National Institutes Of Health Tender

Amendment Twelve - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Twelve Is To: i) Update The "date Offers Due" In Beta Sam To April 20, 2020, 3:00pm Est For Research Area 001. Please Note That The "date Offers Due" For Each Research Area 003, 004, And 005 Remains Unchanged At April 9, 2020, 3:00pm Est. _______________________________________________________ amendment Eleven - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Eleven Is To: i) Provide Responses To Questions Received Regarding The Solicitation. ________________________________________________________ amendment Ten - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Ten Is To: i) Clarify Language Applicable Only To Covid-19 Proposals For Research Areas 003, 004, And 005. ii) Update 3.2.3.2 - Work Plan And Add Paragraphs J. And K. To Include Language Regarding Technical Proposal Cost Summary. iii) Update 4.3.2.2 - Section 5: Scientific And Technical Proposal And Add Paragraph 3 To Include Language For Offerors Proposing Multiple Principal Investigators. iv) Provide Responses To Questions Received Regarding The Solicitation. ________________________________________________________  amendment Nine - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Nine Is To: i) Provide Responses To Questions Received Regarding The Solicitation. _______________________________________________________ amendment Eight - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Eight Is To: i) Provide Responses To Questions Received Regarding The Solicitation. _________________________________________________________ amendment Seven - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Seven Is To: i) Provide A Cut-off Date For Questions For Research Areas 001, 003, 004, And 005. ii) Provide Responses To Questions Received Regarding The Solicitation. _________________________________________________________ amendment Six - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Six Is To: i) Update The "date Offers Due" In Beta Sam To April 9, 2020, 3:00pm Est For Research Areas 001, 003, 004, And 005. Please Note That The "date Offers Due" For Research Area 002 Remains Unchanged As February 28, 2020, 3:00pm Est. ii) Provide Responses To Questions Received Regarding The Solicitation. _________________________________________________________ amendment five - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Five Is To:  i) add A Deadline For Submission Of Attachment 1 – Proposal Intent Response Form - For Research Areas 003, 004, And 005. ii) Provide Responses To Questions Received Regarding The Solicitation. ___________________________________________________________ amendment four - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Four Is To:  i) provide Responses To Questions Received Regarding The Solicitation. ______________________________________________________________ amendment three - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment Three Is To:  i) Revise Section 3.2.2.2.3 – Technical Approach (page 20 And 21) And Section 3.2.2.2.4. – Additional Requirements (page 21) Of Research Area 003. ii) Revise Section 3.2.2.3.2 – Technical Objectives (page 22 -24) And Section 3.2.2.3.3 – Technical Approach (page 24) Of Research Area 004. iii) Revision Section 3.2.2.4.3 – Technical Approach (page 36) Of Research Area 005. iv) Provide Responses To Questions Received Regarding The Solicitation. ______________________________________________________________ amendment two - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment two Is To: i) Revise Section 3.1.2.1.2 – Technical Objectives (page 6) Of Research Area 001. ii) Revise Section 3.2.1 – Background (page 17), Section 3.2.2.2.3 – Technical Approach (pages 20 And 21) Of Research Area 003, And Section 3.2.2.3.2 – Technical Objectives (page 22) And Section 3.2.2.3.3 – Technical Approach (page 24) Of Research Area 004. iii) Provide Responses To Questions Received Regarding The Solicitation. ______________________________________________________________ amendment One - Hhs-nih-niaid-baa2020-1 the Purpose Of Amendment One Is To: 1) Reiterate The Proposal Due Dates And Time For Research Areas. 2) Provide A Cut-off Date For Questions For Research Area 002. _______________________________________________________________ niaid 2020 Ominbus Broad Agency Announcement (baa) No. Hhs-nih-niaid-baa2020-1 Contains Five (5) Distinct Research Areas, Each With A Specified Closing Date And Time. The Proposal Due Date Of February 28, 2020, Specified In This Solicitation Posting, Is The Due Date For Research Area 002 Only. An Amendment Will Be Issued At A Later Date To Update The Proposal Due Date For Responses To Research Area 001, 003, 004, And 005.  