Part 1. Overview Information

Key Dates

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

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The NIH Office of Strategic Coordination (Common Fund - https://commonfund.nih.gov/) has generated many valuable and widely available datasets. The Common Fund Data Ecosystem is helping to ensure that all Common Fund (CF) data are Findable, Accessible, Interoperable, and Reusable (FAIR). The purpose of this Notice of Funding Opportunity (NOFO) is to announce the availability of funds for projects that involve collaboration with multiple CF Data Coordinating Centers (DCCs) to combine discovery and/or translational approaches with work that will enhance reusability of Common Fund data and contribute knowledge to the Common Fund Data Ecosystem. Clinical trials will not be accepted through this NOFO. A clinical trial planning component is allowable, provided it is appropriate and rigorously developed.

Background

The NIH Common Fund (CF) supports bold scientific programs that catalyze discovery across all biomedical and behavioral research. CF programs create a space where investigators and multiple NIH Institutes and Centers (ICs) collaborate on innovative research addressing high-priority challenges for the NIH as a whole and make a broader impact in the scientific community.

Approximately two-thirds of CF programs generate large-scale data resources and digital tools that are intended to be used by researchers across the entire spectrum of biomedical research. These resources provide unprecedented opportunities to understand biological mechanisms, interrogate complex biological systems, deliver new types of discoveries, and rapidly advance novel treatments and cures for many diseases. NIH is taking steps to modernize the NIH-funded biomedical data-resource ecosystem, as described in the NIH Strategic Plan for Data Science. In alignment with this plan, the Common Fund Data Ecosystem (CFDE) is an infrastructure investment made by the CF to address the growing challenges facing scientific programs that leverage data-intensive strategies.

CFDE’s driving focus is to foster scientific discovery through the (re)use of data generated by CF programs. This will be achieved through three aims: 1) Enable users to query across and use multiple CF data sets; 2) Provide training and outreach to bring people to CF data and train them to work in the cloud; and 3) Coordinate and integrate infrastructure and activities into a cohesive ecosystem. Unlocking the full potential of CF resources through reuse will require expertise from multiple scientific domains, including biomedicine, data science, data management, and cloud workspace training. CF Program Data Coordinating Centers (DCCs) are foundational components of CFDE. The following CF DCCs contain established data sets that are well-poised for increased community use and/or are actively supporting ongoing data generation:

• 4D Nucleome (4DN) (https://www.4dnucleome.org/): Reference nucleomics and imaging data sets, including an expanding tool set for open data processing and visualization
• Acute to Chronic Pain Signatures (A2CPS) (https://a2cps.org/): Imaging, high-throughput omics, sensory testing, and psychosocial assessment data from patients who either transition to or are resilient to chronic pain.
• Bridge to Artificial Intelligence (Bridge2AI) (https://bridge2ai.org/): Ethically sourced, trustworthy, and well-defined flagship biomedical and behavioral datasets on salutogenesis, critical care, functional genomics, and voice as a biomarker. This program is in its early phase and data generation is ongoing.
• Cellular Senescence Network (SenNet) (https://commonfund.nih.gov/senescence): Atlases and datasets of senescent cells and their secretomes. This program is in its early phase and data generation is ongoing.
• Extracellular RNA Communication (exRNA) (https://exrna.org/): Catalog of exRNA molecules found in human biofluids like plasma, saliva, and urine; and potential exRNA biomarkers for diseases
• Gabriella Miller Kids First (KF) (https://kidsfirstdrc.org/): Data from whole-genome sequencing of cohorts with structural birth defects and/or susceptibility to childhood cancer, with associated phenotypic and clinical data
• Genotype-Tissue Expression (GTEx) (https://www.gtexportal.org/home/): Whole genome- and RNA sequence data from multiple human tissues to study tissue-specific gene expression and regulation, including tissue samples
• Glycoscience (GL) (https://glygen.org/): A data integration and dissemination project for carbohydrate and glycoconjugate related data
• H3Africa (https://www.h3abionet.org/resources/h3africa-archive/): Genomic and phenotypic research data generated by the Human Heredity and Health in Africa program. Includes population-based genomic studies of common, non-communicable disorders (e.g., heart and renal disease), as well as communicable diseases (e.g., tuberculosis).
• Human BioMolecular Atlas Program (HuBMAP) (https://hubmapconsortium.org/): An open and global platform to map healthy cells in the human body to determine how the relationships between cells can affect the health of an individual
• Human Microbiome Project (https://www.hmpdacc.org/): Characterization of the microbiomes from healthy human participants at five major body sites using 16S metagenomic shotgun sequencing; as well as characterization of microbiome and human host from three cohorts of microbiome-associated conditions
• Illuminating the Druggable Genome (IDG) (https://druggablegenome.net/): Data on understudied druggable proteins, including mRNA and protein expression data, phenotype associations, bioactivity data, drug target interactions, disease links, and functional information
• Integrated Human Microbiome Project (iHMP) (https://hmpdacc.org/ihmp/): Microbiome, epigenomic, metabolomic, and phenotypic data for 3 cohorts
• Knockout Mouse Phenotyping Program (KOMP2) (http://www.mousephenotype.org/): Data from broad, standardized phenotyping of a genome-wide collection of mouse knockouts
• Library of Integrated Network-based Cellular Signatures (LINCS) (http://lincsproject.org/): Molecular signatures that describe how different types of cells respond to a variety of agents that disrupt normal cellular function
• Metabolomics Workbench (https://www.metabolomicsworkbench.org/): Metabolomics data and metadata from studies on cells, tissues, and organisms
• Molecular Transducers of Physical Activity in Humans (MoTrPAC) (https://motrpac-data.org/data-access): Data contain assay-specific results, associated metadata, quality control reports, and animal phenotype data related to molecular transducers that underlie the effects of physical activity
• Nutrition for Precision Health (NPH) (https://commonfund.nih.gov/nutritionforprecisionhealth): The goal of the NPH program is to predict individual responses to food and dietary patterns. Data being collected include metabolomics, clinical assays, microbiome, and dietary assessments. This program is in its early phase and data generation is ongoing.
• Somatic Mosaicism Across Human Tissues (SMaHT) (https://commonfund.nih.gov/smaht): Data on DNA sequence variants within personal genomes in tissues from human donors. This program is in its early phase and data generation is ongoing.
• Stimulating Peripheral Activity to Relieve Conditions (SPARC) (https://sparc.science/): Maps and tools to identify and influence therapeutic targets that exist within the neural circuitry of a wide range of organs and tissues
• Undiagnosed Diseases Network (UDN) (https://commonfund.nih.gov/Diseases): A network of clinical and research centers helping individual patients and families living with the burden of undiagnosed disease and using advanced technologies to solve the most challenging clinical mysteries.

More information about these datasets can be found via theCommon Fund Data Ecosystem (CFDE) Portal. Other Common Fund programs may also be eligible to participate in CFDE and be deemed to be appropriate CFDE resources for partnering please reach out to the scientific contact (Section VII) with questions about partnering with programs not listed above. Additional information about the CFDE program and the FAQs for this NOFO are available on the program website at?https://commonfund.nih.gov/dataecosystem/faqs.

Additionally, CFDE will include the following tightly integrated Centers:

Data Resource Center (DRC) (OTA-23-004): This center will be responsible for creating and maintaining the CFDE portal that enables users to query and use data sets from across CF programs. The portal will include a landing page for CFDE that integrates information and products from the other CFDE centers.

Knowledge Center (KC) (OTA-23-004): This center will be responsible for establishing a knowledge portal, a knowledge management platform that: aggregates and integrates the knowledge generated by different CF programs to amplify their impact, makes the knowledge accessible to a wide user community in a user-friendly manner, and enables various ways to query and access the available knowledge.

Integration and Coordination Center (ICC) (RFA-RM-23-002): This center will focus on ensuring internal cohesion within CFDE and implementing a structured evaluation process to ensure a continuous improvement cycle. It will have three major responsibilities: (1) Integration and coordination across the CFDE Centers and CFDE-related activities among participating CF programs; (2) Sustainability services; and (3) Leading an annual program evaluation.

Cloud Workspace Implementation Center (CWIC): This center will be responsible for creating a cloud workspace that enables users to import their data and co-analyze them with other CF data sets and/or utilize CFDE-constructed analysis pipelines, workflows, and other analytical or visualization resources. The cloud workspace will meet the needs of both novice and expert users.

Center for Training (CT): This center will be responsible for performing a landscape analysis to identify the training opportunities and needs of the CFDE community. It will also develop and help other CFDE Centers develop and administer targeted training to address gaps in the training landscape.

Research Objectives and Scope

Applications to this Notice of Funding Opportunity (NOFO) must involve a collaboration between at least two CF DCCs listed in the Background section above and at least one external PI not currently funded by a CF program. Eligibility questions should be directed to the scientific contact listed in Section VII. Partnerships that explore, strengthen, and enhance multiple CFDE DCC-DCC interactions are strongly encouraged. Each proposal must contain two primary components: a scientific use case and a CFDE demonstration project.

