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

Introduction

This Notice of Funding Opportunity (NOFO) aims to promote innovative research to enhance the utility and usability of selected Common Fund data sets. The submission of small research (R03) applications is encouraged from institutions and organizations proposing projects that lead to enhanced use of selected Common Fund (https://commonfund.nih.gov/) data sets by the wider scientific community.

Small research (R03) grants provide flexibility for initiating discrete, well-defined projects that can be completed in one year and require only limited levels of funding. To be eligible for consideration through this NOFO, the proposed research plan must substantially leverage data from at least TWO eligible Common Fund programs (see full list in the Objectives and Scope section). Substantial leverage is defined as the use and citation of the relevant dataset(s) in the envisioned research products of the proposed work (e.g., manuscripts, presentations, book chapters, portals, etc.) Data from other publicly available datasets, including Common Fund programs not listed above, can be included as needed.

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have an exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

This Notice of Funding Opportunity does not accept applications proposing clinical trial(s).

Background

Since its initial inception as the NIH Roadmap for Biomedical Research, the NIH Common Fund (https://commonfund.nih.gov/) has supported many transformative research programs that generate new technologies, methods, and data. Many of these programs generate rich public data sets containing various multi-dimensional molecular and phenotypic data from several organisms, including mice and humans. To maximize the impact of these data, engage a broader community of end-users for wider adoption of these data sets, and to obtain feedback from award recipients to enhance the data resources, the Common Fund plans to support small research projects (R03) encouraging the use of Common Fund data sets. Awards are intended to enable novel and compelling biological questions to be formulated and addressed, and/or to generate cross-cutting hypotheses for future research.

Objectives and Scope

The goals of this NOFO are to 1) promote the use of Common Fund data sets by supporting pilot studies based on analyses across two or more Common Fund data sets; 2) enhance the utility of existing Common Fund data sets by developing workflows, analytic and simulation tools which will enable simultaneous analysis of multiple Common Fund data sets; and 3) demonstrate the added-value of integrating multiple Common Fund data resources in addressing biomedical research questions.

Investigators are encouraged to utilize various approaches including, but not limited to, systems approaches, artificial intelligence (including generative)/machine learning/deep learning methods, advanced data science methods for data set integration and harmonization, and incorporating computational modeling to bring together high throughput genotype and phenotype data sets. Because information regarding the user experience could help NIH improve its data resources, the awardees will be asked to provide feedback on the findability, usability, and utility of data sets and public data portals, which the awardees will provide during a virtual CFDE R03 awardee meeting and in their close-out reports.

The established Common Fund data sets listed below are well-poised for increased community use. Applicants must propose using TWO or more Common Fund program data sets from the following list, and they can propose using other data sets (including additional NIH Common Fund data sets not listed, other NIH data sets, and non-NIH data sets that are publicly available).

• 4D Nucleome (4DN) (https://www.4dnucleome.org/): Reference nucleomics and imaging data sets, including an expanding tool set for open data processing and visualization
• 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 First 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
• 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
• H3Africa (https://h3abionet.org/): The initiative consists of 51 African projects across 30 African countries that include population-based genomic studies of common, non-communicable disorders such as heart and renal disease, as well as communicable diseases such as tuberculosis
• Human Microbiome Project (HMP) (https://commonfund.nih.gov/hmp): Characterization of 5 major human body sites and three cohorts using multiomics, including16s and metagenomics shotgun sequencing
• 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 three 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
• 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://undiagnosed.hms.harvard.edu): Provides clinical, multiomics, and model organism data to provide answers for patients and families affected by these mysterious conditions

This NOFO accepts different types of projects with the intent of generating preliminary and/or validation data for subsequent funding, including, but not limited to, the following:

• Building synthetic cohorts, by combining and comparing data sets;
• Creating synthetic data from extant CF data to enable the use of AI or advanced modeling methods;
• Leveraging existing data across humans and model organisms for novel discovery;
• Developing research methods or analytic tools to support data visualization, harmonization, and integration;
• Developing workflows and tools to automate data integration and interoperability;
• Applying new artificial intelligence (AI)/machine learning/deep learning approaches for metadata harmonization to aid in data integration;
• Developing new approaches and tools for simultaneous analysis of data available on multiple platforms (e.g., data sets residing in two separate cloud platforms);
• Investigating gene expression, genome topology, protein expression, and/or epigenetic patterns across several disease conditions, phases of the lifespan, or in the analysis of sexual dimorphism;
• Identifying biomarkers (metabolites, genetic variants, DNA methylation and/or histone marks, etc.) associated with various diseases and risk factors;
• New approaches for integrating and analyzing single cell data;
• Network analysis across genetic variation, expression profiling, and/or GWAS data to reveal pathways associated with various diseases;
• Incorporating machine learning and computational approaches to imaging data for data harmonization;
• Enhancement of information in the data resources through the development of analytic tools, the curation and annotation of existing data, or the addition of phenotypic or clinical information.

