Notice of Availability of Administrative Supplements for Collaborative Activities to Promote Metabolomics Research

Notice Number: NOT-RM-11-024

Update: The following update relating to this announcement has been issued:

• December 13, 2012 - See Issuance of PA-13-041; Collaborative Activities to Promote Metabolomics Research (Admin Supp).

Release Date: December 15, 2011
Receipt Date: March 15, 2012
Earliest Anticipated Start Date: July 1, 2012

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 Cancer Institute (NCI/NIH), (http://www.nci.nih.gov) on behalf of the NIH)

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 administrative supplement applications to provide funds to current NIH-funded research projects for new collaborations between basic or clinical researchers and metabolomics experts to pursue biomedical studies requiring a metabolomics approach that are within the scope of the peer-reviewed and approved project.

The purpose of this program is to support collaborative, multi-disciplinary basic and clinical research using metabolomics and help expand the cadre of investigators experienced in metabolomics study design, analytical methodology, and data interpretation. This funding opportunity is part of the Common Fund program Increasing Metabolomics Research Capacity . The overall goal of this Common Fund Program is to increase and improve the nation’s ability to undertake metabolomics analyses in translational and clinical research.

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). 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. These include the recent biomarkers of diabetes risk (Nat.Med.17:448-453. 2011), novel metabolites associated with cancer (Nature 462:739-44. 2009), and the discovery of over 500 unique lipids in plasma (J. Lipid Res. 51: 3299-3305. 2010).

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 metabolism and physiology. Few institutions are equipped to handle the volume of analyses required to undertake comprehensive studies and fewer still have personnel with metabolomics expertise. An investment in training 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 collaborations that exploit metabolomics approaches to move basic and clinical research towards translational goals and will increase the number of investigators cross-trained in metabolomics methodology, bioinformatics analysis, biochemistry and physiology.

The total amount of funds available for these awards is approximately $2 million for FY2012, contingent upon receiving scientifically meritorious proposals. 12-14 awards are anticipated from this solicitation.

A maximum budget of $100,000 direct costs for one year may be requested for this supplement program.

This announcement is for supplements to Research Project Grants (R00/R01/R37/U01/P01).

To be eligible:

• The parent grant funded project period must be active through July 2013 (excluding no cost extensions), and the research proposed in the supplement must be accomplished within the competitive segment.
  
• The collaborations must be new and composed of at least one biomedical research investigator and an investigator with documented capability to undertake comprehensive metabolomics analyses. Collaborators with prior history of collaboration (including publications) in the past 5 years are not eligible.
• The collaborative study must propose a large metabolomics study consistent with the general scope of the parent research grant.
• Intellectual collaboration between the PD(s)/PI(s) and the metabolomics facility personnel must be integral to the research plan. Supplements to support a fee-for-service metabolomics analysis are not eligible.
• The proposed study cannot be duplicative of any active or previously funded research topic for any of the collaboration members.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

To be considered for an administrative supplement, the request must be signed by the Authorized Organizational Representative/Signing Official (AOR/SO), and must describe the need for additional funding and the categorical costs.

Submit one original, hard copy of the request packet (with original signatures of the authorized business official) to the address listed below:

Bryan Baker
Office of Grant Administration
National Cancer Institute
6130Executive Blvd, Suite T44
Rockville MD 20852
E-mail: bb117a@nih.gov

In addition, applicants are encouraged to send an electronic copy of the submitted supplement request as an e-mail attachment in PDF format to the email listed above

Requests should be submitted on the PHS398 Application Guide forms (font size and other formatting rules apply as designated in the instructions), as indicated below. Include only the following elements:

Cover Letter which cites this Notice, and the following information:

• Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) name
• Parent grant number and title
• Amount of the requested supplement
• Name and title of the institutional official, and
• Phone, email, and address information for both the PD/PI and institutional official.
• The cover letter must be signed by the authorized organizational representative/institutional official.

PHS 398 Form Page 1 (Face page)

• The title of the project should be the title of the parent award.
• This Notice should be cited in Box 2, and the yes box should be checked.
• The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must be the same as the PI on the parent award. For Multiple PD(s)/PI(s) parent awards, the Contact PI must be the PI listed on the supplement request, and the supplement cannot change the Multiple PD(S)/PI(s) team.
• The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.

PHS 398 Form Page 2

• Note: The project summary is that of the administrative supplement, not the parent grant.

A brief proposal describing the project, including:

• Scope of the overall project and the anticipated contribution of the requested supplement (not to exceed five pages).
  • Provide a brief description of the scope of the overall project on which the supplemental request is based.
  • This section should include a description of the supplement's specific aims, including research design and methods and data analysis. Describe the relationship of the supplement request to the parent grant.
  • Description of the interactions, and anticipated information and technology exchange between the investigator and the expert metabolomics collaborator. Include information on the technology platform and method of analysis that will be used, as well as the available bioinformatics support and data storage plans.
  • Description of how the collaborative study is expected to enhance the expertise of the PD(s)/PI(s) in metabolomics.
• Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs.
  • Budget request should include travel expenses for the principal investigator and the metabolomics collaborator to attend one Common Fund Metabolomics Program meeting to be held at a domestic site.
  • Budget requests for equipment are not allowed.
• Biographical Sketch for all new key personnel (those who are additions on the supplemental project
• Human Subjects/ Vertebrate Animal documentation (if applicable).
  • Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
  • Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted.
  • When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions.
• PHS 398 Checklist Form

Resource Sharing Plan

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan that includes deposition of metabolomics data and appropriate metadata in a database identified by the NIH consistent with achieving the goals of the program. Governance of this repository will provide for appropriate proprietary period and policies.

Administrative supplement requests will be reviewed administratively by NIH Staff. Selection factors will include the following:

• Relevance of the proposed activities to the parent grant
• Integral use of metabolomics to accomplish the proposed goals
• Expertise of the research team proposed to conduct and achieve the goals the supplemental study
• Significance and likely high impact of the proposed activities to a biomedical research question
• Adequate progress on the parent grant appropriate to the current stage of the project
• Appropriate and well-described plan to accomplish the goals within the timeframe proposed
• Sample collection amenable for metabolomic analyses
• Appropriate level of power calculations and statistical analyses for an informative study
• Data sharing plan

Program Inquiries:

Inquiries and discussion of plans for responding to this Notice are strongly encouraged. Interested applicants can contact the Program Officer for the parent research grant or the Common Fund Working Group representative for this FOA listed below for questions relevant to the scientific scope of the request.

Barbara Spalholz, Ph.D.
National Cancer Institute
Telephone: 301-496-7028
E-mail: spalholb@mail.nih.gov

Grants Management Contact:

For administrative inquiries, please contact the NIH grants administrative representative listed below.

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
Telephone: 301-496-8634
E-mail: wolfreyc@mail.nih.gov