Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/).  The FOA will be administered by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (www.niddk.nih.gov) on behalf of the NIH.)

Funding Opportunity Title

Metabolomics Data Repository and Coordinating Center (DRCC) (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-RM-11-020

Companion FOA

RFA-RM-11-016 U24 Resource-Related Research Projects – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.310

FOA Purpose

The purpose of this FOA is to provide a coordinating center and data repository for the accompanying metabolomics FOAs and metabolomics research community.  One goal of the Data Repository Coordinating Center (DRCC) is to enhance metabolomics research by broadly disseminating data to researchers across the metabolomics community.  Therefore the repository will store published primary data for examination and analysis with high performance computation methods in a cloud computing environment.  It will help develop the necessary tools to allow access to data and available analytical tools. The center will also contribute to the coordination of domestic and international metabolomics efforts.

Key Dates
Posted Date

December 2, 2011

Open Date (Earliest Submission Date)

January 15, 2012

Letter of Intent Due Date

January 15, 2012

Application Due Date(s)

February 15, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 2012

Expiration Date

February 16, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance 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.

Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Purpose

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.

This funding opportunity announcement (FOA) solicits applications for the Metabolomics Data Repository and Coordinating Center (DRCC) to advance metabolomics research by facilitating data sharing and communication among Regional Comprehensive Metabolomics Resource Cores (RCMRCs).  Both the DRCC and RCMRCs are components of the Common Fund Metabolomics Program (www.commonfund.nih.gov/metabolomics).  This program's overall goal is to increase metabolomics research capacity in the United States by supporting infrastructure expansion, metabolomics training, technology development and reference standards synthesis.  The data repository will collect and share metabolomics data generated from the RCMRCs and allow data deposition and access from other national and international efforts.  The coordinating center will integrate activities across the RCMRCs and other appropriate components of the Common Fund Metabolomics Program.  The DRCC will also interact with related national and international activities to further the goal of enhancing the use of metabolomics approaches in translational research.

Background

Metabolomics is the study of low molecular weight molecules or metabolites found within cells and biological systems and the metabolome is a measure of the functional output of biological pathways.  Metabolites are conserved across various animal species, facilitating the extrapolation of research findings in laboratory animals to humans and thus clinical and translational research.  Common technologies for measuring the metabolome include mass spectrometry (MS) and nuclear magnetic resonance spectroscopy (NMR), which can measure hundreds to thousands of unique chemical entities (UCE). 

Metabolomics analysis often involves identification of UCEs based on their spectrometric, spectrographic or chromatographic properties.  Biological interpretation of metabolomics data is based on these identifications which are subject to multiple sources of error.  In order to effectively advance metabolomics it is necessary to be able to objectively evaluate reported UCEs by examining the primary data used to make the identification.  These primary data include the spectrometric, spectrographic, and chromatographic traces and the relevant associated metadata.  The storage and use of these data will benefit from coordination among the RCMRCs and similar national and international efforts.

Requirements of the DRCC

Data Repository

The successful applicant will provide a plan to store primary metabolomics data and at a minimum the meta-data necessary to interpret these data.  These data will include spectrometric, spectrographic and chromatographic information and the interpreted UCEs and quantitative values where appropriate.  The allowable formats and minimal criteria for deposition will be determined by the Executive Committee (see Governance Structure below). This information will be collected and made publicly available for the purpose of better defining the human metabolome in normal and disease cases and improving the quality and reproducibility of metabolomics research. The applicant is expected to have demonstrated ability to implement his/her plan early in the project period.  Ideally, the repository should be able to accept 1 terra byte of data within the first year of funding.  Therefore, it is expected that a successful applicant should be able to demonstrate current database capability for the use of metabolomics data.  It is expected that data storage will be within a 5 to 50 terra byte range by the end of the project period and applicant plans should account for this scale up capacity.  The applicant will work closely with the Executive Committee to develop priorities and standards for the storage and retrieval of metabolomics data.  Functionality should include public access to individual data sets through a web portal and the ability for researchers to submit published data sets that meet appropriate quality criteria.

