Amendment_26_Changes_Table_20210603.pdf

Change History Table: Original – Amendments (1 – 26) 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

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 mailto:BARDA-BAA@hhs.gov

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

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 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.

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

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

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) mailto:Daniel.Wolfe2@hhs.gov mailto:Timothy.Belski@hhs.gov mailto:Carol.Lavrich@hhs.gov

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.

mailto:Wendell.Conyers@hhs.gov

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)

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.

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 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.

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

Amendment 7 (March 29, 2019) Amendment 8 (April 9, 2019) 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 the instructions in Part VI of the BAA, and include the information requested therein.

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 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 –

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

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 Interest #14: Visual Analytics an Enabling Technology for Influenza, Emerging Infectious Disease, and CBRN Threats, the Contracting Point of Contact is changed to “To Be Determined”.

19. For all instances noting Acquisition Management Contracts and Grants (AMCG), change to Biomedical Advanced Research Development Authority (BARDA) / Contracts, Management, and Acquisition (CMA) mailto:Carl.Newman@hhs.gov mailto:Amanda.Zarrabian@hhs.gov mailto:Carl.Newman@hhs.gov mailto:Carl.Newman@hhs.gov mailto:Carl.Newman@hhs.gov mailto:James.Bowers@hhs.gov mailto:James.Bowers@hhs.gov mailto:Kevin.Nilles@hhs.gov mailto:Kevin.Nilles@hhs.gov mailto:Kevin.Nilles@hhs.gov mailto:Kevin.Nilles@hhs.gov

Amendment 5 and 6 (November 20, 2018): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Updated Points of Contact under AOI Numbers 1, 6, 8, 9, 10, 11, 12, and 13.

Amendment 4 (October 12, 2018): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Incorporated under AOI #8: Note: Emerging Infectious Diseases White Paper and Full Proposal submissions under AOI #8 are suspended until further notice. Influenza submissions will continue to be accepted.

2. Incorporated under AOI #9: Note: Emerging Infectious Diseases White Paper and Full Proposal submissions under AOI #9 are suspended until further notice. Influenza submissions will continue to be accepted.

Amendment 3 (August 30, 2018): BARDA BAA-18-100-SOL-00003 List of Changes:

Amendment 2 (June 20, 2018) Amendment 3 (August 30, 2018)

1. Revised Area of Interest 6:

Burn MCMs: 6.1

6.1 Products to prevent or control burn

wound conversion: For a product to be considered, Offerors must demonstrate preliminary efficacy data to modulate wound healing. Proposed products must therefore contribute towards autograft sparing when applied to deep partial thickness burns and savings in resources. Appropriate value propositions should be provided such as rationale for ease in administration and/or use in large TBSA burns in a mass casualty within a short timeframe. Products, which are non-autologous and used off-the-shelf for any patient would be of significant interest.

6.1 Products to prevent or control burn wound

conversion: For a product to be considered, Offerors must demonstrate preliminary efficacy data to modulate wound healing. Proposals with investigational products to mitigate burn wound conversion in animal models alone, while important and supportive, is not the primary focus or sole purpose of this effort. Rather, achieving true clinical impact with improved metrics of wound healing and related aspects, such as autograft sparing are the goals. Proposed products must therefore contribute towards autograft sparing when applied to deep partial thickness burns and contribute to savings in resources. Appropriate value propositions should be provided such as rationale for ease of administration and/or use in large TBSA burns in a mass casualty within a short timeframe. Products, which are non-autologous and used off-the-shelf for any patient would be of significant interest. Offerors proposing clinical evaluation of their products to demonstrate the potential to mitigate burn wound conversion effects should include at least a preliminary feedback from the FDA on the end points, evaluation factors, and the overall regulatory pathway for approval and marketability.

2. Revised Area of Interest 6:

Burn MCMs: 6.2

6.2 Smart imaging systems: For a product to

be considered, Offerors must demonstrate preliminary effectiveness to improve the performance in one or both of these actions compared to the current standards. Common desirable attributes include but are not limited to being non-invasive, mobile/portable,

6.2 Smart imaging systems: For a product to be

considered, Offerors must demonstrate preliminary effectiveness to improve the performance in one or both of these actions compared to the current standards.

Common desirable attributes identified in the table below include but are not limited to being non-invasive, compliant with data security, and having user-friendly interfaces.

o Identification of burn depth and/or assessment of a burn wound’s healing potential without further intervention such as grafting.

