Amendment_39_Changes_Table.pdf

Change History Table: Original – Amendments (1 – 39)

Amendment 39 (March 14, 2023): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 38 (Mar 3, 2023) Amendment 39 (Mar 14, 2023)

1. This amendment extends the submission deadline to May 17, 2023

2. Suspend AOI 9.7 Implementation of phase 2 clinical trial to investigate novel host-directed therapeutics candidates to treat acute respiratory distress syndrome (ARDS) effective 3/15/2023.

Amendment 38 (March 3, 2023): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 37 (Jan 13, 2023) Amendment 38 (Mar 3, 2023)

1. Updates to Area of Interests #9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics

• Updates to 9.7 Implementation of phase 2 clinical trial to investigate novel host-directed therapeutics candidates to treat acute respiratory distress syndrome (ARDS) this amendment provides responses to the questions received regarding Area of Interest (AOI) 9.7 “Implementation of Phase 2 Clinical Trial to Investigate Novel Host-directed Therapeutics Candidates to Treat Acute Respiratory Distress Syndrome (ARDS) [Open until March 14, 2023].” Additionally, an updated Transfer of Obligation Table for the Draft Protocol Synopsis is attached.

A summary of changes in the Transfer of Obligation Table is listed below:

o Deleted “diary” in 6.0 Data Management and “diaries” in 9.0 Medical Writing and Report Publishing Activities.

o Replaced “comparator,” “comparator agent,” or “comparator agents” with “placebo” or “placebos” in 2.4 Clinical

Monitoring/Site Mgmt. (Lab Monitoring/Pharmacy/Unblinded Monitoring/Other) & 11.0 Other Outsourced Activities (Please Specify).

• This amendment also provides the Small Business Subcontracting Plan Template as an attachment.

Amendment 37 (Jan 13, 2023): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 36 (Dec 14, 2022) Amendment 37 (Jan 13, 2023)

2. Updates to Area of Interests #9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics

Amendment 36 (Dec 14, 2022) Amendment 37 (Jan 13, 2023)

• Added new 9.7 Implementation of phase 2 clinical trial to investigate novel host-directed therapeutics candidates to treat acute respiratory distress syndrome (ARDS)

Amendment 36 (Dec 14, 2022): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 35 (Nov 15, 2022) Amendment 36 (Dec 14, 2022)

3. This amendment extends the submission deadline to Mar 17, 2023

4. Updates to Area of Interests #7: Diagnostics

• Added new 7.10 Diagnostics for Effective Therapy Utilization

Amendment 35 (Nov 15, 2022): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 35 (November 15, 2022): BARDA BAA-18-100-

SOL-00003 List of Changes:

Amendment 34 (Oct 14, 2022) Amendment 35 (Nov 15, 2022)

1. Updates to Area of Interest #3: Antibacterials

• Added new 3. 2 Treatment of MDR fungal infections

2. Updates to Area of Interests #7: Diagnostics

• Revised 7.2 Biothreat Agent Diagnostics

• Revised 7.3 Antibiotic Resistance Diagnostics for priority bacterial pathogens

• Revised 7.4 Radiation Exposure (Biodosimetry) Diagnostics

• Revised 7.6 Influenza Diagnostics

• Suspend 7.8 Sequencing System Development

• Added new 7.9 Threat Agnostic

Amendment 34 (October 14, 2022): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 33 (July 14, 2022) Amendment 34 (October 14, 2022)

1. This amendment updates all instances of the Office of the Assistant Secretary for Preparedness and Response to Administration for Strategic Preparedness and Response.

2. Updates the Contact and Submission Information to Submission Instructions. Updates submission instructions to require that all submissions be through the BARDA Digital Resources (BDR) Portal.

3. Updates Quad Chart and White Paper Submission to refer to the Submission Instructions paragraph.

4. Updates Stage 2: Full Proposal Submission to refer to the Submission Instructions paragraph.

Amendment 33 (July 14, 2022): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 32 (May 2, 2022) Amendment 33 (July 14, 2022)

1. Updates to Area of Interest #7: Diagnostics

• Revised 7.2 Biothreat Agent Diagnostics

2. Updates to Part V: Quad Chart/White Paper Instructions (Stage 1)

• Revised White Paper Format Paragraph 7

Amendment 32 (May 2, 2022): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 31 (May 2, 2022) Amendment 32 (May 2, 2022)

1. This amendment updates the SAM.GOV description to reflect the extended submission deadline of Dec 15, 2022.

Amendment 31 (May 2, 2022): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 30 (Apr 15, 2022) Amendment 31 (May 2, 2022)

1. This amendment extends the submission deadline to Dec 15, 2022

Amendment 30 (April 15, 2022): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 29 (Oct 26, 2021) Amendment 30 (Apr 15, 2022)

1. Updates to Area of Interests 7.7: Emerging Diseases Diagnostics Area of Interest #7.7 Emerging Diseases Diagnostics remains suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive.

