Amendment_11_Changes_Table_20200123 (002).pdf

Change History Table: Original – Amendments (1 – 11)

BARDA BAA-18-100-SOL-00003 List of Changes: Amendment 1

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

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. BARDA’s strategy to address this priority includes 1) improve vaccine effectiveness; 2) modernize production processes to decrease response time; 3) increase and diversify the sustainable domestic vaccine manufacturing infrastructure; 4) develop new adjuvants, delivery approaches, and other strategies that can provide a priming and protective response with a single vaccine dose and are more amenable to mass vaccinations in a response event. 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 in specific cases as described in subsequent sections, 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 immune systems. BARDA will endeavor to prioritize projects that provide benefits to all populations, while also allowing for focused development projects or studies for at-risk populations where necessary.

with compromised immune systems. BARDA will endeavor to prioritize projects that provide benefits to all populations, while also allowing for focused development projects or studies for at-risk populations where necessary.

2. Updated Area of Interest 1:

CBRN Vaccines to add sub-Area of Interest 1.4 Vaccines against Burkholderia pseudomallei and Burkholderia mallei

[None] [Addition sub-area of interest]:

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

3. Revised Area of Interest 2:

CBRN Antitoxins and Therapeutic Proteins to revise priorities.

2.1 Development of peptide or small

molecule antitoxins, and other novel compounds, with innovative formulations offering enhanced long-term stability. The candidate must be at TRL-6 (active IND and human safety data).

2.2 Development of antibody treatments

and other therapeutic agents for viral hemorrhagic fevers viruses. Programs must be at TRL-5 with a lead candidate identified.

2.3 Development of antibody treatments

and other therapeutic agents against smallpox.

Programs must have evidence for antiviral activity against orthopoxviruses. Programs at higher TRLs will be given priority.

2.1 Anthrax Antitoxins. Candidates for funding

under this BAA must be at TRL-6 or higher and either expand current response capabilities through product type (e.g., peptides, small molecules or novel compounds), mechanism of action or transformational change in operational use and total life cycle cost (e.g., shelf-life >10 years, significant reduction in cost of goods, etc.).

2.2 Botulism Antitoxins. Candidates for funding

under this BAA must either expand current response capabilities through product type (e.g., monoclonal antibodies, peptides, small molecules or novel compounds), mechanism of action or transformational change in operational use and total life cycle cost (e.g., shelf-life >10 years, significant reduction in cost of goods, etc.). Candidates at TRL-5 or higher are preferred; however, candidates earlier in development may be considered based on the significance of potential improvement upon existing capabilities.

2.3 Smallpox Antiviral. Programs must have

evidence of antiviral activity against orthopoxviruses.

Programs at higher TRLs (above TRL 5) will be given priority.

2.4 Viral Hemorrhagic Fevers Antiviral. Candidates

for funding under this BAA must be at TRL-5 (lead identified) or higher and either expand current response capabilities through product type (e.g., single mAbs, peptides, small molecules or novel compounds), mechanism of action or transformational change in operational use and total life cycle cost (e.g., shelf-life >10 years, significant reduction in cost of goods, etc.).

4. Revised Area of Interest 5:

Chemical Threat Medical Countermeasures to include Opioids sub-Area of Interest

[None] 5.2 Opioids: Development of MCMs to treat life-threatening respiratory depression caused by exposure to opioids during a large-scale event. These products should be fast acting, long lasting, and effective against a variety of opioids, including synthetic opioids such as Fentanyl and should preferably have a mechanism of action different from existing opioid receptor antagonists.

5. Revised Area of Interest 7:

added language to clarify “propose activities to advance to TRL 4-5” for sub-Area of Interest 7.1 Diagnostics Innovations.

7.1 Diagnostic Innovations

This section encourages innovative technologies that will provide capabilities for novel diagnostics with improved performance, as well as for their expedited development, manufacturing, and use for existing and emerging threats. Projects may be at an earlier stage of development (TRL 3).

7.3 Antibiotic Resistance Diagnostics for

priority bacterial pathogens

7.1 Diagnostic Innovations

This section encourages innovative technologies that will provide capabilities for novel diagnostics with improved performance, as well as for their expedited development, manufacturing, and use for existing and emerging threats. Projects may be at an earlier stage of development (TRL 3), and propose activities to advance to TRL 4-5.

BARDA is providing support to advance innovative rapid and improved diagnostics to detect drug resistant urgent and serious priority public health pathogens* and to characterize their resistance profiles both for biological threats and routine healthcare conditions.

7.3 Antibiotic Resistance Diagnostics for priority

bacterial pathogens BARDA is providing support to advance innovative rapid and improved diagnostics to detect drug resistant urgent and serious priority public health bacterial pathogens* and to characterize their resistance profiles, for biological threats and/or routine healthcare conditions.

6. Revised Area of Interest 8:

Influenza and Emerging Infectious Diseases (IEID) Vaccines

Under this Area of Interest, BARDA is seeking technologies that will improve preparedness against influenza and emerging infectious diseases with pandemic potential. Successful Offerors will provide evidence that the proposed vaccine product represents a transformative improvement in key vaccine attributes as compared to currently licensed products.