Desired attributes may include improvements for faster, comprehensive, and more accurate non-invasive, wound depth identification, real-time feedback and a model for decision support in signal triage.

o Ability to multiplex or be multifunctional, i.e., one system that could have different modules and more than one function. For example, detect burn depth and have ability to detect traumatic injury complication associated with mass casualties, such as high impact injuries leading to quicker diagnosis of internal bleeding and the damage caused by trauma to the abdomen such as liver or spleen lacerations or perforation of other organs. Additional range of products includes but not limited to those products that could screen for and detect potential injuries to internal organs (such as by using ultrasounds to detect pooled blood, measure brain pressure to predict death risk).

mobile/portable, compliant with data security, and having user-friendly interfaces.

o Identification of burn depth and/or assessment of a burn wound’s healing potential without further intervention such as grafting. Examples of such technologies that may have the capability of determining burn depth may include but are not limited to: Laser Doppler Imaging (LDI), Spatial Frequency Domain Imaging (SFDI), Multispectral Imaging (MSI), Forward Looking Infrared (FLIR), Short Wave Infrared (SWIR), Laser Speckle Imaging (LSI), Photoplethysmorgraphy (PPG), and machines capable of Deep Learning and/or Artificial Intelligence (AI). Desired attributes may include improvements for faster, comprehensive, and more accurate non-invasive, wound depth identification, real-time feedback and a model for decision support in signal triage.

o Ability to multiplex or be multifunctional, i.e., one system that could have different modules and more than one function. For example, detect burn depth and have ability to detect traumatic injury complication associated with mass casualties, such as high impact injuries leading to quicker diagnosis of internal bleeding and the damage caused by trauma to the abdomen such as liver or spleen lacerations or perforation of other organs. Additional range of products includes but not limited to those products that could screen for and detect potential injuries to internal organs (such as by using ultrasounds to detect pooled blood, measure brain pressure to predict death risk).

3. Insertion of Table 2: Description of Desirable Attributes for Smart Imaging System (Applies to Area of Interest 6.2). All tables renumbered automatically.

4. Clarify that submissions to Area of Interest 8.1 requires TRL equal to or greater than 6.

5. Clarify submissions to 8.2 “for which feasibility data is available. Vaccine production enhancements are not expected to adhere to TRLs.”

6. For Area of Interest #3: Antibacterials, the Technical Point of Contact is changed to Dr. Mark Albrecht; Mark.Albrecht@hhs.gov.

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

8. For Area of Interest #9 Influenza and Emerging Infectious Diseases (IEID) Therapeutics, the Technical Point of Contact is changed to Dr.

Kimberly Armstrong; Kimberly.Armstrong@hhs.gov.

9. For Area of Interest #12: MCM Production Platform Systems, the Contracting Point of Contact is changed to Juan Wooten;

Juan.Wooten@hhs.gov.

mailto:Mark.Albrecht@hhs.gov mailto:Erin.Greninger@hhs.gov mailto:Kimberly.Armstrong@hhs.gov mailto:Juan.Wooten@hhs.gov

Amendment 2 (June 20, 2018): BARDA BAA-18-100-SOL-00003 List of Changes:

1. Incorporated under AOI #8:

Note: Emerging Infectious Diseases White Paper and Full Proposal submissions under AOI #8 are suspended until October 1, 2018. Influenza submissions will continue to be accepted.

2. Incorporated under AOI #9:

Note: Emerging Infectious Diseases White Paper and Full Proposal submissions under AOI #9 are suspended until October 1, 2018. Influenza submissions will continue to be accepted.

Amendment 1 (June 15, 2018): BARDA BAA-18-100-SOL-00003 List of Changes:

Original (Nov 6, 2017) Amendment 1 (Jun 15, 2018)

1. Revised the “Background” section to update BARDA’s priority for influenza vaccines.

Vaccines, therapeutics, diagnostics, ventilators, and respiratory protective devices are essential for protecting all segments of the civilian population from pandemic influenza and other emerging infectious diseases. This BAA will support advanced development activities of medical countermeasures for influenza and other emerging respiratory viruses to be specified by BARDA. BARDA priorities for influenza vaccines are focused on those vaccines that induce long-lasting and broad (heterotypic and/or heterosubtypic) immunity in all populations compared to currently licensed influenza vaccines. In addition, BARDA will prioritize support for vaccines that induce broad immunity so as to prime the population against newly emerging influenza viruses or other respiratory viruses of pandemic potential. BARDA is also prioritizing broadly reactive immunotherapeutics, such as monoclonal antibodies, that will be effective in treating severely ill, hospitalized patients of all ages who are infected with influenza or other emerging infectious diseases.

Such therapeutics will demonstrate effectiveness when given later than 48 hours after onset of symptoms. Additional focus will be placed on MCM and devices suitable for use in at-risk populations such as children, pregnant women, the elderly, and persons with compromised immune systems. BARDA will endeavor to prioritize projects that provide benefits to all

Vaccines, therapeutics, diagnostics, ventilators, and respiratory protective devices are essential for protecting all segments of the civilian population from pandemic influenza and other emerging infectious diseases. This BAA will support advanced development activities of medical countermeasures for influenza and other emerging respiratory viruses to be specified by BARDA. BARDA’s priority for influenza vaccines is sustainable, cost effective approaches that improve pandemic influenza preparedness and rapid response capabilities.