Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting
The Food and Drug Administration encourages participation from the public during the public hearing portion of FDA advisory committee meetings. A specific time allotment is scheduled at each of these meeting, so that individuals may have an opportunity to express their views.
If you wish to speak, please observe the following guidelines:
- Submit your wish to participate orally or in writing by providing your name, address and telephone number to the designated FDA staff person listed in the Federal Register notice announcing the advisory committee meeting. In addition, state the general nature of the presentation and the approximate time desired. If you are speaking on behalf of an organization or group, please include the name and a brief description. Also, if you are a member of a group which will have more than one presenter, please list each presenter's name, address and telephone number. This notification may be submitted by FAX or telephone and should be received by FDA not later than the deadline listed in the Federal Register notice announcing the advisory committee meeting. FDA staff will make every effort to accommodate requests to speak from individuals received after the deadline listed in the Federal Register notice. However, this may not always be possible and will depend upon the number of requests to speak.
- Submit a copy of all written information to be discussed during the meeting in advance to the designated FDA staff person; this material may be distributed or mailed by FDA to the committee. [According to the regulation, the mailing or distribution may be undertaken only by FDA unless FDA grants permission to a person to mail or distribute the material.]
- Once FDA receives the requests to speak, a time allocation for each speaker will be assigned. The time allotted to each speaker will depend upon the number of requests received. The FDA staff will contact the speakers, by FAX or telephone, to confirm their participation, inform each speaker of the time that has been allotted for his/her presentation, and answer questions.
- Specify the amount of time your presentation will require. FDA regulations permit FDA staff to ask speakers with similar viewpoints to consolidate their presentations.
- Incorporate into your presentation an explanation of your financial association, if any with the company whose drug, device, or biologic is being considered by the FDA advisory committee. If for example, a company has paid your transportation or other expenses to appear at the meeting or your organization receives funding from this company, this should be disclosed in your comments.
- Prepare paper copies (20) of slides or overheads you plan to use. The copies will be distributed during the meeting to members of the FDA Advisory Committee and incorporated into the permanent meeting record.
Please contact the designated FDA staff person if you cannot attend the open public hearing during the time scheduled and would still like to make a presentation, of if you arrive late to the meeting. In either case, it may be possible to arrange for you to speak at another time during the meeting, to have your statement read by a representative, or to have your complete or summarized statement included in the record. However, once the public hearing portion of the meeting has ended, further oral comments from the pubic will be accepted only if time permits and at the discretion of the FDA advisory committee chair.
Some Tips on Speaking at the Open Public Hearing
- If the FDA staff anticipates a large audience, reserved seats will be set aside for speakers at the open public hearing. Please check with FDA staff at the registration table to introduce yourself and to see if reserved seating has been set aside for you. If not, you are welcome to sit wherever you choose. The FDA executive secretary may be coordinating many last minute details and may only have a few minutes to greet you. However, there will be FDA staff available to welcome you and answer your questions.
- When your name is called to speak, you usually have a choice about where to deliver your remarks. There are usually three microphone choices:
- a podium microphone in the front of the meeting room
- a lapel microphone, also on the podium at the front of the room, and
- an audience microphone, located on the floor in the middle of the isle.
- If you speak from the podium, there may be a three-light system to assist you in keeping track of your time allotment. The green light comes on when you begin. The yellow light comes on near the end of your time and the red light appears when your time has expired. If you speak from the audience microphone, the FDA executive secretary will remind you when your time allotment is close to expiring.
- When you have completed your statement, the FDA advisory committee members may ask you questions. Please remain at the microphone until the questioning is completed.