FOOD AND DRUG ADMINISTRATION USA Tender

75f40124q00381 Sources Sought 1 Each (ea)oxford Nanopore Promethion 2 Solo Long Read Sequencing Instrument And Purchase Of Consumables. this Is A Sources Sought Notice To Determine The Availability And Capability Of Small Businesses (including Certified 8(a), Small Disadvantaged, And Hubzone Firms; Veteran And Service-disabled Veteran-owned Small Businesses, And Women-owned Small Businesses. This Notice Is For Planning Purposes Only, And Does Not Constitute An Invitation For Bids, A Request For Proposals, Solicitation, Request For Quotes, Or An Indication The Government Will Contract For The Items Contained Herein. This Notice Is Not To Be Construed As A Commitment On The Part Of The Government To Award A Contract, Nor Does The Government Intend To Pay For Any Information Submitted As A Result Of This Notice. The Government Does Not Reimburse Respondents For Any Cost Associated With Submission Of The Information Being Requested Or Reimburse Expenses Incurred To Interested Parties For Responses To This Source Sought. Any Responses Received Will Not Be Used As A Proposal. the U.s. Food And Drug Administration (fda) Is Conducting Market Research To Support The Center For Veterinary Medicine Requires A Lease Or Purchase Of A 1 Each (ea)oxford Nanopore Promethion 2 Solo Long Read Sequencing Instrument And Purchase Of Consumables. the Fda Is Seeking Small Business Sources To Determine The Availability And Capability Of Small Business Providers For The Items Described Herein. Other Than Small Business Concerns Are Also Encouraged To Submit Capability Statements. The Following Information Is Provided To Assist The Fda In Conducting Market Research To Identify Potential Contractors For This Effort. the Fda Anticipates Only One Source Available Therefore The Fda Intends To Award A Sole Source, Firm Fixed Price Purchase Order To Oxford Nanpore Technologies Under The Authority Of Far 13.106-1(b)(1), Only One Responsible Source And No Other Supplies Or Services Will Satisfy Agency Requirements; Depending On The Results Of This Sources Sought/market Research Notice If No Other Capable Sources Are Found. the Associated North American Industry Classification System (naics) Code Is-334516- Analytical Laboratory Instrument Manufacturing.; Small Business Size Standard Is 1000 Employees. statement Of Work background: Traditional Next Generation Sequencing Of Whole Genomes Is Done In Short 75bp – 150bp Fragments. However, These Short Reads Are Not Optimal For Discovering Large Scale Genomic Changes, And Will Not Align To The Reference Genome Using Established Pipelines. To Ascertain Whether Large scale Genomic Rearrangements Have Occurred, An Instrument With Long Read Length Sequencing Technology Is Required. The Division Of Applied Veterinary Research At The Center For Veterinary Medicine’s Office Of Applied Science (cvm/oas/davr) Requires An Instrument With Long Read Length Capability That Can Sequence A Mammalian Genome In A Cost-effective Manner To Perform Our Studies On The Safety Of Gene Editing Technologies In Food And Drug Producing Animals. In Addition, The Division Of Emerging Technologies At The Center For Veterinary Medicine’s Office Of Applied Science (cvm/oas/det) Needs Specific Oxford Nanopore Consumables In Support Of Multiple Studies. purpose: this Acquisition Is For The Lease Or Purchase Of An Oxford Nanopore Promethion 2 Solo Long Read Sequencing Instrument And Purchase Of Consumables. This Covers The Device And Consumables, Which Must Be Cross Compatible With Each Other, And The Device Shall Be Compatible With An Existing Instrument In Our Laboratory, The Oxford Nanopore Gridion. If The Device Is Normally Offered To Other Purchasers Or Lease In Conjunction With Consumables, The Consumables Should Also Be Included. salient Features: 1. The Sequencing Device When Connected To An Existing Oxford Nanopore Gridion, Shall Meet The Following Requirements At The Minimum: shall Be Able To Produce Dna Sequencing Reads Greater Than Or Equal To 4 Mb Long shall Be Able To Produce A Raw Read Accuracy Greater Than 99% shall Be Able To Concurrently Run At Least 2 Independent Sequencing Experiments (rna And/or Dna) shall Be Able To Produce Sequencing Reads At A Rate Equal To Or Greater Than 150 Gb Per Independent Sequencing Experiment Per 75-hour Instrument Run Period shall Be Able To Connect And Operate In Conjunction With An Oxford Nanopore Gridion. shall Be Able To Fit On A Benchtop Space With A Footprint Equal To Or Less Than 18 Inches In Length By 18 Inches In Width, And Be Less Than 12 Inches In Height Due To Limitations In Lab Space shall Use A Standard 120-volt, Type B Plug shall Have Published Sequencing Protocols For Mammalian Genomic Dna Available shall Have Been Cited In Peer Reviewed Publications, To Show That This Instrument Produces High Quality Sequencing Data Across Multiple Users warranty: A 1-year Manufacturer Warranty, With The Option To Renew Annually, Whereby Payment Of The License Renewal Fee Extends The Lease Time At No Additional Cost, If Applicable. The Requirements Of This Warranty Are Specified In The Following Section. 