Office of Science and Technology Policy 2022 – Federal Register Recent Federal Regulation Documents
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Request for Information; National Biotechnology and Biomanufacturing Initiative
The President's Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy launched a National Biotechnology and Biomanufacturing Initiative (NBBI) to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, and supply chain resilience, and to advance national and economic security. Biotechnology and biomanufacturing offer new opportunities to strengthen supply chains and lower prices, create more sustainable products through bio-based production, expand domestic production of goods and materials, create jobs across all of America, and spur new opportunities in agricultural communities, as some examples. This RFI seeks public input on how advances in biotechnology and biomanufacturing can help us achieve goals that were previously out of reach and what steps can be taken to ensure we have the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy.
Request for Information; Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology
The National Biotech and Biomanufacturing Initiative (NBBI) identified biotechnology regulation clarity and efficiency as a priority of the Administration. Thus, the White House Office of Science and Technology Policy (OSTP)on behalf of the primary agencies that regulate the products of biotechnology, the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. The information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products.
National Nanotechnology Initiative Meetings
The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), will facilitate stakeholder discussions of targeted nanotechnology topics through workshops and webinars, as well as community of research and network meetings between the publication date of this Notice and December 31, 2023.
Request for Information; Clinical Research Infrastructure and Emergency Clinical Trials
On October 26, 2022, the Office of Science and Technology Policy (OSTP) published in the Federal Register a document entitled ``Request for Information (RFI) on Clinical Research Infrastructure and Emergency Clinical Trials.'' This RFI invited comments on improving the U.S. clinical trials infrastructure and in particular, our ability to carry out emergency clinical trials. In accordance with the 2022 National Biodefense Strategy for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (National Biodefense Strategy) and the American Pandemic Preparedness Plan (AP3), OSTP, in partnership with the National Security Council (NSC), is leading efforts to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies. In response to requests by prospective commenters that they would benefit from additional time to adequately consider and respond to the RFI, OSTP has determined that an extension of the comment period until January 27, 2023 is appropriate.
Request for Information; Sustainability of Microgravity R&D During and Beyond ISS Transition
The White House Office of Science and Technology Policy (OSTP) published a document in the Federal Register on November 17, 2022, concerning a request for information to help inform the development of a National Strategy for Microgravity Research and Development (R&D). The document contained an incorrect date for the submission deadline.
Request for Information (RFI) on Data Collection for Emergency Clinical Trials and Interoperability Pilot; Extension of Comment Period
On October 28, 2022, the Office of Science and Technology Policy (OSTP) published in the Federal Register a document entitled ``Request for Information (RFI) on Data Collection for Emergency Clinical Trials and Interoperability Pilot.'' This RFI, issued by OSTP in partnership with the Office of the National Coordinator for Health Information Technology (ONC), invited comments on how to optimize data collection for clinical trials carried out across a range of institutions and sites, both in emergency settings and in the pre- emergency phase. OSTP and ONC are seeking input on viable technical strategies to distribute clinical trial protocols and capture clinical trial data using common application programming interfaces (APIs). OSTP and ONC also seek information about whether there is value in a pilot or demonstration project to operationalize data capture in the near term, for example within 6-12 months of the close of comments on the RFI. In response to requests by prospective commenters that they would benefit from additional time to adequately consider and respond to the RFI, OSTP has determined that an extension of the comment period until January 27, 2023 is appropriate.
Request for Information; Sustainability of Microgravity R&D During and Beyond ISS Transition
The White House Office of Science and Technology Policy (OSTP) requests input to help inform the development of a National Strategy for Microgravity Research and Development (R&D) to ensure sustainability of space-based research during and beyond microgravity platform transitionfrom the International Space Station (ISS) to future commercial platforms. This particular request seeks information regarding the future vision of a robust research ecosystem in low-earth orbit (LEO) and the role of the U.S. government in enabling that future.
Request for Information; Clinical Research Infrastructure and Emergency Clinical Trials; Correction
The Office of Science and Technology Policy published a document in the Federal Register of October 25, 2022, concerning a request for information on Clinical Research Infrastructure and Emergency Clinical Trials. This document corrects an error in that notice.
