2015-31238. Office of the Director, Office of Science Policy, Office of Biotechnology Activities; Notice of Meeting

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the meeting of the National Science Advisory Board for Biosecurity (NSABB).

Name of Committee: National Science Advisory Board for Biosecurity.

Date: January 7-8, 2016.

Time: January 7, 2016, 8:30 a.m.-5:30 p.m. Eastern; January 8, 2016, 8:30 a.m. to adjournment.

Agenda: Presentations and discussions regarding: (1) Preliminary findings of the NSABB Working Group on Evaluating the Risks and Benefits of Gain-of-Function (GOF) Studies; (2) the results of the risk-benefit assessment of GOF studies involving pathogens with pandemic potential; (3) ethical and policy issues relevant to the conduct and oversight of GOF studies; and (4) other business of the Board.

Place: National Institutes of Health, Bldg. 31, C Wing, 6th Floor, Conference Room 6, 9000 Rockville Pike, Bethesda, MD 20892.

Contact Person: Christopher Viggiani, Ph.D., Executive Director, NSABB, NIH Office of Science Policy, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892, [phone], [e-mail].

Under authority 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services established the National Science Advisory Board for Biosecurity (NSABB) to provide advice regarding federal oversight of dual use research—defined as legitimate biological research that generates information and technologies that could be misused to pose a biological threat to public health and/or national security. The NSABB is currently charged with providing formal recommendations to the United States Government on a conceptual approach for the evaluation of proposed gain-of-function studies.

The meeting will be open to the public and will also be webcast as space will be limited. Persons planning to attend or view via the webcast may pre-register online using the link provided below or by calling Palladian Partners, Inc. (Contact: Ida Donner at 301-650-8660). Online and telephone registration will close at 12:00 p.m. Eastern on January 4, 2016. After that time, attendees may register onsite on the day of the meeting. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should indicate these requirements upon registration on or prior to January 4.

Meeting materials: The meeting agenda and links to the online registration and webcast will be available at: http://osp.od.nih.gov/​office-biotechnology-activities/​biosecurity/​nsabb/​nsabb-meetings-and-conferences. Preliminary findings of the NSABB working group as well as the results of the risk-benefit assessment, performed by Gryphon Scientific, will be posted prior to the meeting. Please check this Web site for updates.

Public Comments: Many presentations and panel discussions at the meeting will be accompanied by question and answer periods that are open to members of the public, time permitting. In addition, there will also be time allotted on the agenda for the presentation of public comments. Members of the public interested in presenting prepared comments relevant to the mission of the NSABB should indicate so upon registration. Sign-up for delivering prepared oral comments will be limited to one per person or organization representative per open comment period. Individual presentations will be time-limited to facilitate broad participation from multiple speakers. Participants viewing the meeting by webcast may submit questions and comments during the meeting via email sent to [e-mail]. While time constraints and the volume of questions may not allow for all questions and comments submitted via email to be aired during the meeting, all relevant correspondence received will be relayed to the Board. Emailed correspondence should include the name, contact information, and when applicable, professional affiliation of the sender.

In addition, interested persons may file written comments at any time with the Board via an email sent to [e-mail] or by regular mail sent to the Contact Person listed on this notice. Written statements should include the name, contact information, and when applicable, the professional affiliation of the interested person. Written comments received by 5:00 p.m. Eastern on December 31, 2015, will be relayed to the Board prior to the NSABB meeting. Any written comments received after this deadline will be provided to the Board either before or after the meeting, depending on the volume of comments received and the time required to process them in accordance with privacy regulations and other applicable Federal policies.

Please Note:

In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxis, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Please visit the NIH Visitor Security page for important security and campus access information.

Dated: December 8, 2015.

David Clary,

Program Analyst, Office of Federal Advisory Committee Policy.