Amendment 0002 - Questions and Answers.xlsx
XLSX spreadsheet 40 KB Posted
- Solicitation number
- 75F40126R00040
About this file
This is a Questions and Answers amendment document addressing 84 clarifications to FDA Solicitation 75F40126R00040 for Third Party Tobacco Retailer Inspection Services in Region 4 (Alaska, Idaho, Utah, Nevada, Oregon, New Mexico, and Wyoming). The document provides critical guidance on proposal submission requirements, pricing structure, personnel qualifications, and contract performance standards.
Key proposal submission requirements include: Volume I Technical Proposals limited to 25 pages each for Mandatory Minimum Qualification-Commissioning and Tradeoff Evaluation Factors 1-3 (with separate pagination), using 12-point font throughout; resumes, pay stubs/employer letters, and commitment documentation are excluded from page limits; supporting documentation is capped at 15 pages; transmittal and cover letters are excluded but tables of contents are included in page counts; and PDF submission is acceptable for narrative volumes with pricing submitted in Excel format (Attachment 5). For commissioning, offerors must identify nine proposed inspectors minimum (three per state across three states) with current employer verification documents dated within three months of proposal submission. The Quality Control Plan, Inspection Plan addressing all Region 4 jurisdictions (not just Alaska), and immunity approach for Alaska and Utah must be included with proposals. The inspection plan may reference statute summaries rather than full statutory text. Regarding pricing, the contract employs three CLINs: 0001 for Inspections, 0002 for Program Management (monthly fixed-price supported by fully burdened hourly rates for Program Coordinator and Backup Program Coordinator using 2,080 annual hours), and 0003 for Other Direct Costs including non-inspection travel and witness testimony. Offerors may propose alternative escalation rates and additional labor categories beyond key personnel. Past Performance Questionnaires (Attachment 10) must be provided to customer Points of Contact for direct government submission by the July 31, 2026, 2:00 PM ET proposal deadline; CPARS records are not acceptable substitutes. Key personnel are limited to Program Coordinator and Backup Program Coordinator; no more than 30 inspectors per jurisdiction/task order may be proposed, with inspectors required to perform minimum 10 inspections monthly. Performance standards, AQL metrics, and surveillance methods are tracked per jurisdiction/task order. Active Year 1 task orders anticipated for Utah, Oregon, Idaho, Alaska, Nevada, New Mexico, and Wyoming, with task orders issued via RFTOP. The document also clarifies that Attachment 13 (pricing spreadsheet) has been removed; Attachment 5 is the sole government-provided pricing workbook. Wage Determination 1988-0407 applies to Inspector positions; pending DOL determinations for New Mexico, Utah, and Wyoming Underage Purchaser rates should use $15 per hour until official rates issue.
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Other files
| File | Type | Posted |
|---|---|---|
| Solicitation 75F40126R000400003 0723.pdf | ||
| Amendment 0003 - Questions and Answers.xlsx | XLSX spreadsheet | |
| SF33 75F40126R000400003.pdf | ||
| SF 33 75F40126R000400002.pdf | ||
| Solicitation 75F40126R0004000010002 Final.pdf | ||
| Attachments - Amendment 0002.zip | ZIP file | |
| SF 33.pdf | ||
| SF33 - 75f40126R000400001.pdf | ||
| Solicitation 75F40126R00040.pdf | ||
| Solicitation 75F40126R00040.pdf | ||
| Attachments 75F40126R00040.zip | ZIP file | |
| SF33.pdf |
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Sheet1
| Attachment TBD - RFP Question Submittal Form; Solicitation No. TBD |
| Attachment TBD - Question Submittal Form; Solicitation XXXXX |
| Offerors shall use this form to submit all questions in relation to Solicitation XXXX - FDA Tobacco Retailer Inspection Services |
| The Reference column contains drop-down menus from which the applicable section must be selected. The remaining sections are fill-in cells. | Description of Requirement/Statement of Work | |||||
| Proposal Instructions | ||||||
| Basis for Award and Evaluation Factors | ||||||
| Attachments | ||||||
| Terms and Conditions/Provisions/Clauses | ||||||
| Misc. | ||||||
| # | Reference | Section & Page #s | Question | Agency Response | ||
| Column1 | Column2 | Column3 | Column4 | Column5 | Column6 | |
| 1 | Proposal Instructions | L.2, 138; L.3, 139 | Are offerors permitted to use a reduced font size (less than 12-point) for tables, graphics, and charts, so long as they remain legible? | Offerors are not permitted to use a reduced font size for tables, graphics and charts. | ||
| 2 | Proposal Instructions | L.2, 138; L.3, 139 | Are tables of contents excluded from the page limitation? | No, the Table of Contents will be included in the page limitation. |
3 Proposal Instructions L.3, 139 Are transmittal/cover letters excluded from the page limitation? Yes, the transmittal and cover letter are excluded from the page limitation.
