The NSABB is a federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the United States Government. The NSABB has up to 25 voting members with a broad range of expertise including molecular biology, microbiology, infectious diseases, biosafety, public health, veterinary medicine, plant health, national security, biodefense, law enforcement, scientific publishing, and other related fields.
For additional information about the NSABB, please email SciencePolicy@od.nih.gov.
NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY
AUTHORITY
Authorized by 42 U.S.C. 217a, section 222 of the Public Health Service (PHS) Act, as amended, and the Pandemic and All-Hazards and Preparedness Act, Pub. L. No. 109-417, section 205, 120 Stat. 2851 (2006) (PAHPA), codified at 42 U.S.C. 262a note. The National Science Advisory Board for Biosecurity (NSABB or Committee) is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2).
OBJECTIVES AND SCOPE OF ACTIVITIES
The purpose of the NSABB is to provide, as requested, advice, guidance, and recommendations regarding biosecurity oversight of dual use research, defined as biological research with legitimate scientific purpose that may be misused to pose a biologic threat to public health and/or national security. The NSABB will provide advice on and recommend specific strategies for the efficient and effective oversight of federally conducted or supported dual use biological research, taking into consideration both national security concerns and the needs of the research community to foster continued rapid progress in public health and agricultural research. Toward this end, the NSABB will also provide strategies to raise awareness of dual use issues relevant to the life science and related interdisciplinary research communities. In addition, pursuant to Section 205 of the PAHPA, when requested by the Secretary of Health and Human Services (HHS), the NSABB shall also provide to relevant Federal departments and agencies, advice, guidance, or recommendations concerning (1) a core curriculum and training requirements for workers in maximum containment and biological laboratories; and (2) periodic evaluation of maximum containment biological laboratory capacity nationwide and assessments of the future need for increased laboratory capacity.
DESCRIPTION OF DUTIES
The NSABB will be composed of subject matter experts who are not full-time employees of the Federal Government, as well as ex officio members from HHS, and will perform the following activities:
AGENCY OR OFFICIAL TO WHOM THE COMMITTEE REPORTS
The NSABB will advise the Secretary, HHS, and the Director of the National Institutes of Health (NIH). In addition, as discussed above under “Objectives and Scope of Activities,” when requested by the Secretary, HHS, the NSABB will advise the heads of all Federal entities that conduct, support, or have an interest in life sciences research on the matters delineated in Section 205 of the PAHPA.
SUPPORT
Management and support services for the NSABB will be provided by the Office of Science Policy (OSP), within the Office of the Director, NIH.
ESTIMATED ANNUAL OPERATING COSTS AND STAFF YEARS
The estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support, is $204,265. The estimated annual person years of staff support required is 0.3 at an estimated cost of $57,829.
DESIGNATED FEDERAL OFFICER
The Director, NIH, will assign a full-time or permanent part-time NIH employee to serve as the Designated Federal Officer (DFO) of the NSABB. In the event that the DFO cannot fulfill the assigned duties of the NSABB, one or more full-time or permanent part-time NIH employees will be assigned as DFO and carryout these duties on a temporary basis.
The DFO will approve or call all of the Committee’s and subcommittee/working group meetings, prepare and approve all meeting agendas, attend all Committee and subcommittee meetings, adjourn any meetings when it is determined to be in the public interest, and chair meetings when directed to do so by the official to whom the committee reports.
ESTIMATED NUMBER AND FREQUENCY OF MEETINGS
Meetings of the Committee will be held approximately three times within a fiscal year. Meetings will be open to the public except as determined by the Secretary, of Health and Human Services (Secretary) at the request of the DFO in accordance with 5 U.S.C.552b(c) and 41 C.F.R. 102-3.155 including specifying the specific exception(s) the justifies closure. Notice of all meetings will be given to the public. In the event a portion of a meeting is closed to the public, as determined by the Secretary, in accordance with the Government in the Sunshine Act (5 U.S.C. 522b(c)) and the Federal Advisory Committee Act, an annual report of closed or partially-closed meetings will be prepared which will contain, at a minimum, a list of members and their business addresses, the Committee’s functions, dates and places of meetings, and a summary of the Committee’s activities and recommendations made during the fiscal year.
DURATION
Continuing.
TERMINATION
Unless renewed by appropriate action, the NSABB will terminate two years from the date the charter is filed.
