Metabolite Standards Synthesis Centers

The National Heart, Lung, and Blood Institute is seeking an organization with the ability to serve as a Metabolomics Standards Synthesis Facility (SF). The Metabolomics Standard Synthesis Facility will be a component of the National Institutes of Health (NIH) Common Fund, Metabolomics Program. 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 acquisition will be competed under full and open competition. It is anticipated that one or more award(s) will be made by July 2013 for a base period of one year with four (4) one year option periods. Metabolomics is the study of low molecular weight molecules or metabolites found within cells and biological systems. It involves technologies, such as mass spectrometry and nuclear magnetic resonance spectroscopy which can measure hundreds to thousands of unique chemical entities. The metabolome is a measure of the output of biological pathways and is the most integrated measure of a cell's functional state and thus presents a powerful platform for discerning mechanistic information on different normal and disease states. Despite early promise, challenges remain before the full potential of metabolomics can be realized for translational research. One of the challenges identified was the lack of authentic standards to help in identification, coverage as well as quantitative and qualitative validation of metabolomic findings. The Metabolomics Standards Synthesis Facility (SF) will support the activities of the NIH Common Fund Metabolomics Program and provide services as a US FDA-defined current good manufacturing practice (cGMP) production facility for candidate metabolomic standards. One or more award (s) is anticipated under a Request for Proposal (RFP). The Metabolomics SF shall: Wihin the first 45 calendar days, develop and deliver a Comprehensive Program Summary and Timetable (i.e. Gantt chart) that summarizes the key activities and deliverables,with milestones, for the entire program. Use a separate chart for each contract year. 1. Participate as a member of the Metabolomics Program committees and subcommittees as necessary, which will provide overall guidance to achieve program objectives. Attend the annual Common Fund Metabolomics Program meetings and participate in monthly teleconferences with the Common Fund Metabolomics Data Repository and Coordinating Center as outlined in the chart. Further, participate in a monthly teleconference with the COR to discuss synthesis specific issues. 2. Develop a manual of procedures (MOP) to describe the methodologies to be employed and amendments for the synthesis of requested metabolite standards. The MOP shall conform to US FDA cGMP guidelines as well as Good Laboratory Practices (GLP) guidelines and include procedures for production of candidate metabolomic standards. Provide the Metabolomics Program with updates to metabolomics standard molecules SF portion of the MOP. 3. Collaborate with the COR to document and record all requests for metabolomics standard synthesis and their current status in production. 4. Develop Material Transfer Agreements (MTA) in collaboration with the COR and other components of the Program, for use between the SF and the research investigator's institution that are part of the Metabolomics Program. 5. Provide services as a US FDA-defined current good manufacturing practice (cGMP) production facility for candidate metabolomic standards. 6. Synthesize to ? 95% purity, process, analyze, store, and ship products synthesized. 7. Evaluate and report to the COR the feasibility of, and approximate time required to fulfill each request for synthesis received from the COR. 8. Collaborate with the COR and Metabolomics Program to contribute synthesized product data to its electronic databases and web sites. Submit data as defined and called for in the MOP. 9. Implement and maintain quality control and quality assurance plans to ensure at least 95% or greater purity for all candidate metabolomic standards requested. Have the ability to perform analysis of chemical purity and propose a plan to monitor stability of the standards, detailing a recommended method and frequency of analysis. Synthesis shall be repeated as needed until the yield; procedures and purity are well established. Analytical protocols shall be developed to ensure metabolomic standards of uniformly high quality are synthesized and shipped as requested by the COR. 10. Contractor shall ensure that sufficient quantities of all metabolomic standards synthesized are available to meet the needs of the Metabolomics Program. 11. Design and implement monitoring plans for standards, including production and compliance with regulatory requirements. Maintain and make available for review, as necessary, records of monitoring activities. 12. Develop a tracking tool, accessible to the COR, of all requests received and corresponding estimated costs for synthesis and distribution. 13. Provide reports as described in Article C.2. Make available, for site visits, documents and data to support these reports, as requested by the Metabolomics Program. 14. Participate in site visits to the synthesis facility to be conducted by the Metabolomics Program. 15. In the event that quality control/assurance issues arise with the synthesis, purity, storage, or handling of compounds under the NIH contract, the Contractor shall cooperate fully with the COR to resolve the issues, if necessary repeating one or more steps in the synthesis protocol or repurifying the compound at no additional monetary cost to the contract. In the event that compound quality control or assurance issues cannot be resolved between the Contractor and COR, a scientific advisory group chosen by the COR and the Metabolomics Program shall be asked to review the synthesis, analysis, purification, storage, and handling protocols of the compound(s) in question and make recommendations to resolve the issues. 16. Maintain a laboratory that meets all requirements for the production of research grade and clinical grade reagents. 17. Provide complete protocol information, including quality control and quality assurance procedures, in accordance with the MOP to the COR for each synthesized product and also track amount of product remaining. 18. Establish and implement a plan to work with institutional technical transfer offices to facilitate the completion of material transfer agreements and contracts required to ship materials from one institution to another. 19. Outline transition and closeout activities in collaboration with the Metabolomics Program staff. This is not a request for proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about 15 calendar days from the date of this notice. All responsible sources may submit a proposal which shall business considered by the NHLBI. No paper copies will be available. Offerors are responsible for downloading their own copy of the solicitation and for routinely checking the FBO website for any possible solicitation amendments that may be issued by the government. Original Point of Contact Rashida Ferebee, Contracting Officer, CSB Contracts Branch, Phone +1 (555) 000-0000, Fax +1 (555) 000-0000, Email: contact@example.gov Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions 6701 Rockledge Dr RKL2/6145 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES