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| Does the Government have a timeframe or dates in mind for the initial meeting or any of the other listed events? |
| Spring 2023. Tentative dates will be provided to the contractor after award at regular intervals as soon as they are determined to give the contractor time to plan. |
| 2 |
| Is leveraging subcontractor personnel permissible? |
| Yes |
| 3 |
| Can we confirm that no personnel under this contract will be badged or require an FDA Network account for this effort? |
| Yes |
| 4 |
| Would the Government prefer to have preparation for meetings listed as a separate line item or included in the three-day price? |
| Include in the price, not a separate line item |
| 5 |
| Will the COR be the primary POC or will there be another POC to work with vendors? |
| The COR will be the primary POC overall, followed by the Designated Federal Officer assigned to each advisory committee meeting. |
| 6 |
| Would the Government be willing to review and consider a revised set of assumptions that accounts for escalation/inflation over time? |
| The Government would be willing to review assumptions for option years over time. |
| Can the government please provide a current list of all meeting dates? |
| Spring 2023. Tentative dates will be provided to the contractor after award at regular intervals as soon as they are determined to give the contractor time to plan. |
The SOW states that all Contractor personnel are expected to routinely respond promptly, professionally, and courteously to requests for service assistance.
Will there be a separate FFP or T&M Clin for requests for service assistance?
No separate clin. This was a general statement about the contractor needing to be responsive to emails and act professionally during public meetings.
| Can the Government define in detail requests for service assistance? |
| The request for service is when the COR or DFO informs the contractor of a meeting date and wants to start planning for the meeting, followed by additional communications about the meeting. |
The pricing table only has FFP pricing per meeting.
Will there be a separate Clin for additional meeting coordination, ad-hoc meetings, and additional dry-runs?
How many meeting dry runs/walkthroughs (virtually) are expected per meeting?
No, there should not be a separate Clin.
Virtual training and dry-run (approximately 8 hours) to be held over approximately 1-2 days within a week of the planned meeting day for both one and two day virtual meetings.
| How many off-site locations are planned for Base Year and option year? and are the offsite locations 2-day meetings? |
| Not known at this time, more information may be given at time of award. |
| What voting systems are now used or expected for FDA CBER in-person, off-site, and virtual meetings; other than Adobe Connect Polling? |
| Zoom poll for virtual meetings, voting microphones for in-person meetings |
| What AV equipment will the FDA Great Room location provide? |
| FDA Great Room can provide HDMI cables to connect laptops to the projectors in the Great Room if needed. The Great Room also has push-to-talk table microphones that can be used for meetings, however please note that these are not voting microphones. |
What AV equipment will off-site locations provide?
Contractor will need to provide all needed off site AV equipment.
| What off-site locations has CBER used for past meetings? |
| Tommy Douglas Conference Center, Silver Spring, MD and hotels near FDA White Oak Campus, Silver Spring, MD |
| 16 |
| Note about shorter Timeline. This may require additional resources. Will CBER allow for additional T&M Clin for billing shorter timeline requests since meetings in the pricing guide are FFP? |
| No |
| 17 |
| Will FDA CBER badge, provide FDA laptop, and FDA network access to contractor resources assigned to meetings? |
| Contractor will get a visitor badge for on-site meetings at FDA White Oak Campus, Silver Spring, MD. Contractor will not be provided a laptop and should provide their own. Contractor will not be provided access to FDA network, however, they will be able to connect to public internet for meeting purposes in the Great Room. |
