Feedback

h. Method for Feedback

You should specify how you prefer FDA to provide the feedback you are seeking. You may request our feedback through an in-person meeting, a teleconference, facsimile, or by email. Please note that FDA will ultimately decide the means of communicating the feedback, but will consider the desired method requested in the Pre-Sub. If FDA has already agreed to a meeting, it is the sponsor’s decision regarding whether this previously scheduled meeting should occur even if FDA has provided a written response to the sponsor’s questions. If we provide feedback through a meeting or teleconference, the final meeting minutes will be considered FDA’s formal written feedback (see Section IV.D. below).

If you are requesting a meeting or teleconference as the method for feedback, your submission should include:

• the meeting format you are requesting (i.e., in-person or by teleconference);
• three (3) or more preferred dates and times when you are available to meet using the guidelines in Table 1 above for scheduling;
• the planned attendees, including each attendee’s position, or title, and affiliation. If you have not yet identified all of your attendees, you should indicate the type of subject matter experts you plan to invite so that we can ensure appropriate FDA experts are in attendance. Please note foreign visitors meeting in an FDA facility require advanced security clearance. See Section IV. B. “Security Screening” below for additional information on how to request security clearance for Foreign Nationals; and
• a list of any audiovisual equipment you will need, such as conference phone or LCD projector.

You should propose the duration of the meeting you are requesting. In our experience, one (1) hour is adequate for most meetings. If you believe that more than one (1) hour is needed, please provide a rationale for the duration you propose. You should also refer to the rationale and confirm the duration requested when the division contact person schedules your meeting.

We recommend that your agenda allocate the last ten (10) minutes of the meeting for summarizing the discussions and any next steps or action items.