BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)

Amendment / Modification

This amendment makes the following changes to the EZ-BAA-22-100-SOL-00003:

• Pause AOI #27: Stopping Secondary Spread: This Area of Interest is now paused.

• Remove Topic from AOI #20: DRIVe Forward: Specifically, Topic #4, "Novel Portable Diagnostics/Detection Methods for Prions as Protein-Based Agents of Disease," has been removed from AOI #20.

• Update Closing Date for AOI #20: The closing date for abstract submissions for AOI #20: DRIVe Forward has been updated to 12:00 PM ET on April 15, 2024.

• Areas of Interest (AOI) #27 and #20 are affected.

• The closing date for abstract submissions for AOI #20 is updated.

• The deadline for abstract submissions for AOI #20 has been extended to April 15, 2024.

• Vendors interested in AOI #27 should note it is currently paused.

• The scope of AOI #20 has been narrowed by the removal of Topic #4.

Amendment / Modification

• Adds a new Area of Interest (AOI) #27: Stopping Secondary Spread.

• This AOI focuses on developing and evaluating novel Medical Countermeasures (MCMs) to block the person-to-person transmission of respiratory viral pathogens.

• The goal is to develop agents that either reduce the likelihood of transmission from infected individuals or prevent infection following exposure.

• The program is particularly interested in influenza and SARS-CoV-2, but other common respiratory viral pathogens may be considered with justification.

• The ideal Target Product Profile (TPP) for these agents includes targeted delivery to the upper respiratory tract, ease of administration, immediate biologic activity, low reactogenicity, patient access, and targeting of adult and/or pediatric populations.

• Abstracts will be evaluated based on alignment with the TPP and responsiveness to AOI requirements, including clear descriptions of direct-acting or platform-based anti-viral products, focus on specific pathogens, compelling preclinical evidence, drug-device compatibility if applicable, and a plan for clinical evaluation and commercialization.

• "Out of scope" topics include evaluation of vaccine candidates, non-pharmaceutical interventions, sanitizers/cleaning products not for human use, and proposals using murine models for disease transmission.

• Abstracts will be reviewed at the end of the open period, not on a rolling basis.

• Interested vendors are encouraged to schedule a market research call with BARDA in advance of abstract submission.

• Abstract submissions must conform to the EZ-BAA requirements and entities must have an active registration with SAM.gov.

• Interested vendors are strongly encouraged to request and schedule a pre-submission call.

• Introduces AOI #27 and its associated details, including objectives, scope, TPP, evaluation criteria, and submission deadlines.

• The closing date for abstract submissions for AOI #27 is May 3, 2024, at 12:00 PM ET.

• Respondents awarded contracts will be required to share de-identified data.

Amendment / Modification

This amendment (Amendment #020) makes the following changes to the Easy Broad Agency Announcement (EZ-BAA):

• Pauses Area of Interest (AOI) #26: Agnostic Diagnostic.

• Adds a new topic to AOI #20: DRIVe Forward. The new topic is "Enhancing vaccine efficacy," focusing on innovative products and technologies to boost vaccine efficacy and duration. Other topics for AOI #20 include:

  • Extremely mobile viral diagnostic platforms for remote settings.
  • Computational models for precision MCM and non-pharmaceutical intervention (NPI) rapid development and deployment.
  • Novel portable diagnostics/detection methods for prions.

• Updates the closing date for AOI #20: DRIVe Forward.

• Introduction and Overview Information (Section A. Development Opportunity Objective)

• Eligible Respondents & Scope Parameters (Section B.)

• The closing date for abstract submissions for AOI #20: DRIVe Forward has been updated to 12:00 PM ET on April 15, 2024.

• The closing date for abstract submissions for AOI #26: Agnostic Diagnostic remains 12:00 PM ET on January 15, 2024.

• Abstract submissions are only accepted from applicants who have completed a market research call prior to submission.

• Interested vendors are strongly encouraged to request and schedule a pre-submission call before submitting an abstract.

Amendment / Modification

This amendment (Amendment #019) makes the following changes to the EZ-Broad Agency Announcement (BAA-22-100-SOL-00003):

• Reopens Area of Interest (AOI) #15: ReDIRECT.

