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. 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

This initiative will fund the dissemination and implementation of clinical and organizational patient-centered outcomes research (PCOR) findings into primary care practice to improve the delivery of patient-centered approaches to identifying and managing unhealthy alcohol use among adults, including screening and brief intervention (SBI) and medication-assisted therapy (MAT).

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

Unhealthy Alcohol Use: Unhealthy alcohol use refers to the full spectrum of alcohol misuse, including risky or hazardous drinking, harmful drinking, alcohol abuse, alcohol dependence, alcoholism, alcohol addiction, and alcohol use disorder (AUD). These varied terms have been and continue to be used to describe points along the spectrum of drinking behaviors. For simplicity and clarity in this FOA, the term unhealthy alcohol use encompasses the entire spectrum.

Alcohol Use Disorder: Alcohol Use Disorder (AUD) is a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using. To be diagnosed, individuals must meet at least two of 11 criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5. Depending on the number of criteria present, AUD is defined as mild, moderate, or severe.

Screening and Brief Intervention: Screening and brief intervention (SBI) is an evidence-based approach to reducing unhealthy alcohol use among adult primary care patients. SBI involves using an effective screening instrument to detect unhealthy alcohol use, and if needed, following up with a brief behavioral counseling intervention.

Medication-assisted therapy: Medication-assisted therapy (MAT) is the use of FDA-approved medications in combination with counseling and behavioral therapies to provide a whole-patient approach to the treatment of AUD.

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 that use lead clinicians such as family medicine physicians, general internal medicine physicians, general practice physicians, general pediatric physicians, geriatrician physicians, nurse practitioners, and physician assistants.

Patient-Centered Outcomes Research: Patient-Centered Outcomes Research (PCOR) is comparative clinical effectiveness research of the impact on health outcomes of two or more preventive, diagnostic, treatment, or healthcare delivery approaches. PCOR produces not only clinical findings (e.g. brief multi-contact interventions are more effective than brief single-contact interventions), but also evidence about the effectiveness of how health care is delivered, referred to in this FOA as organizational practices (e.g., use of electronic screening and brief intervention [e-SBI] compared to face-to-face SBI). There are multiple sources of PCOR findings including those listed below:

• AHRQ Effective Health Care Program (http://www.effectivehealthcare.ahrq.gov/)
• Patient-Centered Outcomes Research Institute (http://www.pcori.org/)
• U.S. Preventive Services Task Force (http://www.uspreventiveservicestaskforce.org/)
• Community Preventive Services Task Force (https://www.thecommunityguide.org/task-force-findings)

Dissemination: Dissemination is defined as the spread of findings from research to a target audience, such as patients, families, providers and health care teams, healthcare systems, and payers. The intent is to make stakeholders aware of the research findings.

Implementation: Implementation is defined as the use of strategies and processes to adopt and integrate research findings and evidence-based interventions into day-to-day practice. Implementation often requires the need to change practice patterns. In essence, implementation is putting the evidence-based interventions to use within the setting and population of interest.

Unhealthy alcohol use, which affects almost a third of adults, is the third leading cause of preventable death and a major risk factor for many health, social, and economic problems. A study released by the Centers for Disease Control and Prevention estimated the annual economic burden of unhealthy alcohol use at $249 billion in 2010. Unhealthy alcohol use is associated with a wide range of adverse consequences related to physical and mental health (neurological damage, cardiovascular disease, liver disease, depression, etc.), injuries (due to motor vehicle accidents, falls, drowning, etc.), social outcomes (intimate partner violence, child neglect, etc.), and economic indicators (unemployment, poverty, etc.). According to the 2015 National Survey on Drug Use and Health, 26.9% of adults reported binge drinking or heavy drinking over the past month and 15.1 million adults had alcohol use disorder (AUD). Between 2002 and 2013 the prevalence of AUD increased dramatically in African Americans, older adults, and individuals with lower levels of education and income. Unhealthy alcohol use affects individuals across the lifespan, which requires tailored interventions for prevention, screening, and treatment. Management of unhealthy alcohol use in older adults, for example, is complicated by concomitant medication use, presence of comorbid conditions, and age-related physiologic changes.

