Request for Information; Potential Changes to the Policies for Oversight of Dual Use Research of Concern (DURC) and the Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Framework, 60513-60516 [2023-18906]

Download as PDF 60513 Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices that allows users to view the Contact Officials currently on file for the employer. Users will be able to edit and delete existing Contact Officials, as well as add new Contact Officials. The screen to edit and add Contact Officials collects essentially the same information as the approved paper Form G–117a. The internet version provides for the required notices and certifications, contains help messages to ensure users provide valid contact information, and prevents users from deleting Contact Officials without first providing a replacement. Completion is voluntary. One response is requested from each respondent. Previous Requests for Comments: The RRB has already published the initial 60-day notice (88 FR 41994 on June 28, 2023) required by 44 U.S.C. 3506(c)(2). That request elicited no comments. Information Collection Request (ICR) Title: Designation of Contact Officials. OMB Control Number: 3220–0200. Form(s) submitted: G–117A & G–117A (internet). Type of request: Revision of a currently approved collection. Affected public: Private sector; businesses or other for profits. Abstract: The Railroad Retirement Board (RRB) requests that railroad employers designate employees to act as Annual responses Form No. Time (minutes) Burden (hours) G–117A ........................................................................................................................................ G–117a (Internet) ........................................................................................................................ 25 200 15 5 6 17 Total ...................................................................................................................................... 225 ........................ 23 Additional Information or Comments: Copies of the forms and supporting documents can be obtained from Kennisha Money at (312) 469–2591 or Kennisha.Money@rrb.gov. Comments regarding the information collection should be addressed to Brian Foster, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611– 1275 or Brian.Foster@rrb.gov. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. Brian Foster, Clearance Officer. [FR Doc. 2023–18980 Filed 8–31–23; 8:45 am] BILLING CODE 7905–01–P OFFICE OF SCIENCE AND TECHNOLOGY POLICY lotter on DSK11XQN23PROD with NOTICES1 liaison with the RRB on a variety of Railroad Retirement Act and Railroad Unemployment Insurance Act matters. Changes proposed: The RRB proposes to change the Form G–117a (Paper) by adding updated language in section 12, Signature line. The language proposed is, ‘‘The above officials of this employer are authorized to serve in the capacities indicated and to act as trusted referees for the RRB in accordance with the National Institute of Standards and Technology (NIST) Special Publication 800–63A guidelines for online reporting access.’’ The RRB proposes no changes to Form G–117a (internet). The burden estimate for the ICR is as follows: Request for Information; Potential Changes to the Policies for Oversight of Dual Use Research of Concern (DURC) and the Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Framework Office of Science and Technology Policy (OSTP). ACTION: Notice of request for information. AGENCY: VerDate Sep<11>2014 17:24 Aug 31, 2023 Jkt 259001 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 SUMMARY: PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 issuance of a revised policy (Revised Policy). Responses are due by 11:59 p.m. Eastern Time on October 16, 2023. Submissions received after the deadline may not be taken into consideration. ADDRESSES: Comments must be submitted via the Federal eRulemaking Portal at regulations.gov. However, if you require an accommodation or cannot otherwise submit your comments via regulations.gov, please use the email or phone number listed under FOR FURTHER INFORMATION CONTACT. OSTP will not accept comments by fax or by email. To ensure that OSTP does not receive duplicate copies, please submit your comments only once. Additionally, please include the Docket ID (EOP–2023–0001) at the top of your comments. Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on how to use Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under ‘‘FAQ’’ (https://www.regulations.gov/faq). Privacy Note: OSTP’s policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available. OSTP requests that DATES: E:\FR\FM\01SEN1.SGM 01SEN1 60514 Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices no proprietary information, copyrighted information, or personally identifiable information be submitted in response to this RFI. Instructions: Response to this RFI is voluntary. Each individual or organization is requested to submit only one response. Commenters can respond to one or multiple questions. Submissions are suggested to not exceed the equivalent of ten (10) pages in 12 point or larger font. Submissions should clearly indicate which questions are being addressed. Responses should include the name(s) of the person(s) or organization(s) filing the response. Responses containing references, studies, research, and other empirical data that are not widely published should include copies of or electronic links to the referenced materials. Responses containing profanity, vulgarity, threats, or other inappropriate language or content will not be considered. Please note that the U.S. Government will not pay for response preparation, or for the use of any information contained in the response. A response to this RFI will not be viewed as a binding commitment to develop or pursue the project or ideas discussed. FOR FURTHER INFORMATION CONTACT: Direct questions to Asad Ramzanali, research-oversight-policy@ostp.eop.gov, or 202–456–4444. Life sciences research is essential to the scientific advances that underpin improvements in the health and safety of the public, agricultural crops, and other plants, animals, and the environment. While life sciences research provides enormous benefits to society, there can be risks associated with certain subsets of work, typically related to biosafety