Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

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.

It is critical that applicants follow the instructions in 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 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. 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The Office of Research on Women's Health (ORWH) in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to promote a new initiative by reissuing RFA-OD-21-010, "Advancing Gender Inclusive Excellence (AGIE) Coordinating Center (U54 Clinical Trial Not Allowed)" to solicit applications for an Advancing Gender Inclusive Excellence (AGIE) Coordinating Center (U24 Clinical Trial Not Allowed).

The purpose of the AGIE Coordinating Center will be to provide the organizational framework for the management, direction, and overall coordination of all common activities aimed at investigating strategies, approaches, and interventions promoting gender equity or addressing barriers to gender equity, including for women, at the faculty and leadership levels in many areas of science, technology, and engineering.

Background

Though parity is being reached between men and women at the graduate level in the biomedical sciences and in medical schools, women remain underrepresented in Science, Technology, Engineering, Mathematics, and Medicine (STEMM) faculty and leadership ranks. Underrepresentation of women faculty is particularly severe in the mid- to senior-level and leadership ranks, but women may also be underrepresented at other faculty ranks in some scientific disciplines. For example, a reported 22% of U.S. medical school department chairs were women in 2021. This compares with almost 48% of U.S. medical school graduates reporting they are female in 2018/19 and female having been 30% or more of medical school graduates since 1984/85.

Advancing scientific progress requires a well-trained, diverse, and robust STEMM workforce. The NIH recognizes the important role of organizational change strategies to enhance diversity and gender equity in STEMM academic and research careers. Through NIH funding, our understanding has increased about the systemic and organizational factors that impact gender equity. For example, the NIH funded a 2009-2013 grant program, Research on Causal Factors and Interventions that Promote and Support the Careers of Women in Biomedical and Behavioral Science and Engineering. A summary of this research can be found on the ORWH website at: https://orwh.od.nih.gov/about/director/messages/research-shows-us-how-address-underrepresentation-women-academic-medicine. On behalf of the NIH Working Group on Women in Biomedical Careers (WgWBC) and in collaboration with NIH Institutes, Centers, and Offices (ICOs), ORWH is working to end systemic gender-based inequities impacting the academic and research workforce in STEMM.

The research conducted under the AGIE Coordinating Center will aim at providing a more inclusive environment to enhance gender equity in retention and advancement at the faculty and leadership levels in the STEMM academic and research workforce. The primary vision for the AGIE Coordinating Center is to ensure collaborative coordination of data collection and the AGIE Coordinating Center will serve as a means for developing and operating as a centralized resource hub to collect, store, and disseminate resources for and results of current and future programs. The research is anticipated to include diverse research designs, approaches, and multidisciplinary and interdisciplinary academic disciplines and target different or multiple organizational levels (from interpersonal to departmental to institutional). NIH encourages applications that include diverse groups that can aid in understanding and investigating the intersectionality issues faced in these research areas.

The AGIE Coordinating Center will also serve as a hub to house evidence-based and evidence-informed strategies aimed at various levels of an institution that promote gender equity including in recruitment, retention, and advancement of women in the biomedical research workforce, particularly at the faculty and leadership levels. The AGIE Coordinating Center will establish effective collaboration methods for partnering with stakeholders and institutions to effect change.

Research Objectives and Scope

The AGIE Coordinating Center will be responsible for the administration and management of a Pilot and Feasibility Studies program (expected to start in year two (2) of the agreement). The AGIE Coordinating Center will lead, coordinate, manage, and harmonize the research work conducted under the Pilot and Feasibility Studies program among the Pilot and Feasibility Studies program implementers and with its own research work. The AGIE Coordinating Center will support the provision of quality assurance and monitoring, and function as a central repository for data and other tools and resources across NIH programs. Specifically, the AGIE Coordinating Center will:

1. Develop an organizational research strategy, including planning, organizing, and supporting meetings, education, and outreach activities to engage and interact with stakeholders. This includes developing a research plan that considers costs and available resources and overall management and coordination of AGIE-related research. NIH anticipates that the AGIE Coordinating Center will examine major sources of existing research, such as the NSF Advance program, NIH programs, American Association for the Advancement of Science, Department of Education programs, and Department of Labor programs, and develop ways to centralize and present existing research in a coordinated manner.
2. Work collaboratively with NIH to establish and curate a system for data coordination and resource sharing and serve as a central repository for program activities and results. Ensure that data collection tools, implementation strategies, common data elements and outcome measures, and other resources are readily accessible to anyone pursuing research on organizational change strategies to enhance diversity and gender equity.
3. Develop and implement a multipronged communication and dissemination plan to maximize the impact of the overall AGIE Coordinating Center activities This includes developing a process for synthesizing and assessing the approaches taken to enabling gender equity at the faculty and leadership levels in science and presenting and disseminating the activities and results of the research conducted. The development of the communication and dissemination plan should include the solicitation and incorporation of feedback from stakeholders.
4. Administer and manage the Pilot and Feasibility Program, to begin in year two (2) of the AGIE Coordinating Center and to end after year four (4), to support awards to entities to investigate the feasibility or piloting of programs aimed at identifying and addressing any systemic gender-based inequities that may be impacting the biosciences workforce in academia and other research institutions. The Pilot and Feasibility Program will support small awards (up to $50,000 total costs per year per site) to entities requesting stimulus funds to investigate the feasibility of programs or piloting of programs aimed at identifying and addressing any systemic gender-based inequities that may be impacting the STEMM academic and research workforce. It will advertise the availability, review the applications, and select awards. At present, up to five (5) pilot awards are expected to be made in year 2 (that is, up to a total cost of $250,000 for all of the Pilot and Feasibility Program awards in year 2). The AGIE Coordinating center will develop a description of the organizational and governance structure, explanation of the roles and responsibilities, formal plans for assuring compliance with NIH regulations (including Human Subjects Research and Data Management and Sharing Policy), and plans for an evaluation of the Pilot and Feasibility Program. The AGIE Coordinating Center will develop and implement quality assurance and quality control plans to ensure the rigor of the research across the Pilot and Feasibility Program. The AGIE Coordinating Center must make plans to ensure that data from multiple years will be collected from individual Pilot and Feasibility Programs. Multiple years of data from programs will inform assessment of programs after the initial year of implementation. Funding for the Pilot and Feasibility Program may be used to support follow-up data collection and submission to the AGIE Coordinating Center. The AGIE Coordinating Center will design the Pilot and Feasibility Program so that awards fund activities that are intended to include investigators from a broad range of scientific disciplines and expertise, promote the inclusion of investigators from diverse backgrounds, including investigators from underrepresented groups (see the Notice of NIH's Interest in Diversity (NOT-OD-20-031)), and promote new collaborations, with an emphasis on early-stage investigators.
5. Provide subject matter experts (SMEs) to work with NIH officials to determine milestones and define evaluation criteria and sustainability metrics. The AGIE Coordinating Center will provide SMEs in fields not traditionally supported by NIH that recognize the importance of the behavioral and systemic analyses and evaluations required to understand the complexities and nuances of organizational culture change to achieve gender-inclusive excellence and to ensure that results can be properly contextualized to specific settings.

Expected outcomes from the project period will be:

• Development of a central portal that successfully shares resources, tools, technologies, expertise, and strategies that identify and address challenges in overcoming any systemic gender-based inequities that may be impacting the biosciences academic and research workforce and provide tools and resources to interested parties who are searching for ways to identify and overcome systemic gender-based inequities. The portal must be inclusive of dissemination of existing resources and research, findings that emerge under the Pilot and Feasibility Program, and, as much as possible, newly emerging resources and research from other programs.
• Active monitoring and reporting of QA/QC (Quality Assurance/Quality Control) for all AGIE-related activities and resources.
• Informed stakeholder engagement and perspectives incorporated into every aspect of the AGIE Coordinating Center.
• Lead highly collaborative discussions that successfully identify emerging areas of science.
• Implementation of a multipronged communication and dissemination plan increases awareness at STEMM institutions of the approaches, processes, and activities that promote greater gender equity at the faculty and leadership levels in these institutions.
• Implementation of the Pilot and Feasibility Program, supported by appropriate oversight and rigorous external peer review, that addresses scientific gaps and promotes collaboration.
• Inclusive excellence, collaboration, and understanding of intersectionality in the investigation of strategies, approaches, and interventions promoting gender equity at the faculty and leadership levels in STEMM research.