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen adults for alcohol misuse (the term unhealthy alcohol use was used in the 2018 draft recommendation) and provide brief behavioral counseling to persons engaged in risky or hazardous drinking. The USPSTF identified several effective screening tools such as Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and Single-item Alcohol Screening Questionnaire (SASQ). The USPSTF also found that behavioral counseling interventions vary in their specific components, delivery methods, duration, and intensity. Interventions commonly included providing feedback (e.g., how the patient’s drinking compares to recommended limits, ways to reduce drinking) and other cognitive behavioral strategies (e.g., drinking diaries, action plans), involved the primary care team, and could be office- or web-based.

For individuals with moderate to severe AUD, medication-assisted therapy (MAT) has been shown to be an effective treatment. The U.S. Food and Drug Administration has approved three medications for treating AUD: acamprosate, naltrexone, and disulfiram. An AHRQ evidence report found moderate strength evidence for the effectiveness of oral acamprosate and naltrexone in reducing alcohol consumption for adult patients with AUD. (Evidence related to injectable naltrexone was limited at the time of the evidence review). While evidence did not support the effectiveness of disulfiram in trials, it may be recommended to individuals for whom acamprosate and naltrexone are not suitable and who understand the risk of alcohol consumption while taking disulfiram.

Despite the serious public health impact of AUD and the demonstrated effectiveness of SBI and MAT, only 6.7% of adults with AUD receive treatment. Rates of screening for risky drinking use with standard instruments (13%), brief intervention (18%), and use of MAT (1.3%) are low in primary care settings. The complexity of managing unhealthy alcohol use, including AUD, in primary care may explain why rates of screening, brief intervention, and treatment with either referral or MAT are so low. There are numerous patient-, clinician-, and systems-level barriers, including stigma when seeking care for unhealthy alcohol use, beliefs among patients and clinicians that medications are ineffective, clinicians lack of knowledge about pharmacologic treatment options, limited availability of clinical decision support systems, unspecified clinical treatment protocols, limited shared decision making tools to engage patients and elicit their treatment preferences, lack of insurance coverage for AUD medications or complicated pre-authorization requirements, and limited capacity for referral and treatment.

Overcoming these barriers will be challenging, but supporting the use of a stepped approach to identifying and managing unhealthy alcohol use in primary care could have a significant positive impact on drinking behaviors and alcohol-related health outcomes. Screening all adults, brief intervention for patients with unhealthy alcohol use, initiating treatment in primary care for patients with mild to moderate AUD, and referral to treatment when appropriate are approaches to evidence-based models of care. Increasing SBI and MAT in primary care offers several advantages.

• Initiating treatment in the primary care setting may lead to more people treated, especially when access to specialty care is limited and insufficient to meet demand. Primary care clinicians are often the only medical professionals patients with AUD encounter.
• Screening, diagnosis and treatment of unhealthy alcohol use within one setting can improve patient motivation and cooperation by preventing delays in treatment or referral.
• Unhealthy alcohol use can impact management of many common conditions, including hypertension, diabetes, and liver disease. Integration of treatment for AUD with management of other comorbid conditions can improve treatment adherence and overall patient outcomes.
• Familiarity with primary care settings and routine medical management to treat AUD can reduce stigma.
• The ongoing relationship and trust many patients have with their primary care clinicians and teams may help identify unhealthy alcohol use earlier, and, when needed, make treatment and referral more acceptable to patients.
• Patients may not need to travel as far to access their primary care clinicians compared to a specialty clinic, especially in rural communities or other areas where specialty treatment clinics are sparse.

Given the substantial burden of unhealthy alcohol use, increasing the delivery of SBI and MAT in primary care can have a significant impact on population health. However, it is well recognized that primary care is functioning in a complex and changing health care environment. New models for organizing and paying for primary care have changed the landscape of primary care. The movement from volume-based payment to value-based payment, the widespread use of electronic health records and a large number of often unaligned quality improvement programs have impacted primary care practices and clinicians. In addition, a growing opioid epidemic has affected the availability of specialty substance abuse care. The dynamic environment, combined with an ongoing need to integrate mental and behavioral health with primary care, provides a unique opportunity to support primary care’s ability to deliver evidence-based interventions for unhealthy alcohol use.

