NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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.

In 2012, the National Institutes of Health (NIH) Common Fund developed a comprehensive program to increase the national capacity in metabolomics for understanding human health and combating disease (http://commonfund.nih.gov/Metabolomics/). The first stage of the Common Fund Metabolomics Program (2012-2018) supported a Data Repository and Coordinating Center (DRCC) to house and promote sharing of public metabolomic data; 6 Regional Comprehensive Metabolomics Resource Cores (RCMRC) to increase access to affordable, high-quality metabolomic analyses and expert collaborative opportunities; technology development research grants to address technical roadblocks impeding the use of metabolomics; a variety of training support mechanisms to increase the cadre of investigators trained in metabolomics; and metabolite standard synthesis contracts to increase the repertoire of reference metabolites for validation of chemical identity.

Investment in this technology from the Common Fund and from research institutions across the United States has enhanced the ability of the biomedical research community to generate and analyze high quality metabolomic data. This success is reflected in the large number of recent biomedical research publications employing metabolomic approaches and in the substantial increase in the number of funded NIH research grants using metabolomics. Recent published examples illustrate how metabolomics can provide functional read-outs for genomic or transcriptomic changes and reveal novel biological understanding with high clinical impact. However, despite the enhanced infrastructure and widespread use of metabolomics, challenges remain in generating and utilizing metabolomic data. To overcome these challenges the community needs:

• An enduring public repository for metabolomic data with capacity for large, well-annotated basic and clinical datasets; searchable and user-friendly access for re-analysis; and community agreement and adoption of data sharing policies.
• Novel approaches to dramatically facilitate chemical identification of unknown spectral features from metabolomic analyses.
• Open-source, generalizable, and scalable bioinformatics tools for scientists with limited expertise in bioinformatics to use for metabolomic data analysis and biological interpretation, including ability to integrate with other -omics data.
• Identification and adoption of best practices in metabolomic study design, sample handling, platform choice, quality control, and data harmonization to ensure accuracy and reproducibility of metabolomic data.

Accordingly, the goal of the second stage of the Common Fund Metabolomics Program is to realize the potential of metabolomics to inform basic, translational and clinical research by 1) establishing an enduring national public repository for metabolomic data; 2) overcoming technical hurdles in analyzing and interpreting metabolomics data, including the ability to determine metabolite identities; and 3) developing consensus for, and promoting adoption of, best practices and guidelines to promote accuracy, reproducibility, and re-analysis of metabolomics data in collaboration with the national and international communities. Four components will be supported: 1) a National Metabolomics Data Repository (NMDR); 2) Compound Identification Development Cores (CIDC); 3) Metabolomic Data Analysis and Interpretation Tools; and 4) a Stakeholder Engagement and Program Coordination Center (SEPCC). The different funded components will work together as a consortium to accomplish their specific goals and reach out to the greater metabolomics community to identify additional hurdles impeding the use of metabolomics in biomedical and translational research, and develop strategies to overcome them.

This Funding Opportunity Announcement (FOA) addresses the need for a robust National Metabolomics Data Repository to store, and make publicly available, raw and processed metabolomic data generated by large NIH programs, individual research grants, and other biomedical research groups, in a cloud computing environment accessible for searching and reanalysis by the biomedical research community. The Metabolomics Data Repository and Coordination Center (DRCC), created in Stage I of the Common Fund Metabolomics Program, has begun to address this need. This cloud-based metabolomic data repository is one of a very few public metabolomic data repositories in the United States that allow researchers to both freely upload and access metabolomic datasets. It includes easy-to-use online data entry with defined metadata standards, an established metabolite ontology for consistent nomenclature (RefMet), and curation processes to assure data upload accuracy. The DRCC currently houses more than 500 datasets from investigators across the country and has developed an exchange index with MetaboLights, a European metabolomics data repository with similar goals but different capabilities. The new National Metabolomics Data Repository will incorporate existing DRCC data.

In the transition to a National Metabolomics Data Repository, the successful applicant is expected to continue and enhance the current technical capabilities of the Data Repository and create a governance structure that engages the wider metabolomics community to guide the repository’s efforts toward continual technical improvement and expansion and policy development for data deposition, access, and accreditation.

The goal of this FOA is to establish a National Metabolomics Data Repository (NMDR), which is widely adopted by the national and international metabolomics community, supports facile data and metadata deposition and access for re-use, and provides a means for citing the data and its provenance. The National Metabolomics Data Repository will consist of 3 required components: 1) The Data Repository, 2) an Administrative Core, and 3) a Governance Core. Key activities of each Core are described below. The Program Director/Principal Investigator (PD/PI) is expected to have experience in managing large multi-faceted consortia requiring policy development and in promoting data sharing and outreach as well as the technical infrastructure and experience in managing metabolomic data.

