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 FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for a Coordinating Center (U54) to serve as a resource hub for existing and future Advancing Gender Inclusive Excellence (AGIE) programs. The AGIE Coordinating Center will provide the organizational framework for the management, direction, and overall coordination of all common activities. Specifically, this program is aimed at investigating strategies, approaches, barriers, and interventions to women attaining leadership positions in many areas of science, technology, engineering.

Though parity is being reached between men and women at the graduate level in the biomedical sciences and in medical schools, women remain underrepresented at the faculty level in Science, Technology, Engineering, Mathematics, and Medicine (STEMM) particularly in the mid- to senior-level ranks and may also be underrepresented at other faculty levels in some scientific disciplines. On behalf of the Working Group on Women in Biomedical Careers (WgWBC) and in collaboration with NIH Institutes, Centers and Offices (ICO), ORWH is working to address and intervene with the systemic gender-based inequities impacting the STEMM academic and research workforce.

Advancing STEMM requires a well-trained, diverse, and robust workforce which is the engine of scientific progress. 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.

The AGIE Coordinating Center will design and implement data collection methods, ensure data quality, develop strategies for the dissemination of findings; and serve as a resource hub for future programs.

This research will add to the understanding of the strategies, approaches, barriers that range from interpersonal interventions to changes in the structure and culture at the institutional level. The Center will make data available to those who want to study and implement such strategies. NIH encourages applications that include diverse groups at various levels that can speak to the intersectionality issues faced in implementing strategies.

This research will be accomplished by conducting self-assessments for various programs such as the American Association for the Advancement of Science's (AAAS) SEA Change. The AGIE Coordinating Center will serve as a hub to house evidence-informed and evidence-based strategies, including validity and reliability data, implementation strategies aimed at various levels of an institution that will promote the recruitment, retention and advancement of women in the biomedical research workforce. The AGIE Coordinating Center will establish effective collaboration methods for partnering with stakeholders and institutions to effect change.

The AGIE Coordinating Center will serve as an integrated hub for data collection of programs that will be funded by the NIH. The successful applicant for the AGIE Coordinating Center will work collaboratively with the NIH to develop common data elements and data dictionaries, ensuring that associations and connections can be made among the various research being conducted. The Center will ensure the rigor of the research to drive reproducibility, to create evidence-based programs by providing subject matter experts, and to craft future milestones, evaluation criteria and sustainability metrics.

NIH recommends applications follow the below adaptation of the "Compendium of Best Practices for Coordinating Centers" developed by the National Heart, Lung and Blood Institute (NHLBI):

Coordinating Center Operations

A. Program Initiation for Success

• Identify Coordinating Center (CC) staff and their roles within the program.
• Develop a plan that would facilitate frequent communications and interactions with all stakeholders.
• Identify staff or committed collaborators with subject matter, methodology and statistical analysis expertise as needed.

B. Communication

• Develop a plan that highlights lines of communication and authority and establishes accessible and secure methods of communication (e.g., conference calls, SharePoint, websites, email, paper records, newsletters) among collective project staff.
• Develop a plan to ensure that a public website remains current and includes an adequate description of the interventions, approaches or strategies (e.g., protocol, manual of operations, contact information, validity and reliability data, cost to implement, etc.), as appropriate.
• Determine how internal/administrative websites with password access for different bodies (e.g., Steering Committees, Data and Safety Monitoring Board, CC staff) will be used for communication purposes and maintained.
• Have a plan for making project plan documents accessible to appropriate study staff.

C. Administrative Coordination

• Identify fixed and variable costs at the start of the study, strategies for constraining or reducing costs and potential areas where there may be insufficient funds.
• Establish a plan for monitoring costs on a scheduled basis.
• Facilitate and arrange logistics for in-person meetings and conference calls and identify staff responsible for meeting coordination (e.g., planning, note taking, and distribution of minutes and reports for meetings).

D. Study Planning and Management

• Provide expert assistance in design and analysis plans.
• Establish processes for tracking related studies.

E. Publication and Presentation Development

• Establish, document, and follow processes for manuscripts and presentations tracking, preparation, review, communication, and submission (including interaction collaborators as appropriate).
• Provide leadership in coordination of and analysis for publications and presentations including establishing timelines for preparation and submission of primary and secondary manuscripts.

