FOOD AND DRUG ADMINISTRATION USA Tender

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. the Government Intends To Negotiate And Solicit Solely With Oxford Nanopore Technologies, As It Is The Only Vendor That Meets Our Specific Requirements. This Acquisition Is Justified Under The Authority Of Far 13.106(b)(1)(i). No Substitutes Will Be Considered, As Only Oxford Nanopore Technologies Can Provide The Necessary Products And Services. This Is A Sole Source Procurement, And We Will Only Work With Oxford Nanopore Technologies For This Requirement. However, Any Responsible Offeror May Submit A Quote For This Specific Vendor, Which Will Be Given Due Consideration By The Agency. vendor Information: Oxford Nanopore Technologies gosling Building, Edmund Halley Road, oxford Science Park, Oxford, Ox4 4dq, United Kingdom (ii) Acquisition Issued As: this Acquisition Is Issued As A Request For Quote (rfq). (iii) Solicitation Document And Clauses: the Solicitation Document And Incorporated Provisions And Clauses Are Those In Effect Through Federal Acquisition Circular 2024-05. (iv) Acquisition Identification Number: 75f401-24-q-1279476 for Purposes Of This Acquisition, The Associated Naics Code Is 811310. The Small Business Size Standard Is $11 Million1. This Action Is Being Solicited As A Noncompetitive/sole Source/brand Name. 0001 :1 Funding For Cfsan-2024-124778 - Software License And Device Warranty For Gridion Instruments For Oarsa (vi) Specifications/requirement: the Purpose Of This Requirement Is To Acquire A Software License And Device Warranty For Two (2) Nanopore Technology’s Gridion Instruments, Device Id Gxb02111 And Device Id Gxb02130. These Gridion Instruments Are Used To Support Fda’s Next Generation Sequencing (ngs) Business Needs For Genomic Data Collection And Analysis. The Instruments Were Originally Purchased In Fy19, And This Procurement Includes One Instrument Belonging To The Division Of Veterinary Medicine (dva) And Another Belonging To The Division Of Microbiology (dmb). (vii) Delivery: the Period Of Performance Shall Be From 9/28/2024 Through 9/27/2025, With Acceptance Performed At The Destination. fob Point: Fda, Mod1 8301 Muirkirk Road, Laurel, Md 20708 delivery Location: Fda, Mod1 8301 Muirkirk Road Laurel, Md 20708. (viii) Provision At 52.212-1, Instructions To Offerors: the Provision At 52.212-1, Instructions To Offerors – Commercial Deviation 2018-o0018, Applies To This Acquisition. Offerors Should Follow The Instructions Provided In The Solicitation Document, Including Any Addenda. in Addition To The Requirements Set Forth In Far 52.212-1, All Offers Responding To This Solicitation Must Provide Their Business Size In Relation To The Naics Codes Contained In This Solicitation And Shall Identify Any Socioeconomic Categories To Which They Belong. (ix) Evaluation Criteria: this Acquisition Will Be Evaluated On A Noncompetitive Basis. As Only One Vendor Or Brand-name Is Available To Meet The Requirement, No Competitive Evaluation Is Applicable. (x) Offerors Representation: offerors Shall Include A Completed Copy Of The Provision At Far 52.212-3 (with Its Alternate I), Offeror Representations With Its Offer. (xi) Contract Terms And Conditions: the Clause At 52.212-4, Contract Terms And Conditions - Commercial Items, Applies To This Acquisition. Any Addenda To These Clauses Will Be Included In The Solicitation. (xii) Contract Terms And Conditions Required To Implement Statutes Or Executive Orders: 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: - 52.219-28: Post-award Small Business Program Representation (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) - 52.222-50: 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) Additional Contract Requirements Or Terms And Conditions: 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) - 52.204-27: Prohibition On A Bytedance Covered Application (jun 2023) - 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) Dpas Rating: this Acquisition Is Rated Under The Defense Priorities And Allocations System (dpas) As N/a. (xv) Date, Time, And Place Offers Are Due: date: 9/19/24 time:11:59 Pm Eastern Standard Time place: Offers Must Be Submitted Electronically To Raphael.hall@fda.hhs.gov (xvi) Contact Information For Solicitation: raphael Hall, Contract Specialist - Raphael.hall@fda.hhs.gov james O'keefe Iii, Contracting Officer - James.okeefeiii@fda.hhs.gov