Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Strategic Coordination (Common Fund)

This FOA is a Common Fund initiative (http://commonfund.nih.gov) through the NIH Office of the Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/). The FOA will be administered by a trans-NIH team led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Heart, Lung, and Blood Institute (NLHBI), the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI).

Funding Opportunity Title
Limited Competition: Continued Development of the Gabriella Miller Kids First Pediatric Data Resource Center (U2C Clinical Trial Not Allowed)
Activity Code

U2C - Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type
Reissue of RFA-RM-16-010
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-RM-21-014
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.310
Funding Opportunity Purpose

This limited competition Funding Opportunity Announcement (FOA) 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 and Outreach 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 structural birth defects by facilitating access to and querying of annotated genomic sequence and phenotypic data from cohorts of patients with these conditions. The Data Resource Core will continue to develop the Data Resource, which serves as an indispensable research resource where genomic and phenotypic data can be aggregated, accessed, analyzed, and shared within and across the childhood cancer and structural birth defects research communities as well as the broader scientific community. The Data Coordination Core will work with Kids First investigators and sequencing centers to facilitate data collection, harmonization, and sharing. The Administrative and Outreach Core will oversee administrative activities, work closely with the NIH Kids First Working Group, and provide outreach and education to the research community on using the Data Resource.

Key Dates

Posted Date
August 24, 2021
Open Date (Earliest Submission Date)
September 20, 2021
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable October 20, 2021 Not Applicable March 2022 May 2022 July 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Expiration Date
October 21, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance toall requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. 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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. 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.



  3. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Objectives

The objective of this limited competition FOA is to support further 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 and Outreach Core. The vision of Kids First is to “alleviate suffering from childhood cancer and structural birth defects by fostering collaborative research to uncover the etiology of these diseases and by supporting data sharing within the pediatric research community.” In pursuit of this vision, the Data Resource Center is charged with continuing to build a large-scale data platform facilitating access to clinical and genetic data from patients and their families affected by these conditions in order to accelerate discovery and ultimately clinical impact. The Data Resource Core will lead the continued development of the Kids First Data Resource, including a portal, cloud-based workspaces, tools, and other services. The 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 birth defects research communities as well as the broader scientific community. The DCC will work with data generators, including Kids First investigators and sequencing centers, to facilitate data submission, tracking, processing, and harmonization. The Administrative and Outreach Core will oversee administrative activities and educate the research community and public on using the Data Resource Portal.

Background

The Gabriella Miller Kids First Pediatric Research Program is a trans-NIH effort initiated in response to the 2014 Gabriella Miller Kids First Research Act and is seeking to help researchers uncover new insights into the biology of childhood cancer and structural birth defects, including the discovery of shared genetic pathways between these disorders. This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have 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. Additional information about the NIH Common Fund can be found at http://commonfund.nih.gov. The Kids First program enables scientists to rapidly explore underlying etiologies and shared genetic 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). Both childhood cancers and structural birth defects are critical and costly conditions associated with substantial morbidity and mortality. Elucidating the underlying genetic etiology of these diseases has the potential to profoundly improve preventative measures, diagnostics, and therapeutic interventions.

This FOA 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 structural birth defects. The Kids First Program has identified cohorts for sequencing via X01 announcements (PAR-15-259, PAR-16-150, PAR-17-063, PAR-18-583, PAR-19-104, PAR-19-390 and PAR-21-040) and will continue to do so through future announcements, pending the availability of funds. Kids First supported sequencing center(s), solicited through RFA-RM-21-013 , will generate genomic, transcriptomic, and epigenomic data. Additional data types may be contributed by research teams, for example imaging and electronic health record data generated through RFA-RM-21-011. The goal of the Kids First Data Resource Center is to facilitate Findability, Accessibility, Interoperability, and Reusability (FAIRness) of the data by providing a portal that allows for 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 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.

Scope

The awardee funded by this FOA will have three broad responsibilities: managing and expanding the Data Resource Portal for Kids First and associated pediatric datasets, serving as a Data Coordination Center (DCC) for the Program, and assembling an Administrative and Outreach Core for the entire Data Resource Center. The Data Resource Portal is envisioned as a single point-of-entry, web-based platform for community access to the Kids First genomic, phenotypic and other -omics data. Applicants are encouraged to interoperate or integrate with existing data portals, platforms, and standards to promote cross-initiative data sharing and analysis, wherever possible. The DCC will aggregate and harmonize data from Kids First researchers and develop and provide tools for the community. The Administrative and Outreach Core will coordinate administrative logistics as well as education on using the Data Resource Portal, and work closely with the NIH Kids First Working Group (https://commonfund.nih.gov/kidsfirst/members) on overall implementation of the program goals.

