SOURCES SOUGHT
A -- Metabolite Standards Synthesis Centers
- Notice Date
- 3/9/2012
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-CSB-SBSS-HV-2013-13-RSF
- Archive Date
- 4/10/2012
- Point of Contact
- Rashida S. Ferebee, Phone: 3014352605
- E-Mail Address
-
ferebeers@nhlbi.nih.gov
(ferebeers@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to this information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under NAICS code 541711 should not submit a response to this notice. Background The National Heart, Lung, and Blood Institute (NHLBI), is seeking a small business with the ability to serve as a Metabolomics Standards Synthesis Facility (SF) for the production of candidate metabolomic standards, isotopically-labeled and unlabeled, from key mammalian metabolic pathways including but not limited to such pathways as the glycolytic pathway, tricarboxylic acid cycle pathway, sterol, lipid and aminoacid metabolism pathways. The Metabolomics Standard Synthesis Facility is 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. 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. Project Requirements The Metabolomics SF shall: 1) participate in the Steering Committee (SC), and subcommittees as necessary, and attend SC meetings and participate in teleconferences, 2) provide, maintain and update a Manual of Procedures (MOP), 3) participate as a member of the Metabolomics Program committees and subcommittees, 4) attend the annual Common Fund Metabolomics Program meetings and participate in monthly teleconferences with the Common Fund Metabolomics Data Repository and Coordinating Center, 5) Develop Material Transfer Agreements (MTA) in collaboration with the Contracting Officer's Representative (COR) and other components of the Program, for use between the SF and the research investigators' institutions that are part of the Metabolomics Program, 6) Provide services as a US FDA-defined current good manufacturing practice (cGMP) production facility for candidate metabolomic standards. 7) Synthesize to ≥ 95% purity, process, analyze store, and ship products synthesized, 8) Evaluate and report to the COR the feasibility of, and approximate time required to fulfill, each request for synthesis received from the COR, 9) 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, 10) implement and maintain quality control and quality assurance plans to ensure at least 95% or greater purity for all candidate metabolomic standards requested, 11) 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, 12) develop analytical protocols to ensure metabolomic standards of uniformly high quality are shipped as requested by the COR, 13) ensure that sufficient quantities of all metabolomic standards synthesized are available to meet the needs of the Metabolomics Program, 14) design and implement monitoring plans for standards including production and compliance with regulatory requirements, 15) maintain and make available for review, as necessary, records of monitoring activities, 16) develop a tracking tool accessible to the COR of all requests and corresponding estimated costs for synthesis and distribution received, 17) participate in site visits to the synthesis facility be conducted by the Metabolomics Program, 18) maintain a laboratory that meets all requirements for the production of research grade and clinical grade reagents, 19) comply with all relevant Office of Human Research Protections (OHRP) and Office of Laboratory Animal Welfare (OLAW) regulations, 20) provide complete protocol information, including quality control and quality assurance procedures, in accordance with the MOP to the COR for each synthesized product, 21) 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, and 22) provide the Metabolomics Program with updates to metabolomics standard molecules SF portion of the MOP. Capability Statement Small business concerns that believe they possess the capabilities necessary to perform this requirement should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of similar research projects in which the organization and proposed personnel have participated, 6) documentation exhibiting ability to provide the required services outlined under Project Requirements, and 5) any other information considered relevant to this program. The capability statement must not exceed 10 single sided or 5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will not be considered. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Rashida Ferebee, Contract Specialist, at ferebebeers@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate 1-2 cost-reimbursement contracts for a period of five years with an approximate award date of July 2013. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Original Point of Contact Rashida Ferebee, Contracts Specialist, COAC Services Branch, Phone (301) 435-2605, Fax (301) 480-3338, Email: ferebeers@nhlbi.nih.gov Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6145 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-SBSS-HV-2013-13-RSF/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN02693753-W 20120311/120309235835-2c2b05959d68c3eae4ad707f347f18f2 (fbodaily.com)
- Source
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