2021 Niaid Dmid Omnibus Broad Agency Announcement Hhs Nih Niaid Baa2021 1 Introduction The National Institute Of Allergy And Infectious Diseases Niaid National Institutes Of Health Nih Of The Department Of Health And Human Services Dhhs Supports Research Related To The Basic Understanding Of Microbiology And Immunology Leading To The Development Of Vaccines Therapeutics And Medical Diagnostics For The Prevention Treatment And Diagnosis Of Infectious And Immune Mediated Diseases This Broad Agency Announcement Is Soliciting Proposals That Possess The Research And Development R Amp D Expertise Necessary For Successfully Carrying Out Research Toward Meeting The Program Objectives Of The Division Of Microbiology And Infectious Diseases Dmid Niaid Nih The Research Areas Included In This Niaid Dmid Omnibus Broad Agency Announcement No Hhs Nih Niaid Baa2021 1 As Well As The Projected Amounts Of Available Funding Are Discussed Below Division Of Microbiology And Infectious Diseaes Dmid Niaid Nih Research Area 001 Advanced Development Of Vaccine Candidates For Biodefense And Emerging Infectious Diseases The Objective Of Research Area 001 Is To Advance Vaccine Technologies And Platforms That Have Sufficient Proof Of Concept Data And Or Clinical Data To Support Vaccine Development Through Manufacturing Toxicology Testing And Testing In Phase 1 Or 2 Clinical Trials The Goal Of Research Area 001 Is To Advance Vaccine Technologies And Platforms Which Could Be Deployed Against Agents Important For Biodefense And Or Emerging Pathogens To Protect Human Health And Well Being The Development Of These Platforms And Technologies To Rapidly Progress Into Phase 1 Clinical Trials Will Provide Critical Data To Reduce The Risk For Future Development Of These Technologies Into Approved Therapies And Vaccines Solicited Products Are Anticipated To Include Vaccines For Anti Microbial Resistant Amr Organisms And Vaccines For Pandemic Preparedness And Emerging Infectious Diseases Niaid Estimates That Three 3 Or More Awards May Be Issued Across This Research Area And The Next Research Area Entitled Development Of Therapeutic Products For Biodefense Anti Microbial Resistant Amr Infections And Emerging Infectious Diseases For A Total Cost Of Up To 11 Million For The Non Severable Base Work Direct And Indirect Costs Combined Across All Contracts The Total Duration Of A Proposed Contract Should Be Consistent With The Nature And Complexity Of The Offeror S Proposed Research The Total Performance Period Comprised Of The Base And Any Options Proposed By An Offeror Shall Not Exceed Five 5 Years Research Area 002 Development Of Therapeutic Products For Biodefense Anti Microbial Resistant Amr Infections And Emerging Infectious Diseases The Objective Of Research Area 002 Is The Development Of Promising New Therapeutics To Address Infections Caused By Niaid Category A B And C Priority Pathogens And Select Bacterial And Fungal Infections Identified In The 2019 Cdc Antibiotic Resistance Threats Report Https Www Cdc Gov Drugresistance Pdf Threats Report 2019 Ar Threats Report 508 Pdf For The Purposes Of This Solicitation Therapeutic Activity Is Defined As The Cure Or Mitigation Of Disease Preferably Once Signs And Symptoms Of Infection Are Evident For The Purposes Of This Solicitation A Therapeutic Candidate Refers To An Advanced Lead Series Optimized Leads Or Product Candidate And Is Either A Small Molecule Synthetic Or Natural Product Or A Biological Product E G Monoclonal Antibodies Recombinant Proteins Solicited Products Are Anticipated To Include Antimicrobial Therapeutics Antiviral Therapeutics And Anti Toxin Therapeutics Niaid Estimates That Three 3 Or More Awards May Be Issued Across This Research Area And The Preceding Research Area Entitled Advanced Development Of
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