National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Notice of Funding Opportunity (NOFO) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (https://commonfund.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The NOFO will be administered by the National Cancer Institute on behalf of the NIH.
U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements
This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite application(s) from the eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered. This NOFO solicits applications for the continued development of the Gabriella Miller Kids First Pediatric Data Resource Center (DRC), which consists of the following components: a Data Resource Core, a Data Coordination Core, and an Administrative Core. The goal of the cloud-based Data Resource is to accelerate discovery of genetic etiology and shared biologic pathways within and across childhood cancers and congenital anomalies by facilitating access to and querying of annotated genomic sequence and phenotypic data from cohorts of patients with these conditions. The Data Resource Core serves as a research resource where genomic and phenotypic data can be aggregated, accessed, analyzed, and shared within and across the childhood cancer and congenital anomalies research communities as well as the broader scientific community. The Data Coordination Core will work with Kids First investigators and KF Genomic Data Generation Centers to facilitate data collection, harmonization, and sharing. The Administrative Core will oversee administrative activities, work closely with the NIH Kids First Working Group, and with the Kids First Training and Outreach Core, to provide resources to the research community.
This listing covers multiple offices in the NIH Office of the Director which offers assistance awards or supplements to assistance awards.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| Not Applicable | January 08, 2027 | Not Applicable | July 2027 | August 2027 | September 2027 |
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).
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.
This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite application(s) from the eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.
The Gabriella Miller Kids First Pediatric Research Program (Kids First or KF) was established by The Gabriella Miller Kids First Research Act, or Kids First (https://www.congress.gov/bill/113th-congress/house-bill/2019/text), for an initial 10 years, 2015-2024. The program was reauthorized as Kids First 2.0 by the 118th Congress for an additional five years.
The overall goal of the Kids First program is to help researchers uncover new insights into the biology of childhood cancer and congenital anomalies, including the discovery of shared genetic pathways between these disorders, to understand the underlying mechanisms of disease. This understanding would lead to novel and more refined prevention tools, diagnostics, and ultimately more targeted therapies and interventions for patients and families.
The Kids First program enables scientists to rapidly explore underlying etiologies and shared pathways of diverse pediatric conditions occurring throughout development by building, maintaining, and expanding the Gabriella Miller Kids First Pediatric Data Resource (Kids First Data Resource). This NOFO solicits the continued development of the Kids First Data Resource, which catalogs and shares whole-genome sequence (WGS), gene expression, phenotypic, and other associated data, from a wide range of childhood cancers and congenital anomalies. Kids First supported Genomic Data Generation Center(s) will generate genomic, transcriptomic, and epigenomic data. Additional data types may be contributed by research teams, generated through complementary mechanisms (RFA-RM-21-011, RFA-RM-22-006).
Starting this grant cycle, the controlled access data will be distributed through appropriate nodes within the NCI Cancer Research Data Commons (CRDC). The DRC is expected to collaborate with the NCI CRDC to register, submit and release data through its controlled access data repository, in alignment with recent requirements (NOT-OD-25-083, NOT-OD-24-157, NOT-OD-25-021), and to integrate and coordinate related components and processes.
Objectives
The objective of this Single Source NOFO is to support continued development of a cloud-based Data Resource for the Gabriella Miller Kids First Pediatric Research Program (Kids First), led by a Data Resource Core, its companion Data Coordination Center (DCC), and an Administrative Core. The Kids First Data Resource serves as an indispensable research resource where genomic and other types of data can be queried, aggregated, visualized, accessed, analyzed, and shared within and across the childhood cancer and congenital anomalies research communities as well as the broader scientific community.
The Data Resource Core is charged with collaborating with the NCI CRDC to continue developing a large-scale data platform facilitating access to clinical and genetic data from participants affected by childhood cancer and/or congenital anomalies and their families, in order to accelerate discovery and ultimately clinical impact. The Data Resource Core will facilitate Findability, Accessibility, Interoperability, and Reusability (FAIRness) of Kids First data by providing a portal that serves as a single point of entry to the data and resources that promote comprehensive and cross-cutting research and collaboration among researchers studying various types of pediatric disease. The DRC also provides and/or integrates with analysis tools that empower researchers to co-analyze large datasets, build, run, and share multiple pipelines and workflows over the data, and integrate with existing knowledge bases. The Data Coordination Core aggregates and harmonizes data from Kids First researchers. The DCC works with data generators, including Kids First investigators and Genomic Data Generation Centers, to facilitate data submission, tracking, processing, and harmonization. The Administrative Core oversees administrative activities, works closely with the NIH Kids First Working Group, and with the Kids First Training and Outreach Core, to provide resources to the research community on using the Data Resource.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the How to Apply - Application Guide provides 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.
