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

Purpose

The purpose of this initiative is to disseminate and implement in primary care practices the latest patient-centered outcomes research (PCOR) evidence regarding nonsurgical treatments for urinary incontinence (UI) in women.

This initiative will fund up to 5 projects to use lessons learned from previous AHRQ primary care practice improvement initiatives to implement and test implementation strategies which address urinary incontinence in women, and to integrate these with specialty care.

Projects may draw on community-based resources and/or include multi-level implementation strategies aligning improvement strategies between primary care practices and healthcare systems.

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 on nonsurgical treatment of UI in women 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.

Definitions of Key Terms

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

• Urinary incontinence: any involuntary leakage of urine or loss of bladder control
• 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 a change in practice patterns. In essence, implementation is putting the evidence-based interventions to use within the setting and population of interest.

Background

Urinary Incontinence affects a large number of women. In the National Health and Nutrition Examination Survey data, more than one-half of women over 20 years of age reported any urinary leakage (Markland et al. 2011). In addition, a significant number of women experience moderate to severe urinary incontinence with rates increasing with age (17% of women older than 20 years of age and 38% of women over 60 years of age) (Wu et al. 2014).

UI is not merely a nuisance condition, it also increases morbidity. In a population-based cohort of women ages 54 to 65 years, UI was associated with increased risk of depression and work disability (Hung, Awtrey, and Tsai 2014). Complications due to urinary incontinence are more severe in women over 65 years old, and those with moderate to severe UI are at increased risk for falls (Hasegawa, Kuzuya, and Iguchi 2010; Coyne et al. 2013), mortality (John et al. 2014; Damian et al. 2017), and nursing home admissions (Schluter et al. 2017). Urinary incontinence also complicates other conditions that affect women. For example, multiple chronic conditions (MCC) such as obesity, congestive heart failure, depression, diabetes, and cognitive impairment commonly occur with UI (John et al. 2014); (Thom, Haan, and Van Den Eeden 1997; Grimshaw et al. 1995; Coyne et al. 2013). Due to symptoms associated with UI, women may not be compliant with recommendations for therapies such as exercise or diuretics that could help them avoid worsening their incontinence.

Older adults with UI often restrict their participation in social activities due to concerns about odor, failure of absorbent products, or discomfort related to skin issues. As social withdrawal progresses, depression becomes a significant risk (Emmons and Robinson 2014). Older women also report decreased independence and unmet care needs (Yang et al. 2018). UI imposes significant burden on caregivers, and about 6% of nursing home admissions for women were directly attributable to UI (Morrison and Levy 2006). Finally, UI is costly. The economic impact of UI in women was estimated to be $19.5 billion in 2004. Two thirds of the costs were attributable to ambulatory care, and most women were over 65 years old and covered by Medicare (Wilson et al. 2001).

There are also disparities in UI and UI care. The prevalence of daily incontinence is reported to be twice as high in Hispanic women compared to Asian women. The same study found that black women were less likely to have stress UI compared to all other groups but had the highest prevalence of urgency UI (Thom et al. 2006). In one population-based study, 70% of white compared to 16% of Latina, 6% black and 5% Asian women with UI admitted to seeking care for UI symptoms (Morrill et al. 2007).

There is a significant gap between evidence-based care and actual practice: Fewer than 30% of women (> age 40) with UI report any care for UI symptoms (Minassian et al. 2012). Only 16% of women over age 65 who reported UI had any outpatient visits for UI in the prior two years (Erekson et al. 2019). However, safe and effective non-surgical treatments for UI are available. A recent systematic review by PCORI and AHRQ’s EPC program found moderate strength of evidence for effective treatments that not only treat but cure urinary incontinence (ECRI Institute-Penn Medicine Evidence-based Practice Center 2020; Balk et al. 2018). These include behavioral approaches, pharmacologic therapy, neuromodulation, and combinations of two or three therapies. These interventions were safe in older women and in those with MCC.

Several factors align to make implementation efforts successful at this time. Diagnosis and stepped care are supported by guidelines from professional organizations. Effective implementation strategies, both generic and specific to UI, have been published (Albers-Heitner et al. 2011; Brennen, Sherburn, and Rosamilia 2019; Doughty 2003; Halleberg Nyman et al. 2019; Wenger et al. 2010). Third-party payers, including Medicare and Medicaid, reimburse for UI assessment and treatment.