The activities of the Data Resource Center 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 and 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 structural birth defects/developmental biology and pediatric cancer. Additionally, in an effort to integrate tools and functions amenable to appropriate statistical analyses into the Data Resource, the Center should include statistical genomics expertise within their team. The team should demonstrate experience handling different data types (such as genomic, transcriptomic, epigenomic, phenotypic, electron health record, and imaging data), and expertise in the areas of data security, phenotype ontology technical standards, and data harmonization.

Kids First emphasizes creating and using available open source technology and architecture to the extent practicable. It is expected that all aspects of infrastructure, including code for portals, tools, workflows, and/or pipelines created or used with support from this FOA will be well-documented and shared with the wider scientific community, in a timely manner that would enable other researchers to replicate and build on for future research efforts, aligned with the open source regime used to distribute software, where possible. Exceptions to open source technology will be considered only in compelling cases. Applicants should demonstrate that their cloud-based platform has robust interoperability within the rapidly growing NIH-wide data ecosystem. As this is the second phase of the Kids First Program, the applicant should consider preparing the Kids First Data Resource, including data and infrastructure, for long-term sustainability and continued impact among the pediatric and broader research community.

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 Common Fund Data Ecosystem, the NCI Cancer Research Data Commons, NHLBI BioData Catalyst, 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 the Data Resource for robust interoperability within the NIH data ecosystem.

Leveraging STRIDES for Cloud Computing Activities

The NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) initiative has established partnerships with commercial cloud service providers (CSPs) Google and Amazon Web Services (AWS) to provide favorable pricing for cloud-based costs. The NIH Common Fund, managed by the Office of Strategic Coordination, is using the STRIDES partnerships to provide in-kind support for CSP costs. For more details, please see NOT-RM-20-009.

Coordination and Governance

In addition to the NIH Kids First Working Group, a Steering Committee will contribute to governing the Kids First Program. The Steering Committee will be composed of the PDs/PIs of the Kids First Data Resource Center, the PDs/PIs of the Kids First Sequencing Center(s), representatives of X01 sample/project PDs/PIs, NIH program staff, and an NIH-appointed Chair. An independent group of 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.

Data Resource Core

The Data Resource Core will manage and expand the Kids First Data Resource, which houses, displays organizes, and indexes Kids First data, and is integrated with a public facing portal, analytical tools, workspaces, knowledge bases, data services, and authentication and authorization services. The Data Resource will continue to make whole genome sequence, other -omics and associated phenotypic data readily accessible to users with various levels of expertise. To that end, the design of the features and tools are to reflect statistical rigor and valid methods and approaches relevant to the fields of childhood cancer and structural birth defects, serving a range of experts from developmental biologists to clinicians to bioinformaticists. The web portal should be based on open source software and should continue to be developed through an iterative process based on user feedback. Additionally, in collaboration with NCI’s Protected Data Cloud Trusted Partnership (University of Chicago’s Bionimbus, Leidos Biomedical Research Contract 16X063), the DRC will manage controlled-access Kids First data via a data commons framework that is integrated with dbGaP, in accordance with NIH policies (e.g., the Genomic Data Sharing Policy, NOT-OD-14-124). The Data Resource should have the capacity to grow and adapt with the Kids First Program, including being able to incorporate other types of data, such as imaging or other -omics data, and to interoperate with other data systems. To the extent possible, the Data Resource Portal should link to, and interact with, other relevant datasets. The Data Resource may continue to tap into tools from NCBI as well as other resources readily accessible to the research community. The Data Resource shall support analysis tools and allow users to bring their own tools and pipelines to the environment for analysis. The Data Resource Core should design and implement a robust data life cycle management plan that reduces duplication and associated costs, while fostering rapid data accessibility of high value data, ensuring data back-ups are available, and taking into account long-term sustainability.

Federal Information Security Management Act

The Awardee’s information systems, electronic or hard copy, which contain Federal data need to be protected from unauthorized access consistent with the Federal Information Security Management Act (FISMA), as amended, including by the Federal Information Security Modernization Act of 2014, P.L. 113-283 (https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.9_federal_information_security_man agement_act.htm).

Data Coordination Core (DCC)

The DCC will collect and facilitate the deposition and sharing of whole genome sequence, other -omics, imaging and phenotypic data from childhood cancer and structural birth defects 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, which may require external collaboration or subcontracts. This harmonization effort of phenotypes and metadata, in general, may extend to other NIH collaborations, such as the NIH Cloud Platform Interoperability (NCPI) Working Group and the Common Fund Data Ecosystem.

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. Deposition, registration, and release of data from Kids First studies are of top priority; however, 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 and provide support to researchers using the data and tools.