Amendment 29 (Oct 26, 2021) Amendment 30 (Apr 15, 2022)

• Suspended 7.7.1 Diagnostic Assay for Human Coronaviruses

• Suspended 7.7.2 Diagnostic Assay for Detection of SARS-CoV-2 Virus

• Suspended 7.7.3 Diagnostic Assay for Detection of COVID-19 Neutralizing Antibodies

• Suspended 7.7.5 Screening Tests at Point of Care (2-minute Time to Result)

2. Updates to Area of Interest #9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics

• Added New 9.6 Pre-exposure Prophylaxis – Influenza

Amendment 29 (Oct 26, 2021): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 28 (Aug 2, 2021) Amendment 29 (Oct 26, 2021)

1. Updates to Area of Interests 1 CBRN Vaccines

• Revised 1.2 Ebola and Marburg virus

• Deleted 1.3 Antimicrobial Resistant Threats

2. Updates to Area of Interest #2: CBRN Antivirals and Antitoxins

• Revised 2.1 Anthrax Antitoxins

• Revised 2.2 Botulism Antitoxins

• Revised 2.3 Smallpox Antiviral

• Deleted 2.4 Viral Hemorrhagic Fevers Antiviral

• Added New 2.4 Filovirus Therapeutics

3. Updates to Area of Interest #3: Antibacterials

• Deleted 3.1 Develop antibacterial products for post exposure prophylaxis (PEP) and treatment of one or more biothreat pathogens

• Deleted 3.2 Develop new drugs that treat or prevent resistant bacterial infections either alone or in combination with other therapeutics

• Deleted 3.3 Develop non-traditional therapeutics that treat or prevent resistant infections

• Added New 3.1 Develop products for treatment of MDROs and biothreat pathogens

4. Updates to Area of Interest #4: Radiological/Nuclear Threat Medical Countermeasures

• Revised 4.1 Advanced Development of MCMs to treat radiation injury due to acute exposure to ionizing radiation

• Revised 4.2 Blood Products

5. Updates to Area of Interest #5: Chemical Threat Medical Countermeasures

• Revised 5.1 Pulmonary Agents

• Revised 5.2 Opioids

• Revised 5.3 Vesicants

• Revised 5.4 Blood/Metabolic Agents

• Revised 5.5 Nerve Agents and Organophosphorus (OP) Pesticides

• Revised 5.6 Novel MCM Delivery Mechanisms

6. Updates to Area of Interest #6: Burn Medical Countermeasures

• Deleted 6.1 Non-autologous products to prevent or reduce burn wound conversion

• Deleted 6.3 Products promoting wound closure

• Deleted 6.4 Products for temporizing burn injuries

• Deleted 6.5 Countermeasures for Cutaneous Radiation Injuries (CRI)

• Deleted 6.6 Products for treatment of pulmonary inhalation and blast related injuries

• Added New 6.1 Enabling Technologies to Address General Burn & Blast Traumatic Injuries

• Added New 6.2 Head & Neck Injuries in Trauma

• Added New 6.3 Detection and Management of Internal or External Hemorrhage from Non-Compressible Trauma Wounds

• Added New 6.4 Detection and Management of Airway Access Complications in Trauma

• Added New 6.5 Non-autologous topical products to prevent or reduce burn wound conversion (defined as a worsening of a burn wound from its original depth)

7. Updates to Area of Interest #7: Diagnostics

• Revised 7.2 Biothreat Agent Diagnostics

• Revised 7.3 Antibiotic Resistance Diagnostics for priority bacterial

• Revised 7.4 Radiation Exposure (Biodosimetry) Diagnostics

• Revised 7.6 Influenza Diagnostics

• Revised 7.7 Emerging Diseases Diagnostics

• Revised 7.8 Sequencing System Development

8. Updates to Area of Interest #8: Influenza and Emerging Infectious Diseases (IEID) Vaccines

• Revised 8.2 Innovative vaccine production enhancements

9. Updates to Area of Interest #9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics

• Revised 9.1 Influenza Antiviral Therapeutics

• Deleted 9.2 COVID-19 Therapeutics

• Revised 9.3 Immunomodulators or therapeutics targeting lung repair

• Deleted 9.4 Innovative approaches to improve clinical trial execution for hospitalized influenza patients

10. Deleted Area of Interest #10: Respiratory Protective Devices

11. Deleted Area of Interest #11: Ventilators

12. Deleted Area of Interest #13: Modeling as an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats

13. Deleted Area of Interest #14: Visual Analytics an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats

14. Area of Interest 10-17 are renumbered to remove deleted AOIs.

15. This amendment extends the submission deadline to May 2, 2022

16. Adds Part IV K regarding implementation of Executive Order 14042

Amendment 28 (Aug 2, 2021): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 27 (June 29, 2021) Amendment 28 (Aug 2, 2021)

1. Updates to Area of Interests 7.7 Emerging Diseases Diagnostics

• Revised 7.7.2 Diagnostic Assay for Detection of SARS-CoV-2 Virus

• Revised 7.7.5 [NEW] Screening Tests at Point of Care (2-minute Time to Result)

2. Suspend Area of Interest # Area of Interest #17: Advanced Manufacturing Technologies. This area of interest is suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive

Amendment 27 (June 29, 2021): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 26 (June 3, 2021) Amendment 27 (June 29, 2021)

1. Removed Special Instructions for Area of Interest #3.4 Antibacterial Accelerator issued in Amendment 25 and revised in Amendment 26 that expired on June 28, 2021. Suspend Area of Interest #3.4 Antibacterial Accelerator.

2. Updated hyperlinks.

3. Reminder: We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests. BARDA will not be able to meet the timelines highlighted in the Broad Agency Announcement. Thank you for understanding this unprecedented response and delays that will occur.

Amendment 26 (June 3, 2021): BARDA BAA-18-100-SOL-00003 List of Changes:

*Note: All textual additions included in the conforming copy of BARDA BAA-18-100-SOL-00003 are highlighted in yellow.