The Proposal Due Dates For Each Research Area Are Identified Below: dait: Research Area 001 - Development Of Radiation/nuclear Medical Countermeasures (mcms) proposals Due Date And Time: 3:00 Pm Eastern Time, 04/09/2020 dmid: Research Area 002 - Advanced Development Of Vaccine Candidates For Acute Flaccid Myelitis Associated With Enterovirus D68 proposals Due Date And Time: 3:00 Pm Eastern Time, 02/28/2020 dmid: Research Area 003 - Advanced Development Of Vaccine Candidates For Biodefense And Emerging Infectious Diseases proposals Due Date And Time: 3:00 Pm Eastern Time, 04/09/2020 dmid: Research Area 004 - Development Of Therapeutic Products For Biodefense, Anti-microbial Resistant (amr) Infections And Emerging Infectious Diseases proposals Due Date And Time: 3:00 Pm Eastern Time, 04/09/2020 dmid: Research Area 005 - Advanced Development Of Diagnostics For Biothreats And Emerging Infectious Diseases proposals Due Date And Time: 3:00 Pm Eastern Time, 04/09/2020 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. The Niaid, Nih, Of The Dhhs Is Soliciting Proposals That Possess The Research And Development (r&d) Expertise Necessary For Successfully Carrying Out Research Toward Meeting The Program Objectives Of The Following Niaid Divisions: - Division Of Allergy, Immunology, And Transplantation (dait), Niaid, Nih - Division Of Microbiology And Infectious Diseases (dmid), Niaid, Nih the Baa Is Governed By Federal Acquisition Regulation (far) 6.102 And Far 35.016, As Well As The Nih Policy Manual, Chapter 6035, Broad Agency Announcements. A Baa May Be Used As A Solicitation Mechanism For Basic And Applied Research Directed Toward Advancing The State-of-the-art Or Increasing Knowledge Or Understanding And That Part Of Development Not Related To The Development Of A Specific System Or Hardware Procurement. Baas Are General In Nature, Identifying Areas Of Research Interest, And Shall Only Be Used When Meaningful Proposals With Varying Technical/scientific Approaches Can Be Reasonably Anticipated. offerors May Submit A Proposal In Response To One, Or More, Of The Research Areas Contained Herein.  Offers Submitted In Response To This Baa Must Present Separate Detailed Technical And Business Proposals Designed To Meet The Technical Objectives Described For Each Research Area Proposed. The Statement Of Work (sow), Including The Specific Technical Requirements And Performance Specifications, Shall Be Developed And Proposed By The Offeror, Not The Government. proposals Are Not Evaluated Against Each Other Since They Are Not Submitted In Accordance With A Common Sow Issued By The Government.  Instead, Research And Technical Objectives Are Provided In The Baa That Describe Individual Research Areas In Which The Government Is Interested.  Proposals Received In Response To The Baa Are Evaluated In Accordance With The Evaluation Factors For Award Specified In This Announcement. The Government Reserves The Right To Conduct Discussions With All, Some, One, Or None Of The Proposals Received In Response To This Baa.  If Discussions Are Conducted, Niaid Reserves The Right To Suggest Modifying, Adding Or Deleting Milestones, Decision Points, Research Plans, Processes, Schedules, Budget Or Product. The Government Also Reserves The Right To Make Awards Without Discussions. Additionally, The Government Reserves The Right To Accept Proposals In Their Entirety Or To Select Only Portions Of Proposals For Award. Multiple Awards Are Anticipated. The Selection For Award Under This Baa Will Be Based Upon The Evaluation Factors, Importance To The Agency Programs, And The Availability Of Funds. the Research Areas Included In The Niaid 2020 Omnibus Broad Agency Announcement No. Hhs-nih-niaid-baa2020-1, As Well As The Projected Amounts Of Available Funding, Are Discussed Below. Dates For Receipt Of Proposals Will Be Identified Separately For Each Research Area Within The Solicitation. division Of Allergy, Immunology, And Transplantation (dait), Niaid, Nih research Area 001: Development Of Radiation/nuclear Medical Countermeasures (msms) the Objective Of This Research Area Is To Advance The Development Of Candidate Mcms To Reduce Mortality And/or Major Morbidities Associated With Exposure To Radiation From A Radiological Or Nuclear Incident. Niaid Anticipates That Research And Development Studies Supported By This Baa Will Advance Lead Candidate Mcms Toward Eventual Fda Approval Or Licensure To Mitigate Or Treat Radiation-induced Injuries And Thereby Improve Survival Following A Radiological Event. niaid Estimates One Or Two Cost-reimbursement, Completion Type Contracts May Be Awarded For This Research Area For An Average Annual Total Cost (direct And Indirect Costs Combined) Of Up To $2 Million