and biosecurity, that can and should be mitigated. The United States has existing, complementary statutes, regulations, policies, and guidelines that address these potential biosafety and biosecurity risks, particularly those associated with research oversight and management.1 Together these existing regulatory authorities and guidelines provide a foundation to ensure that scientific lotter on DSK11XQN23PROD with NOTICES1 SUPPLEMENTARY INFORMATION: 1 Examples include: Select Agents and Toxins Regulations (42 CFR part 73, 9 CFR part 121, and 7 CFR part 331); National Institutes of Health Guidelines on Research Involving Recombinant and Synthetic Nucleic Acids; (https://osp.od.nih.gov/ wp-content/uploads/NIH_Guidelines.pdf); Biosafety in Microbiological & Biomedical Laboratories (BMBL) 6th Edition (https://www.cdc.gov/labs/ BMBL.html); Additional U.S. Laws, Regulations and Guidelines (https://www.phe.gov/s3/law/Pages/ default.aspx). VerDate Sep<11>2014 17:24 Aug 31, 2023 Jkt 259001 research and innovation is safe and secure. Scientists, institutions, and the USG have gained valuable insight over the past decade from implementing research oversight policies such as the policies for oversight of DURC 2 and the P3CO Policy Framework.3 During this time, advances in science and technology have occurred that present realized and potential future benefits. However, these advances also present potential risks of misuse. The National Science Advisory Board for Biosecurity (NSABB), a Federal advisory committee that addresses issues related to biosecurity and dual use research, provided recommendations in a March 2023 report 4 to inform United States Government (USG) policy evaluations and the development of a more comprehensive and integrated framework for the oversight of research with pathogens and toxins that may pose significant biosafety or biosecurity risks. Since the release of this report, OSTP has been working with Federal departments and agencies to review, harmonize, and revise these policies in accordance with USG goals of promoting safe and secure biological practices and strengthening responsible conduct for biological research as outlined in the 2022 National Biodefense Strategy and Implementation Plan.5 The policy review and revision process has three broad goals: 1. Assess whether and how to merge the existing Federal DURC, Institutional DURC, and P3CO policies into a harmonized policy that addresses oversight for research with pathogens and toxins. 2. Consider revising the scope of the Federal DURC, Institutional DURC, and P3CO policies to include a broader set of pathogens and toxins, including—but not limited to—biological select agents 2 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (https://www.phe.gov/s3/dualuse/Documents/uspolicy-durc-032812.pdf); United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (https:// www.phe.gov/s3/dualuse/Documents/durcpolicy.pdf). 3 Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO) (https://www.phe.gov/s3/dualuse/ Documents/P3CO-FinalGuidanceStatement.pdf). 4 Proposed Biosecurity Oversight Framework for the Future of Science (nih.gov); https:// osp.od.nih.gov/wp-content/uploads/2023/03/ NSABB-Final-Report-Proposed-BiosecurityOversight-Framework-for-the-Future-of-Science.pdf. 5 National Biodefense Strategy and Implementation Plan: https://www.whitehouse.gov/ wp-content/uploads/2022/10/National-BiodefenseStrategy-and-Implementation-Plan-Final.pdf. PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 and toxins (BSAT) that impact humans or have the potential to impact humans. 3. Examine ways to strengthen effective implementation of oversight for life sciences research on pathogens and toxins throughout the research lifecycle. The USG acknowledges that effective oversight helps maintain public trust in the life sciences research enterprise by demonstrating that the scientific community recognizes the implications of research conducted and is acting responsibly to protect public welfare and preserve national security. Scope: OSTP invites comment from any interested stakeholders. In particular, OSTP is interested in input from research institutions, including both domestic and international entities, currently subject to the PC3O Policy or the DURC policies or that may be subject to the revised scope of a potential policy update, researchers within those institutions, scientific and professional organizations, and organizations representing diverse interests across the U.S. research ecosystem. Information Requested: Respondents may provide information for one or more of the topics included below. Respondents are asked to note the corresponding number/s to which responses pertain. 1. The NSABB recommended that USG develop an integrated approach to oversight of research that raises significant biosafety and biosecurity concerns, including ePPP research and DURC (Recommendation 1). By merging the existing Federal DURC, Institutional DURC, and P3CO policies into a harmonized policy, a merged policy could potentially adopt the institutional applicability outlined in the Institutional DURC policy framework, making the following entities subject to a Revised Policy: • U.S. Government departments and agencies that fund, sponsor, or conduct life sciences research. • Institutions within the United States or its territories that both: D Receive U.S. Government funds to conduct or sponsor life sciences research; and, D Conduct or sponsor research that is within the revised scope, regardless of the source of the funding for the specific project. • Institutions outside of the United States that receive U.S. Government funds to conduct or sponsor research that falls under the scope. (a) What are the anticipated benefits and challenges of applying a Revised Policy, inclusive of both DURC and E:\FR\FM\01SEN1.SGM 01SEN1 Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 ePPP research, to the scope of entities outlined above? (b) What are the anticipated benefits and challenges of investigators and institutions having primary responsibility for identification of both DURC and ePPP research? (c) What types of resources or tools would be useful for researchers and institutions to determine if their research falls into a revised policy scope that is risk-based rather than list-based, and adequately conduct risk assessments to identify DURC and ePPP research? 