Amendment 25 (May 12, 2021) Amendment 26 (June 3, 2021)

1. Revised “Contact and Submission Information”

Contact and Submission Information:

All inquiries and submissions regarding this BAA must be sent to:

BARDA-BAA@hhs.gov.

Technical questions only should be directed to the Technical Point of Contacts (POC) listed under each area of interest. The Technical POCs are located in “Part I: Research and Development Areas of Interest.”

For respondents interested in the Special Instructions for Area of Interest #3.4 issued through Amendment #25, see the separate Special Instructions document for appropriate contact information. Do not contact the inbox above for inquiries related to BARDA’s Special Instructions for Area of Interest #3.4. Technical POCs and general inquiries are detailed in the Special Instructions document.

Contact and Submission Information:

All inquiries and submissions regarding this BAA must be sent to:

BARDA-BAA@hhs.gov.

Technical questions only should be directed to the Technical Point of Contacts (POC) listed under each area of interest. The Technical POCs are located in “Part I: Research and Development Areas of Interest.”

For respondents interested in the Special Instructions for Area of Interest #3.4 revised through Amendment #26, see the separate revised Special Instructions document for appropriate contact information and separate Inquiries and Responses document. Do not contact the inbox above for inquiries related to BARDA’s Special Instructions for Area of Interest #3.4. Technical POCs and general inquiries are detailed in the Special Instructions document included in Amendment #26 to this BAA.

2. Revised “Special Instructions” Language

Special Instructions:

Special instructions will be advertised via the BAA as they become apparent. These additional instructions would be tailored to specific AOI and may have unique submission due dates. The information requested in these instructions should be used along with Part VI of the BAA to format and prepare the

Special Instructions:

Special instructions will be advertised via the BAA as they become apparent. These additional instructions would be tailored to specific AOI and may have unique submission due dates. The information requested in these instructions should be used along with Part VI of the BAA to format and prepare the mailto:BARDA-BAA@hhs.gov

Technical (Volume I) and Cost (Volume II) Proposals.

Offerors shall follow the instructions in Part VI of the BAA, and include the information requested therein.

NOTE: For respondents submitting to the Special Instructions for AOI #3.4 issued through Amendment #25, please follow the full proposal preparation and submission directions found in the Special Instructions document.

Technical (Volume I) and Cost (Volume II) Proposals.

Offerors shall follow the instructions in Part VI of the BAA, and include the information requested therein.

NOTE: For respondents submitting to the Special Instructions for AOI #3.4 revised through Amendment #26, please follow the full proposal preparation and submission directions found in the revised Special Instructions document and Inquiries and Responses document included in Amendment #26 to this BAA.

3. Inserted “Special Instructions Area of Interest #3.4 Antibacterial Accelerator”

Special Instructions Area of Interest #3.4 Antibacterial Accelerator

For details on Special Instructions Area of Interest #3.4, please see separate document included in Amendment #25 to this BAA titled “Special Instructions – Area of Interest #3.4 Antibacterial Accelerator.”

Note: Application procedures differ from Areas of Interest #1-3.3 and #5-17 as detailed in the Special Instructions document. Submissions to the Special Instructions Area of Interest #3.4 are limited in time and will not be accepted after June 28, 2021.

Special Instructions Area of Interest #3.4 Antibacterial Accelerator

For details on Special Instructions Area of Interest #3.4, please see separate revised document included in Amendment #26 to this BAA titled “Special Instructions – Area of Interest #3.4 Antibacterial Accelerator” and separate Inquiries and Responses document included in Amendment #26 to this BAA.

Note: Application procedures differ from Areas of Interest #1-3.3 and #5-17 as detailed in the Special Instructions document. Submissions to the Special Instructions Area of Interest #3.4 are limited in time and will not be accepted after June 28, 2021.

4. Revised Special Instructions document updated Section 1.1 Overview of Opportunity, Section 4.4. Evaluation Rating and Section 4.8 Contact Information.

5. Reminder: We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19 or in response to the Special Instructions for Area of Interest #3.4, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests. BARDA will not be able to meet the timelines highlighted in the Broad Agency Announcement. Thank you for understanding this unprecedented response and delays that will occur.

Amendment 25 (May 12, 2021): BARDA BAA-18-100-SOL-00003 List of Changes:

*Note: All textual additions included in the conforming copy of BARDA BAA-18-100-SOL-00003 are highlighted in yellow.

Amendment 24 (May 5, 2021) Amendment 25 (May 12, 2021)

1. Revised “Contact and Submission Information”

Contact and Submission Information:

All inquiries and submissions regarding this BAA must be sent to:

BARDA-BAA@hhs.gov.

Technical questions only should be directed to the Technical Point of Contacts (POC) listed under each area of interest. The Technical POCs are located in “Part I: Research and Development Areas of Interest.”

All inquiries and submissions regarding this BAA must be sent to:

BARDA-BAA@hhs.gov.

Technical questions only should be directed to the Technical Point of Contacts (POC) listed under each area of interest. The Technical POCs are located in “Part I:

Research and Development Areas of Interest.”

For respondents interested in the Special Instructions for Area of Interest #3.4 issued through Amendment #25, see the separate Special Instructions document for appropriate contact information. Do not contact the inbox above for inquiries related to BARDA’s Special Instructions for Area of Interest #3.4. Technical POCs and general inquiries are detailed in the Special Instructions document.

