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 toall 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. Applicationsthat do not comply with these instructions may be delayed or not accepted for review,

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The NIH Bridge to Artificial Intelligence (Bridge2AI) Program seeks to bridge the biomedical and behavioral research communities with the rapidly growing community of experts developing AI/ML models by producing flagship datasets that adhere to the FAIR principles (Findable, Accessible, Interoperable, Reproducible) and critically integrate ethical considerations in preparing data for computation. The program will use biomedical and behavioral research grand challenges (described in ROA OTA-21-008) to drive the development of ethics, standards, tools, datasets, and skills and workforce development strategies for linking scientific workflows, protocols, and other information about the data collection process into computable knowledge. Datasets may be linked to existing clinical, environmental and surveillance data as required by the chosen grand challenges. The overall goal of the Bridge2AI Program is to generate flagship datasets and best practices for the collection and preparation of AI/ML-ready data to address biomedical and behavioral research grand challenges. The Bridge2AI program will require multiple scientific domains to come together with data science, data management and analytic experts to unlock the potential of AI/ML for the scientific community.

Primary objectives

Planned objectives of the Bridge2AI program include: 1) New biomedical and behavioral datasets, which are ethically sourced, trustworthy, well-defined and accessible; 2) Software to standardize data attributes across multiple data sources and across data types (establishing new standards as needed); 3) Automated tools to assist the creation of FAIR and ethically sourced datasets (e.g.: through the intelligent workflows, sensorized instruments, etc.); 4) Resources to disseminate data, ethical principles, tools and best practices; and, 5) Cross-training materials and activities for workforce development that bridges the AI/ML and biomedical/behavioral research communities. Completion of these objectives will establish a culture for rigorously generating credible, ethical and generalizable data which will enable AI/ML methods to address key biomedical and behavioral grand challenge problems.

Background

Rapid advancements in AI/ML analysis in recent years show promise in discovering new biomedical and behavioral research insights (that are often surprising). In 2018, members of the AI/ML and computational biomedicine research communities, and in 2019, the AI Working Group of the Advisory Committee to the NIH Director, presented visions to propel progress in biomedical and behavioral research through AI/ML analysis. These groups encouraged NIH to stimulate widespread adoption of AI/ML models that can tackle cross-cutting biomedical and behavioral research grand challenges, with the following recommendations:

• Support flagship data generation efforts to propel progress by the scientific community.
• Develop and publish criteria for AI/ML-friendly data sets.
• Design and apply datasheets and model cards for biomedical AI/ML.
• Develop and publish consent and data access standards for biomedical AI/ML.
• Publish ethical principles for the use of AI/ML in biomedicine.
• Develop curricula to attract and train AI/ML-BioMed experts.
• Expand the pilot for AI/ML-focused trainees and fellows.
• Convene cross-disciplinary collaborators.

The AI Working Group of the Advisory Committee strongly emphasized the need for the NIH to generate flagship (AI/ML-friendly) data sets that can be used by experts in the AI/ML community. To truly harness the emerging power of AI/ML models for human health, NIH must begin with an analysis-first approach which values the machine-understandability of data and incorporates ethical principles surrounding data collection and use.

Currently, the classical instantiation of the scientific discovery process dominates the biomedical and behavioral research enterprise. It begins with models of varying sorts generating hypotheses that are tested in experimental studies. Research protocols are designed, data are collected from a variety of instruments and subsequently analyzed to address defined hypotheses, and new knowledge is reported based on human interpretation of the analyses. By defining a question and collecting the data expected to answer it, researchers typically make assumptions and choices that ultimately limit the ability of analytic tools to generate new insights. While useful, this process is not ideal for generating data to maximize the potential of new methods in AI/ML modeling.

Machines (computers) need to understand or capture the conditions in which the data are collected and the questions the data are intended to answer. Modern AI/ML models place priority on the analysis and the data requirements. All possible information about the data generation process must be captured, including human assumptions and inferences. Typical data sets generated from biomedical and behavioral research, including almost all large data sets currently in existence, do not include this level of detail and are not amenable to AI/ML analysis at scale. In addition, variability exists between scientific study designs, data sources, expert labels, and data processing methods. Moreover, uncertainties, biases and errors occur due to ethical issues, hardware, software, and operator attributes. The systematic translation of this highly heterogenous information into a format that is understandable by machines will maximize the potential of new AI/ML methods to make scientific discoveries in health.

Close interdisciplinary collaboration will be key to this endeavor. The Bridge2AI program is dedicated to bringing together biomedical and behavioral science communities with AI/ML data science experts to incorporate FAIR and ethical principles into data-handling tools for generating data sets that will transform science through AI/ML models.

Structure

The Bridge2AI program will support several interdisciplinary Data Generation Projects and one complementary cross-cutting Integration, Dissemination and Evaluation (BRIDGE) Center to generate flagship data sets and best practices for the collection and preparation of AI/ML-ready data to address biomedical and behavioral research grand challenges. In the long-term, we expect the community to build on these efforts to further assess and evaluate the utility of the flagship data sets and create new data sets using the Bridge2AI framework. The program will strive to provide sustainable long-term resources for the community to train and replicate generalizable Bridge2AI tools for ethical and reproducible scientific discoveries using AI/ML models.

The Bridge2AI Program will support interdisciplinary collaborations to merge biomedical and behavioral research and AI/ML data science communities. It is expected that the Data Generation Projects and the BRIDGE Center will work together to accomplish the goals of the Bridge2AI program. Teams will include relevant expertise in biomedical and behavioral research domains, ethics, data science and data management expertise, as well as teaming and logistical expertise to facilitate interdisciplinary collaboration.

It is critical that the Bridge2AI program proactively recruits and develops individuals from diverse social, cultural, economic, academic, industrial and technical/non-technical backgrounds and communities. NIH is particularly interested in Bridge2AI data generation projects that have the potential to characterize the diversity of society and health problems and for Bridge2AI teams to include members from groups (e.g. researchers, research cohorts and institutions) that are underrepresented in biomedical and behavioral research (see NIH’s Interest in Diversity, information about IDeA states, and the NIH UNITE initiative). Individuals with training in different disciplines, and from varied backgrounds tend to focus on different project details and constraints and contribute unique experiential knowledge. This diversity increases the likelihood that all critical ethical details will be captured, and provides a holistic approach to identifying solutions, while combating against biases, such that the AI/ML system will be more effective with the best efficiencies for all population groups, including those who are underrepresented in biomedical and behavioral research. This required concept of team science across the Bridge2AI program will lead to revolutionizing the production, dissemination, acquisition, and impact of scientific knowledge through AI/ML.

This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material on the Bridge2AI website, www.commonfund.nih.gov/bridge2ai/programresources.

The Bridge2AI Data Generation Projects (OTA-21-008) will be centered around a biomedical and/or behavioral research grand challenge chosen by each project team to produce data sets amenable to AI/ML analyses. The data collected may include multi-scale, multi-modal, and multi-stream data that span the entire spectrum of biomedical and behavioral methods, from atoms to populations, and should be hypothesis-agnostic, ethically sourced, trustworthy, clean, sharable and machine readable. Datasets may incorporate existing data streams, such as clinical, environmental and surveillance data, as needed. Data collected along with annotations and metadata will be curated and shared with the community as it is collected. Projects are envisioned as multi-component undertakings with loci of expertise in team science, ethics, standards, ancillary tools, the relevant data acquisition methods, and skills and workforce development.

The Bridge2AI Integration, Dissemination and Evaluation (BRIDGE) Center Initiative (this opportunity)

The BRIDGE Center will be responsible for integrating activities and knowledge across Data Generation Projects, disseminating products, best-practices, and training materials/activities, and evaluating all aspects of the Bridge2AI program with input from external stakeholder communities. The BRIDGE Center will combine cores of expertise in administration, team science, ethics, standards, tools optimization, and skills and workforce development to harmonize the data generated across all the Bridge2AI Grand Challenges. The BRIDGE Center cores must be positioned to be well-informed of the changing landscape of ethical principles, standards, AI/ML model requirements, automated software tools, and skills and workforce development methods. Each core will work across relevant components of the Data Generation projects to facilitate interdisciplinary team science and to create cross-cutting products, such as workflow and practice analyses, standards harmonization, ethical AI/ML best-practices, community skills development activities, and workforce development opportunities.

The BRIDGE Center should be interdisciplinary (biomedical science, computer science, engineering, behavioral and social science, team science, and other fields) to effectively integrate activities of the Bridge2AI Program across funded Data Generation Projects. Each Data Generation Project will be centered on a biomedical and/or behavioral grand challenge and may include a wide array of data types (e.g., text, image, audio) across the broad landscape of biomedical and behavioral data to address human health. Biomedical and behavioral data span across multiple spatial and temporal scales; spatially from molecular data (atoms to cell) to physiological data (multiple cells to whole human) to population data (from individual to populations), temporally ranging from sub-second dynamic to entire human lifetimes. These data are collected from a wide variety of sources (e.g., instruments, scientific protocols, and data collectors). In order to integrate across the expected wide variability of Data Generation Projects, BRIDGE Centers will need strong program management/administrative skills and cross-cutting expertise to integrate technical and social teaming, data and model standards, tools, ethical principles and skills and workforce development across funded Data Generation Projects.

