The massive US stimulus package responding to the coronavirus disease 2019 (COVID-19) crisis includes over $6 billion of funding dedicated to research and development (R&D) activities.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act legislative package, also known as Phase 3 in the ongoing efforts to provide a federal government response to the health and economic implications of the pandemic, is the largest rescue package in US history. The bill passed the Senate by a vote of 96-0, while the House of Representatives passed the bill by voice vote. The CARES Act was signed into law on March 27, 2020.
R&D funding in the CARES Act is being appropriated for agencies across the federal government and is dedicated to a wide range of research topics, including the development of vaccines, testing diagnostics, spatial analysis and mapping of infectious COVID-19 hot spots, and public health data analytics and infrastructure. Notably, $3.5 billion is provided to the Biomedical Advanced Research and Development Authority (BARDA), which is part of the HHS Office of the Assistant Secretary for Preparedness and Response, to support the manufacturing, production, and purchase of vaccines, therapeutics, diagnostics, and other similar initiatives.
The following is a summary of R&D funding in the CARES Act broken out by federal departments and agencies.
If you have questions regarding these issues or would like assistance in pursuing the R&D funding described below, please contact your DLA Piper relationship partner or a member of the DLA Piper Federal Law and Policy team.
HEALTH AND HUMAN SERVICES (HHS)
Biomedical Advanced Research and Development Authority (BARDA)
$3.5 billion is provided to BARDA for production and purchase of vaccines, therapeutics, diagnostics, and small molecule active pharmaceutical ingredients. These funds also may be used for constructing or renovating US-based next-generation manufacturing facilities that are not owned by the government. There are also provisions under the CARES Act that allow BARDA to partner more easily with private sector companies on research and development by removing the cap on BARDA’s “other transaction authority” (OTA) during a public health emergency. Before the CARES Act, BARDA was authorized to take away a company’s patent exclusivity rights, allowing other applicants to develop the same drug. BARDA, which manages Project Bioshield, an act passed by the US Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack, works with pharmaceutical companies to finance and accelerate the market entrance of necessary vaccines and treatments. In just the past week, BARDA has announced partnerships with several major pharma companies to identify and mass produce a viable COVID-19 vaccine.
BARDA is investing in an array of medical countermeasures to diagnose, treat, or protect against COVID-19 under the BARDA Broad Agency Announcement (BAA-18-100-SOL-00003). Specifically, BARDA is pursuing the following products or technologies:
- Diagnostic assays for human pan-coronaviruses
- Point-of-care diagnostic assays for SARS-CoV-2 virus
- Diagnostic assay to detect COVID-19
- Nonclinical model
- Vaccines for COVID-19
- Therapeutics for COVID-19
- Immunomodulators or therapeutics targeting lung repair
- Pre-exposure and post-exposure prophylaxis for COVID-19
- Respiratory protective devices
- Advanced manufacturing technologies
National Institutes of Health (NIH)
$945.5 million is provided to NIH to prevent, prepare, and respond to COVID-19 spread out across multiple different Institutes and Offices, including:
- $103.4 million - National Heart, Lung and Blood Institute
- $706 million - National Institute of Allergy and Infectious Diseases
- $60 million - National Institute of Biomedical Imaging & Bioengineering
- $10 million - National Library of Medicine
- $36 million - National Center for Advancing Translational Sciences
NIH guidance for applicants and funding opportunities specific to COVID-19 can be found here.
Centers for Disease Control and Prevention (CDC)
- $500 million is provided to the CDC for global disease detection and emergency response
- $500 million is provided to the CDC to invest in better COVID-19 tools and build state and local public health data infrastructure
Information for CDC Applicants and Recipients of CDC Funding can be found here.
Food and Drug Administration (FDA)
- $80 million is provided to the FDA to support the development of necessary medical countermeasures and vaccines, advance domestic manufacturing for medical products, and monitor medical product supply chains.
Agency for Toxic Substances and Disease Registry
- $7.5 million is provided for the Geospatial Research, Analysis and Services Program to support spatial analysis and mapping of infectious disease hot spots, including for cruise ships, and providing technical assistance to support efforts by cruise line industry to address health concerns associated with COVID-19.
DEPARTMENT OF COMMERCE
National Institute of Standards and Technology (NIST)
- $10 million is provided to NIST for the National Network for Manufacturing Innovation (also known as Manufacturing USA). The US Department of Commerce’s National Institute of Standards and Technology (NIST) opened this funding opportunity for “rapid, high-impact projects that support the nation’s response to the COVID-19 pandemic.” NIST will award these grants through the NIST Manufacturing USA National Emergency Assistance Program with no requirements for cost matching. Funding will be awarded to eligible Manufacturing USA institutes, a network of 14 public-private partnerships that work with academic and private sector manufacturing organizations on research and development and manufacturing skills training. Each institute focuses on a particular advanced manufacturing specialty such as biofabrication, 3D manufacturing or advanced functional fabrics. More information can be found here.
- $6 million is provided to NIST to prevent, prepare, respond to COVID-19 through continuity of operations including measurement science to support viral testing and bio-manufacturing.
NATIONAL SCIENCE FOUNDATION (NSF)
Rapid Response Research Grants
- $75 million for grants through NSF’s Rapid Response Research (RAPID) funding mechanism to respond to COVID-19, through near real-time research at the cellular, physiological, and ecological levels to better understand COVID-19. According to NSF guidance, proposals will be accepted “to conduct non-medical, non-clinical-care research that can be used immediately to explore how to model and understand the spread of COVID-19, to inform and educate about the science of virus transmission and prevention, and to encourage the development of processes and actions to address this global challenge.” The requests for RAPID proposals may be for up to $200,000 and up to one year in duration, but “well-justified proposals that exceed these limits may be entertained.”
DEPARTMENT OF DEFENSE (DOD)
Defense Health Program
- $415 million is provided to the DOD for the development of vaccines, antivirals, 24/7 lab operations and the procurement of diagnostic tests. The Defense Health Program is overseen by the DOD’s Defense Health Agency, which operates under the authority and oversight of the Assistant Secretary of Defense for Health Affairs.
DEPARTMENT OF ENERGY (DOE)
Office of Science
- $99.5 million to the DOE to prevent, prepare, and respond to COVID-19 for expenses related to providing support and access to scientific user facilities and national laboratories in the Office of Science and National Nuclear Security Administration, including equipment, technologies, and personnel associated with their operations. Information about DOE’s Office of Science funding opportunities can be found here.
ENVIRONMENTAL PROTECTION AGENCY (EPA)
Science and Technology
- $7.2 million is provided to the EPA for research on methods to reduce risks from environmental transmission of COVID-19 via contaminated surfaces and materials to support research efforts regarding cleaning and disinfecting of EPA facilities.
DEPARTMENT OF AGRICULTURE (USDA)
Forest Service, Forest and Rangeland Research
- $3 million is provided to the USDA to re-establish scientific experiments impacted by travel restrictions, such as the Forest Inventory and Analysis program, which is a critical forest assessment tool for states.
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This information does not, and is not intended to, constitute legal advice. All information, content, and materials are for general informational purposes only. No reader should act, or refrain from acting, with respect to any particular legal matter on the basis of this information without first seeking legal advice from counsel in the relevant jurisdiction.