Special Instructions:

Special instructions will be advertised via the BAA as they become apparent. These additional instructions would be tailored to specific AOI and may have unique submission due dates. The information requested in these instructions should be used along with Part VI of the BAA to format and prepare the Technical (Volume I) and Cost (Volume II) Proposals. Offerors shall follow

Special Instructions:

Special instructions will be advertised via the BAA as they become apparent. These additional instructions would be tailored to specific AOI and may have unique submission due dates. The information requested in these instructions should be used along with Part VI of the BAA to format and prepare the Technical (Volume I) and Cost (Volume II) Proposals. Offerors shall follow the instructions in Part VI of the BAA, and include the

Amendment 24 (May 5, 2021) Amendment 25 (May 12, 2021) the instructions in Part VI of the BAA, and include the information requested therein.

information requested therein. NOTE: For respondents submitting to the Special Instructions for AOI #3.4 issued through Amendment #25, please follow the full proposal preparation and submission directions found in the Special Instructions document.

#3.4 Antibacterial Accelerator”

N/A Special Instructions Area of Interest #3.4 Antibacterial Accelerator

For details on Special Instructions Area of Interest #3.4, please see separate document included in Amendment #25 to this BAA titled “Special Instructions – Area of Interest #3.4 Antibacterial Accelerator.”

Note: Application procedures differ from Areas of Interest #1-3.3 and #5-17 as detailed in the Special Instructions document. Submissions to the Special Instructions Area of Interest #3.4 are limited in time and will not be accepted after June 28, 2021.

4. Corrected footnote numbering.

Amendment 24 (May 5, 2021): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Suspend Area of Interest 9.2 COVID-19 Therapeutics. This area of interest is suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive.

2. Reminder: We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests. BARDA will not be able to meet the timelines highlighted in the Broad Agency Announcement. Thank you for understanding this unprecedented response and delays that will occur.

Amendment 23 (March 8, 2021): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Updates to Area of Interests 7.7: Emerging Diseases Diagnostics

• Revised 7.7.1 Diagnostic Assay for Human Coronaviruses

• Revised 7.7.2 Diagnostic Assay for Detection of SARS-CoV-2 Virus

• Revised 7.7.3 Diagnostic Assay for Detection of COVID-19 Neutralizing Antibodies

• Suspended 7.7.4 Diagnostic Assay Panel for SARS-CoV-2, Influenza A/B, and other Respiratory Viruses

• Added NEW 7.7.5 Screening Tests at Point of Care (2-minute Time to Result)

2. Area of Interest #12.2 Vaccine Production Platform remains suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive.

3. Reminder: We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests. BARDA will not be able to meet the timelines highlighted in the Broad Agency Announcement. Thank you for understanding this unprecedented response and delays that will occur.

Amendment 22 (November 27, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Clarification of Revised Area of Interest #12.2 Vaccine Production Platform. This is a targeted request to support messenger ribonucleic acid (mRNA) technologies that have the potential to decrease the time required to go from sequence of a novel strain of influenza with pandemic potential to initiating clinical trials. This is not a request for development of vaccines against SARS-CoV-2.

White Papers and Proposals submitted to AoI 12.2 will be accepted through February 28, 2021.

2. Area of Interest #12.1 Monoclonal Antibody Platform remains suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive.

3. Reminder: We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests. BARDA will not be able to meet the timelines highlighted in the Broad Agency Announcement. Thank you for understanding this unprecedented response and delays that will occur.

Amendment 21 (November 24, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Revised Area of Interest #12.2 Vaccine Production Platform. White Papers and Proposals submitted to AoI 12.2 will be accepted through February 28, 2021.

2. Area of Interest #12.1 Monoclonal Antibody Platform remains suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive.

3. Reminder: We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests. BARDA will not be able to meet the timelines highlighted in the Broad Agency Announcement. Thank you for understanding this unprecedented response and delays that will occur.

Amendment 20 (October 26, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 19 (August 17, 2020) Amendment 20 (October 26, 2020)

1. Extended deadline to October 31, 2021 N/A 1. Additional submission deadlines:

January 31, 2021 April 30, 2021 July 31, 2021 October 31, 2021

2. The final White Paper submission deadline is October 31, 2021.

3. Full Proposal submissions deadline is October 31, 2021.

4. Quad Charts and White Papers WILL NOT BE ACCEPTED after 4:30 PM (Eastern Time) on October 31, 2021.

2. Revision to: “For COVID-19 response only white paper and full proposal submissions: all awards are anticipated to be expedited and made in FY2020/2021.”

3. Update Part VIII Attachment 9: Biographical Sketch

Amendment 19 (August 17, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Suspend Area of Interest #8.3: COVID-19 vaccine. White Paper and Full Proposal submissions under AOI #8.3 are suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive. However, evaluation of vaccine development under Operation Warp Speed (OWS) program continues outside of BAA-18-100-SOL-00003. If promising candidates are identified, there is an opportunity for this area of interest to be reopened or for potential partnership with our colleagues at the Joint Program Executive Office (JPEO-CBRND).

2. Reminder: We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests. BARDA will not be able to meet the timelines highlighted in the Broad Agency Announcement. Thank you for understanding this unprecedented response and delays that will occur.

3. Updated hyperlinks

Amendment 18 (July 24, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Suspend Area of Interest #10: Respiratory Protective Devices. This area of interest is suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive

Amendment 17 (June 3, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Revised language to Area of Interest #3: Antibacterials Note: Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests.