The scientific use case should include the following:

• A detailed description of the motivating scientific/clinical questions and their significance/impact.
• The datasets involved, including systems in which they reside and dataset level identifiers (if feasible).
• The interoperability/integration activities required to enable the proposed analysis, and how the CFDE datasets will be substantially leveraged. Substantial leverage is defined as the use and citation of the relevant datasets in the envisioned research products of the proposed work (e.g., manuscripts, presentations, book chapters, portals, etc.).
• A detailed experimental plan that allows for adequate assessment of feasibility and interpretability of the proposed work. Preliminary data are not required but may be included.

The CFDE demonstration project should include the following:

• A detailed description of the new capabilities (e.g., tools, workflows, APIs, harmonized datasets, etc.) that will be developed to support the scientific use case.
• Plans for adoption of the new capabilities by the systems involved, including the CFDE DRC/KC and other centers (if relevant).
• Plans for soliciting and incorporating feedback from the end user community throughout the product development lifecycle, from conception through to deployment and maintenance
• A detailed implementation plan, including a proposed timeline of agile development milestones, plans for product documentation and recruitment of beta-testers, and parameters for a minimum viable product (MVP).
• A sustainability/community engagement plan, which describes and quantifies the user community that will benefit from the successful implementation of the demonstration project, how these users will be engaged, how their feedback will be used to improve the MVP (if relevant), and how usage metrics will be tracked.

Any pre-clinical biomedical or social-behavioral question that falls within the mission of the NIH can serve as premise for a scientific use case. This pilot program will not support clinical trials. However, basic, translational, and clinical trial planning projects are acceptable.

The goal of the partnerships is to improve the Findability, Accessibility, Interoperability, and Reusability (FAIRness) of Common Fund data while synergistically supporting researcher-driven questions that leverage analyses of datasets across multiple CFDE components. In the process, the project should improve the overall re-use potential of Common Fund data by developing and testing services needed to efficiently access, analyze, and, if necessary, integrate the data. These activities should happen in close coordination with the DCCs that will provide the relevant datasets and with the DRC, KC, and ICC components of CFDE All data and knowledge generated via the partnership must be made available through the relevant CF DCCs and/or other CFDE-affiliated resources.

Data Management and Sharing Plan

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan (see NOT-OD-22-189). Applicants must consider and describe the anticipated timeline, formats, and methods for depositing products (e.g., computational, annotation, derived, aggregated, summary, etc.) created under this NOFO into a relevant CF Data Coordinating Center or CFDE-affiliated resource. Where applicable, the applicants should describe how they plan to share any tools, pipelines, or workflows through open access channels (e.g., public GitHub links).

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 NOFO.

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 Government

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Emails: CFDE@od.nih.gov and anthony.kirilusha@nih.gov

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

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

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

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

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

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

R&R Budget

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

R&R Subaward Budget

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

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

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

Research Strategy: The Research Strategy must clearly describe the proposed scientific use case and the accompanying CFDE demonstration project. For the scientific use case, please include:

• A detailed description of the motivating scientific/clinical questions and their significance/impact.
• The datasets involved, including systems in which they reside and dataset level identifiers (if feasible).
• The interoperability/integration activities required to enable the proposed analysis, and how the CFDE datasets will be substantially leveraged. Substantial leverage is defined as the use and citation of the relevant datasets in the envisioned research products of the proposed work (e.g., manuscripts, presentations, book chapters, portals, etc.).
• A detailed experimental plan that allows for adequate assessment of feasibility and interpretability of the proposed work. Preliminary data are not required but may be included.

For the CFDE demonstration project, please include:

• A detailed description of the new capabilities (e.g., tools, workflows, APIs, harmonized datasets, etc.) that will be developed to support the scientific use case.
• Plans for adoption of the new capabilities by the systems involved, including the CFDE DRC/KC and other centers (if relevant), including minimal requirements assumed for adoption.
• A detailed implementation plan, including a proposed timeline of agile development milestones, plans for product documentation and recruitment of beta-testers, and parameters for a minimum viable product (MVP). Timeline should address prototyping, refining, outreach, and sustainability elements.
• A sustainability/community engagement plan, which outlines groups of users who will benefit from the successful implementation of the demonstration project, how users will be engaged and how their feedback will be used to improve the MVP (if relevant), and how usage metrics will be tracked.

