Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance tall 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 Funding Opportunity Announcement (FOA) 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 FOA is specifically part of the Common Fund Metabolomics Program, the overall goal of which is to increase and improve the nation’s ability to undertake metabolomics analyses in translational and clinical research.

Metabolomics has great potential to advance our understanding of human diseases, but requires specialized expertise in metabolomics study design, technology, and data analysis and interpretation. This initiative supports supplemental funds to current NIH-funded research projects for new interactive collaborations between basic or clinical researchers and metabolomics experts to pursue biomedical studies requiring a metabolomics approach and increase metabolomics expertise in the biomedical research community.

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 (NMR) spectroscopy, which can measure hundreds to thousands of unique chemical entities.  Metabolomic profiling in basic, epidemiological, clinical and translational studies has revealed potential new biomarkers of disease and therapeutic outcome and led to novel mechanistic understanding of pathogenesis.  

Comprehensive, high quality metabolomics investigations require access to specialized equipment and highly trained personnel with expertise in bioinformatics, biochemistry, physiology, and spectrometry. Proper metabolomics study design, particularly for studies involving clinical samples, is critical for translationally relevant outcomes, and interpretation of metabolomics results requires an in-depth understanding of metabolism and physiology.  Few institutions are equipped to handle the intricacy of analyses required to undertake comprehensive studies and fewer still have personnel with metabolomics expertise. An investment in enhancing the expertise of investigators in the disciplines required to undertake metabolomics analyses is expected to help increase the capacity to apply this powerful approach to translational questions. This initiative will support new highly interactive collaborations that exploit metabolomics approaches to move basic and clinical research towards translational goals. In doing so, it will also increase the number of investigators cross-trained in metabolomics, methodology, bioinformatics analysis, biochemistry, and physiology.

Fee-for-service only arrangements where samples are analyzed without an extensive interactive collaboration are not eligible as they will not increase the pool of investigators with direct experience in metabolomics analysis. Similarly, groups which have collaborated before in the area of metabolomics are only eligible if this project expands the collaboration to involve new areas of metabolomics, as this opportunity is intended to enhance the expertise of the biomedical investigator in metabolomics.

• The collaborations must be composed of at least one biomedical research investigator and at least one investigator with documented experience in comprehensive metabolomics analyses.
• Collaborative projects must be distinct from previous collaborations between the investigators in order to enhance the expertise of the biomedical investigator in metabolomics.
• The collaborative study must propose a metabolomics study consistent with the general scope of the parent research grant. Analysis of a small number of known metabolites will not be considered for funding. Pilot projects in preparation for an extensive study are appropriate.
• Interactive collaboration between the biomedical researcher and the metabolomics personnel must be integral to the research plan so as to increase the metabolomics expertise of the biomedical researcher.
• Fee-for-service only arrangements where samples are analyzed without an extensive interactive collaboration will not be considered for funding as they will not increase the pool of investigators with direct experience in metabolomics analysis.
• The proposed study cannot be duplicative of any active or previously funded research for any of the collaboration members.
• The PD/PI or metabolomics collaborator must be available to attend the annual Common Fund Metabolomics Program meeting, which will be held domestically.

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.

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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
• 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)

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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.

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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 is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.

Only one application per parent award is allowed

Since applications to this announcement will only receive administrative review by the awarding Institute or Center, and will not receive a peer review, the NIH policy on resubmissions will not apply. However, applications not accepted by the Institute or Center for review, or not funded by the Institute or Center, should not be submitted again without contacting the scientific contact from the awarding Institute or Center to discuss issues raised in the first submission.

Applicants must prepare applications using current forms in accordance with the Application Guide.

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements 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.

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• The Research Strategy (including details of the collaboration) should not exceed 6 pages.

Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

Instructions for Electronic Application Submission through Grants.gov

Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

• R&R Cover form: Select Revision in the Type of Application field.
• Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities, with the exception of Specific Aims which are not required and will not be evaluated.
  • The Research Strategy should address, in separate sections, the bulleted items below:
    • Describe the scope of the overall project on which the supplemental request is based.
    • Describe the rationale for adding the proposed metabolomics component and how this activity will benefit achieving the goal of the parent grant.
    • Describe the supplement's metabolomics research design, methods, and expected outcomes. Include information on the technology platform. Describe methods that will be used for data analysis, interpretation, and integration with other biological or clinical data, as well as the available bioinformatics support and data storage plans. Applicants proposing work in vertebrate animals must include the number and sex of the animals to be used. Applicants are encouraged to incorporate sex into their analyses when scientifically appropriate and feasible.
    • Describe the interactions between collaborators, anticipated information and technology exchange, and how the collaborative study is expected to enhance the expertise of the biomedical collaborator in metabolomics and analysis of metabolomics data. If the parent grant already contains metabolomics analyses, the application must clearly state the added value of the new collaboration and how the new collaboration will meet the goals of increasing metabolomics knowledge and expertise in the biomedical research community. If there is a history of prior collaboration using metabolomics between the components, the application must address how the proposed collaboration is distinct from previous collaborative projects and would expose the biomedical investigator to a substantially different sub-field of metabolomics.
    • Describe any technical or conceptual innovations central to this application
  • Letters of Support: All applicants should include a letter from the metabolomics collaborator that briefly describes his/her commitment to the project and lists his/her active research grant support, including the annual direct costs. The letter should be countersigned by the authorized organizational representative/institutional official of the collaborators institution.
  • Resource Sharing Plans: All applications, regardless of the amount of direct costs requested for any one year, are expected to include a Data Sharing Plan that includes deposition of metabolomics data and appropriate metadata in the Common Fund Metabolomics Program Data Repository and Coordinating Center (DRCC). Governance of this repository will provide for appropriate proprietary period and policies. For more information about the NIH Common Fund Metabolomics Data Sharing Plan, see http://www.metabolomicsworkbench.org/nihmetabolomics/datasharing.html.
• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each. Clearly identify the collaborator serving as the metabolomics expert.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities. Include travel budget for the biomedical researcher or metabolomics collaborator to attend the annual Common Fund Metabolomics Program meeting, held domestically. Do not include travel to additional scientific meetings, except where vital to establish or maintain collaboration. Budgets should not include equipment, service contracts, or publication costs. Provide justification that details the items requested.
• R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available, with the following additional guidance:

• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period. Include travel budget for the biomedical researcher or metabolomics collaborator to attend the annual Common Fund Metabolomics Program meeting, held domestically. Do not include travel to additional scientific meetings, except where vital to establish or maintain collaboration. Budgets should not include equipment, service contracts, or publication costs. Provide justification that details the items requested.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the Add Other Attachments function to include the following PDF documents:
  • Research Strategy including a summary or abstract of the funded parent award or project. The research strategy should address, in separate sections, the bulleted items below.
    • Describe the scope of the overall project on which the supplemental request is based.
    • Describe the rationale for adding the proposed metabolomics component and how this activity will benefit achieving the goal of the parent grant.
    • Describe the supplement's metabolomics research design, methods, and expected outcomes. Include information on the technology platform. Describe methods that will be used for data analysis, interpretation, and integration with other biological or clinical data, as well as the available bioinformatics support and data storage plans. Applicants proposing work in vertebrate animals must include the number and sex of the animals to be used. Applicants are encouraged to incorporate sex into their analyses when scientifically appropriate and feasible.
    • Describe the interactions between collaborators, anticipated information and technology exchange, and how the collaborative study is expected to enhance the expertise of the biomedical collaborator in metabolomics and analysis of metabolomics data. If the parent grant already contains metabolomics analyses, the application must clearly state the added value of the new collaboration and how the new collaboration will meet the goals of increasing metabolomics knowledge and expertise in the biomedical research community. If there is a history of prior collaboration using metabolomics between the components, the application must address how the proposed collaboration is distinct from previous collaborative projects and would expose the biomedical investigator to a substantially different sub-field of metabolomics.
    • Describe any technical or conceptual innovations central to this application.
  • A specific aims section is not required and will not be evaluated.
  • If applicable, attach documents indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.
  • All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan that includes deposition of metabolomics data and appropriate metadata in the Common Fund Metabolomics Program Data Repository and Coordinating Center (DRCC). Governance of this repository will provide for appropriate proprietary period and policies. For more information about the NIH Common Fund Metabolomics Data Sharing Plan, see http://www.metabolomicsworkbench.org/nihmetabolomics/datasharing.html.
  • All applications should include a letter from the metabolomics collaborator that briefly describes his/her commitment to the project and lists his/her active research grant support, including the annual direct costs. The letter should be countersigned by the authorized organizational representative/institutional official of the collaborators institution.