2. Addition of new Area of Interest 7.7.4: Diagnostic Assay for SARS-CoV-2 as part of FDA-cleared panel for influenza and other respiratory viruses using FDA-cleared platforms

3. Revision to Area of Interest 9.2: COVID-19 Therapeutics: clarified requirement for in vitro and in vivo efficacy against SARS-CoV, MERS-CoV, and SARS-CoV-2 (2019-nCoV).

Addition of: “White papers and full proposals that do not have SARS-CoV-2 in vitro inhibition data, in vivo efficacy data, a cGMP manufacturing plan or a regulatory strategy that leads to FDA-approval/licensure will be considered non-responsive.”

4. Suspend Area of Interest 9.3 Immunomodulators or therapeutics targeting lung repair. This area of interest is suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive.

5. Suspend Area of Interest 9.5 Pre-exposure and Post-exposure Prophylaxis. This area of interest is suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive.

6. Suspend Area of Interest #11: Ventilators. This area of interest is suspended until further notice. All white papers or full proposals submitted to this area of interest will be considered automatically non-responsive.

7. Added FDA communication to the technical proposal attachment list so it coincides with Table 3: Technical Proposal Attachments

8. Added Reason for the Proposed Award Type to the cost proposal attachment list so it coincides with Table 4: Cost Proposal Attachments

9. Updated hyperlinks

Amendment 16 (April 24, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Clarification of rolling review: BARDA will accept full proposal submissions for rolling reviews to accelerate the research and development of only medical countermeasures to fight the 2019 novel coronavirus disease (COVID-19) or the SARS-CoV-2 virus. The submission must highlight how your product addresses SARS-CoV-2 and if not directly acting on the virus, provides documentation of how your product addresses the COVID-19 disease. Rolling review means an offeror can submit a completed Technical Proposal and Attachment section of its Full Proposal for review by BARDA, rather than submitting the Full Proposal package (Technical and Cost) prior to technical review. Offerors must submit the omitted Cost Proposal and Cost Proposal Attachments no later than two weeks after the submission of the Technical Proposal and Technical Proposal Attachment. BARDA will not accept rolling reviews for white papers.

2. Revision of AOI 7.7.3 Diagnostic Assay for detection of COVID-19 disease (SARS-CoV-2infection), including Serology Tests.

3. Clarification of manufacturing of products in the United States are in a 21 CFR 210, 211 current Good Manufacturing Practices compliant facility.

4. Clarification of Area of Interest 9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics, specifically: AOI 9.2, 9.3, 9.4:

White papers and proposals should address any ongoing clinical trials of their candidate therapeutic, and how a proposed study is different than the ongoing studies. White paper and proposal submissions should address clinical supply of candidate therapeutics. Submissions that have enough drug to complete the proposed clinical study and at least 10,000 treatment courses available within 6 months will be prioritized.

5. Clarification of Area of Interest 11: Ventilators - clarification inclusion for Acute Respiratory Distress Syndrome (ARDS).

6. Clarifcation of Area of Interest 17: Advanced Manufacturing Technologies: for pharmaceutical manufacturing platforms. Specifically excluded from this AOI are manufacturing technologies related to personal protective equipment (PPE) and medical devices (ventilators, respirators, etc.).

Amendment 15 (April 2, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. All contracting related questions should be sent to BARDA-BAA@hhs.gov with the appropriate subject line “Contracting questions: AOI?

<abbreviated AOI heading>: <brief description>”.

2. BARDA will accept full proposal submissions for rolling reviews to accelerate the research and development of only medical countermeasures to fight the 2019 novel coronavirus disease (COVID-19) or the SARS-CoV-2 virus. The submission must highlight how your product address SARS-CoV-2 and if not directly acting on the virus, provide documentation of how your product can address COVID-19 disease. Rolling reviews mean an offeror can submit completed sections of its Full Proposal for review by BARDA, rather than wait until every section of the Full Proposal is completed before the entire Full Proposal can be reviewed. Offerors are encouraged to submit the technical proposal in sufficient detail to address the program relevance, technical merits, and offeror’s capabilities and experience to ascertain the validity of the technical proposal during the Technical Review. Completed sections for technical proposal attachments, cost proposal, cost proposal attachments can be submitted in a timely manner as these sections are completed. BARDA will not accept rolling reviews for white papers.

3. For COVID-19 response only white paper and full proposal submissions:

• all reviews will be continuous (i.e., the "soft" submission deadline indicated in “Table 1: Submission Deadlines and Government Response Time” will not apply) as they are received in the BARDA-BAA@hhs.gov mailbox,

• all reviews and responses are anticipated to be expedited,

• all awards are anticipated to be expedited and made in FY2020.

The final white paper submission deadline is October 31, 2020. The final full proposal submission deadline is October 31, 2020 or as specified in the invitation letter.

4. Submission Data Integration Table Complete Attachment 11: Submission Data Integration Table as an appendix to the white paper and full proposal submission to facilitate processing and tracking of the submission. This table will not count against the page count.

Amendment 14 (March 9, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. We appreciate your interest in partnering with BARDA. Due to the COVID-19 response, any white papers or full proposals submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests. BARDA will not be able to meet the timelines highlighted in the Broad Agency Announcement. Thank you for understanding this unprecedented response and delays that will occur.

