BARDA Broad Agency Announcement (BAA)

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Last updated: August 07, 2020

Pre-exposure Prophylaxis - Influenza

ACTiVE Areas of Interest

CBRN Vaccines

1.1 Needle-Free Technologies to Administer Licensed Vaccines
1.2 Sudan Ebolavirus and Marburg Virus
1.3 Flexible Vaccine Manufacturing Technologies

CBRN Antivirals and Antitoxins

2.1 Anthrax Antitoxins
2.2 Botulism Antitoxins
2.3 Smallpox Antivirals
2.4 Filovirus Antivirals

Antimicrobials

3.1 MDR Bacteria and Biothreat Pathogens
3.2 MDR Fungal Infections

Radiological/Nuclear Threat Medical Countermeasures

4.1 Acute Radiation Syndrome (ARS)
4.2 Uncontrolled Hemorrhage
4.3 Radiation Injury and Trauma Pathophysiology
4.4 Enabling Technologies and Platforms
4.5 Decorporation Agents

Chemical Medical Countermeasures

5.1 Pulmonary Agents
5.2 Opioids and Other Respiratory Depressants
5.3 Vesicants
5.4 Nerve Agents and Organophosphorus (OP) Pesticides
5.5 Knockdown Agents/Cellular Asphyxiants
5.6 Novel MCM Delivery Mechanisms
5.7 Innovative Approaches to Understanding Chemical Injury in Humans

Burn and Blast Medical Countermeasures

6.1 Enabling Technologies to Address General Burn & Blast Traumatic Injuries
6.2 Management of Head Injuries in Trauma
6.3 Hemorrhage Control
6.5 Management of Blunt Trauma Injuries
6.6 Advanced Imaging Technologies in Management of Trauma
6.7 Special Instruction for Health Economic Impact Assessment of Burn MCMs
6.8 Special Instruction for Platform Agnostic Software for AI Augmentation of Ultrasound Imaging Data

Diagnostics

7.1 Biothreat Agent Diagnostics
7.1.1 Biothreat Agent Diagnostics: Point-of-Care
7.1.2 Biothreat Agent Diagnostics: Laboratory
7.1.3 Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings
7.2 Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens
7.2.1 Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen
7.2.3 Antimicrobial Resistance (AMR) Sequencing Solutions
7.3 Influenza Diagnostics
7.3.1 Influenza Home-Use Testing (for OTC or Prescription at Home)
7.3.2 Pan-Influenza Diagnostics: Point-of-Care or Laboratory
7.3.3 Point-of-Care Multiplex Assay for Detection of Influenza Virus
7.4 Threat-Agnostic Diagnostics
7.4.1 Next-Generation Sequencing (NGS)-Based Agnostic Diagnostic for Viral Pathogens

Influenza and Emerging Infectious Diseases (IEID) Vaccines

8.1 Advanced Development of Faster or More Effective Vaccines
8.1.1 Faster Vaccines
8.1.2 More Effective Vaccines
8.1.3 Clinical Trials to Expand the Age Range on the Label of Currently Licensed Vaccines
8.2 Innovative Vaccine Production Enhancements
8.2.1 Platforms
8.2.2 Manufacturing
8.2.3 Assays for Product Release
8.2.4 Administration

Influenza and Emerging Infectious Diseases (IEID) Therapeutics

9.1 Influenza Antiviral Therapeutics
9.2 Immunomodulators or Therapeutics Targeting Lung Repair
9.3 Pre-exposure Prophylaxis – Influenza

ImmuneChip+

10.0 ImmuneChip+

Flexible and Strategic Therapeutics (FASTx)

12.0 Flexible and Strategic Therapeutics (FASTx)

ABOUT BARDA BROAD AGENCY ANNOUNCEMENTS

BARDA supports advanced research and development of medical countermeasures and is a component of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).