2. Currently, the scope of the DURC policies is research that uses one or more of 15 listed agents or toxins and that produces, or is anticipated to produce, any of seven listed experimental effects. The NSABB recommended that the scope of research requiring review for potential DURC should include research that directly involves any human, animal, or plant pathogen, toxin, or agent that is reasonably anticipated to result in one or more of the seven experimental effects outlined in the DURC policy 6 (Recommendation 10.1). a. Considering the diversity of federally-funded research settings and portfolios, how would adoption of NSABB’s Recommendation 10.1 affect policy implementation and research programs at the institutional level? b. Rather than including any pathogen within the scope of DURC review, one possible modification of Recommendation 10.1 would be to include DURC experiments that utilize: i. HHS and Overlap Biological Select Agent and Toxins (BSAT) List 7 and/or ii. Pathogen risk group (RG) classification of 3 or 4 8 and/or iii. Any pathogen where the conduct of work (e.g., one of the DURC experimental categories) would require biosafety level 3 or 4 containment. Would a modification of Recommendation 10.1, in line with the outlined scope of pathogens above, be useful for policy implementation? What specific benefits, challenges, and/or gaps are anticipated by this revised scope? 6 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (https://www.phe.gov/s3/dualuse/Documents/uspolicy-durc-032812.pdf); United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (https:// www.phe.gov/s3/dualuse/Documents/durcpolicy.pdf). 7 Select Agents and Toxins Regulations (42 CFR part 73, 9 CFR part 121, and 7 CFR part 331). 8 Risk groups as defined in ‘‘NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules’’ (https://osp.od.nih.gov/ wp-content/uploads/2019_NIH_Guidelines.htm). VerDate Sep<11>2014 17:24 Aug 31, 2023 Jkt 259001 c. Are there other risk-based approaches that would expand the scope beyond the current list of 15 agents and toxins provided in the DURC policy that would facilitate the identification of research that poses significant risks by investigators and institutions while not resulting in undue burdens? d. Given the possible revised scope of research requiring review for potential DURC, what modifications, if any, to the current DURC policy list of 7 experimental effects should be considered for a Revised Policy that captures appropriate research without hampering research progress? e. What resources or tools would be valuable to assist with implementation of a DURC policy with a scope that is revised to include more than the current list of 15 agents and toxins? 3. A PPP is currently defined in the P3CO policy framework 9 as: ‘‘a pathogen that satisfies both of the following: 1. It is likely highly transmissible and likely capable of wide and uncontrollable spread in human populations; and 2. It is likely highly virulent and likely to cause significant morbidity and/or mortality in humans.’’ The NSABB recommended that the definition of PPP be modified to: (1) Likely moderately or highly transmissible and likely capable of wide and uncontrollable spread in human populations; and/or (2) Likely moderately or highly virulent and likely to cause significant morbidity and/or mortality in humans; and, in addition (3) Likely to pose a severe threat to public health, the capacity of public health systems to function, or national security’’ (Recommendation 2). (a) How would the change in the definition of PPP affect the overall scope of a Revised Policy and its subsequent implementation? (b) One possible modification to the NSABB PPP definition is to specify a respiratory route of transmission within clause (1). Would that definition of PPP be an appropriate scope to mitigate risks and enhance effective implementation? (c) Do you have additional suggestions to modify the PPP definition to mitigate the most significant risks not currently addressed and enhance effective implementation, while limiting negative or unintended consequences and burden on researchers, institutions, and the Federal government? (d) Are there characteristics related to human pathology, pathogen 9 Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO) (https://www.phe.gov/s3/dualuse/ Documents/P3CO-FinalGuidanceStatement.pdf). PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 60515 characteristics, or other features that would be helpful to clarify the intent of ‘‘moderately virulent’’? Are there characteristics related to human pathology that would be helpful to clarify the intent of ‘‘moderately transmissible’’? 4. A Government Accountability Office (GAO) report from January 2023 10 recommended that the Department of Health and Human Services funding agencies should develop and document a standard to define ‘‘reasonably anticipated’’ to ensure consistency in identifying research that falls within scope of a Revised Policy. One possible definition of ‘‘reasonably anticipated’’ is: ‘‘ ‘Reasonably anticipated’ describes an assessment of an outcome that an individual with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur and excludes experiments in which an expert would anticipate the outcome to be technically possible, but highly unlikely.’’ (a) Does this definition of ‘‘reasonably anticipated’’ provide additional clarity to ensure greater consistency in identifying research that falls within scope of the Revised Policy? What modifications to this definition (if any) would be most helpful? 5. NSABB recommends the removal of blanket exclusions for research activities associated with surveillance and vaccine development or production for research with ePPPs (Recommendation 3). (a) Should exemptions for certain activities be included in a Revised Policy? (b) What are the benefits and drawbacks of including exemptions for domestic and international pandemic preparedness, biosafety, biosecurity, and global health security? (c) If exemptions are included, how could they be bounded to maximize safety and security and minimize negative impact on domestic and global public health including outbreak and pandemic preparedness and response? For example, would vaccine research and development activities be unjustifiably impeded if the current P3CO policy framework exemption for ‘‘Activities associated with developing and producing vaccines, such as generation of high growth strains’’ was either removed completely or modified 10 Public Health Preparedness: HHS Could Improve Oversight of Research Involving Enhanced Potential Pandemic Pathogens. (GAO–23–105455). E:\FR\FM\01SEN1.SGM 01SEN1 60516 Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices to ‘‘Research on PPPs directly associated with testing and/or producing vaccines, such as generation of high growth strains’’? 