proposed research plan align with AHRQ s mission and research priorities?

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.

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 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.

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.

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please 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. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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://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.

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.

Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

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 4/30/2019, the annual FFR is due 9/30/2019 (90 days after the end of the calendar quarter of 6/30/2019).

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]

Elisabeth Kato
Center for Evidence and Practice Improvement/AHRQ
Telephone: 301-427-1568
Email: Elisabeth.Kato@@AHRQ.hhs.gov

Ying Tian, M.D., Ph.D.
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1530
Fax: 301-427-1740
Email: [email protected]

Nicole Williams
Office of Management Services
Division of Grants Management
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1015
Email address: [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.

This program is described in the Assisted Listings (formerly called the Catalog of Federal Domestic Assistance) 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/fund/hhspolicy.htm.