SOURCES SOUGHT
A -- NIMH Chemical Synthesis and Drug Supply Program (CSDSP)
- Notice Date
- 5/13/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- 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, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-NIDA(MH)-SBSS-13-037
- Point of Contact
- Khaled M. Gohar, Phone: 3014432848, Bruce E. Anderson, Phone: 301-443-2234
- E-Mail Address
-
Khaled.gohar@nih.gov, banderso@mail.nih.gov
(Khaled.gohar@nih.gov, banderso@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This notice is a repost of Sources Sought notice for solicitation no. HHS-NIH-DA-SBSS-13-267. 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) the classification/ type of small business (e.g., whether they are small businesses, 8(a) small businesses, HubZone small businesses, service-disabled veteran-owned small businesses, veteran-owned small business, economically disadvantaged women-owned small business (EDWOSB) or women-owned small business (WOSB)) and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the 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 the applicable NAICS code should not submit a response to this notice. Teaming and partnering arrangements among small businesses is encouraged. A. Background: This initiative is part of the Molecular, Cellular, and Genomic Neuroscience Research Branch (MCGNRB), National Institute of Mental Health (NIMH). The mission of the MCGNRB is to support fundamental research on the mechanisms underlying and influencing brain development, neuronal signaling, synaptic plasticity, signal transduction pathways, and the biochemical and behavioral actions of therapeutic agents in animals and humans. The goals of the MCGNRB include the identification of novel targets (genes or molecules) for therapeutic intervention, characterization of the neurobiological behavioral actions of psychoactive agents, and design and development of novel ligands for functional brain imaging in humans, psychoactive agents for basic and clinical research, and potential therapeutic agents for the treatment of mental disorders. B. Purpose and Objectives: The National Institute of Mental Health (NIMH) is seeking information on all small businesses capable of providing chemical synthesis and compound inventory maintenance and distribution services to continue a project entitled, "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. Synthetic 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 450 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. The purpose of this initiative is to continue current contract services 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. C. Project requirements: The CSDSP was developed to provide access to pharmacologic research tools to support neuroscience and mental health research. Interested small businesses must demonstrate they currently have the necessary expertise and capability to (1) maintain and distribute a compound collection of over 450 compounds, including radiolabeled (generally tritiated) compounds, (2) conduct non-GMP synthesis of a wide variety of compounds of interest to the neuroscience research community, (3) conduct cGMP synthesis of compounds for use in clinical studies, (4) conduct medicinal chemistry optimization of lead compounds for new therapeutics development, and (5) create and distribute small molecule plated compound sets. The estimated annual workload is: (a) 3-5 non-GMP syntheses (but could range from 1-10) (b) 1 GMP syntheses (but could range from 2-4) (c) 1 medicinal chemistry project (but could range from 1-3) (d) 100 shipments of inventory compounds (but could range from 50-150) The current inventory for the CSDSP can be found at: http://nimh-repository.rti.org/. D. Anticipated period of performance: The estimated period of performance is January 30, 2014 - January 29, 2019 E. Other Important Considerations: The Contractor shall use Good Laboratory Practices (GLP) to conduct all aspects of the contract. The contractor shall have the ability to conduct synthesis under Good Manufacturing Practices (GMP) to produce compounds suitable for clinical use. F. Capability statement/information sought: Any small business or organization that believes it has the capability to fulfill this requirement should submit a narrative response indicating previous experience and capabilities related to this work. Capability Statements should clearly state/describe your ability to carry out the services above, including: 1) Information regarding your:(a) staff expertise, including their availability, experience, and formal and other training; (b) organizational experience and qualifications to perform this work, including the laboratory capacity to meet or exceed the estimated workload; 2) Respondent's DUNS number, organization name, address, point of contact, and size and type of business (e.g.,8(a), HUB Zone, etc) pursuant to the applicable NAICS code; NOTE: THE APPLICABLE NAICS CODE FOR THIS REQUIREMENT IS 541711, 500 EMPLOYEES); 3) Information on the management structure and history of your organization; and 4) Any other resources available to perform this work. You are encouraged to limit your response to fewer than 10 pages and must specifically address each of the requirement specific items requested. Responses to this notice should be received no later than the posted due date, and can be sent either by mail or e-mail to the point of contact listed. If using the U.S. Postal Service or commercial overnight services, please send an original plus five (5) copies of your response. Note: for commercial overnight services, use the Rockville, MD. 20852 address. G. Disclaimer and Important Notes: 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 a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, response to this notice will not be considered adequate responses to a solicitation. H. Confidentiality: 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 solicitations (s).
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