6. NSABB recommends that continued assessment of the risks and benefits associated with advances and applications of bioinformatics, modeling, and other in silico experimental approaches and research involving genes from or encoding pathogens, toxins, or other agents must inform future evaluations of the scope of research oversight policies to help ensure that associated risks are appropriately identified and managed. (Recommendation 10.2). This type of research is not currently included in the DURC and ePPP oversight policies. (a) Is there a subset of such in silico research that should require risk assessment and review in a Revised Policy, and if so, how should this research be defined so that the Policy captures the appropriate research without hampering activities with limited biosecurity risks? (b) One possible way to define this category of in silico research within a Revised Policy would be to include experiments that are reasonably anticipated to: ‘‘(i) Develop in silico models that directly enable the predictive design of an enhanced potential pandemic pathogen or novel pathogen or toxin covered under a Revised Policy that could be constructed via genomic editing or de novo synthesis; and/or (ii) Develop a dataset(s) connecting nucleic acid or amino acid sequences with experimentally-determined pathogenic functions in a manner sufficient to enable the development of in silico models described in (i).’’ If a new category of research, similar to the examples provided above, were to require risk assessment and review in a Revised Policy, what would be the benefits and challenges with implementation? Dated: August 28, 2023. Stacy Murphy, Deputy Chief Operations Officer/Security Officer. lotter on DSK11XQN23PROD with NOTICES1 [FR Doc. 2023–18906 Filed 8–31–23; 8:45 am] BILLING CODE 3270–F1–P VerDate Sep<11>2014 17:24 Aug 31, 2023 Jkt 259001 SECURITIES AND EXCHANGE COMMISSION [Release No. 34–98233; File No. SR–ISE– 2023–08] Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change, as Modified by Amendment No. 1, To Make Permanent Certain P.M.-Settled Pilots August 28, 2023. On February 23, 2023, Nasdaq ISE LLC (‘‘ISE’’ or ‘‘Exchange’’) filed with the Securities and Exchange Commission (‘‘Commission’’), pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 a proposed rule change to make permanent the pilot program to permit the listing and trading of options based on 1⁄5 the value of the Nasdaq-100 Index and the Exchange’s nonstandard expirations pilot program. The proposed rule change was published for comment in the Federal Register on March 2, 2023.3 On April 7, 2023, pursuant to section 19(b)(2) of the Act,4 the Commission designated a longer period within which to approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to disapprove the proposed rule change.5 On May 11, 2023, the Exchange filed Amendment No. 1 to the proposed rule change (‘‘Amendment No. 1’’).6 On May 31, 2023, the Commission instituted proceedings to determine whether to approve or disapprove the proposed rule change and published Amendment No. 1 for notice and comment.7 Section 19(b)(2) of the Exchange Act 8 provides that, after initiating proceedings, the Commission shall issue an order approving or disapproving the proposed rule change not later than 180 days after the date of publication of notice of filing of the proposed rule change. The Commission may extend the period for issuing an order approving or disapproving the proposed 1 15 U.S.C. 78s(b)(1). CFR 240.19b–4. 3 See Securities Exchange Act Release No. 96979 (February 24, 2023), 88 FR 13182. 4 15 U.S.C. 78s(b)(2). 5 See Securities Exchange Act Release No. 97261, 88 FR 22509 (April 13, 2023). 6 Amendment No. 1 is available at: https:// www.sec.gov/comments/sr-ise-2023-08/ srise202308.htm. 7 See Securities Exchange Act Release No. 97626, 88 FR 37110 (June 6, 2023). 8 15 U.S.C. 78s(b)(2). 2 17 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 rule change, however, by not more than 60 days if the Commission determines that a longer period is appropriate and publishes reasons for such determination. The proposed rule change was published for notice and comment in the Federal Register on March 2, 2023.9 The 180th day after publication of the proposed rule change is August 29, 2023. The Commission is extending the time period for approving or disapproving the proposed rule change for an additional 60 days. The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change and the issues raised therein. Accordingly, the Commission, pursuant to section 19(b)(2) of the Exchange Act,10 designates October 28, 2023, as the date by which the Commission shall either approve or disapprove the proposed rule change (File No. SR–ISE–2023–08). For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.11 Sherry R. Haywood, Assistant Secretary. [FR Doc. 2023–18898 Filed 8–31–23; 8:45 am] BILLING CODE 8011–01–P SECURITIES AND EXCHANGE COMMISSION [Release No. 34–98231; File No. SR– CboeBZX–2023–062] Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To Amend the Initial Period After Commencement of Trading of a Series of ETF Shares on the Exchange as It Relates to the Holders of Record and/or Beneficial Holders, as Provided in Exchange Rule 14.11(l) August 28, 2023. Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (the ‘‘Act’’),1 and Rule 19b–4 thereunder,2 notice is hereby given that on August 14, 2023, Cboe BZX Exchange, Inc. (the ‘‘Exchange’’ or ‘‘BZX’’) filed with the Securities and Exchange Commission (the ‘‘Commission’’) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. The Commission is publishing this notice to 9 See supra note 3 and accompanying text. U.S.C. 78s(b)(2). 11 17 CFR 200.30–3(a)(57). 1 15 U.S.C. 78s(b)(1). 2 17 CFR 240.19b–4. 10 15 E:\FR\FM\01SEN1.SGM 01SEN1

