Advisory Committee Meeting | Virtual
Event Title
Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting Announcement
October 2, 2020
- Date:
- October 2, 2020
- Time:
- 11:00 AM - 3:30 PM ET
What is an advisory committee?
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.
After the August 11, 2020 meeting announcement notice was published in the Federal Register the webcast links were changed. The new current webcast link with captioning is available at: http://fda.yorkcast.com/webcast/Play/748df6210489480a9b46cfe17e7161f01d
A direct link to only the captioning: https://www.captionedtext.com/client/event.aspx?EventID=4599813&Customer...
Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 2, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.
Meeting Materials
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the time of the advisory committee meeting, and additional materials will be posted on FDA's website after the meeting.
Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.
The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
- Written submissions may be made to the contact person on or before September 25, 2020.
- On October 2, 2020, oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. EST.
Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 17, 2020. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 18, 2020.
Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible.
The link for the webcast and captioning is available at: http://fda.yorkcast.com/webcast/Play/748df6210489480a9b46cfe17e7161f01d
Direct link to just the webcast captioning: https://www.captionedtext.com/client/event.aspx?EventID=4599813&Customer
Recorded Webcast
Contact Information
- Prabhakara Atreya, 240-506-4946, e-mail: Prabhakara.Atreya@fda.hhs.gov
or Monique Hill, 301-796-4620, e-mail: Monique.Hill@fda.hhs.gov - FDA Advisory Committee Information Line: 1-800-741-8138 (301-443-0572 in the Washington, DC area) Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the meetings main page or call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Prabhakara Atreya at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).