Administrative and Outreach Core

The Core will organize, coordinate, and oversee the administrative and outreach activities of the Kids First Program. Administrative activities will include facilitating meetings and communication between the Data Resource Center, NIH, and external key players, and developing procedures and guidelines for the operation of the Data Resource Center. Outreach activities will include establishing and maintaining a registry of investigators participating in the Kids First program, developing a forum where researchers can share experiences and work together to address challenges, and educating the research community on how to use the Data Resource through user training utilizing all available methods (e.g., in person, by webinar, through You Tube videos, during office hours). Equally important will be engaging users for their feedback in order to improve the functionality of the Data Resource.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support 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 FOA.

Application Types Allowed
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

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 NIH Common Fund intends to commit up to $4 million total costs per year for FY 2022 through FY2024, to fund one award, pending annual appropriations.

Award Budget

Application budgets for each year are limited to up to $4 million total costs and need to reflect the actual needs of the proposed project.

Award Project Period

The total award period for this FOA is 3 years (FY2022 - 2024)

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Eligibility is limited to the awardees of RFA-RM-16-010.

Foreign Institutions

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

This is a limited competition open only to the existing Kids First Data Resource Center recipient(s).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

 

Page Limitations

All page limitations described in the SF424 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 and Outreach Core Admin Core 6 Required 1 1
Data Resource Core Data Resource Core 12 Required 1 1
Data Coordination Core Data Coordination 12 Required 1 1

Instructions for the Submission of Multi-Component Applications

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

Overall Component

When preparing your application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

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

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

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

Applicants who anticipate requiring >$10,000 direct costs in commercial cloud services from either Google or AWS in any one year of the anticipated award are expected to request in-kind support via the Common Fund STRIDES partnerships rather than requesting direct cost support for these services. To request in-kind support for cloud services via STRIDES, applicants must outline the anticipated costs of commercial cloud services in the Budget Justification section, including, but not limited to, data storage, analysis, data movement/egress, professional services, training, and related activities. Please review NOT-RM-20-009 for important details about how to provide this information in your application.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Concisely address the goals of the Data Resource Center (DRC) and how the work proposed supports the overall objectives of the Gabriella Miller Kids First Pediatric Research Program and the specific objectives of the Kids First Data Resource and associated components as described in Section I. Funding Opportunity Description.

Research Strategy: Applicants should describe how the DRC will facilitate meeting the specific objectives of the Kids First Program. Applicants should describe the proposed overall design and structure of the DRC including any proposed changes to the existing resource, along with a rationale for such changes (adding, expanding, or removing functionalities). 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.

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

With the following modifications:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Resource Sharing Plans for all components should be addressed here under the Overall Component.

It is expected that portals, tools, workflows, and/or pipelines created or used with support from this FOA will be well-documented and shared with the wider scientific community, in a timely manner that would enable other researchers to replicate and build on for future research efforts, aligned with the open source regime used to distribute software, where possible. In the Data and Resource Sharing Plan, applicants should describe the anticipated timeline, formats, and methods of sharing software created under this FOA (e.g. public GitHub links). Plans to share open source software, including source code, use cases, and system design documentation, in appropriate repositories should be specified. Kids First emphasizes creating and using available open source technology and architecture to the extent practicable. If commercial or proprietary resources will be used, provide a justification for this approach including a description of how requirements for data transparency and interoperability will be maintained.

Considerations

As described in the NIH Strategic Plan for Data Science, applicants should describe how they will make biomedical data Findable, Accessible, Interoperable, and Reusable (FAIR; see https://www.force11.org/group/joint-declaration-data-citation-principles-final). Applicants are encouraged to describe their approaches to ensure that the data and analytical resources supported through this FOA will conform to the FAIR principles. Activities that should be discussed in this regard include, but are not limited to, alignment of data, metadata, and technical standards, indexing of data and other digital resources, and uses of computing platforms that enable better data access and interoperability.

To maximize comparisons across datasets or studies, and facilitate data integration and collaboration, researchers funded through this FOA are strongly encouraged to use the following standards and resources (where applicable):

Where appropriate, NIH encourages the use of data standards including common data elements, such as those available through the NIH CDE repository (cde.nlm.nih.gov), terminologies and ontologies such as the NCI Thesaurus (https://ncit.nci.nih.gov), Mondo Disease Ontology (mondo.monarchinitiative.org), and Human Phenotype Ontology (hpo.jax.org), and common data models such as the Observational Medical Outcomes Partnership (OMOP; ohdsi.org).

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative and Outreach Core

When preparing your application, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover ( Administrative and Outreach Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative and Outreach Core)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Administrative and Outreach 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 and Outreach 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 and Outreach Core)

Budget (Administrative and Outreach 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 and Outreach Core)

Specific Aims: Describe the administrative and outreach requirements of the Data Resource Center and how the work proposed supports these activities.