Data Management

A. Data Security

• Develop and document a data security plan with appropriate security processes and procedures (regardless of data capture approach).
• Develop a plan for disaster recovery that meets project needs for availability, confidentiality, and data/application location.
• Identify available security expertise if applicable to work on the project as needed.
• Develop a plan and assign responsibilities for Information Technology (IT) security for data that are to be uploaded.

B. Data Systems

• Assist with the creation and utilization of data dictionaries that describe the formatting and descriptive contents of uploaded data for all systems and provide appropriate expertise.
• Ensure data management systems comply with privacy and accessibility regulatory requirements and/or Public Laws (e.g., Section 508 amendment to the Rehabilitation Act, Privacy - Impact Assessment, Title 21 CFR Part II, Privacy Act, Health Insurance and Portability and Accountability Act (HIPAA etc.) as necessary.
• Test, validate, and optimize data capture systems to provide immediate feedback on user errors, logic errors.

C. Analysis

• Address primary and secondary analyses in the analysis plan to the extent possible.
• Establish a mechanism to process requests for secondary/ancillary analyses.
• Require that requests for analyses contain a scientific question/hypothesis, and lists of variables, time points and proposed comparisons.
• Establish a plan to set priorities for analyses.
• Quality Assurance/Quality Control.

D. Reporting

• Provide timely feedback to sites concerning data transfers, etc.
• Collaborate with NIH to design and develop appropriate reports and establish reporting frequency.
• Have a plan for ensuring accurate and reliable analyses.
• Use graphics for reports and summaries to ensure that data can be understood and assessed in an efficient and accurate manner.

At minimum the Coordinating Center should consist of:

1. Administrative Core (AC) to provide the administrative structure that facilitates collaboration, communication, evaluation, and dissemination.

2. Data Coordination Core (DCC) to assist the NIH in developing goals and objectives, common data elements, and outcome measures that will drive the future strategies, approaches, etc. The DCC will collect data from various sources conducting studies, evaluations or self-assessment for various purposes and other future program(s) and coordinate with the Toolkit Core (described below) to disseminate data as applicable to any implementation strategy.

3. Communication & Dissemination Core (CDC) to house, organize and disseminate information on programs, processes or other evidence-informed/based strategies that lead to the promotion of women in leadership positions. This could include conducting workshops, webinars, or conferences with stakeholders.

4. Toolkit Core (TC). The Coordinating Center will be expected to provide a "toolkit" type structure for an outward facing resource to institutions who need more information on implementation strategies in different areas (e.g., promotions, hiring, retention, etc.). This toolkit would provide information on the strategies implemented at institutions and include information on demographics of population; type of institution; method of data gathering; validity and/or reliability data if applicable; cost to implement; potential considerations for implementation, etc. Applicants can refer to the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) CollegeAIM for an example of such an outward facing resource.

5. Pilot and Feasibility Core (PFC), to begin in year two (2) of the AGIE Coordinating Center and to end after year four (4), will support small awards (up to $50,000 total costs) to entities requesting stimulus funds to investigate the feasibility of or piloting of programs aimed at addressing systemic gender-based inequities 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.

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

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Governments
• 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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. 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 NOT-OD-11-101).

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

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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:

Lisa Begg, Dr.P.H., RN
Office of Research on Women's Health (ORWH)
Telephone: 301-496-3975

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core	12
Core (use for Data Coordination Core)	12
Communication and Dissemination Core (use for Communication & Dissemination Core)	12
Toolkit Core (use for Toolkit Core)	12
Pilot-Feasibility Core (use for Pilot and Feasibility Core)	12

Additional page limits 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 a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required, 1 maximum
• Data Coordination Core: required, 1 maximum
• Communication and Dissemination Core: required, 1 maximum
• Toolkit Core: required, 1 maximum
• Pilot and Feasibility Core: required, 1 maximum

When preparing your application, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Other Attachments: Center Organizational Structure. Provide a diagram of the Center components and related interconnections.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

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.