4 Proposal Instructions L.3, 139 Are offerors permitted to include cover sheets (in addition to transmittal/cover letters)? Yes, Offerors may include cover sheets in addition to the required transmital/cover letter. As stated in Section L.3 of the solicitation, the transmittal and cover letter for the proposal must contain the name, phone number, and e-mail address of the person to be contacted concerning any matter related to the proposal submitted.
5 Proposal Instructions L.3, 139 If offerors are permitted to include cover sheets, are they excluded from the page limitation? Yes, one (1) cover sheet is permitted and is excluded from the page limitation. The cover sheet should not exceed one page.
6 Proposal Instructions L.2, 138; L.3, 139 Should offerors submit a single Volume I - Technical Proposal document that includes both the Mandatory Minimum Qualification - Commissioning response and Tradeoff Evaluation Factors 1-3 response? No, Volume 1 consists of two (2) separate parts that should be submitted as separate documents: 1) Commissioning and 2) the response to Tradeoff Evaluation Factors 1-3.
As stated in Section L.3 of the solicitation, the Mandatory Minimum Qualification - Commissioning response is limited to 25 pages, and the response to Tradeoff Evaluation Factors 1-3 (Program Management/Staffing, Inspection Plan, and Corporate Experience) is limited at an additional 25 pages. These page limitations excludes resumes, commitment documentation, and supporting documentation.
7 Proposal Instructions L.2, 138; L.3, 139 Or should the Mandatory Minimum Qualification - Commissioning response and Tradeoff Evaluation Factors 1-3 response be submitted as separate documents? Volume 1 consists of two (2) separate parts that should be submitted as separate documents: 1) Commissioning and 2) the response to Tradeoff Evaluation Factors 1-3.
As stated in Section L.3 of the solicitation, the Mandatory Minimum Qualification - Commissioning response is limited to 25 pages, and the response to Tradeoff Evaluation Factors 1-3 (Program Management/Staffing, Inspection Plan, and Corporate Experience) is limited at an additional 25 pages. These page limitations excludes resumes, commitment documentation, and supporting documentation.
