Paperwork Reduction Act Statement:
OMB Control No. 0910-NEW
Expiration date:
According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-NEW. There is no time required to complete this information collection, since this data collection will consist of passive observations of existing or scheduled meetings. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to [email protected].
Teleconference Details |
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Date of Meeting |
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Meeting Start Time |
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Meeting End Time |
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Meeting Duration (in minutes) |
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Sponsor Name (i.e., company name) |
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Device Name |
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List of Other Organizations Present |
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List of Names, roles, and organization of meeting attendees |
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Observer Name |
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Amendment |
☐ Yes (Amendment Number: Click or tap here to enter text.) ☐ No |
Engagement with the TAP Pilot |
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Prompt |
Answer |
Observer Notes |
Did all intended participants join the meeting? |
☐ Yes ☐ No |
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Did participants introduce themselves when relevant? |
☐ Yes ☐ No |
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Were the goals or objectives of the meeting outlined from the beginning of the meeting? |
☐ Yes ☐ No ☐ N/A |
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Collaboration |
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Prompt |
Answer |
Observer Notes |
Did all team members participate in the discussion? |
☐ Yes ☐ No |
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Did team members ask questions? |
☐ Yes ☐ No ☐ N/A |
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Did attendees suggest options or opinions that differed from those around them? |
☐ Yes ☐ No |
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Did participants seem comfortable engaging in the discussion? |
☐ Yes ☐ No |
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Quantity and Quality of Interaction |
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Prompt |
Answer |
Observer Notes |
What type(s) of feedback were sought during the teleconference? |
☐ General Strategy ☐ Commercialization ☐ Device Development Plan ☐ Regulatory Requirements ☐ Stakeholder Engagement Plan ☐ Other |
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Was the feedback provided by the team constructive and actionable? |
☐ Yes ☐ No ☐ N/A |
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Were participants receptive to the feedback received? |
☐ Yes ☐ No ☐ N/A |
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Were there agreements or resolutions reached during the teleconference? |
☐ Yes ☐ No ☐ N/A |
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Program Submission Activities and Their Timeliness |
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Prompt |
Answer |
Observer Notes |
Did the teleconference start on time? |
☐ Yes ☐ No ☐ N/A |
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Did the teleconference end with clearly outlined next steps? |
☐ Yes ☐ No ☐ N/A |
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Was the teleconference documented in minutes? |
☐ Yes ☐ No ☐ N/A |
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File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Vath, Rachel * |
File Modified | 0000-00-00 |
File Created | 2024-07-21 |