FDA_Response_to_vendor_questions_1.pdf

Solicitation Number: 75F40119R00065 Questions

Tobacco Compliance Inspection Contract to conduct Inspections of Tobacco Retailers

*** All potential contractors shall refrain from contacting our state partners for assistance in developing their proposals in response to this RFP or questioning our state partners about their current contracts****

**** There is no guarantee provided to the vendor that they will receive a task order in all the states within a region. FDA is mandated by law to contract with the state to conduct tobacco compliance inspections. Only if a state chooses not to participate in the tobacco compliance inspection program is there a possible opportunity for non-state entities to conduct inspections in that state.

*****If a potential vendor submits a proposal for a region, the contractor MUST be able to perform inspections in all the states contained in that region. You may not submit a proposal for individual states. You must submit a proposal for the region which will include all the states in the region.

1) Please confirm that the Security Requirements described in Section H. of the RFP pertain to this procurement, in whole or in part. Given that the work will be conducted on FDA hardware and data will be captured in FDA systems, it is unclear how a contractor could prepare a comprehensive system security plan (SSP) or POA&M, as examples.

FDA Response:

Page 36 of the RFP states:

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

The Security Requirements in Section H. of the RFP pertain to this procurement, in part.

2) Please confirm FDA is expecting three volumes for the proposal response, including: a Task Order Technical Volume, a Task Order Business Volume and Task Order Past Performance Volume for the jurisdiction corresponding to the region the contractor is proposing for (e.g, TO #1 Jurisdiction = Delaware; Region = 1). Please further confirm that FDA is not expecting separate IDIQ proposal volumes.

FDA Response:

For the proposal response, FDA is expecting three volumes for each region in the IDIQ proposal response.

3) Ref. Section B.2.C Page 5, Period of Performance; Section B.2.G Contract Line Items Page 6; F.1 Period of Performance Page 31 and Attachment 5 Cost Estimate Formatting Example; Section L.5.B Example Price Format Page 93.

a. The RFP sections above indicate the period of performance is stated as 5 years.

b. The Example Price Format shows a Base Year and 2 Option Years.

The Attachment seems to belong to a previous proposal as it show a base plus 2 option years. Therefore, Attachment 5 does not match up with the Price instructions as stated in the referenced sections listed in this question.

Please provide a revised Attachment 5 that accounts for 5 Contract Years, rather than a Base plus 2 Options.

FDA Response:

Attachment 5 has been amended to account for 5 Contract Years.

4) Ref. Section D. Data Transmission and Storage pg. 24. Can you confirm that evidence must be stored in the associated jurisdiction (region), or can it all be shipped to be stored in one central facility?

FDA Response:

Each jurisdiction is a state/territory. Evidence should be stored in the state/territory where the Program Coordinator is located.

5) Ref. Section L.5.C.5 Page 83 Rate Agreement Letter

In the referenced section, the RFP asks for a Rate Agreement Letter signed by the offeror’s cognizant Agency or financial Officer. As this is a small business set aside, offerors may not have nor be subject to filing forward Pricing Rate Agreements or disclosure statements.

Please remove this requirement or at a minimum provide instructions applicable to small businesses that are too small to be required to have Signed Rate Agreement Letters.

FDA Response:

A small business is required to provide proof of their fringe benefit and overhead rates.

This can be done through an approved rate agreement letter or a signed letter from the company’s financial officer indicating what the company’s fringe and overhead rates are.

This proof must be included with your proposal and will be verified.

6) Ref. Labor Hour (CLIN), 2. Program Management, Pg. 6.

In the referenced section, the table seems to indicate a single hourly rate is expected for program management.

FDA Response: A single hourly rate is expected for the program management CLIN on pg. 6.

Program management should be inclusive of all labor categories needed to perform the requirements of this contract. Acceptable documentation must be provided when proposing for this labor hour category to verify proposed cost. Costs associated with performing the program management tasks that are allowable and allocable and reasonable should be included in the hourly program management rate.

a) Does this preclude the contractor from billing for any labor categories besides the program coordinator/backup program coordinator for non-inspection related tasks?