Research Strategy: Discuss how the activities listed below will be accomplished, staffed, and managed in support of the Data Resource Center. Applicants are encouraged to describe how their plans for administration and outreach 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 FOA.

Describe plans for the following administrative activities, which include, but are not limited to:

Describe plans for the following outreach activities, which include, but are not limited to:

Resource Sharing Plan: Do not include a Resource Sharing Plan for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative and Outreach Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Data Resource Core

When preparing your application, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Data Resource Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Data Resource Core)

Enter Human Embryonic Stem Cells in each relevant component.

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)

Specific Aims: Briefly address the Specific Aims for the Data Resource Core and how they will be accomplished.

Research Strategy: 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. In the remaining years of the program new data types, such as epigenomic and imaging data, are expected to be contributed to and integrated with the Data Resource. For this section, applicants should address how the Data Resource, including the public-facing portal, cloud-based workspaces, tools, and other services will be improved, expanded, changed, and/or maintained to address the needs of the program, and what activities will prepare the resource for long-term sustainability. 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:

Should funds become available through Kids First or other sources, the NIH and DRC will work together to assess and possibly pursue interoperability opportunities in alignment with program goals and priorities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Do not include a Resource Sharing Plan for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Data Coordination Core

When preparing your application, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Data Coordination Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Data Coordination Core)

Enter Human Embryonic Stem Cells in each relevant component.

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)

Specific Aims: Briefly address the Specific Aims for the Data Coordination Center 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 SF424 (R&R) Application Guide, with the following modification:

Do not include a Resource Sharing Plan for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

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

Investigator(s)

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

Specific to this FOA:

Innovation

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

Specific to this FOA: Does the applicant propose innovative strategies for sharing and/or visualizing data to facilitate cross-cutting data analysis?

Approach

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

Specific to this FOA:

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

 

 

Environment

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

Specific to this FOA: Are resources available within the scientific environment to support electronic information handling, data systems, website development, and data security?

Additional Review Criteria - Overall

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed Data Resource Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the Data Resource Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Resource sharing for all components of the Resource Center will be considered under the Overall Component. Reviewers will comment on whether there is a plan for sharing tools, workflows, and/or pipelines created or used with support from this FOA.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

Review Criteria - Administrative and Outreach Core

Reviewers will provide only one overall adjectival rating for the Administrative and Outreach Core (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component

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). Reviewers will consider the following aspects while determining scientific and technical merit of this component

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). Reviewers will consider the following aspects while determining scientific and technical merit of this component

2. Review and Selection Process

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

 

2. Administrative and National Policy Requirements

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

Additionally, the Data Resource Center (DRC) is responsible for adhering to the following:

Software sustainability and transition to another grantee

Stewardship of and access to pre-release and controlled data

In-kind cloud storage & computer support through STRIDES

Through the Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) initiative agreements, the NIH Common Fund provides in-kind value for cloud storage of data, costs associated with users who compute on the data in a cloud environment, and costs required to engage some services from engineers or other staff of Cloud Service Provider companies, if needed. The NIH Common Fund will not award funds to the institution for this purpose. Allowable in-kind value associated with data egress are not covered unless specifically noted below:

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 Institute Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This stewardship will include evaluation and monitoring progress with respect to the achievement of specific aims, completion of project milestones, conformance to regulatory and policy requirements, fiscal accountability, and adherence to any special terms and conditions of the award. In addition, the Program Official will be responsible for approval of budget adjustments and changes in technical or scientific plans that potentially constitute a change in scope of the project, approval of changes in key personnel or their effort on the project and approval of any carryover or supplemental funding requests. The Program Official will continually assess risk regarding potential issues related to accomplishing the scientific aims of the research and protection of human subjects, taking appropriate actions if serious problems are identified.

Areas of Joint Responsibility include:
In addition to the NIH Kids First Working Group, a Steering Committee will contribute to governing the Kids First Program. The Steering Committee will be composed of the PDs/PIs of the Kids First Data Resource Center, the PDs/PIs of the Kids First Sequencing Center(s), representatives of X01 sample/project PDs/PIs (one from structural birth defects community and one from the pediatric cancer community), NIH program staff, and an NIH-appointed Chair. The Steering Committee Chair will be appointed by the Kids First Working Group and will not be an NIH staff member or a Kids First funded investigator. Other government or recipient staff may attend the Steering Committee meetings if their expertise is required for specific discussions.

The Steering Committee may be asked to:

Dispute Resolution:

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

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

James Coulombe, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-1390
Email: coulombej@mail.nih.gov

Peer Review Contact(s)

Mark Caprara, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-613-5228
Email: capraramg@csr.nih.gov

Financial/Grants Management Contact(s)

Bonnie Jackson
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5482
Email: jacksobo@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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, 45 CFR Part 75 and 2 CFR Part 200.


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