FINAL_QA_for_Pre_Solicitation_call_-_Jan_23_2018.pdf

Q&A from Pre-Proposal Call on 1/23/18

Contract & Invoicing

1. Please clarify billing -- will we no longer invoice fixed cost and will need to send receipts for everything again?

FDA Response: These contracts will be cost-reimbursement-type contracts. Under a cost-reimbursement structure, the contractor incurs the initial costs and the allowable expenses are then reimbursed by the government. These contracts establish a cost ceiling that the contractor may not exceed. Labor hours incurred must be for work performed in support of the contract to be eligible for payment. Any work performed for the state or any other program cannot be charged to this contract.

All supplies, equipment, and training must directly support contract work. All costs incurred must have supporting documentation, to include receipts and timesheets to support charges.

2. Under the FDA-directed inspections, will follow-up inspections still consist of two parts?

FDA Response: Generally, there are two types of FDA-directed inspections. FDA may request that both types of assignments be conducted within a short timeframe of each other at a retail outlet.

Additionally, these contracts will be cost-reimbursement-type contracts. As such, contractors will not bill FDA a fixed price per inspection. Instead, the contractor will invoice FDA for allowable expenses incurred while performing the contracted work.

3. How do you suggest we best budget for PC and BPC travel? Do we just add one trip to DC for the 5-year period or 2? And at least 1 trip out of state for laptop refresh/problems?

FDA Response: The in-person training in the Washington, DC, area is currently planned to be held every three years. As such, we anticipate that these trainings will occur in 2020 and 2023. Similarly, laptop refreshes are scheduled every three years. The timing of these trips will depend on the warranty expiration for each machine. For new PCs/BPCs, two trips to the nearest FDA field office are typically needed to complete background check requirements and receive the laptop and PIV card. Contractors should budget enough flexibility to allow for more than the minimum amount of travel.

Inspections

4. Can we request "abbreviated inspections" to determine what establishments are selling tobacco products?

FDA Response: FDA will have a standard FDA Directed/Complaint Follow-up A&L inspection to address establishments of concern.

5. Are the inspection numbers provided in the RFP for our state negotiable?

FDA Response: The number of Contractor Directed UB inspections are negotiable, as long as they are within the requirements of the contract. Offerors proposing different inspection numbers must include a justification in their proposals with support for the numbers proposed by the state/jurisdiction.

6. If we cannot conduct an A&L inspection how are we to determine if an establishment sells since we do not have a tobacco license?

FDA Response: Please refer to the section of the solicitation regarding updating the retailer list. By maintaining an updated retailer list, per the contract requirements, it will provide an opportunity to conduct inspections of new retailers that sell regulated tobacco products.

Program Management

7. Does the PC need to be funded at 40 hours per week for this project?

FDA Response: The PC should be available for communicating with FDA for the 40-hour work week. If an Offeror wishes to propose that the PC be funded at less than full time, the proposal must address how the PC will be available for the full 40 hours per week.

8. Isn't minor training now done by MIT rather than LMS?

FDA Response: Yes. MIT, not LMS, is the current source for minor training.

9. Will you plan on subpoenaing past inspectors that have left the program that we no longer can control if they plan to attend hearings and re-hearings?

FDA Response: FDA may need inspectors to testify for a hearing after they have left employment with the contracting agency. Inspectors should be made aware of the requirement to testify both during and after employment as an FDA inspector. FDA will contact inspectors to obtain their availability for hearing and will attempt to schedule hearings accordingly whenever possible. I

10. Just to clarify one more time. Our PC is a full time employee with the organization and available 40 hours per week but splits time between FDA and Synar. Is that no longer allowed?

FDA Response: The Program Coordinator shall be available at all times within the 40-hour work week to communicate with the FDA. In the event, the PC is not available, the Contractor shall designate a back/alternate PC to provide a response to FDA within the timeframe identified in the solicitation. . If an Offeror wishes to propose that the PC be funded by FDA at less than full time, the proposal must address how the PC will be available to communicate with FDA for the full 40 hours per week.

11. Because of time difference in the CNMI, will FDA conduct hearing that would be convenient in the event an inspector is required to testify?

FDA Response: FDA will work with the court and the PC to attempt to schedule the hearing at a time that will be convenient for the inspector.

12. As a follow up, their current jobs may not allow them to testify without a subpoena if these hearings are in the 9-5 working hours.

FDA Response: FDA typically schedules its hearings with significant lead time, which should provide ample opportunity for inspectors to adjust their schedules accordingly and make themselves available to testify, as required by the contract. Upon request, FDA can provide the PC with court documentation regarding the hearing to support inspectors in requests for schedule adjustments.

Other Questions

1. Will there be an opportunity to have another call with each individual state to further clarify some issues we are not able to further explain on this call?

FDA Response: No additional call will be held. Questions should be directed in writing to Madeline Bryant, the POC for this solicitation.

2. Feb 19 is a federal holiday.

FDA Response: The solicitation will be amended to change the proposal due date to Tuesday, February 20th.