Center Organization

The BRIDGE Center will include an Administrative Core and five Scientific Cores:

• Teaming Core
• Ethics Core
• Standards Core
• Tool Optimization Core
• Skills and Workforce Development Core

Applicants must include an Administrative Core and at least one of the Scientific Cores listed above. Applicants may propose all five Scientific Cores. Regardless of the structure of the applications and how many cores are proposed, each core will be individually reviewed. Post review, cores from different applications may be selected and funded to work collaboratively as a single BRIDGE center.

Collectively, the BRIDGE Center cores will cooperate with federal partners to foster collaborations across the Bridge2AI Program to address overarching conceptual and methodological issues. A Steering Committee (to be established) will be the governing body for all Bridge2AI Program awardees. The Bridge2AI Steering Committee will include principal investigators from each BRIDGE Center Core and Data Generation Projects and NIH representatives. The Steering Committee will have the ability to establish sub-committees to advise the larger Steering Committee.

The purposes and main roles of each BRIDGE Center core are described below. Applicants should consider how to promote diversity, equity and inclusion across all proposed BRIDGE Center cores (see NIH’s Interest in Diversity, information about IDeA states, and the NIH UNITE initiative), and include core-specific details in the required Plan for Enhancing Diverse Perspectives.

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Administrative Core: This core maintains the organization of the Center and internal/external collaborations and ensures each of the cores are being supported to achieve the Center’s goals. The main roles of the Administrative Core will include:

• Provide logistical and organizational support for all aspects of the Center, including administrative oversight of all funded Cores.
• Create and manage relevant logistic and communications infrastructure to plan and support all Bridge2AI Program meetings (e.g., Steering Committee meetings, External Advisory Board/Panel meetings, Core meetings). Meeting formats may include conference calls, web-based meetings, video conferences, and in-person meetings.
• Develop and maintain a website or other shared workspace to facilitate communication and collaboration among Bridge2AI-funded researchers. Develop and maintain an external facing Bridge2AI website that provides instructions for accessing data sets from Data Generation Projects and provides a platform for dissemination of Bridge2AI products and skill development materials/activities and interaction with stakeholder communities.
• Facilitate dissemination of Bridge2AI results across multiple venues, including the website, scientific reports, workshops, seminars, conferences, collaborative manuscripts, themed journal issues, etc.
• Formal record keeping and reporting across all Cores.

The Administrative Core must demonstrate the ability to provide the logistical skills needed to support a large, multi-team system.

Teaming Core: Team science is critical to the success of the Bridge2AI program, which will bring together teams with broad arrays of expertise, as well as technical and non-technical backgrounds in a multi-team system. The Teaming Core will play the central role in the Bridge2AI Program, providing intellectual and scientific leadership to foster communication, coordination, and collaboration within the BRIDGE Center and across Data Generation Projects.

It is anticipated that the Bridge2AI program may begin as a multidisciplinary endeavor, with each team member bringing individual expertise; however, the Teaming Core will work to transition the Bridge2AI program into an interdisciplinary collaboration that integrates these different disciplines, sectors and viewpoints into a synergistic team to accomplish Bridge2AI goals. Eventually, Bridge2AI should become a transdisciplinary effort, bridging fields and backgrounds in ways that transcend and extend beyond discipline-based boundaries to create new approaches. The primary purposes of the Teaming CORE are to:

• Enable interdisciplinary team science across all components of the Bridge2AI Program. This will include:

• Task integration, creating a governance structure and common workflows across the Bridge2AI program. This includes establishing the structure and decisional authority of the Bridge2AI Steering Committee and developing standard operating procedures for the BRIDGE Center in consultation with core leads and NIH staff.
• Relationship Building and Social Integration, establishing a Collaborative Agreement for the Bridge2AI program to lay a foundation for effective collaboration. This includes promoting a culture in which a diverse array of participants can thrive, optimal team formation and functioning, efficiency in communication and decision making, and leadership development of participants throughout career stages.
• Team Composition, identifying needed areas of expertise and brokering new partnerships as needed, including partnerships with individuals from diverse social, cultural, economic, academic, industrial, and technical/non-technical backgrounds.

• Actively solicit and discuss lessons-learned regarding team science at the intersection of biomedical, behavioral science, and AI/ML fields across Bridge2AI. This should include a plan for assessing, evaluating, and disseminating successful collaboration models within the context of multiple, rapidly changing fields.

The Teaming Core from the BRIDGE Center will be expected to take a leading role in BRIDGE Center activities to accomplish the above cross-cutting teaming activities across the Bridge2AI Program. The Teaming Core will provide scientific team managers to work with each of the other BRIDGE Center Cores to facilitate team science within each core. The Teaming Core should provide strong leadership and capacity to bring diverse teams together and is expected to include expertise in team science, social engineering, group facilitation and/or organizational psychology.

Ethics Core: Achieving ethical and trustworthy AI (ETAI) is critical to the success of the Bridge2AI program. Bridge2AI defines ETAI as the influence and behavior of humans and/or AI/ML systems during the design, development, and implementation of AI/ML tools and technologies as well as the effects and implications of those behaviors on users and society. ETAI encompasses the ethical, legal, and social implications of AI/ML in addition to principles of trustworthy AI including but not limited to: accuracy, reliability, and fairness of AI/ML tools; transparency, accountability, and auditability of the machine and the human; safety, privacy; and user trust.

The field must adapt and incorporate current knowledge around the ethical practices of human research and medicine. It must simultaneously work to solve novel issues as AI/ML and its products are brought to biomedicine. The purpose of the Ethics Core of the U54 is to serve as a hub for ethical and trustworthy AI across the Bridge2AI program, with the end goal of developing and providing tools, best practices and resources to address cross-cutting ETAI challenges impacting the data generation projects. To do this the Ethics Core must perform several functions including convening, analysis and curation, outreach, and original research.

Convening Functions: The Ethics Core will be required to convene and lead collaborations with the B2AI Data Generation Project, as well as biomedical and behavioral ETAI efforts outside Bridge2AI, to begin to create an integrated ETAI research community that is collaborating to inform research practices.

Analysis and Curation Functions: The Ethics Core will curate and synthesize ETAI research relevant to Bridge2AI priorities.

Outreach Functions: To help bring ETAI research and products to the growing set of potential users, this Core should include plans to work with BRIDGE Center cores for outreach and dissemination activities aimed at researchers across the career development pipeline including trainees and investigators new to AI/ML research.

Original ETAI Research: The Ethics Core is expected to allocate time and resources to conduct research on cross-cutting ETAI issues. Proposed research should be included as research aims that will inform the work proposed in the data generation project from the outset of the award. Examples of research topics include but are not limited to:

• Conducting ETAI relevant evaluations and analyses such as assessing the adoption uptake and integration of ETAI tools within Bridge2AI and in the broader research community;
• Development of standard ethical operating procedures (SOPs) that will inform the conduct of ethical data curation, algorithm development, machine training and application to mitigate biases and ensure no harm. This includes ensuring equity of access to data and AI/ML tools using evidence-based metrics and best practices for validating equity and diversity integration as a return on investment (ROI);
• Research on ways to meaningfully integrate community perspectives in AI/ML design;
• Evaluating the trustworthiness and transparency of AI/ML tools and technologies;
• Examining the costs-benefits and/or unintended consequences of AI/ML for health including the impact of potential harms (i.e., who, what, how, and why) and implications of maximizing functions and outcomes that are not strictly health-related

Successful applications should include multidisciplinary teams with the relevant ETAI expertise that bridge traditional AI/ML and data science fields and ethical and trustworthy related fields including but not limited to: bioethics, law, health disparities research, health services and implementation research, public health, computer science, AI/ML, bioinformatics and health information sciences, behavioral and social sciences (e.g., psychology, sociology, anthropology, political science, economics, communication science, and humanities).

Standards Core: The purpose of the Standards Core in the BRIDGE Center is to coordinate the activities of the Standards Modules across all the Bridge2AI Data Generation Projects. The Standards Modules in each Data Generation Project will bring together multi-disciplinary experts to unify data attributes across multiple data sources and across data types required to address the chosen grand challenge. The goal will be to combine the multi-disciplinary expertise to create an interdisciplinary output instantiated in the standards establishment, within the sociocultural context of the Grand Challenge. These experts will organize themselves according to their roles and functions through the Teaming Module of their Data Generation Project as the Bridge2AI program proceeds, adapting to the changing needs of each Data Generation Project. The experts will draw from their domain background to determine a flexible strategy for addressing the chosen Grand Challenge, identifying potential AI/ML analysis methods that may be used in the future (after the data are curated), the requirements for employing the associated analysis, and the data attributes needed to fulfill the analysis requirements. The BRIDGE Center Standards Core will in turn harmonize these activities across the Data Generation Projects as follows:

• Incorporate relevant standards being developed in other domain areas for AI/ML modeling into the Bridge2AI standards discussions
• Coordinate with the BRIDGE Center Ethics (ETAI) Coreto implement overarching ethics principles into the Standards Modules of the Bridge2AI Data Generation Projects
• Coordinate with the BRIDGE Center Tool Optimization Core to incorporate harmonized standards into the automated algorithms for data management
• Review and update the implementation of standards in the data being collected from the Bridge2AI Data Acquisition Modules, through quality assessment of the metadata and data
• Interact with the BRIDGE Center Skills and Workforce Development Core and Administrative Core to disseminate datasheets and model cards and other outputs employing standards

The Standards Core is required to ensure the standards being used in the Bridge2AI program are generalizable to the extent possible in other biomedical and behavioral applications. The standards are required to produce reproducible, credible outputs that can be reused by the broader NIH community. Finally, the Standards Core must create a sustainable process for continually updating standards as the biomedical AI/ML community matures.