The PD/PI and Associate Director (if applicable) are expected to commit substantive effort (greater than 15% combined) to ensure success of the Coordinating Center.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: This section should include the overall aims of the AGIE Coordinating Center. Describe the specific aims for the Center as a whole. These should not be the same as the specific aims of the individual cores but should be overarching and should include a vision for how the Center will enable future institutions that are undertaking the pilot studies to: (1) Provide data on strategies and approaches to increasing the participation of women at various levels of the biomedical research workforce; (2) Work with experts to assess validity and reliability 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 such concerns as staff needed to implement; environment original strategy was implemented in; 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.

The Overall section states the theme, vision, and rationale for the proposed AGIE Coordinating Center, and provides an overview of planned synergistic activities to achieve stated Aims.

Research Strategy: Organize the Research Strategy into sections on Significance and Approach.

Significance. The application should address the contribution of the Coordinating Center in improving diversity in the biomedical research workforce. The application should also explain why it is important to assess or evaluate its biomedical research hiring, retention, promotion, career development, training, and mentoring activities. The Coordinating Center should describe how the participating sites will work collaboratively and build consensus with diverse stakeholder groups, and provide plans on how it will coordinate multi-site evaluation activities.

Innovation: Describe novel organizational concepts, management strategies, or instrumentation in coordinating the programs the Center will serve. The concepts, strategies, or instrumentation should be novel to one type of program or applicable in a broad sense. The application should propose a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation.

Approach. Describe the overall model for the AGIE Coordinating Center, the plans to organize data from the different self-assessments, strategies and interventions institutions are implementing and gathering data on; and for the creation of an interactive, dynamic toolkit for purposes of disseminating interventions. Within this section, the applicant should provide a timeline for the proposed activities. How would the Center manage collaborating with institutions to either conduct self-assessments and/or implement programs aimed at the issues? How would the Center engage stakeholders to accomplish goals, encourage collaborations, and disseminate information?

Letters of Support: Applicants are required to comply with the instructions for the Letters of Support as provided in the SF424 (R&R) Application Guide with the following modification:

Letters of collaboration: Collaboration letters do not need to be provided by authorized officials from partner institutions/organizations

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Because the goal for the AGIE Coordinating Center involves the housing of data from outside sources, the applicants, regardless of the amount of direct costs requested for any one year, are expected to refer to the National Institute of General Medical Science's Data Sharing requirements set forth in "Diversity Program Consortium Data Sharing Policy." A copy of this policy can be found at: https://www.nigms.nih.gov/training/dpc/Pages/datasharing.aspx. Concerns, governances, policies and procedures set forth in this document around data collection, integrity, storage, security, etc. should be addressed in the proposal.

The application is expected to include the development and maintenance of an outward facing toolkit to disseminate information on existing evidence-informed strategies that may address the barriers to women achieving leadership roles in the biomedical research workforce. The dynamic, interactive, searchable toolkit 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 toolkit.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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

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

When preparing your application, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Project Narrative: Do not complete.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Administrative Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe the Specific Aims for the Administrative Core and how they relate to the Overall Specific Aims

Research Strategy: Organize the Research Strategy into the sections below.

Approach. Describe the proposed activities of the Core, including but not limited to the following roles:

• Promote the integration and function of Center components and activities.
• Provide support for the Center Director in oversight of Center governance.
• Schedule regular meetings of the Center Executive Committee.
• Organize timely meetings of the Center External Steering Committee (ESC).
• Allocate and prioritize fiscal and other resources.
• Develop and execute annual community conferences/workshops that specifically bring together those conducting work in the area of gender inclusive excellence.
• Provide advance notice of manuscripts and embargoed publications to the ORWH and NIDDK program officials; work with the ORWH and NIDDK Communication Offices on press releases and social media outreach.
• Prepare and submit annual progress reports.
• Provide assurance of compliance with NIH policy requirements.

The Approach section should also include plans for the following:

Administrative Structure. Describe the administrative structure of the Coordinating Center, including decision-making processes and lines of communication. Detail the administrative, technical, and scientific responsibilities for Center personnel and collaborators.

Center Governance. Describe plans to convene an internal Executive Committee, consisting of the Center Director, Associate Director (if applicable), Center Administrator and Core Leads, to assist the Director with scientific and administrative decisions. Describe Executive Committee activities, including regular meetings to discuss Center activities and direction. Outline inclusion of institutional officials. Include conflict resolution strategy.