Data Repository

The successful applicant will provide a plan to develop a robust metabolomics data repository to store raw and primary metabolomic data with the metadata necessary for analysis. The required extent of metadata will be determined by community input and guidance from the Governance Core (see below). The data repository must have flexibility to accommodate metabolomic datasets of multiple formats, including spectrometric, spectrographic and chromatographic information derived from MS, NMR and gas chromatographic platforms and the associated unique chemical entities (UCE) and quantitative values where appropriate. Metabolomics experiments may include ion mobility or other orthogonal chromatographic information, topological information with mass spec imaging, isotopic information including isotopoloques and isotopomers, and qualitative and quantitative values requiring unique data formats. As metabolomic technologies continue to evolve, additional formats and information content should be accommodated. The applicant is expected to propose cost-effective and efficient strategies to support a data repository that allows easy data deposition, searchable access, and retrieval of datasets. Computational analysis of Repository datasets should be possible within the cloud environment to avoid issues associated with downloading very large datasets. The National Metabolomics Data Repository will need to work with the Stakeholder Engagement and Program Coordination Center (SEPCC; see companion FOA RFA-RM-17-014) to ensure that the appropriate computational tools are available and, when possible, can be used in the cloud environment. The Repository Governance Core and the Stakeholder Engagement and Program Coordination Core, in consultation with the NMDR PD(s)/PI(s), will develop strategies to ensure that data formats meet evolving community standards.

Key to a successful data repository is the ability to easily deposit, search, retrieve and make the data available for wider usage, in accordance with Findable, Accessible, Interoperable, and Re-usable (FAIR) data principles. The successful applicant will describe a robust and demonstrated repertoire of means and tools for facile data deposition and access. Similarly, clear annotation and curation of datasets is essential for the interpretation and meaningful reuse of metabolomic data. Typical annotation includes metadata information about the experimental subjects, conditions and protocols used, quality control measures and data analysis workflow. The ability to store additional annotations of protocol information becomes exceptionally important in stable isotope resolved metabolomics experiments. While metadata is essential for rigor and reproducibility of experiments, requiring extensive information can become onerous and lead to reluctance on the part of researchers to deposit their data. Therefore, requirements will be developed by the Repository Governance Core in consultation with the SEPCC (see below) and the Metabolomics Steering Committee (see section VI). Furthermore, the National Metabolomics Data Repository will provide sufficient expert staff to work with members of the Consortium and the greater metabolomics community to facilitate efficient data upload, ensure required metadata has been included, and proactively advise the metabolomics community on data deposition and sharing requirements.

A Repository Technical Enhancement Core is not required, but may be included, to address repository technical enhancement needs. Any tool development within the data repository should be focused on lowering the effort associated with data deposition and retrieval. Development of novel data analysis tools and approaches are not appropriate as they are the subject of a companion FOA (RFA-RM-17-012).

Additional specific requirements for the repository, discussed below, should be addressed in the application.

Clinical Data

Metabolomics measurements are increasingly being used in epidemiological, observational, and interventional clinical studies. The clinical metadata often include elaborate patient/participant demographic information and other relevant clinical data as part of the study. Clinical study designs and protocols include vital information on the study size, specifics related to study arms (components), randomization process, nature and duration of the intervention and other critical information including subject exclusion and inclusion criteria, that is specific to the parent study. Without accompanying clinical metadata, utility of the metabolomics datasets is limited.

The Data Repository or Administrative Core, in consultation with the Governance Core and NIH staff, will develop a plan for the deposition of, or access to, de-identified phenotypical and clinical data. Specific topics to address include, but are not limited to:

• Identification of individual-level phenotype data that should be deposited for all human studies, if available, to promote harmonization across deposited datasets (e.g. age, sex, case-control status);
• Strategies to identify an expanded set of individual-level phenotypical and clinical data that should be deposited in the repository;
• Development of policies and procedures for depositing, or providing a facile means of linking and accessing, individual-level phenotypical and clinical data to the data repository; and
• Development of policies and procedures that follow privacy laws and address issues of consent.

Cloud Computing

The collection and storage of publicly available metabolomic data are expected to persist beyond the project period for this announcement. In addition, the data repository and core functions of the data repository must be independent of physical location and use publicly available software because stewardship of the repository will be subject to transfer at the end of the project period. The amount of metabolomic data is expected to grow exponentially; therefore, capabilities to scale up storage and analysis need to be planned in a manner independent of physical location. To meet these requirements, the data repository and core functions of the data repository must be compatible with cloud computing technologies and the applicant must be able to host the data repository on a cloud platform. While the compatibility with cloud computing technology is a requirement, operational hosting of the data repository should be driven by functional requirements and cost analysis.

Web Portal

As part of the DRCC funded in the first stage of the Common Fund Metabolomics Program, a web portal termed the Metabolomics Workbench was developed. The Metabolomics Workbench provides public access to the DRCC data repository to upload new datasets and to search and retrieve public datasets stored in the DRCC. It also provides access to Program-related resources for the community, such as protocols, data analysis tools, training programs, community news, and links to additional metabolomics resources. In the second stage of the Common Fund Metabolomics Program, a separate coordination center, the SEPCC, will be responsible for the content and management of the Consortium’s public web portal, which will include the portal to the data repository. However, the data repository will work with the SEPCC to integrate access to the data repository and associated tools. Collaboration with the SEPCC is essential in order to promote data sharing and mining by the greater metabolomics community, and to ensure usability of the data repository by users from a wide variety of disciplines.