Metabolomics data sets can come in many formats and the applicant is expected to establish data standards and common data elements with the guidance of the Executive Committee.  The applicant should have a data management plan that provides free access for typical research use and minimizes costs for large scale downloads or database replication by third parties.  The RCMRCs are expected to have their own laboratory information management systems (LIMS) and analysis capability.  The DRCC is expected to provide the application protocol interfaces (API) for data transfer for uploading and downloading data, connectivity to national and international relevant metabolomics resources and to develop APIs to common use analytical platforms in consultation with the Executive Committee. In addition, the data repository should assist in coordinating and developing tools for common use by the regional cores.

Cloud Computing

The collection and storage of publicly available metabolomics data are expected to persist beyond the project period for this announcement.  In addition the database 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 metabolomics 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.  In order to meet these requirements the database 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 database should be driven by functional requirements and cost analysis.

Coordinating Center

Integral to the success of the Common Fund Metabolomics Program are communication and interaction between program participants and participants of the various complementary national and international activities.  The coordinating center, in conjunction with NIH staff, will organize an annual Common Fund Metabolomics Program meeting that will include participants from all components of the program, the Executive Committee and the External Evaluation Committee (see Governance Structure).  In addition the coordinating center will facilitate interactions among the RCMRCs by convening monthly conference calls and semiannual meetings between NIH staff and the Executive Committee. These regular meetings should include development of standards and policies for the data repository, coordination of collaborative projects among cores and external investigators, and outreach to the national and international metabolomics community. The cost of holding these meetings should be included in the budget requests.

Research and Development

The primary function of the data repository and coordinating center is to store published primary research data and help facilitate the collaboration among cores and the external community.  It is expected that some informatics tool development or adaptation will be needed to accomplish these goals.  The applicant should develop a plan for pilot and feasibility studies to develop high priority APIs to facilitate these tasks and to assist in the development of tools that are a high priority of the Executive Committee for use by RCMRCs and the general metabolomics community.  These tools should leverage other national and international metabolomics databases including relevant chemical, spectrometric and spectrographic resources.

Governance Structure

In order to facilitate the management of the Data Repository and Coordinating Center two administrative bodies will be created, the Executive Committee (EC) and the External Evaluation Committee (EEC).

The EC will consist of the PD(s)/PI(s)of the DRCC and the PD(s)/PI(s) of each RCMRC, and the NIH Project Scientists for each RCMRC and the DRCC.  The DRCC and each RCMRC PD/PI will be voting members.  The NIH will have one vote on the EC.  The chair of the EC will be selected by the EC membership with the approval of NIH staff.  The EC will be the principal governing body of the DRCC.  The purpose of the EC will be to develop data repository policy, including data sharing requirements for the associated Common Fund Metabolomics Program awards.  The EC will also evaluate operational concerns of each core facility, discuss important issues relevant to the general metabolomics community, help with the planning of major events (semi and annual meeting etc.), evaluate collaborative activities, and provide feedback to the NIH Program Staff.  The EC will also discuss implementation of recommendations or suggestions from the NIH or the EEC and then plan a timely implementation strategy.

The EEC will help the NIH staff in its task of administering this award.  It will be composed of 5-7 highly-regarded scientists, selected by NIH, who will provide oversight and recommendations regarding ongoing activities and future directions of the Metabolomics DRCC to the NIH.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The total amount of funds available for this award is approximately $6 million for FY2012-2016, contingent upon receiving scientifically meritorious applications. One award is anticipated from this solicitation.

Award Budget

Total costs for FY2012 shall not exceed 2 million and total costs shall not exceed 1 million per year for FY2013-2016. It is anticipated that start up costs for up-scaling database capabilities in the first year will exceed out year costs.

Award Project Period

The total project period for applications submitted in response to this FOA may not exceed 5 years..

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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/PI) 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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Letter of Intent

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:

The letter of intent should be sent to:

Arthur L. Castle, Ph.D.
Program Director, Metabolomics and Informatics
National Institute of Diabetes & Digestive & Kidney Diseases
National Institutes of Health
6707 Democracy Blvd, Room 791, MSC 5460
Bethesda, Maryland  20892-5460
(fed ex 20817)
Phone: 301-594-7719
FAX: 301-480-0475
castlea@niddk.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:.

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) 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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115..