| 8 | Proposal Instructions | L.3 (Commissioning), 140 | This section states: "The Offeror shall include: 1) a copy of a proposed inspector’s pay stub from their current employer; OR 2) a letter (on the employer’s official letterhead) from the inspector’s current employer verifying that he/she is a health, food or drug officer/employee of the State, Territory, or political subdivision thereof." Are these submissions considered "supporting documentation"? (referenced on pg. 138 and 139) | Yes, these submissions are considered supporting documentation. As stated in Section L.3 of the solicitation, supporting documentation is excluded from the applicable page limitations. |
| 9 | Proposal Instructions | L.3 (Commissioning), 140 | This section states: "The Offeror shall identify the proposed inspectors it plans to hire for the region. The Offeror shall at a minimum provide three (3) proposed inspectors for at least three (3) states in the proposed region, for a total of nine (9) proposed inspectors." Should offerors submit resumes for all 9 proposed inspectors? | Yes, Offerors shall submit resumes for all nine (9) proposed inspectors identified in their proposal. As required by Section L.3.A, offeror shall at a minimum provide three (3) proposed inspectors for at least three (3) states in the proposed region, for a total of nine (9) proposed inspectors. The Offeror shall include: 1) a copy of a proposed inspector’s pay stub from their current employer; OR 2) a letter (on the employer’s official letterhead) from the inspector’s current employer verifying that he/she is a health, food or drug officer/employee of the State, Territory, or political subdivision thereof. All pay stubs or letters shall be dated within three (3) months of the date the Offeror submits a proposal. |
| 10 | Proposal Instructions | L.3 (Inspection Plan), 142 | This section states: "The Offeror shall submit the specific jurisdiction’s statute (if any) that addresses how tobacco compliance check inspections must be conducted..." Are offerors required to include the full text of these statutes? | No, Offerors are not required to submit the full text of the applicable statute. Offerors may submit the relevant portions of the statute necessary to demonstrate how tobacco compliance check inspections must be conducted within the applicable jurisdiction. |
| 11 | Proposal Instructions | L.3 (Inspection Plan), 142 | This section states: "The Offeror shall submit the specific jurisdiction’s statute (if any) that addresses how tobacco compliance check inspections must be conducted..." Is it acceptable for offerors to provide a summary/explanation of these statutes instead of the full text of the statute? | Yes, Offerors may provide a summary or explanation of the applicable statute in lieu of the full statutory text, provided the submission clearly identifies the applicable statute and includes the information necessary to demonstrate how tobacco compliance check inspections must be conducted within the applicable jurisdiction. |
| 12 | Proposal Instructions | L.3 (Inspection Plan), 142 | This section states: "The Offeror shall submit the specific jurisdiction’s statute (if any) that addresses how tobacco compliance check inspections must be conducted..." If offerors are required to include the full text of these statutes, can they be submitted as "supporting documentation"? | No. Offerors are not required to submit the full text of the applicable statute. Offerors should provide the information from the applicable statute necessary to demonstrate how tobacco compliance check inspections must be conducted within the applicable jurisdiction. This information is part of the required proposal submission and is not considered supporting documentation. |
| 13 | Proposal Instructions | L.5, 149 | This section states: "The Offeror shall provide the Past Performance Questionnaire (Attachment 10) and Past Performance Template (Attachment 7), to each of the customer Points of Contact identified for each of the relevant past performance efforts." Since the Past Performance Template is to be completed by the offeror and submitted as part of Volume III, please clarify the purpose of providing it to the customer Point of Contact. | The solicitation has been revised to clarify this requirement. The Offeror shall complete the Past Performance Template (Attachment 7) for each past performance citation submitted with its proposal. The Offeror shall provide only the Past Performance Questionnaire (Attachment 10) to each customer Point of Contact (POC) identified for the relevant past performance efforts. Customer POCs shall complete the questionnaire and submit it directly to the Contract Specialist and Contracting Officer. Completed questionnaires are considered Source Selection Information in accordance with FAR 2.101 and FAR 3.104 and shall not be released to the Offeror. Completed Past Performance Questionnaires are due no later than the proposal submission date. |
| 14 | Proposal Instructions | L.5, 149 | This section states: "The Offeror shall provide the Past Performance Questionnaire (Attachment 10) and Past Performance Template (Attachment 7), to each of the customer Points of Contact identified for each of the relevant past performance efforts." Should this instruction refer only to the Past Performance Questionnaire, since the Past Performance Template is to be submitted by the offeror as part of Volume III? | The solicitation has been revised to clarify this requirement. The Offeror shall complete the Past Performance Template (Attachment 7) for each past performance citation submitted with its proposal. The Offeror shall provide only the Past Performance Questionnaire (Attachment 10) to each customer Point of Contact (POC) identified for the relevant past performance efforts. Customer POCs shall complete the questionnaire and submit it directly to the Contract Specialist and Contracting Officer. Completed questionnaires are considered Source Selection Information in accordance with FAR 2.101 and FAR 3.104 and shall not be released to the Offeror. Completed Past Performance Questionnaires are due no later than the proposal submission date. |
