The Listening Session is scheduled! Now what? Patient Affairs Staff (PAS) will be in contact with you in the weeks leading up to the session. If you have any questions, don’t hesitate to call or email PAS! In the meantime, this page will help you prepare for the upcoming Listening Session.
Refine your agenda – Patient Affairs Staff (PAS) can help you develop an agenda for a successful Listening Session
- Identify the main messages you want to share with FDA
- Send your final agenda and any additional materials such as background documents and slide presentations to PAS at least 2 weeks before the Listening Session
Identify participants – Identify and confirm the attendance of participants from the patient community
- For in-person Listening Sessions, send PAS a list of attendees a week prior to the meeting
- Identify if any participants are not US citizens and notify PAS at least 3 weeks before the meeting
- Identify if any participants require special accommodations and notify PAS as soon as possible, but at least a week before the meeting
Plan your transportation to and from FDA – For in-person Listening Sessions, consider whether you will be dropped off at FDA, park in the visitor lot, or take public transportation.
FDA believes that the Agency and the public benefit from a transparent process to ensure that information is used to make well-informed decisions. If you have any financial interests related to this Listening Session topic, you are encouraged to share these interests in advance. Such interests may include:
- A company or group pays for your travel or other expenses.
- A medical product company gives you money for a grant.
If you do not have anything to share, you may wish to state that for our purposes. If you prefer not to share your financial interests at this time, you may still participate in the Listening Session.
10903 New Hampshire Avenue
Silver Spring, MD 20993
PAS will provide you with the building number prior to the Listening Session. PAS selects conference rooms that allow for a collaborative discussion between the patient community and FDA staff. If participating by teleconference, PAS will provide you will a phone number and meeting ID in advance.
Participants parking at FDA should arrive at the visitor parking lot an hour and 15 minutes before the start of the session. While driving to the lot, you will go through a vehicle security checkpoint.
Participants being dropped off at FDA should arrive an hour before the start of the session. You will be dropped off at Building 1.
Call, text, or email PAS to notify us of your arrival. Enter Building 1 and sign into the Visitor Management System. Be prepared to show a government-issued photo ID. You must undergo security procedures similar to those at the airport. Be prepared to remove your laptop and power cables from your bags.
PAS will meet you at security and escort to the meeting room. PAS will escort you during your entire visit at FDA.
PAS will open up the meeting and read a brief disclaimer. Then, you will lead the Listening Session according to your agenda. We recommend allowing 15 minutes at the end of the meeting for an open discussion. FDA may use this time to ask clarifying questions.
Things to remember during the Listening Session:
- FDA staff will listen and learn from you but may not be able to address your questions or concerns during the session
- If participating by phone, identify a quiet place to take the call and plan to join 15 minutes before the scheduled start time; when not speaking, put yourself on mute to eliminate background noise
- Listening Sessions are not recorded/transcribed and are not public meetings