Questions and Answers Report_75F40125R00034_8-21-2025.pdf

Questions and Answers Report 75F40125R00034 (dated 8/8/2025) 8/21/2025

Date RFP Reference &/or Page

Question/Comment FDA Response Amendment Y/N?

1. 7/9/2025 Section F- Deliverables or Performance (pg 35)

. F.1. states that POP 2-5 may have varying periods of performance. Does this mean each Period is not 12 months in duration?

Yes. However, we anticipate that the subsequent task orders will be for a period of 12 months.

N

2. 7/9/2025 F.2 Deliverables C1.1.V: are we required to notify FDA of any Underage Purchaser (UP) added to TIMS or only adults?

Yes, all Underage Purchasers should be added to TIMS with confirmation that a background check has been completed, if applicable.

N

3. 7/9/2025 F.2 Deliverables C.2.6: verifying that we are to return all evidence collected at the end of each POP?

All evidence should be returned at the end of the contract. If there is adequate evidence to be returned, prior to the end of your contract please reach out to your

COR.

N

4. 7/9/2025 F.2 Deliverables Footer states “The Contractor shall submit the deliverables to the CS, and COR’s e-mail or mailing addresses (as required) which are specified in section G.1.,”but the timeline/due date column states to email COR only. Please clarify.

The table will be corrected to correctly identify the recipient for the deliverables in the correct column.

Y

5. 7/9/2025 Section H.6- Task Orders

Will the number of task orders (inspections) be known to us at the beginning of the performance period or will it be given to us on a monthly basis during the year?

The Government intends to issue a minimum of one task order per year.

N

6. 7/9/2025 Section H.6- Task Orders

Will this contract be a fixed price or a cost per task order (inspection) reimbursement?

Tied to prior question.

As provided at Section B.2, “All Task Orders will be cost reimbursement orders”

N

7. 7/9/2025 L.5 General Proposal

States that the attached Subcontracting Plan template included with the RFP as an

Correct. Input of the subcontract plan in SBCX will occur after the CO has

Y

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

Instructions, Volume III (pg 101) attachment is to completed in its entirety and submitted simultaneously with the proposal submission. Upon review and acceptance of the plan by the contracting officer, offerors will be required to input in the plan in SBCX system. At such time, the offeror shall provide to the contract specialist/contracting officer, a copy of the email notification and/or confirmation message from the SBCX system regarding the completion of the submission.

accepted the written plan submitted with the offeror’s proposal.

8. 7/9/2025 L.5 General Proposal Instructions, Pamela Lee stated that the subcontracting plan for the State Tobacco Inspection and Compliance requirement has not been established in SBCX.

Correct. The SBCX will be established for each jurisdiction after acceptance of the written plan.

Y

9. 7/9/2025 L.5 General Proposal Instructions, When will we receive the subcontracting plan template?

Attachment included in Amendment 0001.

Y

10. 7/9/2025 L.5 General Proposal Instructions, When will we be permitted to access the SBCX system?

After acceptance of written plan by the

CO.

N

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

11. 7/9/2025 L.5 General Proposal Instructions, We are unsure if our Underage Purchaser recruiting service is included as a subcontractor. CDPH performs all inspections, reports and evidence collection.

Please Clarify

The recruiting service can be included as a subcontractor if this work is performed by another entity other than the state.

N

12. 7/9/2025 L.5.2.V. Travel Expense (pg 106)

Is the FDA planning an annual training during this contract period that will require overnight travel?

FDA does not anticipate hosting an annual training during the contract period that will require overnight travel.

N

13. 7/9/2025 L.5.2.IX.b. Addl Docs to be submitted (pg 107)

States that the offer[o]r must complete Section B.3.1 inspections

• For CA, this is a table indicating 150

UB/50 AL

• Is the FDA asking how many work orders (inspections) we can complete within each POP or is the FDA indicating that only 150 UBs are to be completed? Per week/ per month/ per POP?

Offerors are to provide pricing based on the maximum inspection per a 12-month performance period.