8.1 Advanced development of more

effective vaccines. Candidates, which have achieved TRL 6 or greater, and that will improve preparedness against influenza and emerging infectious diseases with pandemic potential are desired. Specifically for influenza, support for advanced development of new influenza vaccine candidates with the potential to stimulate broader (across influenza subtypes and/or within influenza subtypes), durable and more effective immunity than currently licensed products. The Offeror should provide data or a plan for validation of vaccine potency and release assays that are specific for the new influenza vaccine candidate. The Offeror should provide a regulatory strategy for FDA approval of the

Under this Area of Interest, BARDA is seeking technologies and approaches that will improve preparedness and response against pandemic influenza and emerging infectious diseases with pandemic potential. Successful Offerors will discuss and provide evidence that the proposed effort substantially enhances pandemic influenza preparedness and response, and describe plans and requirements for long-term sustainability.

8.1 Advanced development of more effective

vaccines. Candidates and approaches, which have achieved TRL 6 or greater, and that will improve preparedness and response against pandemic influenza are requested. Vaccine candidates and approaches that provide one or more of the following are of particular interest: a) licensure of domestically manufactured vaccines amenable to both rapid production from time of strain identification to release of bulk product, and rapid scale up and manufacturing technology transfer to new facilities; b) clinical trials to expand the age range on the label of currently licensed vaccines; c) decrease response time, such as adjuvants or other technologies that allow a priming and protective response with a single vaccine dose; or d) improve the stability, vaccine candidate and data demonstrating transformative improvements in immunogenicity/efficacy as compared to existing FDA licensed vaccines. Proposed clinical activities (Phase 1b/Phase 2 studies) should support development toward FDA licensure and evaluate key vaccine attributes, such as dose schedule, mechanism of action, time to onset of protection, broader cross- protection across influenza A virus subtypes, induction of priming immunity against viruses of pandemic potential, efficacy in multiple age groups, and multiyear duration of protection.

Efforts might include development, qualification and validation of correlates of protection assays used to evaluate the immune response to the new influenza vaccine candidate. BARDA may request responses to this BAA for vaccine against specific emerging pathogens of pandemic potential. BARDA will prioritize vaccine candidates against specified emerging infectious diseases that have reached the TRL6 level, however, earlier stage candidates may be considered.

8.2 Innovative vaccine production

enhancements. Support for improvements in vaccine production and platform technologies that accelerate the availability of vaccines against viruses with pandemic potential.

[None. Administration] sustainability and/or utility of stockpiled vaccines. All Offerors should provide commercialization and life cycle planning approaches and any sustainability costs that would be requested to maintain the capability. Proposed clinical activities should support development toward FDA licensure or additional label claims. Offerors proposing to develop vaccines not yet licensed by FDA should provide data supporting proposed vaccine potency and release assays that are specific for the influenza vaccine candidate, and clinical data supporting dose, schedule, mechanism of action, and safety of the vaccine candidate, as well as immunogenicity against pandemic strains of influenza. The Offeror should provide a regulatory strategy for FDA approval of the vaccine candidate and data demonstrating the proposed improvements to pandemic influenza response/preparedness. Proposed efforts might include qualification and validation of correlates of protection and other assays used to evaluate the immune response to the vaccine.

8.2 Innovative vaccine production enhancements.

Support for improvements in vaccine production and administration that accelerate the availability of pandemic influenza vaccines.

4. Administration:

a. Improved approaches to route of vaccine delivery that are more amenable to large scale vaccination campaigns in a short period of time.

7. Revised Area of Interest 12:

MCM Production Platform Systems

[In 12.2 Vaccine Production Platform] Technologies will be evaluated by criteria that address the rapid response goal (time to human clinical testing, manufacturing scalability and capacity, cost to develop and manufacture, current development and regulatory status), and the applicability of the technology to a range of threats as a platform (categories of pathogens covered, completeness of the technology from candidate generation to full manufacturing, use without variation for each new application).

Additional criteria that relate to the use of the technology for public health vaccines as well as the capabilities of the Offeror will also be considered.

[In 12.2 Vaccine Production Platform] Technologies are sought that address the rapid response goal. Attributes related to this goal include:

completeness of the technology from candidate generation to full manufacturing; use without variation for each new application; applicability of the technology to a range of threats as a platform (categories of pathogens covered); time to human clinical testing and cost to develop and manufacture (compared to current technologies); manufacturing scalability and capacity, current development and regulatory status (TRL 6 or greater), other commercial applications of the technology, and any additional attributes that relate to the use of the technology for public health vaccines (e.g., route and ease of administration).

8. Incorporated under AOI #8:

Note: White Paper and Full Proposal submissions under AOI #8 are suspended until October 1, 2018.

9. Incorporated under AOI #9:

Note: White Paper and Full Proposal submissions under AOI #9 are suspended until October 1, 2018.

10. Incorporated under AOI #12:

Note: White Paper and Full Proposal submissions under AOI #12 are suspended until further notice.

11. Incorporated under AOI #13:

Note: White Paper and Full Proposal submissions under AOI #13 are suspended until further notice.

12. Incorporated under AOI #14:

Note: White Paper and Full Proposal submissions under AOI #14 are suspended until further notice.

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

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.

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

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

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

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

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

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.

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

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

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

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

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

*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.”

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 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.

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

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 mailto:BARDA-BAA@hhs.gov mailto:BARDA-BAA@hhs.gov

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.

3. Inserted “Special Instructions Area of Interest #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.

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

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.

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

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

1. Added availablility 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.

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

Amendment 10 (October 15, 2019) Amendment 11 January 23, 2020)

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.

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 mailto:Wendell.Conyers@hhs.gov mailto:Wendell.Conyers@hhs.gov mailto:Wendell.Conyers@hhs.gov mailto:Wendell.Conyers@hhs.gov