Administrative Core

The Administrative Core is responsible for overall management of the National Metabolomics Data Repository and implementations of the recommendations of the Governance Core. Specifically, this Core is responsible for facilitating operation of the Governance Core, implementing its recommendations, and reporting periodically to NIH on such activities. It is also responsible for tracking dataset upload, download, and re-use, and for ensuring proper citation of datasets from the repository. The Administrative Core will coordinate with the SEPCC and other components of the Common Fund Metabolomics Consortium. This Core (or an optional Promotion and Outreach Sub-Core) will also work with the SEPCC to increase community adoption of data deposition and sharing requirements; to acquire important datasets generated outside of the Consortium, including those from other Common Fund and large NIH programs; and to develop collaborative or pilot & feasibility opportunities to engage the biomedical research community in data re-use. In addition, the two topics below should be specifically considered.

Consortium Interactions

The National Metabolomics Data Repository is expected to interact with all components of the Common Fund Metabolomics Program Consortium. This interaction must include partnering with the SEPCC to develop and maintain the web portal; collaborating with the Metabolomic Data Analysis and Interpretation Tools grantees to validate tools using data in the repository; and working closely with Repository Governance Core as described below. The Data Repository is also expected to interact with the national and international metabolomics communities and the greater biomedical research community and with various large NIH programs generating metabolomic data.

Succession Planning

The value of collecting and storing metabolomics data is in allowing easy access to the data for independent validation and for further mining of the data to reveal new biological insights. Planning for continued support of the data repository is therefore a critical component of the repository’s management. Accordingly, this Core should present strategies to engage invested communities in developing plans for sustainability of a data repository after the end of Common Fund Program. Development of strategies for future support will be refined in consultation with NIH staff (e.g. BD2K program), the Governance Core, the SEPCC, and the wider metabolomics community.

Governance Core

The goals of the Governance Core will be three-fold: Development of policies for deposition and sharing of Repository data; identification and prioritization of technical improvements to the repository; and periodic evaluation of the performance of the repository in meeting the needs of the biomedical research community. To accomplish these goals, the Governance Core will create a Governing Board that has autonomy within the National Metabolomics Data Repository to make independent recommendations, but consults with the SEPCC, the Consortium Steering Committee (SC), the NIH, the broader Metabolomics community, relevant national and international data repositories, and the scientific publishing community in developing those recommendations. It is expected that the Governing Board would meet as a group several times a year and that Governance Core staff would facilitate development of Board recommendations by researching and compiling requested information and data. The Governance Core is distinct from the Consortium External Scientific Consultants (see section VI) in that it is an integral part of the National Metabolomics Data Repository, its members are recruited by the Repository PD(s)/PI(s), and its recommendations will guide the operations of the Repository. In contrast, the External Scientific Consultants will oversee the progress and coordination of the entire Consortium and make recommendations to NIH staff and Consortium members.

The Governing Board will consist of 6-8 external experts, and the successful applicant must include Letters of Commitment (see below) from 3-4 in the application. Additional members will be selected post-award in consultation with the Consortium Steering Committee (SC) and NIH staff. Potential communities from which to recruit experts include, but are not limited to, biomedical researchers; journal editors; metabolomics experts; database developers; and bioinformaticists. The successful applicant will also describe a meeting and leadership structure to achieve meaningful governance and oversight of the data repository. Key metrics for success of the repository, and for its future potential support, are community adoption of the data deposition and sharing policies and extensive use of the repository by the biomedical research community for both data deposition and re-analysis.

Additional topics to be addressed by the Governance Core include, but are not limited to:

• Who are the relevant stakeholders needed to establish, disseminate, and enforce community-developed standards of data quality, deposition, and sharing? How are these stakeholders best engaged?
• What parameters describe metabolomic datasets most valuable to biomedical research to inform policies on dataset deposition?
• What metadata is required to allow validation and/or re-analysis of metabolomic datasets?
• What is needed to increase metabolomic data deposition and reuse? How can we simplify the process for researchers to submit data into the database or retrieve meaningful data for re-analysis?
• What additional types of metabolomics data being generated by the community need to be captured in the repository and how can that be achieved?

External Expert’s Letter of Commitment

At the time of application, it is expected that the Governance Core would obtain commitments from 3-4 external experts, coming from diverse disciplines relevant to the operations and goals of the National Metabolomics Data Repository, to serve on the Governing Board. These experts should have national recognition in their respective fields and be willing to work with the metabolomics and biomedical communities to develop consensus recommendations.