Project Organization

The efforts of the AGIE Coordinating Center will be governed by an External Steering Committee (ESC) composed of the PD(s)/PI(s) of the awarded cooperative agreement and at least five total outside experts convened to provide unbiased scientific and programmatic oversight (see under Section VI, Cooperative Terms and Conditions). The ESC will collaborate to share best practices; develop relevant common programming; provide networking and other opportunities; and to develop an evaluation for the overall and program-specific components of the consortium. The ESC will meet at least two times per year; one of these meetings should be held in-person in the Bethesda, MD area if possible given pandemic conditions, while the other meeting(s) can be virtual. The ESC will also establish defined metrics to permit evaluation of the program components. It is expected that the ESC will disseminate best practices, recommendations, and lessons learned from the program to the broader research community or to inform NIH of potential future directions and the field. NIH anticipates that the ESC will participate in the evaluation of the Pilot and Feasibility Program. The ORWH Advisory Council will provide oversight, which will act as an advisory to the ORWH.

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

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

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 NIH 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)

Local 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)

Federal Governments

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

Other

• 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
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.
  • 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.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 instructions in 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.

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 IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Benjamin Johns, Ph.D.
Office of Research on Women’s Health
Email: [email protected]
Tel: 301-435-1681

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

SF424(R&R) Cover

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

SF424(R&R) Project/Performance Site Locations

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

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

SF424(R&R) Other Project Information

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

Statement of Willingness:

This statement should be provided as an PDF attachment and should be entitled Willingness . It is expected that the PD(s)/PI(s), as well as the applicant institution, have a commitment to serve the AGIE Coordinating Center objectives as outlined in this FOA. Thus, applicant(s) should provide a statement counter signed by the Department Chair indicating their willingness to:

• Cooperatively work with NIH to share all AGIE related resources with the national research community and participate in all activities, conference calls, meetings, or as needed during the award.
• Actively seek input from NIH regarding resource or expertise needs that may arise during the performance of the project.
• Cooperatively work to develop and execute Material Transfer Agreements (MTAs) to permit sharing of resources, including but not limited to tools, technologies, services, protocols, biological specimens, molecules, cells, animals, genetic material, de-identified patient samples, de-identified patient data, and images.

SF424(R&R) Senior/Key Person Profile

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

The Center Director(s) (PD/PI) should be an established investigator in biomedical workforce development with relevant publications. Interdisciplinary teams are encouraged to apply.

The PD/PI is responsible for ensuring that AGIE Coordinating Center goals are met, for developing and managing a decision-making structure, and for allocation of resources to achieve stated goals. If named, the Associate Director will partner with the PD/PI to facilitate and advance the goals of the Center.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working for the AGIE Coordinating Center.

R&R Budget

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

The PD(s)/PI(s) will be required to declare a minimum effort of 1.95 person-months (15 percent) effort per year. Applications proposing Multiple PD(s)/PIs(s) must have a minimum combined PD/PI effort of 1.95 person months, and the role of each PD/PI should be clearly defined. Applications that do not propose this minimum effort will be withdrawn and will not be reviewed. The AGIE Coordinating Center may also include administrative assistant(s) and specialized support personnel (e.g., central repository developer) and be clearly justified.

Applicant(s) should also include:

• Central repository development and maintenance costs.
• To the extent that meetings are proposed to be in-person, support for all key personnel to travel to Bethesda MD area at least once per year throughout the project period, including the launch meeting anticipated for January 2024 if possible given pandemic conditions.
• Travel, lodging and per diem for up to ten ESC members to attend an annual in-person in Bethesda, MD, if applicable. Travel, lodging and per diem for Pilot and Feasibility Program PIs to attend the annual in-person in Bethesda, MD, if applicable.