N

14. 7/9/2025 L.8 Pre- Proposal Conference (Pg 110)

States that any questions after the pre-proposal conference should be submitted …by COB on April 19, 2025

• Can we clarify the true date?

The correct date as identified in the final solicitation is August 20, 2025.

N

15. 8/11/2025 Attachment 4 cell A4 says

CLIN 1

Yearly estimate for A&L Inspections. Should this be for both A&L and UB inspections?

The totals are for the entire 5-year estimated period of performance of the IDIQ contract. Offerors are to propose for each year. 1 – 12 months task order.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

16. 8/11/2025 In prior proposals we submitted Standard Form 33, is this not required in this proposal?

SF 33 is included with the final RFP and is to be completed by the offeror.

N

17. 8/11/2025 The Cost Estimate Pricing workbook

The Cost Estimate Pricing workbook states “CLIN 1 labor and ODCs should be based upon the number of inspections listed in Cell B4 and C4,” however, those cells are blank.

What numbers are we basing the estimate on?

Instructions have been updated to state that the ODCs are relative to the number of inspections. Specifically, ODCs for yearly inspections

Y

18. 8/11/2025 The Cost Estimate Pricing workbook

The Cost Estimate Pricing workbook A&L inspections tab cell E23 states 2000 for Estimated Number of Inspections Per Ordering Period. What number is this supposed to be used for? Are we supposed to update this number for how many inspection we believe we can conduct in 12 months, and is this for both UBs and A&Ls?

Correct. N

19. 8/11/2025 Attachment 4 Can we adjust the Unit in Attachment 4 – Cost Estimate to Yearly due to all employees are on a salary schedule and not hourly?

Hourly rates are to be provided. Offerors are reminded that this is an estimate.

N

20. 8/11/2025 The Cost Estimate Pricing workbook

Is the CLIN 1 ODP tab in the Cost Estimate Pricing workbook separate and not subject to the limits listed for CLIN 2 ($10,000) and CLIN 3 ($20,000.00) maximum? And can we include in CLIN 1 office rental space for FTE, Answered above at #17. N

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

vehicle leases, laptop leases, cell phone leases, and buy money for UPs, as we have in our current contract?

21. 8/11/2025 Do we need to submit any written technical proposal if we currently have an active FDA/CTP tobacco retailer compliance check inspection contract? The solicitation only mentions oral.

No. Technical proposal will need to be submitted.

N

22. 8/11/2025 Can we assume the inspections will be distributed relatively evenly over each of the Performance Periods? Since the box for each POP just states “completed at award”, we want to clarify. And is there any negotiation room for the number specified? Can we expect additional task orders to assign further inspections beyond the number listed in CLIN 1 if we meet the assigned number as long as we have not exceeded the price schedule for the POP?

Yes, inspections will be distributed relatively evenly over each of the Performance Periods. Inspection numbers may be increased or decreased as needed on each task order.

N

23. 8/11/2025 Is there a set pre-proposal conference call date? I see that interest needs to be submitted to Pamela by the 13th, but I don’t see when the actual call will take place.

The established date for the Pre-Proposal Conference was August 15, 2025, at 1:00 PM. Offerors were notified by email and the RFP notice was updated on 8/11/2025, accordingly.

N

24. 8/11/2025 With the federal legal purchasing age now being 21 years, what is the justification for continuing to hire 16-17-year-old minors?

The designated age for UPs are required because 16-17 year olds are not legally authorized to purchase tobacco products.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

We have several concerns around continuing this.

25. 8/11/2025 Will we need to submit a subcontracting plan if we do not use subcontractors?

A waiver may be requested. Y

26. 8/11/2025 This solicitation does not include PC travel for in-person FDA meeting in Maryland.

Should we expect this or will it not be a reimbursed cost?

Currently, we are not holding a PC conferences.

