1 0 Description The Department Of Health And Human Services National Institutes Of Health National Cancer Institute Nci Division Of Cancer Epidemiology And Genetics Dceg Plans To Procure On A Sole Source Basis Services For Laboratory Testing Services For The Helicobacter Pylori Genome Project From Vanderbilt University Medical Center At 1161 21St Ave S Ste D3300 Mcn Nashville Tn 37232 0011 The Response Close Date Of The Notice For This Requirement Is In Accordance With Far 5 203 B This Acquisition Will Be Processed Under Far Part 12 Acquisition For Commercial Items And Will Be Made Pursuant To The Authority In Far Part 13 106 1 B 1 And Is Exempt From The Requirements Of Far Part 6 The North American Industry Classification System Code Is 541380 And The Small Business Size Standard Is 16 5 Million The Period Of Performance Shall Be 12 Months From The Date Of Award The Anticipated Award Shall Be A Firm Fixed Price Purchase Order For Severable Services It Has Been Determined There Are No Opportunities To Acquire Green Products Or Services For This Procurement 2 0 Background Helicobacter Pylori A Gram Negative Bacterium Associated With A Spectrum Of Benign And Malignant Gastric Conditions Is One Of The Most Genetically Variable Pathogens Variations In A Few Genes Have Been Associated With Risk Of Inflammation And Carcinogenesis But To Date No Systematic Study Has Evaluated The Entire Bacterial Genome The U S Department Of Health And Human Services National Institutes Of Health National Cancer Institute Nci Division Of Cancer Epidemiology And Genetics Dceg Requires Laboratory Testing Services To Enlarge An Informative Collection Of H Pylori Clinical Isolates From Residents Of Defined Geographic Areas Molecular Characterization Will Be Conducted At The Nci S Cancer Genomics Research Laboratory Dceg Is Investigating The Hypothesis That Genetic And Epigenetic Variations In H Pylori Strains Among Chronically Infected Individuals May Affect Risk Of Progression To Gastric Cancer Additional Testing Is Required From International Populations To Characterize The Differential Virulence Among H Pylori Isolates And Suggest Predictive Biomarkers For Early Diagnosis Of Cancer The Bacterial Isolates And Databases From This Requirement Will Also Provide A Foundation For Further Elucidation Of H Pylori Pathogenesis 2 1 Objective The Specific Aims Of This Requirement Are To Characterize The Spectrum Of Genomic And Epigenomic Variations Of Benign Strains Of H Pylori Based On Isolates From Chronically Infected Individuals To Identify Molecular Features That May Contribute To Pathologic Effects By Comparing The Profile Of Benign Infection To Corresponding Spectra Of Isolates From Individuals With Gastric Cancer And Premalignant Lesions To Establish A Resource Repository Of Multidimensional Data And Well Characterized Strains For Utilization By The Scientific Community 3 0 Scope The Contractor Shall Expand Extract And Store Dna From H Pylori Isolates Culture Isolate And Extract Dna From H Pylori Pools Perform H Pylori Analysis On Successful Patient Biopsies Or Resections And Perform H Pylori Analysis On Un Successful Patient Biopsies Or Resections As Specified Below The Contractor Shall Use Reduced Oxygen Conditions And Other Best Practices For Isolation Of H Pylori With Appropriate Laboratory Biosafety Provisions From The Cdc Samples Shall Be Cultured In Trypticase Soy Agar With 5 Sheep Blood Containing Vancomycin 20 Mg L Bacitracin 200 Mg L Nalidixic Acid 10 Mg L And Amphotericin B 2 Mg L Sigma Aldrich Agar Plates Shall Be Incubated Under Microaerobic Conditions 6 O2 6 Co2 And 88 N2 Campy Pak Plus Envelope Bbl At 37 C For 4 To 8 Days Until Small Grey Translucent Colonies Appear Gram Stains And Assays For Oxidase And Urease Shall Be Performed To Confirm Bacteria As H Pylori Dna 1 5 2Ug Shall Be Extracted From Single Colonies Using The Dnaeasy Mini Kit The Cost Of Shipping Samples To From The Contractor S Facility Shall Not Be Included In This Order Nci Shall Ship The Samples For This Requirement To The Contractor Via The Nih Shipping Service The Samples Shall Be Delivered To The Contractor S Facility In Six 6 Separate Shipments The First Sample Shipment Shall Be Delivered To The Contractor S Facility Within One 1 Month Of Award And The Final 6Th Shipment Shall Be Delivered To The Contractor S Facility Within Six 6 Months Of Award 3 1 Tasks The Contractor Shall Perform The Following Tasks 3 1 1 Task 1 For Existing H Pylori Isolates The Contractor Shall Expand 7 Petri Plates Extract Dna 2 Plates Separately And Store 5 Plates In Separate Vials Total Samples