Support for a Pilot and Feasibility Program of about $250,000 or more per year (inclusive of all F&A costs) over three years that will enable the conduct of research and the formation of new collaborations and partnerships. The AGIE Coordinating Center should not calculate F&A on Pilot and Feasibility Program set aside. Rather, the AGIE Coordinating Center should budget for costs associated with the administration of the Pilot and Feasibility Program (including key personnel). The AGIE Coordinating Center is also entitled to F&A costs on the first $25,000 of each subaward made from the Pilot and Feasibility Program. Please note that the F&A costs for the subaward institution are included in the total costs of each subaward.

R&R Subaward 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 must be followed, with the following additional instructions:

Specific Aims: This section should include the overall aims of the AGIE Coordinating Center. These should be overarching and should include a vision for how the Center will enable future institutions that are undertaking studies under the Pilot and Feasibility Program to: (1) Provide data on strategies and approaches to promoting gender equity at the faculty and leadership levels of the biomedical research workforce; (2) Work with experts to assess validity and reliability of the evaluation/assessment and of the data for any newly developed strategies or approaches; (3) Obtain information on the types of evidence-informed or evidence-based programs that exist and information on concerns staff need to address as programs are implemented; environment where the original strategy was implemented; and any other validity or reliability data available; and (4) Obtain training or connect with other experts in the field to provide guidance, recommendations and assist in the development or implementation of strategies.

Research Strategy: The Research Plan should outline strategies to:

1. Develop an organizational research strategy, including planning, organizing, and supporting meetings, education, and outreach activities to engage and interact with stakeholders. This should include:
   • An overview of the AGIE Coordinating Center, its objectives, and how they are aligned with the objectives of the research program.
   • An organizational chart of the AGIE Coordinating Center, identifying the proposed PD(s)/PI(s) and key personnel.
   • Plans to establish an external steering committee (ESC), to include one PI/PD, the NIH Project Scientist(s), and at least five outside experts convened to provide unbiased scientific and programmatic oversight and who will also be used to evaluate the Pilot and Feasibility Program. One of the outside experts appointed to the ESC will be a member of the ORWH's Advisory Committee on Research on Women's Health (ACRWH). Describe the anticipated expertise required on the ESC, but do not name or include letters from potential ESC members. NIH requests no contact with potential ESC members before an application for the award is made. Regular ESC meetings (in-person and/or web-based) should be held to obtain timely external assessments of Center progress. The ORWH and NIDDK program officers will attend ESC meetings as observers and a resource for NIH programs and policies. Regular ESC updates are to be forwarded to the program officer and included in noncompeting continuation reports.
   • A description of relevant expertise, experience, and accomplishments of the proposed key personnel in the successful planning, direction, coordination, and management of a complex multi-institution research efforts. It is expected that multi-faceted scientific (including relevant social science) expertise will be included at every level of AGIE Coordinating Center leadership. NIH encourages a diverse and inclusive research environment (NOT-OD-20-031).
   • Plans to organize and support at least two meetings of the ESC per year. As noted above, one of these meetings should be in-person if possible given pandemic conditions. In years 2 through 5 of the agreement, include plans for meetings with the investigators from the Pilot and Feasibility Program awards, the AGIE Coordinating Center, and other interested stakeholders (including but not limited to NIH).
   • Plans for communications with NIH, including provision of advance notice of manuscripts and embargoed publications to the ORWH and NIDDK program officials and/or project officers and preparation and submission of annual progress reports.
   • Plans to negotiate, establish, execute, and manage third-party and consortium agreements (e.g., Material Transfer Agreements) between all Pilot and Feasibility Program recipients and investigators and other external collaborators.
   • Plans to develop a research strategy that considers costs and available resources, including strategies to identify existing research and resources.
2. Work collaboratively with NIH to establish and curate a system for data coordination and resource sharing and serve as a central repository for program activities and results. This should include plans to develop metrics to evaluate usage and impact of the central repository and how to make the repository dynamic, interactive, and searchable. This should include:
   • A proposed method for synthesizing and assessing the approaches taken to promoting gender equity at the faculty and leadership levels in science and presenting and disseminating the activities and results of the research being conducted.
   • Functionality to permit institutions to search criteria for factors that assess the implementation of strategies. While there may be multiple potential interventions to address a particular issue, not all are equally effective; nor are they all equally relevant for a given set of circumstances. Information must be provided in a format that allows users to understand important contextual information about interventions such as strategies used to implement an intervention, environment of implementation site (e.g., primarily undergraduate institutions, minority serving institutions), costs, expertise and/or staff needed, validity and/or reliability of data, barriers to implementation or "considerations" for implementation. These types of factors may be critical factors in determining the potential success of implementing the strategy. Applicants may wish to investigate the College Aim Toolkit developed by the National Institute on Alcohol Abuse and Alcoholism as an example.
3. Establish and implement a multipronged communication and dissemination strategy that incorporates feedback from stakeholders to maximize the impact of overall AGIE Coordinating Center activities. This should include:
   • Plans to use all appropriate modes of communication (including social media platforms) to maximize dissemination to institutes and researchers where STEMM research is conducted and other interested stakeholders.
   • Indications of how promotion of the central repository and the Pilot and Feasibility Program will be incorporated into the communication and dissemination strategy.
   • Plans to execute and manage a national outreach program intended to help enhance the diversity of the biomedical research workforce. Outreach may consist of a variety of activities and strategies like social media, seminar series, lectures, symposia, etc.
4. Plans to establish, manage, and promote a Pilot and Feasibility Program. Pilot and Feasibility projects involving Humans Subjects Research must develop a detailed, formal plan for assuring compliance with all relevant NIH regulations. The plans for implementation of this oversight plan must be included in the application, as appropriate for either clinical studies or clinical trials. Do not duplicate information already provided in the PHS Human Subjects Clinical Trial Information form. It is expected that any Human Subjects Research Studies will be 'delayed onset.' This program should also:
   • Work with stakeholders to identify key knowledge gaps in ways that organizations and institutions can build a more inclusive environment to enhance gender equity at the faculty and leadership levels in the STEMM academic and research workforce.
   • Help develop and announce requests for applications, advertise solicitations, and manage acceptance.
   • Seek prospective applicants from diverse scientific and demographic backgrounds.
   • Efforts to recruit individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from rural areas and under-resourced educational settings are always encouraged.
   • Describe specific guidelines for applicant eligibility and any additional review criteria necessary for selecting meritorious Pilot and Feasibility programs.
   • Establish an administrative process, with appropriate oversight and rigorous external peer review, to prioritize, fund, and track awards.
   • Include information about how the AGIE Coordinating Center will ensure compliance with relevant NIH guidance for research, including Data Management and Sharing (NOT-OD-22-189).
   • Establish procedures, formats, and timelines for integrating awardees and monitoring and reporting progress and outcomes (e.g., publications, subsequent awards). Include plans to integrate and harmonize the activities of supported projects with ongoing Consortium activities.
   • Develop and implement quality assurance and quality control plans to ensure the rigor of the research.
   • Include a process for encouraging the participating sites to work collaboratively and build consensus with a broad array of stakeholder groups and provide plans on how it will coordinate multi-site evaluation activities. The AGIE Coordinating Center will also be responsible for the coordination of at least three meetings or conferences of investigators, including virtual sessions, who are funded to do work in this field. The Core should describe the plan for organizing the conference. The AGIE Coordinating Center will be responsible for maintaining a conference website, handling registration and other organizing components. Planning of the Agenda, invited speakers, guests and attendees will be coordinated with NIH program officials.

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.