| 15 | Proposal Instructions | L.5, 149 | This section states: "The Offeror shall provide the Past Performance Questionnaire (Attachment 10) and Past Performance Template (Attachment 7), to each of the customer Points of Contact identified for each of the relevant past performance efforts." Please clarify what action, if any, is expected of the customer Point of Contact with respect to the Past Performance Template. | The solicitation is revised to clarify this requirement. The Offeror shall complete the Past Performance Template (Attachment 7) for each past performance citation submitted with its proposal. The Offeror shall provide only the Past Performance Questionnaire (Attachment 10) to each customer Point of Contact (POC) identified for the relevant past performance efforts. Customer POCs shall complete the questionnaire and submit it directly to the Contract Specialist and Contracting Officer. Completed questionnaires are considered Source Selection Information in accordance with FAR 2.101 and FAR 3.104 and shall not be released to the Offeror. Completed Past Performance Questionnaires are due no later than the proposal submission date. |
| 16 | Attachments | Attachment 7 | Are offerors permitted to change the formatting of the Past Performance Volume template? | Yes, Offerors may make reasonable formatting adjustments to the Past Performance Volume Template, provided all required information is included and the content and organization of the template are not altered in a manner that omits or changes the required information. |
| 17 | Attachments | Attachment 10 | Attachment 10 - Past Performance Questionnaire says: "The Questionnaire is due no later than proposal due date of 07/27/2026." Are offerors permitted to update this date to reflect the current proposal due date of 07/31/2026? | The due date on the Past Performance Questionnaire has been revised to reflect the current proposal due date of 7/31/2026 at 2:00 PM ET. |
| 18 | Proposal Instructions | C.2.3; L.4.A & B (p. 17; 144-145) | C.2.3 designates only the Program Coordinator (PC) and Backup Program Coordinator (BPC) as key personnel, and Section L.4.A states a Program Analyst will be proposed only for jurisdictions with more than 5,000 inspections. May Offerors propose and price additional program management labor categories (e.g., Program Manager, Evidence Custodian, administrative support, etc.) in their response? If so, how should that information be presented for evaluation? | Yes, Offerors may propose other positions. As described in Volume I, Technical Proposal Instructions, Section L.4.A1. Program Management/Staffing on p.140 of the solicitation, please provide the organizational structure of the personnel and a description of their role in the inspection retail program including tasks that will be performed (e.g., program coordinator, back-up program coordinator, technical supervisors, Inspectors, as applicable) and the number of hours proposed for each position for the task orders included in the solicitation; describe how the personnel are (including current job title) or will be employed, and where they will be physically located (e.g., within the jurisdiction, regionally, or outside of the region); and for each proposed employee, describe whether they are currently an employee of the Offeror, in the process of being hired by the Offeror, an employee of a subcontractor, or working on this contract through another arrangement(s) and please specify the arrangement. Only the Program Coordinator (PC) and Backup Program Coordinator (BPC) are designated as key personnel. |
| 19 | Description of Requirement/Statement of Work | C.2.3; C.2.7 (p. 17; 23) | Given the size, scope, and multi-jurisdiction nature of this IDIQ, will the Government consider recognizing a dedicated Program Manager and an Evidence Custodian as allowable (key personnel) labor categories- especially considering the strict quality performance standards? A Program Manager supports consistency of processes and oversight across task orders, and an Evidence Specialist supports consistent chain-of-custody handling across jurisdictions. | No, for this IDIQ, the Government has designated only the Program Coordinator and Backup Program Coordinator as key personnel. Offerors may propose additional labor categories as necessary to support contract performance; however, those positions will not be recognized as key personnel. |
| 20 | Attachments | C.2.4; L.4.C; Attachment 11 (p. 18; 146) | Can the government confirm Wage Determination 1988-0407, Rev. 69) for "Inspector" is applicable for the requirements necessary for those Inspector candidates obtaining an FDA commission? Please consider a wage determination that appropriately acknowledges the minimum qualifications for Inspectors performing work on this contract. | The Department of Labor (DOL) provided the applicable Wage Determination. The Wage Determination inlcuded in the solicitation is current and up-to-date. |
| 21 | Description of Requirement/Statement of Work | C.2.4 (p. 18) | C.2.4 states the Contractor shall have no more than thirty (30) Inspectors and that inspectors must perform a minimum of 10 inspections per month in their respective jurisdictions. Please confirm whether the 30-inspector limit applies per jurisdiction/task order or across the entire Region 4 contract. Will the Government consider setting these thresholds at the task-order level to account for the unique staffing needs of each jurisdiction? | The limitation of no more than 30 inspectors applies to each jurisdiction/task order, not across the entire Region 4 contract. |
Due to logistics and associated expenses, the Contractor shall have no more than 30 Inspectors. Inspectors must maintain regular performance of inspections to remain active on a task order within this contract. Inspectors that do not perform a minimum of 10 inspections per month in their respective jurisdictions may be deactivated from the program.