Applications are expected to utilize the existing data in the above listed Common Fund data sets. Generation of new data should be limited to testing/validation of predictions. As noted in the R&R or Modular Budget section, there is a budget limit for such activities if experimental studies are proposed.

If a website or online tool is proposed for users, a sustainability plan addressing the maintenance of the tool is expected to be discussed in the submission, with plans that allow up to two additional years of maintenance/utility encouraged. Where applicable, the applicants should describe how they plan to share any tools, pipelines, or workflows used or created through open access channels (e.g., public GitHub links).

Applicants should describe the anticipated timeline, formats, and methods of providing the data generated or annotated -and other products used or created under this NOFO to the relevant Data Coordinating Center or public repository.

For applications that aim to co-analyze Common Fund data with other genomic data sets that are currently accessible through an NIH-approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe the database through which the proposed data are accessible to the research community and the details of the data sets including any data use limitations based on the associated consent form and discuss the applicability of the data sets to?diverse?human?populations.

For applications that aim to co-analyze Common Fund data with genomic data sets that are not currently accessible through an NIH-approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe their ability and willingness to submit the individual-level sequence data to an NIH-approved repository (e.g., dbGaP) and provide an associated Institutional Certification using the current NIH template (https://osp.od.nih.gov/-sharing/institutional-certifications/). If the Institutional Certification is not available, provide a Provisional Certification and describe the anticipated data use limitations and associated modifiers separately. If submitting a Provisional Certification with the application, please note that a completed Institutional Certification may be required prior to award.

Frequently Asked Questions regarding this NOFO will be posted on the Common Fund Data Ecosystem Frequently Asked Questions (FAQs) (https://commonfund.nih.gov/dataecosystem/faqs) website. Applicants are encouraged to review the FAQs prior to submitting their applications.

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.

Program Directors/Principal Investigators (PDs/PIs) and key personnel of the Data Coordinating Centers (DCCs) of the Common Fund programs, PDs/PIs of CFDE OTAs, and researchers who are involved in the DCC activities as senior/key investigators are not eligible to respond to this announcement. Applicants who are not sure about their eligibility are strongly recommended to contact the Program Officers listed below to discuss their situation prior to submission.

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.

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 or Modular Budget

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

If experimental approaches are proposed, they should be limited to 20% of the requested budget.

Applicants are expected to attend one two-day CFDE Consortium meeting in the Spring to be held in Bethesda, MD, to present their work and are also given an opportunity to present their work at a scientific meeting, as well as one additional external scientific meeting/symposium to present and discuss their findings. Travel and related expenses to attend a CFDE meeting and attend a secondary meeting as a presenter should not exceed $5,000 in total costs.

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:

Applicants must propose to use data sets from at least two Common Fund programs (i.e., at least one data set each from two different Common Fund programs) from the list under Part 2, Section I, Funding Opportunity Description, and in addition, they can propose to use additional publicly available data sets. Integration across multiple data sets is required. Applicants should provide justification for why particular data sets were chosen for study. The applicant should provide sufficient evidence that the proposed work is feasible, will advance the overall stated goals by increasing knowledge and/or broader utility of the data sets under study, and will enable novel and compelling biological questions to be formulated and addressed to form the basis for a subsequent research application.

Both primary and secondary analyses of Common Fund data sets may be proposed in order to develop hypotheses to address research questions. Investigators should have received access to data sets prior to the award start date. Proposed data analyses must utilize data sets from at least two Common Fund programs from the list above, and may include other NIH or other data sets, as long as the external data are currently accessible through a public controlled access database or can be shared through such a database. For example, studies proposed may combine data within cohorts or across phenotypically different cohorts to more powerfully address research questions if the intent is to catalyze the discovery of new variants, to reveal unrealized common genetic pathways shared by related conditions, or to provide a means to generate preliminary data supporting larger projects focused on functional studies.

Applicants may enhance the value of Common Fund data sets for the research community by proposing to develop analytic methods, tools, pipelines, or workflows that can be incorporated into the data sets and used to address research questions. Applicants may also propose approaches that reflect unique and under-utilized aspects of the listed Common Fund data sets (e.g., using tissue samples from GTEx). If experimental approaches are proposed, the expense of the associated research activities should be limited to 20% of the project budget.

