Current January 2006
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.
For additional information, please contact the Office of Special Health Issues
at oshi@oc.fda.gov or telephone 301.827.4460.
Patient Involvement Index