Tool Optimization Core: The purpose of the Tool Optimization Core is to integrate work being done across all the Tool Development and Optimization Modules in the Data Generation Projects. Through this, the Core will provide the biomedical and behavioral research community with a centralized source of tools for collecting data optimized for downstream AI/ML-based analysis, as well as the tools that would enable such analysis to be done by both AI/ML experts as well as researchers without current AI/ML expertise.

Since the individual Data Generation Projects are each based around scientifically dispersed biomedical grand challenges, and tools being developed within each module are likely to be linked to the needs of the corresponding grand challenge, the Tool Optimization Core will have the challenging but rewarding mandate to bring together these tools being developed in specific biomedical AI/ML contexts, optimize them for use by the larger research community in a broader range of research purposes than the set of biomedical grand challenges initially funded through Bridge2AI, and work with the BRIDGE Center Administrative Core to disseminate these tools into the hands of individual researchers, many of whom may not have technical expertise in AI/ML themselves. This will entail substantial expertise among staff in the Core in not just software, hardware and firmware tool development, but also the creation of user interfaces that are optimized for interdisciplinary science through which intuitive and easy-to-use wrappers are built around tools that cover the full lifecycle of AI/ML-based research, including data collection and annotation, analysis and application of AI/ML models, and visualization and communication of results from AI/ML-bases analysis to the general scientific audience. Where needed, this Core may include independent work to fills gaps in AI/ML tooling that were not covered by simply aggregating the output of the individual modules, as well as optimizing any tools built inside these modules to be broader in their applicability.

While the individual Tool Development and Optimization Modules are mandated to communicate across each other and with this Tool Optimization Core during their funded work through Bridge2AI, this Core (in collaboration with the Teaming Core) has the responsibility for breaking down silos and facilitating the creation of combined workflows that have relevance across multiple flagship data generation projects in Bridge2AI. In this context, tools built in Bridge2AI are expected to evolve in the direction of a composable AI/ML infrastructure, whereby the appropriate individual tools for addressing future biomedical grand challenges (i.e. those not currently funded through Bridge2AI) can be brought together from tools developed in this program under software control to build workflows that match the analysis requirements of these future challenges. Finally, a cornerstone of the Bridge2AI program is to follow the principles of ethical and trustworthy AI in all work done under the program; in this context, it will be the responsibility of the Tool Optimization Core to work closely with the Ethics Core to provide the tools for collection of ethically sourced data, and for ensuring that tools built in this program are free of inherent bias and follow ethical AI best practices.

Skills and Workforce Development Core: The Bridge2AI program is an inherently interdisciplinary endeavor that will require collaboration across a broad array of expertise and technical and non-technical backgrounds. The Bridge2AI program will provide multiple opportunities for investigators, end-users, and other communities to develop new skills, and will also work to develop a new transdisciplinary AI-biomedical and behavioral research workforce that will be equipped to utilize AI/ML methods to address biomedical and behavioral research grand challenges. The primary purpose of the Skills and Workforce Development Core is to bridge expertise across biomedical and behavioral research domains, ethics, AI/ML data science and data management, and team science in order to enhance skill development and attract and develop an AI-biomedical and behavioral research workforce. The Core includes the following two primary components:

• Skills Development: Develop, implement and assess integrated and coordinated curricula and educational materials/activities to support use of the AI/ML-ready datasets created by the Data Generation projects, as well as to support use of products and cross-cutting best practices developed by all BRIDGE Center Cores, with ethics as a central theme incorporated throughout. This includes organizing annual data jamborees/hackathons for stakeholders to interact with and provide feedback to the Data Generation Projects.
• Workforce Development: Support career development and mentoring across the Bridge2AI Program, with emphasis on the recruitment, nurturing, and retention of prospective participants, at all career stages, from underrepresented backgrounds.

A key aspect of skills and workforce development involves outreach and involvement of individuals and communities who are underrepresented in biomedical and behavioral research (see NIH’s Interest in Diversity, information about IDeA states, and the NIH UNITE initiative). There is a diversity crisis in biomedical and behavioral research fields and in the AI/ML sector across gender and race. Diversity of AI/ML engineers is especially critical for the development of tools that represent the backgrounds and needs of all groups. Recruiting, retaining, and developing individuals from disadvantaged and/or underrepresented backgrounds requires customized and focused efforts. This core should incorporate specific outreach, recruitment, and retention plans to enhance diversity throughout both skills development and workforce development activities.

Responsiveness Criteria:

Applications nonresponsive to terms of this FOA will not be reviewed.

• Applications proposing to develop databases or data repositories are not responsive to this FOA.
• Applications proposing to set up high performance computing infrastructures and frameworks are not responsive to this FOA.
• Applications proposing to use AI/ML models to address biomedical grand challenges are not responsive to this FOA.
• Applications proposing to use Bridge2AI tools and resources to improve or enhance existing data are not responsive to this FOA.
• Applications that do not include the Administrative Core and at least one of the optional cores are not responsive to this FOA.

Technical Assistance Webinar and Bridge2AI Team Building Activities
Potential applicants for BRIDGE Center cores are encouraged to participate in the pre-application Technical Assistance Webinar and the Bridge2AI Program Grand Challenge Team Building activities. More information about the webinar and team building activities, including how to register and participate, will be posted on the Bridge2AI website (https://www.commonfund.nih.gov/bridge2ai).

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

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

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 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.
  • 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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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).

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Shurjo Sen, Ph.D.
National Human Genome Research Institute
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Teaming Core: optional
• Ethics Core: optional
• Standards Core: optional
• Tool Optimization Core: optional
• Skills and Workforce Development Core: optional
• The application must include 1 or more of the optional cores to be responsive.

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.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

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

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.

Budget (Overall)

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

To allow maximal flexibility for BRIDGE Center team members to participate in Bridge2AI program collaborative events, applicants are expected to include budgetary support for staff participation and travel for relevant meetings, hackathons, jamborees, and interviews, including the possibility that all of these may be virtual. If budgetary support for such collaborative events is not included in the application, applicants must provide an explanation for their plans to support participation in such events.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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.

PHS 398 Research Plan (Overall)

Specific Aims: Describe the specific aims for the Center and summarize how the proposed core components and activities will 1) enhance the success of the Bridge2AI Program, 2) integrate activities across Bridge2AI Data Generation Projects, 3) disseminate products, knowledge, best practices and lessons learned from the Bridge2AI Program, and 4) provide opportunities to evaluate and improve Bridge2AI products and activities.

Research Strategy: The Overall Research Strategy should present the overall vision for the proposed BRIDGE Center including the following components:

• Describe a unifying well-defined mission and vision for the BRIDGE center.
• Propose a plan for how Cores will interact to accomplish BRIDGE center integration, dissemination and evaluation goals.
• Provide BRIDGE center milestones; include the year of projected completion. Center milestones should reflect discrete steps toward the overall goal(s) of the Center. They should be supported by Core-specific milestones.
• Describe how the Center will enhance the success of the Bridge2AI program.
• Outline the major strengths of the Center teams in context of the proposed areas of focus; characterize the relevant expertise of team members and the advantages of their respective research environments.

Applicants must include an Administrative Core and one or more of the five optional cores (Teaming, Ethics, Standards, Tools Optimization, Skills and Workforce Development). Applicants should provide justification for proposing their selected cores. Applicants must propose plans for collaborating with cores from other applications to form a comprehensive BRIDGE Center.

Letters of Support: Include letters of support/agreements for any collaborative/cooperative arrangements, subcontracts, or consultants.

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.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, or the number of BRIDGE Center Cores budgeted for and included in the application, must address a Data Sharing Plan. For the purposes of this funding announcement, the scope of Data Sharing includes both raw and processed data, as well as related tools, software and/or code, standards, and skills or workforce development resources developed in any of the BRIDGE Center Cores. NIH encourages data sharing efforts that allow for aggregation and/or reuse of data and maximize the value of research participant contributions. Where applicable, this could include the use of validated and/or harmonized measures and provision of associated metadata to contextualize data for future users. To increase the scientific impact of individual studies and facilitate collaboration, comparison, and replication, NIH also encourages investigators to make data collection tools, instruments, and other resources publicly accessible. Applicants are encouraged to review NOT-OD-21-014 Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan to prepare a plan to share data, tools and resources that will be developed through this FOA. For applicants including multiple BRIDGE Center Cores in their application, the Data Sharing Plan should cover work completed in all Cores.

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.

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and within each BRIDGE Center Core. The PEDP can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 2-pages in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see resources on the Bridge2AI website: www.commonfund.nih.gov/bridge2ai/programresources.

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.

PHS Assignment Request Form (Overall)

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

Administrative Core

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.

SF424 (R&R) Cover (Admin 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 (Admin Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Admin Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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.
• Core leadership should possess strong logistical and program management expertise

Budget (Admin 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.