The NIH Common Fund intends to commit up to $5 million per year to fund one award, contingent upon availability of funds.
Application budgets for each year are limited to up to $3.2 million direct costs, plus applicable indirect costs, and need to reflect the actual needs of the proposed project.
The total award period is 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
This is a single source NOFO open only to the existing Gabriella Miller Kids First Pediatric Data Resource Center recipient, the Children's Hospital of Philadelphia, previously awarded under RFA-RM-21-014.
Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the 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 NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
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.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.
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.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
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:
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) 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) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - 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.
| Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
|---|---|---|---|---|---|
| Overall | Overall | 12 | Required | 1 | 1 |
| Administrative Core | Admin Core | 6 | Required | 1 | 1 |
| Data Resource Core | Core | 6 | Required | 1 | 1 |
| Data Coordination Core | Core | 6 | Required | 1 | 1 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
When preparing the application, use Component Type 'Overall'.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.
Scope
The grant recipient funded by this Kids First (KF) NOFO will have three broad responsibilities: managing and expanding the Data Resource for Kids First, serving as a Data Coordination Core (DCC) for the Program, and managing an Administrative Core to work closely with a separate Training and Outreach Core (TOC). The Data Resource includes a Portal which is a single point-of-entry, web-based platform for community search of and access to the Kids First data. The DCC will aggregate and harmonize data from Kids First researchers. The Administrative Core will provide administrative logistics and will interact closely with the separate TOC to help the research community use the Data Resource.
FAIR Principles
Applicants are encouraged to consider the NIH Strategic Plan for Data Science, especially as it pertains to ensuring data are Findable, Accessible, Interoperable, and Reusable (FAIR), and utilizing cloud-based infrastructure with the capability for elastic compute and generalizable, accessible workflows.
Interactions with other NIH data initiatives
In alignment with program goals and priorities, the DRC is expected to engage with researchers and NIH staff from other initiatives and platforms, including, but not limited to, NCBI/dbGaP, the NCI CRDC, the Common Fund Data Ecosystem (CFDE), NHLBI's BioData Catalyst, NHGRI's AnVIL, and the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project, to assess and, where appropriate, adopt standards, identify and pursue use cases for collaboration, and, overall, position Kids First for robust interoperability within the NIH data ecosystem.
Coordination and Governance
The NIH Kids First Working Group is responsible for governing the Kids First Program, with oversight from Institute and Center Director co-Chairs. A Leadership Team comprised of members of the WG, may be convened to handle details of program management. An independent group of external Program Consultants will be engaged by the NIH to evaluate the progress of the program and to provide advice to the program about scientific direction.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims: Concisely address the goals of the DRC and how the work proposed supports the overall objectives of the Kids First program and the specific objectives of the DRC and associated components as described in Section I. Funding Opportunity Description.
Research Strategy: Applicants should describe the proposed overall design and structure of the DRC, including any changes to the existing resource, along with a plan for the continued development. The applicant should describe how lessons learned through developing and operating the current DRC inform the proposed Research Strategy. A description of the management structure, integration of components, plans for additional activities or features, and any possible subcontracts must be provided. Applicants should include an organizational chart of the tasks and milestones for what they will accomplish, identifying the types of staff associated with each task, and indicating their respective roles and responsibilities. Describe plans collaborate with the NCI CRDC to register, submit and release data through CRDC's controlled access data repository and to coordinate and integrate related components and processes.
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.
Other Plan(s):
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - 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 How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Admin Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
The Administrative Core will organize, coordinate, and oversee the administrative activities of Kids First. Administrative activities include facilitating meetings and communication between the DRC, NIH, and external key players; developing procedures and guidelines for the operation of the DRC, and coordinating activities with the Genomic Data Generating Center/s and TOC.
SF424 (R&R) Cover (Administrative Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Administrative Core)
Follow standard instructions.
Research & Related Other Project Information (Administrative Core)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Administrative Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Administrative Core)
Budget (Administrative Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Administrative Core)
The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO–specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete "Letters of Support" if there are no NOFO-specific instructions.
Specific Aims: Describe the work of the Administrative Core to support the administrative requirements of the DRC.
Research Strategy: Discuss how the activities listed below will be accomplished, staffed, and managed in support of the DRC. Applicants are encouraged to describe how their plans for administration will leverage staff experience described in the Biographical Sketch. Applicants are encouraged to propose and justify any other coordination activity that would be beneficial to the Kids First program, but is not listed explicitly elsewhere in this NOFO.
