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SAMDAILY.US - ISSUE OF JULY 22, 2022 SAM #7539
SOURCES SOUGHT

A -- NIMH PSYCHOACTIVE DRUG SCREENING PROGRAM (PDSP)

Notice Date
7/20/2022 12:27:07 PM
 
Notice Type
Sources Sought
 
NAICS
541715 — Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
 
Contracting Office
NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
 
ZIP Code
20892
 
Solicitation Number
NIDA-SSN-75N95022R00083
 
Response Due
8/10/2022 12:00:00 PM
 
Point of Contact
Michael Horn, Christine Frate
 
E-Mail Address
michael.horn@nih.gov, christine.frate@nih.gov
(michael.horn@nih.gov, christine.frate@nih.gov)
 
Description
SOURCES SOUGHT NOTICE This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. Background:� The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.� Specifically, for this requirement, the goal 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 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. To further these goals, a requirement� for the NIMH Psychoactive Drug Screening Program (PDSP) was initiated to provide broad-based screening capabilities, in the form of pharmacological and functional assays to the scientific research community with the intent of stimulating innovative research and development efforts in the design and development of novel psychoactive compounds for preclinical research, neuroimaging, and as potential therapeutic agents in the treatment of psychiatric disorders.� The program focuses on the use of state-of-the-art, high-throughput screening (HTS) of compounds in human and rodent central nervous system (CNS) binding and functional assays. Purpose and Objectives: The purpose of the NIMH PDSP is to provide screening of novel synthetic compounds and natural products for potential use as research tools or probes for basic and clinical research, as therapeutic agents for mental disorders, and as PET, SPECT, and fMRI ligands for functional brain imaging.� This program is primarily intended as a screen for compounds that have previously been shown to possess pharmacological, biochemical, or behavioral activities relevant to NIMH and not for the purpose of large-scale, random screening of natural products or combinatorial libraries (e.g., libraries containing >1000 compounds).� However, screening may be conducted on small libraries of synthetic or natural product compounds of unknown activity and on hit or lead compounds generated through NIH-funded HTS or chemistry programs.� Compounds will be provided by the research community, primarily NIH-supported investigators.� It is anticipated that the Contractor will receive and screen compounds on a continuous and on-going basis, although the volume of requests will vary from month to month. The objectives of the requirement are to receive and test approximately 2,500-3,000 samples (e.g., small molecules, gene products, and natural product extracts) per year in broad-based human and rodent CNS screening assays against hundreds of CNS targets (see https://pdsp.unc.edu/pdspweb/?site=clones for current list of available targets), and to provide an electronic data file for each of the screened compounds.�� Samples for screening can include, but are not limited to, novel chemical entities, structural analogs of lead compounds, genes or gene products, and natural products.� It is anticipated that NIMH-approved and coded samples will be submitted in individual vials or in a plated format from NIH-funded research programs, academic research programs, or other sources.� It is expected that the screening information derived from this program will provide individual investigators with data addressing the specificity and/or activity of compounds at CNS targets.� Project requirements: The Contractor is expected to 1) obtain required assurances and 2) develop and implement approved project protocols; 3) process requests and manage sample receipt and storage; 4) maintain confidentiality and intellectual property and patent rights; 5) screen assays (primary, secondary, functional, and ADMET); 5) develop and validate new assays and incorporate novel techniques and technologies; 6) Develop and maintain two databases (i.e. Assay Results and PDSP Ki Databases) that are 508 compliant; and 7) provide outreach and communication. The annual assay workload is estimated as follows: ����������� 35,000 primary pharmacologic assays ����������� 10,000 secondary pharmacologic assays ����������� 125,000 functional assays ����������� 1,500 Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) assays ����������� 5-10 new assays developed and validated As demand for contract services may vary, the Contractor must maintain the capability of expanding throughput to meet a higher assay volume.� The requirement will contain options for increased quantities that may be exercised multiple times within a performance period to fund a higher volume of screening. In addition, an option for fee-for-service may be included to provide screening at no cost to approved investigators.� The contractor shall have the ability to conduct screening on a fee-for-service basis, if requested by the government.� Prices for the services provided shall be set based on full or partial recover of actual costs.� REPORTS/DELIVERABLES: The Contractor is expected to provide 1) Assay Reports within one week of completion of testing; 2) Quarterly Reports within seven (7) calendar days after the end of each contract quarter; 3) Annual Reports within fourteen (14) calendar days after the expiration of each contract performance period; 4) Final Report on or before the contract expiration date; and 5) a Transition Plan - Transition to a subsequent Contractor or to the Government upon request at any time within the contract performance period.� Anticipated period of performance: The anticipated period of performance is one 12-month base period and four 12-month option periods from August 2023 through August 2028.� Additionally, the option for increased quantities is expected to be exercised within the contract period of performance. Other important considerations: �The Government is expected to use procedures in FAR Part 15, Contracting by Negotiations.� It is anticipated that a Level of Effort, Cost Reimbursement type contract will be issued. The North American Industry Classification System (NAICS) Code 541715 with a size standard of 1,000 employees is being contemplated.� In case domestic sources are available and capable of fulfilling the Government�s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.� Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and 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 number 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 be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2� x 11� paper size, with 1� top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit.� The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.� Facsimile responses are NOT accepted. The response must be submitted to Michael Horn, Contracting Officer, at e-mail address michael.horn@nih.gov . The response must be received on or before August 10, 3:00 pm, Eastern Time. 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 presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. 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 solicitation(s).
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/1b63d2e70977496b87740145a3604b74/view)
 
Place of Performance
Address: USA
Country: USA
 
Record
SN06396233-F 20220722/220720230119 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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