U.S. FDA SOURCES SOUGHT NOTICE (SSN) Luciferase Substrate Assays SSN #: 75F40122R1255030 Posted Date: June 7, 2022 Response Date: June 17, 2022 Classification: 6550 – In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets NAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the single cell partitioning instrument described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible. The appropriate NAICS code for the acquisition is 325413 – In-Vitro Diagnostic Substance Manufacturing, Small Business Size Standard of 1,250 employees. Requirement and Background The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Laboratory of Immunoregulation (OVRR/DVP) requires substantial quantities of firefly luciferase substrate assays (Promega #4550 1000 or equal), for an ongoing, large-scale project incorporating neutralization assays to assess the potency of potential monoclonal antibodies SARS-CoV-2 (COVID-19) as part of Operation Warp Speed to aid in determining which antibodies may best show clinical utility in treating COVID-19. Of paramount importance to the current research is an assay which emphasizes higher sensitivity versus a lower degradation of signal over time. This assay was optimized and validated in 2020 using a luciferase substrate from Promega, catalog# E4550, 1,000 reactions. Ongoing research since then has relied on the Promega 1000 assays for increased sensitivity and measuring capabilities down to (10)-20 moles, and is currently used in this validated SARS CoV-2 neutralization assay. In order to preserve the scientific integrity and continuity of the current study, additional quantities of the Promega Luciferase 1000 Assay System are required to complete the work for assessing potential antibody therapies for COVID-19 as part of Operation Warp Speed. It is anticipated that any solicitation issued subsequent to this Notice shall include the clause at FAR 52.211-6 Brand Name or Equal (Aug 1999). Minimum Technical Requirements - Promega Luciferase 1000 Assay System, Item #: E4550 or Equal: Salient physical, functional, or performance characteristics that an “equal” luciferase substrate assay system must meet are specified as follows and shall be identified by brand name and make/model/catalog number: *Shall be a quantity of 80,000 reactions; each assay shall be capable of 1,000 reactions; *Substrate shall be of the same manufacturing lot to minimize assay-to-assay drift; *Substrate shall be compatible with the same luciferase reporter gene, firefly luciferase, present within our existing pseudo virus stocks; *Substrate shall exhibit reproducibility, signal-to-noise ratio, and sensitivity equal to Promega #E4550 Luciferase 1000 Assay System; * Shall be capable of measuring firefly luciferase in single-tube or multi-well plate luminometer equipped with auto-injector; *Substrate shall provide linear results over at least eight orders of magnitude of firefly luciferase enzyme concentration; *Shall be capable of measuring amounts less than or equal to (10)-20 moles of luciferase under optimal conditions; *Include all shipping charges FOB Destination. Delivery Terms : 28 days from receipt of order Contract Type : Commercial Item-Firm Fixed Price Period(s) of Performance (Estimated) 3-4 weeks from issuance of PO Delivery Address U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72, Room 1244 109003 New Hampshire Ave. Silver Spring, MD 20993-0002 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in supplying the quantity and quality of the firefly luciferase substrate described herein. Although the target audience for this Notice are small businesses or small businesses capable of providing this equipment from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following: Business name and bio, SAM Unique Entity Identifier (UEI), business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding with the capability of providing an instrument offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the firefly luciferase substrate which the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements identified above can be met; Provide recent (within the last three years) and relevant past performance information where the offeror has provided same or substantially similar firefly luciferase substrate. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address and phone number, and e-mail address (if different from that provided for client); If applicable, standard commercial warranty and payment terms; If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested; If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns; Though this is not a request for quote, informational pricing is encouraged; The Government is not responsible for locating or securing any information, not identified in the response; Respondent shall advise if the services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract. If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required. Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on June 16, 2022, to Tim Walbert, Contract Specialist, at the following e-mail address:
[email protected]. Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 pre‐solicitation synopsis and/or combined synopsis-solicitation may be published on SAM/Federal Contract Opportunities (formerly FBO) at https://sam.gov/content/opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality and Proprietary Information 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).