BAA Submission Process

SELECT THE FOR DETAILS

Pre-submission Call with BARDA Experts Market Research Abstract Submission Proposal Submission BARDA Review Negotiation

Pre-Submission Call

Offerors are strongly encouraged to request a call with the AOI Technical POC and/or submit a request for a TechWatch meeting, prior to starting an abstract or proposal. Learn More

Market Research Abstract Submission

Potential offerors shall complete and submit a Market Research Abstract, prior to submitting the proposal.

Proposal Submission

The Proposal Submission is comprised of a Technical Proposal and a Cost Proposal.

BARDA Review

Market Research Abstract: BARDA will assess the Market Research Abstract.

Potential offerors whose submission receives a favorable assessment will be invited via email to submit a Proposal.

Potential offerors whose submission does not receive a favorable assessment will be notified via email and will be provided with information on technical issues and concerns regarding the proposed product. This written feedback is the only response provided.

Proposal: A panel of BARDA experts will review the proposal.

Potential offerors whose Proposal is rated acceptable may be invited to enter into negotiations with the government. Award decisions will take into consideration program priorities, negotiations, and availability of funds.

Potential offerors whose Proposal is rated unacceptable will not be given further consideration.

Negotiation

Proposal submissions given an Acceptable rating may proceed into negotiations. This rating does not guarantee contract award; BARDA will consider program priorities, negotiations, and availability of funds.

Proposals submitted in response to the BARDA Broad Agency Announcement (BAA) must focus on research and development activities that relate to specific areas of interest, consisting of medical countermeasures for chemical, biological, radiological, and nuclear threats; pandemic influenza and emerging infectious diseases.

Prior to starting a market research abstract or proposal, BARDA strongly recommends offerors participate in a TechWatch meeting or a pre-submission call with the area of interest technical point of contact to gain technical feedback and strategic input.

The BARDA BAA Toolkit

The following tools and templates will help you develop your Market Research Abstract/Quad Chart and Proposal in response to the BARDA Broad Agency Announcement (BAA). For more information, review the full BARDA BAA. Prior to starting an application, BARDA strongly recommends that you participate in a TechWatch Meeting to discuss your product, technology or capabilities and explore potential partnership opportunities.

The application process occurs in three stages:

STAGE 1: Pre-sumbission call with technical point of contact

The government realizes that the preparation of a development proposal often represents a substantial investment of time and effort by the offeror. To minimize this burden, BARDA strongly encourages organizations and individuals interested in submitting proposals to make targeted inquiries with the technical point of contact (POC) of the Area of Interest (AOI) as to the general need for the type of research and development (R&D) effort contemplated before expending extensive effort in preparing a detailed abstract and proposal or submitting proprietary information. Specific instructions for requesting a pre-submission call are provided in Part IV (pgs. 24-25) of the BARDA BAA. For more general inquiries about potential partnerships with the U.S. government and to speak with a larger BARDA audience as well as PHEMCE partners, consider requesting a TechWatch meeting as noted in the General Market Research (TechWatch Program) section (page 9) of the BARDA BAA.

STAGE 2: QUAD CHART AND MARKET RESEARCH ABSTRACT

Your Stage 2 submission provides a brief summary of your project and consists of three components: the Quad Chart, Market Research Abstract, and Rough Order of Magnitude. Specific instructions for preparing each of these components are provided in Part IV (pgs. 25-26) of the BARDA BAA .

The Market Research Abstract provides a brief technical discussion of the offeror’s objective, approach, level of effort, and the nature and extent of the anticipated results.

You must identify in your Quad Chart and Market Research Abstract the current Technology Readiness Level (TRL) of your product, and the TRL identified should meet or exceed the requirements of the given Development Area of Interest. Refer to TRLs for Drugs and Biologics (applicable to AOIs 1-6, 8-9, & 12), TRLs for Medical Countermeasure Product Development Tools (applicable to AOIs 10-11), and TRLs for Diagnostics and Medical Devices (applicable to AOI 7) for specific criteria in determining TRLs.

Table 1: Components of a Market Research Abstract Submission

Details, Samples,
and Templates