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SAM.gov SOURCES SOUGHT NOTICE Solicitation Number: 75N95024Q00494_SB Title: Human and Mouse Hepatopac plates for the National Center for Advancing Translational Sciences Classification Code: 6505 - DR... SAM.gov SOURCES SOUGHT NOTICE Solicitation Number: 75N95024Q00494_SB Title: Human and Mouse Hepatopac plates for the National Center for Advancing Translational Sciences Classification Code: 6505 - DRUGS AND BIOLOGICALS NAICS Code: 325414 - Biological Product (except Diagnostic) Manufacturing Size Standard: 1,250 employees Description: 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; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). 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 Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting, and making medical discoveries that improve people’s health and save lives. The Malaria project aims to develop a drug that is capable of treating the malaria infection in a person with a single oral dose. For that, the compounds have to be extremely resistant to metabolism. The project has been very successful in avoiding metabolism but that rendered the usual methods employed by the DMPK group to measure metabolic stability incapable of measuring such low metabolic stability. To better support this project, we aim to test these compounds in the Micropatterned Hepatocyte Co-cultures (HEPATOPAC) system which allows for a long-term hepatocyte incubation which is capable of assessing the low clearance of these drug candidates. Purpose and Objectives: The Malaria project aims to develop a drug that can last 7-10 days in a patient to be able to resolve the malaria infection with a single dose of the drug. Because of that, the Medicinal Chemists have developed methods to make very metabolically stable drugs, which, in turn, display very low clearances in in vitro systems. To evaluate such low clearance drugs, it is necessary to use systems that are meant for long incubations. The Hepatopac system is patented by Massachusetts Institute of Technology and exclusively licensed to BioIVT, LLC. This system allows for 5-7 days of incubation, which allows the evaluation of the metabolic clearance of such low clearance drugs. Project requirements: Please see PURCHASE DESCRIPTION attached to this posting. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products or 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 Nick Niefeld at the e-mail address nick.niefeld@nih.gov. The response must be received on or before August 13th, 2024, 09:00 AM, EDT. “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).”