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

The following modifications also apply:

Regardless of the amount of direct costs requested for any one year, applicants are expected to refer to the Implementation Details for the NIH Data Management and Sharing Policy notification (NOT-OD-22-189) and related announcements. Concerns, governances, policies, and procedures set forth in this notice around data collection, integrity, storage, security, etc. should be addressed in the application. NIH has issued a Data Management and Sharing notification (NOT-OD-22-189) and applications in response to this FOA should be responsive to this notification. Specifically, consistent with achieving the objectives of the AGIE Coordinating Center, all resources, tools, technologies, protocols (including analytical methods), and other research resources are to be made publicly available to the larger national research community as soon as QA/QC procedures have been completed, and in accordance with the policies developed by the AGIE Coordinating Center.

The application is expected to include the development and maintenance of an outward facing central repository to disseminate information on existing evidence-informed strategies that may identify and address any barriers to gender equity at the faculty and leadership levels in the biomedical research workforce. The central repository would house information on the cost, methods, outcomes, modality, expertise needed, target population, barriers to implementation, etc. and, where possible, information on obtaining data from studies that implemented these strategies. Where possible:

• Information should be freely available to researchers and educators.
• Connections should be made between researchers and educators with those responsible for implementing strategies for further collaborations; and
• Plans should be presented for the identification of studies to be included in the repository.

ORWH and NIDDK will make all final decisions concerning resource sharing and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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. NIH 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. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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 form. 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 unique entity identifier provided on the application is the same identifier 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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

For this particular announcement, note the following:

Reviewers are asked to especially consider the justification of the following:

• Plans to share AGIE Coordinating Center resources.
• Plans to lead, manage, and coordinate all activities to achieve AGIE Coordinating Center objectives.
• Plans to establish a comprehensive nationwide communication and dissemination plan.
• Plans to administer and manage the Pilot and Feasibility Program.

The methodologies and approaches proposed in the application may not be innovative but should address the AGIE Coordinating Center needs in achieving its goals and objectives.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance 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 NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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 grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 NIH 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. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals 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 information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, 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, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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), NIH 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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipient is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipients 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 reside with the recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Ensuring adherence to the overall objectives of the AGIE Coordinating Center.
• Convening regular meetings to evaluate the progress of the AGIE Coordinating Center.
• Serve as a voting member of the ESC, and participate, along with critical staff, in ESC meetings including in-person or virtual meetings as scheduled; in person meetings should be held in the Bethesda MD area or at an alternate location approved by the NIDDK and ORWH.
• Apprise the Project Scientist (PS) and Program Officer (PO) of any potential impediments to execution of the objectives of the project.
• Abiding by the governance and all program policies agreed upon by the ESC and approved by the NIDDK and ORWH. All aspects of the Center, including any modification of project design, conduct of the project, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators will be verified, confirmed, and established, when necessary, by the ESC.
• Supporting the Pilot and Feasibility Program recipients.
• Provide representation on all relevant committees and working groups established by the ESC.
• Participating in any additional meetings and activities to promote sharing of best practices.
• Reporting annual and ad hoc progress reports to the NIDDK and ORWH on all AGIE Coordinating Center activities and provide goals and progress toward those goals at regular intervals to NIDDK program officer and as requested by the ESC.
• Recipient will agree to accept close coordination, cooperation, and participation with ORWH and NIDDK. In turn, ORWH staff will work with the Working Group on Women in Biomedical Careers or the NIH Institute, Center, or Office (ICO) Partners Group and the Advisory Committee on Research on Women's Health (ACRWH) in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
• Participation in AGIE Coordinating Center program evaluation activities, including ad hoc site visits by the NIDDK, ORWH and other external evaluators.

Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIH Program staff. Any relevant proposed third-party agreements between the grantee and the third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies. Further, at the request of the NIH Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions , and Section 8.5.2, titled: Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support , noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.

Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and Pilot and Feasibility Program activities that includes access to any Pilot and Feasibility Program generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.