All costs associated with the Administrative Core should be included in the budget. This includes but is not limited to costs associated with: planning and convening Advisory Board Meetings and bi-annual Bridge2AI Steering Committee Meetings and, communication tools for cross-site communication, costs associated with dissemination of products and training materials/activities, and funds to support travel of BRIDGE Center investigators to the Bridge2AI Steering Committee meetings.

The Core Lead must devote a minimum of 2.4 person months annually to direct the core. If the core has multiple leads, then the total effort from all leads must equal 2.4 or more calendar months annually to direct the core, with at least one core lead devoting a minimum of 1.2 calendar months. Staff members must be in sufficient numbers and have adequate training and effort to support logistical aspects of the Bridge2AI Program.

Direct costs requested for the Administrative Core should not exceed $800,000/yr. The amount requested should be well justified.

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 (Admin Core)

Specific Aims: Succinctly list and describe the aims for achieving the specific goals of the Administrative Core.

Research Strategy: The Administrative Core is expected to oversee the overall administration and management of the BRIDGE Center. Clearly describe how the following activities will be achieved and explain the roles and responsibilities of Administrative Core personnel:

• Describe the structure of the Administrative Core and how personnel will provide logistical and organizational support across BRIDGE Center Cores.
• Describe a process to organize both internal and external Bridge2AI program meetings (e.g. Steering Committee meetings, External Advisory Board/Panel meeting) in consultation with other BRIDGE Center cores.
• Provide a plan to develop and maintain state-of-the-art cross-site communication and collaboration tools for Bridge2AI researchers (e.g. a private website or other shared workspace).
• Provide a plan to develop and maintain a Bridge2AI program website for external stakeholder communities that can direct individuals to repositories where the Bridge2AI flagship data sets will be stored, and host completed products from BRIDGE Center Cores, including interactive skill development materials and activities. Describe methods for tracking use of products and skill development materials/activities. Provide a plan for how to sustain this website beyond the period of NIH funding.
• Provide a plan for dissemination of Bridge2AI results/products across multiple venues.
• Describe processes to complete formal record keeping and reporting for the BRIDGE Center.

Timeline and milestones: Applications should establish a timeline and define a clear set of measurable milestones for the Administrative Core. Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section VI.2.

Letters of Support: Include letters of support as appropriate.

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, are required to 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.

PHS Human Subjects and Clinical Trials Information (Admin 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.

Teaming Core

When preparing your application, use Component Type Teaming Core.

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

SF424 (R&R) Cover (Teaming 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 (Teaming Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Teaming Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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.
• Core leadership should possess strong leadership, capacity to bring diverse teams together, and expertise in team science, social engineering, group facilitation and/or organizational psychology.

Budget (Teaming Core)

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

All costs associated with the Teaming Core should be included in the budget. The Teaming Core should include effort for scientific team managers who will be assigned to each of the other BRIDGE Center cores to provide inter-team leadership and boundary-spanning communication.

The Core Lead must devote a minimum of 2.4 person months annually to direct the core. If the core has multiple leads, then the total effort from all leads must equal 2.4 or more calendar months annually to direct the core, with at least one core lead devoting a minimum of 1.2 calendar months. Staff members must be in sufficient numbers and have adequate training and effort to support logistical aspects of the Bridge2AI Program.

Direct costs requested for the Teaming Core should not exceed $800,000/yr. The amount requested should be well justified.

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 (Teaming Core)

Specific Aims: Succinctly list and describe the aims for achieving the specific goals of the Teaming Core.

Research Strategy: The Teaming Core should promote a culture of communication, coordination, and collaboration among investigators within the Bridge2AI Program. The Teaming Core must provide for central operations to coordinate, monitor, and facilitate attainment of Bridge2AI Program goals. Address the following two main components as part of the Research Strategy:

Component 1: Enabling Interdisciplinary Team Science Across Bridge2AI: The Teaming Core should build upon known teaming strategies and resources, such as https://www.inscits.org/ and https://www.teamsciencetoolkit.cancer.gov/default.aspx. Applicants should propose specific plans to accomplish the following teaming activities for a large, multi-team system and explain the roles and responsibilities of Teaming Core personnel:

• Task Integration: Applicants should propose a plan to establish a governance structure for the Bridge2AI Program, creating common workflows across all BRIDGE Center Cores and across Data Generation Projects. The draft governance structure should include clear lines of authority and an overall programmatic structure that effectively promotes scientific interactions. Include a description of the structure of the BRIDGE Center, including a brief management plan and organization chart with the role of the Teaming Core delineated. Provide a draft plan for establishing the structure and decisional authority of the Bridge2AI Steering Committee (to be jointly completed with NIH staff post-award). Applicants should address plans for ongoing performance assessment and improvement of all cores.
• Relationship Building and Social Integration: Provide a draft plan for establishing a Collaborative Agreement across all components of the Bridge2AI program that will be continually maintained. Applicants should address how they will develop trust and a shared vision, as well as how shared responsibilities, interpersonal interactions, and professional credit will be managed. Applicants should consider the need for coordinating varied expertise and cultivating diversity and cultural awareness in individual relationships and throughout the Bridge2AI culture. Applicants should proactively identify potential barriers to optimal team formation and consider strategies to mitigate against them (e.g., propose deliberative within-group interaction processes in which alternative courses of action can be proposed by team members from all levels, evaluated, and acted upon; include conflict resolution processes).
• Team Composition: Applicants should consider the need for diverse disciplines, demographics, and perspectives, which includes biomedical and behavioral research, ethics, AI/ML data science and data management, teaming, and technical and non-technical experts across components of the Bridge2AI program. Include details on strategies and procedures for identifying partners and engaging in formal relationships, as well as assessing the effectiveness of those relationships on an ongoing basis and resolving disputes or misunderstandings. Consider how to engage the broader community to solicit perspectives on the goals and potential outcomes from Bridge2AI, including views about propagating/preventing biases and/or health disparities. Include plans to work with the Administrative Core to use an external advisory structure that is charged to provide appropriate and objective advice and evaluation. Describe a continual process to evaluate and update needed expertise (internally and externally) across the Bridge2AI program.

Component 2: Assessing Team Science within the Bridge2AI Program: Cross-disciplinary team science is the collaborative effort to address a scientific challenge by leveraging the strengths and expertise of professionals trained in different disciplines and fields. The Teaming Core will require expertise in the science of team science to enhance team formation and functioning across the Bridge2AI Program. Applicants should propose how to assess and evaluate the team science occurring within Bridge2AI to identify best practices, particularly on approaches to shift the culture of multidisciplinarity to interdisciplinary collaborative efforts and ultimately transdisciplinary efforts. Applicants should propose a plan for assessing and evaluating collaboration models within the context of multiple, rapidly changing fields, and working with the Administrative Core to disseminate successful models both within the Bridge2AI program, as well as to external stakeholder communities.

Timeline and milestones: Applications should establish a timeline and define a clear set of measurable milestones for the Teaming Core. Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section VI.2.

Letters of Support: Include letters of support as appropriate.

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, are required to 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.

PHS Human Subjects and Clinical Trials Information (Teaming 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

Ethics Core

When preparing your application, use Component Type Ethics Core.

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

SF424 (R&R) Cover (Ethics 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 (Ethics Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Ethics Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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. Core leadership should have demonstrated history of research experience in ethical, legal and social aspects of biomedical research, ideally with previous involvement in the intersection of these research topics with AI/ML.

Budget (Ethics Core)

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

All costs associated with the Ethics Core should be included in the budget.

The Core Lead must devote a minimum of 2.4 person months annually to direct the core. If the core has multiple leads, then the total effort from all leads must equal 2.4 or more calendar months annually to direct the core, with at least one core lead devoting a minimum of 1.2 calendar months. Staff members must be in sufficient numbers and have adequate training and effort to support logistical aspects of the Bridge2AI Program.

Direct costs requested for the Ethics Core should not exceed $800,000/yr. The amount requested should be well justified.

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 (Ethics Core)

Specific Aims: These should address the specific aims of the Ethics Core. A description of the Ethics Core’s high priority research topics and how it will serve as the focus for ETAI activities across the Bridge2AI program should be included.

Research Strategy: The Research Strategy section should consist of the following subsections, uploaded as a single pdf attachment.

• Management Plan: The Ethics Core will require a strong, multidisciplinary organizational structure to ensure the creation of integrated, effective, and sustainable trans-disciplinary ETAI research and resources. The description of the Research Management Plan should include the following:

• The vision and goal(s) of the Ethics Core;
• The organization and management of the Ethics Core including leadership roles; and plans to work with the BRIDGE Center Teaming Core to facilitate collaboration and integration with the data generation projects and each of the BRIDGE Center cores;
• Expertise of any planned project advisors, along with a clear description of the role that will be played by these advisors in guiding the Core’s activities. (Note: to facilitate the review of new applications and to avoid unnecessarily creating conflicts of interest, the actual individuals that will serve as advisors should NOT be listed in the application and should NOT be contacted until the review of the application is completed);
• How to work with the BRIDGE Center Administrative and Teaming cores to integrate stakeholder input in the Ethics Core;
• How the core will be prepared to adapt to address emerging ETAI issues and inform on-going activities of the Bridge2AI program; and
• How the Core will work towards sustainability of ETAI work during and beyond the funding period of the Bridge2AI program.

