FOOD AND DRUG ADMINISTRATION USA Tender

This Is A Sources Sought Announcement, A Market Survey For Written Information Only. This Is Not A Solicitation Announcement For Proposals And No Contract Will Be Awarded From This Announcement. No Reimbursement Will Be Made For Any Costs Associated With Providing Information In Response To This Announcement Or Any Follow-up Information Requests. No Telephone Calls Will Be Accepted Requesting An Rfq Package Or Solicitation. There Is No Rfq Package Or Solicitation. In Order To Protect The Procurement Integrity Of Any Future Procurement, If Any, That May Arise From This Announcement, Information Regarding The Technical Point Of Contact Will Not Be Given And No Appointments For Presentations Will Be Made. the U.s. Food And Drug Administration (fda), Office Of Acquisitions And Grants Services (oags) Is Issuing This Source Sought Announcement On Behalf Of The Center For Biologics Research And Review (cber), Office Of Blood Research And Review (obrr), In Order To Determine If There Are Existing Small Business Sources Capable Of Providing A “brand Name Or Equal” Terumo Blood And Cell Technologies (bct), Mirasol Illuminator, Ultraviolet (uv)/riboflavin Whole Blood Pathogen Reduction Device. Other Than Small Business Concerns, Especially Vendors Who May Be Able To Offer Domestic Products, Are Also Encouraged To Submit A Capability Statement That Provides Company Information, As Well As Information Demonstrating That It Can Meet All Of The Minimum Requirements Included Below, To Include The Country Of Manufacture Of Products Offered. if Your Firm Is Considered A Small Business Source Under North American Industry Classification System (naics) Code 334516 - Analytical Laboratory Instrument Manufacturing; With A Small Business Size Standard Of 1,000 Employees And You Believe That Your Firm Would Be Able To Provide The Fda With The Supplies/services Described Below, Please Submit An Email To Warren.dutter@fda.hhs.gov. background: the Office Of Blood Research And Review Conducts Research On Pathogen Reduction Of Blood And Blood Components Through The Laboratory Of Pathogen Reduction Research, A Collaborative Group Of Principal Investigators. Currently, There Is No Approved Device For Pathogen Reduction Of Whole Blood Or Red Blood Cells In The United States. However, Internationally, A Pathogen Reduction Device Based On Addition Of Riboflavin Followed By Exposure To Uv Light (313 Nm), Known As The Mirasol System (terumo Bct), Has Been Approved By The European Medicines Agency (ema) For Use In Whole Blood. This Technology Demonstrated The Ability To Reduce The Transfusion Transmission Of Malaria In Clinical Studies (allain Jp, Et Al. Effect Of Plasmodium Inactivation In Whole Blood On The Incidence Of Blood Transfusion-transmitted Malaria In Endemic Regions: The African Investigation Of The Mirasol System (aims) Randomized Controlled Trial. Lancet. 2016;387(10029):1753–1761.). Furthermore, The Technology Is Being Tested In Clinical Studies To Prevent A Composite Of Seven Transfusion-transmitted Infections (tti) (kasirye R, Et Al. The Mirasol Evaluation Of Reduction In Infections Trial (merit): Study Protocol For A Randomized Controlled Clinical Trial. Trials. 2022 Apr 4;23(1):257.). Because Mirasol Treated Whole Blood Has Been Characterized Through Clinical Studies Demonstrating Tti Reduction, Whole Blood Treated With This Technology Serves As A Critical Control When Investigating And Comparing To New Methods Of Pathogen Reduction. Although Fda Has Previously Conducted Research Into Pathogen Reduction (pr) Using Riboflavin/uv Treatment With Prior Generations Of The Mirasol Device, That Device Is No Longer Operational, And Fda Does Not Currently Have Access To A Device For Its Pr Research Program. the Center For Biologics Research And Review (cber), Office Of Blood Research And Review (obrr) Has A Requirement For A “brand Name Or Equal” Terumo Blood And Cell Technologies (bct), Mirasol Illuminator, Uv/riboflavin Whole Blood Pathogen Reduction Device. The Pathogen Reduction (pr) Device Will Be Used To Treat Whole Blood With And Without Inoculation Of Model Pathogens As A Control For Inactivation Capacity And Off-target Effects Of Candidate Pr Technologies Being Evaluated By Laboratory Of Pathogen Reduction Research (lprr). the Terumo Blood Bct, Mirasol Illuminator Has Been Validated By A Clinical Trial To Reduce Transfusion Transmitted Disease In A Patient Setting. It Is A Unique, Stand-alone Device, That Delivers A Standard Dose Of Uv Which Activates A Chemical Photosensitizer, Riboflavin. The Dose Of Uv Light Delivered Is Controlled By The Device And Varies With The Particular Blood Component Being Treated. For Example, A Unit Of Apheresis Platelets Will Be Exposed To A Different Dose Than A Unit Of Whole Blood. Performance Of This Device In Reducing Pathogens Introduced Into Various Blood Components Will Be The Standard In The Laboratory To Which All Other Developed Pathogen Reduction Methods Will Be Compared To. For Example, We Plan To Introduce A Virus (hepatitis) Into A Unit Of Blood And Treat One Half Of The Unit With The “brand Name Or Equal” Mirasol Illuminator Device And One Half With A New Pathogen Reduction Method Under Development. The Remaining Amounts Of Virus, After Treatment, Will Be Compared Between The “brand Name Or Equal” Mirasol Illuminator Treated Portion And The Alternate Method Treated Portion. If The Alternate Method Produces Similar Or Better Reduction Of The Virus, We Would Be Able To Conclude That The Alternate Method Would Also Provide Similar Protection Against Transfusion Transmitted Disease In Patients. this Requirement Is Configured As A “brand Name Or Equal”: Terumo Blood And Cell Technologies (bct), Mirasol Illuminator minimum Technical Requirements: illuminator Device shall Generate Uv Light To Illuminate Blood Products. uv Light Dose Shall