Describe plans for the following administrative activities, which include, but are not limited to:
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, with the following modification:
A Data Management and Sharing Plan is not applicable for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Administrative Core)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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 using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Data Resource Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
The Data Resource Core (DRC) is responsible for the overall management, development and/or coordination of the cloud-based data resource, which includes a large-scale data repository of genomic, phenotypic and other -omics data, the data resource Portal, a cloud-based analysis platform, and various analytical tools for the research community.
The activities of the DRC comprise areas of computer science and bioinformatics but also require effective communication with the experimentally-oriented user community, such as developmental biologists, human geneticists, as well as clinicians, to achieve its goals. This requires that the Data Resource Center have personnel with sufficient knowledge to serve as liaisons and translators between experimentalists, bioinformaticists and clinicians. Each component is therefore expected to be comprised of teams with expertise sufficient to allow them to function in this way. The areas of expertise included should cover both the existing Kids First data and more broadly the fields of pediatric cancer and congenital anomalies/developmental biology. The team should have expertise in the areas of data infrastructure, data architecture, and high-performance computing, data security, phenotype ontology technical standards, and data harmonization, and demonstrated experience handling different data types (such as genomic, transcriptomic, epigenomic, proteomic, phenotypic, electron health record, and imaging data).
Kids First controlled access data, for both congenital anomalies and childhood cancer studies, has been migrated to NCI's CRDC, and the CRDC's Cancer Data Services (CDS) General Commons (GC). Therefore, the KF Data Resource Center must collaborate with NCI to integrate with and operate within the CDS data ecosystem for its controlled access data repository activities (NOT-OD-25-083, NOT-OD-24-157, NOT-OD-25-021).
Applicants are encouraged to interoperate or integrate with existing relevant data repositories, platforms, and standards to promote cross-initiative data sharing and analysis wherever possible. Applicants should also be able to demonstrate that the Data Resource will interoperate with the rapidly growing NIH-wide data ecosystem.
The Data Resource Core will also collaborate with the Training and Outreach Core to provide support to researchers using the data and tools.
SF424 (R&R) Cover (Data Resource Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Data Resource Core)
Follow standard instructions.
Research & Related Other Project Information (Data Resource Core)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Data Resource Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Data Resource Core)
Budget (Data Resource Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Data Resource Core)
The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO–specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete "Letters of Support" if there are no NOFO-specific instructions.
Specific Aims: Briefly address the Specific Aims for the Data Resource Core and how they will be accomplished.
Research Strategy: The Data Resource Core will continue to lead the development of the Kids First Data Resource, a large-scale, cloud-based platform designed to empower community access to and analysis of Kids First genomic and phenotypic data. For this section, applicants should address how the Data Resource, including the public-facing portal, cloud-based workspaces, tools, and other services will be maintained, improved, or expanded to address the needs of the program, including activities that track usage metrics and prepare the resource for long-term sustainability. Applicants should describe proposed changes to processes and technologies to account for the collaboration with NCI on controlled access data repository activities. Plans should incorporate user-centered design strategies that outline how the DRC engages users to identify and refine use cases; design, test, and improve the usability of the system; and solicit and incorporate ongoing feedback. Applicants should describe the relevant experience and expertise of the Data Resource Core investigators and provide a detailed timeline of activities with a particular focus on milestones for additional features. Applicants should specify metrics to evaluate usage, usability, and overall impact of the Data Resource.
Describe plans for the following activities to continue developing the Data Resource, which include, but are not limited to:
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, with the following modification:
A Data Management and Sharing Plan is not applicable for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Data Resource Core)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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 using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Data Coordination Core'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
The Data Coordination Core (DCC) will collect and facilitate the deposition and sharing of whole genome sequence, other -omics, imaging and phenotypic data from childhood cancer and congenital anomalies cohorts through the Kids First Data Resource. To that end, it will be necessary to have a detailed understanding of diverse data types and the ability to manage quality control of the data. The variety and volume of data included in the Kids First program are expected to increase with the number of participating cohorts, and the DCC will need to be able to adapt to handle different types of data, including longitudinal data. Using existing community and domain-specific standards, where appropriate, the DCC will work with investigators to harmonize phenotypes. This harmonization effort of phenotypes and metadata, in general, may extend to other NIH collaborations, such as the NIH Cloud Platform Interoperability (NCPI) program and the Common Fund Data Ecosystem (CFDE).
The DCC is required to participate in CFDE. This includes contributing metadata and data assets for ingestion into the CFDE Data Resource Portal; providing metadata, documentation, and other resources to facilitate data reuse; collecting and reporting usage statistics; and actively engaging with CFDE activities. The grant recipient will work closely with the CFDE Data Resource Center (DRC), Knowledge Center (KC), Training Center (TC), (CWIC), and Integration and Coordination Core (ICC), and will provide a Data Repository Service (DRS) identifier to Kids First data.
