Assess inhibition activity of 2 test articles (TA) for general Efflux and Uptake Transporters

SOURCES SOUGHT NOTICE Solicitation Number: 75N95023Q00312 - SBSS Title: Assess inhibition activity of 2 test articles (TA) for general Efflux and Uptake Transporters Classification Code: Q301 – Medical- Laboratory Testing NAICS Code: 541380 Testing Laboratories and Services Size Standard: $19 M 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 National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. To support drug development for Mitragynine and its major metabolite 7-hydroxymitragynine, the inhibition and substrate potential of the test article for major human transporters needs to be assessed. Purpose and Objectives: Assess inhibition activity and substrate potential of 2 test articles (TA) for each human transporter individually, using study designs in compliance with FDA recommendations. Project requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: 1. The inhibition and substrate potential for mitragynine and 7-OH-mitragynine will be assessed for P-gp, BCRP, OCT2, OAT1, OAT3, OATP1B1, OATP1B3, MATE1 and MATE2-K. 2. TAs are tested for potential transporter substrate or inhibition at one concentration. 3. All conditions are performed in triplicate, and mean data are calculated. 4. Controls/probe substrates will be used to validate the test system. Scientists who are capable to run the human transporter studies. The effort includes to conduct in vitro cell based assays, data analysis and report writing. NCATS will review study protocol, provide the test article, review experiment data, and review/approve study report. The final report should include experiment protocol, study date and site, materials used, substrate results, inhibition results, data interpretations, and conclusions. This draft final report will be subject to review and revisions that may be requested by NCATS prior accepting the final report. Anticipated period of performance: Four months after award the report must be completed. Capability statement /information sought. Respondents must provide clear and convincing documentation of their capability of providing the equipment specified in this notice. The respondent must also provide their 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 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 an outline format that addresses each of the elements of the service requirement and in the capability statement /information sought paragraphs stated herein. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Claudia Ventola, Contract Specialist at [email protected] The response must be received on or before Friday, May 19, 2023, 12:00 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).”