Questions_Responses_2.pdf

Questions-Responses

Contract & Invoicing

1. Currently in our state, Project Management and inspection activities are performed under subcontract on a unit rate per type of service delivered (UB inspection, A&L inspection, administration, etc.). Can the state continue this method of payment under the new solicitation?

FDA Response: As this contract is a cost reimbursement, the State (Prime contractor) will submit their invoices in accordance with the terms and conditions of the contract. The type of subcontract used is at the discretion of the contractor, however, if a fixed price (unit rate) contract is used, supporting documentation (same as primes contractor) regarding the rates and subcontracting cost must be provided as part of the business proposal, for evaluation by FDA.

2. If we are required to include an explanation for all subcontractor costs – rate per hours for inspectors, chaperones, minors, Project Manager, Backup Program Manager, administrative assistants, estimated cost per tobacco product purchased, etc., what format should be used to record these costs? Also, will these costs need to be invoiced separately in a line item invoice by month or per each inspection?

FDA Response: For the submission of the proposal, the subcontractor costs shall be submitted the same as the contractor in accordance with section L.5 (A) Cost or Pricing Data of the RFP.

Subcontractor supporting documentation requirements are required the same as the prime. The format (Attachment 4) shall be used. For submission of invoices, the cost reimbursement invoice form (Attachment 6) shall be used. Please refer to section G.3 Invoice Instructions that explains how costs need to be invoiced. The Contractor’s monthly invoice must be submitted in a format showing expenditures for that period, as well as cumulative amounts for each contract period of performance. Detailed supporting documentation must be submitted as an attachment.

3. What supporting documentation is required for subcontracted entities? Do receipts for gas/rental cars/tobacco purchased during an inspection, staff time sheets, etc. need to be attached to each invoice?

FDA Response: As this is a cost reimbursement contract, the Contractor shall maintain documentation (receipts/invoices) to substantiate costs incurred for the invoice reporting period. Copies of such documentation shall be submitted with the invoice.

4. If we are changing the job classifications of inspectors and program management, we will not have the pay stub documentation requested. Can we substitute this with the documentation with new hires? If not, how would do we go about documenting this?

FDA Response: For the purpose of commissioning an individual as an FDA-inspector, supporting evidence that the individual is an employee of the state can be provided through a pay stub, payroll documentation through Human Resources or through a clear demonstration that the individual has been offered and accepted a position with the state.

5. If leasing state vehicles, where is this included? Under direct costs?

FDA Response: Yes, leased vehicles would be a direct cost.

6. Does the FDA have guidelines for providing bonuses for contracted employees if the money is available in the contract?

FDA Response: Under a cost reimbursement contract, all expenses must be directly related to cost incurred through providing the deliverables required in the contract, as such, payment of bonuses is not a reimbursable expense.

7. When a new employee/agent comes on board but has not been issued his or her Fed credentials but reaches that point when they are authorized to conduct the mandatory Fed computer training that is a mandatory step in becoming authorized to conduct operations on their own, Is that work time reimbursable?

FDA Response: Yes, time spent on FDA-required training is reimbursable.

Inspections

8. Can A&Ls be negotiated for states with no tobacco licenses to assist us with determining who sells tobacco products?

FDA Response: No. There will not be any contractor directed A&L assignments under this contract. If a State has concerns about a specific establishment, FDA may issue an FDA directed A&L inspection for the establishment. Additionally, refer to the section of the solicitation regarding maintaining and updating the retailer list. The process of updating the retailer list will provide an opportunity add establishments that may sell regulated tobacco products.

9. If we cannot have contractor directed A&Ls how are we determine who sells without a tobacco license?

FDA Response: See response to Question 9 above.

10. Can we negotiate the inspection number proposed to add additional contractor directed inspections per year?

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.

11. If an individual (program staff member) has multiple roles in TIMS (Program Coordinator, assignment coordinator, state read only, and/or state inspector), during the upcoming 2018 RFP would the individual have to maintain regular performance of inspections (minimum of 10) in order to remain active and/or be considered an inspector, or would they have to return FDA iPhone, credentials but still have access to assignment coordinator, etc.?

FDA Response: The 10 inspection monthly minimum does not apply to the PC or BPC. Other administrative staff who are not expected to conduct inspections should not hold commissions.

The Contractor should return iPhones and credentials for staff who are not expected to conduct inspections under this contract.

12. Does the minimum inspection requirement apply to program management that also hold pocket credentials?

FDA Response: See response to Question 12 above.

13. Will there be a change in the breakdown of what tobacco products are purchased under the new contract?

FDA Response: Products purchased will continue to include all regulated tobacco products.

Program Management

14. In determining travel distance and time, will laptop refreshes take place at the nearest field office or at the Washington DC facility where refreshes are currently being done? In addition, how many days should be planned to complete the refresh process?

FDA Response: Laptop refreshes will take place at the FDA field office closest to the Contractor’s normal place of business. The refresh process requires one visit to the FDA field office.