The National Institute of Standards and Technology (NIST) has published a Request for Information seeking public input on how best to implement the U.S. Government National Standards Strategy for Critical and Emerging Technology (USG NSSCET).
The U.S. standards development system is unique because it is built upon a wide variety of processes that are open, voluntary, decentralized, and led by the private sector. These processes feature openness to participation by materially interested stakeholders with consensus-based decision making. Finalized standards are primarily published by private sector standards organizations, not the U.S. Government.
“It is critical to our economy and national security that we have high quality standards for the critical and emerging technologies that will transform the way we live and work,” said Under Secretary of Commerce for Standards and Technology and NIST Director Laurie E. Locascio. “We are asking experts and stakeholders to share their best ideas for implementing a national strategy that will strengthen U.S. leadership and competitiveness in each of these sectors.”
The strategy promotes technologically sound standards that help American industry compete internationally on a level playing field and is intended to support and complement existing private sector-led activities. The strategy focuses on critical and emerging technologies including, among others:
- Biotechnologies
- Artificial intelligence and machine learning
- Communication and networking technologies
- Semiconductors and microelectronics
- Positioning, navigation and timing services
- Digital identity infrastructure and distributed ledger technologies
- Clean energy generation and storage
- Quantum information technologies
There are also specific applications of CET that departments and agencies have determined will impact our global economy and national security. These include, but are not limited to:
- Biobanking
- Automated and Connected Infrastructure
- Automated, Connected, and Electrified Transportation
- Critical Minerals Supply Chains
- Cybersecurity and Privacy
- Carbon Capture, Removal, Utilization, and Storage
The USG NSSCET reinforces the U.S. Government’s support of a private sector-led, open, consensus-based international standards system, to which the U.S. Government is an active stakeholder and participant.
NIST is seeking information that will support the development of the most effective implementation plan for the USG NSSCET, which was published in May. The agency is seeking public input on the best ways to partner with relevant stakeholders, remove barriers to participation in international standards development, and enhance the U.S. government’s support for an international standards system that is open, consensus-based, and led by the private sector.
The RFI poses several questions in each of four broad categories: investment, participation, workforce, and integrity and inclusivity. While specifically seeking input on these topics, NIST welcomes all responses that stakeholders believe will support a robust and successful implementation of the strategy.
Highlighted questions include:
- What are the most important challenges faced by the biotechnology private sector (i.e., industry, including start-ups and small- and medium-sized enterprises (SMEs), academic community, and civil society organizations) when participating in standards development activities for Critical Emerging Technology (CET), and how can these challenges be addressed?
- How can the U.S. Government establish policies that promote biotechnology standards development for CET as a critical component of U.S. innovation culture?
- How can the U.S. Government utilize biotechnology Federal spending on research and development to drive technical contributions for CET standards development activities?
- How can the U.S. Government better support biotechnology publicly funded and private research in standards development activities for CET?
- How can the U.S. Government increase the amount and consistency of biotechnology private sector engagement in standards development activities for CET?
- How can the U.S. Government foster early collaboration with biotechnology private sector stakeholders to identify standards for CET that would encourage market and regulatory acceptance as needed? At what stage is early collaboration most effective?
- What roles do the academic community and civil society organizations play in biotech standards development activities for CET, and how can they increase their contributions to a private sector-led system?
- How can the U.S. Government better support state, local, and tribal governments in participating in standards development activities for CET?
- How can the U.S. Government leverage existing or develop new digital tools and resources that facilitate access to standards development processes, and increase engagement by private sector?
- What biotech standards development activities for CET can U.S. government and private sector stakeholders promote or develop to encourage increased participation by students and trainees?
- How can the U.S. Government work with biotechnology private sector stakeholders to more effectively coordinate with international partners and reinforce private sector-led standards development activities for CET?
- How should the U.S. Government share information on biotechnology standards development activities for CET with like-minded partners and allies?
- How can the U.S. Government further advance the design and implementation of biotechnology technical assistance programs for CET that enable broad and inclusive participation by developing countries in international Standards Developing Organizations (SDOs)?
- How can the U.S. Government work with international partners to ensure that biotechnology standards for CET are developed in a way that supports U.S. interests, including a commitment to free and fair market competition in which the best technologies come to market?
All submissions received in response to this RFI will be posted on the NIST website. Responses are due by 5 p.m. Eastern time on Nov. 6, 2023. Full details on responding can be found in the Federal Register notice.
About the NIST Biosystems and Biomaterials Division
NIST has been at the forefront of fostering innovation and building confidence in quantitative biology and biomaterial measurements across government and industry to support the bioeconomy. Through extensive outreach and collaboration with academia and the private sector, NIST led the development of a framework for the development of the first meaningful methods to compare cell quantity measurements. NIST’s recent work has focused on collaborations with a wide range of stakeholders to implement the approach for cell therapy and regenerative medicine applications. NIST chairs and administers the U.S. Mirror Committee to ISO/TC 276: Biotechnology, which develops standards for all sectors of biotechnology. NIST has created an inclusive, collaborative environment among over 40 organizations to best represent U.S. interests while promoting international cooperation on the development of emerging biotechnology and biomanufacturing technology through global standards.
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