External Steering Committee (ESC). Required External Steering Committee (see roles and composition defined by the NIH in Section VI). Provide plans for the ESC, to be composed of at least five total outside experts convened to provide unbiased scientific and programmatic oversight and who will also be used to evaluate the Center as described in the Pilot and Feasibility Core. Five total members will be appointed to the ESC including one 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 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 an observer and resource for NIH programs and policies. Regular ESC updates are to be forwarded to the program officer and included in noncompeting continuation reports.

Letters of Support: Any letters of support should be attached in this section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

When preparing your application, use Component Type Core .

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

SF424 (R&R) Cover (Data Coordination Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Coordination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Coordination Core)

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Data Coordination Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Coordination Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Data Coordination Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Data Coordination Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Data Coordination Core)

Specific Aims: This section should include specific aims of the Data Coordination Core and how they relate to the overall Coordinating Center aims.

: Describe the framework or conceptual model for the coordination of data collection activities that will be used to (1) solicit data; (2) transfer data (e.g., upload or transfer); and (3) maintain data integrity, access and use across varying types of Institutions and Organizations.

Describe the current and future strategies and processes to promote standardization or harmonization of data collection. Describe the approach to successfully collect, store, and manage data across the programs. Describe monitoring or oversight mechanisms to maximize data quality and minimize missing data when uploading. Describe how implementation or operational difficulties regarding data transfer will be addressed. Describe procedures to ensure privacy and security of coded data obtained from performance sites. Identify planned committees or workgroups to guide, support, or implement data coordination activities.

Letters of Support: Not applicable for this section.

Resource Sharing Plan: Not applicable. The Resource Sharing Plan for the entire application is included in the Administrative Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Data Coordination Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

When preparing your application, use Component Type Communication and Dissemination Core .

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

SF424 (R&R) Cover (Communications and Dissemination Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Communications and Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Communications and Dissemination Core)

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Communications and Dissemination Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Communications and Dissemination Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Communications and Dissemination Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Budget (Communications and Dissemination Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Communications and Dissemination Core)

Specific Aims: Describe the aims and objectives that will be pursued to support the communication and dissemination of interventions proven to be effective in enhancing the role of women in leadership positions in the biomedical research workforce and how they related to the overall specific aims.

Research Strategy: The application should describe how the core leadership will provide expertise in communications. As part of the communications efforts, describe the strategies to keep various stakeholders informed about the various aspect of data collection and the implications toward validity and reliability of evidence informed interventions. The application should provide plans to use the data provided from institutions who collect data during self-assessment projects to further our understanding of factors that may represent barriers to the advancement of women in the STEMM and biomedical research workforce.

The core leadership should describe plans to use the knowledge generated through any interventions research that will be housed in the Toolkit (see "Toolkit Core") for communicating and disseminating to the institutions. Timelines are strongly encouraged.

The Communications and Dissemination Core will also be responsible for the coordination of yearly 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 plan for showcasing activities of the Coordinating Center, the NIH-funded investigators vis- -vis talks, posters, etc. 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.

Letters of Support: Not applicable for this section.

Resource Sharing Plan: Not Applicable. The Resource Sharing Plan for the entire application is included in the Administrative Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Communications and Dissemination Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

When preparing your application, use Component Type Core .

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

SF424 (R&R) Cover (Toolkit Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Toolkit Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Toolkit Core)

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Toolkit Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Toolkit Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Toolkit Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Toolkit Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Toolkit Core)

Specific Aims: Describe the aims and objectives that will be pursued to support the toolkit for housing and presenting information on the interventions used in enhancing the role of women in leadership positions in the biomedical research workforce. Describe how they relate to the Overall Specific Aims.

Research Strategy: The application should describe how the core leadership will provide expertise in toolkit development and maintenance. As part of the toolkit efforts, describe the strategies to collect and present information on various interventions used to enhance the role of women in leadership positions. The application should present plans to provide the various sectors of the STEMM and biomedical research workforce, policy and decision makers with information on interventions used to advance women in these fields.