All grantees are expected to work collaboratively with other members of the Common Fund Metabolomics Consortium. PD(s)/PI(s) and appropriate staff are also expected to attend semi-annual Consortium program meetings. For budget planning purposes, it can be assumed these will be 2-day domestic meetings.

All applicants are strongly encouraged to contact NIH Staff to discuss the alignment of their proposed work with the goals of this FOA, and the Metabolomics Program. A technical assistance teleconference will be held for potential applicants. NIH staff will be available to answer questions related to this and companion FOAs. Time, date, and dial in information for the call will be announced in an NIH Guide Notice and will be posted on the Common Fund Metabolomics website: https://commonfund.nih.gov/metabolomics.

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

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• o Hispanic-serving Institutions
• o Historically Black Colleges and Universities (HBCUs)
• o Tribally Controlled Colleges and Universities (TCCUs)
• o Alaska Native and Native Hawaiian Serving Institutions
• o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government - Including the NIH Intramural Program
• U.S. Territory or Possession

Other

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.

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

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. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A button to access the online ASSIST system 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent should be sent to:

Arthur Castle
Telephone: 301-594-7719
Fax: 301-480-3503
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	12
Data Repository Core	6
Governance Core	6
Additional Core	6

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required (Maximum of 1)
• Data Repository Core: required (Maximum of 1)
• Governance Core: required (Maximum of 1)
• Additional Core: optional

When preparing your application in ASSIST, use Component Type Overall .

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

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 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.

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.

Specific Aims: Specific Aims should be the overall vision and goals for the National Metabolomics Data Repository. These Aims should be overarching and at a high level and distinct from the aims of the individual components.

Research Strategy: The applicant must provide details of the overall center organization and management plan. Specific plans for the following should be included:

• How the cores within the NMDR will interact and integrate to function as a cohesive whole.
• How the NMDR will work with the Stakeholder Engagement and Program Coordination Center (SEPCC) and other members of the Metabolomics Consortium.
• Plans for management and integration of NMDR activities and communication and evaluation of progress across the NMDR.

The following additional items must also be addressed in the application:

• Evidence of Successful Past Performance. Applicants should provide evidence of successful database management, without duplicating information in the biosketches.
• Information Technology (IT). Applicants should discuss all pertinent informatics issues involved in providing the basic IT infrastructure/system administration for the proposed project.
• Milestones and goals. Applicants should define a clear set of goals for the proposed project that are consistent with developing consensus for, and promoting adoption of, best practices and guidelines to promote accuracy, reproducibility, and re-analysis of metabolomics data in collaboration with the national and international communities, and with establishing a National Metabolomics Data Repository (NMDR), which is widely adopted by the national and international metabolomics community, supports facile data and metadata deposition and access for re-use, and provides a means for citing the data and its provenance. The applicant should describe semi-annual milestones with metrics that will document progress towards the achievement of the ultimate goals. The number and duration of milestones will depend on the project being proposed, so applicants should include these items for every year, as appropriate. Applicants should describe how they will prioritize their activities to ensure that the main goal of the Metabolomics Program will be achieved. Milestones may be revised at the time of the award and/or yearly as described in the terms and conditions of a Cooperative Agreement below.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the Metabolomics Program and approved by NIH staff. The primary goal of the Metabolomics Program is to realize the potential of metabolomics to inform basic, translational and clinical research. Thus, the development of policies, methods, and standards for sharing is critically important. The NIH expects that the awardees, through the Metabolomics Steering Committee (SC), will develop such policies, methods, and standards in concert with the NIH. These policies, methods, and standards will remain consistent with NIH-wide policies on data and resource sharing.
• Specific Plan for Data Sharing: All grantees of the Metabolomics Program will be subject to and expected to abide by data sharing standards adopted by the Metabolomics Steering Committee consistent with achieving the goals of this Program. This will include upload of metabolomics data in the National Metabolomics Data Repository, when applicable, or in other public access databases in cases where the National Metabolomics Data Repository is not a suitable option for the type of data being generated.
• Specific Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected in applications that are developing software. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact:
• The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
• The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center.
• To further enhance the potential impact of their software, applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. Accordingly, awardees are encouraged to manage and disseminate their source code through an open revision control and source code management system such as GitHub.
• Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.
• Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov)
• Prior to funding, NIH Program Staff may negotiate modifications to the Sharing Plan with the applicant.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

PHS 398 Research Plan (Administrative Core)

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Applicants are strongly encouraged to propose and budget for a Center Administrator to manage day-to-day operations.

Budgets should include cost for travel to one annual meeting of the Metabolomics Consortium in each of the proposed project years, and one additional face-to-face Steering Committee meeting annually, both held domestically, in addition to other anticipated travel associated with the research.

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.

Specific Aims: Succinctly describe the strategies and goals for managing the NMDR, organizing its key activities, and connecting the NMDR to the Metabolomics Consortium.

Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support the NMDR, foster synergy and integration of the NMDR with the Metabolomics Consortium, support planning and evaluation activities, and encourage data deposition and re-use of resident metabolomics data. The Administrative Core will support and coordinate project administration within the NMDR, including implementation of the Governance Core recommendations (see below). All applicants are expected to apply project management methods for planning, monitoring, and managing the workload over the award period and are expected to communicate this to NIH program staff upon request.

Applications must describe the administrative structure to support the proposed NMDR, including but not limited, to:

• Management and Communication Plan. The plan should describe the leadership and communication strategies to manage and track progress of the NMDR's projects and activities. The plan should include a description of the NMDR leadership structure and should concisely describe oversight mechanisms that will be used by the Center PD(s)/PI(s). The management plan should describe how the PD(s)/PI(s) will manage the proposed project, who will oversee the day-to-day activities (e.g., a Project Manager if not a PD/PI), and how the management structure will support achievement of the proposed goals and milestones. Useful elements of this description include the organization of the proposed project, its management structure, and roles of key personnel,. The plan should describe any provisions for the mentoring and development of new investigators. The plan should describe the process for prioritizing and implementing Governance Core recommendations.
• Annual Meeting and Other Consortium Activities. Provide a brief description of strategies for connecting and integrating the NMDR with the Metabolomics Consortium. Funded Consortium components are expected to participate in an Annual Investigators meeting, the Program’s Steering Committee (SC), and other Consortium activities. Consortium members are also encouraged to organize and participate in other Consortium meetings and workshops, organize collaborative activities, promote Trans-Consortium collaborations, and organize and participate in scientific and programmatic working groups.
• Outreach Plan. The application should describe how the NMDR will interact with the national and international metabolomics communities and repositories, the greater biomedical research community, and various large NIH programs generating metabolomic data to increase deposition of datasets to the NMDR, evaluate NMDR usability, identify best practices for dataset annotation and curation, etc. Plans should also describe development of programs to encourage re-use of data residing in the NMDR.
• Succession Planning. Provide a brief discussion of strategies to engage invested communities in developing plans for sustainability of a data repository after the end of Common Fund Program. Discussion of potential support and management models and description of metrics needed to entice community investment should be described.
• NMDR and Program Evaluation. The Administrative Core should coordinate participation in NMDR program evaluation activities, including progress reports, site visits, and providing additional communication and materials to the NIH as needed. Applicants should include plans for critically evaluating and revising center milestones on a regular basis.
• 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:
• Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource Sharing Plan.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Admin Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Data Repository 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 Repository Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Repository Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Repository 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 Repository 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 Repository Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Data Repository 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 Repository Core)

Specific Aims: Succinctly describe the strategies and goals for the Data Repository Core.

Research Strategy: This section should outline plans for the Data Repository, including but not limited to, the following:

• Continuing and enhancing the current technical capabilities of the Data Repository to store, curate, and provide access to raw and processed metabolomics data of multiple formats, the requisite associated metadata, and any tools required for efficient data upload and retrieval.
• Developing a robust metabolomics data repository to store and provide user-friendly access to raw and primary metabolomic data with the metadata necessary for analysis. Datasets of diverse formats should be accepted, including but not limited to spectrometric, spectrographic and chromatographic information derived from MS, NMR and gas chromatographic platforms, ion mobility, mass spec imaging, stable isotope resolved metabolomics. As metabolomic technologies continue to evolve, additional formats and information content should be accommodated. Optimizing, implementing, and promoting data standards and common data elements for the Repository as directed by the Governance Core.
• Clear annotation and curation of deposited datasets.
• Maintaining accordance with Findable, Accessible, Interoperable, and Re-usable (FAIR) data principles.
• Incorporation of clinical datasets containing demographic information and phenotypic or clinical metadata.
• Description of the cloud platform hosting the Data Repository, as well as plans to assure data back-up, integrity, and uninterrupted service.
• Plans to meet any technical enhancement needs associated with the Data Repository. Note that any tool development within the data repository should be focused on lowering the effort associated with data deposition and retrieval
• Coordination with SEPCC in order to ensure that the Data Repository can be easily accessed through the web portal they develop for the Consortium.
• Coordination with SEPCC to assess usability of the Data Repository for dataset upload and retrieval for users from a wide variety of disciplines.
• A plan for efficient use and integration of third party tools including those developed by the Metabolomic Data Analysis and Interpretation Tools FOA (see companion FOA RFA-RM-17-012).

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Data Repository Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Governance Core.

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

SF424 (R&R) Cover (Governance Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Governance Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Governance 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) (Governance 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 (Governance Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

The budget request should include the costs associated with regular Governing Board meetings, as well as compensation for Governing Board members.

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.

Specific Aims: Succinctly describe the strategies and goals for creating and managing a Governing Board; engaging metabolomics community stakeholders in discussions to enhance the Data Repository operations and inform policies for data deposition and sharing; and developing recommendations for NMDR implementation.