• Convening Functions: Applicants should demonstrate their awareness and familiarity with both biomedical and behavioral AI/ML communities as well as ETAI-related scholars. Applicants should describe a plan for how to work with BRIDGE Center Administrative and Teaming cores to convene both large and small groups of researchers (Bridge2AI investigators and stakeholder communities) through a variety of mechanisms, including:

• Strategies to incentivize and facilitate involvement of ETAI and AI/ML researchers and other relevant stakeholders in BRIDGE Center activities

• Analysis and Curation Functions: Applicants should describe their overall strategy for systematically collecting, curating and synthesizing the diverse range of ETAI-related research, guidance and tools relevant to Bridge2AI priorities, including:

• A plan for identifying cross-cutting topics and identifying areas where solutions for biomedical AI/ML may be mature or conversely need attention
• Strategies for collaborating with Bridge2AI and outside experts to ensure diverse opinions, expertise and life experience contribute to analysis and curation

• Outreach Functions: Applicants should describe plans to work with other BRIDGE Center Cores (e.g. Administrative, Teaming, Skills and Workforce Development) to conduct outreach and disseminate developed content and resources, including:

• Strategies to connect ETAI researchers more directly to one another and to a broader biomedical research audience to facilitate bidirectional sharing of ideas and resources
• Strategies to inform the ETAI research community about the expanding biomedical and behavioral AI/ML landscape
• Strategies to begin introducing AI/ML and ETAI disciplines to one another to facilitate community building
• Strategies for outreach out to AI/ML and ETAI researchers across the career development pipeline including trainees and new investigators.
• Produce and disseminate resources on ETAI best practices, tools and products.

• Research Activities: This subsection should propose an integrated set of research activities using a range of clearly justified methodologies and approaches to address the high priority ETAI issues. The Applicants should describe how the specific research proposed will contribute to the success of the Core and to the Bridge2AI program. Applicants should succinctly describe and justify each research activity and provide enough detail so that reviewers can assess the value, feasibility, and rigor of the proposed research. The expertise of the Core's researchers to carry out the proposed research as a synergistic team should be clearly described but should not duplicate information provided on individual biosketches. In addition, this subsection should describe the process that will be used to identify new issues coming out of the Core's research that may be targeted for expanded research activities. A description of how these new activities will be developed, reviewed, prioritized and supported should be included.

Applicants should provide evidence of research productivity as part of a consortium or other collaborative research networks. Applicants should demonstrate the capacity to scale activities and maintain flexibility as Bridge2AI evolves.

Timeline and milestones: Applications should establish a timeline and define a clear set of measurable milestones for the Ethics Core. Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section VI.2.

Letters of Support: Include letters of support as appropriate.

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, are required to 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.

PHS Human Subjects and Clinical Trials Information (Ethics 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

Standards Core

When preparing your application, use Component Type Standards Core.

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

SF424 (R&R) Cover (Standards 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 (Standards Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Standards Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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.
• Core leadership should possess expertise in data interoperability, and familiarity with the standards required to implement AI/ML approaches for distributed learning systems.

Budget (Standards Core)

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

All costs associated with the Standards Core should be included in the budget.

The Core Lead must devote a minimum of 2.4 person months annually to direct the core. If the core has multiple leads, then the total effort from all leads must equal 2.4 or more calendar months annually to direct the core, with at least one core lead devoting a minimum of 1.2 calendar months. Staff members must be in sufficient numbers and have adequate training and effort to support logistical aspects of the Bridge2AI Program.

Direct costs requested for the Standards Core should not exceed $800,000/yr. The amount requested should be well justified.

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 (Standards Core)

Specific Aims: Succinctly list and describe the aims for achieving the specific goals of the Standards Core.

Research Strategy: The research plan for the Standards Core must include a detailed strategy for harmonizing the standards being developed and used across all the Bridge2AI Data Generation Projects. The strategy must include:

• Methods for infusing relevant standards being developed in other domains (outside of Bridge2I) into the efforts of the Bridge2AI Data Generation Projects Standards Modules
• Processes to work with the BRIDGE Center Ethics, Tool Optimization and Skills and Workforce Development Cores to incorporate Bridge2AI standards coherently and consistently.
• Evaluation and assessment of the quality of the metadata and data produced from the Bridge2AI Data Generation Projects
• The scope in which the standards process will be generalizable, reproducible, reuseable, credible and sustainable to continually adapt to the changing needs of the biomedical AI/ML community

Timeline and milestones: Applications should establish a timeline and define a clear set of measurable milestones for the Standards Core. Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section VI.2.

Letters of Support: Applicant are encouraged to include letters of support from other communities developing standards are that relevant to the Bridge2AI program goals

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: Standards Cores proposing to develop tools, including models, algorithms and software must provide a Resource Sharing Plan including a Tool Sharing Plan and or Software Sharing Plan as described in the Resource Sharing Plan section of the Tools Optimization Core (below).

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 (Standards 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

Tool Optimization Core

When preparing your application, use Component Type Tool Optimization Core.

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

SF424 (R&R) Cover (Tool Optimization 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 (Tool Optimization Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Tool Optimization Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Tool Optimization 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 (Tool Optimization Core)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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.
• Core leadership should possess substantial prior experience with building computational tools incorporating AI/ML for multiple stages of the biomedical research lifecycle (data collection and annotation, analysis, modeling and visualization).

Budget (Tool Optimization Core)

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

All costs associated with the Tool Optimization Core should be included in the budget.

The Core Lead must devote a minimum of 2.4 person months annually to direct the core. If the core has multiple leads, then the total effort from all leads must equal 2.4 or more calendar months annually to direct the core, with at least one core lead devoting a minimum of 1.2 calendar months. Staff members must be in sufficient numbers and have adequate training and effort to support logistical aspects of the Bridge2AI Program.

Direct costs requested for the Tool Optimization Core should not exceed $800,000/yr. The amount requested should be well justified.

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 (Tool Optimization Core)

Specific Aims: These should address the specific aims of the Tool Optimization and Development Core as a whole. A description of the Core’s philosophy towards creating, optimizing, and sharing tools for AI/ML research with both AI/ML and non-AI/ML backgrounds should be included as part of the Specific Aims.

Research Strategy: The Research Strategy section should consist of the following subsections, uploaded as a single pdf attachment.

• Convening Function: Applicants should describe a plan for how to work with BRIDGE Center Administrative and Teaming cores to convene both large and small groups of researchers working in geographically separated environments for the purposes of software and hardware tool development for AI/ML research, including:

• Strategies to incentivize and facilitate communication among stakeholders involved in broadly different scientific research projects
• Strategies for collaboration with relevant NIH programs as well as other US-based and international efforts to serve as a key convener and source of expertise

• Tool Development and Optimization Function: Applicants should demonstrate their awareness and familiarity with the existing state of the art in scientific AI/ML tooling, including a description of their prior work in this area along with uptake of tools developed by them in the scientific research community. This should cover the following aspects:

• Experience with de novo tool development to fulfil needs in biomedical AI/ML research where existing tools were not adequate
• A strategy for modifying AI/ML tools originally built in narrow project-specific research contexts to be applicable in more general contexts
• A plan for identifying areas of AI/ML tool development that are identified as gaps not filled by the cumulative output of the Tool Development and Optimization Modules in the Data Generation Projects

• Dissemination and Outreach Functions: Applicants should describe plans to work with other BRIDGE Center Cores (e.g. Administrative, Teaming, Skills and Workforce Development) to conduct outreach and disseminate tools built for AI/ML research throughout the broader biomedical research community, including scientists from non-AI/ML backgrounds. This should cover the following aspects:

• A plan to first centralize and then work with the Administrative Core to disseminate AI/ML tools and workflows built through Bridge2AI
• Strategies to work with the Skills and Workforce Development Core to develop user support for these tools in the hands of researchers who may not have analytical/computational backgrounds
• Strategies to collect feedback from the user community so that future tool development work in Bridge2AI can be informed by such feedback
• Strategies to allow members of the broader AI/ML community who have expertise in tool development to build upon and improve these tools through their independent contributions

Timeline and milestones: Applications should establish a timeline and define a clear set of measurable milestones for the Tool Optimization and Dissemination Core. Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section VI.2.

Letters of Support: If expertise is being sought from collaborators, contractors or consultants, include letters of support that describe the extent of commitment from such personnel and have a description of the appropriateness of their scientific/technical background to provide such support.

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, must address a plan for sharing the tools and other resources produced from the Bridge2AI program. The plans may include policies for access and sharing; including provisions for appropriate protection of privacy, confidentiality, security, intellectual property, or other rights or requirements.

For Tools (conceptual, theoretical, algorithmic, modeling, etc.): In the body of the text, the section should begin with a heading indicating "Tool Sharing Plan". Tool Sharing Plans should provide details for the tool components or modules, tool parameters and associated datasets. The plan should include the minimum requirements for tool documentation, tool building, tool validation and tool reproducibility. Applicants are also expected to include plans to link proposed tools with other relevant tools. Any software associated with proposed tools are expected to also be addressed in the Software Sharing Plan (below). Applicants are strongly encouraged to make their tools electronically available in synchrony with paper publication.

