FOOD AND DRUG ADMINISTRATION USA Tender

Purpose this Sources Sought Notice (ssn) Is For Market Research, Information, And Planning Purposesonly. This Ssn Does Not In Any Way Constitute A Request For Quotation (rfq) And As Such, Shall Not Be Construed As A Commitment By The Government (implied Or Otherwise) To Issue A Solicitation Or Ultimately Award A Contract. this Announcement Is Specifically Targeted To A) Identify Qualified Small Business Vendors Capable Of Providing The Equipment In This Notice. And B) Vendors Capable Of Providing A Domestic Product Offering. However, Responses From All Interested Parties Are Appreciated And Accepted. the Purpose Of This Requirement Is To Acquire An Automated Food Pathogens Detection Instrument To Support The Center For Food Safety And Applied Nutrition (cfsan) Efforts To Develop Protocols For Detecting Foodborne Pathogens In Food And Environmental Samples, Such As Shiga Toxin-producing E. Coli, Salmonella, And Food-borne Parasites (cyclospora Cayentanensis). The Automated Food Pathogens Detection Instrument Offers Quality Control Testing Solutions For Fast And Accurate Microbial Identification. With Technology That Includes An Extensive And Robust Identification Database, Rapid Results, And Minimal Training Time, It Will Streamline Laboratory Workflow For Increased Productivity. background the Automated Food Pathogens Detection Instrument Is An Essential Instrument For The Division Of Virulence Assessment (dva). The Instrument Detects A Broad Range Of Food Pathogens Using Proven Enzyme-linked Fluorescent Immunoassay And Current-edge Recombinant Phage Protein Technology. The Precise And Rapid Pathogen Detection Solution Is Suitable For A Wide Range Of Target Foodborne Contaminants And Analytical, Product Release Workflows. This Equipment Plays A Crucial Role In Oarsa/dva Research Endeavors By Enabling Rapid And Accurate Identification Of Foodborne Pathogens. The Automated Food Pathogens Detection Instrument’s Adaptable Automation Will Help Dva Labs Be More Productive, More Accurate, And More Innovative – All In One Simplified Platform. The Entire Operation Is Fully Automated From Incubation To Washing And Final Fluorescence Reading. Incubation Time And The Number Of Washing Cycles Are Optimized For Peak Performance. The Data Generated By The Automated Food Pathogens Detection Instrument Aids In Developing Robust Detection Methods Aligned With The Science-based Approach Required By The Cfsan Program Offices Overseeing The Policy Aspects Of The Produce Safety Rule. The Utilization Of Such Advanced Technology Enhances The Laboratories' Capabilities To Detect Human Pathogens Swiftly And Reliably On Fda-regulated Food Commodities, Supporting The Overarching Goals Of Ensuring Food Safety And Public Health. This Instrument Will Be Used By Several Investigators Within The Division Of Virulence Assessment (dva) And Available To Other Divisions, Within Oarsa, When Needed. system Salient Characteristics the Contractor Shall Provide An Automated Food Pathogens Detection System Meeting The Following Salient Characteristics: accessible Volume ­ Flexibility That Will Run 12 To 72 Samples At A Time. automated Alerts That Detect Leakage, Clogging, Reading, Etc. bi-directional Connectivity & Connect-up Enabled, Which Is A Laboratory Data Management System That Simplifies Workflow Start To Finish. increased Uptime With Vilink Software Which Is A Real-time Support System That Keeps The Instrument Running Via Remote Monitoring. Vilink Provides A Direct Connection Between The Vendor’s Technical Support Team And The System With Full Traceability And Data Security Though User-approved Access And Encrypted Communication. large Routine Test Menu With 13 Different Food Assays. 21 Cfr Part 11 Compliant Software. (software Is On The Mat Legacy Approval List, But Unknown At This Time, If The Instrument Will Be Connected To The Fda Network). system Warranty warranty To Include On-site Engineering Support Monday-friday, From 8am-4pm, Excluding Holidays, Within Forty-eight (48) Hours Of Determination From The Contractor That An On-site Visit Is Necessary. contractor Shall Provide Remote Applications And Engineering Support, Monday-friday, From 8am-4pm, Excluding Holidays. deliverables table 1. Deliverables / Schedule deliverable automated Food Pathogens Detection System. Qty1 Delivery Date: Within 30 Days After Receipt Of Order one Year Standard Warranty To Include On-site Engineering Support Monday-friday, 8am-4pm, Excluding Holidays, Within Forty-eight (48) Hours Of Determination By The Contractor That An On-site Visit Is Necessary. Contractor Shall Provide Remote Applications And Engineering Support, Monday-friday, 8am-4pm, Excluding Holidays. Qty 1 Delivery Date 12 Months Commencing From Th Date Of Delivery. shipping Destination all Deliverables Shall Be Made Fob Destination To The Address As Outlined Below. fda 8301 Muirkirk Rd. laurel Md 20708 the Delivery Or Services Must Be During Regular Business Hours (monday-friday) During The Times Of 8:00 Am – 4:00 Pm, Excluding Holidays. period Of Performance the Instrument Shall Be Delivered Within 30 Days After Receipt Of Order And Shall Come With A One-year Standard Warranty Commencing From The Date Of Delivery. requested Information capable Firms Must Submit Their Responses To The Below: company's Name, Mailing Address, Cage Code, And Unique Entity Identifier (uei) recommended North American Industry Classification System (naics) Code That Your Company Utilizes For In Support Of The Following Equipment: Motion Capture System what Is Your Company Size? If Small, What Is Your Socio-economic Status? identify Any Gsa Schedule Contract Or Other Current Government-wide Contract (e.g., Gwac Or Bpa) That Your Company Currently Holds And Offers These Products/services Under. domestic Manufacturing Status. technical Specifications For The Proposed Solution. disclaimer the Government Will Not Reimburse Respondents For Any Costs Associated With Information Submitted In Response To The Ssn. Responders Are Solely Responsible For All Expenses Associated With Responding To This Ssn. responses To This Ssn Are Not Offers And Cannot Be Accepted By The Government For The Basis Of Forming A Binding Contract. This Ssn Is Being Issued Solely For The Purpose Of Gathering Information For Planning Purposes. This Ssn Does Not Commit The Government To A Contract For Any Supply Or Service. Furthermore, The Government Is Not At This Time Seeking Quotes And Will Not Accept Unsolicited Quotes. respondents To This Ssn May Be Requested To Provide Additional Information/details Based On Their Initial Submittals. The Government Reserves The Right To Select, One (1), Some, Or None Of The Submissions For Further Information. Vendors Who Submit Information In Response To This Ssn Do So With The Understanding That U.s. Government Personnel May Review Their Materials And Or Data. response Deadline: responses Shall Be Submitted In Writing By E-mail To Contract Specialist, Iris Johnson, At Iris.johnson1@fda.hhs.gov, No Later Than August 13, 2024, 12:00 Pm Et. Questions Regarding This Ssn Must Be Submitted Via Email As Telephone Inquiries Willnotbe Addressed And Shallnotcontain Proprietary Or Classified Information.