2. For Area of Interest #1: CBRN Vaccines, the Technical Point of Contact is changed to Daniel Wolfe; Daniel.Wolfe2@hhs.gov

3. Added new Area of Interest #17: Advanced Manufacturing Technologies, The Technical Point of Contact is: Timothy Belski;

Timothy.Belski@hhs.gov. The contracting point of contact is: Carol Lavrich; Carol.Lavrich@hhs.gov mailto:Daniel.Wolfe2@hhs.gov mailto:Timothy.Belski@hhs.gov mailto:Carol.Lavrich@hhs.gov

Amendment 13 (March 4, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. The BARDA Broad Agency Announcement will not allow submissions of white papers or full proposals for any of the research areas of interest until further notice. Due to our response to the SARS-CoV-2 virus and the necessity to prioritize resources, only submissions to special instructions for efforts that directly support our response to SARS-CoV-2 will be accepted. While we regret this action, it is required to focus BARDA's efforts on the immediate need.

All Areas of Interest are suspended except:

a. AoI 7.7.1 Diagnostic Assay for human coronavirus using existing FDA-cleared platforms

b. AoI 7.7.2 Point-of-Care Diagnostic Assay for detection of SARS-CoV-2 virus

c. AoI 7.7.3 Diagnostic Assay for detection of COVID-19 disease (SARS-CoV-2 infection)

d. AoI 8.3 COVID-19 Vaccine,

e. AoI 9.2 COVID-19 Therapeutics,

f. AoI 9.3 Immunomodulators or therapeutics targeting lung repair, and

g. AoI 9.5 Pre-exposure and Post-exposure Prophylaxis,

h. AoI 10 Respiratory Protective Devices,

i. AoI 11 Ventilators.

BARDA will only accept submissions related to the SARS-CoV-2 virus or the COVID-19 disease until further notice.

2. Formatting change in Change History Table – now in reverse order (latest first)

Amendment 12 (February 10, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. BARDA is now accepting submissions to AOI 7.7 for development of assays for coronaviruses. Due to an overwhelming response to Area of Interest 7, BARDA is temporarily closing AOI’s: Innovations (7.1), biothreats (7.2), antibiotic resistance (7.3) and influenza (7.6). AOI’s radiation exposure/biodosimetry (7.4), and chemical threat exposure (7.5) remain closed.

Amendment 11 (January 23, 2020): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Correct typo in AOI 5.3 Vesicants: Correction: Mustard Gas Keratopathy

2. For Area of Interest #8: Influenza and Emerging Infectious Diseases (IEID) Vaccines (suspended EID only), the Contracting Point of Contact is changed to Wendell Conyers; Wendell.Conyers@hhs.gov.

3. For Area of Interest #9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics (suspended EID only), the Contracting Point of Contact is changed to Wendell Conyers; Wendell.Conyers@hhs.gov.

4. For Area of Interest #10: Respiratory Protective Devices, the Contracting Point of Contact is changed to Wendell Conyers;

Wendell.Conyers@hhs.gov.

5. For Area of Interest #11: Ventilators, the Contracting Point of Contact is changed to Wendell Conyers; Wendell.Conyers@hhs.gov.

6. Update hyperlinks.

Amendment 10 (October 15, 2019): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 9 (June 3, 2019) Amendment 10 (October 15, 2019)

1. Added availability of this BAA on the beta.SAM.gov website.

2. Updated authorization legislation to included Pandemic and All-Hazards Preparedness and Advanced Innovation Act of 2019

3. Extended deadline to October 31 2020

N/A • Additional submission deadlines:

January 31, 2020 April 30, 2020 July 31, 2020 October 31, 2020

• The final White Paper submission deadline is October 31, 2020.

• Full Proposal submission deadline is October 31, 2020.

• Quad Charts and White Papers WILL NOT BE ACCEPTED after 4:30 PM (Eastern Time) on October 31, 2020.

4. Removed Special Instructions for DRIVe issued in Amendment 8 that expired on May 28, 2019. Suspend Area of Interest #15 for DRIVe:

Solving Sepsis. Suspend Area of Interest #16 for DRIVe: Early Notification to Act, Control and Treat (ENACT) mailto:Wendell.Conyers@hhs.gov mailto:Wendell.Conyers@hhs.gov mailto:Wendell.Conyers@hhs.gov mailto:Wendell.Conyers@hhs.gov

5. For Area of Interest #2: CBRN Antitoxins and Therapeutic Proteins, the Technical Point of Contact is changed to David Boucher;

David.Boucher@hhs.gov

6. For Area of Interest #3: Antibacterials: significant revisions for clarity and prioritization.

7. For Area of Interest #4: Radiological/Nuclear Threat Medical Countermeasures: revisions for clarity and prioritization. Added 4.4 Enabling Technologies.

8. For Area of Interest #5: Chemical Threat Medical Countermeasures: revisions for clarity and prioritization.

9. For Area of Interest #6: Burn Medical Countermeasures: revisions for clarity and prioritization.

White Paper and Full Proposal submissions to only AOI #6.2 Smart imaging systems are suspended until further notice.

10. For Area of Interest #7: Diagnostics: significant revisions for clarity and prioritization.

Within section 7.1 Diagnostics Innovations: revised subsection 7.1.1 and removed subsection 7.1.2 through 7.1.6 from Amendment 9.

Within section 7.2 Biothreat Agent Diagnostics: revised subsection 7.2.1 , 7.2.3, 7.2.4 and removed subsection 7.2.2.

Suspend section 7.4 Radiation Exposure (Biodosimetry) Diagnostics Within section 7.6 Influenza Diagnostics: revised subsection 7.6.1-7.6.3.

