2015-20815. 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: September 28, 2015.

Time: 8:30 a.m.-4:00 p.m. Eastern.

Agenda: Presentations and discussions regarding: (1) NSABB deliberations towards the development of draft recommendations on a conceptual approach to the evaluation of proposed gain-of-function (GOF) studies involving pathogens with pandemic potential; (2) progress report on the conduct of risk and benefit assessments of GOF studies; (3) ethical, legal, and policy issues relevant to the conduct and oversight of GOF studies; and (4) other business of the Board.

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

Contact Person: Carolyn Mosby, NSABB Program Assistant, NIH Office of Biotechnology Activities, 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 to 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: Maegen Currie at 301-650-8660). Online and telephone registration will close at 12:00 p.m. Eastern on September 25, 2015. 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 September 25.

Please Note: 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. Please check this Web site for updates.

Public Comments: Time will be allotted on the agenda for oral public comments. Any member of the public interested in presenting comments relevant to the mission of the NSABB should indicate so upon registration. Sign-up for oral comments will be limited to one per person or organization representative per comment period, with individual presentations time-limited to facilitate broad input from multiple speakers. In the event that time does not allow for all attendees interested in presenting oral comments to do so at the meeting, any interested person may file written comments with the Board via an email sent to [e-mail] or by regular mail sent to the Contact Person listed on this notice. In addition, any interested person may submit written comments to the NSABB at any time via either of these methods. Written statements should include the name, address, telephone number and when applicable, the professional affiliation of the interested person. Comments received by 5:00 p.m. Eastern on September 22, 2015 will be relayed to the Board prior to the NSABB meeting. Any written comments received after the 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: August 18, 2015.

David Clary,

Program Analyst, Office of Federal Advisory Committee Policy.