MEMBERSHIP AND DESIGNATION
The NSABB will consist of not more than 25 voting members, including the Chair, appointed by the Secretary, HHS, in consultation with the heads of Federal departments and agencies that conduct or support life sciences research, as needed. The Secretary, HHS, will designate the Chair. All appointed members must be eligible to serve as and will serve as Special Government Employees, as defined by 18 U.S.C. § 202, and will serve as such in their individual capacities as subject matter experts. None of these members serves as a Representative.
Areas of expertise to be represented on the NSABB, may include but are not limited to:
There may be nonvoting ex officio members from HHS, also appointed by the Secretary, HHS.
Voting members will be invited to serve for overlapping terms of up to four years. A voting member’s term may be extended until a successor has been appointed.
A quorum for the NSABB will consist of a majority of the appointed members eligible to vote. The nonvoting ex officio members from HHS will not be counted in calculating a quorum. Of the voting members, any who are recused from participating in an action on a particular issue, (e.g., due to a conflict of interest), will not be counted in calculating the quorum. All votes relating to any review of a recommendation by the NSABB will be open to the public unless the meeting has been closed to the public in accordance with the Government in the Sunshine Act and the Federal Advisory Committee Act.
SUBCOMMITTEES
As necessary, subcommittees and ad hoc work groups may be established by the DFO within the Committee’s jurisdiction. The advice/recommendations of the subcommittee/work group must be deliberated by the parent advisory committee. A subcommittee/workgroup may not report directly to a Federal official unless there is statutory authority to do so.
Subcommittee membership may be drawn in whole or in part from the parent advisory committee. Subject to the limitation set forth above the Federal members from agency other than HHS, all subcommittee members may vote on subcommittee actions and all subcommittee members count towards the quorum for a subcommittee meeting. Ad hoc consultants are not members, do not count towards the quorum, and may not vote. A quorum for a subcommittee will be three members. The Department Committee Management Officer will be notified upon establishment of each standing subcommittee and will be provided information on its name, membership, function, and estimated frequency of meetings.
RECORDKEEPING
Meetings of the Committee and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws, and Department policies. Committee and subcommittee records will be handled in accordance with General Records Schedule 6.2, Federal Advisory Committee Records, or other approved agency records disposition schedule. These records will be available for public inspection and copying, subject to any applicable exemptions under the Freedom of Information Act, 5 U.S.C. 552(b) and 41 C.F.R. 102-3.170.
FILING DATE
April 7, 2022
APPROVED
By Xavier Becerra, Secretary, HHS.
Signed on April 6, 2022
ChairPARKER JR., Gerald W., DVM, PhD MembersBENJAMIN, Shannon, MS, MBA BERNARD, Kenneth, MD DENISON, Mark R., MD EGAN, Christina, PhD FLETCHER, Jacqueline, PhD GRABENSTEIN, John D., RPh, PhD |
MembersHAYNES, Karmella, PhD LEVINSON, Rachel, MA LONDON, Alex John, PhD LOUISSAINT, Nicolette, PhD, MBA MADAD, Syra, DHSc, MSc, MCP METZGER, Dennis, PhD SILVER, Pamela A., PhD |
February 28, 2022 from 12pm to 1pm.
Virtual Meeting
For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
September 21, 2022
Virtual Meeting
On September 21, 2022, NIH will be hosting a virtual meeting of the National Science Advisory Board for Biosecurity (NSABB). An agenda and other meeting material will be posted here when available.
If you have any questions, please contact SciencePolicy@od.nih.gov.