FDA Response: No

b) Does this preclude the contractor from utilizing Administrative Assistants (referenced by FDA on page 10) for non-inspection related work under this contract as a billable expense?

FDA Response: No

c) Does this indicate the program coordinator and backup program coordinator are billable to FDA at the same rate?

FDA Response: No

d) If the contractor uses specialized labor for the legal interpretation, planning and securing of grants of immunity is this non-inspection task specifically non-billable?

FDA response: These type of expenses are considered Other Direct Cost, and are billable under this contract within the not-to- exceed limit.

e) If the contractor uses specialized labor to maintain the retail list, match and append updates to retail data, confirm new unique retail data to add to the list, etc. is this non-inspection task specifically non-billable?

FDA response: These type of expenses are considered Other Direct Cost, and are billable under this contract within the not-to- exceed limit.

f) Does bidding multiple contracts/regions require multiple PMs? Or can one PM manage multiple regions?

FDA response: Billing for PM time must be accounted for each on each regional IDIQ separately.

7) Appendix C Contractor Non-Disclosure Agreement and Attachment 4 Form 3398, Non- Disclosure Form – Will FDA require Inspectors to execute both Non-Disclosure documents?

FDA Response: Inspectors are required to execute both Non-Disclosure documents.

8) Attachment 3 Quarterly Report. - Will FDA change reporting frequency to quarterly based on the template title or will it remain monthly per the task order details?

FDA Response: The report will remain monthly per the task order details. An updated Attachment 3 has been amended to update the frequency.

9) Will former cleared Inspectors be allowed to resume inspections upon award or will they need to undergo commissioning and credentialing process again?

FDA Response: Yes, former cleared Inspectors will need to undergo commissioning and credentialing process again.

10) Ref. PR Task Order, Pg 1-2. Can FDA provide clarification regarding the differing amounts of ODC, locating witnesses, and testifying for PR as compared to the other jurisdictions (DE, OH, and VA)?

FDA Response: Costs are region specific, not jurisdiction specific. Therefore, overall costs will differ per region. Each task will contain the limits for that task order.

11) Ref. PR Task Order, Pg 1. Can FDA provide clarification regarding the 0 number of Contractor Directed Undercover Buys for PR?

FDA Response: The required minimum for each regional contract will be satisfied with the issuance of task 1 for each region. For Task Order 1, there will be no Contractor Directed inspections in Puerto Rico.

12) Ref. PR Task Order, Pg 1. Can FDA provide clarification regarding the differing number of FDA Directed UBs (450) and FDA Directed ALs (250) for PR?

FDA Response: Each region has separate inspection requirements.The task provided represents the first task that will be awarded after the IDIQ has been awarded.

13) Ref. B. COR APPOINTMENT AND AUTHORITY #8, pg 33. Is the reference to the Program/Project Manager as key personnel in addition to Program Coordinator and Backup Program Coordinator?

FDA Response: Yes.

14) Will the 12pt font size requirement apply to tables and illustrations or will the Government allow the use of a decreased font size of 10-point font for tables and illustrations as is common?

FDA Response: 10-point font will be allowed for tables and illustrations

15) Ref. B.2 CONTRACT TYPE AND PRICE: G on pg 5 “fixed price per inspection for the entire region.”

FDA Response: Costs are region specific, not jurisdiction specific. Therefore, overall costs will differ per region. If the offeror anticipates difficulty providing the required inspectional coverage as outlined in Section C of the statement of work due to geographical, seasonal, logistical, or safety considerations, the Technical Proposal must address these issues.

a. For Region 4, does FDA expect the contractor to perform successfully in Alaska – where airfare to Barrow, Dutch Harbor and Nome are routine costs - at the same price as the other jurisdictions in the region? FDA Response: See response above.

b. Will FDA limit its directed inspections to minimize airfare expenses to remote locations in Alaska such as Nome or Barrow such that multiple trips per contract year to these locations are not required? FDA Response: See response above. In addition, the number of FDA-directed inspections will be based on considerations other than cost.

c. Will FDA consider reimbursable travel costs for inspection teams performing work in remote locations in Alaska? FDA Response: See above.

d. Will FDA consider a separate fixed price per inspection for Alaska? FDA Response:. No See response above.