Given the substantial burden of UI, increasing recognition of it and offering non-surgical treatment in primary care could have a significant impact on population health. However, primary care is functioning within a complex and changing health care environment. New models for organizing and paying for primary care have changed its landscape. 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, the COVID-19 epidemic has affected the availability of primary care visits. This funding announcement provides a unique opportunity to support primary care s ability to deliver evidence-based interventions for UI in women, and to learn from implementation efforts.

Objectives

The overarching goal of this FOA is to fund projects that use evidence-based approaches to disseminate and implement PCOR findings to improve nonsurgical treatments for urinary incontinence among adult women in primary care practices.

AHRQ is not seeking applications that address populations other than adult women (e.g., adolescents) or settings other than primary care (e.g., emergency departments, specialty settings, nursing homes, long term care facilities).

Applicants must:

• Use evidence-based implementation strategies to increase the delivery of evidence-based care for urinary incontinence among women.
• Convene a team with the expertise and experience to achieve the goals of this FOA. The project team must have existing strong relationships with primary care practices within the targeted region, expertise relevant to the diagnosis and nonsurgical treatment of urinary incontinence among women in primary care practices, expertise in delivery of patient-centered care, and experience in disseminating and implementing PCOR findings. AHRQ encourages applicants to include community partners such as local, state, and/or regional organizations.
• Define the targeted region(s) and develop a plan for recruiting and working with a minimum of 50 primary care practices, or a mix of practices that together reach at least 50,000 adult women. Primary care practice settings may include community health centers and women’s health providers that serve adult women in that region.
  • Practices can be independent or affiliated with local or regional health systems. AHRQ also encourages applicants to choose practices that serve women with a higher burden of urinary incontinence (women who are older, frail, obese), and practices that provide care to diverse populations of women, including racial and ethnic minorities, and those with lower social economic status (SES).
  • A phased approach for recruiting and working with practices is allowed, as long as the project is completed within 36 months.
• Propose evidence-based implementation strategies to increase the delivery of evidence-based care (diagnosis and nonsurgical treatments) for urinary incontinence.
  • These might include stepped care, collaborative or team-based care, patient education and self-management, partnerships and community referrals.
  • Strategies may include home care or referral to specialty treatment in the continuum of care. However, strategies must focus primarily on providing nonsurgical treatments within the primary care practice.
• In addition to the evidence related to nonsurgical treatments for urinary incontinence among women, applicants may identify other evidence-based research to inform their plans. This may include evidence on establishing the correct diagnosis of UI, organizational practices related to implementation, how primary care practices can engage patients or link to community organizations, life course approaches, patient-centered care plans, or the use of technology to support implementation.
• Demonstrate how they will address barriers to diagnosis and treatment, especially among disadvantaged populations and those with competing needs including multiple chronic conditions. This may include caregiver and patient burden.
• Propose innovative strategies to reduce the potential burden on practices that add urinary incontinence care to the services they offer.
• Develop or enhance mechanisms for improving linkages between primary care settings needed supports, such as community-based resources and specialty care.
• Develop patient-centered care plans in the context of co-existing illness(es); this may include shared decision-making techniques and tools. Strategies must demonstrate how they will integrate shared decision-making techniques into practice, as patients select among options based on their own values, preferences, and goals.
• Design an implementation plan that is sustainable, so that changes become a routine element of care delivery, and efforts last after the end of funding. Consider both how UI treatment implementation efforts as well as capacity for practice improvement will be sustained.
• Evaluate the effectiveness of implementation strategies and disseminate findings.
• Propose a robust evaluation to assess the effectiveness of the intervention.
• Plan to participate in a separate, more comprehensive program evaluation to be conducted by an external contractor selected by AHRQ. Examples of the types of indicators are listed in the evaluation plan section See Section iV,2. D under Research Strategy).
• Identify an evaluation liaison with expertise across the project to serve as a chief informant and coordinator with the external evaluator. This team member must have a minimum of 10% full-time effort (i.e. at least four hours per week) dedicated to evaluation liaison activities in each given year of the project.
• Since improving health outcomes is an important ultimate goal of PCOR and this FOA, applications must propose to measure one or more health outcomes (for example, UI symptoms, patient satisfaction, and surgical intervention rates).
• Propose a dissemination plan which must include dissemination of interim findings while the project is still in progress.
• Plan to complete all work within 36 months of the project start date. Applicants plans should not anticipate a no-cost extension.
• Recipients of awards under this FOA must provide annual and final reports of performance in achieving the FOA objective to implement evidence-based strategies to increase the delivery of evidence-based care for urinary incontinence among women (see section VI.3. Reporting).