3) Required Consumables: As Part Of This Acquisition, The Following Consumables Are Required, And Are In Addition To Any Consumables Offered With The Device As Part Of Any Starter Package. The Consumables Shall Arrive Based Upon A Schedule Arranged Between The Contractor And The Tpoc Upon Contract Award, With All Consumables To Be Delivered Within The First Year Of Performance. Due To Evolving Technology, The Contractor Shall Ship The Latest Version Of The Kits Available Unless Otherwise Requested By The Cor. at The Minimum, The Following Consumables Are Required For Cvm/oas/davr For The Sequencing Device And Compatible With The Oxford Nanopore Promethion. Any Consumables Typically Offered With Starter Packages Can Count Towards The Below Listed Items: quantity 4 Sequencing Kits, With Each Kit Capable Of Generating 6 Sequencing Libraries And Compatible With The Promethion 2 Solo Sequencing Device. quantity 24 Individual Flow Cells Compatible With The Promethion 2 Solo Sequencing Device due To Concerns With Product Expiration And Uncertainty On When The Instrument Will Be Received And Accepted, Cvm Anticipates Needing The Consumables To Be Delivered Over The Course Of The Base Year Period Of Performance In Quantities Requested By Cvm In 5 Shipments. The Delivery Of Consumables Shall Occur Within 30 Days Of Request Cvm. at The Minimum, The Following Consumables Are Required For Cvm/oas/det Required To Be Compatible With The Oxford Nanopore Gridion: quantity 10 Rapid Barcoding Kits, 96 Barcodes quantity 2 Native Barcoding Kit, 96 Barcodes quantity 1 Flow Cell Wash Kit, Xl (bulk Size) quantity 24 Gridion Flow Cell 5. Other Requirements: site Preparation Information: Offerors Shall Include In Their Proposal Any, And All Site-preparation Information Required For Proper System Operation And Maintenance, Including Physical Space, Ventilation, And It/network Requirements. 6. Warranty And Maintenance: the Device Shall Be Warrantied For Parts And Labor For At Least 12 Months From The Date Of Acceptance. Warranty Service Shall Include The Following: the Vendor Shall Provide All Travel, Labor, Shipping, And Parts Required At No Additional Charge. coverage Shall Include Troubleshooting Capabilities Based On Complete Knowledge Of The Entire Instrument, Immediate Access To Certified Replacement Parts, And Immediate Access To Improvements And New Procedures Provided By The Original Vendor And Manufacturer. any Necessary Service Shall Be Provided By Service Engineers Who Are Trained And Certified By The Original Manufacturer Of The Instrument. the Vendor Shall Provide Documentation Of Training/certification As Part Of The Proposal Package. If The Vendor Is Not Directly Providing Service, The Vendor Shall Provide Documentation Of Previous Experience Providing Service For The Requested System Through Contract History With The Oem Or Past Performance. engineers Shall Have Access To The Manufacturer’s Latest Technical Developments, Repair Procedures, Application Updates, Diagnostic Software, And Planned Maintenance Procedures. the Technical Point Of Contact (tpoc) Or Their Designee Shall Have Access To The Manufacturer’s Technical Assistance Call Center During Regular Business Hours (8am To 4pm Est). The Technical Assistance Call Center Shall Be Staffed By Engineers Who Provide A High Level Of Expertise For Troubleshooting The Instrument. the Vendor Shall Be Able To Guarantee That A Service Engineer Will Work Remotely With The User To Troubleshoot The Instrument, And Either Send Out An Engineer To Repair The Instrument Or Have The Instrument Sent Back To The Manufacturer For Repair Or Replacement. repair Work That Is Not Covered By The Maintenance/support Agreement Is Not To Be Initiated By The Vendor Unless The Government Contracting Officer Has Given The Vendor Proper Authorization. 