Activate Riboflavin Added To The Blood Products. the Activated Riboflavin Shall React With Dna And Rna To Limit Proliferation Of Bacteria, Viruses, And Parasites. the Device Shall Have Been Tested For Its Effectiveness In Reducing Pathogens And For Toxicological Safety. the Device Shall Accommodate The Following Blood Products: whole Blood-derived Platelets In Plasma, Apheresis Platelets In Additive Solution, And Hyper-concentrated Apheresis Platelets. the Range Of Platelet Volumes Shall Be From 90ml To 450 Ml. the Treatment Shall Be Used For Single, Double, Or Triple Apheresis Platelet Products. the Final Platelet Concentration Shall Range From 0.7-2.10 X 10e11 Platelets /ul. fresh Frozen Plasma Products, Such As Whole Blood, Derived, And Apheresis-collected Products, Shall Be In A Volume Range Of 170-360 Ml. retention Of Clotting Factors After Treatment Shall Range From 100 + 6% To 68 + 7%. whole Blood Units shall Include Consumables For Treatment Of At Least 20 Whole Blood Units shall Include Exposure Bags For Processing Of Various Blood Products. the Bags Shall Be Validated For Delivery Of An Appropriate Dose Of Uv Light To Achieve Adequate Pathogen Reduction. shall Include Riboflavin, Produced, And Characterized For Safe And Effective Clinical Use. installation, Training And Additional System Requirements: the Components And Equipment Shall Be Newly Manufactured, Not Used Or Refurbished, Or Previously Used For Demonstration. offered Systems Shall Be A Turn-key Solution I.e., The Contractor Shall Be Responsible For Providing All Hardware, Components, Instruments, Computers, Software, And That Otherwise Required To Meet These Specifications And The Fda’s Stated Need. the Systems Shall Be Delivered With All Necessary Supplies And Accessories Required For Installation And Start-up. the System And Associated Accessories Shall Include Operations And Maintenance Manuals Covering Proper Operation, Routine Maintenance, And Troubleshooting For The System And Controlling Software. All Manuals And Documentation Shall Be Provided In Hard Copy And/or Electronic Format. the Contractor Shall Provide All Labor, Travel, And Tools To Install The Equipment At The Address Provided Below, To Include Shipping. The Contractor Shall Demonstrate Upon Installation That The Item Meets Or Exceeds All Performance Specifications. Upon Acceptance Of The System, The Contractor Shall Provide On-site Operator Training/familiarization. Such Familiarization Shall Include System Operations, Calibration, Optimization, Troubleshooting And Basic Operational Maintenance Procedures. systems Shall Be Warranted For Not Less Than One (1) Year From Fda Acceptance Of The System(s) To Include On-site Training. Warranty Service Shall Include Troubleshooting Capabilities Based On Complete Knowledge Of The Entire System, Immediate Access To Replacement Parts, And Immediate Access To System Improvements And Updates. Phone And Email Technical Support Shall Be Included For A Minimum Of One (1) Year. place Of Performance: fob Point Destination. All Items Shall Include Shipping, Handling And Inside Delivery And Installation To The Destination Identified Herein. fda/cber 10903 New Hampshire Ave. bldg. 52/72, Room 4242 silver Spring, Md 20993 period Of Performance: delivery, Installation, And Training Shall Occur Within 30 Calendar Days From Date Of Award. responses To This Sources Sought Shall Unequivocally Demonstrate That The Respondent Is Regularly Engaged In The Sale Of Same Or Substantially Similar Product/service. Though The Target Audience Is Small Business Vendors Or Small Businesses Capable Of Supplying A U.s. Service Of A Small Business Vendor Or Producer All Interested Parties May Respond. At A Minimum, Responses Shall Include The Following: business Name And Bio, Unique Entity Identification (uei) 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 Again If Responding To Provide A Service Offered By Another Firm. past Performance Information For The Manufacturer And/or Sale Of Same Or Substantially Similar Product And Service Or Similar Brand Instruments To Include Date Of Sale, Description, Dollar Value, Client Name, Client Address, Client 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 Uei Number And Size Status) If Not The Respondent. descriptive Literature, Brochures, Marketing Material, Etc. Detailing The Nature Of The Product And Service The Responding Firm Is Regularly Engaged In Manufacturing And/or Selling. the Offeror Shall Furnish Sufficient Technical Information Necessary For The Government To Conclusively Determine That The Offered Services Meet The Technical Requirements Identified Above. 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. if Applicable, Identification Of The Firm's Gsa Schedule Contract(s) By Schedule Number And Sins That Are Applicable To This Potential Requirement Are Also Requested. if A Large Business, Provide Whether Subcontracting Opportunities Exist For Small Business Concerns. standard Commercial Warranty And Payment Terms. 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. informational Pricing Is Desired. the Government Is Not Responsible For Locating Or Securing Any Information, Not Identified In The Response. interested Contractors Must Respond With Capability Statements Which Are Due By Email To The Point Of Contact Listed Below On Or Before May 13, 2024 By 1:00 Pm Central Time At The Food And Drug Administration, Field Operations Branch, Fda|oo|ofba|oags|dap, Attn: Warren Dutter, Email Warren.dutter@fda.hhs.gov. Reference: Fda-ssn-123690. 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 And Proprietary Information: 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). additional Notes: if The Stated Requirements Appear Restrictive, Please Submit Comments Detailing The Concern. Though This Is Not A Request For Quote, Informational Pricing For The Service Would Be Helpful.