On September 12, 2022, President Biden issued an Executive Order (“E.O.”) announcing the National Biotechnology and Biomanufacturing Initiative, a “whole-of-government” effort to further biotechnology and biomanufacturing innovations in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security. The White House subsequently announced that the Initiative would cost $2 billion. If successful, the Initiative could have sweeping impacts across the entire biotechnology research and development (“R&D”) lifecycle. A summary of the E.O., its requirements, and key takeaways are set forth below.Continue Reading President Biden Issues Executive Order on National Biotechnology and Biomanufacturing Initiative
On August 25, 2022, President Biden announced a new Executive Order (“EO”) addressing the Implementation of the CHIPS Act of 2022 (“CHIPS Act”). The CHIPS Act was signed by President Biden on August 9, 2022, and, among other things, authorizes $39 billion in funding for new projects to establish semiconductor production facilities within the United States. The new EO identifies the Administration’s implementation priorities for this CHIPS Act funding and creates the CHIPS Implementation Steering Council to aid with the rollout of administrative guidance. In connection with the EO, the Department of Commerce launched CHIPS.gov, which is intended to be a centralized resource for potential applicants of CHIPS funding. The EO and new website reflect the Administration’s intent to swiftly implement the CHIPS Act and increase the domestic production of semiconductors. Continue Reading Biden Administration Announces Priorities for the Implementation of the CHIPS Act of 2022
Last Friday, the National Telecommunications and Information Administration (“NTIA”) took a major step in furtherance of the Biden Administration’s goal of connecting all Americans to broadband by releasing its widely anticipated Notice of Funding Opportunity (“NOFO”) for the landmark $42.5 billion Broadband Equity, Access, and Deployment (“BEAD”) Program, along with NOFOs for two smaller programs. …
Two federal agencies recently released a joint Request for Information (“RFI”) in the latest in a series of concrete steps to meet the Biden Administration’s goal to achieve 100 percent carbon pollution-free electricity (CFE) in federal operations by 2030. The RFI, issued by DLA-Energy and GSA, offers industry a chance to shape future federal CFE procurements by providing information on carbon-free electricity supplied in competitive retail markets. Although not itself a procurement opportunity, the information submitted under the RFI will inform the parameters and conditions of CFE competitions that the federal government expects to begin as soon as this year, with contract deliveries starting in 2023.
Continue Reading RFI Begins to Chart Course for Federal Clean Energy Procurements
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.
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.
Continue Reading White House Seeks Input from Biotech Stakeholders on Bioeconomy