SOURCES SOUGHT
A -- NIMH Chemical Synthesis and Drug Supply Program
- Notice Date
- 7/19/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, MD, 20892-9661, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-SS-NIMH-70009
- Response Due
- 8/10/2007
- Archive Date
- 8/25/2007
- Description
- The National Institute of Mental Health (NIMH) is seeking information on all sources capable of providing contract services to continue the NIMH Chemical Synthesis and Drug Supply Program (CSDSP). The goal of the CSDSP is to synthesize and distribute novel or otherwise difficult-to-obtain psychoactive compounds to the scientific community to stimulate basic and clinical research in mental health. The program provides for the synthesis of ligands for CNS receptors, radiolabeled compounds for autoradiography and neuroimaging, biochemical markers, drug analogs and metabolites, and reference standards, as well as cGMP synthesis of promising compounds for clinical studies. Synthesis projects may also include medicinal chemistry tasks to optimize promising compounds for use as research tools or for clinical applications. The CSDSP Inventory of approximately 400 compounds serves as a repository for the compounds produced and allows for quick distribution of these compounds upon request. The program also distributes plated sets of inventory compounds. Capable sources must be able to provide: (1) Non-GMP synthesis of compounds which may include new drugs, imaging precursors, analogs, metabolites, neuropeptides, small molecules, radiolabeled compounds, analytical standards, synthetic intermediates, probes, and any related compounds; (2) cGMP synthesis of compounds and the preparation analytical results in a format suitable for inclusion in and Investigation New Drug (IND) or NDA Chemistry and Manufacturing section; (3) limited medicinal chemistry optimization of lead compounds; (4) maintenance and distribution of the compounds in the NIMH Chemical Synthesis and Drug Supply Program Inventory; and (5) creation and distribution of small, plated compound arrays. Based upon historical data, the projected annual workload is: (1) 30 non-GMP syntheses; (2) 3 GMP syntheses; (3) 1 medicinal chemistry project; (4) 100 shipments of inventory compounds; and (5) array and distribute 25-50 copies of plated compound sets. This workload is variable from year to year, and the actual volume could range up to 50% higher or lower than these estimates. The NIMH Chemical Synthesis and Drug Supply Program currently operates under a Determination of Exceptional Circumstances (DEC), which allows a deviation from the standard Patent Rights clause in FAR 52.227-14 to ensure the confidentiality and protect the intellectual property and patent rights of an investigator or party supplying a proprietary sample or composition of matter for synthesis through the program. It is the intention of the Government to seek a continuation of that DEC to allow use the deviation in the currently proposed requirement. Any business or organization that believes it has the capability to fulfill this requirement should submit a brief narrative response (no more than 5-10 pages, single-spaced), indicating previous experience and capabilities related to each of the above task areas. Capability Statements should clearly state/describe: (1) the offerors experience and qualifications to perform this work; (2) description of the resources, equipment, available to perform this work; and (3) your type of business or organization, including: (a) size (number of employees); (b) management structure and history of your organization; and (c) your eligibility under 8(a) or other set-aside programs, as applicable (NIACS Code 541710, 500 employees). PLEASE BE ADVISED THAT NO SOLICITATION IS AVAILABLE AT THIS TIME; THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT, NOW OR IN THE FUTURE. NO RECEIPT NOTICE WILL BE SENT TO THE SUBMITTER OF A CAPABILITY STATEMENT OR EVALUATION PROVIDED OF ANY RESPECTIVE CAPABILITY STATEMENT RECEIVED.
- Record
- SN01346662-W 20070721/070720001045 (fbodaily.com)
- Source
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