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

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, AHRQ scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional

Funds Available and Anticipated Number of Awards

AHRQ will invest up to $15 million over three years to support up to five awards. The number of awards is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Future year funding is contingent upon the availability of funds for each year of support.

Award Budget

The total costs (direct and indirect) for a project awarded under this FOA will not exceed $2,000,000 in any given year and $3,000,000 for the entire project period.

Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with applicable OMB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS Grants Policy Statement.

Award Project Period

The scope of the proposed project should determine the project period. The project period may not exceed three years.

42 U.S.C. 299b-37 authorizes AHRQ to make these awards to support the agency's dissemination of comparative clinical effectiveness research findings and the training of researchers in the methods used to conduct such 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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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)

For-Profit Organizations

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

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

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.

Foreign Institutions

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.

Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as consortia or as subcontractors only. Applications submitted by 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.

Required Registrations

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 (SAM)-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.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons- Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one 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.

Eligible Individuals (Program Director/Principal Investigator)

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. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum full-time effort (i.e. at least 8 hours per week) in each given year of the project.

2. Cost Sharing

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, 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.

3. Additional Information on Eligibility
Number of Applications

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

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

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-18-197).
Section IV. Application and Submission Information
1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ 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 may be emailed to UI_grant@ahrq.hhs.gov.

Technical Assistance Conference Call

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 summarize the purpose of this RFA 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 at 3:00 pm, Thursday, February 25, 2021 Eastern Time. To register to participate in the conference call, please send an e-mail request to the Scientific/Research Contacts listed in Section VIII. Agency Contacts by 5:00 pm, February 23, 2021. Please include the phrase Urinary Incontinence [insert this FOA number] 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 request to the Scientific/Research Contacts listed in Section VIII. Agency Contacts by 5:00 pm, February 22, 2021. Please include the phrase UI FOA Questions 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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. For this specific FOA, the Research Strategy section is limited to 25 pages. See details in Research Plan section below.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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.

Applicants who propose the use of identifiable Centers for Medicare and Medicaid Services (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.

R&R Sub award Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement 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:

• AHRQ applicants are reminded to refer to NOT-HS-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html) for additional information on how to incorporate their data management plan into the resource sharing plan.

Research Strategy:

The research plan section of the application is limited to 25 total pages. Applications that exceed 25 pages will not undergo peer review.

The Research Strategy section must include the following sections:

A. Project Team and Partnerships

B. Access to and Recruitment of Primary Care Practices

C. Approach to PCOR Dissemination and Implementation

D. Evaluation Plan

E. Dissemination Plan

F. Project Timeline

Applicants may allocate the 25 total pages as they deem appropriate, but must include all of the sections stated above.

Section A: Project Team and Partnerships

This section must 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 the applicant will ensure collaboration and coordination of all participating entities.
• Any history of working together and previous successful implementation of joint projects.
• Existing relationships with primary care practices within the targeted 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 urinary incontinence in women; providing quality improvement support to primary care practices; etc.).

Section B: Access to and Recruitment of Primary Care Practices

This section must accomplish the following:

1. Define the targeted region or population to be served, including:

• Population demographics (age, race, ethnicity, socioeconomic status) and health status (comorbidities, functional status), particularly with regard to urinary incontinence or risk factors for urinary incontinence;
• The health care environment, especially the state of primary care practice, including:
• The total number of primary care practices, primary care professionals, and women in the region
• The presence of needed supports, such as community organizations and specialty clinics with capacity for referral and treatment
• Other supporting strategies (e.g., pay for performance, public reporting, practice transformation, and quality improvement activities) occurring in the targeted practices and how the proposed project is aligned with them. If not aligned, discuss how competition and confusion will be avoided or minimized.

2. Describe plans for practice recruitment, including:

• The number of practices (=50, or a mix to reach at least 50,000 adult women) that will be recruited
• How primary care practices 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 of participants that will drop out
• Potential barriers to recruiting and engaging the minimum practice sites (=50, or a mix to reach at least 50,000 adult women), and proposed mitigation strategies

3. Describe the characteristics of the practices that will be recruited, including:

• Practice size and independent/affiliated status
• The practice’s access to community and social supports
• Estimate of burden/prevalence of urinary incontinence
• Patient population served, including whether it would reflect the diversity within the region and/or the populations most affected by urinary incontinence, and inclusion of priority populations (racial/ethnic minorities, socioeconomically disadvantaged women, women with disabilities, older, and rural or inner city women)

Section C: Approach to PCOR Dissemination and Implementation

This section must accomplish the following:

1. Applications must include a preliminary list of important PCOR evidence relevant to implementing nonsurgical treatment of UI in women into primary care practices, both at the clinical and organizational level. Describe how new evidence will be identified, vetted and implemented as guidance and evidence-based interventions are updated.

