SAM #75N98026R00083_SB

Small Business Sources Sought for Preclinical Medications Discovery and Abuse Liability Testing Services

This opportunity seeks small business sources for specialized preclinical medications discovery and abuse liability testing services supporting NIH NIDA's Addiction Treatment Discovery Program. - Government Buyer: - National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are named; only small business service providers are sought - Products/Services Requested: - Preclinical pharmacology studies in rodents and primates - Abuse liability testing for new street drugs, medications, and potential pharmacotherapies - Procedures include: - Intracranial self-stimulation - Withdrawal assays for opioids and nicotine - Operant responding studies - Dosing guidance protocols - In vivo receptor activity assays - Security protocols for handling blinded test compounds - Unique/Notable Requirements: - Must possess or obtain DEA registration for Schedule I-V substances - Compliance with NIH and Public Health Service animal welfare policies - Capability to generate data for drug scheduling decisions under the Controlled Substances Act - Expertise in specialized behavioral and pharmacological assays - No products are requested; only highly specialized research and testing services - Place of Performance: - National Institutes of Health NIDA, Bethesda, MD

Description

This is a Small Business Sources Sought (SBSS) 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 qualified small business sources; 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; 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. This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential government requirement and to determine the method of acquisition and whether commercial or non-commercial services are available to meet the needs of the Government. 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. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method, including small business socioeconomic set-aside possibilities, and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541715 — Physical science research and development laboratories or services (except biotechnology and nanotechnology research and development) with a Size Standard of 1,000 employees. DESCRIPTION OF REQUIREMENT The Preclinical Medications Discovery and Abuse Liability Testing Program conducts evaluation of potential pharmacotherapies for substance use disorders and abuse liability testing of new street drugs, medications, and potential medications in rodents. The primary emphasis is testing for NIDA's Addiction Treatment Discovery Program (ATDP); to a lesser extent, the contract will generate abuse liability data to inform drug scheduling decisions under the Controlled Substances Act and applicable international treaties. The ATDP was created in 2005 by consolidating NIDA's Cocaine, Opiate, and Methamphetamine Treatment Discovery Programs with smaller initiatives in smoking cessation and marijuana dependence — in part to address decreased contract funding. This contract continues that tradition of efficiency and flexibility, supporting substance use disorder medications discovery and abuse liability testing for DEA drug scheduling. Capable Organizations must demonstrate the in-house capability to perform in vivo rodent and primate pharmacology studies on potential pharmacotherapies for substance use disorders and on new drugs of abuse. This contract will be utilized by the Addiction Treatment Discovery Program (ATDP) within NIDA's Division of Therapeutics and Medical Consequences. Data gathered on potential pharmacotherapies will be used by the ATDP and NIDA's Medications Development Program. The data generated with new drugs of abuse will be provided to the DEA and FDA by NIDA. Capable Organizations must demonstrate their experience, personnel, facilities, and capabilities for the following activities: Intracranial self-stimulation (ICSS) procedure to evaluate compounds for their ability to produce positive or negative hedonic effects, for their ability to alter the “rewarding” properties of drugs of abuse (e.g., stimulants, opioids), or for their ability to alter the aversive state that exists during withdrawal from the chronic administration of a drug of abuse. Evaluate a compound in assays to determine its ability to alter the aversive state that exists during withdrawal from chronic opioid administration in rodents. Evaluate a compound in assays to determine its ability to alter the aversive state that exists during withdrawal from chronic nicotine administration in rodents. Evaluate compounds for their effects on non-reinforced operant responding (compound effects shall be evaluated under extinction conditions) in rats previously trained to self-administer food. The purpose of these studies will be to serve as behavioral “selectivity controls” for compound evaluations in relapse models (i.e., models of stress-, cue-, and drug prime-induced reinstatement of drug-seeking behavior). The relapse model studies are currently supported under a different NIDA contract. Evaluate compounds in a protocol designed to provide dosing guidance for the studies. Evaluate a compound in assays to determine its in vivo receptor activity in rats or mice. Establish and maintain security protocols to obtain, receive, store, track and monitor the use of blinded test compounds to be distributed by the Government. Maintain a chronological log of compound receipt, evaluation results, documents, and laboratory notebooks. This requirement may include optional periods and increased quantities to continue work or increase work as described above based on the Programmatic needs and budget availability. Capable Organizations must demonstrate their ability to possess or obtain a DEA registration for Schedule I-V substances in order to perform the programmatic requirements. Capable Organizations must demonstrate their understanding and compliance with the NIH Guide for Care and Use of Laboratory Animals and their ability to obtain and comply with Animal Welfare Assurances in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The established NAICS code is 541715. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above; Personnel: Name, professional qualifications, and specific experience in the work requested and knowledge of, and experience in, the field of research. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers, and any other information serving to document the organization's capability, e.g., awards, commendations, etc. CAPABILITY STATEMENT Interested parties are expected to review this notice to familiarize themselves with the requirements of this product or service. Failure to do so will be at your firm's own risk. The respondent must also provide their Unique Entity Identifier (UEI) number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format. The response is limited to twenty (20) pages. The 20-page limit does not include the cover page, executive summary, or references, if requested. The information submitted must be in an outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and email addresses. Respondents must reference announcement number 75N98026R00083 on all correspondence related to this Small Business Sources Sought notice. The response must be submitted electronically to Josh.Lazarus@nih.gov and be received prior to the closing date specified in this announcement. The response must be received on or before June 12, 2026, 5:00 PM, Eastern Time. CONCLUDING STATEMENTS 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. However, responses to this notice will not be considered adequate responses to a solicitation. Based on preliminary market research, the Government has determined that the requirements described herein do not meet the definition of a commercial product or commercial service as defined in FAR 2.101, and therefore, FAR Part 12 procedures are not applicable to this requirement. However, if a Capable Organization believes that these services or products qualify as commercial under FAR 2.101, the offeror may submit a written justification for the Contracting Officer's consideration. Such submissions must be provided to the Contracting Officer no later than June 12, 2026, 5:00 PM, Eastern Time. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any nonproprietary technical information in any resultant solicitation(s).

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