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SOURCES SOUGHT NOTICE Solicitation Number: 75N95024Q00072 Title: HTRF® cAMP Gs Dynamic Assay Kit Brand Name or Equal Classification Code: 6640 NAICS Code: 325414 Size Standard: 1,250 Employees Descrip... SOURCES SOUGHT NOTICE Solicitation Number: 75N95024Q00072 Title: HTRF® cAMP Gs Dynamic Assay Kit Brand Name or Equal Classification Code: 6640 NAICS Code: 325414 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. This is a Sources Sought 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 all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. 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. Small businesses are encouraged to respond. 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). 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 mission of the Tox21 group of NCATS at the National Institutes of Health (NIH) is to develop better toxicity assessment methods to quickly and efficiently test chemicals for their potential disrupt processes in the human body that may lead to negative health effects. The Tox21 10K compound library has been screened against over 50 cell-based assays, in a quantitative high-throughput screening (qHTS) format, generating over 85 million data points, to date. Recently, we have initiated efforts to build computational models using these in vitro assay activity profiles to predict human toxicity including adverse drug effects. These assay data-based models achieved better than random, but <80% accuracy for most of these adverse effects. These results may be the consequence of insufficient coverage of the biological response space and lack of metabolic capacity in the cell lines used. Therefore, we initiated efforts to apply a more systematic and data driven approach to identify targets and pathways for better biological response space coverage and toxicity prediction. As surrogates of in vitro data, we incorporated some examples of known drug target annotation (DTA) information into these models, such as the protein/gene/pathway target of a drug or drug mechanism of action. Based on these results, we identified a list of targets/pathways not presently represented within the Tox21 datasets that show promise of significantly improving the predictive power of the in vitro assay data on in vivo toxicity. A group of G protein-coupled receptors (GPCR) is one of these missing targets/pathways. “HTRF® cAMP Gs Dynamic Assay kit” is a powerful tool to measure Gs coupled receptors. We will build toxicity prediction models with this new assay data combined with the existing 10K data. Purpose and Objectives: The Tox21 group of National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI) requires reagent kit of “HTRF® cAMP Gs Dynamic Assay kit” from PerkinElmer Health Sciences Inc (Cisbio). This reagent kit will use to screen Tox21 library collections (10,000 compounds) in a 1536-well high-throughput format. The purpose of the purchase is to screen Tox21 10K library to identify a group of G protein-coupled receptors (GPCR) for better biological response space coverage and toxicity prediction. This project is one of the cross-partner projects in the Tox21 collaboration between NCATS and NTP/EPA/FDA. Project Requirements: HTRF® cAMP Gs Dynamic Assay Kit Brand Name or Equal: cAMP (cyclic adenosine 3’,5’-monophosphat) is one of the most important GPCR intracellular mediators of Gs coupled GPCRs. The “HTRF® cAMP Gs Dynamic Assay kit” developed by Cisbio (now part of Revvity) uses HTRF® technology (homogeneous time-resolved fluorescence technology) to measure cAMP in a non-separation, high throughput format. The assay is specifically intended for the direct quantitative determination of cAMP. It is based on a competition between native cAMP produced by cells and cAMP labeled with the cryptate for binding to a d2 labeled antibody. The specific signal (i.e. energy transfer signal) is inversely proportional to the concentration of cAMP in the samples. This technology has successfully been used to screen several large libraries in 1536 well format, with high reproducibility and low false positives at NCATS. For example, the HTRF® TSHR assay was used to screen the Tox21 10k library in 1536 well format with great success. Salient characteristics: The salient physical, functional, or performance characteristics that “equal” products must meet are as follows: Gs Dynamic Assay kit: The principle is based on HTRF® technology. It enables the direct compounds acting on Gi-coupled receptors in cells. Principles of the HTRF® technology: Anti-cAMP cryptate and d2-labeled cAMP are the two main components of the detection reagents. cAMP produced intracellularly is detected following cell lysis via competition between the intracellular cAMP and d2-labeled cAMP for the anti-cAMP antibody. An increase in intracellular cAMP leads to disruption of FRET signal, whereas a decrease in intracellular cAMP results in higher FRET signal. Shipping and Handling FOB destination. Quantity: • 8 kits of “HTRF® cAMP Gs Dynamic Assay kit” Anticipated period of performance: The Contractor shall deliver within 4 weeks after receipt of order. Delivery must be Freight on Board (FOB) Destination and include inside delivery. 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. 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. The following information shall be included on the first page: Name of Company GSA Contract No. DUNS No./CAGE Code Street Address, City, State, Zip code Name of Person Authorized to Provide Quote Telephone Number and Email Address of Person Authorized to Provide Quote 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, Contract Specialist at e-mail address nick.niefeld@nih.gov. The response must be received on or before Wednesday, December 20, 2023, 11:00 AM, Eastern Time.