N

27. 8/12/2025 B.3 Is the 17,500 UBs and 2,500 A&Ls being used for B.3 Cost 1. Inspections the ceiling for amount of inspections Pennsylvania can conduct in 1 Period of Performance? Are these the numbers that should be used in the new Attachment 4 Cost Estimate Pricing Format

Yes. N

28. 8/12/2025 Attachment 4 In the new Attachment 4 Cost Estimate Pricing Format, line 21 indicates the “Total Cost CLIN for One (1) UB”, but if we’re pricing it out for just 1 UB, then all units in column C would have to be changed from Hours to per Inspection, yes?

See instructions within Attachment 4 N

29. 8/12/2025 Attachment 4 In addition, for new Attachment 4 Cost Estimate Pricing Format, it has the wages of Program Coordinator and Backup Program Coordinator built into the price for a UB Inspection and A&L Inspection. Program Coordinator and Backup Coordinator salary has nothing to do with the price of an inspection, they are entirely separate Direct Labor Costs. Why has this change to the

CLIN 1 is intended to encompass costs for the specified number of inspections for a full year of conducting inspections within a jurisdiction. CLIN 1 should not include estimated or anticipated staffing costs beyond what would be required for the specified number of inspections listed.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

Attachment been made? What is the appropriate course of action?

30. 8/12/2025 Attachment 4 Cost Estimate Pricing Format

For new Attachment 4 Cost Estimate Pricing Format, it is asking for CLIN 1 UB Inspections to estimate a final UB price for 1,000 UB Inspections. Pennsylvania in the past has done 7,000 UBs every contract year. Should this number be changed from 1,000 to 7,000? Or maybe from 1,000 to the 17,500 listed in the RFP on page 12?

Yes, the number of inspections should be 17,500 as your five-year total.

N

31. 8/12/2025 Attachment 4 For Attachment 4 Cost Estimate Pricing Format: Why does CLIN 1 A&L Inspections tab have an estimate for 2,000? You cannot do more A&L Inspections than UB Inspections, so this is a very significant discrepancy that needs addressed urgently.

The spreadsheet has been correct to delete the “2,000”.

Y

32. 8/12/2025 Attachment 4 For new Attachment 4 Cost Estimate Pricing Format, tab 2 CLIN 1 UB Inspections wants the UB Inspection Estimate to be for just 1 UB Inspection. However, Tab 3 CLIN 1 A&L Inspections is completely different and wants the more standard Cost Ceiling for A&L Inspections. Why are these two tabs in such disconnect from each other? Should UB Inspections Tab line 21 be corrected to read Total Cost Ceiling and priced out for the estimated amount of UB Inspections, however much that may be?

Line 23 should be populated with the number of inspections for each category (UB & A&L). The spreadsheet has been updated accordingly.

See Section B.3.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

33. 8/12/2025 Pages 102 &

On page 102 it states the Subcontracting Template is due at time of submission and once reviewed and accepted by Contracting Officer, we will then be required to submit it in SBCX and then submit email to Contracting Officer. But on page 109 it states that it must be submitted in the SBCX and does not mention that it must be approved before submitting it into SBCX. See below for reference. Will you please clarify the correct steps for submitting the subcontracting plan into SBCX. Are we to submit a template (only received SBCX Guide) with the submission on 8/22/25, wait for your approval of the plan, and then submit it in SBCX, or are we to submit the subcontracting plan into SBCX by 8/22/25 and submit the email with the submission? At what point will we know if it has been approved? For reference, we already use a subcontractor to conduct inspections.

Page 102:

Page 109:

The template has been provided and updated in Amendment 1. The due date for submission of the written plan is 8/27/2025. Negotiations of the plan may be required. After final acceptance of the plan, the offeror will submit its plan in SBCX.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

34. 8/12/2025 Section L, SBCX When registering for the SBCX system, it asks how would you like to use the system. Please see screenshot below. It was prepopulated as shown, but should I also check the box that says- I would like authorization to use the HHS 653 (Small Business Review) functionality? With such a tight deadline, we really want to get this right the first time.

Offerors will receive a notification from HHS for submission of subcontracting plans. For this requirement, notification will be sent after proposal submission.

Note: The Small Business Review is for Government users only.