| 22 | Proposal Instructions | L.2; L.3 (p. 138-139) | Section L requires a 12-point font for the technical proposal. To preserve readability of graphics and tables, will the Government allow a smaller font (e.g., 10-point) within graphics and tables only? | No, Offerors are not permitted to use a reduced font size for tables, graphics and charts. |
| 23 | Attachments | L.4.C; Attachment 12 (p. 146) | Attachment 12 (Wage Determination 2024-0024, Rev. 13) does not include Underage Purchaser rates for New Mexico, Utah, or Wyoming. Please provide the applicable Underage Purchaser wage determinations for New Mexico, Utah, and Wyoming, or confirm the rate/conformance basis that Offerors should use for those jurisdictions. | The Government is awaiting the applicable DOL Wage Determinations for New Mexico, Utah, and Wyoming. Until those are issued, Offerors should use a rate of $15 per hour for all three (3) states. |
| 24 | Proposal Instructions | L.8 (p. 152) | Section L.8 instructs Offerors to submit pricing using "the Government-provided Excel workbook (Attachment 10)," but Attachment 10 is the Past Performance Questionnaire and the Pricing Table appears to be Attachment 13. Please confirm Attachment 13, Pricing Table is the Government-provided Excel workbook? | No. Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing. |
| 25 | Proposal Instructions | L.4.B; L.8; M.1 (p. 145; 152; 159) | The Program Management line item is referenced inconsistently as "Line Item 0002" (Section L, Initial Task Order Pricing) and "Line Item 0003" (Section L.4.B and Section M). Please confirm the correct CLIN number for Program Management. | The Solicitation has been updated. Program Management is Line Item 0002. |
| 26 | Proposal Instructions | L.3; Section L, pp. 138-139 | Do the cover/transmittal letter, table of contents, table of exhibits, and any executive summary count toward the technical (25?) page limit? | The cover/transmittal letter are excluded from the page count. The table of contents and table of exhibits are not excluded from the page limitation. |
27 Proposal Instructions L.3 / L.7; Section L, pp. 138-139, 151 Should the Mandatory Minimum Qualification (Commissioning) and the Tradeoff Evaluation Factors 1-3 be submitted as separate files/documents, or combined within a single Volume I - Technical Proposal with distinct sections? Volume I shall be submitted as one document consisting of two separate parts: (1) the Mandatory Minimum Qualification – Commissioning response and (2) the response to Tradeoff Evaluation Factors 1–3 (Program Management/Staffing, Inspection Plan, and Corporate Experience). See Section L.3 of the solicitation for page limitations.