• Revises AOI #15: ReDIRECT.

• AOI #15: ReDIRECT (Repurposing Drugs In Response to Chemical Threats) is reopened and revised.

• The closing date for abstract submissions for AOI #15: ReDIRECT is May 3, 2024, at 12:00 PM ET.

• Vendors are strongly encouraged to request and schedule a pre-submission call before submitting an abstract for AOI #15.

• The submission process and review procedures remain the same as established in the original EZ-BAA, unless otherwise noted.

Amendment / Modification

This amendment (018) to the DRIVe EZ Broad Agency Announcement (BAA-22-100-SOL-00003) makes the following updates:

• AOI #16: Lab at Home: The closing date is updated, and the Area of Interest itself is revised.
• AOI #17: Digital MCMs: This Area of Interest is now paused.
• AOI #19: Healing Lungs: The closing date for this Area of Interest is updated.

• Areas of Interest (AOI) #16, #17, and #19 are affected.

• Closing dates for AOI #16 and #19 have been modified.

• The closing date for AOI #16 (Lab at Home) and AOI #19 (Healing Lungs) has been updated. The new closing date for AOI #16 and #19 is March 15, 2024, at 12:00 PM ET.

• AOI #17 (Digital MCMs) is paused, meaning submissions are not currently being accepted for this area.

• The document also provides updated contact information for pre-submission calls for specific AOIs.

Amendment / Modification

This amendment reopens and revises Area of Interest (AOI) #20: DRIVe Forward.

• AOI #20: DRIVe Forward is reopened.

• AOI #20: DRIVe Forward is revised.

• The closing date for abstract submissions for AOI #20 is March 15, 2024, at 12:00 PM ET.

• Interested vendors are strongly encouraged to request and schedule a pre-submission call before submitting an abstract.

• Abstracts will only be accepted from applicants who have completed a market research call prior to submission.

• Respondents awarded a contract will be required to share collected, de-identified data.

Amendment / Modification

• This amendment announces the pause of Area of Interest (AOI) #24: REPAIR.

• The closing date for abstract submissions for AOI #24 has been revised to November 1, 2023, at 12:00 PM ET.

• The government anticipates that AOI #24: REPAIR will be reopened for submissions at a later date.

• Area of Interest (AOI) #24: REPAIR

• Closing Date for Abstract Submissions for AOI #24

• The deadline for abstract submissions for AOI #24 has been changed.

• Vendors are encouraged to contact the program regarding AOI #24 before submitting an abstract.

Amendment / Modification

This amendment (015) to the DRIVe EZ Broad Agency Announcement (BAA-22-100-SOL-00003) makes the following updates:

• Updated Closing Dates: The closing dates for Areas of Interest (AOI) #22 (ReBoot) and #25 (FASTx) have been updated.
• Revised Areas of Interest: The scope or details for AOI #22 (ReBoot) and AOI #25 (FASTx) have been revised.

• Area of Interest (AOI) #22: ReBoot

• Area of Interest (AOI) #25: FASTx

• The closing date for abstract submissions for AOIs #22 and #25 is now March 1, 2024, at 12:00 PM ET, unless otherwise extended.

• Vendors are encouraged to request and schedule pre-submission calls for these AOIs.

Amendment / Modification

• This amendment pauses Area of Interest (AOI) #21: Vaccines on Demand.

• The closing date for abstract submissions for AOI #21 was September 28, 2023, at 12:00 PM ET. It is anticipated that this AOI will be reopened for submissions at a later date.

• AOI #21: Vaccines on Demand

• Abstract submissions for AOI #21 are currently paused. Vendors interested in this AOI should monitor for future announcements regarding its reopening. The submission process and review procedures will follow the original EZ-BAA unless otherwise noted in future amendments.

Amendment / Modification

• This amendment announces the pausing of Area of Interest (AOI) #20: DRIVe Forward.

• The closing date for abstract submissions for AOI #20 has been revised to September 15, 2023, at 12:00 PM ET.

• It is anticipated that AOI #20 will be reopened for submissions later in the calendar year.

