AHRQ and PCORI Learning Health System Embedded Scientist Training and Research Centers (P30) is sponsored by U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ). AHRQ and PCORI invite applications from qualified institutions to create Learning Health System Embedded Scientist Training and Research (LHS E-STaR) Centers to support the professional development of scientists to conduct research that accelerates progress towards an integrated…

Expired RFA-HS-23-001: AHRQ and PCORI Learning Health System Embedded Scientist Training and Research Centers (P30) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) Agency for Healthcare Research and Quality ( AHRQ ) Patient-Centered Outcomes Research Institute ( PCORI ) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Where this Notice of Funding Opportunity (NOFO) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual NOFO.

of Participating Organizations Agency for Healthcare Research and Quality ( AHRQ ), Patient-Centered Outcomes Research Institute ( PCORI , http://www. pcori.

org/ ) Notice of Funding Opportunity Title AHRQ and PCORI Learning Health System Embedded Scientist Training and Research Centers (P30) - Expanding Requirement for eRA Commons IDs to All - AHRQ Policy on the Inclusion of Priority Populations in 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 - Changes to the HHS Notice of Award (NoA) Beginning - The Agency for Healthcare Research and Quality Data - AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR - AHRQ Announces Change in Grant Recipient Purchasing of Identifiable CMS Data, effective FY2019 - AHRQ Multiple Program Director/Principal Investigator - AHRQ Policy Guidance Regarding Inflationary Increases (aka, cost-of-living adjustments, or COLAs) beginning in Fiscal Year 2017 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available Funding Opportunity Announcement (NOFO) Number Companion Funding Opportunity III.

3. Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose AHRQ and PCORI invite applications from qualified institutions to create Learning Health System Embedded Scientist Training and Research (LHS E-STaR) Centers to support the professional development of scientists to conduct research that accelerates progress towards an integrated learning health system.

To achieve this aim, the E-STaR Centers will build new models of LHS infrastructure that: strengthens institutional research training in CER and PCOR; enhances diversity in the LHS research workforce; strengthens partnerships with community partners and health system and other stakeholders; and conducts patient-centered clinical comparative effectiveness research projects to improve health system operations, quality, and health outcomes.

Applications will be funded under the P30 Research Program Projects and Centers grant mechanism, which supports Center Core grants intended to fund a multidisciplinary approach to shared resources and facilities for research and training by a number of investigators from different disciplines who focus on a common research problem.

Programs are expected to prepare clinician and research scientists for independent research careers in PCOR/CER and equip them to advance the field through their training and scholarship as the next generation of Learning Health System Scientists and to support PCOR/CER and dissemination, implementation, and use of research findings.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) Generally, four months after receipt date Generally, four months after review date.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

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/NOFOguidance/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 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.

2. Full Text of the Announcement I. Funding Opportunity Description III.

Eligibility Information IV. Application and Submission Information V. Application Review Information VI.

Award Administration Information Full Text of Announcement Section I.

Funding Opportunity Description The Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI) seek applications for Learning Health System Embedded Scientist Training and Research (LHS E-STaR) Centers (P30) grant to support institutions to train the next cadre of embedded Learning Health System (LHS) scientists who have the skills to conduct, apply, and implement patient-centered outcomes research (PCOR) a type of comparative clinical effectiveness research (CER).

CER compares the effectiveness of two or more interventions or approaches to health care, examining their risks and benefits. PCOR compares two or more medical treatments, services, or health practices and addresses questions and outcomes important to patients and other healthcare stakeholders, through studies that engage, and generate evidence meaningful to, those who need this information to make health and healthcare decisions.

The goal of the Notice of Funding Opportunity (NOFO) is to train embedded health system scientists and to conduct PCOR/CER to improve health system operations, quality, and health outcomes. 42 U.S.C. 299b-37 authorizes AHRQ to establish a grant program that provides for the training of researchers in the methods used to conduct PCOR/CER and to support the agency's dissemination of comparative clinical effectiveness research findings.

Consistent with 42 U.S.C. 299b-37(e), grants funded under this program will train clinical and research scientists to have the skills to support and lead efforts to apply PCOR/CER methods and conduct PCOR/CER in a LHS and to facilitate rapid implementation of evidence that will improve quality of care and patient outcomes.