| 28 | Proposal Instructions | L.3.2 / C.1.3; Section L, pp. 139–142 | Section L.3.2 (Inspection Plan) instructs offerors to provide the required information "for the task order attached," which is the Alaska Initial Task Order, while the IDIQ covers all thirteen Region 4 jurisdictions and Commissioning (L.3.A) is region-wide. Should the Technical Proposal (inspection methodology, coverage plan, statutory analysis, monthly estimates, and schedule) be scoped ONLY to the Alaska Initial Task Order? OR should this section address ALL Region 4 jurisdictions? If all jurisdictions, please confirm the level of detail expected for jurisdictions beyond the Initial Task Order. | The Inspection Plan shall address all Region 4 jurisdictions, not just the initial, Alaska Task Order. Offerors shall prepare their Inspection Plan in accordance with Section L.2.1 (starting on page 138) and L.3.A.2 (page 141-142), Volume 1- Technical Proposal. |
| 29 | Proposal Instructions | L.3.1; Section L, pp. 140–141 | The immunity instruction under Evaluation Factor 1 first directs offerors to provide an approach "specifically for Region 4 (Idaho, Utah)," but the same paragraph then directs offerors to provide "each jurisdiction's requirements" and to obtain a grant of immunity "from each applicable jurisdiction." Please confirm the intended scope of the immunity approach and supporting documentation in the Technical Proposal... (a) limited to the Alaska Initial Task Order; (b) limited to the named jurisdictions Idaho and Utah; or (c) covering all Region 4 jurisdictions? | The solicitation has been revised. For evaluation purposes, Offerors shall provide a specific approach for securing a grant of immunity specifically for Region 4 (Alaska, Utah) prior to using Underage Purchasers in any jurisdiction where it would be illegal to use Underage Purchasers to conduct undercover buy assignments or where an Underage Purchaser’s purchase or possession of FDA regulated tobacco products is illegal. The Offeror shall provide a copy, summary, and/or reference to publicly available documents of Alaska and Utah, and submit a plan on how it will obtain a grant of immunity in writing from each applicable jurisdiction. (C.2.5., C.2.7) |
After award, the successful Contractor shall obtain and provide written grants of immunity for each applicable jurisdiction before performing inspections requiring such authorization.
| 30 | Attachments | Attachment 10 (Past Performance Questionnaire), p. 1 | Attachment 10, Past Performance Questionnaire, states that the questionnaire "is due no later than proposal due date of 07/27/2026." However, Section L.7, Proposal Submission, establishes the proposal due date as July 31, 2026, at 2:00 PM ET. Will the Government please confirm that the operative due date for both the proposal and the Past Performance Questionnaires (Attachment 10) is July 31, 2026, at 2:00 PM ET? | Yes, the Past Performance Questionnaire is due no later than 7/31/2026 at 2:00 PM ET. Attachment 10 was revised to address this discrepancy. |
| 31 | Description of Requirement/Statement of Work | B.3.2 Program Management | The contractor shall propose monthly FFP pricing for program management, as well as fully burdened hourly labor rates for program management labor categories. Please confirm how the government anticipates to issue funding for program management, and how the awarded contract can expect to invoice for these services? How will these two structures be evaluated for award? | The contract type for program management will be determined at the task order level. The Government will evaluate the FFP monthly price based on the total price over the 5-year POP, to determine overall reasonableness and competitiveness. For cost reimbursement or T&M hourly rates, the Government will evaluate based on the fully burdened hourly rates proposed for each labor category to determine whether they are fair, reasonable, and consistent with market rates |
Both structures will be considered together as part of the overall price evaluation to determine best value to the government.