This Funding Opportunity Announcement (FOA) seeks applications that propose multicomponent strategies to increase the dissemination and implementation of PCOR findings for managing unhealthy alcohol use, focusing on SBI and MAT, in the primary care setting. A wealth of resources are available from federal agencies and other organizations that can be used to help facilitate the uptake and routine use of evidence-based practices for identifying and treating unhealthy alcohol use, including AUD.

The goal of this FOA is to fund projects that use evidence-based approaches to disseminate and implement PCOR findings to improve identification and management of unhealthy alcohol use among adults in primary care practices. AHRQ is seeking applications that focus primarily on improving SBI and MAT in primary care, although screening, brief intervention, and referral to treatment (SBIRT) may be incorporated into the project as part of the continuum of care for patients whose needs cannot be adequately met within a primary care setting. AHRQ is not seeking applications that address populations other than adults (e.g., adolescents) or settings other than primary care (e.g., emergency departments, specialty settings). Applications that focus primarily on other populations or settings will not undergo peer review. For this project, applicants must focus on implementation of evidence-based interventions and evaluation of the effectiveness of the implementation.

Applicants should:

1. Convene a team, likely drawing from multiple organizations, with the expertise and experience to achieve the goals of this FOA. The project team should have existing strong relationships with primary care practices within the targeted region, expertise relevant to implementing SBI and MAT in primary care practices, and experience in disseminating and implementing PCOR findings.

• AHRQ encourages applicants to propose community partnerships with local, state, and/or regional organizations.

2. Define a discrete geographic region and develop a plan for recruiting and working with a minimum of 125 primary care practices that serve adult patients in that region.

• For the purposes of this initiative, AHRQ encourages applicants to propose supporting small- and medium-sized practices (=10 lead clinicians) and small networks that are less likely than larger practices and networks to have resources for quality improvement. AHRQ also encourages applicants to propose working with practices that have low rates of screening, have access to community and social supports, and do not have integrated behavioral health services; if practices do not meet these specifications, applicants should explain how the proposed intervention will lead to additional improvements.
• If a phased approach for recruiting and working with practices is used, 75% of practices should be engaged with the project within the first two years. (Applicants may propose uneven annual budgets commensurate with their approaches, as described in the Award Budget section.)

3. Develop a process and criteria for identifying PCOR findings and determining what findings will be disseminated to primary care practices.

• Applicants should plan to identify other PCOR findings to supplement the aforementioned PCOR findings related to the effectiveness of SBI and MAT for adults. Other PCOR findings may include additional evidence related to screening for and management of unhealthy alcohol use, findings regarding organizational practices related to implementation, findings on how primary care practices can engage patients, and findings on the use of technology to support implementation.

4. Define a comprehensive, evidence-based dissemination and implementation strategy to increase the use of SBI and MAT in primary care practices. (The implementation strategy may include referral to specialty treatment as an important step in the continuum of care. However, the strategy should focus primarily on providing MAT within the practice whenever appropriate.) While applications must focus on SBI and MAT, strategies related to other PCOR findings may be proposed in addition to the strategies to increase the use of SBI and MAT.

• Applicants may propose a tailored approach to selecting an implementation strategy across practices, or they may propose multiple implementation strategies that vary in type, duration, and intensity.
• Applications that use practice facilitation as a central and unifying strategy within the comprehensive approach are encouraged. (To learn more about practice facilitation, please visit: https://pcmh.ahrq.gov/page/practice-facilitation.) The comprehensive approach may also include other evidence-based strategies, such as practice assessment; the use of data, feedback, and benchmarking; the incorporation of electronic clinical decision support; peer-to-peer local learning; and expert consultation. To learn more, visit: http://www.ahrq.gov/professionals/prevention-chronic-care/improve/capacity-building/pcmhqi2.html.
• Applications that increase opportunities for shared decision making as patients select among options based on their own values, preferences, and goals as well as applications that increase the use of team-based delivery of services are encouraged.
• Applicants planning to incorporate health information technology and computer-based clinical decision support (CDS) as part of their approach may want to visit http://cds.ahrq.gov. Resources exist (e.g., a CDS authoring tool) to help build interoperable CDS in standards-based formats to make it easier to implement CDS within electronic health records (EHRs) and to share CDS across disparate EHRs. Further, applicants can consider the CDS Connect repository (http://cds.ahrq.gov/cdsconnect) as a potential dissemination mechanism for CDS artifacts developed over the course of their project.