AHRQ defines a Learning Health System (LHS) as a health system in which internal data and experience are systematically integrated with external evidence, and that knowledge is put into practice ( https://www. ahrq. gov/learning-health-systems/about.

html ). The goal of these systems is for patients to receive higher quality, safer, and more efficient care, and health care delivery organizations become better places to work. In a learning health system model, both institutional and clinical practice partners are actively engaged and participate in the generation, adoption, and application of evidence.

A LHS scientist is an individual who is embedded within a health system and collaborates with its stakeholders to produce novel insights and evidence that can be rapidly implemented to improve the outcomes of individuals, populations, and health In 2018, AHRQ and PCORI funded 11 institutions to support the training of embedded researchers to conduct PCOR/CER within LHS, producing embedded LHS scientists.

A core component of the LHS training programs was the implementation of AHRQ-developed core competencies (see https://www. ahrq. gov/learning-health-systems/building-workforce.

html ) for training PCOR/CER professionals to become LHS scientists. This AHRQ/PCORI P30 LHS E-STaR program NOFO builds on lessons learned from the AHRQ/PCORI LHS K12 Program ( https://grants. nih.

gov/grants/guide/rfa-files/RFA-HS-17-012. html ) to support the professional development of scientists to conduct research that accelerates progress toward an integrated learning health system.

Successful applicants to the AHRQ/PCORI P30 LHS E-STaR program NOFO will build new models of LHS infrastructure that: strengthen institutional research training in CER and PCOR; enhance diversity in the LHS research workforce; strengthen partnerships with community partners and health system and other stakeholders; and conduct PCOR/CER projects to improve health system operations, quality, and This funding opportunity is open to all eligible applicants.

AHRQ and PCORI invite applications from qualified institutions to create Learning Health System Embedded Scientist Training and Research (LHS E-STaR) Centers that support the professional development of scientists to conduct research that accelerates progress towards an integrated learning health system and build a critical and sustainable LHS research workforce.

Grants will be funded under the P30 Research Program Projects and Centers grant mechanism, which supports Center Core grants that fund a multidisciplinary approach to shared resources and facilities for research and training by investigators from different disciplines who focus on a common research problem.

Programs are expected to prepare clinician and research scientists for independent research careers in PCOR/CER and equip scientists to advance the field through their training and scholarship as the next generation of Learning Health System Scientists. In addition, the LHS E-STaR program supports PCOR/CER and the dissemination, implementation, and use of research findings.

The NOFO objectives are to: Prepare clinicians and research scientists for independent research careers and equip them to advance the field through their training and research as embedded Learning Health System Scientists.

Strengthen LHS Infrastructure by building partnerships between health systems, academic health centers, community partners, and other Provide opportunities for clinicians and research scientists to conduct PCOR/CER and transition to PCORI, AHRQ, and other federally funded Directly engage system, community and other stakeholder leaders with bidirectional opportunities for co-sponsorship within funded grants, such as data access, financial or in-kind support for LHS scientist training and/or compensation or in-kind support for community partners.

Address health system research priorities, including efforts to achieve health equity, enhance the diversity in the LHS research workforce, and accelerate progress towards an integrated learning health system.

Enhance diversity at all levels - from the kinds of research topics and projects to the regions in which it is conducted to the backgrounds of the people conducting it - contributes to excellence in research and training environments and strengthens the research enterprise. This NOFO is intended to support a diverse set of outstanding programs that will train a diverse cadre of embedded learning health system scientists.

Demonstrate value of LHS embedded training and research through program evaluation activities. This program will establish LHS E-STaR Centers that focus on the application and mastery of the core LHS scientist competencies (see https://www. ahrq.

gov/learning-health-systems/building-workforce. html ) to support the professional development of scientists to conduct research that accelerates progress towards an integrated learning health system. The LHS E-Star Centers will build new models of LHS infrastructure that support and enhance existing institutional training and research infrastructure.