Removed section 7.8 Hardware/Software platform development or improvement (novel platform development)

11. Added Part VIII: Attachment 9: Biographical Sketch

12. Added Part VIII: Attachment 10: BARDA BAA Process Flow Chart

13. Contracting office name update from “Contracts, Management, and Acquisition (CMA)” to “Contracts Management & Acquisition (CMA)”

14. Added reference to the BARDA BAA Toolkit for tools and template to help applicants develop their White Paper/Quad Chart and Full Proposal in respone to the BARDA Broad Agency Announcement (BAA). This is in addition to the ASPR Business Tookit.

15. Added reference to additional PHE.gov’s BARDA Broad Agency Announcement resource.

Amendment 9 (June 3, 2019): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 7 (March 29, 2019) Amendment 9 (May 30, 2019)

6. Page 9 Change in Government Response for Stage one (Quad chart and White paper) and Stage 2 (Full Proposal)

A response will be provided within 120 days of the next interim or final deadline following White Paper submission.

A response will be provided within 120 days of the submission deadline.

https://www.phe.gov/about/amcg/BARDA-BAA/Pages/barda-baa-toolkit.aspx https://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx https://www.phe.gov/about/amcg/BARDA-BAA/Pages/default.aspx

Amendment 8 (April 9, 2019): BARDA BAA-18-100-SOL-00003 List of Changes*:

*Note: All textual additions included in the conforming copy of BARDA BAA-18-100-SOL-00003 are highlighted in yellow.

Amendment 7 (March 29, 2019) Amendment 8 (April 9, 2019)

1. Revised “Contact and Submission Information”

Contact and Submission Information:

All inquiries and submissions regarding this BAA must be sent to:

BARDA-BAA@hhs.gov.

Technical questions only should be directed to the Technical Point of Contacts (POC) listed under each area of interest. The Technical POCs are located in “Part I: Research and Development Areas of Interest.”

All inquiries and submissions regarding this BAA must be sent to:

BARDA-BAA@hhs.gov.

Technical questions only should be directed to the Technical Point of Contacts (POC) listed under each area of interest. The Technical POCs are located in “Part I:

Research and Development Areas of Interest.”

For respondents interested in the Special Instructions for DRIVe issued through Amendment #8 please, see the separate Special Instructions document for appropriate contact information. Please do not contact the inbox above for inquiries related to BARDA’s Division of Innovative Research & Ventures (DRIVe). Technical POC’s and general inquiries are detailed in the Special Instructions document.

Special Instructions:

Special instructions will be advertised via the BAA as they become apparent. These additional instructions would be tailored to specific AOI and may have unique submission due dates. The information requested in these instructions

Special Instructions:

Special instructions will be advertised via the BAA as they become apparent. These additional instructions would be tailored to specific AOI and may have unique submission due dates. The information requested in these instructions should be used along with Part VI of

Amendment 7 (March 29, 2019) Amendment 8 (April 9, 2019) should be used along with Part VI of the BAA to format and prepare the Technical (Volume I) and Cost (Volume II) Proposals. Offerors shall follow the instructions in Part VI of the BAA, and include the information requested therein.

the BAA to format and prepare the Technical (Volume I) and Cost (Volume II) Proposals. Offerors shall follow the instructions in Part VI of the BAA, and include the information requested therein. NOTE: For respondents submitting to the Special Instructions for DRIVe issued through Amendment #8, please follow the white paper preparation and submission directions found in the Special Instructions document.

#15 for DRIVe: Solving Sepsis”

N/A Special Instructions Area of Interest #15 for DRIVe:

Solving Sepsis

For details on Special Instructions Area of Interest #15, please see separate document included in Amendment #8 BARDA to this BAA titled “Special Instructions – BARDA’s Division of Research, Innovation & Ventures (DRIVe).”

4. Inserted “Special Instructions Area of Interest #16 for DRIVe: Early Notification to Act, Control and Treat (ENACT)”

N/A Special Instructions Area of Interest #16 for DRIVe: Early Notification to Act, Control and Treat (ENACT)

For details on Special Instructions Area of Interest #16, please see separate document included in Amendment #8 BARDA to this BAA titled “Special Instructions – BARDA’s Division of Research, Innovation & Ventures (DRIVe).”

Note: Application procedures differ from Areas of Interest #1-14 as detailed in the Special Instructions document. Submissions to the Special Instructions Areas of Interests #15 and #16 are limited in time and will not be accepted after May 28, 2019.

Amendment 7 (March 29, 2019): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 6 (November 20, 2018) Amendment 7 (March 29, 2019)

1. Revised Area of Interest 1:

CBRN Vaccines: 1.2

1.2 Sudan ebolavirus and Marburg virus. BARDA

is interested in advanced development projects for monovalent vaccines against Sudan ebolavirus and Marburg virus. The proposed vaccine candidate must have demonstrated protection from lethal challenge in non-human primate studies. Preference will be given to candidate products with one or more of the following:

• Phase 1 clinical data

• active Investigational New Drug (IND) with the

FDA

• safety toxicity data

• preliminary formulation

• stability indicating assay

• demonstrated small scale manufacturing process The objective of this program is to advance projects through the end of Phase 2 clinical development. Multivalent candidates will be considered only upon completion of phase 2 clinical study with clear guidance from FDA on regulatory pathway.

1.2 Sudan ebolavirus and Marburg virus. BARDA is

interested in advanced development projects for monovalent vaccines against Sudan ebolavirus and Marburg virus. The proposed vaccine candidate must have demonstrated protection from lethal challenge in non-human primate studies. Preference will be given to candidate products:

• Phase 1 clinical data

• an active Investigational New Drug (IND) with the FDA

• safety toxicity data, and

• demonstrated manufacturing process to support use in clinical trials The objective of this program is to advance projects through the end of Phase 2 clinical development.

