Office of Science and Technology Policy – Federal Register Recent Federal Regulation Documents

The Office of Science and Technology Policy publishes the names of the members selected to serve on its SES Performance Review Board (PRB).

Life sciences research is vital for improving health outcomes and protecting the Nation from infectious disease threats, but a small subset of this research could potentially pose risk of accidents or misuse that could harm human health. It is important to regularly evaluate and update biosafety and biosecurity oversight policies to keep pace with new technological developments and the evolving risk landscape. The Office of Science and Technology Policy (OSTP) invites comments on potential changes to the Policies for Federal and Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) and Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO). These policies establish frameworks for review and oversight requirements for certain categories of life sciences research, namely research with certain pathogens and toxins, including at institutions that accept Federal funding for such research. These requirements are intended to complement activities under existing Federal regulations or guidelines such as the Federal Select Agent Program. OSTP requests comments on how potential changes to these research oversight policies could mitigate risks associated with DURC and research with enhanced potential pandemic pathogens (ePPP) while minimizing undue burden on institutions. The public input provided through this Request for Information (RFI) will inform policy evaluations and issuance of a revised policy (Revised Policy).

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 National Strategy for a Sustainable Ocean Economy (National Strategy). The National Strategy will describe the vision, goals, and high-level actions for a robust, equitable, secure, sustainable ocean economy enabled by healthy, resilient ocean ecosystems. It will build on current Federal, Tribal, Territorial, State, and regional sustainable ocean management practices and identify needs and opportunities to enhance these efforts with new and emerging science, technology, knowledge, and policy. Through this request for information (RFI), the Ocean Policy Committee seeks public input on what the goals and outcomes of the National Strategy should be, and how the Federal Government can best advance sustainable management of ocean, coastal, and Great Lakes resources and ecosystems of the United States.

The White House Office of Science and Technology Policy (OSTP) notifies the Earth Observations community that a draft of the congressionally-mandated National Plan for Civil Earth Observations (hereinafter ``National Plan'') will be released for a short national review period via a subsequent Federal Register notice in Summer 2023. This notice serves to prepare the community for the upcoming request for information.

Employers are increasingly using automated systems to monitor, manage, and evaluate their workers. These systems may allow employers to manage supply chains, improve health and safety, or make other informed business decisions. At the same time, applications of surveillance and monitoring systems can also pose risks to workers, including to their health and safety, equal employment opportunities, privacy, ability to meet critical needs, access to workplace accommodations, and exercise of workplace and labor rights, including their rights to form or join a labor union. The White House Office of Science and Technology Policy (OSTP) seeks comments from the public to better understand automated surveillance and management of workers, including its prevalence, purposes, deployment, and impacts, as well as opportunities for Federal agencies to work with employers, workers, and other stakeholders to ensure that these systems do not undermine workers' rights, opportunities, access, health, or safety.

The Office of Science and Technology Policy (OSTP) requests comments from the public on draft Research Security Programs Standard Requirement developed in response to National Security Presidential Memorandum 33 on National Security Strategy for United States Government-Supported Research and Development (R&D). The draft Standard Requirement has been created by OSTP, together with Federal agencies and the Office of Management and Budget, to ensure that there is uniformity across Federal research agencies in implementing this requirement.

The Federal Government is developing a National Digital Assets Research and Development Agenda. The White House Office of Science and Technology Policy (OSTP)on behalf of the Fast Track Action Committee (FTAC) on Digital Assets Research and Development of the Subcommittee on Networking and Information Technology Research and Development (NITRD) of the National Science and Technology Council, the National Science Foundation, and the NITRD National Coordination Office requests public comments to help identify priorities for research and development related to digital assets, including various underlying technologies such as blockchain, distributed ledgers, decentralized finance, smart contracts, and related issues such as cybersecurity and privacy (e.g., cryptographic foundations and quantum resistance), programmability, and sustainability as they relate to digital assets.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The Office of Science and Technology Policy publishes the names of the members selected to serve on its SES Performance Review Board (PRB).

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 community of research and network meetings between the publication date of this Notice and December 31, 2022.

The Office of Science and Technology Policy (OSTP) published a document in the Federal Register of December 10, 2021, regarding two meetings. These meetings have been cancelled and will be rescheduled. OSTP will publish an updated notice with the rescheduled information in the future.

The Office of Science and Technology Policy published a document in the Federal Register of December 6, 2021, concerning request for comments on a prospectus for the National Global Change Research Plan. The document did not include necessary web links.

The Office of Science and Technology Policy (OSTP) requests input from interested parties on past deployments, proposals, pilots, or trials, and current use of biometric technologies for the purposes of identity verification, identification of individuals, and inference of attributes including individual mental and emotional states. The purpose of this RFI is to understand the extent and variety of biometric technologies in past, current, or planned use; the domains in which these technologies are being used; the entities making use of them; current principles, practices, or policies governing their use; and the stakeholders that are, or may be, impacted by their use or regulation. OSTP encourages input on both public and private sector use cases.

On July 23, 2021, the Office of Science and Technology Policy (OSTP) and the National Science Foundation (NSF) published in the Federal Register a document entitled ``Request for Information (RFI) on an Implementation Plan for a National Artificial Intelligence Research Resource'' and invited comments to inform the work of the National Artificial Intelligence Research Resource (NAIRR) Task Force (``Task Force''). The Task Force has been directed by Congress to develop an implementation roadmap for a shared research infrastructure that would provide Artificial Intelligence (AI) researchers and students across scientific disciplines with access to computational resources, high- quality data, educational tools, and user support. In response to requests by prospective commenters that they would benefit from additional time to adequately consider and respond to the RFI, OSTP and NSF have determined that an extension of the comment period until October 1, 2021, is appropriate.

The White House Office of Science and Technology Policy (OSTP) is organizing a series of three virtual listening sessions to hear about issues and concerns related to scientific integrity from members of the public who produce, communicate, and use scientific and technical information. Perspectives gathered during the virtual listening sessions will inform the assessment of Federal agencies' scientific-integrity policies and identification of best practices and lessons-learned that the National Science and Technology Council's Task Force on Scientific Integrity is preparing, pursuant to the January 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking.

The White House Office of Science and Technology Policy (OSTP), after consideration of the public comments submitted in response to its Notice of Proposed Rulemaking published on October 31, 2018, is amending its regulations to implement the FOIA Improvement Act of 2016. The regulations reflect OSTP's policy and practices and reaffirm its commitment to providing the fullest possible disclosure of records to the public.

On behalf of the National Science and Technology Council's (NSTC) Subcommittee on Resilience Science and Technology (SRST), OSTP requests input from all interested parties on the development of a National Research and Development Plan for Positioning, Navigation, and Timing (PNT) Resilience. The plan will focus on the research and development (R&D) and pilot testing needed to develop additional PNT systems and services that are resilient to interference and manipulation and that are not dependent upon global navigation satellite systems (GNSS). The plan will also include approaches to integrate and use multiple PNT services for enhancing resilience. The input received on these topics will assist the Subcommittee in developing recommendations for prioritization of R&D activities.