16) Ref. C.1.9 REGION V – SPECIAL CONSIDERATIONS, pg 27, “This may include researching the local state department to compare the postal addresses or researching the local bankruptcy courts to determine if the retailer has declared bankruptcy.”

a. Would performance of the court and state department research be performed by the Program Coordinator or Backup Program coordinator and be billable under the Labor Hour CLIN?

b. Would Inspectors be able to perform the research tasks and bill under the Labor Hour CLIN?

FDA Response: Special Considerations section has been amended.

17) Ref. Section C. FDA Enforcement Actions, pg. 25. Under what category will FDA

Enforcement Actions fall under for billing? (1) issuance of a Warning Letter, (2) imposing an administrative civil money penalty (CMP) or a No-Tobacco-Sale Order (NTSO), (3) initiating judicial actions, such as a seizure or injunction, or (4) initiating criminal prosecution)

FDA Response: FDA Enforcement Actions are issued by the FDA. FDA reviews the compliance check inspection results and the accompanying evidence submitted by the Contractor. This is not a function performed by the contractor.

18) Ref. 6. Testimony Compensation, pg. 7. Will compensation for witness testimony include hearing and prep calls?

FDA Response: Yes.

19) Ref. C.1.9. Region V – Special Consideration, d. Retailers, pg. 27. How does billing occur for physical location checks or research that is not considered an inspection?

FDA Response: It depends on who is performing the task.

20) Would the FDA consider extending the proposal due date to allow small business to adequately address all 5 regional proposals?

FDA response. The RFP has been amended to extend the proposal deadline to July 11, 2019 by 4:00 pm Eastern Time.

21) Would the FDA consider extending the proposal due date considering the work days lost from the 4th of July holiday weekend?

FDA response. See answer above, #20.

22) Will the government consider extending the due date by one week as the State and Federal holiday occur the week prior the current due date?

FDA Response: See answer above, #20.

23) Please confirm that offerors are required to hire current State employees as commissionable officers. Can they be hired as consultants or must they be full-time and leave their employment with the state? Are retired or previous State employees eligible?

FDA Response: As provided in the RFP, “In order to be commissionable, the inspector must be a health, food, or drug officer/employee of any State, Territory, or political subdivision thereof.” The determination if an individual meets these requirements must be made by the contractor prior to submission and will be reviewed on a case-by-case basis during the commissioning review.

Question # Proposal

Section

Sub Section

Question

FDA

Response

Attachment Task order na

In each task order the government highlights the volume of contractor directed under cover buys as well as FDA undercover buys. For purposes of planning does the larger contractor directed requirement include the FDA directed requirement.

No; these are separate requirements. In addition, the tasks provided with the IDIQ are sample tasks provided for informational purposes. Actual task orders will issue after the IDIQ has been awarded.

Section C.1.1. E

Can the minor selected for participation in undercover buys have a previous criminal record?

Due to the nature of the enforcement actions that may result from inspections involving minors, the minors selected for participation should be reliable and credible. We have found that minors with previous criminal records can be easily discredited and therefore should not be selected.

26 Can the government clarify the definition of "drug officers"

As provided in the RFP, “In order to be commissionable, the inspector must be a health, food, or drug officer/employee of any State, Territory, or political subdivision thereof.” The determination if an individual meets these requirements must be made by the contractor prior to submission and will be reviewed on a case-by-case basis during the commissioning review.

27 Section C.1.7 C

Can the government confirm there is no 1.7

RFP has been updated to include section C.1.7 pg.25

28 Section B.2.E

Page 5 Travel: On page 5, the RFP states non-inspection travel is not to exceed $10,000 per region.

