P450-Glo™ CYP26A1, CYP26B1 and CYP3A4 Screening Systems
(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95022Q00383CSS and the solicitation is issued as a for proposal (RFP). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 6—Use of Competitive Procedures; and FAR Part 12—Acquisition of Commercial Items and is expected to exceed the simplified acquisition teshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) Number 2022-06 dated May 26, 2022. (iv) The associated NAICS code is 334516 - Analytical Laboratory Instrument Manufacturing. Size standard in number of employees is 1,000. PSC Code: 6640 – Laboratory Equipment and Supplies (v) This requirement is for P450-Glo CYP26A1, CYP26B1 and CYP3A4 Screening Systems. (vi) Background: Tox21 collaboration between NCATS (then NCGC), NTP, EPA and FDA started with an aim to screen tens of thousands of known drugs and compounds in vitro by reducing the cost and time consuming processes involved in traditional toxiciticy testing methods. Since its inception, several screenings against Tox21 compound collection were performed at NCATS by running cell-based assays focused mainly on different targets and toxicity pathways which included nuclear receptor signaling, stress response, developmental toxicology, GPCR/cAMP signaling, and Epigentics etc. All these assays used either luciferase or fluorescence reporter gene technology for readouts. In order to quanitfy the induction/inhibiton of these reporter gene activities, different detection assay systems have been used. Currently we are testing P450-Glo assay systems to eventually screen the Tox21 libraries for testing the effects of drugs and chemical entities on cytocome P450 26A1, B1, and 3A4 activities Purpose: The purpose of this procurement is acquire P450-Glo Screening systems including CYP26A1, CYP26B1, and CYP3A4. Project Requirements: P450-Glo CYP26A1, CYP26B1, and CYP3A4 with Luciferin-PPXE screening systems: These assays are homogeneous, luminescent method for measuring cytocome P450 CYP26A1, CYP26B1, and CYP3A4 activities. These assays exhibit exquisite sensitivity, low background signals, and broad dynamic range. The half-life of the luminescent output is greater than two hours, eliminating the need for luminometers with injectors and allowing batch plate processing. The formulation also minimizes the incidence of false positives due to inhibition of luciferase by analytes when screening for cytocome P450 inhibitors. The luminescent format also eliminates the need for time-consuming analyses. These assays has the reduced incubation times as the luciferin-based substrates are readily taken up by cells and rapidly converted to luciferin inside the cell. These assays are very stable for a number of thaw and freeze cycles Deliverables: This is a one time delivery. Vendor is responsible for shipping the product(s) within approximately six (6) weeks after receipt of order (ARO). (vii) Period of Performance: This is a one-time delivery to be shipped within 6 weeks ARO. The Government anticipates award of a firm fixed-price purchase order for this acquisition. (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.211-6, Brand Name or Equal (Aug 1999) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2022) FAR 52.225-2, Buy American Certificate (Feb 2021) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached. HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (May 2022) NIH Invoice and Payment Provisions (Vendor has Transitioned to IPP) (April 21, 022) / NIH Invoice and Payment Provisions (Vendor has Not Transitioned to IPP) (April 21, 2022) (ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; and b. Price (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2022), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All offers must be received by 11:00 a.m., Eastern Daylight/Standard Time, on August 03, 2022, and reference Solicitation Number 75N95022Q00383CSS. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted. 75N95022Q00383CSS Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
7/25/22, 2:00 PM P450-Glo™ CYP26A1, CYP26B1 and CYP3A4 Screening Systems
The National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI) Tox21 group is a part of the National Institutes of Health (NIH). Tox21 collaboration between NCATS (then NCGC), NTP, EPA and FDA started with an aim to screen tens of thousands of known drugs and compounds in vitro by reducing the cost and time consuming processes involved in traditional toxiciticy testing methods. Since its inception, several screenings against Tox21 compound collection were performed at NCATS by running cell-based assays focused mainly on different targets and toxicity pathways which included nuclear receptor signaling, stress response, developmental toxicology, GPCR/cAMP signaling, and Epigentics etc. All these assays used either luciferase or fluorescence reporter gene technology for readouts. In order to quanitfy the induction/inhibiton of these reporter gene activities, different detection assay systems have been used. Currently we are testing P450-Glo assay systems to eventually screen the Tox21 libraries for testing the effects of drugs and chemical entities on cytocome P450 26A1, B1, and 3A4 activities. 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: Tox21, an inter-federal collaboration is mainly aimed to develop better toxicity assessment methods by running in vitro screenings against 10,000 compound collections in a high toughput format in order to eliminate the traditional animal toxicology studies. Currently Tox21 group seeks to purchase P450-Glo™ assay systems. These assays can be used for testing the effects of Tox21 chemical entities on cytocome P450 26A1, 26B1, and 3A4 activities. Purpose and Objectives: The purpose of this procurement is acquire P450-Glo Screening systems including CYP26A1, CYP26B1, and CYP3A4. Project requirements: P450-Glo Screening systems including CYP26A1, CYP26B1, and CYP3A4. Salient Requirements: P450-Glo CYP26A1, CYP26B1, and CYP3A4 with Luciferin-PPXE screening systems: These assays are homogeneous, luminescent method for measuring cytocome P450 CYP26A1, CYP26B1, and CYP3A4 activities. These assays exhibit exquisite sensitivity, low background signals, and broad dynamic range. The half-life of the luminescent output is greater than two hours, eliminating the need for luminometers with injectors and allowing batch plate processing. The formulation also minimizes the incidence of false positives due to inhibition of luciferase by analytes when screening for cytocome P450 inhibitors. The luminescent format also eliminates the need for time-consuming analyses. These assays has the reduced incubation times as the luciferin-based substrates are readily taken up by cells and rapidly converted to luciferin inside the cell. These assays are very stable for a number of thaw and freeze cycles Anticipated period of performance: This is a one time delivery. Delivery shall be within 6 weeks after receipt of order (ARO) for screening system kits 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. Small business concerns 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. Small businesses must also provide their Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. Interested small businesses 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. The respondent must also provide their Unique Entity ID from SAM.gov, 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 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 response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. 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 Morgen Slager, Contract Specialist, at e-mail address morgen.slager@nih.gov. The response must be received on or before July 20, 2022 at 11am, 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 Federal Business Opportunities. 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).” 75N95022Q00383SS Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
7/11/22, 8:51 AM