For Software: In the body of the text, the section should begin with a heading indicating "Software Sharing Plan". There is no prescribed single license for software produced through grants responding to this announcement. This FOA, however, includes goals for software dissemination, and requires applicants to include plans for software dissemination plans relative to these goals:

• The software should be freely available to biomedical, biological, behavioral, environmental, and clinical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can reproduce the analytical tool and continue development in the event that the original investigators are unwilling or unable to do so.
• The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software, and should provide a plan to manage the dissemination or adoption of improvements or customizations of that software by others. This plan should include a method to distribute other user's contributions such as extensions, compatible modules, or plug-ins.

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 (Tool Optimization 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

Skills and Workforce Development Core

When preparing your application, use Component Type Skills and Workforce Development Core.

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

SF424 (R&R) Cover (Skills and Workforce Development 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 (Skills and Workforce Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Skills and Workforce Development Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Skills and Workforce Development 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 (Skills and Workforce Development Core)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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.
• Core leadership should possess prior experience with training and mentoring, promoting an inclusive and supportive scientific environment, and providing instruction in scientific rigor. There should also be evident expertise in developing educational materials and activities.

Budget (Skills and Workforce Development Core)

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

All costs associated with the Skills and Workforce Development Core should be included in the budget. This includes but is not limited to potential costs associated with educational materials/activities and curricula development, as well as costs related to hosting annual data jamborees/hackathons .

The Core Lead must devote a minimum of 2.4 person months annually to direct the core. If the core has multiple leads, then the total effort from all leads must equal 2.4 or more calendar months annually to direct the core, with at least one core lead devoting a minimum of 1.2 calendar months. Staff members must be in sufficient numbers and have adequate training and effort to support logistical aspects of the Bridge2AI Program.

Direct costs requested for the Skills and Workforce Development Core should not exceed $800,000/yr. The amount requested should be well justified.

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 (Skills and Workforce Development Core)

Specific Aims: Succinctly list and describe the aims for achieving the specific goals of the Skills and Workforce Development Core.

Research Strategy: The Skills and Workforce Development Core should address the following two main components as part of the research plan. For each component investigators should address important considerations such as inclusion of broad career stages (academically and within industry), challenges of incorporating and developing broad technical expertise, and appropriate outreach, recruitment, and retention methods to reach a wide variety of interested communities, including underrepresented populations. Applicants are expected to incorporate existing educational and mentoring resources from the NIH Office of Data Standards Strategy (https://datascience.nih.gov/) or from other relevant sources.

Component 1: Skills Development All skill development activities should be developed for a wide array of career stages, including students, post-doctorates, early-stage and established investigators, and technical and non-technical backgrounds. Applicants are expected to provide plans for outreach to diverse communities to include underrepresented populations in the development and use of skill development activities.

Applicants should describe plans to interact with Data Generation Projects to develop integrated curricula and/or educational materials/activities to support use of the flagship data sets as they are collected. Applicants should also describe plans to interact with other BRIDGE Center Cores (teaming, ethics, standards, tools) to identify new products and best practices and develop curricula and/or educational materials/activities to support their use. Proposed skill development materials/activities should utilize a broad variety of educational methods with respect to type of instruction (e.g. didactic vs. experiential), manner of content delivery (in-person vs. online), and terms of engagement (self -directed vs. instructor-led, short- vs. long-term). Provide details on methods to integrate ethical use cases into all skill development activities to minimize bias and health disparities. Applicants must include plans for yearly data jamborees/hackathons with broad stakeholder communities that make use of available data from the Data Generation Projects. Thought should be given to how best to include the greatest number of participants, at all career stages and underrepresented groups, and facilitate their participation in the data jamborees/hackathons (e.g. are pre-activities, such as bootcamps, workshops, virtual office hours needed to help participants feel prepared to contribute).

The Core should describe processes to develop, implement, assess, and disseminate skill development activities. Applicants should provide plans to work with the Administrative Core to disseminate skill development activities through the Bridge2AI website as they are developed, and to develop a sustainable long-term dissemination plan for skill development resources for investigative and stakeholder communities.

Component 2: Workforce Development Applicants should describe plans to support career development and mentoring across the Bridge2AI Program. This core is expected to help develop transdisciplinary expertise in AI-Biomedical and Behavioral Research, with a special emphasis on recruiting scientists from underrepresented backgrounds and a focus on ethical considerations. Include plans to provide Bridge2AI investigators with a breadth of exposure to and hands-on experiences with a myriad of Bridge2AI activities. Describe mentoring, onboarding, research experiences and related activities that will enhance the development of relevant expertise across career stages.

Interdisciplinary mentoring between biomedical and behavioral research domains and AI/ML data science domains is a critical aspect of these activities, and this Core may work closely with the Teaming Core to include critical elements of team science and soft skills as part of workforce development activities (e.g. identify and overcome pre-conceived notions, enhance critical thinking, remain resilient when facing uncertainty, expand reflection on ethical considerations). Applicants should provide recommended mentoring plans that address frequency, level (e.g. peer-to-peer, senior-to-junior, junior-to-senior) and type (e.g. formal vs. informal, one-on-one vs. group) of mentoring tailored to career stages and background of investigators. Provide plans for formal recognition of accomplishments from students, trainees and early career investigators involved in Bridge2AI to support career longevity of these transdisciplinary scholars.

Timeline and milestones: Applications should establish a timeline and define a clear set of measurable milestones for the Skills and Workforce Development Core. Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section VI.2.

Letters of Support:

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, are required to 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.

Include the following as an appendix:

PHS Human Subjects and Clinical Trials Information (Skills and Workforce Development 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

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.

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 fieldof 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 the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn

Should intramural scientists submit an application through this FOA, or should an extramural application include a collaboration with NIH intramural scientists, the requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above in the NIH Intramural Source Book.

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.

Section V. Application Review Information

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.

For this announcement, each application will be evaluated both on the basis of the overall impact of the application as a whole and the overall impact of each of the individual components. Cores will receive individual impact scores. Each core will be evaluated based on the particular review criteria outlined in its section. Finally, the overall application will receive an overall impact score reflecting the reviewers' assessment of the BRIDGE Center’s Significance, Investigator(s), Innovation, Approach, and Environment, as well as the likelihood the BRIDGE Center will be successful in accomplishing its goals.

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Center address the needs of the research program that it will serve? 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 research program?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the Center?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing interdisciplinary research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the Center?

Innovation

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

Approach

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? Are 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 timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Resource Sharing Plans

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.

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) 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), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research program 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?

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the Center?

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

Overall Impact - Admin Core

Reviewers will provide an overall impact score for each proposed Core to reflect their assessment of its strengths and weaknesses, in consideration of the following review criteria.

Review Criteria for Admin Core

• Are the core leads highly qualified to successfully lead and manage the proposed core activities within a large, multi-team system involving multiple sites? Is there a diversity of investigator backgrounds? Are the planned efforts for the core leads appropriate and sufficient for the work proposed? Is there evidence of appropriate administrative, organizational expertise and managerial capacity to provide logistical support?
• Are specific and realistic timelines and milestones for the entire project period proposed?
• Are the resources and infrastructure adequate for accomplishing the specific aims of the core? Will the range of departments and/or institutions involved enhance the diversification of the team in terms of the backgrounds, and expertise and skills of the researchers?
• Do the core team members demonstrate experience with collaborative projects? Is there a clear willingness to engage in interdisciplinary collaboration and participate across the Bridge2AI Program? Have the applicants provided clear plans for interacting with the other BRIDGE Center Cores and the Bridge2AI Data Generation Projects to accomplish their goals?
• Is an organizational structure for the Administrative Core clearly identified? Is it effective for overall logistical and organizational support of the BRIDGE Center?
• To what extent is the Research Plan appropriate for addressing the following:
  • Organizing Bridge2AI program meetings, including conference calls, video/web-based conferencing and in-person meetings?
  • Supporting cross-site communication and collaboration?
  • Development, maintenance, and sustainability of a Bridge2AI website for external stakeholders?
  • Facilitating dissemination of Bridge2AI products?
  • Record keeping and reporting?

Additional Review Considerations - Admin Core

• Is the budget justified for the planned core activities?

Overall Impact - Teaming Core

Reviewers will provide an overall impact score for each proposed Core to reflect their assessment of its strengths and weaknesses, in consideration of the following review criteria.

Review Criteria for Teaming Core

• Are the core leads highly qualified to successfully lead and manage the proposed core activities within a large, multi-team system involving multiple sites? Is there a diversity of investigator backgrounds? Are the planned efforts for the core leads appropriate and sufficient for the work proposed? Do the core leads have demonstrated skill with facilitating constructive dialog among investigators with potentially disparate scientific opinions and viewpoints?
• Are specific and realistic timelines and milestones for the entire project period proposed?
• Are the resources and infrastructure adequate for accomplishing the specific aims of the core? Will the range of departments and/or institutions involved enhance the diversification of the team in terms of the backgrounds, and expertise and skills of the researchers?
• Do the core team members demonstrate experience with collaborative projects? Is there a clear willingness to engage in interdisciplinary collaboration and participate across the Bridge2AI Program? Have the applicants provided clear plans for interacting with the other BRIDGE Center Cores and the Bridge2AI Data Generation Projects to accomplish their goals?
• To what extent is the Research Plan appropriate for addressing the following:

• Accomplishing task integration? Are the proposed leadership approaches, governance, and organizational structure appropriate for the proposed BRIDGE Center? Are there realistic plans to establish and implement performance assessment plans for all BRIDGE center cores?
• Accomplishing relationship building and social integration? Is there an emphasis on both individual relationship formation and development of group culture? Are there methods and activities to encourage input from junior personnel and/or individuals from underrepresented and disadvantaged groups, who may be hesitant to contribute? Are there methods to help define a shared purpose and identity across disciplines and career stages? Are there clear plans to elicit input and finalize a Collaboration Agreement?
• Is there a clear process for brokering new partnerships? Does the application describe a practical means to engage a variety of stakeholder communities with an interest in Bridge2AI?
• Assessing Team Science? Is a rigorous plan proposed to solicit feedback, assess and disseminate successful Bridge2AI collaboration models?

