FOOD AND DRUG ADMINISTRATION USA Tender

Market Research Purposes Only not A Request For Proposal Or Solicitation the U.s. Food And Drug Administration (fda) Is Conducting Market Research To Support The National Center For Toxicological Research (nctr) Requirement For A Preventative Maintenance And Service Contract On Biotek Cytation 5, A Cell Imaging Multi-mode Reader Microscope. the Fda Is Seeking Small Business Sources To Determine The Availability And Capability Of Small Businesses Capable Of Providing The Required Services. 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 Associated North American Industry Classification System (naics) Code Is- 811210 – Electronic And Precision Equipment Repair And Maintenance; The Applicable Small Business Size Standard Is $34m. statement Of Work 1.0 Introduction 1.1 Background the Division Of Systems Biology (dsb) Requires A Field Service Contract For The Biotek Cytation 5, A Cell Imaging Multi-mode Reader Microscope. The Post Warranty Field Service Contract Shall Provide Coverage For Repair, Parts, Labor, Travel As Well As One (1) Planned Preventative Maintenance Conducted On-site At Nctr. The Biotek Cytation 5 (s/n 1908282; Fda Barcode: 4006740) Is One Of The Primary Instruments Used For Data Collection On Nctr/cder-funded E0764401. The Instrument Is Also Used By Other Investigators Within Dsb To Support A Wide Range Of Research Protocols Requiring Plate Reading And/or Microscopy Capabilities. 1.2 Objectives field Service Contract Shall Cover Repairs, Parts, Labor, Travel As Well As One (1) Planned Preventative Maintenance Conducted On-site At Nctr. 2.0 Constraints shall Meet All Criteria Listed In Section 4.0. contract Shall Cover: Electronic, Electromechanical And Mechanical Components Necessary For The Proper Operations, Buy May Not Include Cabinet And Housings, Overlays, Painting, Trim Decorations, And Controls External To The Equipment. Consumables (i.e. Normal Wear-and-tear Items Such As Liners, Seals And Tubing) Shall Be Included In The Service Contract. Genuine Biotek Repair Parts Shall Be Covered Under The Contract. 3.0 Scope the Field Service Contract Shall Provide Coverage For Repair, Parts, Labor, Travel As Well As One (1) Planned Preventative Maintenance Conducted On-site At Nctr For The Biotek Cytation 5 Instrument. Option Years For Additional Service Are Being Requested. 4.0 Tasks preventative Maintenance And Repair Requirements For Post Warranty Coverage Shall Include, At Minimum: - One (1) Preventative Maintenance Visit Per Contract Year Inclusive Of All Labor, Travel, Parts, Components, Subassemblies, Etc. Necessary To Provide The Service. - Unlimited On-site Corrective/remedial Maintenance/repairs To Be Scheduled At The Time-of-service Request Within Five (5) Calendar Days From Service Call. On-site Repair Shall Be Inclusive Of All Labor, Travel, Certified Replacement Parts, Components, Subassemblies, Etc. Needed To Return The System To Operational Capacity. If The Instrument Cannot Be Repaired, Then The Instrument Will Be Replaced. - Unlimited Technical Support And Trouble-shooting Assistance And Access By The Fda Contracting Officer's Representative (cor), Technical Point Of Contact (tpoc) And System Operator Personnel To The Manufacturer's Call Center For Technical Assistance, Which Is Staffed By Senior Engineers To Provide A High Level Of Expertise For Troubleshooting The Instrument. Response Within Eight Business Hours Of Contact For Assistance (e.g., Telephone-based, Email-based, Website-based, Etc.). - Formally Trained And Certified Technicians/engineers For All Maintenance And Repair Activities Performed, Following Original Equipment Manufacturer (oem) Specifications, Manuals, And Service Bulletins, Using New Oem Replacement Parts, Components, Subassemblies, Etc. - Unlimited Software And Firmware Updates. - Pricing Shall Be Inclusive Of All Labor, Travel, Replacement Parts, Components, subassemblies, Etc. 5.0 Deliverables the Contractor Shall, Commensurate With The Completion Of Each Service Call, Provide The End-user Of The Equipment With A Copy Of The Field