Novel and Exceptional Technology and Research Advisory Committee (NExTRAC)

Charter

AUTHORITY

Authorized by 42 U.S.C. 282(b)(16), section 402(b)(16) of the Public Health Service (PHS) Act, as amended. The Novel and Exceptional Technology and Research Advisory Committee (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 Committee will provide advice to the Director, National Institutes of Health (NIH), on matters related to the conduct and oversight of research involving emerging technologies in biomedical science (also referred to as emerging biotechnologies).

DESCRIPTION OF DUTIES

The Committee makes recommendations on research involving the use of, and developments in, emerging biotechnologies. The Committee will address scientific, safety, ethical, and social issues associated with areas of emerging biotechnology research for which the NIH requests advice or guidance.

As necessary, and with the approval of the Designated Federal Officer (DFO), the Committee and its subcommittees may call upon special consultants, assemble ad hoc working groups, and convene conferences, workshops, and other activities.

AGENCY OR OFFICIAL TO WHOM THE COMMITTEE REPORTS

The Committee will advise, consult with, and make recommendations to the Director, NIH.

SUPPORT

Management and support services will be provided by the Office of Science Policy (OSP).

ESTIMATED ANNUAL OPERATING COST AND STAFF YEARS

The estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support, is $142,901. The estimated annual person-years of staff support is 0.7 at an estimated annual cost of $131,445.

DESIGNATED FEDERAL OFFICER

The Director, OSP, will assign a full-time or permanent part-time OSP employee as the Designated Federal Officer (DFO) of the Committee. In the event that the DFO cannot fulfill the assigned duties of the Committee, one or more full-time or permanent part-time OSP or NIH employees will be assigned as DFO and carry out these duties on a temporary basis.

The DFO will approve or call all of the Committee’s and subcommittees’ meetings, prepare and approve all meeting agendas, attend all Committee and subcommittee meetings, adjourn any meeting when it is determined to be in the public interest, and chair meetings when directed to do so by the Director, NIH or the Director, OSP.

ESTIMATED NUMBER AND FREQUENCY OF MEETINGS

Meetings of the full Committee will be held approximately 2 times within a fiscal year and as requested by the DFO. Meetings will be open to the public except as determined otherwise by the Secretary in accordance with subsection (c) of section 552b of Title 5 U.S.C. 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, a report 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. A copy of the report will be provided to the Department Committee Management Officer.

DURATION

Continuing.

TERMINATION

Unless renewed by appropriate action, the Novel and Exceptional Technology and Research Advisory Committee will terminate two years from the date the charter is filed.

MEMBERSHIP AND DESIGNATION

The Committee will consist of up to 25 voting members, including the Chair, appointed by the Director, NIH. A majority of the voting appointed members must be knowledgeable in relevant emerging scientific fields (e.g., gene therapy, gene editing, synthetic biology). As needed, the Committee may include persons knowledgeable in fields such as public health, laboratory safety, occupational health, protection of human participants in research, the environment, ethics, law, public attitudes or related fields. All appointed members must be eligible to serve as and will serve as Special Government Employees.

Appointed members will be invited to serve for overlapping four-year terms. A member may serve after the expiration of that member’s term until a successor has taken office. A quorum for the conduct of business by the full Committee will consist of a majority of currently appointed members.

SUBCOMMITTEES

As necessary, subcommittees and ad hoc working groups may be established by the DFO within the Committee’s jurisdiction. The advice/recommendations of a 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. 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 the Freedom of Information Act, 5 U.S.C. 552.

FILING DATE

June 30, 2021

APPROVED

By Lawrence A. Tabak, D.D.S., Ph.D., Acting Director, NIH

Signed on June 7, 2021

Members

Chair

BLOSS, Cinnamon, PhD
Professor
Herbert Wertheim School of Public Health and
Human Longevity Science
University of California, San Diego
La Jolla, CA 92093

Members

ADELMAN, Zach N., PhD
Professor and Presidential Impact Fellow
Department of Entomology
Texas A&M University
College Station, TX 77843

ALBRITTON, Lorraine M., PhD
Professor Emeritus
Department of Microbiology, Immunology, and
Biochemistry
College of Medicine
The University of Tennessee Health Science Center
Memphis, TN 38163

BORIS-LAWRIE, Kathleen, PhD
Professor
Department of Veterinary and Biomedical Sciences
University of Minnesota
Saint Paul, MN 55108

GRONVALL, Gigi Kwik, PhD
Associate Professor
Department of Environmental Health and Engineering
Johns Hopkins Bloomberg School of Public Health
Baltimore, MD 21202

LEE, Benhur, MD
Professor
Department of Microbiology
Ward-Coleman Chair in Microbiology
Icahn School of Medicine at Mount Sinai
New York, NY 10029

LESHNER, Alan I., PhD
Chief Executive Officer, Emeritus
American Association for the Advancement of Science
Potomac, MD 20854

LEWIS-HALL, Freda C., MD, DFAPA
Former Executive Vice President
Pfizer Inc.
New York, NY 10017

OSSORIO, Pilar N., PhD, JD
Professor of Law and Bioethics
University of Wisconsin
Madison, WI 53706

OYE, Kenneth, PhD
Professor, Political Science and Data, Systems and Society
Director, Program on Emerging Technologies
Center for International Studies
Massachusetts Institute of Technology
Cambridge, Massachusetts 02139

PORTEUS, Matthew, MD, PhD
Professor of Pediatrics (Pediatric Stem Cell Transplantation)
Department of Pediatrics
Stanford Medical School
Stanford University
Stanford, CA 94305

RILEY, Margaret F., JD
Professor, School of Law
Professor of Public Health Science
School of Medicine
Professor of Public Policy
Batten School of Leadership and Public Policy
University of Virginia
Charlottesville VA 22903

TURNER, Leigh, PhD
Professor, Health, Society & Behavior
Program in Public Health
University of California
Irvine, CA 92697

Incoming Members

BIRNBAUM, Angela C., MPH
Director, Office of Biosafety
Director of Containment Operations and Quality Assurance
Tulane University
New Orleans, LA 70118

CALLIER, Shawneequa, JD
Associate Professor of Clinical Research and Leadership
School of Medicine and Health Sciences
George Washington University
Special Volunteer, National Human Genome Research Institute
Washington, DC 20037

HYUN, Insoo, PhD
Director,
Center for Life Sciences and Public Learning
Museum of Science
Bioethics Affiliate,
Center for Bioethics
Harvard Medical School
Boston, MA 02114

SAUNDERS, Kevin O., PhD
Associate Professor
Department of Surgery
Duke University
School of Medicine
Durham, NC 27710

Reports and Recommendations

• Gene Drives in Biomedical Research Report
  Published Date: September, 2021
• Report to Establish a NExTRAC Framework
  Published Date: December, 2020

Meetings

Working Group Activities