Slides of January 23, 2020 – Day 1
Wolinetz – Dual Use and Gain-of-Function Research Oversight Policy
Hassell – HHS Oversight of Enhanced PPP Research
Wolinetz – NSABB Charge
Resnik – Balancing Transparency and Security – Ethical Considerations
Gronvall – Balancing Security and Transparency – Policy Considerations
Inglesby – Perspectives on Enhanced PPP Research Transparency and Security
Lipsitch – Balancing Security Transparency – Responsible CommunicationSlides of January 24, 2020 – Day 2
Black – Scientific Peer Review at NIH
Good – Scientific Peer Review at NSF
Edwin – Balancing Security and Transparency for BSAT Research
Vander Linden – USAMRIID Community Engagement on Pathogen Research
Moritz – Making Science, Biosafety, and Biosecurity Transparent
Benjamin – NEIDL Research Transparency
Fischhoff – Responsible Public Communication
Lipson – Engagement and Communications for PPP ResearchFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
(teleconference meeting only)
For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
(teleconference meeting only)
For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
NSABB Working Group Update
Risk and Benefit Analysis of Gain-of-Function Research
The Path Forward on NSABB Deliverable(teleconference meeting only)
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Lurie – Charge to the NSABB
Duprex – History and Utility of Gain-of-Function Studies
Lipsitch – Risks and Alternatives to Gain-of-Function Studies
Resnik – Ethics of Gain-of-Function Studies
Lipkin – Discussion Points
Kawaoka – Gain-of-Function Studies of Influenza Viruses
Peterson – Biosafety and Gain-of-Function Research
Schultz-Cherry – The Case for Public Health
Perez – Gain-of-Function Studies in the Perez Lab
Casadevall – The Case for Gain-of-Function Experiments
Eubank – Modeling and Biological Risk Assessments
Ferson – Uncertainty Quality Assurance for Probabilistic Risk Assessment
Fischhoff – Behaviorally Realistic Risk Management
Stanley – Addressing the Charge to the NSABBFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
(teleconference meeting only)
For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Casadevall and Miller – Journal Review Policies WG Progress Update
Ehrlich – Culture of Responsibility WG Update
Franz – International Engagement WG Update
Grant and Imperiale – Outreach and Education WG Progress Report
Keim – NSABB WG Draft Guidance on Personnel Reliability and Culture of Responsibility
Kwinn – Federal Expert Security Advisory PanelFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Groesch – Impetus for Report from National Research Council
Eddy – Sequence-based classification of Select Agents
Tucker – Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA
Corrigan-Curay – NIH Guidelines to Address Synthetic Nucleic Acids
Groesch – US Government Deliberations on Dual Use Research Oversight
Groesch – Optimizing the Security of Biological Select Agents and Toxins
Relman – Consideration of Advances in Synthetic Biology
Levy – NSABB International Engagement WG Update
Imperiale – NSABB Outreach and Education WG Update
Casadevall – NSABB Journal Review Policies WG Update
Berns – NSABB Codes of Conduct WG UpdateFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Parker – New Tasks for the NSABB
Tucker – Screening Framework Guidance for Synthetic Double-Stranded DNA Providers
Corrigan-Curay – Revising the NIH Guidelines to Address Synthetic Nucleic Acids
Relman – NSABB Draft Report on Synthetic Biology
Imperiale – NSABB Outreach and Education Activities
Levy – NSABB International Engagement ActivitiesFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
(teleconference meeting only)
For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Imperiale – Public Consultation on Personnel Reliability
Keim – NSABB Draft Report on Enhancing Personnel ReliabilityFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Patterson – Personnel Reliability Introduction and Charge
Weyant – Security Risk Assessments for Possession Use and Transfer of Select Agents
Creque – DOE Biological Personnel Reliability
Gard – LLNL Select Agent Human Reliability Program
Kasper – Personnel Reliability WG Preliminary Findings and Recommendations
Imperiale – Strategic Plan for Outreach and Education on Dual Use Research Issues
Mazanec – USG Public Consultation Meeting on NSABB Proposed Oversight Framework
DiEuliis – Implementation of Synthetic DNA and Security Policy Actions
Franz – International Engagement WG Update on 3rd International RoundtableFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Franz – International Engagement on Dual Use Research
Patterson – Biosafety Implications of Synthetic Genomics Technology
Relman – Assessing Biosecurity Concerns Related to Synthetic Biology
Kasper and Imperiale – Outreach and Education on Dual Use Research
Shipp – OBA Outreach and Education Activities on Dual Use Research
Atlas – ASM Perspectives on Outreach on Dual Use Research
Heinig – AAMC Perspectives on Outreach on Dual Use Research
Martyn – APS Perspectives on Outreach on Dual Use Research
McPheron – NASULGC Perspectives on Outreach on Dual Use Research
Peterson – ABSA Perspectives on Outreach on Dual Use Research
Wolinetz – FASEB Perspectives on Outreach on Dual Use Research
