FDA Tobacco Inspection Questions-Responses75F40125R00046.xlsx
XLSX spreadsheet 29 KB Posted
- Solicitation number
- 75F40125R00046
About this file
This is a Q&A document for solicitation 75F40125R00046, which addresses vendor questions about FDA's Tobacco Retail Compliance Check Inspection Program. The document clarifies the two-phase proposal submission process, with Phase I responses for Volume 1, Factor A (Commissioning) due February 18, 2025, at 4:00 PM EST, and Phase II responses for Volume 1 Factors B-D, Volume II, and Volume III due March 11, 2025, at 4:00 PM EST.
Key clarifications include: no external systems or ATO requirements will be required; evidence storage costs must be included in fixed price per inspection or billed as ODCs within the ceiling; FDA may specify tobacco products to be purchased during inspections; and while Contractor Directed Undercover Buys are not included, contractors may determine inspection timing and retailer selection from an approved list. The contract covers multiple regions across the U.S. and territories, with a period of performance from September 30, 2025, to September 29, 2030. This is a small business set-aside under NAICS 561611, requiring contractors to employ commissionable state health, food, or drug officers to conduct inspections.
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Other files
| File | Type | Posted |
|---|---|---|
| 75F40125R00046-0007.pdf | ||
| UPDATED-Questions-Responses_75F40125R00046.xlsx | XLSX spreadsheet | |
| SOL-75F40125R00046-0006.pdf | ||
| SOL-75F40125R00046-0005.pdf | ||
| Questions-Responses_75F40125R00046.xlsx | XLSX spreadsheet | |
| Sol_75F40125R00046-0004.pdf | ||
| Sol_75F40125R00046-0003.pdf | ||
| Attachment 12-Updated Wage Determination for UP.txt | TXT text file | |
| Sol_75F40125R00046-0002.pdf | ||
| Sol_75F40125R00046-0001.pdf | ||
| Sol_75F40125R00046.pdf | ||
| Attachments.zip | ZIP file | |
| Questions And Responses- Solicitation 75F40125R00018- Final.pdf |
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Sheet
| Third Party Tobacco Retail Compliance Check Inspection Program IDIQ 75F40125R00046 | |||
| Volume Reference | RFP Section Number/Page Number | Question | |
| Solicitation | N/A | When does the FDA anticipate releasing responses to vendor questions? To ensure offerors have adequate time to incorporate the provided information into their proposals, we respectfully request a ten-day extension following the release of Q&A responses. | Responses have been released within a seven-day timeframe to ensure prospective offerors have enough time to submit a proposal for Phase1. Based on the review of the questions received, three responses correspond with propsal instruction for Phase I. Consequently, the Government believes offerors will have adequate time to incorporate information obtained from the release of the Q&A responses into their proposal response for Phase I. The Government will not grant a ten-day extension for proposal submissions during Phase I. However, Offerors are afforded additional time during Phase II to address all factors evaluated during Phase II. Hence, Phase I proposal responses should be submitted NO LATER THAN February 18, 2025, at 4:00 PM EST. After evaluation of Phase I proposals responses is complete, Offerors that choose to move forward with submitting a response for Phase II (after receiving their assessment recommendation for Phase I) should submit their response to Volume 1, Factors B-D, Volume II, and Volume III for Phase II evaluation NO LATER THAN March 11, 2025 at 4:00 PM EST. |
| Solicitation | M.1, page 122 | Please confirm that only "Factor 1: Commissionable Inspectors" will be evaluated to determine which bidders are recommended for advancement to Phase II. If confirmed, please also confirm that the offerors are intended to only submit the response to "A. Commissioning" in Phase I, and not other factors. We recommend splitting Volume I into Volume IA and Volume IB-D, where Volume I is the only content submitted in Phase I, and Volume IB-D is only submitted in Phase II. | We have revised the solicitation to delineate the responses expected for each phase. Factor A: Commissioning is the only factor that will be evaluated for technical acceptability, and will yield recommendation feedback based on the evaluation results. To confirm, the revised solicitation now explicitly requests offerors to submit their response to Volume 1, Factor A. Commissioning" in Phase I, and no other factors NO LATER THAN February 18, 2025, at 4:00 PM EST. Offerors that choose to move forward with submitting a response for Phase II (after receiving their assessment recommendation for Phase I) should submit their response to Volume 1, Factors B-D, Volume II, and Volume III for Phase II evaluation NO LATER THAN March 11, 2025 at 4:00 PM EST. |
| Solicitation | p.54, Questions and Responses #48 | Response to question 48 seems to indicate that ATO is not required for any internal systems that a contractor may leverage for this contract. However, on page 54 of the RFP, it implies that an ATO is potentially required. Please clarify. | No external system will be required. Language will be removed ( Privacy act language from page 53-68). |
| Solicitation | p.54, Questions and Responses #48 | If an ATO is required for a contractor internal system outside of TIMS, please confirm the ATO security level required for Contractor technical system will be set to Moderate. | No external system will be required. Language will be removed ( Privacy act language from page 53-68). |
| Solicitation | p.54, Questions and Responses #48 | If an ATO is required for a contractor internal system outside of TIMS, where shall the contractor place the cost associated with maintaining an ATO within the price submission? | No external system will be required. Language will be removed ( Privacy act language from page 53-68). |