Agencies

[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Notices]
[Pages 60513-60516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18906]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Request for Information; Potential Changes to the Policies for 
Oversight of Dual Use Research of Concern (DURC) and the Potential 
Pandemic Pathogen Care and Oversight (P3CO) Policy Framework

AGENCY: Office of Science and Technology Policy (OSTP).

ACTION: Notice of request for information.

-----------------------------------------------------------------------

SUMMARY: 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).

DATES: Responses are due by 11:59 p.m. Eastern Time on October 16, 
2023. Submissions received after the deadline may not be taken into 
consideration.

ADDRESSES: Comments must be submitted via the Federal eRulemaking 
Portal at regulations.gov. However, if you require an accommodation or 
cannot otherwise submit your comments via regulations.gov, please use 
the email or phone number listed under FOR FURTHER INFORMATION CONTACT. 
OSTP will not accept comments by fax or by email. To ensure that OSTP 
does not receive duplicate copies, please submit your comments only 
once. Additionally, please include the Docket ID (EOP-2023-0001) at the 
top of your comments.
    Federal eRulemaking Portal: Go to www.regulations.gov to submit 
your comments electronically. Information on how to use 
Regulations.gov, including instructions for accessing agency documents, 
submitting comments, and viewing the docket, is available on the site 
under ``FAQ'' (https://www.regulations.gov/faq).
    Privacy Note: OSTP's policy is to make all comments received from 
members of the public available for public viewing in their entirety on 
the Federal eRulemaking Portal at www.regulations.gov. Therefore, 
commenters should be careful to include in their comments only 
information that they wish to make publicly available. OSTP requests 
that

[[Page 60514]]

no proprietary information, copyrighted information, or personally 
identifiable information be submitted in response to this RFI.
    Instructions: Response to this RFI is voluntary. Each individual or 
organization is requested to submit only one response. Commenters can 
respond to one or multiple questions. Submissions are suggested to not 
exceed the equivalent of ten (10) pages in 12 point or larger font. 
Submissions should clearly indicate which questions are being 
addressed. Responses should include the name(s) of the person(s) or 
organization(s) filing the response. Responses containing references, 
studies, research, and other empirical data that are not widely 
published should include copies of or electronic links to the 
referenced materials. Responses containing profanity, vulgarity, 
threats, or other inappropriate language or content will not be 
considered.
    Please note that the U.S. Government will not pay for response 
preparation, or for the use of any information contained in the 
response. A response to this RFI will not be viewed as a binding 
commitment to develop or pursue the project or ideas discussed.