Research Strategy: This section should describe the following:

• The strategy for creation of a Governing Board consisting of experts from diverse relevant fields. While the final Board will contain 6-8 members, only 3-4 should be named in the application. Completion of the membership will occur after discussion with the Metabolomics Steering Committee and NIH Staff.
• Experts should have national recognition in their respective fields and express in a Letter of Commitment how they expect to contribute to the goals of the Governance Core and a willingness to work toward assessing needs and developing consensus within the metabolomics and biomedical communities relevant to the policies and operations of the National Metabolomics Data Repository.
• The meeting and leadership structure for the Governing Board.
• Strategies for synthesizing Governing Board recommendations into policies for deposition and sharing of Repository data; identification and prioritization of technical improvements to the repository; and periodic evaluation of the performance of the repository in meeting the needs of the biomedical research community.
• Describe plans to interact with the SEPCC to ensure that NMDR capabilities meet evolving community needs and standards.

Letters of Support: At the time of application, it is expected that the Governance Core would obtain commitments from 3-4 external experts, coming from diverse disciplines relevant to the operations and goals of the National Metabolomics Data Repository, to serve on the Governing Board. These experts should have national recognition in their respective fields and express in a Letter of Commitment how they expect to contribute to the goals of the Governance Core and a willingness to work toward assessing needs and developing consensus within the metabolomics and biomedical communities relevant to the policies and operations of the National Metabolomics Data Repository.

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Governance Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Additional Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Additional Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Additional 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) (Additional 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 (Additional Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Additional 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 (Additional Core)

Specific Aims: Succinctly describe the strategies and goals for this Core including how this optional Core would enhance the ability to achieve the overall goal of the NMDR.

Research Strategy: This section should describe the Core's major strategies and activities.

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Additional Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this announcement, note the following:

Reviewers will provide an overall impact score and individual criterion scores for the entire NMDR (Overall Component), but not for the other components. The Administrative Core, Data Repository Core, Governance Core, and any optional Cores will be evaluated, but each will receive only one overall adjectival (not numerical) rating.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the NMDR 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 pNational Metabolomics Data Repository (NMDR) that by its nature is not innovative may be essential to advance a field.

Does the NMDR address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the NMDR 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?

Specific to this FOA: Does the proposed plan for the National Metabolomics Data Repository generate confidence that it will develop a resource of enduring value to the biomedical research community? Is this application likely to bring about community consensus and adoption of the data deposition and sharing policies and promote extensive use of the repository by the biomedical research community for both data deposition and re-analysis?

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

Specific to this FOA: Does the PD/PI have experience with large multi-faceted consortia requiring policy development? Does the PD/PI have a history of productive interactions with the national and international metabolomics community? Have 3-4 external experts committed to serve on the Governing Board? Are they qualified to make the significant contributions described in their Letters of Commitment? Does their expertise cover a range of backgrounds needed to govern the National Metabolomics Data Repository activities? Are sufficient experienced personnel identified to meet community needs for assistance with data deposition, curation, and reuse?

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?

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

If the NMDR 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 children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Are appropriate plans proposed for transitioning the existing capabilities and data of the DRCC to the National Repository? Are all the requirements for the National Metabolomics Data Repository addressed in the research plan, i.e. cloud computing; technical capability for facile data upload and retrieval; access to critical tools for data use and re-use; public access interface; curation of data sets and adoption of community standards on data set annotation? Does the plan describe flexibility to adapt to changing community needs in metabolomics? Have appropriate issues related to deposition of, or access to, clinical data been addressed? Are adequate plans proposed for handling metabolomics data traditionally challenging to capture in databases (for instance stable isotope data and metabolite imaging), as well as the flexibility to adapt to the changing needs of the metabolomics community as the field matures? Have effective management and leadership plans been proposed to achieve the goals of the Governance Core? Have they described effective strategies for working with other components of the Consortium? Are plans and infrastructure in place to assure data back-up, integrity, and uninterrupted service to the data repository?

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: Does the institution have managerial and technical infrastructure to implement a National Metabolomics Data Repository? Are their computing facilities sufficient to house the data and resources required??

As applicable for the NMDR 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 six 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 six 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.

When the proposed NMDR 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 children 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.

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.

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.

Not Applicable.

Not Applicable.

Not Applicable.

As applicable for the NMDR 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 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 and (4) Analytical Tool/Software Sharing Plan.

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.

In addition to the above criteria, the following components of the NMDR application will be evaluated and will be considered in the determination of the overall impact score for the whole application.

Review Criteria for Administrative Core:

Significance

Does the proposed Administrative Core address the needs of the NMDR? Is the scope of activities proposed for the Administrative Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the NMDR?

Investigator(s)

Are the Core Leader(s)) and other personnel well suited to their roles in the Administrative Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research? Are appropriate effort and attention devoted to the management of day to day operations? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Administrative Core 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 Core? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the NMDR? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the NMDR? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the NMDR, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are appropriate plans for work-flow and a well-established timeline proposed?

