Small Business Sources Sought Notice: NINDS Preclinical Screening Platform for Pain (PSPP)

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 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 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 National Institute of Neurological Disorders and Stroke (NINDS) is seeking to establish a research contract for its Preclinical Screening Platform for Pain (PSPP) program in response to the Helping to End Addiction Long-term (HEAL) initiative, which the National Institutes of Health (NIH) launched in April 2018. The HEAL initiative (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative) is a trans-NIH effort to fast-track basic, translational, and clinical research in the field of addiction and pain to address the national opioid crisis.Purpose and Objectives: The NINDS is seeking to identify small business concerns with established expertise in pain models who could propose a plan to assess pain therapeutics in their labs or facilities with available access to resources and qualified expertise to establish new pain models as needed. The NINDS is also seeking sources that can provide data on potential side effects (in vitro and in vivo), drug abuse liability, in vitro pharmacological profiling and target selectivity, ADME (in vitro and in vivo) profiling, formulation research studies and pharmacokinetic studies of the investigational agents.The PSPP program shall establish a screening platform to test investigational agents/interventions (small molecules, biologics, natural products, devices) in a battery of in-vivo models of pain conditions to identify new non-opioid agents for further preclinical and clinical development. Investigational agents shall be submitted to the contractor in a blinded fashion and testing shall be performed (as directed by NINDS staff) in a series of acute and chronic pain models. Selected testing models of tolerability/side effect liability shall be also performed to determine therapeutic index. Additional testing in models of abuse liability shall also be investigated to evaluate the test agents for addictive potential.Project requirements: The Contractor shall evaluate new investigational agents under the following anticipated performance areas:1) In-vivo testing in pain conditions, abuse liability and side effects assessment models;2) In-vitro pharmacological profiling against opioid receptors and/or other molecular target(s) of safety concerns;3) ADME & formulation studies and in-vivo pharmacokinetic (PK) assessment, and;4) The Contractor may be required to perform supporting studies or establish new pain-related models to support the evolving requirements of the PSPP as needed.Anticipated period of performance: Base Period: September 26, 2024 – September 25, 2025Option Period One: September 26, 2025 – September 25, 2026Option Period Two: September 26, 2026 – September 25, 2027Option Period Three: September 26, 2027 – September 25, 2028Option Period Four: September 26, 2028 – September 25, 2029Capability 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 Renato Gomes, Contract Specialist, at renato.gomes@nih.gov.The response must be received on or before September 04, 2023 at 9:00 am 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).”