5. Propose a robust, internal evaluation that addresses one or more evaluation questions of interest.

6. Plan to participate in a separate, more comprehensive program evaluation to be conducted by an external contractor selected by AHRQ.

• To support the evaluation, applicants should plan to collaborate with the evaluator and other grantees, and plan to collect and share with the evaluator the following types of indicators:
• Number and types of personnel working with practices to support implementation
• Number and type of interactions between project staff/consultants and practices
• Type and quantity of strategies implemented
• Number of practices reached by the implementation
• Number of clinicians engaged
• Number of patients in target population
• Number and percent of patients screened in each practice
• Number and percent of patients who screen positive
• Number and percent of patients who received brief counseling intervention
• Number and percent of patients who received MAT
• Number and percent of patients referred to specialty clinics
• Applicants are not expected to propose measuring patient-level health outcomes. However, since improving health outcomes is an important ultimate goal of PCOR, applicants that are able to efficiently and effectively measure one or more health outcomes (for example, reduction in alcohol intake) are encouraged.
• Applicants should not plan to pay practices for participating in the project, but may compensate practices for data collection activities.

7. Propose a dissemination plan in conjunction with AHRQ (including the Office of Communications) and/or its contractors. The plan should consider dissemination of interim findings while the project is still in progress.

Plan to complete all work within 36 months of the project start date.

Patient-Centered Outcomes Research and AHRQ

AHRQ has been a leader in fostering PCOR developing methods, training researchers, conducting systematic evidence reviews, building national registries, funding research studies, and disseminating the results. In recognition of these efforts, in 2010, with the establishment of the Patient-Centered Outcomes Research Trust Fund, Congress charged AHRQ with disseminating the results of PCOR findings.

This initiative is designed to accelerate the dissemination and implementation of PCOR findings into clinical practice. It recognizes the critical need to develop, test, and spread effective strategies of dissemination and implementation to ensure that Americans are getting high-quality, evidence based care.

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

This project is authorized by Section 937 of the Public Health Service Act (42 U.S.C. 299b-37) and is funded through the Patient-Centered Outcomes Research Trust Fund. Section 937(a) requires AHRQ to broadly disseminate research findings published by the Patient-Centered Outcomes Research Institute (PCORI) and other government-funded research relevant to comparative clinical effectiveness research.

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.

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

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(s)/PI(s)) 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 Director/Principal Investigator (PD(s)/PI(s))

The 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(s)/PI(s) 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual 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-14-074).

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, including Supplemental Grant Application Instructions 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 AHRQ 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 alcoholresearch@ahrq.hhs.gov.

AHRQ will convene a technical assistance conference call to summarize the purpose of this RFA and to respond to questions about the preparation of an application in response to this RFA. The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying.

The conference call will take place on Wednesday, October 24, 2018, at 1:30pm Eastern time. To register to participate in the conference call, please send an e-mail to alcoholresearch@ahrq.hhs.gov by October 22, 2018. Please include the phrase Unhealthy Alcohol Use FOA TA Call 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 the Scientific/Research Contacts by October 17, 2018. Please include the phrase Unhealthy Alcohol Use FOA Questions in the subject line. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be posted on the AHRQ web site.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

NOTE: For this specific FOA, the Research Strategy section is limited to 20 pages. See details in Research Plan section below.

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.

Budget Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process. Applicants applying for funding from AHRQ should 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:

Research Strategy:

The research plan section of the application is limited to 20 total pages. Applications that exceed 20 pages will not undergo peer review.