For Task 1 450 Samples 3 1 2 Task 2 For Existing H Pylori Pools The Contractor Shall Culture Isolate 1 Colony Expand 7 Petri Plates Extract Dna 2 Plates Separately And Store 5 Plates In Separate Vials Total Samples For Task 2 60 Samples 3 1 3 Task 3 For Successful Patient Biopsies Or Resections The Contractor Shall Culture Store 3 Pooled Vials Isolate 1 Colony Expand 7 Petri Plates Extract Dna 2 Plates Separately And Store 5 Plates In Separate Vials Total Samples For Task 3 135 Samples 3 1 4 Task 4 For Unsuccessful Patient Biopsies Or Resections The Contractor Shall Perform Analysis Attempted Culture Total Samples For Task 4 36 Samples 3 1 5 Task 5 The Contractor Shall Provide An Electronic Report To The Nci Containing The Results Of Unsuccessful Patient Biopsies Or Resections In 3 1 4 Task 4 See Also 3 1 7 Task 7 3 1 6 Task 6 The Contractor Shall Coordinate With And Ship The Resulting Materials In Multiple Shipments To The Nci S Cancer Genomics Research Laboratory At 8717 Grovemont Circle Atc Room 149 Gaithersburg Md 20877 3 1 7 Task 7 The Contractor Shall Maintain A Repository Of Bacterial Isolates And Provide Information About Availability The Contractor Shall Provide This Information To Nci Electronically Together With The Final Report For 3 1 5 Task 5 4 0 Type Of Order This Is A Firm Fixed Price Purchase Order 5 0 Period Of Performance The Period Of Performance Shall Be 12 Months From The Date Of Award 6 0 Severable Services The Services Acquired Under This Task Order Are Severable Services Funds Are Only Available For Use For The Line Item To Which They Are Obligated Unused Funds From One Period Line Item May Not Rollover For Use In Other Periods 7 0 Place Of Performance All Services Shall Be Performed At The Contractor S Facility 8 0 Report S Deliverables And Delivery Schedule Deliverable Deliverable Description Format Requirements Amp Due Date 1 3 1 1 Task 1 450 Dna Samples As Specified In Task 3 1 1 Delivered To Nci S Cancer Genomics Research Laboratory Due Within 4 Months Of Specimen Receipt 2 3 1 2 Task 2 60 Dna Samples As Specified In Task 3 1 2 Delivered To Nci S Cancer Genomics Researchlaboratory Due Within 4 Months Of Specimen Receipt 3 3 1 3 Task 3 135 Dna Samples As Specified In Task 3 1 3 Delivered To Nci S Cancer Genomics Researchlaboratory Due Within 4 Months Of Specimen Receipt 4 3 1 5 Task 4 Email Report In Word Format For 36 Unsuccessful Cultures To Be Provided When Applicable At The Time Of Discovery Of Unsuccessful Culture Final Version Due Within 12 Months Of Award 5 3 1 7 Tasks 1 3 Repository Of Bacterial Isolates Information About Availability In Excel Format Via Email Due Within 4 Months Of Final Specimen Receipt 9 0 Payment Payment Shall Be Made Upon Receipt Review And Acceptance Of Each Deliverable In Section 8 0 Payment Authorization Requires Submission And Approval Of Invoices To The Government s Technical Point Of Contact Tpoc And Nih Ofm Electronic Email Submission The Current National Emergency And The Need To Protect Federal And Contractor Staff Has Resulted In A Change To Nih S Invoice Submission Process Effective Wednesday April 1 2020 All Nih Contractors Vendors Invoices Should Be Sent Electronically Via Email To The Nih Office Of Financial Management Ofm And The Nih Contracting Officer Co Using The Electronic Submission Instructions Contained In Attachment 1 Electronic Invoice Submission Shall Remain In Effect Until The Government Formally Notifies The Contractor Of A Return To Mail In Invoice Procedures Detailed In This Purchase Order This Notice Is Not A Request For Competitive Quotation However If Any Interested Party Especially A Small Business Believes It Can Meet The Above Requirements It May Submit A Proposal Or Quote For The Government To Consider The Response And Any Other Information Furnished Must Be In Writing And Must Contain Material In Sufficient Detail To Allow Nci To Determine If The Party Can Perform The Requirement All Responses And Questions Must Be Sent Via Email To Contracting Officer Megan Kisamore At Megan Kisamore Nih Gov By No Later Than 3 00 Pm Est On Friday May 15 2020 5 15 20 A Determination By The Government Not To Compete This Proposed Requirement Based Upon Responses To This Notice Is Solely Within The Discretion Of The Government Information Received Will Be Considered Solely For The Purpose Of Determining Whether To Conduct A Competitive Procurement In Order To Receive An Award Contractors Must Be Registered And Have Valid Certification Through Sam Gov Please Reference75n91020q00072 On All Correspondence
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