Pilot Projects Enhancing Utility and Usage of Common Fund Data Sets (R03 Clinical Trial Not Allowed)

Pilot Projects Enhancing Utility and Usage of Common Fund Data Sets (R03 Clinical Trial Not Allowed) is sponsored by U.S. Department of Health and Human Services, National Institutes of Health. This Notice of Funding Opportunity (NOFO) promotes innovative analysis and integration of NIH Common Fund data sets to advance biomedical research. AI and machine learning are frequently used for complex data analysis and integration.

RFA-RM-26-017: Pilot Projects Enhancing Utility and Usage of Common Fund Data Sets (R03 Clinical Trial Not Allowed) Department of Health and Human Services Part 1. Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations NATIONAL INSTITUTES OF HEALTH ( NIH ) This Notice of Funding Opportunity (NOFO) is developed as a Common Fund initiative ( http://commonfund.

nih. gov/ ) through the Office of the NIH Director, Office of Strategic Coordination ( https://dpcpsi. nih.

gov/ ). All NIH Institutes and Centers participate in Common Fund initiatives. The NOFO will be administered by the National Institute of Dental and Craniofacial Research (NIDCR), ( http://www.

nidcr. nih. gov ) on behalf of the NIH.

Funding Opportunity Title Pilot Projects Enhancing Utility and Usage of Common Fund Data Sets (R03 Clinical Trial Not Allowed) Check for any recent Notices of NIH Policy Changes that may impact application requirements. Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose Many valuable and widely available data sets have been generated by multiple Common Fund programs. The purpose of this NOFO is to announce the availability of funding to demonstrate and enhance the utility of selected Common Fund ( https://commonfund.

nih. gov/ ) data sets, including generating hypotheses and catalyzing discoveries. Award recipients are asked to provide feedback on the utility of the Common Fund data resources.

Funding Opportunity Goal(s) The Office of Strategic Coordination ( Common Fund ) supports research and other projects that will accelerate fundamental biomedical discovery and translation of that knowledge into effective prevention strategies and new treatments.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions 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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description This Notice of Funding Opportunity (NOFO) aims to promote innovative research to enhance the utility and usability of selected Common Fund (CF) 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 either: 1) substantially leverage data from at least TWO eligible Common Fund programs (see the complete list in the Objectives and Scope section), or 2) substantially leverage data from Molecular Transducers of Physical Activity in Humans (MoTrPAC) with or without additional external study data...

“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. Up to two awards will be reserved for use of MoTrPAC data.

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). 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 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 successful applicants 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.

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 recipients will provide feedback on the find ability, usability, and utility of data sets and public data portals, which the awardees will offer 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). Note: applications that use MoTrPAC study data without including other CF datasets below will be considered.

Like all applications for this award, other publicly available data is allowed. Applications using MoTrPAC data with CF datasets may be submitted and will be awarded in consideration with all multi-CF applications. 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, clinical 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 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/ ): Genomic and phenotypic research data generated by the Human Heredity and Health in Africa program, consisting of 51 projects across 30 countries. 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 Microbiome Project (HMP) ( https://commonfund.

nih. gov/hmp ): 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 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 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://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; Incorporating CF data or CFDE Knowledge Graphs to provide grounding predictive models, using methods such as the retrieval-augmented generation (RAG) technique (CFDE’s Data Distillery KG is available here (with CFDE-specific contexts), while others may be listed in the FAQ); Anonymization of imaging or clinical data; Incorporating CF data (e.g., raw, called, or summary) as part of a larger replication, validation, or reproducibility study; Creating synthetic data from extant CF data to enable the use of predictive modeling 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 predictive modeling/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 chronic disease; 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 imagingdata for data harmonization; Enhancement of information in the data resources through the developing analytic tools, curating and annotating existing data, or the adding phenotypic or clinical information.

Note: CF data is well prepared for use in causal models; If experimental approaches are proposed, they should be limited to 20% of the requested budget 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 not yet 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 before 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 before submitting their applications. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. The NIH Common Fund intends to commit approximately $4,000,000 in FY 2026, contingent upon receiving scientifically meritorious applications and having funds available. 10-13 awards are anticipated from this solicitation.

Application budgets are limited to $200,000 in direct costs (excluding subcontract F&A) for one year and need to reflect the actual needs of the proposed project. The maximum project period for an application submitted under this NOFO is one year. 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 Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Foreign Organizations/International Collaborations Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications for additional information. System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

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

Eligible Individuals (Program Director/Principal Investigator) 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.

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 How to Apply-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 funded CFDE Centers, PDs/PIs of RFA-RM-23-013 (Partnerships With Common Fund Data Ecosystem Resources (U24 Clinical Trial not Allowed)), 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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility 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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ). 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 How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- 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. All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - 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 How to Apply - Application Guide .

All instructions in the How to Apply - 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 the required deposition of products (e.g., computational, annotation, derived, aggregated, summary, etc.) created under this NOFO into a relevant CF Data Coordinating Center, CFDE-affiliated resource, or to another public data repository, to be shared with the wider scientific community.

Where applicable, the applicants must describe how they plan to share any tools, pipelines, or workflows through open access channels (e.g., public GitHub links). Functionally, deposition would enable other researchers to replicate and incorporate findings and products into future research efforts.

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 Management 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. Appendix: Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the How to Apply - Application Guide . No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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