The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding to companies seeking to develop products designed to diagnose, prevent or treat coronavirus infections.
On March 4, 2020, BARDA revised a pre-existing BAA to solicit proposals for COVID-19 diagnostic tests, vaccines, medicines such as therapeutics or antivirals (to either help prevent or to treat infections), and respiratory devices and ventilators. A further revised version, BAA‑18‑100-SOL-00003, Amendment 14, was issued on March 9, 2020. The current BAA requests COVID-19 related proposals by April 30. (The BAA also has subsequent submission dates of July 31 and October 31, 2020, with the latter being the latest possible submission date for this BAA.)
The Areas of Interest included in the amended BAA are:
- AOI 7.7.1 Diagnostic assay for human Coronavirus using existing FDA-cleared platforms
- AOI 7.7.2 Point-of-care diagnostic assay for detection of SARS-CoV-2 virus
- AOI 7.7.3 Diagnostic assay for detection of COVID-19 disease (SARS-CoV-2 infection)
- AOI 8.3 COVID-19 Vaccine
- AOI 9.2 COVID-19 Therapeutics
- AOI 9.3 Immunomodulators or therapeutics targeting lung repair
- AOI 9.5 Pre-exposure and post-exposure prophylaxis
- AOI 10 Respiratory protective devices
- AOI 11 Ventilators
- AOI 17 Advanced Manufacturing Technologies
Initial proposals are to take the form of a “Quad Chart” and a brief White Paper. Quad charts must follow this format and include a visual depiction and description of the effort, objectives, benefits, milestones, and other requested information. The White Paper is intended to provide a brief technical discussion of the offeror’s objective, approach, level of effort, and the nature and extent of the anticipated results. (The full Quad Chart and White Paper requirements are described in the BAA-18-100-SOL-00003, Amendment 14, beginning at page 62.)
Related Government Efforts
BARDA is also facilitating a parallel, consolidated U.S. government website for companies to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies being developed for COVID-19. According to the site, it is intended as “a portal for the U.S. government 2019 novel Coronavirus (2019-nCoV) medical countermeasures task force to provide a single point of entry for the submission of market research packages from interested stakeholders.”
In addition, BARDA opened a special, expedited broad agency announcement, an EZ-BAA, seeking diagnostics that use platforms already cleared by the FDA, such that these products could be authorized for use in as soon as 12 weeks. If the government can identify products and technologies that have progressed beyond non-clinical studies, have established domestic large‑scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, and have utilized a platform used to manufacture a product already approved by the FDA, that will significantly expedite time to market. Special instructions on use of the EZ BAA are available here.
Relatedly, the U.S. Food and Drug Administration (FDA) has issued two emergency use authorizations (EUA) of diagnostic tests from the Centers for Disease Control and Prevention (CDC) and the NYS Wadsworth Center. An EUA is a unique authorization that enables the FDA to authorize otherwise unapproved products for use in a public health emergency. That emergency was officially declared on February 3, 2020, opening the door for EUA submissions and authorizations to deal with the COVID-19 pandemic. In addition, FDA also issued a new policy on February 29 to help expedite the availability of diagnostic tools created laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to develop or offer high complexity tests.
In addition, we understand that at least two companies are currently developing Coronavirus vaccines with assistance from BARDA and that another is working with the government on a treatment for people who are already sick.
For those unfamiliar with the organization, BARDA is a federal sub-agency tasked with the procurement and development of countermeasures against bioterrorism (also including chemical, nuclear, and radiological threats), as well as pandemic influenza and emerging diseases. BARDA regularly publishes a series of BAAs through which it seeks submission of proposals at set intervals over a period of time from industry and research centers with novel ideas about ways to fight bioterrorism and disease. BARDA evaluates these initial proposals and then selects those that it would like to pursue further.
Eventually, awards of various values are made, based upon program priorities, proposals’ scientific/technical merits, how well the proposals fit BARDA’s areas of interest, and available funds. Awards may be in the form or cost-reimbursement or other cost-based funding, or BARDA may award grants or make use of its Other Transaction Agreement (OTA) authority to issue that type of agreement.
The BAA process generally proceeds as follows, although BARDA has indicated that the process may be altered somewhat during this unprecedented time:
- Company submits initial proposal by dates specified in BAA. (BARDA generally accepts proposals only four times per year).
- Within 90 days of receipt of the initial proposal, BARDA notifies the company whether it would like a more detailed, Full Proposal.
- The company prepares and submits a Full Proposal in accordance with the BAA instructions.
- Within 180 days, BARDA either accepts the Full Proposal or reverts to the company with additional questions.
- Once BARDA’s questions are answered, it asks the company to submit a Final Proposal Revision (“FPR”).
- Assuming the FPR is acceptable, the FPR will be incorporated by reference into the final contract, OTA or grant. If BARDA has further questions, it will ask again and request another FPR.
- If the parties agree to the FPR, a final agreement is presented by BARDA to the company, and the company will review and sign. Sometimes contract or grant terms and conditions may be negotiated at this stage (if the company is unwilling or unable to accept the agreement as written), although most of the terms and conditions are non-negotiable in that they are statutory or regulatory requirements or otherwise considered mandatory by BARDA.
Our Morrison & Foerster team has extensive experience assisting clients in responding to BAAs and negotiating contracts, grants, and OTAs. We can provide guidance as to which type of vehicle may be most appropriate, and assist with compliance considerations for those companies without significant federal contracting experience or appropriate cost accounting and Federal Acquisition Regulation (FAR) compliance systems. On the FDA front, we are actively engaging with FDA on the EUA process and advising clients on their diagnostic test development. We can help with FDA communications, understanding inter-relationship among public health agencies, and assessing the opportunities presented for new product development in light of the COVID-19 pandemic. Please contact the authors for further information.
For further information about Coronavirus preparedness please also visit the Morrison & Foerster Coronavirus Resource Center.