This program will be structured to support training and PCOR/CER organized around shared resources and research infrastructure within each of the LHS E-STaR Centers. In this model, Centers will be able to use and pool knowledge of mentors to develop the didactic curriculum and learn from one another as they share their experiences in helping scientists to navigate their way through successful LHS projects.

This approach will produce a cadre of LHS scientists, LHS mentors, and rapid learning projects that can accelerate advances in knowledge, health system performance, and patient outcomes. The benefit of supporting multiple institutions is that it broadens the pool of potential expertise beyond what is typically available at a single institution.

Because the aim of the LHS model is to learn through rapid testing and iteration to ultimately scale research that engages health system, community partners, and others, the program will support learning among diverse sites and partners.

This approach will contribute to more rapid growth in the number and diversity of individuals, as well as organizations, capable of successfully working at the interface of clinical operations, informatics and Applications to this NOFO from academic institutions must have a track record of excellence in training clinical and research scientists.

Qualified, established training institutions must demonstrate a commitment to partner with healthcare delivery systems. Applications from healthcare delivery systems should have a track record of excellence in training researchers and conducting system-based research aimed at improving clinical treatment, health outcomes, quality, and/or health care delivery.

Non-academic health systems may apply but would be expected to partner with an academic institution in providing formal, educational training needs.

Both academic institution and system-based applicants must describe prior and planned collaborative relationships Participating in PCORnet , the National Patient-Centered Clinical Research Network, is not a requirement but use of PCORnet is strongly encouraged as a resource to support LHS research.

All applicants will be expected to recruit and train LHS scientists from beyond their own institution (for example, who are affiliated with other health systems or institutions, including PCORnet-participating sites), in order to provide experiential research opportunities for LHS scientists at a variety of institutions.

To ensure a broad reach for didactic and experiential training applicants are encouraged to partner with diverse organizations such as safety net and community organizations and Federally Qualified Health Centers.

All applicants must demonstrate mentoring support from all partners, including research and health care delivery operational Have a focus on supporting the professional development of scientists to conduct embedded research that accelerates progress towards an integrated learning health system.

New models of LHS infrastructure that support PCOR/CER should: Demonstrate a plan for conducting PCOR/CER within health systems that can be rapidly implemented to improve quality of care and patient Demonstrate knowledge and strategy for involving and engaging patients, clinicians, community, and other stakeholders in research.

Integrate health equity into the LHS training program and Use the AHRQ-sponsored LHS training competency domains or identify specific LHS competency domains or specific enhancements to those competencies the program will deploy, with justification.

Develop and implement a training program that includes both didactic and experiential learning and creates opportunities for embedded scholarship at the interface of research, informatics, clinical operations, and engagement within learning health systems.

Have a strong and high-quality infrastructure to support a combination of didactic and experiential training including mentorship and learning opportunities provided within partner organizations.

Partners may include safety net and community organizations and Federally Qualified Health Centers, academic, and learning health system settings allowing for the application and mastery of the knowledge and skills outlined across the LHS scientist core competencies.

The entire program should be designed to rigorously monitor and provide a well-defined structure to ensure progress for Develop a recruitment Plan to Enhance Diversity: The applicant must provide a recruitment plan to enhance diversity.

Include outreach strategies, and activities designed to recruit prospective scientists from diverse backgrounds, and propose metrics to assess the effectiveness of outreach Methodology Standards in the LHS training curriculum. Facilitate Collaboration: Include research projects designed with LHS partners and stakeholders and conducted within a health system.

Projects should focus on systematically engaging stakeholders, generating evidence, systematically adopting evidence and/or systematically applying evidence in order to expand the health system’s ability to support population health management and/or personalized health care. Demonstrate evidence of institutional support (direct or in-kind) from health systems in which embedded scientists would conduct their research.

Conduct Program Evaluation: Conduct an evaluation with clear outcome metrics linked to improvements in health system performance. Assess scientist research training outcomes including patient-centeredness of research, development of tools or policies, dissemination of research, and PCOR/CER outcomes.

Assess scientist training program outcomes including career advancement, attaining funding, publications, etc. encouraged to consider research activities that use PCORnet to conduct LHS research. Collaborating with PCORnet is one strategy to advance understanding and use of the nationally representative network, which can be used to conduct a range of study designs supporting learning health systems.