2. Describe in detail an evidence-based, comprehensive approach to implementation using strategies to accelerate incorporation of nonsurgical treatment of UI in women and other PCOR clinical and organizational findings into practice. Also describe how the implementation will be tailored for practices that serve diverse populations. The following quality improvement/implementation support strategies are well established and if proposed, must be mentioned but require little discussion of the evidence base: practice facilitation, practice assessment, the use of data for feedback and benchmarking, electronic clinical decision support, expert consultation, and peer-to-peer learning.

If the comprehensive approach includes other quality improvement support strategies, applicants must discuss the existing evidence, or how this project will add to the evidence base supporting these other strategies. For the purposes of this FOA, using an established implementation strategy in a new context (i.e., among women, for urinary incontinence, or in primary care) is considered innovative.

3. Provide the 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 model and are expected to contribute to its success.

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

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

6. Describe how implementation of evidence-based nonsurgical treatment of urinary incontinence in women will be sustained at the end of the project. Sustainability may involve both helping practices maintain improvements in care delivery and their capacity for change.

Section D: Evaluation Plan

This section must accomplish the following:

1. Describe the mixed -methods evaluation approach, data sources, data collection (including how and from where data will be collected), and analysis plan for the grantee’s project. Describe the quantitative and qualitative data that will be captured to help assess the effectiveness and impact of the implementation, including impact on symptoms and quality of life. Recognizing the challenges of designing and evaluating implementation interventions, applicants may apply a range of methods including agile design, adaptive trials, or rapid cycle evaluation approaches as well as methods drawn from complexity science.

2. Indicate a commitment to working with AHRQ’s external evaluator on the cross-grant evaluation, including allocation of a team member as a liaison to the external evaluator. Examples of the cross grant evaluation questions and types of indicators to be collected are listed below:

• Process: how were strategies implemented? For example, number and types of personnel working with practices to support implementation, type and characteristics of strategies implemented, barriers and facilitators.
• Reach: Who was reached by the project? Number of practices, clinicians, and patients reached by the implementation, women with UI diagnosed, offered treatment, and who accept treatment.
• Impact: Since improving health outcomes is an important ultimate goal of PCOR and this FOA, applications must propose to measure one or more health outcomes (for example, UI symptoms, patient satisfaction, and surgical intervention rates).

Section E: Dissemination Plan

This section must accomplish the following:

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

2. Describe how the project could be replicated in other regions/practice groups.

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

Section F: Project Timeline

This section must accomplish the following:

1. Provide a project timeline showing the major scheduled activities and milestones for the project across the three year project period, including:

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

2. The application must also include an example timeline of the approach for working with an individual primary care practice.

Appendix:

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

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

Special instructions for this FOA:

• Include letters of commitment from all organizations that are part of the project team.
• Include letters of support from practices or organizations that have agreed to participate in and collaborate as part of the proposed project to document the strength of already established partnerships and/or intention to partner for the purposes of this project.

Letters of support, recommendation, or endorsement from any entity or individual who is not directly participating in the proposed project should NOT be included. These types of letters may impede the review and/or selection process. Letters of Support should be added as an attachment to (item 9 in PHS 398 Research Plan Form) not put in the appendix.

PHS Human Subjects and Clinical Trials Information

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.

• Note: AHRQ’s public webpage on the protection of human subjects. This page is now published and publicly available at https://www.ahrq.gov/funding/policies/human-subjects/index.html. See also, NOT-HS-21-002, AHRQ Guide Notice on Exception to the Use of the Single IRB Review Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). A Delayed Onset study is one in which human subjects research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application.

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

PHS Assignment Request Form

Not Applicable.

3. Unique Entity Identifier and System for Award Management (SAM)

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.

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

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

7. Other Submission Requirements and Information

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 NIH. 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 (https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/research-forms-f.pdf) 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 and compliance with application instructions by the Center for Scientific Review, NIH, and for responsiveness by AHRQ. Applications that are incomplete or non-compliant 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 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. See also https://www.ahrq.gov/priority-populations/about/index.html.

