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.

February 28, 2022 Meeting Information now available.

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:

  • 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.

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:

  • 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
  • Bioethics
  • National Security
  • Military Biodefense Programs and Military Medicine
  • Intelligence
  • Biodefense
  • Law
  • Law Enforcement
  • Academia
  • 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.

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

Advisory Committee Roster

Chair

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

Members

BENJAMIN, Shannon, MS, MBA
Associate Director, Research Safety BSL-3
Environmental Health & Safety
National Emerging Infectious Disease Laboratory
Boston University
Boston, MA 02215

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
Nashville, TN 37232

EGAN, Christina, PhD
Deputy Director, Division of Infectious Disease and
Chief, Biodefense and Mycology Laboratories
Wadsworth Center
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
President
Vaccine Dynamics
Easton, MD 21601

Members

HAYNES, Karmella, PhD
Associate Professor
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
Knowledge Enterprise
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

LOUISSAINT, Nicolette, PhD, MBA
Senior Vice President of Policy and Strategic Planning
Healthcare Distribution Alliance
Arlington, VA 22203

MADAD, Syra, 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

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.

Webcasts

(teleconference meeting only)

Agenda

Additional Materials

For 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.

Working Group Roster

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:

  1. 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;
  2. Reevaluate the DURC definition, considering advances in life sciences research and convergence with other scientific disciplines and sectors;
  3. 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
  4. 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:

  1. 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.

Working Group Roster

  • 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.

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).

Please click here for information on current and recent NSABB tasks.

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:

  • Executive Office of the President
  • Department of Health and Human Services
  • Department of Energy
  • Department of Homeland Security
  • Department of Veterans Affairs
  • Department of Defense
  • Department of the Interior
  • Environmental Protection Agency
  • Department of Agriculture
  • National Science Foundation
  • Department of Justice
  • Department of State
  • Department of Commerce
  • National Aeronautics and Space Administration
  • Intelligence Community
  • Others as appropriate

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:

  • Criteria for identifying dual use research and guidance for the responsible oversight, conduct and communication of dual use research
  • Biosecurity concerns related to the synthesis of select agents
  • A strategic plan for outreach and education on dual use research issues
  • Strategies for enhancing personnel reliability among individuals with access to select agents
  • Biosecurity concerns related to synthetic biology
  • Recommendations for the evaluation and oversight of proposed gain-of-function research

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.