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the approach be able to rapidly provide the minimal functionality of the data repository, ideally, within the first year of funding?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Does the institution have the resources to rapidly provide a functional data repository, ideally, within the first year of funding?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable.

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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


As part of the scientific peer review, all applications:

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 appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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.

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

The grant application must also include a statement indicating the applicant’s willingness to abide by the Cooperative Agreement Terms and Conditions of the Award.

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

The NIH Project Scientist will serve as the contact point for all facets of the scientific interaction with the awardee (s). 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 Executive Committee (see Governance Structure) and, if applicable, subcommittees that oversee the DRCC.

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 a common research activity or in reviewing procedures for assessing data quality and study performance monitoring.

In addition, a separate NIH Program Official identified in the Notice of Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions.  Additional responsibilities include interacting with the principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Executive Committee and related meetings. The NIH retains, as an option, periodic review of progress by researchers not involved with the study. The NIH Program Official will review and approve protocols prior to implementation to insure they are within the scope of peer review. The NIH will not permit further expenditures of NIH funds for a study after requesting closure except as specifically approved by NIH. The NIH Program Official will make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Executive Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements. 

In addition, the NIH will:

Upon award the NIH will convene an initial "kick-off" meeting with the Executive Committee (DRCC and the RCMRC PD(s)/PI(s)) at which a series of milestones will be developed along with timelines for their completion. The chair of the Executive Committee will be selected by the Executive Committee membership with the approval of NIH staff. PD(s)/PI(s) are responsible for the travel costs associated with this meeting

Constitute an External Evaluation Committee which will meet periodically with the Awardees and NIH Staff to help evaluate progress against agreed upon milestones. The PD(s)/PI(s) of the Data Repository Coordinating Center must indicate a commitment to be responsive to recommendations provided by an independent External Evaluation Committee (EEC). The EEC will meet annually (coinciding with the annual Common Fund Metabolomics Program meeting) to review interim progress and will provide an annual report and recommendations to NIH and to the Executive Committee on consortium activities. The Data Repository Coordinating Center Executive Committee will be responsible for organizing and providing minutes of these meetings. Members of the EEC will be nominated by the Data Repository Coordinating Center Executive Committee, selected and invited by the NIH. A chairman will be chosen from among the EEC membership, who will be accomplished senior scientists from academia and industry with backgrounds in the mission of NIH and metabolomics and technologies associated with web portal and database development and function, software use and development, and concepts of large scale data handling and analysis. If voting is necessary for an action item, members of the EEC and the EEC chair hold one vote each. The Executive Committee will discuss implementation of EEC recommendations, and provide a timeline and action plan for making changes in a timely fashion. The action plan will be reported to the EEC.

Areas of Joint Responsibility include:

The annual Common Fund Metabolomics Program meeting shall be in person meetings, jointly organized by the Awardees and the NIH. The EEC will be in attendance at this meeting.

All other responsibilities are divided between awardees and NIH staff as described above.

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 Executive 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.

Transfer of Data Repository and Core Functions:

The development and management of this data repository is a stewardship that shall be subject to transfer at the end of the project period. Therefore, the data and core functions of the database shall be cloud compatible and use publicly available software.  Any proprietary tools must be able to be decoupled from core functions of the database or be made publically available so stewardship of the repository can be transferred.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Arthur L. Castle, Ph.D.
Program Director, Metabolomics and Informatics
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
6707 Democracy Blvd, Room 791, MSC 5460
Bethesda, Maryland  20892-5460 (20817 for express mail)
Phone: 301-594-7719
E-mail: castlea@niddk.nih.gov

Peer Review Contact(s)

J. Thomas Peterson, Ph.D.
Chief - Bioengineering Sciences and Technologies
Center for Scientific Review
6701 Rockledge Drive, MSC 7849, Room 5170
Bethesda, MD 20892-7814 (20817 for Express mail)
Telephone: 301-408-9694
E-mail: petersonjt@csr.nih.gov

Financial/Grants Management Contact(s)

Christina Coriz
Grants Management Specialist
Grants Management Branch
Division of Extramural Affairs
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
6707 Democracy Blvd, Room 709B, MSC 5456
Bethesda, MD 20892-5456 (express zip: 20817)
Telephone: 301-594-8848
Fax: 301-594-9523
Email: corizc@niddk.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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