Additional Review Considerations - Teaming Core

• Is the budget justified for the planned core activities?

Overall Impact - Ethics Core

Reviewers will provide an overall impact score for each proposed Core to reflect their assessment of its strengths and weaknesses, in consideration of the following review criteria.

Review Criteria for Ethics Core

• Are the core leads highly qualified to successfully lead and manage the proposed core activities within a large, multi-team system involving multiple sites? Is there a diversity of investigator backgrounds? Are the planned efforts for the core leads appropriate and sufficient for the work proposed? Do the investigators have a track record of success in carrying out ethical and trustworthy artificial intelligence related research programs?
• Are specific and realistic timelines and milestones for the entire project period proposed?
• Are the resources and infrastructure adequate for accomplishing the specific aims of the core? Will the range of departments and/or institutions involved enhance the diversification of the team in terms of the backgrounds, and expertise and skills of the researchers?
• Do the core team members demonstrate experience with collaborative projects? Is there a clear willingness to engage in interdisciplinary collaboration and participate across the Bridge2AI Program? Have the applicants provided clear plans for interacting with the other BRIDGE Center Cores and the Bridge2AI Data Generation Projects to accomplish their goals?
• If the aims of the application are achieved, will our understanding or ability to address ETAI issues be significantly advanced? Will the outcomes be relevant and useful to the broader research, health, and social policy communities?
• Is the management plan, including the management structure, appropriate and adequate to support and sustain the Center?
• Is the research clearly described and is it focused on the cross-cutting ETAI issues? If there are multiple projects proposed, are they well integrated and do they clearly contribute to the Core’s overall goals? If appropriate, are the proposed conceptual tools, empirical data and analyses used to explore and help to define policy options or professional guidelines?
• Where appropriate, are diverse points of view incorporated, including, communities that may be particularly vulnerable or disproportionately affected by the issues being addressed? Are the proposed strategies for ensuring that the Core's research can be used, as appropriate, to inform policies and practices, well described and likely to succeed?
• Is the process used to identify, review, support and prioritize new issues that are emerging out of Core's research clearly described and likely to be successful? Is there evidence that this process is well integrated with other Bridge2AI activities?

Additional Review Considerations - Ethics Core

• Is the budget justified for the planned core activities?

Overall Impact - Standards Core

Reviewers will provide an overall impact score for each proposed Core to reflect their assessment of its strengths and weaknesses, in consideration of the following review criteria.

Review Criteria for Standards Core

• Are the core leads highly qualified to successfully lead and manage the proposed core activities within a large, multi-team system involving multiple sites? Is there a diversity of investigator backgrounds? Are the planned efforts for the core leads appropriate and sufficient for the work proposed?
• Are specific and realistic timelines and milestones for the entire project period proposed?
• Are the resources and infrastructure adequate for accomplishing the specific aims of the core? Will the range of departments and/or institutions involved enhance the diversification of the team in terms of the backgrounds, and expertise and skills of the researchers?
• Do the core team members demonstrate experience with collaborative projects? Is there a clear willingness to engage in interdisciplinary collaboration and participate across the Bridge2AI Program? Have the applicants provided clear plans for interacting with the other BRIDGE Center Cores and the Bridge2AI Data Generation Projects to accomplish their goals?
• To what extent does the Standards Core propose a process that optimally incorporates the current state of the art in standards development from multiple relevant domain areas to the Bridge2AI program?
• To what extent is the Research Plan appropriate for addressing the following:

• Harmonizing Standards across the Data Generation Projects
• Coordinating with the BRIDGE Center Ethics, Tool Optimization, and Skills and Workforce Development Cores
• Evaluating and assessing the metadata and data produced from the Bridge2AI Data Generation Projects

• To what extent is the scope of the standards harmonization justified to be generalizable, reproducible, reuseable, credible and sustainable to continually adapt to the changing needs of the biomedical AI/ML community?

Additional Review Considerations - Standards Core

• Is the budget justified for the planned core activities?

Overall Impact - Tool Optimization Core

Reviewers will provide an overall impact score for each proposed Core to reflect their assessment of its strengths and weaknesses, in consideration of the following review criteria.

Review Criteria for Tool Optimization Core

• Are the core leads highly qualified to successfully lead and manage the proposed core activities within a large, multi-team system involving multiple sites? Is there a diversity of investigator backgrounds? Are the planned efforts for the core leads appropriate and sufficient for the work proposed? Do the investigators have a track record in tool development and optimization for AI/ML in scientific research settings and of building composable AI infrastructures where tools developed in distributed contexts can be brought together under software control to build customized workflows for biomedical AI/ML research?
• Are specific and realistic timelines and milestones for the entire project period proposed?
• Are the resources and infrastructure adequate for accomplishing the specific aims of the core? Will the range of departments and/or institutions involved enhance the diversification of the team in terms of the backgrounds, and expertise and skills of the researchers?
• Do the core team members demonstrate experience with collaborative projects? Is there a clear willingness to engage in interdisciplinary collaboration and participate across the Bridge2AI Program? Have the applicants provided clear plans for interacting with the other BRIDGE Center Cores and the Bridge2AI Data Generation Projects to accomplish their goals?

• To what extent does the Tool Optimization Core propose a process that optimally balances existing tools for biomedical AI/ML with the need to develop new tools from scratch?
• Have the applicants proposed a strategy for technically optimizing tools being developed in biomedical grand challenge-specific contexts in the different Data Generation projects for use in the broader context of biomedical AI/ML research?
• Does the Research Plan proposed by the Tool Optimization Core take into account the full lifecycle of AI-based research, including data collection and annotation, analysis and application of AI/ML models, and visualization and communication of results from AI-based analysis to the general scientific audience?
• Have the applicants provided a plan for how they will coordinate with the Admin Core to disseminate AI/ML tools and workflows built through Bridge2AI?
• Have the applicants provided a plan for how they will work with the Skills and Workforce Development Core to support new users of these tools in the hands of researchers who may not have previous expertise in AI/ML research?
• Have the applicants demonstrated adequate consideration of ethical and trustworthy AI considerations as these relate to the work of the Tool Optimization Core?

Additional Review Considerations - Tool Optimization Core

• Is the budget justified for the planned core activities?

Overall Impact - Skills and Workforce Development Core

Reviewers will provide an overall impact score for each proposed Core to reflect their assessment of its strengths and weaknesses, in consideration of the following review criteria.

Review Criteria for Skills and Workforce Development Core

• Are the core leads highly qualified to successfully lead and manage the proposed core activities within a large, multi-team system involving multiple sites? Is there a diversity of investigator backgrounds? Are the planned efforts for the core leads appropriate and sufficient for the work proposed? Do the investigators have a track record in: Culturally aware career development and mentoring? Curriculum and/or educational materials/activities development, assessment, and dissemination? Outreach to a wide array of communities? Incorporation of ethical considerations in skills and workforce development activities?
• Are specific and realistic timelines and milestones for the entire project period proposed?
• Are the resources and infrastructure adequate for accomplishing the specific aims of the core? Will the range of departments and/or institutions involved enhance the diversification of the team in terms of the backgrounds, and expertise and skills of the researchers?
• Do the core team members demonstrate experience with collaborative projects? Is there a clear willingness to engage in interdisciplinary collaboration and participate across the Bridge2AI Program? Have the applicants provided clear plans for interacting with the other BRIDGE Center Cores and the Bridge2AI Data Generation Projects to accomplish their goals?
• To what extent is the Research Plan appropriate for addressing the following:

• Skills development plans to enhance use of data sets from Data Generation Projects, as well as products and best-practices from BRIDGE Center Cores? Do the plans incorporate activities for different career stages and different technical expertise? Have they considered type of instruction (e.g. didactic vs. experiential), manner of content delivery (in-person vs. online), and terms of engagement (self -directed vs. instructor-led, short- vs. long-term)? Do skill development plans incorporate ethics use cases? Do they provide outreach plans tailored to a wide array of diverse communities?
• Hosting annual data jamborees/hackathons ? Do plans include consideration for how to facilitate participation from Bridge2AI investigators as well as a broad array of stakeholder groups and underrepresented communities, including multiple career stages and technical and non-technical backgrounds?
• Workforce development plans for different career stages, backgrounds, and levels of technical expertise? Have they considered the frequency, level (e.g. peer-to-peer, senior-to-junior, junior-to-senior) and type (e.g. formal vs. informal, one-on-one vs. group) of mentorship? Do they incorporate hands-on interdisciplinary activities and opportunities to develop soft skills ? Is it reasonable to expect that the workforce development plans will develop transdisciplinary expertise in AI-Biomedical and Behavioral Research?

