Synthesis of NCGC00588997 in 500g quantities of GMP grade material and stability study to support preclinical and clinical studies for the Early Translation Branch at NCATS.

SOURCES SOUGHT NOTICE Solicitation Number: 75N95023Q00555_SB Title: Synthesis of NCGC00588997 in 500g quantities of GMP grade material and stability study to support preclinical and clinical studies for the Early Translation Branch at NCATS. Classification Code: 6505 – Drugs and Biologicals NAICS Code: 325414 – Biological Product (except Diagnostic) Manufacturing Size Standard: 1,250 Employees Description: 500g quantities of GMP grade material to support preclinical and clinical studies. The material needs to meet the FDA requirements for GMP material and must be >98 % purity with single impurity less than 0.5% with complete analyses. The products should be fully characterized with standard analytical techniques such as NMR, HRMS, LCMS. 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. The Early Translational Branch (ETB) is tasked with identifying and developing novel small molecule leads for improving human health. In pursuit of this goal, the Center has a strong internal trans-disciplinary team of scientists who continually discover novel small molecules to modulate molecular targets to identify novel treatment strategies. As such, discovering lead molecules that could serve as starting points for therapeutic development for patients is a key part of discovery. Formulation of small molecule lead compounds is an important part of the discovery process and key to advancing a molecule for the treatment of patients. As such right formulation condition is essential for toxicity and IND studies. Purpose and Objectives: This requisition is to Synthesize NCGC00588997 in 500g quantities of GMP grade material to support preclinical and clinical studies. The material needs to meet the FDA requirements for GMP material and must be >98 % purity with single impurity less than 0.5% with complete analyses. The products should be fully characterized with standard analytical techniques such as NMR, HRMS, LCMS. Anticipated delivery: The Period of Performance (PoP) is 12 weeks from the contract award and receipt of the materials. DELIVERY OR DELIVERABLES A written report on the result of study in the form of email or electronic document Other important considerations: 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. A vendor whose production site is FDA certified and can provide GMP certificates for both the site and the material is required. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products 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 Claudia Ventola, Contract Specialist at e-mail address [email protected]. The response must be received on or before July 27, 2023 at 4:00 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).”