AHRQ Data Management Plan Policy

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

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. Please see: The Agency for Healthcare Research and Quality Data Management Plan Policy, Notice Number NOT-HS-20-011.

Data Confidentiality

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

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

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on 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.

Grantees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Section V. Application Review Information
1. Criteria

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. 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.

AHRQ's priority areas of focus are available at https://www.ahrq.gov/funding/policies/foaguidance/index.html

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate objective 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, National Institutes of Health, and for responsiveness by AHRQ.

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

Overall Impact

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).

Scored Review Criteria

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.

Significance
• 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?
• Is the proposed project likely to result in dissemination and implementation of PCOR findings directly to primary care practices?
• Is the proposed project likely to improve implementation of nonsurgical treatment of urinary incontinence to women in primary care practices?
Investigator(s)/Personnel
• Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If investigators are in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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?
• Are letters of support included for collaborating organizations?
• Is the single PD/PI, or are the multiple PD(s)/PI(s) combined, devoting at least 20% minimum full-time effort (i.e. at least 8 hours per week) in each given year of the project?
• Has the applicant identified an evaluation liaison with expertise across the project to serve as a chief informant and coordinator with the external evaluator, and is this individual devoting a minimum of 10% full-time effort (i.e. at least four hours per week) to evaluation liaison activities in each given year of the project?
• Are the total hours described for all other key personnel appropriate to the level of effort required for the performance of their responsibilities?
Innovation
• 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?
• Does the project identify and leverage innovative facilitators for successful implementation?
• Does the project include innovative approaches for evaluation or adaptations to overcome barriers and challenges?
• For the purposes of this FOA, using an established implementation strategy in a new context (i.e., among women, for urinary incontinence, or in primary care) is considered innovative.
Approach
• 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?
• 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?
• Is the practice recruitment plan realistic and likely to succeed in recruiting at least 50 primary care practices or a mix to reach at least 50,000 adult women?
• Does the patient population served reflect the diversity within the region and/or the populations most affected by urinary incontinence, and underserved communities?
• Does the approach include an appropriate plan for identifying and selecting interventions to implement to improve UI in women? Does the applicant describe how they will identify and incorporate changing evidence as new guidance and findings evolve)?
• Is the approach to dissemination and implementation, including specific strategies within the approach, feasible, evidence-based, and likely to achieve the project’s stated aims?
• Does the applicant delineate a clear 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 allocated appropriate resources to cooperate with the external evaluator?
• Has the applicant demonstrated a commitment to sharing results in a timely fashion?
• How likely is the applicant to complete the project within 36 months of award?
Environment
• Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
• How likely are the capacities, experience, and other resources of the applicant institution and participating organizations to contribute adequately to the project’s success?
• Does the proposed project benefit from features of the region such as recent or on-going 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?
• If expansions of existing dissemination and implementation efforts are proposed, have problems with coordination or other any potential challenges and learning from prior experience on this or related initiatives been acknowledged/properly anticipated, and are possible resolutions proposed?
Additional Review Criteria

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.

Protections for Human Subjects

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

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

Note: See also AHRQ’s public webpage on the protection of human subjects. This page is now published and publicly available at https://www.ahrq.gov/funding/policies/human-subjects/index.html. See also, NOT-HS-21-002 AHRQ Guide Notice on Exception to the Use of the Single IRB Review Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. See NOT-HS-20-005 for Single IRB implementation https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html

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 Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical 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 ).

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

Resubmissions

If Resubmissions are not allowed for this FOA (i.e., are not included in Section II. Award Information Application Types Allowed), replace the text with Not Applicable . Otherwise, do not change.

Not Applicable

Renewals

If Renewals are not allowed for this FOA (i.e., are not included in Section II. Award Information Application Types Allowed), replace the text with Not Applicable . Otherwise, do not change.

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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.

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

2. Review and Selection Process

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.
3. Anticipated Announcement and Award Dates

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).

Section VI. Award Administration Information
1. Award Notices

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). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

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

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.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Post-Award Grants Management portion of the AHRQ website: https://www.ahrq.gov/funding/grant-mgmt/index.html#terms. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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.

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

Accessibility Provisions for All Grant Application Packages and Funding Opportunity Announcements.

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.

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.

• 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. For information about AHRQ's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, please see https://grants.nih.gov/grants/policy/harassment.htm.
• 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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.

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.

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.