Additional Review Considerations - Skills and Workforce Development Core

• Is the budget justified for the planned core activities?

2. Review and Selection Process

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

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

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

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 appropriate national Advisory Council or Board. 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.
• Relevance of the proposed project to program priorities including the PEDP.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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 grantee’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: Grantee 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.

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or 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.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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, Grantees, 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.

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, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is 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 resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The Project Officer (PO) and Project Scientist (PS) roles are held by NIH staff members who are part of the Bridge2AI Working Group. The Project Officer role will be held by an NHGRI Program Director, and this individual will have substantial scientific and programmatic involvement during the conduct of this activity through facilitating technical assistance, advice, and coordination. Multiple program staff may be designated as Project Scientists to manage Bridge2AI Program Objectives as needed for different BRIDGE Center Cores, who will work closely with the Project Officer. The Project Officer will be responsible for the normal scientific and programmatic stewardship of the award and manages concerns about bias as it affects the project. The role of NIH PO/PS team will be to facilitate and not to direct the activities. The Project Officer will be named in the Notice of Award.

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

• Determining research approaches, designing protocols, setting project milestones and timelines, and conducting research
• Planning and directing the coordinating activities of the BRIDGE Center in accordance with the goals of the Bridge2AI program to meet the timeline stated in their application.
• Ensuring that the data, software, resources, materials, etc. produced as part of this project are released appropriately according to the Resource Sharing Plan and in a consistent manner to be monitored by NIH staff and the Bridge2AI Steering Committee.
• Adhering to policies regarding sharing of genomic and other types of data, data access, and standardized formats; timely publication; and intellectual property established by the NIH, NHGRI, and the Steering Committee (SC)
• Preparing abstracts, presentations and publications to ensure that results are published or disseminated in a timely manner.
• Accepting and implementing priorities, procedures and policies agreed upon by the Bridge2AI Steering Committee to the extent of corresponding grant regulations.
• Not disclosing confidential information.
• Interacting with other relevant NHGRI and NIH activities, as needed, to promote synergy and consistency among similar or related projects.
• Communicating across Bridge2AI Data Generation projects and cooperating with participating NIH staff to facilitate collaborative efforts.
• Fully participating in a cooperative, interactive, and collaborative manner with NIH staff, Bridge2AI investigators and other BRIDGE Center PIs.
• Submitting data for quality assessment and/or validation in the manner specified by the External Scientific Panel or the NIH PO.
• Submitting periodic progress reports to the Bridge2AI consortium or External Scientific Panel, as agreed by the Steering Committee, the External Scientific Panel or the NIH PO/PS
• Submitting periodic progress reports and milestone updates to the NIH, at least annually in the RPPR, or in more frequent reporting that may be requested by the NIH PO.
• Cooperating with the other PDs/PIs, and with Federal staff members in various joint activities; examples include research collaborations and core working groups
• Cooperate with the NIH staff members and/or external evaluators in the course of a site visit or other evaluation process
• Informing the NIH PO of plans to change or modify any project’s specific aims or research strategy, and obtaining receipt of NIH approval prior to the implementation of changes and expenditure of funds
• Provide updates at least annually on implementation of the PEDP
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The PO/PS team will have the following substantial involvement:

• Serving as a liaison, helping to coordinate activities among and for the multiple Bridge2AI awardees, including acting as a liaison between the Bridge2AI Steering Committee and NIH, and as an information resource for the awardees about genome research activities. The PO/PS team will also coordinate the efforts of the grantee(s) with other groups conducting similar studies.
• Reporting periodically on the progress of the grantees to the NIH IC and Common Fund Leadership and to the NIH Council of Councils.
• Assisting the Bridge2AI Steering Committee in developing and drafting operating policies and other policies for dealing with recurring situations that require coordinated action
• Providing advice, technical assistance and coordination for the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
• The Program Officer will be responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the awardee has met any milestones required for each year of funding.
• The Project Officer (NHGRI Program Director) may propose curtailing, withholding or reducing support for any awardee that fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
• Involving NIH staff who may assist the awardee(s) as designated by the PS/SO.
• Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium/Network decides to publish, co-authoring manuscripts through their role in scientific program management.

The Government, via the NIH PO/PS team, will have access to data generated under this Cooperative Agreement through grantee meetings and progress reports. Federal staff may use information obtained from the data for the preparation of internal reports on the activities of the study.

Consistent with 45 C.F.R. 75.322, the awardee will own the data and software developed under this award and be able to continue to use these data and software upon expiration or termination of the award. NIH will have unrestricted access to and use of the data and software, including the right to transfer them to other resource projects for their use, distribution, and integration with other data. NIH expects that the awardee will grant other resources the ability to use and redistribute the data, including integrating the data with other datasets, without restriction, unless otherwise limited by consent requirements.

External Scientific Panel (ESP): The NIH PO/PS team may engage external scientists with relevant scientific and consortium experience, who are not funded as part of the project and who agree to a confidentiality policy, to provide input and advice to the NIH PO/PS team about the project. The PO/PS team along with other Bridge2AI Program Staff will appoint scientists to the ESP and will determine the durations of service. Activities of the ESP could include:

• Participating, as appropriate, in Bridge2AI Steering Committees calls, and the annual grantees meetings; a subset of ESP members may also meet remotely at other times during the project period, as needed.
• Reviewing and evaluating the progress of grantees (individually or as a group) in achieving the goals of the project.
• Recommending changes in priorities based on scientific advances within and outside the Bridge2AI activities
• Providing individual recommendations regarding any changes in the project or grant(s) as necessary.

The PO/PS team will use these recommendations to make project changes, as appropriate

Areas of Joint Responsibility include:

Close interaction between the participating grantee(s) and the PO/PS team will be required, to manage, assess, and implement the activities towards the common goals of the consortium.

The Bridge2AI Steering Committee (SC) will be the main governing body of the Consortium. The purpose of the SC will be to recommend directions for a consortium consistent with achieving the project goals, develop consortium policies to build synergy and improve communication and collaboration between the projects, and to provide a forum for discussing progress, challenges and opportunities for the consortium.

This is accomplished by:

• Meeting in person twice each year at locations selected by the Steering Committee in consultation with NIH as part of the semi-annual Investigators Meetings to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc. In addition, the Bridge2AI Steering Committee will meet regularly by conference or web-based/video call.
• Establishing best practices for data integration and collaborative analyses as appropriate.
• Setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
• Generating responses to ESP recommendations.
• The PO/PS will assist and facilitate the group process and not direct it.
• In addition to the PD(s)/PI(s), key co-investigators and pre- and postdoctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings.
• The Bridge2AI Steering Committee may invite additional, non-voting scientific advisors to the meetings.
• NIH reserves the right to augment the scientific expertise of the Bridge2AI Steering Committee as it deems necessary
• The SC will be composed of one representative from each BRIDGE Center Core and each Data Generation Project. Each PD/PI will decide who will be its representative. Multi-PI grants will have one representative. Each representative will have one vote. The PO for the BRIDGE Center Award will be a voting member. Co-chairs of the Bridge2AI Steering Committee will be selected on an annual basis and must represent scientific expertise and teaming expertise.
• The Bridge2AI Steering Committee, in partnership with NIH members, will monitor the progress of the BRIDGE Center award, facilitate common data sharing and group publications and identify common resources to support such efforts.
• The BRIDGE Center PDs/PIs will also work closely with each Bridge2AI Data Generation project PDs/PIs, the NIH PO/PS Team and other Bridge2AI program staff to develop and implement governance and oversight of the Brige2AI Program objectives and ensure execution of Bridge2AI Resource Sharing Plans.
• The Teaming Core of the BRIDGE Center is responsible for formalizing the structure and decisional authority of the Bridge2AI Steering Committee in consultation with NIH staff.
• The SC may establish subcommittees or working groups to provide input on specific matters as needed, and to oversee the development and implementation of consortium policies including data and software releases, publications and standards, etc. Subcommittees may be either permanent or time limited, may include additional experts, depending on the needs of the research.
• The PD(s)/PI(s) will be expected to play an active role in these working groups, as appropriate.
• The NIH PO/PS team for Bridge2AI awards will serve on subcommittees, as appropriate. Subcommittees or task forces may also include other representatives from NIH or other government agencies as non-voting members.
• It is expected that most of the decisions on the activities of the SC will be reached by consensus. If a vote is needed, at least 60% of the voting members most vote in favor of the proposal.
• NIH staff will review and approve policies developed by the SC. NIH staff will maintain authority on all matters regarding funding or expenditure of funds.
• Awardees will be required to accept and implement policies approved by the SC.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NHGRI may be addressed by convening a Dispute Resolution Panel. It will be composed of three members: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of disagreement for one award, the first member may be chosen by that awardee.This special dispute resolution procedure does not alter the awardee'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, awardees 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 awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare 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.

Section VII. Agency Contacts

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

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

Finding Help Online: 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]

Shurjo K. Sen, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-827-7028
Email: [email protected]

Mark Caprara, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-827-3076
Email: [email protected]

Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: [email protected]

Section VIII. Other Information

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

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