| Solicitation | p.7 | What is the timeline FDA requires the Contractor to prepare and transfer evidence to FDA custody after the contract expires? | As reflected in the highlighted verbiage on page 7 of the RFP, all contract activities must occur during the period of performance of the contract. Collection of evidence should conclude allowing for enough time during the period of performance to ensure evidence can be transfered. |
| Solicitation | p.9 | May the Contractor bill for evidence storage costs during the performance period of the contract? | As reflected in the highlighted verbiage on page 9 of the RFP, Evidence storage cost must either be included in the contractor fixed price per inspection or invoiced as an ODC provided that this allows the contractor to perform without exceeding the ODC ceiling. |
| Solicitation | p.9 | May the Contractor bill for evidence storage costs after the performance period of the contract? | As reflected in the highlighted verbiage on page 9 of the RFP, all cost must be incurred during the period of performance for each Task Order.Invoices will not be accepted for any activities outside the period of performance for each Task Order. |
| Solicitation | p. 15-16 | Will the FDA specify which tobacco products the Contractor should purchase? | As indicated in section C.1.6 (Compliance Check Inspections) of the RFP, FDA may request that a specific type of regulated product(s) be purchased during an inspection. Contractor shall purchase requested regulated product(s) if available during inspection. |
| Solicitation | p.15 | Will FDA provide written support if required by the state to assist the Contractor with obtaining immunity for Minors? | FDA will provide confirmation of contractual relationship. |
| Solicitation | L.8 page 121 | Section L.8 (p 121) of the solicitation states Phase 1 responses are due no later than 18 February. However, the Proposal Instructions (L.3, starting on p 110) do not include any delineation for a phased response and only provides information on a single, unified Technical Proposal (Volume I), Business Proposal (Volume II), and Past Performance (Volume III). Can the Government please provide clarity on the exact requirements of each phase? | The answer to this question has been provided in Row 4, Column F above. |
| Attachment 5 - Sample Task Orders for Each Region | 1 | The Sample Task Order lists only FDA Directed Undercover Buys for pricing and no longer includes Contractor Directed Undercover Buys as on the previous contracts. Is it the Government's intent to only have FDA Directed Undercover Buys be priced and performed? | FDA does not intend to have the contractor price out Contractor Directed Undercover Buys (CDUBs) however, FDA may specify retailers or geographic area.Alternatively, the contractor may be responsible for identifying retailers to inspect in each jurisdiction.Subject to the terms of the task order, the Contractor may determine the date of issuance, retailer location (selected from the retailer list), and timeframe for completion of those inspections. |
| Attachment 5 - Sample Task Orders for Each Region | 1 | The Sample Task Order lists only FDA Directed Undercover Buys and no longer includes Contractor Directed Undercover Buys as on the previous contracts. Contractor Directed Undercover Buys historically allow for greater efficiency and cost savings on the program as the Contractor can better group Undercover Buy locations. Will the Government please add Contractor Directed Undercover Buys back into the program and pricing? | In order to better meet FDA compliance enforcement mission, FDA has decided not to add Contractor Directed Undercover Buys.However, FDA may specify retailers or geographic area.Alternatively, the contractor may be responsible for identifying retailers to inspect in each jurisdiction.Subject to the terms of the task order, the Contractor may determine the date of issuance, retailer location (selected from the retailer list), and timeframe for completion of those inspections. |
| Attachment 5 - Sample Task Orders for Each Region | 1 | The Sample Task Order lists only FDA Directed Undercover Buys and no longer includes Contractor Directed Undercover Buys as on the previous contracts. Contractor Directed Undercover Buys historically allow for greater efficiency and cost savings on the program as the Contractor can better group Undercover Buy locations. If the Government will not add Contractor Directed Undercover Buys back into the program and pricing, can you confirm that FDA Directed Undercover Buys will be assigned as they have been on past contracts (please note this will increase overall pricing to the program as FDA Directed UBs are typically less efficient and more spread out geographically)? | In order to better meet FDA compliance enforcement mission, FDA has decided not to add Contractor Directed Undercover Buys.However, FDA may specify retailers or geographic area.Alternatively, the contractor may be responsible for identifying retailers to inspect in each jurisdiction.Subject to the terms of the task order, the Contractor may determine the date of issuance, retailer location (selected from the retailer list), and timeframe for completion of those inspections. |
| Attachment 5 - Sample Task Orders for Each Region | 1 | The Sample Task Order lists only FDA Directed Undercover Buys and no longer includes Contractor Directed Undercover Buys as on the previous contracts. Contractor Directed Undercover Buys historically allow for greater efficiency and cost savings on the program as the Contractor can better group Undercover Buy locations. If the Government will not add Contractor Directed Undercover Buys back into the program and pricing, can you confirm that FDA Directed Undercover Buys will be grouped in bulk quantity geographically by zip code? | FDA may specify retailers or geographic area.Alternatively, the contractor may be responsible for identifying retailers to inspect in each jurisdiction.Subject to the terms of the task order, the Contractor may determine the date of issuance, retailer location (selected from the retailer list), and timeframe for completion of those inspections. |
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