Support or other involvement of industry or any other third party in the study (e.g., participation by the third party; involvement of project resources or citing the name of the study or NIH support; or special access to project results, data, findings, or resources) may be advantageous and appropriate. However, except for licensing of patents or copyrights, support, or involvement of any third party will occur only following notification of and concurrence by NIH.

Recipient will adhere to the NIH policies regarding intellectual property, data release and other policies. If additional policies are established during the course of this activity, they must be consistent with applicable NIH policies, laws, and regulations.

Resource Management and Sharing Plan:

The NIH-approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, a recipient or study group may not continue to use or share study-generated resources until those resources are available to the public via an NIH approved repository per the NIH approved sharing plan. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, biosamples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for the eventual archiving and distribution of the study generated resources that are to be maintained in the Central Repository. All resources transferred to the Central Repository will be under the custodianship of the NIDDK. The study’s leadership will have proprietary control of and exclusive access to the resources per the NIDDK-approved sharing plan. Subsequently, these resources will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharingand,https://sharing.nih.gov/, andhttps://sharing.nih.gov/faq#/data-sharing.htm) as well as the NIDDK policy for resource sharing,https://www.niddk.nih.gov/-/media/Files/Research-Funding/Process/PublicversionNIDDKdatasharingpolicy2013July2013.pdf.

The NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIDDK and ORWH will designate program staff, including a Project Scientist (PS), a Program Officer (PO), and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The PO and Grants Management Specialist will be named in the Notice of Grant Award.

The role of the Project Scientist (PS) in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s). The PS will:

• Help guide the development of the AGIE Coordinating Center by providing advice and coordination.
• Facilitate partnership with the NIH and ensure that the directions taken by the AGIE Coordinating Center are consistent with the NIDDK and NIH missions and objectives. The PS will serve as a liaison between the recipient and Working Group on Women in Biomedical Careers (WgWBC), the ICO Partners group and the Advisory Committee on Research on Women's Health (ACRWH) and will periodically report progress to the ORWH Director.
• Help coordinate collaborative research efforts that involve multiple sites.
• Attend and participate as a voting member in all ESC meetings.
• Participate in organizing the meetings of program stakeholders, specialized workshops, etc.
• Review the scientific progress of the AGIE Coordinating Center for compliance with operating policies developed by the ESC, and may recommend to the NIDDK to withhold support, suspend, or terminate an award for lack of scientific progress or failure to adhere to policies established by the ESC.

The Program Officer is responsible for the normal scientific and programmatic stewardship of the award. The PO will:

• Interact with the PD(s)/PI(s) on a regular basis to monitor study progress. Monitoring may include regular communications with the PD(s)/PI(s) and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters, as well as attendance at ESC and related meetings. The NIDDK retains, as an option, a periodic review of progress by researchers not involved with the study.
• Have the option to recommend, following evaluations of AGIE Coordinating Center progress, the possible withholding, reduction, or reallocation, as appropriate, of support from any AGIE Coordinating Center component that substantially fails to achieve its objectives according to the approved milestones or fails to comply with the Terms and Conditions of the award, at the appropriate times. The NIH/NIDDK will not permit further expenditures of NIH funds for a study after requesting closure except as specifically approved by the NIH.
• Have the option to recommend, following evaluations of AGIE Coordinating Center, an increase in support to engage in further research efforts within the original research scope, as appropriate, for any AGIE Coordinating Center component exceeding its objectives according to the approved milestones and substantially improving state-of-the-art capabilities, at the appropriate times.
• Participate in the ESC meetings as an annex officio(non-voting) member.
• Retain the option to recommend, with the advice of the PS, re-allocation of NIH support among recipients, as scientific objectives evolve.
• Carry-out continuous review of all activities to ensure objectives are being met.
• Consult the NIDDK Technology Advancement Office to facilitate a review, comment, and approval of any Consortium management agreements or research collaboration agreements with third-party collaborators to assure compliance with NIH/NIDDK policies and network policies.
• Serve as the official NIH representative in all communication with the ESC.