The research plan section must include the following sections:

1. Project Team and Community Partnerships

2. Access to and Recruitment of Primary Care Practices

3. Approach to PCOR Dissemination and Implementation

4. Evaluation Plan

5. Dissemination Plan

6. Project Timeline

Section 1: Project Team and Community Partnerships

This section should accomplish the following:

Describe the parent organization's and each partnering organization’s capacities, 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 implementation of joint projects.
• Existing strong relationships with primary care practices within the targeted geographic region.
• The resources and expertise that each organization and key personnel brings to the project that would support the goals of this initiative (e.g., identifying, evaluating, disseminating, and implementing PCOR findings related to SBI and MAT; providing quality improvement support to primary care practices; etc.).

Section 2: Access to and Recruitment of Primary Care Practices

This section should accomplish the following:

Define the geographic region to be served, including:

• The population and its health status, particularly with regard to alcohol use;
• The health care environment, including the state of primary care practice;
• The total number of primary care practices and primary care professionals in the region; and
• The capacity for behavioral health and specialty clinics to support referral and treatment;
• Other supporting strategies (e.g., pay for performance, public reporting, practice transformation, and quality improvement activities) occurring in the region and how the proposed project is aligned with them. If not aligned, discuss how competition and confusion will be avoided or minimized.

Describe plans for practice recruitment, including:

• The number of practices that will be recruited (=125) and why this number is appropriate given the approach to implementation;
• How primary care practices within the region will be identified, recruited and engaged, including primary care practices that serve underserved communities and/or are resource-limited;
• An estimate of the percent of primary practices that will agree to participate and the percent participating that will drop out; and
• Potential barriers to recruiting and engaging a minimum of 125 primary care practice sites, and proposed mitigation strategies.

Describe the characteristics of the practices that will be recruited and/or the primary care environment within the geographic region from which practices will be recruited, including:

• Practice size;
• Access to community and social supports;
• Current rates of screening;
• Availability of integrated behavioral health services; and
• Patient population served, including whether it would reflect the diversity within the region and/or the populations most affected by unhealthy alcohol use/AUD.

Section 3: Approach to PCOR Dissemination and Implementation

This section should accomplish the following:

Explain how PCOR findings will be identified and the criteria to be used for determining which findings will be disseminated to primary care practices. Applications should include a preliminary list of important PCOR evidence relevant to implementing SBI and MAT.

Describe in detail an evidence-based, comprehensive approach to implementation using strategies to accelerate incorporation of SBI, MAT, and other PCOR clinical and organizational findings into practice.

• If the comprehensive approach includes quality improvement support strategies other than the following, applicants must discuss the evidence base supporting these additional strategies: practice facilitation, practice assessment, the use of data for feedback and benchmarking, electronic clinical decision support, expert consultation, and peer-to-peer learning.

Provide the theoretical basis, conceptual model, and/or logic model for the overall approach to dissemination and implementation with an explanation of how individual strategies and techniques fit within the theory or model and are expected to contribute to its success.

Discuss potential challenges and barriers to executing the dissemination and implementation approach and proposed mitigation strategies.

Describe how the strategy will address barriers to screening and treatment in disadvantaged populations served, among people with complex needs, including older adults and persons with multiple chronic conditions, and across the life course.

Describe how implementation of SBI and MAT will be sustained at the end of the project.

Describe whether and how the infrastructure for practice improvement support will be sustained once the grant funding ends. Sustainability may involve both helping practices implement lasting change and building infrastructure within the grantees region that can be leveraged in future projects.

Section 4: Evaluation Plan

This section should accomplish the following:

Describe the evaluation approach, data sources, data collection (including how and from where data will be collected), and analysis plan for the internal evaluation.

Indicate a commitment to working with AHRQ’s external evaluator on the cross-grant evaluation.

Section 5: Dissemination Plan

This section should accomplish the following:

Describe plans for sharing project progress, insights into the implementation, and/or findings from the evaluation. The plan should address dissemination to multiple stakeholder groups and should not be limited to peer-reviewed publications and presentations at the end of the project.