5. Maintenance Agreement the Original Equipment Manufacturer (oem) Shall Propose An Base (12 Months) And 4 Option Period (12 Months) For The Maintenance Agreement Covering The Instrument Preventative Maintenance, Repairs, And All Consumables, Labor, And Parts. period Of Performance the Deliver Of The Instrument Shall Be Within 60-days Of Award. consumables: Base Period (12 Months) 7 Shipments/within The Base Period. consumables For Davr Are Anticipated To Be Requested In 5 Shipments During The Base Period Of Performance; The Schedule Will Be Determined By The Timing Of The Instrument Delivery And Acceptance. Consumables For Det Will Be Requested In 2 Shipments. acceptance: the Delivery Will Be Inspected By The Tpoc For Order Accuracy And Condition. When Package Is Received In Good Order, And Then The Acceptance Will Take Place. Acceptance Will Take Place Within 5 Business Days Of Receipt. The Delivery Will Be Rejected If There Is Any Damage To The Box Or Instrument Or If The Product(s) And Delivery Packing Slip Does Not Match The Order. No Partial Orders Shall Be Accepted. address: 8401 Muirkirk Rd, Bldg Mod2, Loading Dock, Laurel, Md 20708 installation Of The Instrument By The Contractor Is Not Required. pocs: instrument And Davr Consumables – Tbd det Consumables –tbd the Offeror Shall Furnish Sufficient Technical Information Necessary For The Government To Conclusively Determine That The Offered Products/services And Components Meet The Technical Requirements Identified Above. Though The Target Audience Is Small Business Manufacturers Or Small Businesses Capable Of Supplying A U.s. Made Product/service Of A Small Business Manufacturer Or Producer All Interested Parties May Respond. At A Minimum, Responses Shall Include The Following: business Name, Sam Unique Entity Id Number, 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 If Responding To Provide A Product Manufactured By Another Firm); sufficient Descriptive Literature That Unequivocally Demonstrates That Offered Products And Services Can Meet The Above Requirements. All Descriptive Material Necessary For The Government To Determine Whether The Service/product Offered Meets The Technical Requirements Including: Technical Specifications, Iso Certifications, Descriptive Material, Literature, Brochures And Other Information, Which Demonstrates The Capabilities Of The Contractor To Meet The Requirement. past Performance Information Within The Last Three Years In Which The Offeror Has Provided Same Or Substantially Similar Solutions And Used For Same Or Near-same Applications For Mass Spectrometry Analysis For Human Plasma Samples As Set Forth Herein. 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 (if Different From That Provided For Client), Client Point Of Contact Phone Number, Client Point Of Contact Email Address, And Name Of The Manufacturer (to Include Sam Unique Entity Id Number And Size Status) If Not The Respondent. if Applicable, Identification Of The Firm's Gsa Schedule Contract(s) By Schedule Number And Sins That Are Applicable To This Potential Requirement. Detailed List Of Items Included And Not Included On The Gsa Contract To Meet This Requirement. if Applicable, Identification Of Best In Class (bic) Contract Information Or Other Government-wide Or Hhs-wide Contracts That The Equipment/service Is Available On. provide Information If Any Of These Specifications Are Too Restrictive. No Response Will Be Considered That The Listed Specifications Are Adequate In A Competitive Environment. if A Large Business, Identify The Subcontracting Opportunities That Would Exist For Small Business Concerns; standard Commercial Warranty And Payment Terms; provide Place Of Service Performance And Any Other Applicable Information To Enable Review And Analysis To Place Of Performance. Provide (1) The Place Of Performance For The Services. though This Is Not A Request For Quote, Informational Pricing Is Required. the Government Is Not Responsible For Locating Or Securing Any Information, Not Identified In The Response.the Government Encourages Any Comments And/or Suggestions From Any Interested Party, Regarding The Specifications. While The Government Will Not Respond Directly To Your Comments And/or Suggestions; We Will Consider Them As We Finalize The Specifications In Preparation For The Forthcoming Solicitation. interested Parties Shall Respond With Capability Statements Which Are Due By Email To The Point Of Contact Listed Below On Or Before July 9, 2024, By 10:00 Hours Et To Patricia.natividad@fda.hhs.gov. notice Of Intent responses To This Source 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 Solicitation May Be Published In Sam.gov. 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).