While there may be various interventions to address the issue, not all are equally effective; nor are they "plug and play" ready for institutions to implement. Information must be provided in a format that allows one to see the strategies used to implement, environment of implementation site (e.g., primarily undergraduate institutions, minority serving institutions), costs, expertise and/or staff needed, validity and/or reliability data if available, barriers to implementation or "considerations" for implementation to name a few. The toolkit should permit institutions to search criteria for factors that assess the implementation of strategies. Factors named above, such as the size of the institution, 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.

The core leadership should describe plans to communicate and disseminate the availability of the Toolkit.

Letters of Support: Not applicable for this component.

Resource Sharing Plan: Not Applicable. The Resource Sharing Plan for the entire application is included in the Administrative Core.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

When preparing your application, use Component Type Core .

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

SF424 (R&R) Cover (Pilot and Feasibility Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates: These dates must reflect that this component is only active in years 2 to 4.

PHS 398 Cover Page Supplement (Pilot and Feasibility Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot and Feasibility Core)

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Pilot and Feasibility Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pilot and Feasibility Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Pilot and Feasibility Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot and Feasibility Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot and Feasibility Core)

Specific Aims: Describe the Specific Aims for the Pilot and Feasibility Core and how they relate to the Overall Specific Aims.

Research Strategy: Describe how, in years 2 - 4, the Pilot and Feasibility Core will advertise, review, and award and administer a minimum of 5 performance sites (maximum of $50,000 in total costs) to reviewed and approved applications. A description of the organizational and governance structure and explanation of the roles and responsibilities of the Pilot and Feasibility Core personnel must be included. 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.'

Letters of Support: Not applicable for this component.

Resource Sharing Plan: Not Applicable. The Resource Sharing Plan for the entire application is included in the Administrative Core.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

If the Pilot and Feasibility Core will accept projects that include Human Subjects research, the justification should include a description of the broad areas of Human Subjects research that would be eligible for Pilot and Feasibility support in addition to other relevant information. Applicants should provide institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

This initiative is not subject to intergovernmental review.

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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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 NIH Center for Scientific Review and responsiveness by components of participating organizations. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center 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 Core that by its nature is not innovative may be essential to advance a field.

Does the proposed Center address the needs of the programs that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the study of the issues? Does the expected end-products of the Center change the current paradigm ?

RFA/PAR only: Additional Questions may be added and should be explained to the applicant in Section IV.2.

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the roles in the Center? Do they have appropriate experience and training, and have the demonstrated experience and an ongoing record of accomplishments in managing this type of effort? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approaches, governance, plan for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards if needed? Have the PD(s)/PI(s) demonstrated the ability to coordinate complex consortia to establish and implement joint goals? Are the PD(s)/PI(s) experienced with programs that focus on the issue? Have the PD(s)/PI(s) demonstrated leadership in coordinating data collection activities across multiple sites? Do the investigators have the necessary experience and scientific/technical expertise to manage and analyze types of data that will be collected from the programs? Do the investigators have expert facilitation skills to support solution and consensus building in collaborative environments? Do the investigators have experience disseminating findings to various stakeholders?

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the programs the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? Are the overall plans for the Center likely to foster collaboration?

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the programs it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Is the environment appropriate for collaboration?

As applicable for the Center 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.

Administrative Core

Is a clear and logical organizational and governance structure described, including the decision-making process for evaluating the Center productivity and the management of resources? Are the processes to be used to allocate and prioritize fiscal and other resources appropriate? Does the management plan adequately describe the composition and roles of any committees or boards, including an External Steering Committee, proposed to help manage and oversee the Center? Is the composition of the committee(s) appropriate and reasonable? Will the Coordinating Center work collaboratively and build consensus with diverse stakeholder groups? Will the Coordinating Center coordinate multi-site evaluation activities?

Data Coordination Core

Is a clear and logical framework or model for the coordination of data collection provided? Are proposed strategies and processes to promote standardization and harmonization of operating procedures appropriate? Are examples of previous successful strategies provided where applicable? Are strategies and procedures to ensure data privacy and security of coded data appropriate?

Communications and Dissemination Core

Is there an effective plan to evaluate the knowledge generated through the interventions research to inform rec institutional policies, programs, and practices? Are the dissemination plans feasible and likely to be widely available and likely to have a national influence? Is an adequate infrastructure to support communication and dissemination, data coordination and toolkit activities described?