Instructions for Paper-based Submissions using the PHS 398 Application Forms

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:

• Checklist: Select Revision in the Type of Application field.
• Face Page (Form Page 1): On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.
• Research Plan: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities, with the exception of Specific Aims which are not required and will not be evaluated.
  • Research Strategy: The research strategy should address, in separate sections, the bulleted items below.
    • Describe the scope of the overall project on which the supplemental request is based.
    • Describe the rationale for adding the proposed metabolomics component and how this activity will benefit achieving the goal of the parent grant.
    • Describe the supplement's metabolomics research design, methods, and expected outcomes. Include information on the technology platform. Describe methods that will be used for data analysis, interpretation, and integration with other biological or clinical data, as well as the available bioinformatics support and data storage plans. Applicants proposing work in vertebrate animals must include the number and sex of the animals to be used. Applicants are encouraged to incorporate sex into their analyses when scientifically appropriate and feasible.
    • Describe the interactions between collaborators, anticipated information and technology exchange, and how the collaborative study is expected to enhance the expertise of the biomedical collaborator in metabolomics and analysis of metabolomics data. If the parent grant already contains metabolomics analyses, the application must clearly state the added value of the new collaboration and how the new collaboration will meet the goals of increasing metabolomics knowledge and expertise in the biomedical research community. If there is a history of prior collaboration using metabolomics between the components, the application must address how the proposed collaboration is distinct from previous collaborative projects and would expose the biomedical investigator to a substantially different sub-field of metabolomics.
    • Describe any technical or conceptual innovations central to this application.
  • Letters of Support: All applicants should include a letter from the metabolomics collaborator that briefly describes his/her commitment to the project and lists his/her active research grant support, including the annual direct costs. The letter should be countersigned by the authorized organizational representative/institutional official of the collaborators institution.
  • Resource Sharing Plans: All applications, regardless of the amount of direct costs requested for any one year, are expected to include a Data Sharing Plan that includes deposition of metabolomics data and appropriate metadata in the Common Fund Metabolomics Program Data Repository and Coordinating Center (DRCC). Governance of this repository will provide for appropriate proprietary period and policies. For more information about the NIH Common Fund Metabolomics Data Sharing Plan, see http://www.metabolomicsworkbench.org/nihmetabolomics/datasharing.html.
• Project/Performance Sites section (Form Page 2): Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each. Clearly identify the collaborator serving as the metabolomics expert.
• Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities. Include travel budget for the biomedical researcher or metabolomics collaborator to attend the annual Common Fund Metabolomics Program meeting, held domestically. Do not include travel to additional scientific meetings, except where vital to establish or maintain collaboration. Budgets should not include equipment, service contracts, or publication costs. Provide justification that details the items requested.
• If applicable, attach documentation in the Appendix section indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

Dawn M. Mitchum
Office of Grants Administration
National Cancer Institute, NIH
9609 Medical Center Drive
West Tower, 2W464
Rockville MD, 20850-9710
Telephone: 240-276-5699
Email: [email protected]

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit electronic applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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 using the instructions specified above.

Applicants must complete all required registrations prior to submission. 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.

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(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 (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

• NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:
• Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
• Is the use of metabolomics integral to accomplish the proposed goals?
• Does the collaborative team have documented expertise in metabolomics to conduct and achieve the goals of the supplemental study?
• Are the analytical platforms appropriate for the supplement goals and is the metabolomics study design well-rationalized?
• Is the sample collection for the study appropriate for metabolomics analyses?
• Are power calculations and statistical analyses appropriate for an informative study?
• Is there an appropriate plan for data analysis, interpretation, and integration with other biological or clinical data?
• Will the proposed activities enhance metabolomics knowledge of the biomedical investigator leading to increased metabolomics expertise in the biomedical research community?

Other Selection Factors

• Is the requested timeframe adequate to accomplish scientific goals and enhance the expertise of the biomedical researcher in metabolomics research?
• Is there an adequate Data Sharing Plan, including deposition of data in the Common Fund Metabolomics Program Data Repository and Coordinating Center (DRCC), to meet the goals of the program?
• Is there adequate progress on the parent grant appropriate to the current stage of the project? Is there a current estimated unobligated balance?
• While not criteria for exclusion, the review panel will consider whether the biomedical investigator or metabolomics collaborator has submitted additional applications in response to this FOA that are currently being considered for funding, and whether the biomedical investigator has received an award in previous years through this Metabolomics Administrative Supplement program

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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 project 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.

NIH staff 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 tthe Worksheet for Review of the Vertebrate Animal Section.

NIH staff 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.

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required 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.

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

eRA Commons Help Desk (Questions regarding 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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Keren Witkin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6230
Email: [email protected]

Not Applicable

Dawn M. Mitchum, MPH, CRA
National Cancer Institute (NCI)
Telephone: 240-276-5699
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.