Either in the context of the above requirements or independently, the Research Strategy should address the timeline for completing both the computational and the scientific goals of the proposed work within the 3 year project period. The use of digital identifiers (e.g. DOI) to enable citation and reference of datasets is strongly encouraged.

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.

Other Plan(s):

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

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Applicants must consider and describe the anticipated timeline, formats, and methods for depositing products (e.g., computational, annotation, derived, aggregated, summary, etc.) created under this NOFO into a relevant CF Data Coordinating Center or CFDE-affiliated resource. Where applicable, the applicants should describe how they plan to share any tools, pipelines, or workflows through open access channels (e.g., public GitHub links).

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the Office of Strategic Coordination (OSC), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed partnership address an important scientific need that is well justified? Is the scope of activities proposed for the partnership appropriate to meet those needs? Could the needs have been easily satisfied in other ways? Will successful completion of the aims provide unique advantages or develop new capabilities?

Specific to this NOFO:

How well is the community of users that will benefit from the CFDE demonstration project defined? How clear is the synergy between the scientific use case and the CFDE demonstration project?

Investigator(s)

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

Specific to this NOFO:

Innovation

Does the application propose to develop a novel resource not otherwise available to the broader scientific community? 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 computational and/or experimental methodologies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the partnership? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the partnership, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the CFDE demonstration project and the scientific use case are in the early stages of development, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the partnership? 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?

If the project 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?

Specific to this NOFO:

How adequately are datasets from CFDE programs listed in Section I being leveraged? How reasonable is the timeline under which the scientific use case work is to be accomplished? How adequate are the sustainability/community engagement plans for the proposed CFDE demonstration project?

Environment

Will the institutional environment in which the partnership will operate contribute to the probability of success in facilitating the research [program/projects/network/consortium] it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed partnership? Will the partnership benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

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).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For [programs/projects/networks/consortia/resources] 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.

2. Review and Selection Process

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

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. 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.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

2. Administrative and National Policy Requirements

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

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of 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 (HHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

The Program Officer (PO) and Project Scientist (PS) roles are held by NIH staff members. The PO role will be held by a member of the Office of Strategic Coordination, the office responsible for overseeing the Common Fund. This individual will facilitate but not direct activities, will be named on the Notice of Award, and will be responsible for evaluating the progress of the partnership. The PS will be an NIH staff member with relevant programmatic and scientific expertise. This individual will have substantial programmatic involvement during the conduct of this award through facilitating technical assistance, advice, and coordination. Multiple program staff may be designated as Project Scientists as needed to manage CFDE program objectives and will work closely with the PO.

CFDE will be governed by a Steering Committee (SC), composed of one representative from each CFDE Center and each CF program participating in CFDE. Co-chairs of the CFDE Steering Committee will be selected on an annual basis. The SC will have the responsibility to provide strategic guidance and recommendations. While the SC can form working groups and subcommittees as needed, there will only be one CFDE SC. The SC will provide guidance and recommendations and NIH will review and approve policies developed by the SC. NIH staff will maintain authority on all matters regarding funding or expenditure of funds.

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

• Determining project approaches, designing protocols, setting project milestones and timelines, and conducting research.
• Coordinating their activities with CFDE DCCs and Centers to meet the timeline stated in their application.
• 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, NIDCR and the Steering Committee (SC)
• Collaborating with other CFDE Centers, DCCs, initiatives, and partnerships (if necessary) to prepare abstracts, presentations, and publications to ensure timely dissemination of CFDE tools and resources.
• Accepting and implementing priorities, procedures and policies agreed upon by the SC to the extent of corresponding grant regulations.
• The CFDE SC may establish subcommittees or working groups to provide input on specific matters as needed, and to oversee the development and implementation of ecosystem 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.
• Not disclosing confidential information.
• Interacting with other relevant NIH programs and activities, as needed, to promote synergy and consistency among similar or related projects.
• Communicating across CFDE Centers, DCCs, initiatives, and partnerships, and cooperating with participating NIH staff to facilitate collaborative efforts.
• Fully participating in a cooperative, interactive, and collaborative manner with NIH staff, CFDE-funded investigators and other CFDE Center PIs.
• Submitting periodic progress reports to the CFDE Technical Working Group or an external scientific panel, at the request of the SC with the concurrence of the NIH PO/PS
• Submitting regular 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 CFDE PDs/PIs, and with federal staff members in various joint activities.
• Cooperate with the NIH staff members and/or external evaluators to conduct a site visit during the first three months of the award and additional site visit(s) or other evaluation process as needed as determined by the NIH PO/PS
• Informing the NIH PO of plans to change or modify any project’s specific aims or strategy, and obtaining receipt of NIH approval prior to the implementation of changes and expenditure of funds
• Recipients 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 HHS, PHS, and NIH policies.