Both the Project Scientist and the Program Official will cooperate in carrying out research, and maintenance of high-quality research in each of the individual research project(s) and review the project(s) for compliance with operating policies developed by the External Steering Committee and may recommend to the NIH to continue funding; withhold support or restrict an award for lack of scientific progress or failure to adhere to policies established by the ESC.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PD(s)/PI(s) and NIH PS will be jointly responsible for participating in Consortium-wide activities and for establishing collaborations across the Consortium and with other related activities.

External Steering Committee (ESC)

The ESC will be the primary governing body for all AGIE Coordinating Center activities. The voting membership of the ESC will include: one PD/PI from the AGIE Coordinating Center and the NIH PS(s), plus at least five appointed members, including one member of the ORWH's Advisory Committee on Research on Women's Health (ACRWH). The Chair(s) of the ESC will be selected by the ESC. A portion of the ESC meetings may be open to the public.

If needed, other NIH staff members may also participate in ESC meetings as nonvoting members. All ESC decisions and recommendations that require voting will be based on a majority vote. The ESC will meet at least twice annually or as needed, with intermittent conference calls as needed. The frequency of ESC meetings can be adjusted on a AGIE Coordinating Center need basis. The ESC may, as it deems necessary, invite additional, non-voting scientific consultants to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the expertise of the ESC when necessary. The ESC will schedule the time for and prepare concise (3 to 4 pages) summaries of the ESC meetings, which will be delivered to members of the group within 30 days after each meeting.

The ESC will:

• Review progress of the AGIE Coordinating Center toward meeting the overall Consortium objectives.
• Ensure that the AGIE Coordinating Center adheres to the guidelines developed by the ESC and NIH.
• Discuss and prioritize the projects from the Pilot and Feasibility Program.
• Ensure that the AGIE Coordinating Center takes advantage of existing NIDDK, ORWH, and NIH resources and programs.
• Establish, as necessary, subcommittees or working groups to ensure the progress and productivity of the AGIE Coordinating Center.
• Monitoring the overall program performance, identifying impediments to success, and developing appropriate strategies to overcome the problems, including working to evaluate the progress of the AGIE Coordinating Center and advise the PD(s)/PI(s) regarding the scientific directions of the program.
• Developing agendas and content for meetings.
• Guide the development and documentation of the AGIE Coordinating Center standards and guidelines.
• Establish a robust administrative process, with appropriate oversight and rigorous external peer review, to prioritize, fund, and track all Pilot and Feasibility Program expenditures.
• Evaluate progress in the Pilot and Feasibility Program sites and recommend adjustments in approaches if necessary, including implementation of new projects and changes to ongoing studies, and termination of projects.
• Develop and approve the AGIE Coordinating Center intellectual property agreements consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the recipient institutions.

The NIH intends the resource sharing plans for the AGIE Coordinating Center to follow the policy and objectives stated in the original FOAs. Specifically, consistent with achieving the objectives of the AGIE Coordinating Center, all resources, tools, technologies, services, expertise, protocols (including analytical methods), ontologies, biological samples and other research resources are to be made publicly available to the larger national research community as soon as QA/QC procedures have been completed, and in accordance with the policies developed by the ESC. Limited exceptions to the requirement for community dissemination may be identified by the ESC. The NIDDK, in consultation with the ESC for this project, will make all final decisions concerning resource sharing and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.

Recipients will comply with and implement the recommendations and decisions of the ESC with respect to the sharing of resources developed by the AGIE Coordinating Center investigators.

Recipients are expected to register resources supported by this FOA with the NIDDK Information Network (dkNET) at https://dknet.org/ and use Research Resource Identifiers (RRID) assigned through dkNET in any publication supported by this FOA.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the ESC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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.

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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Benjamin Johns, Ph.D.
Office of Research on Women's Health (ORWH/OD)
Tel: 301-435-1681
email: [email protected]

Robert Rivers, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 443 8415
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Helen Cox, M.H.S.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK))
Telephone: 301-496-7274
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301, and 405, and 486 of the Public Health Service Act as amended (42 USC 241, and 284, and 287d) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.