Document a commitment to cooperating with AHRQ and its contractors in disseminating information about the project.

Section 6: Project Timeline

This section should accomplish the following:

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

• Start-up activities (e.g., hiring and training staff);
• Practice recruitment;
• Implementation of intervention;
• Data collection; and
• Project close-out (e.g. accomplishment within 36 months).

The application should include a general timeline of the approach for working with an individual primary care practice.

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.

Delayed Onset Study

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

PHS Assignment Request Form

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 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

The 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(s)/PI(s) 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&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, and may impede the review and/or selection process.

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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-066.html. Any instructions provided here are in addition to the instructions in the policy.

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.

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.

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.

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. 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.

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 JournalPublishing@ahrq.hhs.gov 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:

• 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 dissemination and implementation of patient-centered outcomes research (PCOR) findings directly to primary care practices?
• Is the proposed project likely to improve implementation of screening and brief intervention (SBI) and medication assisted therapy (MAT) in primary care practices?

• 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 within the target region and an approach that ensures that the project can start quickly and deliver the proposed approach within the proposed timeline?
• 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 and leverage innovative facilitators for successful implementation?
• Does the project include innovative approaches to overcoming barriers and challenges?

• 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 125 primary care practices?
• If the cohort of practices to be recruited does not meet the criteria in the FOA (e.g., low rates of screening), 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/or the populations most affected by unhealthy alcohol use/AUD?
• Will the project reach primary care practices that serve underserved communities?
• Does the approach include an appropriate plan for identifying and selecting PCOR findings for dissemination?
• Is the approach to dissemination and implementation, 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 approach, its implementation, and expected outcomes) supporting the approach to implementation?
• Does the approach adequately address sustainability beyond the project time frame?
• Does the applicant clearly articulate a robust evaluation plan that will produce results that are meaningful and valid?
• Has the applicant demonstrated a strong commitment to actively cooperate with the external evaluator and are appropriate resources allocated to this activity?
• Has the applicant demonstrated a commitment to cooperate with AHRQ and its contractors on 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 application effectively leverage regional and local expertise?
• Is the region clearly defined, logical, and of appropriate size to allow successful engagement with a minimum of 125 diverse primary care practices without being overly large?
• Does the proposed project benefit from features of the region such as recent or on-going health and health care initiatives, health information exchanges, clinical environments, political environments, community settings, and patient populations?
• Have potential environmental obstacles and the means for avoiding or mitigating their effects been identified?
• For expansions of existing dissemination and implementation efforts, have problems with coordination or other any potential challenges (e.g. technical constraints, resource limitations, other) and learning from prior experience on this or related initiatives been acknowledged/properly anticipated, and are possible resolutions proposed?

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(s)/PI(s) 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.5. 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 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), 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 (NoA). As necessary, additional Terms and Conditions will be incorporated into the NoA.

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/resource/laws/revisedlep.htmlThe HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. 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. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

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 quarterly 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 on-time submission, and post-submission issues)

Finding Help Online: http://grants.NIH.gov/support/ (//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 submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

General Grants Information (Questions regarding application processes and AHRQ grant resources)
Email: GMI@ahrq.hhs.gov

Monique D. Cohen, PhD, MPH, PMP
Agency for Healthcare Research and Quality
Center for Evidence and Practice Improvement
Division of Practice Improvement
Telephone: 301-427-1630
Email: Monique.Cohen@ahrq.hhs.gov

Robert McNellis, MPH, PA
Agency for Healthcare Research and Quality
Center for Evidence and Practice Improvement
Division of Practice Improvement
Telephone: 301-427-1888
Email: Robert.McNellis@ahrq.hhs.gov

Celeste Torio, PhD
Agency for Healthcare Research and Quality

Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: 301-427-1664
Email: Celeste.Torio@ahrq.hhs.gov

Kathryn Carr
Agency for Healthcare Research and Quality
Office of Management Services
Division of Grants Management
Telephone: 301-427-1025
Email: Kathryn.Carr@mail.AHRQ.gov

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided at https://www.ahrq.gov/funding/policies/polnotice/index.html.

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

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