Y

35. 8/12/2025 From the Cost Estimate Pricing Sheet:

• Tab 1- Total 5-YR Cost:

o Where does CLIN 2 and CLIN

3 costs draw from within the

RFP?

• Tab 2- CLIN 1 UB Inspections:

o Notes state CLIN 2 and CLIN

3 costs should not be changed when completing the template, but we don’t see where there is mention of CLIN 2 or CLIN 3 for this worksheet. Does this refer the cost of CLIN 2 and CLIN 3 within Tab 1?

See Section B.2, Cost; B.3.2 & B.3.3 of the RFP to map to CLIN 2 and CLIN 3.

CLIN 2 and CLIN 3 are “Not-to-Exceed amounts and have been incorporated in the first tab of the spreadsheet entitled “Total 5-YR Cost.”

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

36. 8/12/2025 From Page 10 of the RFP, B.3 Cost, 1.

Inspections:

• California is asked to complete 15,000 UBs and 5,000 A&L inspections, however the paragraph preceding the grid states:

o Task orders will indicate the number of inspections to be performed.

o The Task orders may be issued in period of performance increments up to the maximum UB/A&L inspections and each task order will be based on the pricing set below for each year of this IDIQ contract (See Attachment 4).

o Note: CLIN 1 is intended to encompass costs for the specified number of inspections for a full year of conducting inspections within a jurisdiction.

• We wanted to be sure that the 15,000 UBs and 5,000 A&L Inspections were the maximum number of inspections for the full 5-year contract, not the number of inspections to be conducted each year.

Yes, this is a correct understanding.

37. 7/2/2025 What is an Indefinite Delivery/Indefinite Quantity (IDIQ) contract? Is that a different type of contract than what Minnesota has had before?

An indefinite delivery/indefinite-quantity contract provides for an indefinite quantity, within stated limits, of supplies or services during a fixed period. The Government places orders for individual requirements. Quantity limits may be stated as number of units or as dollar

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

values. (Reference FAR 16.504). The contract is different from the previous contract which contract type was a hybrid, cost-reimbursement stand-alone contract that did not include the issuance of task orders.

38. 7/2/2025 Pg 8 Is the max contract value for Minnesota predetermined to be $6,794,413 and what does the contract minimum of $80,266 represent?

Correct; the maximum contract value cited at paragraph B.2, for each jurisdiction will be the ceiling amount in the resulting contract. The cited minimum contract amount is the estimated guaranteed minimum that will be obligated on the initial task order.

39. 7/2/2025 Pg 9/ para 8 – Will 8 months of the base period run October 2025 through May 2026? Have you considered beginning the contracts October 1 and running the base year th[r]ough September 30 to align with the federal fiscal year?

In lieu of aligning the task orders’ period of performance with the Federal fiscal year, it is FDA’s intent to award task orders with a 12-month period of performance that begins no later than May 28, annually.

N

40. 7/2/2025 B3 Costs/ Pg 10 Is the state to determine the cost of completing 250 UB inspections and 60 A&L inspections per month for the first 8 months or just for one month? What does pop 1, 2, 3, 4, 5 mean?

Attachment 4, Cost Proposal, included in the final RFP, cites the estimated 5-year total number of UB and A&L inspections.

Offerors are to propose cost for five 12-month period of performances.

N

41. 7/2/2025 Pg 12/ para 3 Is this saying if [Offeror] purchases postage stamps, for example, we need prior written approval from CO and will need to include that approval as supporting documentation with monthly invoice?

Prior approval is needed for any ODC’s not identified and accepted as an allowable ODC for the establishment and performance of the contract.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

42. 7/2/2025 Pg 15 The issuance of a commission… - Did you want to include language here something to the effect of – It is the inspector’s responsibility to notify the FDA within 5 business days of any developments that may impact his/her ability to be commissioned. If The PC becomes aware of any developments that may impact an inspector’s ability to hold a commission, they must notify the FDA within 5 business days. I also recommend all inspectors undergo a background check every contract year, not just at the time of commissioning.

The requirement will remain as stated.

The suggestion has been taken under advisement.