For A Non-severable Base And Option Periods. It Is Anticipated That The Total Cost For The Award(s) May Vary Depending Upon The Scope Of The Project And The Technical Objectives Of The Award(s). The Length Of Time For Which Funding Is Requested Should Be Consistent With The Nature And Complexity Of The Proposed Research. In No Event Shall The Period Of Performance Proposed By An Offeror Exceed 3 Years. division Of Microbiology And Infectious Diseases (dmid), Niaid, Nih research Area 002: Advanced Development Of Vaccine Candidates For Acute Flaccid Myelitis (afm) Associated With Enterovirus D68 the Objective Of This Research Area Is To Support The Development Of A Candidate Vaccine For Ev D68 Associated Afm.  The Primary Vaccine Candidate Requested Is An Inactivated Ev D68 Vaccine; However, Other Technologies To Develop A Non-replicating Ev D68 Vaccine Will Be Considered (e.g.,vlp).  Proposed Inactivated Ev D68 Vaccines Most Likely Will Require An Adjuvant Using Either A Single Vaccine Vial Format Or A Combination Two Vial Antigen Plus Adjuvant Format That Uses Bedside Mixing.  The Preference Is To Use Adjuvants That Minimize Regulatory Concerns And Expedite Vaccine Development Into A Phase I Clinical Trial.  niaid Estimates That One Or More Awards May Be Issued For This Research Area For A Total Cost Of Up To $3 Million For The Non-severable Base Work Across All Contracts (direct And Indirect Costs Combined). 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 Should Not Exceed Five (5) Years Which Includes Stability Studies.  research Area 003: Advanced Development Of Vaccine Candidates For Biodefense And Emerging Infectious Diseases one Objective Of This Research Area Is To Develop Vaccines To Address Antibiotic Resistant Gram-negative Bacteria Focusing On, But Not Limited To, Burkholderia Spp., Pseudomonas Aeruginosa, Francisella Tularensis, Yersinia Pestis, And E. Coli.  A Second Objective Is To Support Development Of Vaccines For Emerging Viruses And Pandemic Preparedness That Includes But Is Not Limited To Alphaviruses (for Example Eastern Equine Encephalitis) And Bunyaviruses (for Example Rift Valley Fever Virus). niaid Estimates That Three Or More Awards May Be Issued Across This Research Area 003 And Research Area 004 For A Total Cost Of Up To $11.5 Million For The Non-severable Base Work Across All Contracts (direct And Indirect Costs Combined). 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 Should Not Exceed Five (5) Years. research Area 004 - Development Of Therapeutic Products For Biodefense, Anti-microbial Resistant (amr) Infections And Emerging Infectious Diseases the Objective Of This Research Area Is The Development Of Promising New Therapeutics To Address Infections Caused By Niaid Category A, B, And C Priority Pathogens. 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 Is Either A Lead Series, Lead, Or Product Candidate, And Is Either A Drug (synthetic Or Natural Product) Or A Biological Product (e.g. Monoclonal Antibodies, Recombinant Proteins). This Research Area Supports Lead Optimization, Pre-clinical (ind Enabling) And Clinical Trials That Include Phase 1 And Phase 2 Studies. niaid Estimates That Three Or More Awards May Be Issued Across This Research Area 003 And Research Area 004 For A Total Cost Of Up To $11.5 Million For The Non-severable Base Work Across All Contracts (direct And Indirect Costs Combined). 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 Should Not Exceed Five (5) Years. research Area 005 - Advanced Development Of Diagnostics For Biothreats And Emerging Infectious Diseases the Objective Of This Research Area Is To Advance The Development Of Novel, Rapid Sample-to-answer Candidate Diagnostic Products That Will Address Biodefense And Pandemic Preparedness. The Capability To Detect And Distinguish Among A Required Agent And Multiple Other Pathogens Common To A Geographic Region Or Population Is Strongly Encouraged. Priority Will Be Given To Pathogens For Which There Are No U.s.-fda Approved/cleared/authorized Diagnostics. niaid Estimates That One Or More Awards May Be Issued For This Research Area For A Total Cost Of Up To $2 Million For The Non-severable Base Work Across All Contracts (direct And Indirect Costs Combined). 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 Should Not Exceed Five (5) Years.  any Responsible Offeror May Submit A Proposal Which Shall Be Considered By The Agency. For This Solicitation, The Niaid Requires Proposals To Be Submitted Online Via The Niaid Electronic Contract Proposal Submission (ecps) Website. Submission Of Proposals By Facsimile Or E-mail Is Not Acceptable. For Directions On Using Ecps, Go To The Website: Https://ecps.nih.gov And Then Click On "how To Submit."