Service Report/ticket By Email Identifying The Equipment Name, Manufacturer, Model Number And Serial Number Of The Equipment Being Serviced/repaired And Detailing The Reason For The Service Call, A Detailed Description Of The Work Performed, The Test Instruments Or Other Equipment Used To Affect The Repair Or Otherwise Perform The Service, The Name(s) And Contact Information Of The Technician Who Performed The Repair/service, And For Information Purposes, The On-site Hours Expended, And Parts/components Replaced. In Addition, The Contractor Shall Provide A Written Report To The Fda Contracting Officer’s Representative And/or Tpoc By Email, Summarizing All Maintenance And Repair Activities Each Time Service And/or Repair Is Performed. 6.0 Period Of Performance period Of Performance For Base Year 09/04/24-09/03/25. period Of Performance For Option Years: Option Year 1 09/04/25-09/03/26 Option Year 2 09/04/26-09/03/27 7.0 Place Of Performance the Field Service Contract Shall Cover Repairs, Parts, Labor, Travel As Well As One (1) Planned Preventative Maintenance Conducted On-site At The Following Address: nctr/fda 3900 Nctr Road jefferson, Ar 72079 building 53a, Room 204 8.0 Government Furnished Equipment (gfe)/government Furnished Information no Government-furnished Property Or Government-furnished Information Will Be Provided In The Scope Of This Acquisition. 9.0 Security Requirements the Field Service Contract Requires On-site Visits For Performing Preventative Maintenance And/or Repairs. All Visits By Off-site Contracted Personnel Will Be Coordinated In Advance With The Appropriate Security Officials. Off-site Contract Staff May Be Required To Provide Information Or Documentation, Such As Citizenship Information, To Receive Clearance For On-site Visits. software And Firmware Updates On The Instrument And/or Associated Computer Workstation May Also Be Performed Under The Field Service Contract. fob Point Destination. All Items Shall Include Shipping And Handling To The Destination Identified Herein. alternative Solutions Will Be Considered Insofar As Any Such Alternate System And/or System Components Meet The Minimum Intended Use Of The System And Brand Name Or Equal Technical Requirements. 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 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, Descriptive Material, Literature, Brochures And Other Information, Which Demonstrates The Capabilities Of The Contractor To Meet The Requirement. • Three (3) Years Of Past Performance Service Information, If Not The Manufacturer Of The Equipment Identified Herein, Where The Respondent Has Provided Same Or Substantially Similar Service Solutions On The Same Or Near-same Brand Name Equipment. 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. • Capability And Understanding Of Accessibility Testing And Customization To Conform With The Applicable Section 508 Standards Identified Herein. Provide Information If The Respondent Has An Accessibility Conformance Report (acr) For The Products Offered For The Revised 508 Standards. The Acr Should Be Based On The Voluntary Product Accessibility Template Version 2.0 (ms Word) Provided By The Industry Technology Industry Council (itic). • If A Large Business, Identify The Subcontracting Opportunities That Would Exist For Small Business Concerns; • Standard Commercial Warranty And Payment Terms; • Differing Levels Of Service Agreement Coverage Available; • Provide Place Of Product Manufacture Or Service Performance And Any Other Applicable Information To Enable Review And Analysis Pertaining To The Buy American Statute And Requirements Relating To Made In America In The Event A Nonavailability Waiver Request Through The Miao Digital Waiver Portal Is Needed; And • Though This Is Not A Request For Quote, Informational Pricing Is Encouraged. 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 May 17, 2024 By 13:00 Hours (central Time In Jefferson, Arkansas) To Nick.sartain@fda.hhs.gov. Reference Nctr-2024-123527. notice Of Intent responses To This Sources 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).