N

43. 7/2/2025 Pg 110/ Para L.7 All questions re solicitation [m]ust be submitted by July 10, 2025 – will this date be moved back to allow time to submit questions once the solicitation is finalized and published?

The dates cited in the draft solicitation has been resolved in the final RFP. The correct date for receipt of Questions as cited in the final solicitation (Issued 8/8/2025), was August 12, 2025.

N

44. 7/7/2025 The number of inspections set for California in the new RFP is 150 UB’s and 40 A&Ls with a 17-million-dollar budget.

Is this a typo?

With that budget, we are planning our cost estimates for closer to 3500 UB’s per POP.

Please refer to the final RFP. The solicitation cites the maximum number of inspections for the 5-year IDIQ period of performance. Completion of Attachment should be based on five (5) 12-month performance periods. The total number of inspections per the 12-month performance can be determined by dividing the maximum number of inspections by 5, for your respective state.

N

45. 8/12/2024 Background: [Contractor] option year three annual budget for “Other Direct” was

Inspection related ODCs can be listed under CLIN 1.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

$142,790. It appears these costs will now be included in #1 Inspections and “Other Direct” will only be for non-inspection related costs such as wifi, printers etc– is that correct?

46. 8/12/2025 Attachment 4

Cost Estimate Pricing Format appears to be missing from the Zip file that was posted on SAM.gov. Will this be provided to us prior to us submitting our proposal?

Based on current budget, being fully staffed, current operation expenditures, and expected increase in costs to conduct business over the next five years, we are projecting that we would have budget costs above the ceiling amount. Are we bound by the ceiling amount for the 5 years? What if we determine that we need additional money?

This has been corrected as of 8/13/2025.

Attachment 4 has been uploaded on SAM.gov.

47. 8/12/2025 Are we limited to $20,000/year for [Other] direct costs?

Yes, this cost is established in the IDIQ and will not be changed.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

48. 8/12/2025 We currently have an active contract with FDA/CTP, will we be required to present an oral technical proposal presentation?

Current incumbents are not required. N

49. 8/12/2025 L.6 Do we need to provide Past Performance information, or will this be pulled from

CPARS?

Reference Section L.6, the Government will be utilizing the Contractor Performance Assessment Reporting System (CPARS) for reviewing past performance.

N

50. 8/13/2025 The [Offeror] is currently the contractor with the Food and Drug Administration, Center for Tobacco products, and has been for the past 13+ years. We recently changed divisions within the Department of Human Services from the Behavioral Health Division to the Office of the Inspector General. Given we remain the same state Department (Human Services) as our current contract are we not required to submit a technical proposal?

Current incumbents are not required to submit a technical proposal.

51. 8/13/2025 Are Undercover Tobacco Purchasers considered sub-contractors? If so we will need to compete Volume III – if not we will not be using any sub-contractors – then do we just say volume III is non-applicable?

3. VOLUME III - SUBCONTRACTING

PLAN EMAIL NOTIFICATION In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror(s) is a

As defined in FAR 19.701, Subcontract means any agreement (other than one involving an employer-employee relationship) entered into by a Government prime contractor or subcontractor calling for supplies and/or services required for performance of the contract, contract modification, or subcontract.

Determination of the applicability of a subcontracting plan for each respective contract will be on a case-by-case basis and determined by the OSDBU.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

requirement as a part of the proposal submission process for all states and must be submitted separately from the technical and cost proposals. The state’s subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award. The state must submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov Pg 101 of Solicitation 75F40125R00034

Offerors are to either submit a subcontracting plan or a request for a waiver.

52. 8/15/2025 Is indirect charged on Salary only or can it be charged to Salary and Fringe?

Indirect costs can be charged on fringe benefits and should not be charged on salaries. Salaries should be a direct labor cost.

53. 8/15/2025 CLIN 1 A&L TAB: Is Cell D19 supposed to be blank and we are to enter our own Indirect rate? Because currently it inserts 6%.