The DCC is also charged with preparing Kids First datasets for release through the Data Resource on a regular basis, including facilitating dbGaP registration steps. Kids First may seek to link to data from other sources, which may require coordination with the DCC. Prior to public release, the DCC will also stage the data for investigator access in the Data Resource.
SF424 (R&R) Cover (Data Coordination Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Data Coordination Core)
Follow standard instructions.
Research & Related Other Project Information (Data Coordination Core)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Data Coordination Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Data Coordination Core)
Budget (Data Coordination Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Data Coordination Core)
The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO–specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete "Letters of Support" if there are no NOFO-specific instructions.
Specific Aims: Briefly address the Specific Aims for the Data Coordination Core or DCC and how they will be accomplished.
Research Strategy: The applicant should discuss how data coordination tasks will be accomplished, staffed, and managed. Applicants are encouraged to describe how their plans in this section will leverage their experience described in the Biographical Sketch.
Working closely with data submitters, the DCC is responsible for coordinating timely data submission, quality control, registration, provenance, harmonization, delivery to investigators, and public sharing.
Activities of the DCC will include, but may not be limited to:
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, with the following modification:
A Data Management and Sharing Plan is not applicable for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Data Coordination Core)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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 using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.
See Part 2. 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. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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 How to Apply- Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.
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 How to Apply - 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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).
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.
Does the proposed Center address the needs of the research program that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research projects the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of [organizational concepts, management strategies or instrumentation] proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
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.
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.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Review Criteria - Administrative Core
Reviewers will provide only one overall adjectival rating for the Administrative Core (criterion scoring is not used for this component). Possible adjectival ratings are: 'excellent,' 'good,' 'acceptable,' or 'unacceptable.' Reviewers will consider each of the review criteria below in the determination of the scientific merit of the application.
Review Criteria - Data Resource Core
Reviewers will provide only one overall adjectival rating for the Data Resource Core (criterion scoring is not used for this component). Possible adjectival ratings are: 'excellent,' 'good,' 'acceptable,' or 'unacceptable.' Reviewers will consider each of the review criteria below in the determination of the scientific merit of the application.
Review Criteria - Data Coordination Core
Reviewers will provide only one overall adjectival rating for the Data Resource Core (criterion scoring is not used for this component). Possible adjectival ratings are: 'excellent,' 'good,' 'acceptable,' or 'unacceptable.' Reviewers will consider each of the review criteria below in the determination of the scientific merit of the application.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, 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.
Requests for reconsideration 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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board (NCAB). The following will be considered in making funding decisions:
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 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.
After the peer review of the application is completed, the PD/PI will be able to access their 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.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.
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.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations 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.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on MAT/MOUD.
Recipients of both Clinical Trial Required and Clinical Trial Optional awards subject to this term shall report standardized clinical trial activation and enrollment performance data for any interventional clinical trial supported under the award. These metrics are intended to assess trial startup efficiency, site activation, and post-activation performance and to support continuous quality improvement in clinical trial operations (see supplemental guidance). Recipients shall report required data annually at the time of Research Performance Progress Report (RPPR) submission on clinical trial activation and enrollment performance milestone dates as calendar dates; NIH will calculate standardized interval metrics from these dates.
Institutions are expected to maintain capabilities that support efficient clinical trial startup, participant enrollment, and performance monitoring, including streamlined workflows and systems for electronic tracking of milestones. Recipients are encouraged to implement and evaluate approaches that improve trial efficiency and the participant experience.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
In administering programs under this and all funding announcements, NIH prioritizes:
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, 45 CFR 75 (for indirect cost provisions), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The DRC must collaborate with NCI to integrate with and operate within the CDS data ecosystem for its controlled access data repository activities.
Software sustainability and transition to another grant recipient
Stewardship of and access to pre-release and controlled data
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NIH staff will have the role of Project Scientist(s) through technical assistance, advice, and coordination. However, the role of the Project Scientist(s) will be to facilitate but not to direct the activities.
Project Scientists' responsibilities are defined as follows:
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
The PDs/PIs of the Kids First Training and Outreach Core (TOC), the PDs/PIs of the Data Resource Center (DRC), the PDs/PIs of the Genomic Data Generating Center, and NIH members will work together to constitute the Kids First Working Group. Each Working Group member will have one vote; the NIH collectively will have one vote on the Working Group.
The NIH Kids First Working Group is responsible for governing the Kids First Program, with input from Institute and Center Director co-Chairs.
The Kids First Working Group may be asked to:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Working Group chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.
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 Section 8.6 Closeout. 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 2 CFR Part 200.301.
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.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
Gabriella Miller Kids First Program
kidsfirst@od.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Gabriella Miller Kids First Program
kidsfirst@od.nih.gov
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 2 CFR Part 200.