Applicants are expected to attend one two-day CFDE Consortium meeting in the Spring to be held in Bethesda, MD, to present their work and are also given an opportunity to present their work at a scientific meeting, as well as one additional external scientific meeting/symposium to present and discuss their findings. Travel and related expenses to attend a CFDE meeting and attend a secondary meeting as a presenter should not exceed $5,000 in total costs.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. The Data Sharing Plan will be evaluated during peer review to note any deficiencies, but these deficiencies shall not impact scoring. Program staff will review noted deficiencies to make sure awards are appropriate for achieving the program's goals. It is expected that data (including resultant raw, derived, aggregated, and summary data), tools, workflows, and/or pipelines created or used with support from this FOA will be provided to the relevant data coordinating center or to another public data repository to be shared with the wider scientific community, in a timely manner that would enable other researchers to replicate and build on the analyses for future research efforts. These details should be provided in the Data Sharing and Resource Sharing plans.

In the Data and Resource Sharing Plan, applicants should describe the anticipated timeline, formats, and methods of providing the data generated or annotated -and other products used or created under this NOFO to the relevant Data Coordinating Center or public repository. Some example resultant data types could include variant call files from multi-sample comparisons, plots or graphs of variant associations, lists or tables of gene summaries, network/pathway analysis results, and other summary statistics. Where applicable, the applicants should describe how they plan to share any tools, pipelines, or workflows used or created through open access channels (e.g., public GitHub links).

For applications that aim to co-analyze Common Fund data with other genomic data sets that are currently accessible through an NIH approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe the database through which the proposed data are accessible to the research community and the details of the data sets including any data use limitations based on the associated consent form and discuss the applicability of the data sets to diverse human populations.

For applications that aim to co-analyze Common Fund data with genomic data sets that are not currently accessible through an NIH approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe in the Data Sharing Plan their ability and willingness to submit the individual-level sequence data to an NIH-approved repository (e.g., dbGaP) and provide an associated Institutional Certification using the current NIH template (https://osp.od.nih.gov/-sharing/institutional-certifications/). If the Institutional Certification is not available, provide a Provisional Certification and describe the anticipated data use limitations and associated modifiers separately. If submitting a Provisional Certification with the application, please note that a completed Institutional Certification may be required prior to award.

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.
• All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. The Data Sharing Plan will be evaluated during peer review to note any deficiencies, but these deficiencies shall not impact scoring. Program staff will review noted deficiencies to make sure awards are appropriate for achieving the program's goals. It is expected that data (including resultant raw, derived, aggregated, and summary data), tools, workflows, and/or pipelines created or used with support from this FOA will be provided to the relevant data coordinating center or to another public data repository to be shared with the wider scientific community, in a timely manner that would enable other researchers to replicate and build on the analyses for future research efforts. These details should be provided in the Data Sharing and Resource Sharing plans.
• In the Data Management and Resource Sharing Plan, applicants should describe the anticipated timeline, formats, and methods of providing the data generated or annotated -and other products used or created under this NOFO to the relevant Data Coordinating Center or public repository. Some example resultant data types could include variant call files from multi-sample comparisons, plots or graphs of variant associations, lists or tables of gene summaries, network/pathway analysis results, and other summary statistics. Where applicable, the applicants should describe how they plan to share any tools, pipelines, or workflows used or created through open access channels (e.g., public GitHub links).
• For applications that aim to co-analyze Common Fund data with other genomic data sets that are currently accessible through an NIH approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe the database through which the proposed data are accessible to the research community and the details of the data sets including any data use limitations based on the associated consent form. and discuss the aApplicability of the data sets to diverse human populations must be addressed.
• For applications that aim to co-analyze Common Fund data with genomic data sets that are not currently accessible through an NIH approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe in the Data Sharing Plan their ability and willingness to plans for submitting the individual-level sequence data to an NIH-approved repository (e.g., dbGaP) and providinge an associated Institutional Certification using the current NIH template (https://osp.od.nih.gov/-sharing/institutional-certifications/), if applicable. If the Institutional Certification is not available, plans for provideing a Provisional Certification and describe the anticipated data use limitations/modifiers must be addressed. and associated modifiers separately. If submitting a Provisional Certification with the application, please note that a completed Institutional Certification may be required prior to award.

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.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

Awards to be made through this announcement will be limited to one year of support, so reviewers should evaluate the items below with this temporal framework in mind.

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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Will the work proposed enhance the utility of Common Fund datasets for the wider scientific community and/or add information value to the data sets?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in 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?

Will the project integrate data across multiple data sets and will the integration allow investigations that could not proceed without the funded integration?
Will the proposed methods enable unique knowledge generation from the utilized Common Fund data sets?
Is it likely that the proposed work will generate preliminary data to form the basis for a subsequent research application?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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 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.

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.

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

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.

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.

Not Applicable

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 Award Term and Conditions for Recipient Integrity and Performance Matters.

Enter text here.

Section VII. Agency Contacts

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

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

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

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

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

George J. Papanicolaou, Ph.D.
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Telephone: 301-480-6722
Email: [email protected]

Anthony Kirilusha, Ph.D.
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Telephone: 301-402-7617
Email: [email protected]

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

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
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 and 2 CFR Part 200.