FOR FURTHER INFORMATION CONTACT: Direct questions to Asad Ramzanali, 
[email protected], or 202-456-4444.

SUPPLEMENTARY INFORMATION: Life sciences research is essential to the 
scientific advances that underpin improvements in the health and safety 
of the public, agricultural crops, and other plants, animals, and the 
environment. While life sciences research provides enormous benefits to 
society, there can be risks associated with certain subsets of work, 
typically related to biosafety and biosecurity, that can and should be 
mitigated. The United States has existing, complementary statutes, 
regulations, policies, and guidelines that address these potential 
biosafety and biosecurity risks, particularly those associated with 
research oversight and management.\1\ Together these existing 
regulatory authorities and guidelines provide a foundation to ensure 
that scientific research and innovation is safe and secure.
---------------------------------------------------------------------------

    \1\ Examples include: Select Agents and Toxins Regulations (42 
CFR part 73, 9 CFR part 121, and 7 CFR part 331); National 
Institutes of Health Guidelines on Research Involving Recombinant 
and Synthetic Nucleic Acids; (https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf); Biosafety in Microbiological & 
Biomedical Laboratories (BMBL) 6th Edition (https://www.cdc.gov/labs/BMBL.html); Additional U.S. Laws, Regulations and Guidelines 
(https://www.phe.gov/s3/law/Pages/default.aspx).
---------------------------------------------------------------------------

    Scientists, institutions, and the USG have gained valuable insight 
over the past decade from implementing research oversight policies such 
as the policies for oversight of DURC \2\ and the P3CO Policy 
Framework.\3\ During this time, advances in science and technology have 
occurred that present realized and potential future benefits. However, 
these advances also present potential risks of misuse. The National 
Science Advisory Board for Biosecurity (NSABB), a Federal advisory 
committee that addresses issues related to biosecurity and dual use 
research, provided recommendations in a March 2023 report \4\ to inform 
United States Government (USG) policy evaluations and the development 
of a more comprehensive and integrated framework for the oversight of 
research with pathogens and toxins that may pose significant biosafety 
or biosecurity risks. Since the release of this report, OSTP has been 
working with Federal departments and agencies to review, harmonize, and 
revise these policies in accordance with USG goals of promoting safe 
and secure biological practices and strengthening responsible conduct 
for biological research as outlined in the 2022 National Biodefense 
Strategy and Implementation Plan.\5\
---------------------------------------------------------------------------

    \2\ United States Government Policy for Oversight of Life 
Sciences Dual Use Research of Concern (https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf); United States 
Government Policy for Institutional Oversight of Life Sciences Dual 
Use Research of Concern (https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf).
    \3\ Recommended Policy Guidance for Departmental Development of 
Review Mechanisms for Potential Pandemic Pathogen Care and Oversight 
(P3CO) (https://www.phe.gov/s3/dualuse/Documents/P3CO-FinalGuidanceStatement.pdf).
    \4\ Proposed Biosecurity Oversight Framework for the Future of 
Science (nih.gov); https://osp.od.nih.gov/wp-content/uploads/2023/03/NSABB-Final-Report-Proposed-Biosecurity-Oversight-Framework-for-the-Future-of-Science.pdf.
    \5\ National Biodefense Strategy and Implementation Plan: 
https://www.whitehouse.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf.
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    The policy review and revision process has three broad goals:
    1. Assess whether and how to merge the existing Federal DURC, 
Institutional DURC, and P3CO policies into a harmonized policy that 
addresses oversight for research with pathogens and toxins.
    2. Consider revising the scope of the Federal DURC, Institutional 
DURC, and P3CO policies to include a broader set of pathogens and 
toxins, including--but not limited to--biological select agents and 
toxins (BSAT) that impact humans or have the potential to impact 
humans.
    3. Examine ways to strengthen effective implementation of oversight 
for life sciences research on pathogens and toxins throughout the 
research lifecycle.
    The USG acknowledges that effective oversight helps maintain public 
trust in the life sciences research enterprise by demonstrating that 
the scientific community recognizes the implications of research 
conducted and is acting responsibly to protect public welfare and 
preserve national security.
    Scope: OSTP invites comment from any interested stakeholders. In 
particular, OSTP is interested in input from research institutions, 
including both domestic and international entities, currently subject 
to the PC3O Policy or the DURC policies or that may be subject to the 
revised scope of a potential policy update, researchers within those 
institutions, scientific and professional organizations, and 
organizations representing diverse interests across the U.S. research 
ecosystem.
    Information Requested: Respondents may provide information for one 
or more of the topics included below. Respondents are asked to note the 
corresponding number/s to which responses pertain.
    1. The NSABB recommended that USG develop an integrated approach to 
oversight of research that raises significant biosafety and biosecurity 
concerns, including ePPP research and DURC (Recommendation 1). By 
merging the existing Federal DURC, Institutional DURC, and P3CO 
policies into a harmonized policy, a merged policy could potentially 
adopt the institutional applicability outlined in the Institutional 
DURC policy framework, making the following entities subject to a 
Revised Policy:
     U.S. Government departments and agencies that fund, 
sponsor, or conduct life sciences research.
     Institutions within the United States or its territories 
that both:
    [ssquf] Receive U.S. Government funds to conduct or sponsor life 
sciences research; and,
    [ssquf] Conduct or sponsor research that is within the revised 
scope, regardless of the source of the funding for the specific 
project.
     Institutions outside of the United States that receive 
U.S. Government funds to conduct or sponsor research that falls under 
the scope.
    (a) What are the anticipated benefits and challenges of applying a 
Revised Policy, inclusive of both DURC and