Multivalent candidates will be considered only upon completion of phase 2 clinical study with clear guidance from FDA on regulatory pathway.

2. Removed Area of Interest 1:

CBRN Vaccines: 1.3

1.3 Expansion of availability of licensed anthrax

and smallpox vaccines to at risk populations:

BARDA is interested in programs to expand availability of licensed anthrax and smallpox vaccines for at risk populations, e.g., pediatric populations. Interested parties should refer to the Presidential Commission for the Study of

<removed>

Bioethical Issues report “Safeguarding Children:

Pediatric Medical Countermeasures”

3. Removed Area of Interest 1:

CBRN Vaccines: 1.4

1.4 Vaccines against Burkholderia pseudomallei

and Burkholderia mallei. BARDA is interested in advanced development projects for vaccines against B. pseudomallei and B. mallei. The proposed vaccine candidate must have demonstrated protection from lethal challenge in mouse and non-human primate studies. The following characteristics provide information regarding BARDA’s preferred profile:

• Vaccines against B. pseudomallei will be acceptable, but those that would target B. mallei in addition are preferred.

• Vaccines showing protection against aerosolized infection, or protection against multiple routes of exposure, are preferred.

• Timeline to Investigational New Drug (IND) submission of less than two years is preferred.

• Vaccines with preliminary formulation ready to be transitioned to GMP manufacturing are preferred.

• Vaccine candidates that offer sterilizing immunity in addition to protection are preferred, but not required.

The objective of this program is to advance projects through the end of Phase 1 clinical development. The following activities are expected to be included:

• Development of any necessary assay(s) for lot release

• Establishment of animal models acceptable to FDA, if necessary

• Development of small scale GMP manufacturing process

• GLP toxicology studies

• Nonhuman primate efficacy studies to include pre-exposure prophylaxis and post-exposure prophylaxis (in conjunction with antibiotic treatment)

• Development and qualification of necessary immunoassays

• Conduct of a Phase 1 clinical trial

4. Inserted Area of Interest 1:

CBRN Vaccines: 1.3 (new)

<Area of Interest - not available> 1.3 Antimicrobial Resistant Threats. BARDA is interested in the development of general use prophylactic vaccines to prevent bacterial infections (including antimicrobial resistant strains) caused by the following pathogens:

• Escherichia coli

• Pseudomonas aeruginosa

• Staphylococcus aureus

• Acinetobacter baumannii Preference will be given to candidate vaccines that have an active Investigational New Drug (IND) filed with the FDA and have completed a Phase 1 clinical study.

5. Removed Area of Interest 9:

Influenza Therapeutics: 9.4c

9.4.c Use electronic health record data to improve future enrollment by identifying the optimal target population characteristics and comparing alternative endpoints.

1. Offerors will use de-identified electronic health records to identify the inclusion/exclusion criteria resulting in a more optimal target population for the evaluation of new investigational therapeutics in hospitalized influenza clinical trials.

2. Offerors will use existing de-identified hospital data sets or electronic health record data to compare alternative endpoints in response to early vs. late treatment of oseltamivir. The strongest proposals will provide a head to head comparison of the vital sign endpoint to a multi-category ordinal scale in early vs late treatment with oseltamivir.

6. Page 9 Change in Government Response for Stage 1 (Quad chart and White paper) and Stage 2 (Full Proposal)

A decision will be made within 90 calendar days of the submission deadline

A response will be provided within 120 days of the next interim or final deadline following White Paper submission.

7. For Area of Interest #1: CBRN Vaccines, the Contracting Point of Contact is changed to Carl Newman; Carl.Newman@hhs.gov .

8. For Area of Interest #1: CBRN Vaccines, the Technical Point of Contact is changed to Amanda Zarrabian; Amanda.Zarrabian@hhs.gov .

9. For Area of Interest #2: CBRN Antitoxins and Therapeutic Proteins, the Contracting Point of Contact is changed to Carl Newman;

Carl.Newman@hhs.gov

10. For Area of Interest #3: Antibacterials, the Contracting Point of Contact is changed to Carl Newman; Carl.Newman@hhs.gov

11. For Area of Interest #5: Chemical Threat Medical Countermeasures , the Contracting Point of Contact is changed to Carl Newman;

Carl.Newman@hhs.gov .

12. For Area of Interest #6: Burn Medical Countermeasures, the Contracting Point of Contact is changed to James Bowers;

James.Bowers@hhs.gov

13. For Area of Interest #7: Diagnostics, the Contracting Point of Contact is changed to James Bowers; James.Bowers@hhs.gov

14. For Area of Interest #8: Influenza and Emerging Infectious Diseases (IEID) Vaccines (suspended EID only), the Contracting Point of Contact is changed to Kevin Nilles, Kevin.Nilles@hhs.gov .

15. For Area of Interest #9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics (suspended EID only), the Contracting Point of Contact is changed to Kevin Nilles; Kevin.Nilles@hhs.gov .

16. For Area of Interest #10: Respiratory Protective Devices, the Contracting Point of Contact is changed to Kevin Nilles; Kevin.Nilles@hhs.gov.

17. For Area of Interest #11: Ventilators, the Contracting Point of Contact is changed to Kevin Nilles; Kevin.Nilles@hhs.gov .

18. For Area of…