• The "Closing Date for Abstract Submissions" for AOI #20 has been updated.

• The deadline for abstract submissions for AOI #20 has been extended to September 15, 2023.

• Vendors interested in AOI #20 should note that it is currently paused but expected to reopen later this year.

Amendment / Modification

This amendment (012) to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003 makes the following changes:

• Updated Closing Dates: The closing dates for Areas of Interest (AOI) #16 (Lab at Home), #17 (Digital MCMs), and #19 (Healing Lungs) have been updated.

• Revised Area of Interest: AOI #16 (Lab at Home) has been revised.

• New Area of Interest Added: AOI #26 (Agnostic Diagnostic) has been added.

• Areas of Interest (AOI) #16, #17, and #19 closing dates.

• AOI #16 description.

• Introduction and Overview Information section regarding Development Opportunity Objective.

• Eligible Respondents & Scope Parameters section, specifically the closing dates for abstract submissions.

• The closing date for abstract submissions for AOI #16, #17, and #19 is now December 15, 2023.

• The closing date for abstract submissions for the new AOI #26 is January 15, 2024.

• Vendors are encouraged to schedule pre-submission calls and should ensure their SAM.gov registration is active.

Amendment / Modification

This amendment makes the following changes to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003:

• Closes Area of Interest (AOI) #18: Host-Directed Therapeutics.

• Closes Area of Interest (AOI) #23: Host-Based Diagnostics.

• Updates closing date for AOI #19: Healing Lungs.

• Areas of Interest #18, #19, and #23 are affected.

• The closing date for abstract submissions for AOI #18 and #23 was June 30, 2023.

• The closing date for abstract submissions for AOI #19 has been updated to October 4, 2023.

• Vendors are encouraged to reach out to the respective program before submitting an abstract due to limited funding.

Amendment / Modification

This amendment (Amendment 010) revises and updates information related to Area of Interest (AOI) #24: REPAIR.

• Area of Interest (AOI) #24: REPAIR: This AOI has been revised.

• Closing Date for Abstract Submissions for AOI #24: The closing date has been updated.

• The closing date for abstract submissions for AOI #24: REPAIR is now December 1, 2023, at 12:00 PM ET.

• The amendment does not alter the overall submission process or review procedures established in the original EZ-BAA, which should be read in its entirety along with all amendments.

Amendment / Modification

• This amendment reopens Area of Interest (AOI) #21: Vaccines on Demand.

• AOI #21: Vaccines on Demand is reopened.

• The closing date for abstract submissions for AOI #21 is September 28, 2023, at 12:00 PM ET, unless otherwise extended.

• Interested vendors are encouraged to request and schedule a pre-submission call.

• Abstract submissions must conform to the requirements outlined in the EZ-BAA and require an active SAM.gov registration at the time of submission.

Amendment / Modification

This amendment (008) to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003 makes the following changes:

• Addition of New Area of Interest (AOI): AOI #25, titled "FASTx: Nucleic acid-based platform development for Flexible and Strategic Therapeutics," has been added.

• Update to "Plus (+) Phase" Language: Section III (F) of the original EZ-BAA has been updated regarding the "Plus (+) Phase." The review procedures remain the same, but there may be differences in award contract type, duration, funding thresholds, and cost accounting standards.

• The addition of AOI #25 introduces new scope and requirements for abstract submissions.

• Section III (F) "Plus (+) Phase" has been modified.

• Abstract submissions are now being accepted for the new AOI #25.

• The closing date for abstract submissions for AOI #25 is 12:00 PM ET on October 15, 2024.

• Interested vendors for AOI #25 are strongly encouraged to request and schedule a pre-submission call.

• The original EZ-BAA and all previous amendments should be reviewed for complete details, especially concerning the "Plus (+) Phase" and submission requirements.

Amendment / Modification

• Updates the closing date for Area of Interest (AOI) #24: REPAIR.

• The new closing date for abstract submissions for AOI #24 is June 1, 2023, at 12:00 PM ET.

• The closing date for abstract submissions for AOI #24 has been modified.

• The deadline for submitting abstracts for AOI #24: REPAIR has been extended to June 1, 2023.