Frankel – Outreach and Education on Responsible Conduct of Dual Use Research
Cook-Deegan – SECRB Biosecurity and Dual Use Education Activities
Stebbins – FAS Educational Efforts Related to Dual Use ResearchFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Kasper – Draft Oversight Framework
Levy – International Collaboration WG Report on International RoundtableFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Kasper – Introduction
Relman – Sythnetic Genomics WG Status Report
Franz – International Collaboration WG Status Report
Kasper – Oversight Framework Status ReportFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Kasper – Dual Use Criteria WG Status Report
Keim – Communications WG Status Report
Nance – Codes of Conduct WG Status Report
Relman – Synthetic Genomics WG Status Report
Hemphill – Select Agent Rules Intent and Interpretation of Controls for Nucleotides
Mulligan – Commercial Gene Synthesis
Baric – Synthetic Viruses Risks and Benefits
Franz – International Collaborations WG Status Report
Kasper – Overview of Next Steps and Closing Remarks
NSABB WG Draft on Codes of Conduct
NSABB WG Draft on Criteria for Identifying Dual Use Research
NSABB WG Draft on Responsible CommunicationFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Kasper – Dual Use Criteria WG Status Report
Nance – Codes of Conduct WG Status Report
Relman – Synthetic Genomics WG Status Report
Lemon – NRC Globalization Report Presentation
Keim – Communication of Dual Use Research
Cosivi – Overview of Global Perceptions and Priorities
Carr – Managing Risks of Research Misuse
Taylor – Enhancing Biological Security with International CooperationFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Patterson – Overview of NSABB Activities
Kasper – Criteria for Identifying Dual Use WG Progress Report
Nance – Codes of Conduct WG Progress Report
Keim – Communication of Dual Use WG Progress Report
Franz – International Collaboration WG Progress ReportFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Zerhouni – Opening Remarks
Kasper – Next Steps for NSABB
Holohan – NSABB Structure and Operations
Casadevall – Microbes as Weapons
Atlas – Criteria for Identifying Dual Use Research
Franz – Dual Use Dilemma
Fauci – Balancing Biosecurity and Scientific Progress
Reppy – Dual Use Information Issues
Bowles – Lessons from Nuclear Physics and Cryptography
Campbell – Dual Use Results and Scientific Journals
White – Communication of Dual Communication of Dual Use Research
Sharp – Code of Conduct
Rappert and Dando – Challenges in Proposing a Code of Conduct
Dale – International Aspects
Venter – Synthetic Genomics
Church – Risks and Rewards of Synthetic Biology
Mulligan – Biosecurity Concerns Involving Genome Services ProvidersFor accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.
Charge:
The NSABB will evaluate and provide recommendations to the Office of Science and Technology Policy (OSTP) and the Department of Health and Human Services (HHS) on the effectiveness of the current oversight framework for research involving enhanced potential pandemic pathogens (ePPPs). In developing these recommendations, the NSABB should consider the OSTP Recommended Policy Guidance for Departmental Development of Review Mechanism for Potential Pandemic Pathogen Care and Oversight and the process adopted by HHS for the review and oversight of proposed research involving enhanced potential pandemic pathogens. Review should include:
A. Policy scope, in terms of preserving benefits of ePPP research while minimizing potential biosafety and biosecurity risks, including whether wild type pathogens, animal models of transmissibility, etc., should be considered;
B. Considerations for supporting ePPP research internationally, per OSTP framework encouraging harmonized policy guidance; and
C. Balancing considerations regarding security and public transparency when sharing information about research involving ePPPs.
The review should consider the impact that the Policy Guidance has had on work involving the creation, transfer, or use of enhanced potential pandemic pathogens, research programs, and institutions when developing these recommendations.
Charge:
The Office of Science and Technology Policy (OSTP) and the National Security Council (NSC) formally request the National Science Advisory Board for Biosecurity (NSABB) evaluate, analyze, and provide specific recommendations on the following tasks and subtasks:
A. The U.S. Government DURC Policies, the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern and the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, were released in 2012 and 2014 respectively, and require thorough review to inform future policy and governance deliberations. The NSABB should:
B. With the understanding that U.S. Government DURC Policies will undergo review in Phase 2A., and in accordance with Section 8 of the January 2017 Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO), the NSABB should:
Throughout Phase 2, the NSABB should consider the need for flexible and adaptive governance approaches that 1) keep pace with scientific advances and the evolving understanding of risks and benefits; 2) can coalesce and integrate existing governance guidance or policy, 3) can be applied to mitigate risk not only from research of concern but other biosecurity and biosafety considerations.
