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The world has been almost singularly focused on the 2019 coronavirus for more than 18 months now, but the fact remains that we still face an array of other known pathogens with pandemic potential and any number of unknown pathogens that could pose a similar risk.  These threats have periodically been an area of congressional focus since the 2009 H1N1 influenza pandemic, and most recently a bill for the Disease X Act would renew this focus and direct it at new, currently unknown viral threats.  The bill is poised to be a key piece of legislation in ongoing and future biodefense initiatives and pandemic preparedness.…
Continue Reading The Next Pandemic: New Bill Looks Ahead to Counteract Novel Threats

Following up on our post earlier this week giving a general overview of the Defense Production Act of 1950 (“DPA”), 50 U.S.C. §§4501 et seq., this post comments on President Trump’s March 18, 2020 Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (the “COVID-19 E.O.”) and provides some key considerations that companies should keep in mind if they are concerned about receiving prioritized or rated contracts or allocation orders or directives under the DPA.…
Continue Reading The Defense Production Act and the Coronavirus Executive Order: Key Considerations

As a followup to our recent post on the implications of the PREP Act for government contractors working to respond to the COVID-19 outbreak, this post will provide an overview of the Defense Production Act—including its key powers that the federal Government might invoke to counter the pandemic.…
Continue Reading A Coronavirus Contractor’s Guide to the Defense Production Act

We’ve covered several topics already this week on the U.S. Government’s varied responses to the COVID-19 outbreak and how these responses will affect contractors that do business with the government, including BARDA’s EZ-BAA for COVID-19 diagnostics, mission-essential services during the outbreak, and how excusable delay provisions may help federal contractors affected by the outbreak.  But one area that has yet to receive in-depth discussion is the federal government’s mechanisms for addressing liability concerns raised by the use and distribution of countermeasures to the virus.  After all, while contractors are no doubt responding with appropriate speed and diligence in developing and deploying various COVID-19 countermeasures, no contractor wants to be the subject of a product liability, warranty, or negligence lawsuit later down the road.

Thankfully, Congress anticipated this concern and addressed it in 2005 by passing the Public Readiness and Emergency Preparedness Act (“PREP Act”), codified at 42 U.S.C. § 247d-6d.  Since enactment, the PREP Act has been used to issue declarations covering various countermeasures, including therapeutics, diagnostics, devices, vaccines, and constituent materials for pandemic influenza, acute radiation syndrome, smallpox, Botulism, anthrax, Zika, nerve agents, certain insecticides, and Ebola.  And earlier this week, the Secretary of the U.S. Department of Health and Human Services (the “Secretary”) issued a declaration pursuant to the PREP Act specifically for COVID-19 countermeasures.

This post will cover the PREP Act generally before discussing the implications of the COVID-19 declaration.…
Continue Reading A Coronavirus Contractor’s Guide to the PREP Act

In the latest World Health Organization daily situation report, as of March 11, 2020, the WHO reported 118,326 COVID-19 cases confirmed and 4,292 deaths worldwide, and the U.S. Centers for Disease Control and Prevention (CDC) reported 938 cases and 29 deaths in the United States.  The same day, WHO characterized COVID-19 as the first global pandemic sparked by a coronavirus.  Additionally, the Secretary of the U.S. Department of Health and Human Services (HHS), issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to provide liability immunity for entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of covered medical countermeasures (MCMs).  Prioritized pathways are now available to expedite review of new, responsive technology proposals for MCMs from diagnostics to therapeutics.
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Continue Reading Expanding the Coronavirus Disease 2019 (COVID-19) Response through Diagnostic Development