Amendment / Modification

This amendment (006) to the DRIVe EZ Broad Agency Announcement (BAA-22-100-SOL-00003) makes the following updates:

• Updated Closing Dates:
  • AOI #19: Healing Lungs
  • AOI #17: Digital MCMs
  • AOI #16: Lab at Home
• Revised Area of Interest: AOI #16: Lab at Home has been revised.

• Areas of Interest (AOIs) #16, #17, and #19 are affected by updated closing dates.

• AOI #16: Lab at Home is revised.

• The closing date for abstract submissions for AOI #16 and #17 is now February 6, 2024, at 12:00 PM ET.

• The closing date for abstract submissions for AOI #19 is now June 30, 2023, at 12:00 PM ET.

• The revised AOI #16 details are provided, focusing on developing novel platform technologies and instrumentation for on-demand detection of multiple biochemical health markers at the point of need. This includes requirements for quantitative biomarker data, adaptability to various test panels, non-invasive sample collection (saliva, urine, sweat, breath, nasal swabs, finger stick blood, or interstitial fluid), and a testing process of no more than 2 hours. Priority is given to platforms developed in the U.S. Non-responsive topics include venous blood draws, invasive samples, and proposals focusing solely on clinical validation or interpretation.

Amendment / Modification

• This amendment announces the pausing of Area of Interest (AOI) #15: ReDIRECT.

• The closing date for abstract submissions for AOI #15 has been revised to February 15, 2023, at 12:00 PM ET.

• It is anticipated that AOI #15: ReDIRECT will be reopened for submissions later in the calendar year.

• The "Development Opportunity Objective" section is updated to reflect the pausing of AOI #15.

• The "Eligible Respondents & Scope Parameters" section is updated to reflect the revised closing date for AOI #15 and provides the contact email for pre-submission calls for this AOI.

• The deadline for abstract submissions for AOI #15 has been changed to February 15, 2023.

• Vendors interested in AOI #15 should note that it is currently paused but expected to reopen later in the year.

Amendment / Modification

• This amendment updates the closing date for Area of Interest (AOI) #21: Vaccines on Demand.

• The closing date for abstract submissions for AOI #21 has been changed.

• The new closing date for abstract submissions for AOI #21 is February 28, 2023, at 12:00 PM ET.

• The amendment states that this is the closing date unless otherwise extended.

• The submission process and review procedures remain the same as established in the EZ-BAA and its prior amendments.

• Respondents are reminded that active SAM.gov registration is required at the time of submission.

• Vendors are encouraged to schedule a pre-submission call, including project title, key staff, and project description, to the provided email address for AOI #21.

Amendment / Modification

This amendment revises Area of Interest (AOI) #19: Healing Lungs. The original AOI has been updated to reflect new details regarding the development opportunity.

• AOI #19: Healing Lungs has been revised.

• The closing date for abstract submissions for AOI #19 is February 3, 2023, at 12:00 PM ET.

• Vendors are encouraged to request and schedule a pre-submission call.

• Abstract submissions must conform to the requirements outlined in the EZ-BAA and all amendments.

• Active registration on SAM.gov is required at the time of submission.

Amendment / Modification

• Adds a new Area of Interest (AOI) #24: REPAIR.

• Clarifies an administrative error in the "Determination of Interest in the Abstract Submission" section of the original posting.

• Introduces AOI #24: REPAIR, detailing its objective, scope, and requirements for responsive submissions.

• Modifies the wording in Section D.1 regarding the basis for determination of interest in abstract submissions.

• Introduces a new closing date for abstract submissions for AOI #24: REPAIR, which is February 28, 2023, at 12:00 PM ET.

• Vendors are encouraged to schedule pre-submission calls for AOI #24.

• Clarifies that the determination of interest will only be based on the content of the submission, and prior market research communications will not be considered.