The National Science Advisory Board for Biosecurity (NSABB) is a Federal advisory committee chartered to provide advice, guidance, and leadership regarding biosecurity oversight of dual use research to all Federal departments and agencies with an interest in life sciences research. The NSABB advises on and recommends strategies for the efficient and effective oversight of federally conducted or supported dual use biological research and related issues, taking into consideration national security concerns and the needs of the research community.
As with all Federal advisory committees, the NSABB is chartered for two-year intervals and will continue its work pending biennial renewals of the charter by the Secretary of the Department of Health and Human Services (HHS).
The NSABB has up to 25 voting members who serve for terms of up to four years. The NSABB members provide expertise in areas such as molecular biology, microbiology, clinical infectious diseases, laboratory biosafety and biosecurity, public health/epidemiology, health physics, pharmaceutical production, veterinary medicine, plant health, food production, bioethics, national security, biodefense, intelligence, national security, law and law enforcement, recombinant or synthetic nucleic acid research, and export control. NSABB members may come from various stakeholder communities, including academia, medical and scientific journal publishing, industry, institutional biosafety committees, and the general public. In addition, the NSABB includes non-voting ex officio members from 15 federal agencies and departments. The NSABB roster can be found here.
The NSABB members are appointed by the Secretary of HHS in consultation with other Federal departments and agencies with an interest in life sciences research. Members of the public can submit nominations for future NSABB membership through the ex officio agencies or directly to the National Institutes of Health (NIH), Office of Science Policy (OSP).
The Board includes nonvoting ex officio members from relevant Federal departments and agencies that have an interest in life sciences research. These include:
The NSABB meets approximately two times within a fiscal year, and may also be convened on an as-needed basis. All meetings of the NSABB are announced in the Federal Register and on the NSABB web site . NSABB meetings are open to the public, except as determined otherwise by the Secretary of HHS, in accordance with the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act.
The NSABB has submitted a series of reports advising the USG on issues related to dual use research including:
Please visit the NSABB page for NSABB reports on these and other issues. In addition, the NSABB has hosted a series of international meetings on dual use research, with the aim of raising awareness of the dual use research issues, and to facilitate international engagement and information sharing on strategies for managing risk(s) posed by dual use life science research.
The HHS Secretary designated the NIH to provide management and support services for the NSABB. The NSABB staff is located in the Office of Science Policy in the Office of the Director, NIH. You may contact NSABB staff through the NIH OSP at 301-496-9838 or by email at nsabb@od.nih.gov.
Life sciences research is vital to improving public health, agriculture, and the environment, and to strengthening our national security and economy. Yet the very research designed to better the health, welfare, and safety of mankind can also yield information or technologies that could potentially be misused for harmful purposes. Research yielding new technologies or information with the potential for both benevolent and malevolent applications is referred to as “dual use research.”
Some degree of dual use potential may be inherent in a significant fraction of life sciences research. However, the small subset of life sciences research with the highest potential for yielding knowledge, products, or technology that could be misapplied to threaten public health or national security is referred to as “dual use research of concern.”
The U.S. Government (USG) defines dual use research of concern as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
When the USG receives recommendations from the NSABB, it convenes relevant Federal agencies to analyze the findings and recommendations and to identify options for considering the recommendations. Once options for addressing the recommendations are identified, policy actions are decided upon and the relevant Federal agencies are tasked with implementing those policy actions. Examples of policy actions taken in response to NSABB recommendations include the development of screening guidance for providers of synthetic double-stranded DNA; clarification of language in the Select Agent Rules regarding their applicability to synthetic genomics; a legal interpretation of the applicability of 18 USC 175c to research involving orthopoxviruses; revision of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to more explicitly address synthetic nucleic acids; and convening a panel of the National Academies to address scientific milestones needed before a predictive oversight system could be contemplated for select agents and toxins. Federal policies and guidance for the evaluation and oversight of dual use research of concern, as well as research anticipated to involve enhanced potential pandemic pathogens, were also informed by NSABB findings and recommendations.