PCORnet resources can facilitate collaboration between researchers, patient communities, clinicians, and health systems in research partnerships that leverage large volumes of health data while also ensuring that research focuses on the questions and outcomes that matter most to patients and those who care for them. For more information, applicants are encouraged to contact the PCORnet Front Door ( https://pcornet. org/front-door/ ).

Applicants must identify the career levels for which the proposed research education program is planned and describe the intended embedded scientists and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program.

Embedded scientists to be supported by the program must be at the career level for which the planned program is intended and appointed for no more than three-year period. Each LHS E-STaR Center should be organized around a series of core activities related to the Center's infrastructure-building and mentoring goals.

The cores should be organized to provide intellectual leadership and innovation; facilitate and develop novel PCOR/CER strategies; conduct community-level engagement; stimulate incorporation of emerging technologies, methods, and scientific advances into research designs as appropriate; and provide mentoring for future leaders in LHS research from Centers are expected to create a structure that integrates activities across the site’s Cores to support scientific and educational advancement.

A minimum of three Cores is required: Each application must include an Administrative Core (AC), a Research Education Core (REC), and Research and Data Analysis Core (RDAC). The AC will provide leadership and governance for the LHS E-STaR Center and ensures that the program activities remain within the Center's scientific area of focus.

The goal of the REC is to provide a mentoring mechanism leading to enduring careers in LHS research for LHS scientists. Individuals targeted for mentoring relationships may include clinician or research scientists. The RDAC will create, identify, catalogue, and disseminate scientific information produced by PCOR/CER projects conducted by the Center with a specific focus on AHRQ and PCORI priorities.

Applicants should refer to Section IV. 2 of this announcement for specific instructions on requirements for each of the Cores. Requirements of Required Cores Requirements: Administrative Core (Required Core) The Administrative Core (AC) will provide leadership for the LHS E-STaR Center, with a focus on training program administration.

The LHS E-STaR Centers should have strong and experienced central leadership with an Administrative Core (AC) directed by the PD/PI(s). The PD/PI(s) should be recognized leaders in LHS embedded PCOR/CER and training and should be experienced in successfully mentoring investigators from diverse backgrounds and in supporting engagement with community and stakeholder partners in the context of LHS.

The AC will coordinate proposed activities and maintain internal information flow.

The AC is responsible for managing and coordinating interactions among the PD/PI(s), the core leaders, LHS scientists, mentors of pilot projects, other researchers at the applicant institution as well as partner institutions, stakeholders, other AHRQ/PCORI-funded programs, appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located.

Key responsibilities of the Administrative Core include: Liaising with AHRQ/PCORI program staff, ensuring that program objectives and priorities, performance, challenges, and related information is Creating mechanisms and procedures for ensuring interaction between the site’s Cores and partner institutions.

Creating mechanisms and procedures for ensuring regular and meaningful engagement between the site and community and stakeholder partners (for more information, see PCORI s Building Effective Multi-Stakeholder Research Teams , and the section on Addressing Contextual Challenges to Engagement and Patient-Centered Outcomes Research: The Benefits of Multi-Stakeholder Engagement resource).

Ensuring that LHS scientists engage with colleagues at the primary and partner institutions, as well as community partners. Developing approaches to ensure recruitment and retention of LHS scientists and the viability of mentoring and training relationships among Facilitating communications, both internal and external. Planning for LHS scientists research project development, including project solicitation, review and selection.

Coordinating LHS scientists participation in meetings and Designing and conducting program evaluation with clear outcome and impact metrics linked to improvements in health system performance, going beyond preparing manuscripts for publication.

Requirements: Research Education Core (Required) The goal of the Research Education Core (REC) is to produce LHS embedded scientists and enhance diversity in the LHS workforce by: supporting PCOR/CER research projects for LHS scientists relevant to AHRQ/PCORI priorities; providing continuing mentoring activity for LHS Scientists to achieve research career training objectives; offering education in LHS research using AHRQ-sponsored LHS training competencies or specific enhancements to those competencies the program will deploy, with justification; and providing activities and resources to the LHS scientists throughout their training program affiliation.