Amendment / Modification

This amendment adds descriptions for nine new Areas of Interest (AOIs) to the Broad Agency Announcement (BAA) BAA-22-100-SOL-00003:

• AOI #15: ReDIRECT - Focuses on repurposing existing therapeutics as medical countermeasures (MCMs) against chemical threats.
• AOI #16: Lab at Home - Seeks proposals for novel platform technologies and instrumentation for on-demand detection of multiple biochemical health markers in a CLIA-waived environment.
• AOI #17: Digital MCMs - Supports the development of digital health diagnostic tools to augment existing medical countermeasures against health security threats.
• AOI #18: Host-Directed Therapeutics - Aims to advance therapies that fortify and restore balance to the body's defense mechanisms to prevent, reduce, or mitigate immediate and long-term harm from infections.
• AOI #19: Healing Lungs - Interested in developing novel technologies to sustain healthy oxygenation levels in ARDS patients and advancing solutions for patients refractory to mechanical ventilation.
• AOI #20: DRIVe Forward - Captures promising approaches that don't fit into current program areas but would advance DRIVe's mission, including microbiome-based therapies and resilience to infection.
• AOI #21: Vaccines on Demand - Seeks abstracts to advance the development of on-demand vaccine manufacturing technologies/systems for distributed vaccine production.
• AOI #22: ReBooT - Requests abstract submissions for projects evaluating existing therapeutics as medical countermeasures (MCM) against filoviruses.
• AOI #23: Host-Based Diagnostics - Focuses on tools that evaluate the host response to infection to prognosticate disease severity or aid in triaging patients.

This amendment introduces and describes the new AOIs listed above.

Potential applicants should review the descriptions of these new AOIs and their respective closing dates for abstract submissions, which are provided in the amendment.

Solicitation / RFP / RFQ

This Broad Agency Announcement (BAA) from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response (ASPR), Office of Biomedical Advanced Research and Development Authority (BARDA), Division of Research, Innovation, and Ventures (DRIVe), seeks submissions for research efforts to accelerate innovation and improve the availability of transformative tools, products, and technologies to protect Americans from health security threats. It aims to fund innovative approaches that address unmet needs and have the potential to create new research and development fields.

• The BAA covers basic or applied research and development projects to advance or evaluate cutting-edge technologies and approaches.

• Areas of interest (AOIs) will be detailed in amendments to this announcement.

• Submissions are a two-stage process: Abstract Submission followed by a Full Proposal if the abstract is favorably reviewed.

• Projects can be at various stages of technological readiness level (TRL).

• Respondents must propose a Resource Contribution of a minimum of 30-50% of the total proposed project value.

• Contracts awarded may be in the form of any appropriate contract type under FAR or non-FAR instruments, including Other Transactional Agreements. Grants and cooperative agreements will not be awarded.

• Initial awards are anticipated to be firm fixed price (FFP) contracts.

• The period of performance for most initial awards is expected to be 12-24 months.

• Awards may not exceed $20 million in U.S. Government funding for the Plus (+) Phase.

• Abstract Submissions are required and must be submitted through the BARDA Digital Resources (BDR) Portal.

• Key components of the Abstract Submission include a Technical Section (problem statement, solution, impact, innovation, supporting data/feasibility, technical approach, regulatory approach, manufacturing, intellectual property, risks) and Project Price/Costs (Rough Order of Magnitude).

• Abstract review determines "Interested" or "Not Interested" status.

• "Interested" respondents are invited to submit a Full Proposal.

• Full Proposals are evaluated based on: Alignment with AOI requirements, Technical Approach, Ability to transition technology, Cost/Price Reasonableness, and Past Performance.

• Submission deadlines are established by individual AOIs and communicated through amendments.

• The overall EZ-BAA is open until October 18, 2027, unless revised or superseded.

• Open to all responsible sources, domestic and international, including single entities, teams, private sector organizations, non-profits, NGOs, and academic institutions.

• Encourages submissions from small businesses, historically black colleges and universities, minority institutions, and minority researchers.

• Respondents must be registered in the System for Award Management (SAM).

• Certain individuals (former federal employees involved in the announcement creation or those providing SETA/A&AS support) are ineligible to respond.

• Amendments are expected to be added regularly and are crucial for understanding AOIs, submission details, and deadlines.

• Market research calls with AOI representatives are encouraged.

• All submissions must be Unclassified.

• Communication after submission must be through the Contracting Officer/Contract Specialist.