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.

The RFI encourages responders, either as individuals or consortia, to respond to one or more of the questions below.

1. What specific actions could the U.S. Government take to reinforce a values-based ecosystem that will guide the transformation and expansion of the U.S. Bioeconomy, in both the short- and long-term? Please consider:

a. Policy or regulatory opportunities and gaps throughout the continuum of basic science translation, product development and commercialization;

b. Scientific areas where research funding could be strategically targeted to stimulate discovery;

c. Novel public-private partnership mechanisms;

d. International opportunities;

e. Challenges to taking identified actions or implementing change.

2. In what ways can the U.S. Government partner with the private sector, industry, professional organizations, and academia to ensure the training and continued development of a skilled workforce to support the growth of the Bioeconomy? Please consider:

a. Potential needs and solutions at the skilled technical, undergraduate, professional master’s program or graduate level;

b. Specific needs within basic science, translational research, product development, and commercialization;

c. Approaches for the development of non-traditional, multi-disciplinary educational backgrounds that address the convergent nature of emerging technologies and integrate core values including safety and security;

d. Effective geographic distribution of workforce and talent development across the United States;

e. The development of a public and private ecosystem that will attract and retain domestic and foreign talent within the United States at all skill levels.

3. In what ways can the U.S. Government partner with the private sector, industry, professional organizations, and academia to establish a more robust and efficient Bioeconomy infrastructure? Please consider:

a. Current infrastructure—from databases to world-class technology and manufacturing capabilities;

b. Geographic distribution of manufacturing capabilities compared to future manufacturing needs;

c. Leveraging existing public-private partnerships and identifying trusted information sharing mechanisms to accelerate innovation and facilitate fruitful, equitable domestic and international collaborations;

d. Institutional models for achieving translation of basic science discoveries to application and/or entry into the marketplace.

4. Across the spectrum, from basic discovery to practical application, what data policies, information-sharing mechanisms, and safeguards will be necessary for a prosperous U.S. Bioeconomy? Please consider:

a. Scientific, regulatory, manufacturing standards and/or benchmarks and/or best practices around data that should be developed to best accelerate Bioeconomy growth;

b. Possible safeguards for technology, data, and emergent products, such as patent/intellectual property protection, data quality and provenance validation, and privacy and security assurances.

In conclusion, providing input to OSTP at this stage could be an opportunity for stakeholders to have a meaningful impact on the principles guiding and protecting the U.S. Bioeconomy. Again, responses are due on or before 11:59 pm on October 22, 2019.

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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.