[[Page 60515]]

ePPP research, to the scope of entities outlined above?
    (b) What are the anticipated benefits and challenges of 
investigators and institutions having primary responsibility for 
identification of both DURC and ePPP research?
    (c) What types of resources or tools would be useful for 
researchers and institutions to determine if their research falls into 
a revised policy scope that is risk-based rather than list-based, and 
adequately conduct risk assessments to identify DURC and ePPP research?
    2. Currently, the scope of the DURC policies is research that uses 
one or more of 15 listed agents or toxins and that produces, or is 
anticipated to produce, any of seven listed experimental effects. The 
NSABB recommended that the scope of research requiring review for 
potential DURC should include research that directly involves any 
human, animal, or plant pathogen, toxin, or agent that is reasonably 
anticipated to result in one or more of the seven experimental effects 
outlined in the DURC policy \6\ (Recommendation 10.1).
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    \6\ United States Government Policy for Oversight of Life 
Sciences Dual Use Research of Concern (https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf); United States 
Government Policy for Institutional Oversight of Life Sciences Dual 
Use Research of Concern (https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf).
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    a. Considering the diversity of federally-funded research settings 
and portfolios, how would adoption of NSABB's Recommendation 10.1 
affect policy implementation and research programs at the institutional 
level?
    b. Rather than including any pathogen within the scope of DURC 
review, one possible modification of Recommendation 10.1 would be to 
include DURC experiments that utilize:
    i. HHS and Overlap Biological Select Agent and Toxins (BSAT) List 
\7\ and/or
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    \7\ Select Agents and Toxins Regulations (42 CFR part 73, 9 CFR 
part 121, and 7 CFR part 331).
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    ii. Pathogen risk group (RG) classification of 3 or 4 \8\ and/or
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    \8\ Risk groups as defined in ``NIH Guidelines for Research 
Involving Recombinant or Synthetic Nucleic Acid Molecules'' (https://osp.od.nih.gov/wp-content/uploads/2019_NIH_Guidelines.htm).
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    iii. Any pathogen where the conduct of work (e.g., one of the DURC 
experimental categories) would require biosafety level 3 or 4 
containment.
    Would a modification of Recommendation 10.1, in line with the 
outlined scope of pathogens above, be useful for policy implementation? 
What specific benefits, challenges, and/or gaps are anticipated by this 
revised scope?
    c. Are there other risk-based approaches that would expand the 
scope beyond the current list of 15 agents and toxins provided in the 
DURC policy that would facilitate the identification of research that 
poses significant risks by investigators and institutions while not 
resulting in undue burdens?
    d. Given the possible revised scope of research requiring review 
for potential DURC, what modifications, if any, to the current DURC 
policy list of 7 experimental effects should be considered for a 
Revised Policy that captures appropriate research without hampering 
research progress?
    e. What resources or tools would be valuable to assist with 
implementation of a DURC policy with a scope that is revised to include 
more than the current list of 15 agents and toxins?
    3. A PPP is currently defined in the P3CO policy framework \9\ as: 
``a pathogen that satisfies both of the following: 1. It is likely 
highly transmissible and likely capable of wide and uncontrollable 
spread in human populations; and 2. It is likely highly virulent and 
likely to cause significant morbidity and/or mortality in humans.''
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    \9\ Recommended Policy Guidance for Departmental Development of 
Review Mechanisms for Potential Pandemic Pathogen Care and Oversight 
(P3CO) (https://www.phe.gov/s3/dualuse/Documents/P3CO-FinalGuidanceStatement.pdf).
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    The NSABB recommended that the definition of PPP be modified to: 
(1) Likely moderately or highly transmissible and likely capable of 
wide and uncontrollable spread in human populations; and/or (2) Likely 
moderately or highly virulent and likely to cause significant morbidity 
and/or mortality in humans; and, in addition (3) Likely to pose a 
severe threat to public health, the capacity of public health systems 
to function, or national security'' (Recommendation 2).
    (a) How would the change in the definition of PPP affect the 
overall scope of a Revised Policy and its subsequent implementation?
    (b) One possible modification to the NSABB PPP definition is to 
specify a respiratory route of transmission within clause (1). Would 
that definition of PPP be an appropriate scope to mitigate risks and 
enhance effective implementation?
    (c) Do you have additional suggestions to modify the PPP definition 
to mitigate the most significant risks not currently addressed and 
enhance effective implementation, while limiting negative or unintended 
consequences and burden on researchers, institutions, and the Federal 
government?
    (d) Are there characteristics related to human pathology, pathogen 
characteristics, or other features that would be helpful to clarify the 
intent of ``moderately virulent''? Are there characteristics related to 
human pathology that would be helpful to clarify the intent of 
``moderately transmissible''?
    4. A Government Accountability Office (GAO) report from January 
2023 \10\ recommended that the Department of Health and Human Services 
funding agencies should develop and document a standard to define 
``reasonably anticipated'' to ensure consistency in identifying 
research that falls within scope of a Revised Policy. One possible 
definition of ``reasonably anticipated'' is:
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    \10\ Public Health Preparedness: HHS Could Improve Oversight of 
Research Involving Enhanced Potential Pandemic Pathogens. (GAO-23-
105455).
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    `` `Reasonably anticipated' describes an assessment of an outcome 
that an individual with scientific expertise relevant to the research 
in question would expect this outcome to occur with a non-trivial 
likelihood. It does not require high confidence that the outcome will 
definitely occur and excludes experiments in which an expert would 
anticipate the outcome to be technically possible, but highly 
unlikely.''
    (a) Does this definition of ``reasonably anticipated'' provide 
additional clarity to ensure greater consistency in identifying 
research that falls within scope of the Revised Policy? What 
modifications to this definition (if any) would be most helpful?
    5. NSABB recommends the removal of blanket exclusions for research 
activities associated with surveillance and vaccine development or 
production for research with ePPPs (Recommendation 3).
    (a) Should exemptions for certain activities be included in a 
Revised Policy?
    (b) What are the benefits and drawbacks of including exemptions for 
domestic and international pandemic preparedness, biosafety, 
biosecurity, and global health security?
    (c) If exemptions are included, how could they be bounded to 
maximize safety and security and minimize negative impact on domestic 
and global public health including outbreak and pandemic preparedness 
and response? For example, would vaccine research and development 
activities be unjustifiably impeded if the current P3CO policy 
framework exemption for ``Activities associated with developing and 
producing vaccines, such as generation of high growth strains'' was 
either removed completely or modified

