As part of the US government’s ongoing public health response to the 2019 novel coronavirus outbreak, first recognized in Wuhan, China, the US Department of Health and Human Services (HHS) recently announced the opening of an easy broad agency announcement (EZ-BAA) to support the development of 2019-nCoV diagnostics. The department is now accepting abstract submissions for potential funding.
Under the department’s EZ-BAA, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS office of the assistant secretary for preparedness and response, will review concise abstract submissions from organizations seeking funding to support the development of molecular diagnostics for 2019-nCoV. The diagnostics must utilize platforms already cleared by FDA, and must offer a viable plan to meet requirements for FDA to consider emergency use authorization (EUA) within 12 weeks of an award.
“Diagnostics in close proximity to the patient are essential to ensure appropriate, prompt care, and to help curb the spread of infectious diseases such as 2019-nCoV,” says Rick Bright, PhD, director of BARDA. “The 2019-nCoV poses a serious global health challenge, and at BARDA we are working rapidly with our government and industry partners to accelerate development of medical products needed to help protect the health of the American people.”
The EZ-BAA was created to provide a streamlined process through which BARDA and its division of research, innovation, and ventures can review and accept applications for funding to develop transformative products and technologies to protect Americans from health security threats. In response to the 2019-nCoV outbreak, the process has been modified to support diagnostic products that fit the profile outlined above. The application process is both business-friendly and easy to follow.
Since its inception, BARDA’s EZ-BAA solicitation process has averaged more than one abstract submission per day, while active, with awards made in as few as 30 days. The EZ-BAA process has helped transform the contracting process by providing innovators, entrepreneurs, and organizations with a simplified and rapid mechanism for partnering with agencies of the US government. BARDA is leveraging the process in order to respond rapidly to the current outbreak of the 2019 novel coronavirus, which the secretary of HHS has identified as a public health emergency.1
For additional details, see HHS solicitation BAA-20-100-SOL-0002.2
1. Determination that a public health emergency exists [online]. Washington, DC: US Department of Health and Human Services, 2019. Available at: www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx. Accessed February 8, 2019.
2. Special instructions 001 issuance for easy broad agency announcement (EZ-BAA) [BAA-20-100-SOL-0002, online]. Washington, DC: US Department of Health and Human Services, 2019. Available at: https://beta.sam.gov/opp/6d5f514d69c94f60ae277f4ec33ca68d/view. Accessed February 8, 2019.