Validation Test Plan for the Agshield Pen-Side ASF Nucleic Acid Detection Device

Solicitation Number: 70RSAT22R00000003 Action Code: Pre-solicitation Notice Contracting Office: DHS, MGMNT, OCPO, OPO, STAD Contracting Office Address: 245 Murray Lane SW, Mailstop 0115 Washington DC 20528 Contact Point: Kimberly.Oneill@hq.dhs.gov (Contract Specialist) Contracting Officer (CO): Joseph P. Pianese Title/Subject: VALIDATION TEST PLAN FOR THE AGSHIELD PEN-SIDE ASF NUCLEIC ACID DETECTION DEVICE Synopsis: The Department of Homeland Security (DHS) intends to issue, on a sole source basis, a Firm Fixed Price award to Gate Scientific LLC for the acquisition to procure the further development, production of validation test units and validation testing of the AgShield Pen-side African Swine Fever Virus (ASFV) device for DHS's Science & Technology Directorate. DHS anticipates needing to manufacture a total of 3,000 tests to complete the licensing validation protocol including pre-validation activities. This One (1) year service contract will include One (1) four-month base period and One (1) eight-month anticipated option period. This requirement is to be solicited as FAR Subpart 6.302-1 entitled - Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. More specifically, FAR Subpart 6.302-1(a)(2)(ii)(A), supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition. DHS currently anticipates the following Estimated Timeline: RFP Issue Date (on or about) October 28, 2021 Contract Award by November 12, 2021 Procedures to be used in awarding the contract: Written Proposal Description: (1) National Stock Number (NSN) - N/A (2) Qualification Requirements - This requirement is to be a Non-competitive Contract Action (3) Manufacturer, including part number, drawing number, etc.: N/A (4) Size, dimensions, or other form, fit or functional description: The United States (US) Department of Homeland Security (DHS) is seeking the further development, production of validation test units and validation testing of the AgShield Pen-side African Swine Fever Virus (ASFV) device. This device was previously developed under the DHS Long Range Broad Agency Announcement (LRBAA) and is being transitioned from the research and design phase to the development phase, including validation testing. (5) Predominant material of manufacture: N/A (services type contract) (6) Quantity, including any options for additional quantities: N/A (services type contract) (7) Unit of issue: Firm-Fixed-Price (8) Destination information: The work described will be performed by Gate Scientific, Inc. in collaboration with government labs certified to perform tests with live ASFV. The primary place of performance will be the Contractor's facilities with visits to the Department of Homeland Security facilities in the Washington Metro Area. (9) Delivery schedule: with 12 months of award (10) Duration of the contract period/POP: The period of performance includes a four-month Base Period and an eight-month Option Period; a total of twelve-months. (11) Sustainable acquisition requirements: N/A (12) For a proposed contract action in an amount estimated to be greater than $25,000 but not greater than the simplified acquisition threshold; N/A (13) For Architect-Engineer projects: N/A (14) (i) The solicitation will not include the FAR clause at 52.225-3, Buy American - Free Trade Agreements'Israeli Trade Act, (ii) The solicitation will not include the FAR clause at 52.225-5, Trade Agreements (iii) The solicitation will not include the FAR clause at 52.225-11, Buy American--Construction Materials under Trade Agreements, or 52.225-23, Required Use of American Iron, Steel, and Manufactured Goods--Buy American Statute--Construction Materials under Trade Agreements. (15) This is a non-competitive contract action. Gate Scientific is the sole manufacturer of the device and the tests to be validated. (16) (i) N/A (ii) All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. (17) The solicitation shall be synopsized through the GPE. (18) Electronic data interchange: N/A (19) Technical data required to respond to the solicitation will be furnished as part of the solicitation, and obtained on https://www.sam.gov Set asides: N/A Codes to be used in Synopses: PSC: AJ15 Life Sciences - Basic Research and NAICS: 541611