Framing the National Nature Assessment
Nature is important in its own right, and provides value to the lives of all Americans. To increase our knowledge of nature in the United States and its links to global change, the Office of Science and Technology Policy (OSTP), on behalf of the United States Global Change Research Program (USGCRP), requests input from the public to help inform the framing, development, and eventual use of the first National Nature Assessment (NNA). USGCRP committed to conducting a National Nature Assessment on April 8, 2022, under the authority of the Global Change Research Act of 1990. President Biden reinforced and elevated the importance of this assessment to a matter of national policy by calling for it in Executive Order 14072 (https://www.federalregister.gov/ documents/2022/04/27/2022-09138/strengthening-the-nations-for ests- communities-and-local-economies) on Strengthening the Nation's Forests, Communities and Local Economies (April 22, 2022). This request for information (RFI) will inform USGCRP as it develops this first-of-its- kind assessment.
Request for Information; Clinical Research Infrastructure and Emergency Clinical Trials
In accordance with the 2022 National Biodefense Strategy for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (National Biodefense Strategy) and the American Pandemic Preparedness Plan (AP3), the White House Office of Science and Technology Policy (OSTP), in partnership with the National Security Council (NSC), is leading efforts to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies. Efforts in this area could include the establishment of a U.S.-level governance structure and outreach to a wide range of institutions, clinical trial networks, and other potential trial sites that can participate in emergency research, both domestically and internationally. A further goal of this emergency clinical trials initiative is to support the expansion of clinical research into underserved communities, and increase diversity among both trial participants and clinical trial investigators. Building U.S. capacity to carry out emergency clinical trials will enlarge and strengthen the U.S. clinical trials infrastructure overall.
Ocean Climate Action Plan
The Office of Science and Technology Policy (OSTP) and the Council on Environmental Quality (CEQ), on behalf of the interagency Ocean Policy Committee (OPC), request input from all interested parties to inform the development of a U.S. Ocean Climate Action Plan (OCAP) that will help guide and coordinate actions by the Federal government and civil society to address ocean, coastal, and Great Lakes-based mitigation and adaptation solutions to climate change. The OCAP will summarize planned Federal ocean-based climate action and the benefits of these actions, identify gaps in knowledge and application of knowledge to emerging ocean-climate issues, and recommend actions to advance the effectiveness of the Nation's response to the impacts of climate change. The input received will be used to inform the development of the OCAP.
Request for Information; Draft National Strategy on Microelectronics Research
The White House Office of Science and Technology Policy, on behalf of the Subcommittee on Microelectronics Leadership (SML) of the National Science and Technology Council (NSTC), requests comments from the public on the Draft National Strategy on Microelectronics Research (referred to in this document as ``the Draft National Strategy'') and some specific questions relevant to that strategy. The Draft National Strategy is posted at https://www.whitehouse.gov/wp-content/uploads/ 2022/09/SML-DRAFT-Microlectronics-Strategy-For-Public-Comment .pdf. This draft is being released at an intermediate, development stage for the sole and limited purpose to collect public input to inform the work of the SML as it develops the final National Strategy.
Request for Information; Identifying Critical Needs To Inform a Federal Decadal Strategic Plan for the Interagency Council for Advancing Meteorological Services; Correction
The Office of Science and Technology Policy (OSTP) and the National Oceanic and Atmospheric Administration (NOAA), on behalf of the Interagency Council for Advancing Meteorological Services (ICAMS), published a document on August 19, 2022, concerning request for information. The document contained an incorrect email address for comments.
Request for Information; Equitable Data Engagement and Accountability
The White House Office of Science and Technology Policy (OSTP), on behalf of the Subcommittee on Equitable Data of the National Science and Technology Council, requests information on how Federal agencies can better support collaboration with other levels of government, civil society, and the research community around the production and use of equitable data. This RFI will support Federal equitable data efforts described in the Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (E.O. 13985), including the Vision for Equitable Data issued to the President in April 2022.
Request for Information; Federal Evidence Agenda on LGBTQI+ Equity
In this notice, the White House Office of Science and Technology Policy (OSTP) requests input from the public to help inform the development of the Federal Evidence Agenda on LGBTQI+ Equity. Executive Order 14075 on Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals (June 15, 2022) required the co-chairs of the Interagency Working Group on Equitable Data to establish a subcommittee on sexual orientation, gender identity, and variations in sex characteristics (SOGI) data. That body, now part of the National Science and Technology Council (NSTC) Subcommittee on Equitable Data, is tasked with the development and release of a Federal Evidence Agenda on LGBTQI+ Equity, which will improve the Federal government's ability to make data-informed policy decisions that advance equity for the LGBTQI+ community.
