Prior to the sponsor meeting

• OTP will send the preliminary response according to the timeline indicated above in Table 4. 
• The sponsor is expected to respond to OTP’s preliminary responses according to the timeline indicated above in Table 4. 
• If the sponsor finds that OTP’s preliminary responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor should inform OTP in writing as soon as possible so that OTP may cancel the meeting. These responses would then become the official OTP responses to the sponsor’s questions.
  • If, after cancellation of the meeting, the sponsor subsequently wishes to follow-up on topics from the preliminary responses or pose new questions, then the sponsor should submit these follow-up or new questions as an IND amendment.
• If the sponsor wishes to continue with the meeting, the sponsor should identify which of the original questions in the briefing package they wish to discuss and list the questions in the proposed order of discussion. As a general rule, the order of discussion is usually the order of importance to the sponsor.  When referencing questions, the sponsor should use OTP’s preliminary responses document numbering format.
• After receiving OTP’s preliminary response, the sponsor should not submit new questions and new information (e.g., alternative approaches or new proposals to address OTP comments) not previously submitted in the original briefing package. OTP preliminary responses are prepared after deliberative review, and usually include cross‑discipline internal discussion, of the original meeting package and questions.  OTP will not have adequate time to review new material and have sufficient inter-discipline internal discussion necessary to prepare answers to new questions.  Therefore, sponsors should thoughtfully prepare their meeting package and questions. 
  • In some situations, a sponsor may want to develop new questions/alternative approaches in response to OTP’s preliminary responses or discussion at the meeting.  Such new questions/alternative approaches should be submitted as an amendment to the sponsor’s existing IND.

During the meeting

The meeting is the sponsor’s opportunity to obtain clarifications on OTP preliminary responses. As stated above, during the meeting the OTP team will not be able to provide feedback on new information (e.g., new question, alternative approaches or new proposals to address OTP comments) that was not previously submitted in the original briefing package.

Sponsors may choose to make a presentation at the beginning of the meeting. However, because OTP staff will be familiar with the meeting package content and questions, OTP recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTP’s preliminary responses to the sponsor’s questions.

OTP recommends that time be reserved at the end of the meeting for the sponsor to summarize the major discussion points and action items.

Meeting Minutes

OTP will issue meeting minutes within 30 calendar days after the meeting. OTP’s version of the meeting minutes is official and the final record of the meeting.  OTP minutes are not a meeting transcript, but focus on any clarifications (e.g., of unclear preliminary responses), agreements and disagreements, and action items as discussed during the meeting.

The sponsor may submit their version of the minutes to the file to summarize their understanding of issues discussed at the meeting. However, OTP may not review such submissions; therefore, the absence of an OTP response to such submissions does not imply OTP concurrence with the sponsor’s version of the minutes.

If sponsors disagree with the content of OTP’s minutes, OTP’s meeting minutes will not be altered except to correct a substantive mistake for the record (on extremely rare occasions).

Request for Clarification

To ensure the sponsor’s understanding of OTP feedback from meeting discussions or a WRO, sponsors may submit clarification questions to the Regulatory Project Manager (RPM) within 20 calendar days following receipt of meeting minutes or a WRO. OTP will consider the request for clarification, and if determined to be limited to a clarifying nature (i.e., to confirm something in minutes or a WRO issued by OTP, rather than raising new issues or new proposals), OTP will issue a response in writing within 20 calendar days after receipt of the clarifying questions. OTP’s response will reference the original meeting minutes or WRO.