Last week, the White House Office of Science and Technology Policy (“OSTP”) issued a request for information (“RFI”) to learn how the Government can more effectively “support scientific discovery, the development of technological advances, and increase the impact of a vibrant bioeconomy on the Nation’s vitality and our citizens’ lives.” 84 Fed. Reg. 47561 (Sep. 10, 2019). The Bioeconomy is the “infrastructure, innovation, products, technology, and data derived from biologically-related processes and science that drive economic growth, promote health, and increase public benefit.” Id. To establish guiding principles to promote and protect the U.S. Bioeconomy, OSTP is seeking input from interested parties, including “those with capital investments, performing innovative research, or developing enabling platforms and applications in the field of biological sciences, to include healthcare, medicine, pharmaceuticals, biotechnology, manufacturing, energy production, and agriculture.” Id. Of particular interest to government contractors, OSTP is seeking information regarding opportunities for public-private partnerships, infrastructure investments, and best practices for data sharing and data protection. Id. at 47562. Responses are due on or before 11:59 pm on October 22, 2019. We have included the specific topics on which OSTP seeks input below.
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Continue Reading White House Seeks Input from Biotech Stakeholders on Bioeconomy

Last week, the GSA Office of Inspector General (“OIG”) released a Report explaining how GSA decided to abandon previous plans to build a new suburban campus for the FBI, and instead demolish and then rebuild the J. Edgar Hoover (“JEH”) building in Washington, D.C.  Although much of the coverage of the Report has focused on the role of the White House in the decision-making process and the GSA Administrator’s failure to acknowledge that role in testimony before Congress, the Report also highlights the Office of Management and Budget’s (“OMB”) strict approach to the budget scoring rules found in OMB Circular A-11, Appendices A and B.
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Continue Reading OIG Report Chronicles Recent Attempts To Construct FBI Headquarters Through Public-Private Partnership, Highlights Proposed Use of Federal Capital Revolving Fund

Registration will open soon for the Biomedical Advanced Research and Development Authority’s (“BARDA”) 2018 Industry Day to be held on October 29 and 30 at the Grand Hyatt in Washington, D.C. This event has been an integral part of BARDA’s outreach efforts to the life sciences community since 2007, and the newest version of this event promises to continue to provide meaningful insight into BARDA’s role in the nation’s public health preparedness efforts.

BARDA is expected to revisit annual topics like revisions to its broad agency announcement and updates to its goals and Government-wide strategic plans. In addition, this year BARDA will have a particular focus on innovation with the rollout of its Division of Research, Innovation, and Ventures (“DRIVe”) and lightning talks on noteworthy development efforts. Applications to participate in lightning talks are due soon, and potential participants should consider whether to take advantage of this unique opportunity.

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Continue Reading Save the Date – BARDA Industry Day Is Coming

[This article was originally published in Law360 and has been modified for the blog.]

Earlier this year, President Trump revealed his plan to facilitate new (and much-needed) federal real property projects in part through a $10 billion “mandatory revolving fund,” commonly known as the Federal Capital Financing Fund or the Federal Capital Revolving Fund (the “Revolving Fund” or “FCRF”).  In this article, we take a close look at the Revolving Fund, and discuss the interaction between the Revolving Fund and the Office of Management and Budget (“OMB”) budgetary scoring rules.  As described below, the Revolving Fund is structured to allow federal agencies to meet the large, upfront dollar obligations often required by OMB’s budgetary scoring rules.  But despite this welcome and significant development, questions still remain about the scope and operation of the Revolving Fund.

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Continue Reading How Trump Plans To Finance Federal Real Property Projects

Last week, President Donald Trump released his long-awaited infrastructure plan, entitled a “Legislative Outline for Rebuilding Infrastructure in America.”  Clocking-in at 53 pages, this plan is designed to “stimulate at least $1.5 trillion in new investment over the next 10 years” through $200 billion of federal funding.  The infrastructure plan is intended to provide a “roadmap for the Congress to draft and pass the most comprehensive infrastructure bill in our Nation’s history.”  Our high-level key takeaways from that plan are discussed below.
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Continue Reading Key Takeaways from Trump’s Infrastructure Plan—Private Financing And A Capital Budget, But No “Buy American” Requirements?