National Science Advisory Board for Biosecurity (NSABB)

Charter

NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY

AUTHORITY

Required by 42 U.S.C. 283r, section 404O 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. §§ 1001-1014).

OBJECTIVES AND SCOPE OF ACTIVITIES

The NSABB will provide technical advice, guidance, or recommendations to relevant Federal departments and agencies related to biosafety and biosecurity oversight of biomedical research.

DESCRIPTION OF DUTIES

The NSABB shall provide technical advice, guidance, or recommendations, to relevant Federal departments and agencies related to biosafety and biosecurity oversight of biomedical research, including — (1) oversight of federally-conducted or federally-supported dual use biomedical research, such as the review of policies or frameworks used to assess and appropriately manage safety and security risks associated with such research, taking into consideration national security concerns, the potential benefits of such research, considerations related to the research community, transparency, and public availability of information, and international research collaboration; and (2) pursuant to section 205 of the PAHPA, when requested by the Secretary of Health and Human Services (Secretary) (a) a core curriculum and training requirements for workers in maximum containment biological laboratories; and (b) periodic evaluations of maximum containment biological laboratory capacity nationwide and assessments of the future need for increased laboratory capacity. The NSABB will also address other issues related to biosafety and biosecurity oversight of biomedical research as directed by the Secretary.

In carrying out the duties above, the NSABB may consider strategies to improve the safety and security of biomedical research, including through — (1) leveraging or using new technologies and scientific advancements to reduce safety and security risks associated with such research and improve containment of pathogens; and (2) outreach to, and education and training of, researchers, laboratory personnel, and other appropriate individuals with respect to safety and security risks associated with such research and mitigation of such risks.

AGENCY OR OFFICIAL TO WHOM THE COMMITTEE REPORTS

The NSABB will advise the Secretary and the Director of the National Institutes of Health (NIH), along with relevant Federal department and agencies, consistent with the duties as set forth in the above section.

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 $147,127. The estimated annual person-years of staff support required is 0.2, at an estimated cost of $43,539.

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 NSABB and subcommittee/working group meetings, prepare and approve all meeting agendas, attend all NSABB and subcommittee/working group 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 to be convened on an as-needed basis, at the call of the DFO. Meetings will be open to the public except as determined by the 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) that 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. 552b(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 charter for the National Science Advisory Board for Biosecurity will terminate two years from the date the charter is filed.

MEMBERSHIP AND DESIGNATION

The NSABB shall be composed of not more than 25 voting members, including the Chair, appointed by the Secretary, with expertise in biology, infectious diseases, public health, ethics, national security, and other fields, as the Secretary determines appropriate.

Other fields of expertise may also include but are not limited to:

• Molecular Biology/Genomics
• Microbiology (Bacteriology)
• Microbiology (Virology)
• Clinical Infectious Diseases/Diagnostics
• Institutional and/or Laboratory Biosafety and Biosecurity
• Epidemiology
• Health Physicist/Radiation Safety
• Pharmaceutical Production
• Veterinary Medicine
• Plant Health
• Food Production
• Military Biodefense Programs and Military Medicine
• Intelligence
• Biodefense
• Law
• Law Enforcement
• Academia
• Scientific Publishing
• Export Controls
• Industry Perspective
• Public Perspective

Voting members must be eligible to 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. The Secretary will designate the Chair. Appointed members will be invited to serve for overlapping terms of up to four years. An appointed member may serve after the expiration of that member’s term until a successor has been appointed.

Non-voting ex officio members, including at least one representative of each of the following: (i) The Department of Health and Human Services; (ii) The Department of Defense; (iii) The Department of Agriculture; (iv) The Department of Homeland Security; (v) The Department of Energy; (vi) The Department of State; (vii) The Office of Science and Technology Policy; and (viii) The Office of the Director of National Intelligence.

Representatives of such other Federal departments or agencies as the Secretary determines appropriate to carry out NSABB’s duties.

A quorum for the NSABB will consist of a majority of the appointed members eligible to vote. The non-voting ex officio members 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 working groups may be established by the DFO to perform functions within the Committee’s jurisdiction. The advice/recommendations of the subcommittee/working group must be deliberated by the parent advisory committee. A subcommittee/working group 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. The nonvoting ex officio subcommittee members will not be counted in calculating a quorum. 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 Departmental 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, 2024

APPROVED

By Xavier Becerra, Secretary, HHS.

Signed on April 4, 2024

Roster of Voting Members

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, Environmental Health & Safety
Ginkgo Bioworks
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

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

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

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

Meetings

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
• Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function Research
  Published Date: May 2016
• Framework for Conducting Risk and Benefit Assessments of Gain-of-Function Research
  Published Date: May 2015
• Guidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility
  Published Date: September 2011
• Strategies to Educate Amateur Biologists and Scientists in Non-life Science Disciplines About Dual Use Research
  Published Date: June 2011
• Addressing Biosecurity Concerns Related to Synthetic Biology
  Published Date: April 2010
• Enhancing Responsible Science: Development of Codes of Conduct for Dual Use Research
  Published Date: March 2010
• Enhancing Personnel Reliability Among Individuals with Access to Select Agents
  Published Date: May 2009
• Strategic Plan for Outreach and Education on Dual Use Research Issues
  Published Date: December 2008
• Proposed Framework for the Oversight of Dual Use Life Sciences Research
  Published Date: June 2007
• Addressing Biosecurity Concerns Related to the Synthesis of Select Agents
  Published Date: December 2006

Additional Activities

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.