National Science Advisory Board for Biosecurity (NSABB)
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
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:
- Provide recommendations on the development of programs for outreach, education and training in dual use research issues for scientists, laboratory workers, students, and trainees in relevant disciplines.
- Advise on policies governing publication, public communication, and dissemination of dual use research methodologies and results.
- Recommend strategies for fostering international engagement on dual use biological research issues.
- Advise on the development, utilization, and promotion of codes of conduct to interdisciplinary life scientists and relevant professional groups.
- Advise on policies regarding the conduct, communication, and oversight of dual use research and research results, as requested.
- Advise on the Federal Select Agent Program, as requested.
- Address any other issues as directed by the Secretary, HHS.
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.
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.
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:
- Molecular Biology/Genomics
- Microbiology (Bacteriology)
- Microbiology (Virology)
- Clinical Infectious Diseases/Diagnostics
- Institutional and/or Laboratory Biosafety and Biosecurity
- Public Health/Epidemiology
- Health Physicist/Radiation Safety
- Pharmaceutical Production
- Veterinary Medicine
- Plant Health
- Food Production
- National Security
- Military Biodefense Programs and Military Medicine
- Law Enforcement
- Scientific Publishing
- Export Controls
- Industry Perspective
- Public Perspective
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.
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.
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.
April 7, 2022
By Xavier Becerra, Secretary, HHS.
Signed on April 6, 2022
Roster of Voting Members
PARKER JR., Gerald W., DVM, PhD
Associate Dean for Global One Health
College of Veterinary Medicine and Biomedical Sciences
Texas A&M University
College Station, TX 77843
BENJAMIN, Shannon, MS, MBA
Associate Director, Environmental Health & Safety
Boston, MA 02210
BERNARD, Kenneth, MD
RADM, U.S. Public Health Service (Retired)
Former Special Assistant to the President for Biodefense, Homeland Security Council, White House
Former Special Adviser for Health and Security, National Security Council
Pebble Beach, CA 93953
DENISON, Mark R., MD
Edward Stahlman Professor of Pediatrics
Professor of Pathology, Microbiology and Immunology
Director of the Division of Pediatric Infectious Diseases
Vanderbilt University Medical Center
EGAN, Christina, PhD
Deputy Director, Division of Infectious Disease and
Chief, Biodefense and Mycology Laboratories
New York State Department of Health
Albany, NY 12208
FLETCHER, Jacqueline, PhD
Regents Professor Emerita
National Institute for Microbial Forensics and Food and Agricultural Biosecurity
Oklahoma State University
Corrales, NM 87048
GRABENSTEIN, John D., RPh, PhD
Easton, MD 21601
HAYNES, Karmella, PhD
Wallace H. Coulter Department of Biomedical Engineering
Georgia Institute of Technology and Emory University
Atlanta, GA 30322
LEVINSON, Rachel, MA
Executive Director, National Research Initiatives
Arizona State University
Washington, DC 20006
LONDON, Alex John, PhD
Clara L. West Professor of Ethics and Philosophy
Department of Philosophy
Carnegie Mellon University
Pittsburgh, PA 15213
MADAD, Syra Madad, DHSc, MSc, MCP
Faculty, Boston University’s Center for Emerging Infectious Diseases Policy & Research
Fellow, Harvard Kennedy School Belfer Center for Science and International Affairs
Senior Director, System-wide Special Pathogens Program, NYC Health + Hospitals
New York, NY 10013
METZGER, Dennis, PhD
Distinguished Professor Emeritus
Department of Immunology and Microbial Disease
Albany Medical College
Albany, NY 12208
SILVER, Pamela A., PhD
Elliot T. and Onie H. Adams Professor of Biochemistry and Systems Biology, Harvard Medical School
Member, Wyss Institute of Biologically Inspired Engineering, Harvard University
Boston, MA 02115
|National Science Advisory Board for Biosecurity (NSABB) Meeting||01/27/2023||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||09/21/2022||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||02/28/2022||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||01/23/2020||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||05/11/2017||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||11/04/2016||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||05/24/2016||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||01/07/2016||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||09/28/2015||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||05/05/2015||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||11/25/2014||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||10/22/2014||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||11/27/2012||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||12/15/2011||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||06/23/2011||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||10/19/2010||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||12/03/2009||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||05/27/2009||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||04/29/2009||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||12/10/2008||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||02/27/2008||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||04/19/2007||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||10/25/2006||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||07/13/2006||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||03/30/2006||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||11/21/2005||View Event|
|National Science Advisory Board for Biosecurity (NSABB) Meeting||06/30/2005||View Event|
Reports and Recommendations
- Proposed Biosecurity Oversight Framework for the Future of Science
Published Date: March 2023
- Report of the Blue Ribbon Panel to Review the 2014 Smallpox (Variola) Virus Incident on the NIH Campus
Published Date: May 2017
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.
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:
- Evaluate the effectiveness of the DURC Policies in achieving the issuances’ intent; evaluate the impact on research institutions and the U.S. Government’s ability to support research; and identify any challenges with implementation;
- Reevaluate the DURC definition, considering advances in life sciences research and convergence with other scientific disciplines and sectors;
- Evaluate the effectiveness of the DURC pathogen list and experimentation type construct to determine if the approach sufficiently addresses future potential threats, including across the spectrum of life sciences, is conducive to research risk-mitigation, and whether alternative approaches are warranted for consideration by the USG; and
- Evaluate the effectiveness of the DURC policies with regard to publication, public communication, and dissemination of dual-use research methodologies and results.
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:
- Evaluate Section 8 of the Policy Guidance for P3CO, Future Commitments of the P3CO Policy Guidance, and provide recommendations on possible P3CO Policy Guidance incorporation into policy frameworks associated with any recommended revisions of the DURC Policies.
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.
Stakeholder Engagement Workshop on Implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences DURC
On September 25-26, 2017, the U.S. Government hosted a public workshop to engage with stakeholders and facilitate information sharing among research institutions regarding their approaches to, and experiences with, implementing the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC). The National Science Advisory Board for Biosecurity helped to develop the agenda and plan the workshop. More information and archived video recordings can be found HERE.
Potential Pandemic pathogen Care and Oversight (P3CO) Policy Development
On October 16, 2014, the White House Office of Science and Technology Policy announced the launch of the U.S. Government (USG) gain-of-function (GOF) deliberative process to re-evaluate the potential risks and benefits associated with GOF studies with potential pandemic pathogens. The NSABB served as the official federal advisory body on the GOF issue and was tasked with providing recommendations to the USG on a conceptual approach for evaluating proposed GOF research. More information about this topic can be found HERE.