Request for Information; Identifying Critical Needs To Inform a Federal Decadal Strategic Plan for the Interagency Council for Advancing Meteorological Services
The Office of Science and Technology Policy (OSTP) and the National Oceanic and Atmospheric Administration (NOAA), on behalf of the Interagency Council for Advancing Meteorological Services (ICAMS), requests input from all interested parties to identify opportunities for, and inform the advancement of Federal meteorological services across the meteorological enterprise. ICAMS invites input from States; Tribes; territories; individuals, including those belonging to groups that have been historically underserved, marginalized, or subject to discrimination or systemic disadvantage; local governments; appropriate industries; academic institutions; nongovernmental organizations; and international organizations with expertise in meteorological research and development, and service delivery, in both the short- (2-3 years) and long-term (next decade). This information will be used to inform the development of a new decadal strategic plan for Federal coordination of meteorological science and services using an earth system approach.
Request for Information on the Energy and Climate Implications of Digital Assets
The United States is committed to combatting the climate crisis and reaching net-zero greenhouse gas emissions no later than 2050. On March 9, 2022, President Biden signed an Executive Order on Ensuring Responsible Development of Digital Assets, which outlines a whole-of-government strategy to harness the benefits and mitigate the risks of digital assets, including the implications for energy use and the climate. The Executive Order tasked the White House Office of Science and Technology Policy (OSTP) to submit a report to the President that examines the potential for digital assets to impede or advance efforts to tackle climate change and the transition to a clean and reliable electricity grid. As OSTP conducts this examination, it invites comments from interested stakeholders, including the public. In particular, this RFI seeks comments on the protocols, hardware, resources, economics, and other factors that shape the energy use and climate impacts of all types of digital assets. It also seeks comment on attempts to mitigate climate harms and reduce energy use associated with digital assets, potential energy or climate benefits from digital assets and opportunities for natural asset or emissions accounting, likely future developments or industry trajectories related to digital assets, and implications that digital assets have for U.S. policy including as it relates to electricity grid reliability and greenhouse gas intensity.
Request for Information (RFI) on Strengthening Community Health Through Technology; Correction
OSTP published a document in the Federal Register of January 5, 2022, requesting input on how digital health technologies are used, or could be used in the future, to transform community health, individual wellness, and health equity. The document closing date was stated as February 28, 2022. We are extending the closing date to March 31, 2022 to allow more time for input.
Request for Information to the Update of the National Artificial Intelligence Research and Development Strategic Plan
The Office of Science and Technology Policy, on behalf of the National Science and Technology Council's (NSTC) Select Committee on Artificial Intelligence (Select Committee), the NSTC Machine Learning and AI Subcommittee (MLAI-SC), the National AI Initiative Office (NAIIO), and the Networking and Information Technology Research and Development (NITRD) National Coordination Office (NCO), requests input from all interested parties on updating the National Artificial Intelligence Research and Development Strategic Plan. Through this Request for Information (RFI), OSTP, the Select Committee, NAIIO, and NITRD NCO seek input from the public, including academic, State, and industry groups; those directly performing Artificial Intelligence (AI) research and development (R&D); and those directly affected by such R&D, on the ways in which the strategic plan should be revised and improved. The public input provided in response to this RFI will assist OSTP, the Select Committee, MLAI-SC, NAIIO, and NITRD NCO in updating the National Artificial Intelligence Research and Development Strategic Plan.
Performance Review Board Membership
The Office of Science and Technology Policy publishes the names of the members selected to serve on its SES Performance Review Board (PRB).
Request for Information (RFI) on Strengthening Community Health Through Technology
The White House Office of Science and Technology Policy (OSTP) requests input from community health stakeholders, technology developers, and other interested parties about how digital health technologies are used, or could be used in the future, to transform community health, individual wellness, and health equity. This request is part of an initiative led by OSTP dedicated to Community Connected Healthan effort that will explore and act upon how innovation in science and technology can lower the barriers for all Americans to accessing quality healthcare and lead healthier lives by meeting people where they are in their communities. We are particularly interested in information from community-based health settings and about populations traditionally underserved by healthcare. To support this effort, OSTP seeks information about: Successful models of strengthening community health through digital health technologies within the United States and abroad, barriers to uptake, trends from the COVID-19 pandemic, how user experience is measured, need for tools and training, ideas for potential government action, and effects on health equity.
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