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Solicitation Number: 75F401-24-Q- 1279662 Contracting Office Address: 10903 New Hampshire Ave, WO62 RM 4215, Silver Spring, MD, 20993 Subject: MIoBS ELISA Test Kits Classification Code: 6640 NAICS Cod... Solicitation Number: 75F401-24-Q- 1279662 Contracting Office Address: 10903 New Hampshire Ave, WO62 RM 4215, Silver Spring, MD, 20993 Subject: MIoBS ELISA Test Kits Classification Code: 6640 NAICS Code: 334516 Response Date: 6 September 2024 at 4:30PM EDT due via email to the Primary Point of Contact listed in the sam.gov webpage for this combined synopsis-solicitation. Description: (i) Disclaimer: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 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. This contract is designed to facilitate development of the methods used for food allergen and gluten detection by providing required MIoBS ELISA test kits. Further, the contract makes it possible to acquire MIoBS ELISA test kits with maximum shelf life and minimal kit-to-kit variability, two features critical to the success of the project. (ii) This acquisition is issued as a Request for Quote (RFQ). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-05 (iv) For purposes of this acquisition, the associated NAICS code is 334516. The small business size standard is 1,000 employees. This action is being solicited as a sole source. (v) Line-Item Structure: The following is a list of line-item number(s) and items, quantities and units of measure, (including option(s), if applicable) and should be reflected in the Offeror’s quote/proposal: Line Item 0001: ELISA Test Kits x7 (vi) Specifications/Requirement: Substitute ELISA test kits are not acceptable due to the unique features of the MIoBS ELISA test kits. Requirements • On a quarterly basis, the vendor shall provide up to seven (7) ELISA Test Kits. The specifics of which test kits (e.g., gluten, casein, peanut, egg, etc.) will be made at the time the quarterly order is placed. • The Vendor shall provide FDA with the test kits for an analyte from multiple lots. This will be stipulated when the order is placed for the quarter. Otherwise, it is understood that all test kits for a specific analyte would be from the same lot with maximum shelf-life. • Whether the receipt of the test kits should be in multiple, or a single shipment will be specified by the FDA at the time the order is placed for the quarter. The methods currently being employed by the FDA involve the use of analyte specific ELISA technology to detect seven of the eight major food allergens; namely, egg, gluten/wheat, milk, peanut, tree nut (almond, hazelnut, and walnut), crustacean shellfish, and soy protein. The most sensitive of these methods are those developed by MIoBS (Morinaga Institutes of Biological Sciences, Inc.) with limits of detection (LOD values) of 0.3 micrograms/mL. These MIoBS ELISA Test Kits have been demonstrated to be reliable in multi-laboratory validation studies, analyses conducted in support of regulatory actions taken by the FDA, and research and development efforts conducted by the Center for Food Safety and Applied Nutrition. Delivery The vendor is responsible for overnight shipping under temperature controlled conditions of the (insured) test kits to the FDA/CFSAN laboratory facility located at 5001 Campus Drive, College Park, MD 20740 The vendor is responsible for delivery of the MIoBs ELISA Test Kits specified above. It is understood that delivery of the ELISA Test Kits to the FDA may take up to 8 weeks from the date the order is placed. Any additional delay must be approved by the FDA. Fixed unit pricing includes packaging/handling and shipping costs Trade and Service Specifications: The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. FOB Point destination to include inside delivery and clean-up of area after installation. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. Preventative maintenance (PM) visit shall be included for the base contract year. This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification. Records and Reports: 1) The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges. 2) The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits. 3) The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS/FDA or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS/FDA environment. No sensitive data shall be used during software testing. 4) The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract. The Contractor shall, commensurate with the completion of each service call relating to the first year warranty, provide the end-user of the equipment with a copy of the field corrective service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being repaired and detailing the reason for the warranty call, a detailed description of the work performed. The parts and the test equipment used to repair the system shall be on the report. This will include the name (s) and contact information of the engineer who performed the repair, and for information purposes, the on-site hours expended, and parts/components replaced. Security and Privacy Requirements Section 2 of FDA Security and Privacy Language does not apply to procurements for only hardware and software licenses. Section 508 Compliance The Contractor shall be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that documents generated as part of the tasks are fully Section 508-accessible using the available COTS tools. Each order will identify the standards applicable to that order. (vii) Delivery: Delivery is required by 60 days after award. Delivery shall be made to: POC: To be identified at time of award. The vendor is responsible for overnight shipping under temperature controlled conditions of the (insured) test kits to the FDA/CFSAN laboratory facility located at 5001 Campus Drive, College Park, MD 20740 Acceptance shall be performed at the delivery locations. The FOB point is DESTINATION. (viii) The provision at 52.212-1, Instructions to Offerors – Commercial DEVIATION 2018-O0018, applies to this acquisition. The following addenda have been attached to this provision: In addition to the requirements set for the in FAR 52.212-1, all offers responding to this solicitation must provide their business size in relation to the NAICS code contained in this solicitation and shall identify any socioeconomic categories to which they belong. (ix) Evaluation Criteria - The specific evaluation criteria to be used are as follows: Lowest Price Technically Acceptable (x) Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer. (xi) The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to this clause. (xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10 REPORTING EXECUTIVE COMPENSATION AND FIRST-TIER SUBCONTRACT AWARDS (JUN 2020) 52.209-6 PROTECTING THE GOVERNMENT’ INTEREST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED, SUSPENDED, OR PROPOSED FOR DEBARMENT (NOV 2021) 52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (FEB 2024) 52.222-3 CONVICT LABOR (JUN 2003) 52.222-19 CHILD LABOR--COOPERATION WITH AUTHORITIES AND REMEDIES (FEB 2024) 52.222-21 PROHIBITION OF SEGREGATED FACILITIES (APR 2015) 52.222-26 EQUAL OPPORTUNITY (SEP 2016) 52.222-35 EQUAL OPPORTUNITY FOR VETERANS (JUN 2020) 52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH DISABILITIES (JUN 2020) 52.222-37 EMPLOYMENT REPORTS ON SPECIAL DISABLED VETERANS, VETERANS OF THE VIETNAM ERA, AND OTHER ELIGIBLE VETERANS (JUN 2020) 52.222-50 COMBATING TRAFFICKING IN PERSONS (NOV 2021) 52.225-5 TRADE AGREEMENTS (NOV 2023) 52.225-13 RESTRICTIONS ON CERTAIN FOREIGN PURCHASES (FEB 2021) 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER—CENTRAL CONTRACTOR REGISTRATION (OCT 2018) (xiii) The following additional contract requirement(s) or terms and conditions apply: 52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018) 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018) 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016) 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016) 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019) 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) 353.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 15) 252.239-73 Electronic and Information Technology Accessibility Notice (Dec 15) (xiv) This acquisition is rated under the Defense Priorities and Allocations System (DPAS) as N/A (xv) Date, Time, and Place offers are due: Offers due via email to joshua.reid@fda.hhs.gov no later than (NLT) 4:30 PM EST on 6 September 2024 (xvi) Name and phone number of the Individual to Contact for Information Regarding the Solicitation: Joshua Reid, 954-271-9362