Environment

Will the institutional environment in which the Administrative Core will operate contribute to the probability of success in facilitating the NMDR? Are the institutional support and any physical resources available to the investigators adequate for the Administrative Core proposed? Will the NMDR benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Significance

Does the proposed Core address the needs of the NMDR, the Metabolomics Consortium, and the greater metabolomics community? Is the scope of activities proposed for the Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the Consortium?

Investigator(s)

Are the Core Leader(s)and other personnel well suited to their roles in the Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of relevant accomplishments? If the Core 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 Core? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational or implementation concepts? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of NMDR? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? How appropriate are the proposed work-flow and timeline? Are issues associated with clinical data and non-traditional forms of metabolomics (i.e. metabolic imaging and stable isotope data) adequately considered?

Environment

Will the institutional environment in which the Core will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Core proposed? Will the Core benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Are the computing facilities sufficient to house the data and resources required?

Significance

Does the proposed Core address the needs of the NMDR, the Metabolomics Consortium, and the greater metabolomics community? Is the scope of activities proposed for the Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the Consortium?

Investigator(s)

Are the Core Leader(s)) and other personnel well suited to their roles in the Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of relevant accomplishments? If the Core 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 Core? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational or implementation concepts? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of NMDR? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? How appropriate are the proposed work-flow and timeline? Are issues associated with clinical data and non-traditional forms of metabolomics (i.e. metabolic imaging and stable isotope data) adequately considered?

Environment

Will the institutional environment in which the Core will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Core proposed? Will the Core benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Are the computing facilities sufficient to house the data and resources required?

Significance

Does the proposed Core address the needs of the NMDR? Is the scope of activities proposed for the Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the Consortium?

Investigator(s)

Are the Core Leader(s)and other personnel well suited to their roles in the Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of relevant accomplishments? If the Core 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 Core? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel concepts? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the NMDR? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? How appropriate are the proposed work-flow and timeline?

Environment

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

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:

• 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.
• 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 National Diabetes & Digestive & Kidney Diseases Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 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, 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Definitions

NIH Metabolomics Working Group (WG): Consists of NIH programmatic staff from multiple Institutes and Centers of the NIH. This group will be primarily responsible for the stewardship of the Common Fund Metabolomics Program.

Steering Committee (SC): The SC will provide coordination activities for the Common Fund Metabolomics Program. PD(s)/PI(s) of each of the Program components and the NIH Metabolomics WG members will serve on the SC.

External Scientific Consultants (ESCs): The NIH Metabolomics WG will recruit outside experts (non-awardees) of relevance to the Metabolomics Program to provide advice to NIH. The NIH Metabolomics WG may solicit from the ESCs input on progress made by individual awardees, progress made towards the overall goals of Metabolomics Program, and any changes in scope or governance that might make the Program more effective and useful to the biomedical community.

Metabolomics Consortium: The Metabolomics Consortium will be composed of awardees from the four Common Fund Metabolomics Program initiatives, the NIH Metabolomics WG, and other scientists and groups the SC agrees to include within the Consortium. The Consortium structure is meant to enable the overall goals of the Metabolomics Program.

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

• Determining research approaches, designing protocols, setting project milestones, and ensuring scientific rigor.
• Conducting the scientific research in the project, reporting progress and milestones or objectives to NIH staff, reporting results to the scientific community, and disseminating approaches, methods, and tools broadly.
• Coordinating and cooperating with other components of the Consortium and with NIH staff to maximize impact of the Metabolomics Program and meet Program goals and objectives.
• Agreeing to the governance of the Metabolomics Consortium through the SC and the NIH Metabolomics WG, including accepting approved recommendations from the ESCs.
• Updating goals and milestones at the time of award and providing summaries of progress toward those goals at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the NIH Metabolomics WG and Project Scientists as appropriate.
• Actively participating as a voting member in the Metabolomics SC, including attending both in-person and teleconference meetings, and participating in collaborative activities and subcommittees. There will be an Annual Program Meeting, and at least one other in-person SC meeting held each year. PD(s)/PI(s) are expected to budget appropriately for travel to these meetings.
• Contributing to, adhering to, and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee. This includes, but is not limited to, policies pertaining to intellectual property, data and software release, publication of Metabolomics Consortium papers, quality control metrics, standardization, metadata requirements, and public copyright licensing that are recommended by the Metabolomics SC and approved by the NIH Metabolomics WG, as well as applicable NIH policies, laws, and regulations. This also includes protection of human subjects, where applicable.
• Ensuring that data generated by Consortium members are deposited in a timely manner in the appropriate public databases as agreed upon by the Metabolomics SC and approved by the NIH Metabolomics WG. Ensuring that software and other tools and resources developed as part of this project are made publicly available per NIH and Consortium policies, and that results of the project are published in a timely manner.
• Being prepared for any administrative site visits by NIH staff, as determined the NIH Metabolomics WG.
• Agreeing to participate in the collaborative activities of the Consortium, and agreeing not to disclose confidential information obtained from other members of the Metabolomics Consortium.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Program Officer

• A NIH Program Officer (PO) will provide the standard programmatic oversight and stewardship of the projects, including review of pre-award and award documents/requirements, review of progress reports and budgets, and any other programmatic issues that may arise.
• The PO has the option to recommend, following consultation with the NIH Metabolomics WG, the withholding or reduction of support from any project that substantially fails to achieve its goals according to the milestones agreed to at the time of the award. NIH also reserves the right to redistribute funding within the Metabolomics Common Fund Program to take advantage of unforeseen significant advances. NIH also reserves the right to withhold funding or curtail an award in the event of: (a) Substantive changes in the project; (b) failure to deposit data or reagents in accordance with approved Sharing Plans; or (c) ethical or conflict of interest issues.