For both the CLIN 1 UB and CLIN 1 A&L Tab, Cell E23 has a number already inserted— which does not match the number of inspections to be completed for Michigan.

Are we to leave that cell alone or insert our

The numbers provided are examples. You will enter the numbers for your jurisdiction. The formulas are correct.

https://osdbu.hhs.gov/

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

Michigan numbers? (I know the numbers are supposed to be inserted in cells B4 and C4.)

For both the CLIN 1 UB and CLIN 1 A&L Tab, Cell E25 multiplies Total Cost Ceiling CLIN 1 (Cell E21) by Est. # of inspections per ordering period (Cell E23)—is Cell E25 formula correct? Should it be calculating a cost per inspection instead of multiplying these cells together?

54. 8/15/2025 We are curious if the Subcontractor template will be emailed to us or if we will need to monitor SAM.gov?

In advance of posting Amendment 0001, copies of the templates have been emailed to each jurisdiction.

Y

55. 8/18/2025 Does the Volume 2 – Business Proposal page limit of 40 pages include financial tables or is the limit only for demographic information, required forms and supporting documentation?

The 40-Page limitation is inclusive of the pricing spreadsheets

N

56. [This Offeror] does not plan to have a subcontractor so, please confirm that a subcontracting plan is not required.

As provided in the solicitation, the FDA has determined that the subject requirement has subcontracting possibilities. For proposal submission, your state will need to either submit the subcontracting plan or a written request to be waived from submission of the plan.

If it is your State’s position that there are no subcontracting opportunities during the performance of this requirement, please submit sufficient information (e.g., in a letter form) to substantiate your State’s

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

determination with detailed explanation(s) that no subcontracting possibilities exist.

Based on the information supplied by your State in your proposal, the Contracting Officer will make a determination. A detailed rational will be submitted to the OSDBU for approval. The rational will be based on the information supplied in your detailed written request for a waiver for submitting a subcontracting plan (see FAR 19.705-2(c)).

As provided above, FDA has determined that subcontracting opportunities for the requirement do exist. Please provide all applicable explanations as to explain why there are no subcontracting opportunities available for small business, veteran-owned small business (VOSB), service-disabled veteran-owned small business (SDVOSB), HUBZone small business, small disadvantaged business (SDB), and women-owned small business (WOSB) concerns, during the performance of this requirement.

If the CO’s determination is approved by the OSDBU, then a subcontracting plan will not be required for the formation of the subsequent contract.

57. 8/18/2025 We do not intend to have any subcontractors. Can you please send us the waiver?

Unfortunately, there isn’t a sample waiver to share.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

As provided in the solicitation, the FDA has determined that the subject requirement has subcontracting possibilities.

If it is your State’s position that there are no subcontracting opportunities during the performance of this requirement, please submit sufficient information (e.g., in a letter form) to substantiate your State’s determination with detailed explanation(s) that no subcontracting possibilities exists.

Based on the information supplied by your State, the Contracting Officer will make a determination. A detailed rational will be submitted to the OSDBU for approval. The rational will be based on the information supplied in your detailed written request for a waiver for submitting a subcontracting plan (see FAR 19.705-2(c)).

As stated above, FDA has determined that subcontracting opportunities do exist. Please provide all applicable explanations as to explain why there are no subcontracting opportunities available for small business, veteran-owned small business (VOSB), service-disabled veteran-owned small business (SDVOSB), HUBZone small business, small disadvantaged business (SDB), and/or women-owned small business (WOSB) concerns, during the performance of this requirement.

58. 8/18/2025 Is the total Cost Ceiling CLIN 1 supposed to be the total per inspection or the entire

Data should be entered in the boxes highlighted in yellow only. The total per

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

yearly total cost ceiling? There is a formula below (cell E 26) that calculates the Estimated Number of Inspections Per Ordering Period (cell E24) with the Total Cost Ceiling CLIN 1 (cell E22), and I am not sure that cell accurately reflects any totals. Should this be instead dividing the Total Cost Ceiling CLIN 1 by the Estimated Number of inspection Per Ordering Period (cell E24) instead to show the cost per inspection? (We did add a line so our cell numbers have changed).

inspection will be calculated once data has been entered. When adding lines ensure the line is included in the formula in Column E by dragging the formula down from the previous cell.