Toolkit Core

Is the platform for the housing of the toolkit sustainable and easily managed, maintained and updated? Will the toolkit lend itself to ease of use? Is accessibility addressed?

Pilot and Feasibility Core

Is the process for how the Pilot and Feasibility Core will be advertised, reviewed and administered clear and likely to succeed?

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not applicable

Not applicable

Not applicable

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not applicable.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by Center of 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the Notice of Award (NoA).

NIH requires that program staff be notified of pilot awards made by the awardee. Awardee-selected projects that involve studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.

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. More information is provided at Award Conditions and Information for NIH Grants.

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

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to 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. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about 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.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of 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 a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose remains to support and stimulate the recipients' 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 has been and will remain with the awardees for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

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 External Steering Committee. Awardee will agree to the governance of the External Steering Committee.

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."

Recipient will provide goals and progress toward those goals at regular intervals to NIDDK program officer and as requested by the External Steering Committee.

Recipient will ensure that resources (e.g., data sets; procedure manuals; SOPs, data dictionaries, etc.) developed during this project period are made publicly available and that results are published before the end of the funding period.

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.

Recipient will retain custody of and have primary rights to the data collected under these awards, subject to Government rights of access consistent with current DHHS, PHS, NIH policies during the period of the award, including data being publicly available via an NIH-approved repository. All data will be relinquished to the NIH after the award has been terminated.

NIH staff will 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 Program Official, a Grants Management Specialist, and Project Scientist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award.

The NIH Project Scientist(s) will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:

The Project Scientist(s) for the project will serve on the Center Executive Committee and attend all External Steering Committee meetings. The Project Scientist(s) may work with the recipient on any issues that come before these Committees.

The Project Scientist(s) 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.

The NIH Program Official will review the scientific progress. 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 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. Review of progress may include regular communications with the PD/PI and NIH staff, periodic site visits for discussions with recipient research teams, fiscal review, and other relevant matters. The NIH retains the option of periodic external review of progress.

The NIH reserves the right to withhold funding or curtail the study in the event of (a) substantive changes in the agreed-upon work scope with which NIH cannot concur, (b) ethical issues that may dictate a premature termination; or (c) the project is not progressing well.

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 NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between grantee and 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 and network policies. Further, at the request of the NIDDK 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 network activities that includes access to any network generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the network or study or 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.

Areas of joint responsibility include:

An External Steering Committee will function as the primary governing board for the cooperative agreement funded under this FOA. The Steering Committee membership will include the PD(s)/PI(s) of the awarded cooperative agreement, who will serve as Steering Committee Chair(s); and five external members not involved in the project who are jointly selected by the PD(s)/PI(s) and Project Scientist, one each of which will be chosen from the ORWH's Advisory Committee on Research on Women's Health (ACRWH). Additional members of the Working Group on Women in Biomedical Careers or the ICO Partners group may be appointed to the Executive Steering Committee by the co-chairs of the Groups, but the total number of NIH votes may not exceed 1/3 of the Steering Committee voting membership. Other government staff may attend the Steering Committee meetings if their expertise is required for specific discussions.

The External Steering Committee (ESC) will:

Meet at least annually (in-person or virtual) or as needed, with intermittent conference calls as needed.

Be responsible for the review and selection of applications for pilot studies to investigators for funds as described in the Pilot and Feasibility Core.

Develop recommendations for the recipient, as needed, to refine the uniform procedures and policies developed to meet the goals of the FOA.

Provide input to the PD/PI with respect to the activities of the Center and progress in meeting the goals of the FOA.

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.

NIH staff, in concert with the ESC, will have the option to redirect research activities within the U54 grant if it is considered beneficial to the overall program.

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.

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. The three members will be a designee of the External Steering Committee without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area. 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.

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.

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 $25,000. 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 Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Lisa Begg, Dr.P.H., RN
Office of Research on Women's Health (ORWH)/OD)
Telephone: 301-496-3975
Email: [email protected]

Katrina Serrano, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-7855
Email: [email protected]

Heidi Friedman, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-379-5623
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]

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 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52 and 45 CFR Part 75.