Cooperative Agreement Terms and Conditions of Award

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

Terms and Conditions of Cooperative Agreement Award

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

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

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

Activities conducted under this award that involve the collection of information e.g. conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, with certain exceptions, are currently required to be cleared by OMB under the Paperwork Reduction Act (PRA). (44 USC 3501-3521). PRA review and approval is required in cooperative agreements if AHRQ has significant input or control over the data collection activity. Submissions for clearance under the PRA are through AHRQ and HHS. Therefore, impacted awardees should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least 6 months from date of initial submission to AHRQ and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until awardees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found here http://www.hhs.gov/ocio/infocollect/

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

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

The PD(s)/PI(s) will participate in monthly teleconferences with the program official and/or other AHRQ personnel as appropriate. The PD(s)/PI(s) will attend an annual two-day meeting with AHRQ and other grantees, which will be held either virtually or in the Washington, D.C. area.

A learning community will be created to bring together grantees, contract staff and AHRQ staff to discuss progress on the initiative, identify common challenges and engage in problem solving. Each PD/PI and any key personnel for implementation and evaluation are expected to participate in the learning community meetings.

AHRQ Responsibilities

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

Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across the projects. Specific cooperative aims and activities in carrying out individual projects may be shared among the awardees and the AHRQ program officials.

AHRQ staff will provide advice and support to the awardee, and will assist in the cooperative work of the project beyond the usual program stewardship for grants.

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

AHRQ will:

• Review the development of project timelines and project plans and assess progress.
• Work closely with grantees and AHRQ contractors to ensure harmonization of cross-grantee metrics for evaluation.
• Coordinate and facilitate collaboration and engagement with stakeholders.
• Facilitate the development of common frameworks, tool kits, and other products for implementation and evaluation activities.
• Facilitate conference calls with grantees and annual in-person (or virtual, if appropriate) meetings.
• Work closely with grantees and other federal partners to ensure dissemination of products.

Additionally, AHRQ program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Collaborative Responsibilities

Awardees will be required to work collaboratively with each other and with AHRQ to share information and develop common resources as noted above. Awardees and AHRQ will also participate in periodic meetings including monthly teleconferences and annual in-person meetings.

3. Reporting

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 start date of the next budget period of the award.

In addition to the annual progress report, recipients may be required to submit interim progress reports to AHRQ using the AHRQ Research Reporting System (ARRS). If applicable, detailed instructions on interim reporting requirements will be provided with the grant award.

Program Planning and Performance reporting requirements: the overarching objective of this project is to implement evidence-based strategies to increase the delivery of evidence-based care for urinary incontinence among women. Recipients performance will be measured based on success in the following Program goals:

• Reach: Who was reached by the project?
• Performance measures: Number of practices, clinicians, and patients reached by the implementation
• Timeline: reach target by year 3
• Process: How were strategies implemented?
• Performance measures: number and types of personnel working with practices to support implementation, List of strategies implemented
• Timeline: completed by year 3
• Impact: Do health outcomes improve?
• Performance measures: one or more health outcomes (such as UI symptoms or patient satisfaction) will be collected for the evaluation
• Timeline: specific outcomes determined in year 1, data collected through year 3

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 to http://www.ahrq.gov/funding/grant-mgmt/index.html#Closeout.

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 (http://www.ahrq.gov/funding/policies/hhspolicy/index.html) for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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: support@grants.gov

Scientific/Research Contact(s)

Jill S. Huppert, MD, MPH
Center for Evidence and Practice Improvement (CEPI)
Agency for Healthcare Research and Quality
Email: UI_grant@ahrq.hhs.gov

Peer Review Contact(s)

C. Jean Hsieh, PhD, OT
Scientific Review Officer
Office of Extramural Research, Education, and Priority Populations, Division of Scientific Review
Agency for Healthcare Research and Quality
Email: Chinghui.Hsieh@ahrq.hhs.gov

Financial/Grants Management Contact(s)

Kathryn Woolridge
Grants Management Specialist
Office of Management Services
Division of Grants Management
Agency for Healthcare Research and Quality
Email: kathryn.carr@ahrq.hhs.gov

Section VIII. Other Information

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.html.

Authority and Regulations

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

This award is made pursuant to AHRQ's authority to support the dissemination of comparative clinical effectiveness research findings, 42 U.S.C. 299b-37(a) - (c), in accordance with the statutory requirements generally applicable to research supported under Title IX of the Public Health Service Act. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at https://www.ahrq.gov/funding/policies/hhspolicy/index.htm.