The NIH PO will have primary responsibility for:

• Providing scientific and programmatic stewardship of the award, including assessments of progress and how well the recipient has met any milestones required in the Notice of Award.
• Reviewing requests to change the scope of the partnership, to re-budget funds, to modify key personnel and/or their effort, and any other actions that typically require prior approval.
• Providing budget recommendations to Common Fund leadership, which includes curtailing, withholding, or reducing support for any recipient that fails to make satisfactory progress toward the approved scope of work, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award
• Reporting periodically on the progress of the recipients to Common Fund Leadership and to the NIH Council of Councils (responsibility shared by the PO and PS)
• Assisting the CFDE SC in developing and drafting operating policies and other policies for dealing with recurring situations that require coordinated action (responsibility shared by the PO and PS)
• The Government, via the NIH PO/PS team, will have access to data generated under this Cooperative Agreement through recipient 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.

The NIH PS will have primary responsibility for:

• 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 during the award to the scientific community
• Serving as a liaison, helping to coordinate activities among and for the multiple CFDE recipients, including acting as a liaison between the CFDE SC and NIH, and as an information resource for the recipients about data science, interoperability, and data reuse efforts at NIH. The PO/PS team will serve as a liaison to help coordinate with other groups performing related sets of activities (e.g., the NIH Cloud Platform Interoperability [NCPI] effort)
• Involving additional NIH staff who may assist the recipient(s)
• Co-authoring manuscripts, where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium/Network decides to publish
• Reporting periodically on the progress of the recipients to Common Fund Leadership and to the NIH Council of Councils (responsibility shared by the PO and PS)Assisting the CFDE SC in developing and drafting operating policies and other policies for dealing with recurring situations that require coordinated action (responsibility shared by the PO and PS)

Consistent with 45 C.F.R. 75.322, the recipient 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 recipient will grant other resources the ability to use and redistribute the data, including integrating the data with other data sets, without restriction, unless otherwise limited by consent requirements.

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

Areas of Joint Responsibility include:

• Before the initial award is made, NIH and the presumptive recipient(s) will negotiate a detailed set of milestones and timeline. During these negotiations, NIH and the presumptive recipient may discuss clarifications, changes, or additions to the plans and commitments in the application. NIH and the PD(s)/PI(s) will also agree on the reporting structure and on performance elements prior to award. The milestones, timelines, changes to the plans described in the application, reporting structure and performance elements will be documented in a Letter of Agreement (LOA). They may be adjusted by NIH or the PD(s)/PI(s) later by mutual agreement.
• Meeting in person twice each year at locations selected by the CFDE Integration and Coordination Center in consultation with NIH for program meetings to engage in strategic planning and disseminate information about accomplishments.
• Establishing and documenting best practices for collaboration as appropriate.
• Encouraging attendance of the CFDE Program Meetings by key co-investigators and pre- and postdoctoral trainees, especially those from different but related disciplines and those from groups underrepresented in biomedical research.

External Program Consultants (EPCs): 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 CFDE program staff will engage external scientists and will determine the durations of service. Activities of the consultants could include:

• Participating, as appropriate, in CFDE SC calls, and the annual recipients meetings; EPCs may also meet remotely with NIH staff and recipients at other times during the project period, as needed.
• Reviewing and evaluating the progress of recipients in achieving the goals of the project.
• Recommending changes in priorities based on scientific advances within and outside the CFDE activities
• Providing individual recommendations regarding any changes in the project or grant(s) as necessary. The PO/PS team may use these recommendations to make project changes, as appropriate.

Minimal PD(s)/PI(s) Commitments. Applicants must be committed to the success of the Partnership. For a single-PI application, the PI must commit a minimum of 15% or 1.8 person months of effort per year to the program activities. For a multi-PI application, all PIs must commit to a minimum of 10% or 1.2 person months of effort per year to the program activities.

Dispute Resolution:

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

3. Data Management and Sharing

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

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

4. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $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 and 2 CFR Part 200 Award Term and Conditions for Recipient Integrity and Performance Matters.

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Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Anthony Kirilusha, Ph.D.
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Telephone: 301-402-7617
Email: anthony.kirilusha@nih.gov

Vinod Charles, Ph.D
Email: charlesvi@mail.nih.gov
Center for Scientific Review (CSR)

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
Email: gabriel.hidalgo@nih.gov

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 and 2 CFR Part 200.