NIH Project Scientist(s)

• The NIH Project Scientist will serve as the contact point for all facets of the scientific interaction with the awardee. As required for the coordination of activities and to expedite progress, NIH may designate additional NIH staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist(s) or Analyst, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.
• The NIH Project Scientist will be a full participant of the Steering Committee (see below), the Governing Board (see Governance Core) and, if applicable, subcommittees that oversee the NMDR.
• The NIH Project Scientist(s) will serve as a resource with respect to other ongoing NIH activities that may be relevant to the study to facilitate compatibility with the NIH missions and avoid unnecessary duplication of effort.
• The NIH Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of activities to address a Program goal or to review procedures for assessing data quality and repository performance.

Other NIH Program Staff

• May serve on the SC as needed to assist in developing operating guidelines and consistent policies for dealing with situations that require coordinated actions.
• Will review and approve, in consultation with the ESCs (as needed), recommendations and plans provided by the SC for collaborative activities amongst Metabolomics awardees or outside groups

Areas of Joint Responsibility include:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to develop Consortium policies and meet Program goals. The awardees, the PSs, and other designated NIH Staff will participate in the annual in-person SC meeting and scheduled conference calls and share information on data resources, methodologies, analytical tools, as well as data and preliminary results. ESCs will attend the annual in person meetings. Other government staff may attend the SC meetings as necessary.

The Metabolomics SC will have responsibilities in the following areas:

• Serving as the primary governing body of the Consortium. SC membership will include the PI(s) of each Project (limited to one vote for a Project with multiple PIs) and NIH staff appointed by the NIH Metabolomics WG (with NIH staff having only a single vote). The Metabolomics SC Chair will be selected by the SC, with NIH approval, and drawn from the individual project PIs. The Metabolomics SC may add additional, non-voting, members, as needed.
• Working with the NMDR Governing Board to oversee implementation of data repository and data sharing policies.
• Discussing important issues relevant to the general metabolomics community.
• Evaluating collaborative activities.
• Coordinating with SEPCC on the implementation of recommendations from SC, NIH, or ESC.
• Participating in subcommittees or working groups convened by SEPCC as needed to address particular issues. These subcommittees will include representatives from the Metabolomics Consortium and the NIH and possibly other experts. While these groups will be managed by SEPCC, the SC will have the overall responsibility of assessing and prioritizing the progress of the various subcommittees. It is anticipated that multiple subcommittees may need to be formed, for example, to address topics such as data sharing, promotion and outreach, and other key issues.
• The SC may choose to open Consortium membership to collaborators not funded through the Metabolomics Program, provided that such members agree to abide by policies enacted by the SC. The SC may generate additional conditions that apply to non-awardee members of the Consortium. Under direction of the SC, NIH staff and all awardees will be responsible for outreach. This includes advertising Program resources (including the web portal, data repository, data analysis tools, and protocols) to potential users in both the public and private sectors. Outreach will include providing letters of support in applications proposing to use Program-generated resources, including data from the National Metabolomics Data Repository.

External Scientific Consultants (ESCs):

• The ESCs will provide input and advice to the NIH Metabolomics WG. This could include reviewing and evaluating the progress of the entire Metabolomics Program or individual awardees as well as recommending changes in priorities for the Program based on scientific advances within and outside of the Consortium. The ESCs will be senior, scientific experts who are not directly involved in the activities of the Metabolomics Program. NIH will appoint the ESCs. The NIH Metabolomics WG and other NIH staff may attend executive meetings with the ESCs.
• The ESCs will meet at least once a year in conjunction with a meeting of the Metabolomics Consortium. The ESCs may also meet by phone or web at others times of the year, as needed.
• Annually, the ESCs will provide assessments to the NIH of the progress of the Metabolomics Consortium and will present recommendations regarding any changes in the Program as necessary. The assessments and recommendations will be provided through the Metabolomics WG to the Director of the Office of Strategic Coordination, NIH.

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 awardee. This special dispute resolution procedure does not alter the awardee'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.

When multiple years are involved, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)

Telephone: 301-945-7573

Arthur Castle, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7719
Email: [email protected]

Mark Caprara, PhD
Center for Scientific Review (CSR)
Telephone: 301-613-5228
Email: [email protected]

Todd Le
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7794
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.