Individuals participating in mentoring relationships may include clinician or research scientists working in academic and health system or stakeholder partner organizations.

It is the responsibility of the REC to assure successful mentoring of, and collaboration with, LHS scientists from Required REC activities include: A strong and high-quality infrastructure to support a combination of didactic and experiential training including mentorship and learning opportunities provided within both academic and LHS settings allowing for the application and mastery of the knowledge and skills outlined across the LHS scientist core competencies.

The entire program should be designed to rigorously monitor and provide a well-defined structure that promotes the development of professional skills and research productivity for all embedded Be tailored to the LHS embedded scientists needs, using AHRQ-sponsored LHS training competency domains or specific enhancements to those competencies the program will deploy, with justification; Include both didactic and experiential learning and embeds scientists at the interface of research, information, and clinical operations within learning health systems; Conform to individual development plans; Methodology Standards in the LHS training curriculum.

RECs must promote PCOR/CER research that: Incorporates mentorship for rapid cycle research in LHS; Engages system, community, and stakeholder partners; Leverages grant funding to secure partner funding, including funding from PCORI, AHRQ, other federal agencies, and health systems; Uses emerging data and technology to support PCOR/CER, including PCORnet, Medicare and Medicaid data.

Requirements: Research and Data Analysis Core (Required Core) The Research and Data Analysis Core (RDAC) will create, identify, catalogue, and facilitate the dissemination, implementation, and use of scientific information produced by PCOR/CER projects conducted by the Center with a specific focus on AHRQ/PCORI priorities. RDAC personnel should have expertise in PCOR/CER methodology.

Research cores will focus specifically on AHRQ/PCORI priorities, including: Embedded LHS Patient-Centered Outcomes Research (PCOR), a type of comparative clinical effectiveness research (CER).

PCOR compares two or more medical treatments, services, or health practices and addresses questions and outcomes important to patients and other healthcare stakeholders, through studies that generate evidence meaningful to those who need this information to make health and healthcare decisions. Use of emerging data and technology to support PCOR/CER, including PCORnet, Medicare and Medicaid data.

Partnership with state Medicaid programs and other payers, community-based organizations, minority-serving institutions, diverse organizations such as safety net and community organizations, and Federally Qualified Health Centers. Engagement of patients, communities, and other health care stakeholders as partners in research.

Facilitating research on priority topic areas, including: Healthcare disparities, including reducing both racial/ethnic and socio-economic gradient healthcare disparities in order to reduce healthcare and health disparities that are shared by all low-income, working Maternal health and maternal morbidity and mortality (MMM) Intellectual and developmental disabilities (IDD) Patient-centeredness and the science of patient and stakeholder Dissemination and Implementation approaches and tools.

PCOR/CER methods and application of PCORI Methodology Standards. Facilitating dissemination, implementation, and use of research findings to improve health system operations, quality, and health outcomes. VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. AHRQ intends to fund up to $10 million annually over five years to support approximately 10 awards, beginning in fiscal year 2023. Future year funding is contingent upon on the availability of funds.

Total annual costs (combined direct and indirect) for a project awarded under this NOFO will not exceed $1 million in any given year and $5 million for the entire project period.

Funds may be used only for those expenses that are directly related to and necessary to the project and must be expended in compliance with the applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and The scope of the proposed project should determine the project period. The project period may not exceed five 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. These awards will be funded together by PCORI under an agreement pursuant to 42 U.S.C. 299b-37(g).

All applications submitted and AHRQ grants made in response to this NOFO are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www. ecfr. gov/cgi-bin/text-idx?

node=pt45. 1. 75 ) , the HHS Grants Policy Statement (see http://www.

ahrq. gov/funding/policies/hhspolicy/index. html ), and the terms and conditions set forth in the Notice of Award.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism.

For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed.

Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties.

If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the recipient and what substantive role the applicant organization will play.

Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. 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 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 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. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Applicants must have an active SAM registration in order to complete the Program Directors/Principal Investigators 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for 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