Amendment 028 - DRIVe EZ BAA.pdf

EZBAA-22-100-SOL-00003 Amendment #028

Office of Biomedical Advanced Research and Development Authority Division of Research, Innovation & Ventures (DRIVe) Easy Broad Agency Announcement EZBAA-22-100-SOL-00003

The purpose of Amendment #028 is the following:

1) Update the closing date for the following Area of

Interest (AOI):

AOI #15: ReDIRECT

2) Update the closing date for the following Area of Interest (AOI):

AOI #26: Agnostic Diagnostic

3) Reopen the following Area of Interest (AOI):

AOI #17: Digital MCMs

EZBAA-22-100-SOL-00003 Amendment #028

4) Revise the following Area of Interest (AOI):

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

Under this Amendment, DRIVe is doing the following:

1) Updating the closing date for the following research Area of Interest (AOI):

AOI #15: ReDIRECT

2) Updating the closing date for the following research Area of Interest (AOI):

AOI #26: Agnostic Diagnostic

3) Reopening the following research Area of Interest (AOI):

4) Revising the following research Area of Interest (AOI):

We are now seeking abstract submissions for the following AOI:

Digital Medical Countermeasures

BARDA/DRIVe is interested in innovative computational approaches and technologies, such as artificial intelligence (AI), that (1) are the foundation of new medical countermeasures (MCM) for health security threats, or (2) directly support the development or use of MCMs for health security threats. BARDA supports MCMs that diagnose, prevent, or treat injury or illness resulting from chemical, biological, radiological, and nuclear (CBRN) events, including related blast and burn injuries; pandemic influenza;

and emerging infectious diseases.

(1) Computational approaches and technologies that are the foundation of new MCMs may include, but are not limited to, algorithms that use data collected with a smartphone or commonly available wearable device to detect or diagnose an injury or illness described above. Proposals must demonstrate that the resulting MCM would be rapidly deployable, inexpensive, simple to use, and equitable.

EZBAA-22-100-SOL-00003 Amendment #028

(2) Computational approaches and technologies that directly support the development or use of MCMs may include, but are not limited to, those that improve triage or clinical workflows for more efficient responses to health security threats, increase MCM accessibility, support multimodal medicine, or evaluate the utility of real-world data or synthetic data for MCM development.

Proposals to improve MCM availability, access, or user experience for underserved populations are of particular interest.

A proposal may focus on a single threat within BARDA’s mission as a demonstration case, however, the fundamental technology should be threat-agnostic and generalizable to a set of other threat agents.

Project proposals must address the following

• Innovation and uniqueness of the proposed technology

• Relevant preliminary data demonstrating feasibility of the approach

• Expected impact on mitigating a health security threat

• Specific research and development aims for the project

• Plan for equitably addressing different demographic groups, including underserved people

• Data collection plan, including sources and timelines. BARDA will not provide data.

• A plan for evaluating the performance and impact of the technology during the project

• A plan for analysis of user experience as part of the project

• A description of adherence to all relevant regulatory, security, and privacy standards

Proposals for the following will be considered non-responsive

• Technologies for discovery of new, repurposed, or repositioned drugs, therapeutics, or vaccines

• Technologies that inform on infection severity or sepsis

• Technologies that primarily support surveillance

• Technologies that interpret results of an in vitro diagnostic

• Incremental improvement of existing technologies

• Internal infrastructure-oriented projects for existing capabilities (e.g., user scale-up) without a research and development component

B. Eligible Respondents & Scope Parameters:

This Amendment is open to all responsible sources as described in the EZ-BAA. Abstract submissions that do not conform to the requirements outlined in the EZ-BAA may be considered non-responsive and will not be reviewed. An entity must have an active registration with https://sam.gov at the time of submission to be reviewed. If not, the abstract submission will not be reviewed and will be rejected. Please do not attempt to submit an abstract if your registration is not active in https://sam.gov.

IMPORTANT NOTE: Interested vendors are strongly encouraged to request and schedule a pre-submission call before submitting an abstract. This request should include the project title, key project staff, and a brief description of the proposed project. Please submit the requests to the following:

https://sam.gov/ https://sam.gov/

EZBAA-22-100-SOL-00003 Amendment #028

AOI #15: ReDIRECT (chemrepo@hhs.gov) AOI #26: Agnostic Diagnostic (ngs@hhs.gov) AOI #17: Digital MCMs (digitalhealth@hhs.gov)

The closing dates for abstract submissions for these AOIs are listed below.

Area of Interest Closing Date for Abstract Submissions #15 12:00pm ET on May 31, 2024

#26 12:00pm ET on September 30, 2024

#17 12:00pm ET on October 31, 2024

C. Number of Awards:

Multiple awards are anticipated and are dependent upon the program priorities, scientific/technical merit of abstract submissions, how well the abstract submissions fit within the goals of the AOI, and the availability of funding. The program funding is subject to change based on the Government’s discretion.

Funding is limited, so we encourage any interested vendors to reach out to the respective program as soon as possible before submitting an abstract.

D. Amendment Application Process:

This Amendment will follow the same submission process and review procedures as those established under this EZ-BAA, unless otherwise noted. For complete details, please read the EZ-BAA in its entirety along with all amendments.

IMPORTANT NOTE: Respondents who are awarded a contract under each of these AOIs will be required to share any collected, de-identified data to advance the field and knowledge.

Interested Respondents are strongly encouraged to commercialize their technology and algorithms, however, note that consistent with BARDA’s mission and federal standards, data collected through the use of government funding will be delivered to BARDA for government usage pursuant to applicable regulations and law.

mailto:chemrepo@hhs.gov mailto:ngs@hhs.gov mailto:digitalhealth@hhs.gov