Advisory Committee Meeting | Virtual
Event Title
Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement
June 5, 2024
- Date:
- June 5, 2024
- Time:
- 8:30 AM - 4:30 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.
Please note that all meeting participants will be joining this advisory committee meeting through an online teleconferencing and/or video conferencing platform.
How to Attend:
- 6/5/2024
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.
Agenda
On June 5, 2024, the committee will meet in open session to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.
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 on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at the Advisory Committee calendar.
Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Public Participation Information
FDA issued a Federal Register Notice with details of 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 FDA’s website at the Advisory Committee calendar and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website 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).
FDA established a docket for public comment on this meeting. The docket number is FDA–2024–N–0970 and instruction on submitting written comments by the public was provided in the Federal Register Notice.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Eastern Time. 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, along with their names, email addresses, and direct contact phone numbers of proposed participants, and an indication of the approximate time requested to make their presentation on or before 12 p.m. Eastern Time on May 1, 2024. 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 notified interested persons regarding their request to speak by 6 p.m. Eastern Time May 3, 2024.
Contact Information
- Kathleen Hayes or Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, CBERVRBPAC@fda.hhs.gov
- FDA Advisory Committee Information Line:
1-800-741-8138 (301-443-0572, Washington, DC area). - For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.
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).