[[Page 60516]]

to ``Research on PPPs directly associated with testing and/or producing 
vaccines, such as generation of high growth strains''?
    6. NSABB recommends that continued assessment of the risks and 
benefits associated with advances and applications of bioinformatics, 
modeling, and other in silico experimental approaches and research 
involving genes from or encoding pathogens, toxins, or other agents 
must inform future evaluations of the scope of research oversight 
policies to help ensure that associated risks are appropriately 
identified and managed. (Recommendation 10.2). This type of research is 
not currently included in the DURC and ePPP oversight policies.
    (a) Is there a subset of such in silico research that should 
require risk assessment and review in a Revised Policy, and if so, how 
should this research be defined so that the Policy captures the 
appropriate research without hampering activities with limited 
biosecurity risks?
    (b) One possible way to define this category of in silico research 
within a Revised Policy would be to include experiments that are 
reasonably anticipated to:
    ``(i) Develop in silico models that directly enable the predictive 
design of an enhanced potential pandemic pathogen or novel pathogen or 
toxin covered under a Revised Policy that could be constructed via 
genomic editing or de novo synthesis; and/or
    (ii) Develop a dataset(s) connecting nucleic acid or amino acid 
sequences with experimentally-determined pathogenic functions in a 
manner sufficient to enable the development of in silico models 
described in (i).''
    If a new category of research, similar to the examples provided 
above, were to require risk assessment and review in a Revised Policy, 
what would be the benefits and challenges with implementation?

    Dated: August 28, 2023.
Stacy Murphy,
Deputy Chief Operations Officer/Security Officer.
[FR Doc. 2023-18906 Filed 8-31-23; 8:45 am]
BILLING CODE 3270-F1-P
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