February 5, 2020
HHS Seeks Abstract Submissions for 2019-nCoV Diagnostics Development
As part of the U.S. government's ongoing public health response to the 2019 novel coronavirus (2019-nCoV), the U.S. Department of Health and Human Services (HHS) today announced the opening of an Easy Broad Agency Announcement (EZ-BAA) for development of 2019-nCoV diagnostics and is now accepting abstract submissions for potential funding.
Under this 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 for development funding of 2019-nCoV molecular diagnostics. The diagnostics must utilize platforms already cleared by the U.S. Food and Drug Administration, with a viable plan to meet requirements for the 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," said BARDA Director Rick Bright, PhD. "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 BARDA's Division of Research, Innovation, and Ventures (DRIVe) can review and accept applications for development funding of transformative products and technologies to protect Americans from health security threats. In response to the 2019-nCoV outbreak, it has been modified to support diagnostics products that fit the profile outlined above. The application process is both business-friendly and easy to follow.
Since its inception, BARDA DRIVe's EZ-BAA solicitation has averaged more than one abstract submission per day while active, with awards made in as few as 30 days. The EZ-BAA has helped transform the contracting process and provide innovators, entrepreneurs, and organizations with a simplified and rapid mechanism to partner with the U.S. government. BARDA will leverage this process to rapidly respond to the current outbreak that has been identified as a Public Health Emergency by the Secretary of HHS.
For additional details, see solicitation BAA-20-100-SOL-0002.
About HHS, ASPR, and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation's health security. To learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov, and for more on DRIVe, visit drive.hhs.gov.