59. 8/18/2025 Should a separate template be completed for each subcontract?

Please review the following video: https://youtu.be/v8LVU3ILw5A.

Although it provides instructions for inputting into SBCX for submission of the subcontracting plan, it’s also insightful for completing the written template.

60. 8/18/2025 Is a “sample” template available for assistance in completing the template?

Only one template is to be completed. Your subcontracting plan is for the overall subcontracting goals during the 5-year period of performance. (Please review the video cited above for Question #60).

Reference FAR 19.705-2(e).

Y

61. 8/18/2025 If the subcontracts do not equal $750,000 do we need to submit a Volume III?

The $750,000 threshold is in reference to the estimated value of FDA’s requirement. It is estimated that each subsequent contract resulting for the https://youtu.be/v8LVU3ILw5A

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

subject RFP, will individually exceed the $750,000 threshold. See FAR 19.702.

62. 8/18/2025 Is the per inspection cost to include only CLIN 1 labor costs or also CLIN 1 ODC?

The price per inspection should include labor costs associated with conducting inspections and any CLIN 1 ODC.

N

63. 8/18/2025 We have had this contract for 15 years and have never used subcontractors. All our inspectors are full time employees of WSLCB.

We are not sure what subcontracting opportunities would exist for us, as anyone working on this contract must be an employee of this agency.

[Offeror] does contract through the types of business you listed below for procurement opportunities. Our agency does utilize this list when completing purchases at the agency level, but we do not specifically subcontract in the FDA Program. If we explain all of this in our waiver request, is that sufficient?

As a reminder, it’s a statutory requirement that any contractor receiving a contract with a value greater than the simplified acquisition threshold must agree in the contract that small business, veteran-owned small business (VOSB), service-disabled veteran-owned small business (SDVOSB), HUBZone small business, small disadvantaged business (SDB), and women-owned small business (WOSB) concerns will have the maximum practicable opportunity to participate in contract performance consistent with its efficient performance.

(See FAR 19.702).

The decision as to whether a subcontracting plan will be necessary in the resulting contract for your State is solely determined by the OSDBU. If the intent is to submit a request for a waiver to the subcontracting plan, it is strongly encouraged that your state provide adequate supporting documentation as to why there are no subcontracting opportunities that will afford small businesses the opportunities to participate in the contract performance efficiently. This information will assist the CO in making a determination. Approval of the CO’s

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

determination is solely provided by the

OSDBU.

64. 8/18/2025 Just so I’m clear. I fill out the template to describe the subcontracts [Offeror] is entering into—which means [Offeror] is contracting with [two state agencies]. So everything I enter is referencing a combination of the funding and duties/responsibilities for those two agencies, correct?

Submission of a subcontracting plan is for the purpose of satisfying the statutory requirement that any contractor receiving a contract with a value greater than the simplified acquisition threshold must agree in the contract that small business, veteran-owned small business (VOSB), service-disabled veteran-owned small business (SDVOSB), HUBZone small business, small disadvantaged business (SDB), and women-owned small business (WOSB) concerns will have the maximum practicable opportunity to participate in contract performance consistent with its efficient performance. (See FAR 19.702).

Please review FAR 19.704, entitled “Subcontracting plan requirements” that describes what information is required for completing the subcontracting plan. Note, HHS’ FY 2025 goals for subcontracting with the various small business types have been inserted in the template (previously provided).

In completing the template, your plan should clearly delineate how the State’s proposed plan for subcontracting aligns with the cited HHS goals.

Questions and Answers Report 75F40125R00034 (dated 8/8/2025)

Question/Comment FDA Response Amendment Y/N?

65. 8/18/2025 I have been asked if there is any way we can ask for an extension on the RFP submission. I would be helpful if we could have just a little more time. Is this a possibility?

The solicitation is extended to Wednesday, August 27, 2025, 10:00 AM ET.