Questions_ _Answers__FDA-15-Tobacco-1143093.pdf

Questions & Answers for RFP#: FDA-15-Tobacco-1143093

1. Currently, detailed backup documentation is sent with each quarterly report. Since the contract will be negotiated up front for a fixed price for each inspection and documentation presented at that time, does the voluminous amount of backup documentation need to also be included in every monthly report?

This contract only requires supporting documentation for non-inspection related travel and training costs.

Please refer to section G.4, FDA Invoice Submission.

2. Since the deeming of e-cigarettes and alike is potentially going to be deemed a regulated product during this new contract, will contracts be reconfigured when this occurs? The regulation of these stores could potentially double workloads. Will the FDA allow for budget modifications when the Federal law changes soon?

Should FDA finalize regulations that deem additional categories of nicotine-containing products to be subject to FDA’s jurisdiction, FDA will undertake an assessment of the impact on a particular jurisdiction’s retail inspection contract. Because no final regulation has been issued, it is not possible to provide more specific guidance at this time.

3. In the proposal, page 8 sections C.1, the FDA identified the estimated number of retailers in each state. Where did this information come from and what does a State do if it is drastically incorrect? Does the FDA use this number to gauge a potential budget for each state?

FDA used information from its Tobacco Inspection Management System (TIMS) database to estimate the number of retailers in a particular state at the time it posted the solicitation. In its proposal, a state can indicate the number of tobacco retailers it is aware of and the source for its list and propose the cost to perform the requirements of the solicitation based on its list of tobacco retailers.

4. Do current employees have to go through another background check with the new contract or will they continue to carry over. (States – Commission)

No, current employee background checks will carry over into the new contract.

5. On page 58 Section C, all applicants for the RFP are asked to list all “adult supervisors/chaperones.”

South Carolina has 100 volunteer chaperones. Are we to list everyone ever [sic] though they have completed a security background check?

Yes, all personnel who will be involved with the program must be listed.

6. With a 75-25 split, is this overall average or monthly average to be expected.

The 75-25 split is the overall average to be expected each contract year.

7. Under page 19, Section 7 states evidence has to be submitted in 48 hours. This is not feasible in South Carolina. Is this mandatory? If so, how does [sic] the Fed Ex fees get documented in the new proposal as a fixed cost or per inspection?

Yes, Section 7 on page 19 requires that the inspector submit the evidence to the Program Coordinator within 48 hours of the inspection being completed. Offerors have discretion as to how they will incorporate the cost of shipping evidence into their proposals. Shipping costs can either be included in the program management cost or incorporated into the cost per inspection.

Questions & Answers for RFP#: FDA-15-Tobacco-1143093

8. Inspectors have monthly meetings in South Carolina, if the state brings inspectors together to pass off evidence and discuss training issues, is this reflected in the training budget or build into the fixed cost of inspections?

This cost should be included in the Travel/Training line item.

9. Is travel on page 7 considered for conference or can it be broken down into assistance with inspections.

Travel costs on page 7 are only for non-inspection travel costs. All travel a state deems necessary for assistance with inspections should be incorporated into its final cost per inspection figure.

10. In this RFP, allowances are made to purchase digital cameras. Can a state that currently does not use digital cameras purchase them to supplement the FDA issued IPhones for better pictures?

Yes, states can include costs for digital cameras in their budget proposals in response to this RFP.

11. Page 25, Section E.3 (a) and (b) refer to required photos of the 482, primary establishment photo, and establishment signage. The contract states that payment will not be made for that inspections that do not include all of these. What happens if none of these exist and when is the explanation due?

The explanation is due at the time of the inspection.

12. Another question has come to mind about the fixed price for reimbursement on the programmatic side. I understood Ms. Adams state that once the programmatic amount is finalized we would report 1/12th of that every month without backup documentation. For example: final negotiated price of $100,000.00 per year on the program side not associated with inspections would be billed at $8,333.33 each month without backup. Will this direction of 1/12th submission be put in writing?

Direction on Program Management pricing can be found in section B.2 Contract Price. Project Management is identified under the heading “Task” with a quantity of 12. This corresponds with the monthly billing schedule we expect awardees to follow specified in section G.3 Invoice Instructions.

13. From time to time we are asked to hand deliver warning letters and CMP’s. How do we need to figure in the cost for this since it is not an inspection and no assignment on the FDA Phone will be given? In addition, the same holds true for inspector buys that Ms. Adams discussed on the phone call. How are we to plan and get paid for this directed activity. Will the RFP be amended to include this requested activity?

Section C.1.5.6, Other Directed Inspections and Assignments, p.19 of the solicitation, provides information of the level of effort required for this task, which should assist in developing a cost.