As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States.  The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than 2,000 to 3,000 new cases each day.

Due to the lack of approved therapeutics, vaccines, and diagnostics for this threat, developing new products and testing products already approved for other uses is a high priority for the U.S. interagency response effort—the Medical Countermeasure (MCM) Task Force.  The Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), is leading this Task Force in partnership with U.S. Department of Defense, Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health.

BARDA is currently looking at the effectiveness of existing countermeasures for similar viruses, as well as potential new responsive technologies, including vaccines, diagnostics, therapeutics, and medical supplies.  BARDA is serving as the sole point of entry for product and technology submissions to ensure there is an expedited process for receipt and review of proposed solutions for 2019-nCoV.  In this capacity, BARDA has released two opportunities to submit potential solutions for the 2019-nCoV response discussed below: (1) the EZ-BAA for 2019-nCoV diagnostics and (2) market research packages for any and all potential products and supplies.  Covington encourages those with technology that could be potentially useful to respond.

HHS Easy Broad Agency Announcement (EZ-BAA)

An EZ-BAA is now open for abstract submissions for development of an in vitro diagnostic for the detection of 2019-nCoV in clinical specimens.  The diagnostic must be developed for use with an existing FDA-cleared molecular platform that is currently widely placed in U.S. healthcare settings, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization within 12 weeks of an award.  The number of available awards is unlimited, and any awards are expected to be less than $750,000.  Additional details and requirements for submissions are available here, and HHS’ statement on the EZ-BAA is available here.  Abstract submissions are due by March 18, 2020 at 5:00 PM EDT.

Market Research Package Submission for Medical Countermeasures (MCMs)

BARDA also created a portal for submission of products or technology for MCM research and development in an effort to cast a wide net for possible responsive technology to 2019-CoV.  The interagency response to support domestic preparedness includes four key prongs: (1) MCM development; (2) healthcare system preparedness; (3) supply chain resilience; and (4) medical surge.  BARDA is interested in submissions that help the Task Force meet these strategic efforts.  Although a non-exhaustive list, BARDA provides in the submission portal that the ideal technologies and products could include the following characteristics:

  • Relevant to the U.S. government 2019-nCoV medical countermeasure research and development efforts and/or Emerging Infectious Disease rapid response capabilities
  • Utilize an already-approved platform, have non-clinical data suggesting efficacy, and/or have significant manufacturing capability
  • Fully owned or licensed by your organization (you have full IP rights and/or freedom to operate)

Categories for submission include vaccines, diagnostics, therapeutics, as well as a broad catch-all category.  The Task Force is looking for submissions to encompass a wide variety of MCM approaches, including approaches that allow for an expedited product development pathway that would lead to earlier recognition and isolation of new cases.  No deadline is included in the MCM portal, however, potential stakeholders are encouraged to submit as soon as possible.

Tags: ASPR, BARDA, CDC, coronavirus, DoD, FDA, HHS, MCM, NIH, System for Award Management
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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She…

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
  • the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.

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Photo of Sarah Schuler Sarah Schuler

Sarah Schuler is an associate in the firm’s Government Contracts Practice Group, advising clients across a broad range of government contracting compliance issues. Her areas of expertise include advising on intellectual property and data rights issues under the Federal Acquisition Regulation, including obligations…

Sarah Schuler is an associate in the firm’s Government Contracts Practice Group, advising clients across a broad range of government contracting compliance issues. Her areas of expertise include advising on intellectual property and data rights issues under the Federal Acquisition Regulation, including obligations imposed by the Bayh-Dole Act; application of the Freedom of Information Act to government contracts and related records; domestic sourcing requirements imposed under the Buy American Act and Trade Agreements Act; pricing and other compliance related issues arising under Federal Supply Schedule contracts; small business affiliation and certification analyses; the scope of flow-down requirements for subcontractors; and federal grant compliance under the Uniform Guidance and agency supplements. Sarah also counsels clients to navigate time-sensitive inquiries arising from contract compliance-related issues.

Sarah also maintains an active pro bono practice, providing counsel to U.S. service members with respect to the correction of military records and discharge upgrade requests.

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