The $10,000 not-to-exceed amount is for each region. On each individual task order issued the not-to-exceed

However, if all PCs are required and all BPCs are encouraged to attend the FDA conference, and if an Offeror is managing several states within a region, it would be easy to exceed the $10,000 threshold for a region.

Did the Government intend to establish a $10,000 limit on non-inspection travel per state/jurisdiction? Would the Government please clarify its intent?

amount for that state will be established at the task order level.

29 Section B.2.5

Page 7 Compensation is based on the amount of time testifying:

Would the Government please clarify how often, on average, inspectors and minors are requested to be located in order to prepare and give testimony?

Due to the nature of litigation in general, we cannot estimate how often inspectors or minors would need to be located for testimony purposes.

30 Section B.2.6

Page 7 Compensation is based on the amount of time testifying:

Does the “compensation based on amount of time testifying” also include the time associated with preparing the witness to testify (e.g., reviewing the inspection in question), and include interactions between the FDA and the witness prior to testimony? Is this time also eligible for compensation? Please clarify.

Yes

31 Section C.1 Page 8 Number of Inspections:

The second table on page 8 provides a list of the types and number of inspections by region.

Would the Government please confirm that the number of inspections required for various states within a region on subsequent task orders will likely vary from the inspection requirements identified in this table?

The information provided in the table on page 8 are estimates. The actual number of inspections required for various states within a region on subsequent task orders will vary from the inspection requirements identified in this table.

32 Section C.1.2

Page 16 Would the Government confirm that it plans to conduct site visits at the contractor’s facility up to once per year?

Site visits may be conducted once a year.

33 Section C.1.5

Page 19 The RFP states the following on page 19:

“The Contractor is responsible for ensuring that Inspectors submit data to FDA as defined in C.1.5 through C.1.7, below.”

However, Section C.1.7 appears to be missing in the RFP.

Would the Government please confirm that Section C.1.7 does not exist, and that Offerors are not required to respond to any C.1.7 requirements? (We suspect this was related to transition requirements from the 2018 bids and may still apply to C.1.10, Kickoff/Transition In/Transition Out for the

The RFP has been revised to include C.1.7. on page 25.

new procurement.) Please clarify.

34 Section C.1.10

There are two sections identified as C.1.10:

• C.1.10:

Kickoff/Transition In/Transition Out

• C.1.10: Monthly Reports

Will the Government please clarify the correct numbering sequence for these 2 requirements?

The RFP has been renumbered to C.1.9 Kickoff/Transition in/Transition Out And C.1.10 is Monthly Reports

35 C.1.10 Section H

Travel: For budgeting purposes, would the Government please clarify how many trips will be necessary for the PC/BPC for badging and obtaining FDA laptops, and how many days for each trip?

This is considered non-inspection travel. It is estimated that approximately two overnight trips are required for badging and obtaining FDA laptops.

36 Section C.1.11

Page 30 LOCATING

INSPECTORS AND

MINORS:

Does the requirement to locate inspectors or minors no longer affiliated with the FDA program to update contact information or serve as witnesses only apply to those individuals who worked directly for the bidder? Or, does it also apply to inspectors and minors who performed inspections for a PREVIOUS contractor or state agency?

The requirement applies to inspectors who performed inspections for a previous contractor or state agency.

37 Section L.3 Page 87 Proposal Instructions:

To ensure readable and appealing proposals with appropriate graphics and tables, would the

Yes, 10-point font is acceptable for tables exhibits, graphs and other visual elements.

Government please confirm that offerors are permitted to use no smaller than 10-point font for tables, exhibits, graphs, and other visual elements presented in the proposal?

38 Sections L.3

Page 87 Proposal Instructions:

Would the Government please confirm that the cover letter and table of contents are excluded from the 60-page limit?

Yes, the cover letter and table of contents are excluded from the 60-page limit; however, the cover letter and table of contents should not exceed more than 5 pages.