| 32 | Description of Requirement/Statement of Work | B.3.3.3 Other Direct Costs (ODC) | The table provided for Not to Exceed Costs for ODCs is listed per Region, not by jurisdiction (as the NTE travel table is). Please confirm ODCs anticipated per jurisdiction so that a price quote can be accurately reflected. | A sample table (Attachment 5) was attached to the solicitation to provide an outline of the estimated costs. Please use" Breakdown of Other Direct Cost" Tab on Attachment 5 for estimation purposes. |
| 33 | Description of Requirement/Statement of Work | B.3.3.4 Witness Testimony Compensation | The table provided for Witness Testimony Compensation Not to Exceed Costs for is listed per Region, not by jurisdiction (as the NTE travel table is). Please confirm Witness Testimony Compensation per jurisdiction so that a price quote can be accurately reflected. | Witness testimony cost should be proposed on a regional basis rather than by jurisdiction. |
| 34 | Description of Requirement/Statement of Work | C.1.3 Geographic Scope | Besides the initial Task Order of Alaska, can the government please provide a list of other anticipated task orders to be issued for year 1? | The following are active jurisdictions: Utah, Oregon, Idaho, Alaska, Nevada, New Mexico, and Wyoming .There is no guarantee that the Contractor will receive task orders for all jurisdictions or states located within a region. |
| 35 | Basis for Award and Evaluation Factors | 1. Program Management/Staffing (Volume 1- Technical Proposal) | Does the government have a definition of hours for Full time equivalent (FTE)? (i.e. 2080, 1920, etc.)? Is there a requirement for offerors to use a specific level of effort within the price quote? | Section L of the solicitation was updated to include pricing assumptions. For pricing purposes only, one (1) FTE is assumed to equal 2,080 hours annually. |
| 36 | Description of Requirement/Statement of Work | C.6.2 UB Inspections | Are performance standards, AQL, and surveillance methods tracked per jurisdiction/task order, or by region? | Perfomance standard, AQL, and surveillance methods are tracked per jurisdiction/task order. |
| 37 | Description of Requirement/Statement of Work | C.7.1 Reviewing Compliance Check Inspection Results | AQL bullets appear to be referencing the completion of A&L Inspections, not for reviewing inspections. Please confirm AQL standards for C.7.1. | AQL has been revised in C.7.1 . |
38 Description of Requirement/Statement of Work C.8.2 Transition C.8.2 requires key personnel be "available to work immediately upon Task Order award," but C.2.2 requires background investigation and fingerprint clearance before any personnel may participate. Since fingerprint clearance cannot be completed at award, please clarify whether "available to work immediately" means available for administrative activities only (i.e. immunity, recruitment, etc.), rather than performing commissioned duties? Or clarify if no work can be completed before fingerprint clearance? C.2.2 references Inspectors that must be commissioned before conducting inspection activities.
C.8.2 references Transition In activities and is applicable to key personnel.
| 39 | Description of Requirement/Statement of Work | C.10.1 Inspection Quality Performance Standards | C.10.1 sets generic inspection timeliness standards (98% within 5 days, 95% within 15 days, 90% within 90 days; and a 95% acceptability rate), but C.6.2 (UB) and C.6.3 (A&L) already establish separate, inspection-type-specific standards and F.3 states different UB/A&L timelines as well. The C.10.1 percentages match neither the UB nor the A&L standards, and its 95% acceptability rate conflicts with the 98% accuracy standards in C.6.2 and C.10.2. Please clarify what C.10.1 governs, whether its standards supersede or supplement the type-specific standards in C.6.2, C.6.3, and F.3, and which controls in the event of conflict. | The solicitation has been revised to clarify the inspection performance standards in Section C.10.1. Offerors shall refer to the revised solicitation. |
| 40 | Description of Requirement/Statement of Work | C.10.2 Data Accuracy Standards | Please clarify what information C.10.2 governs and how it differs from other standards already defined? | The solicitation has been revised to clarify the requirements of Section C.10.2. Offerors shall refer to the revised solicitation. |
| 41 | Description of Requirement/Statement of Work | H.9 Procedures for Issuing Task Orders | Does the government anticipate to issue RFTOPs for Year 1 awards, or are RFTOPs only for subsequent year awards? | The Government anticipates issuing RFTOP for all task order awards, including Year 1. |
| 42 | Proposal Instructions | L.2 & L.3 | Please confirm the governments intended TOTAL page limit for Volume I: 1) 25 pages or 2) 50 pages (25 for Commissioning PLUS 25 for Factors 1-3). | L.2- Techinical proposal Volume 1- Technical proposal volumes shall be limited to 25 pages with a 12-point font for the Mandatory Minimum Qualification - Commissioning and 25 pages with a 12-point font for Tradeoff Evaluation Factor 1-3. Any pages submitted above the 25 page limit will not be evaluated which could negatively impact your technical evaluation. This limitation excludes resumes (no page limit), commitment documentation (no page limit), and supporting documentation (maximum 15 pages). NOTE: No more than 15 pages of supporting documentation will be allowed. The technical proposal shall include a table of contents. |
L.3- The technical proposal shall be limited to 25 pages for Mandatory Minimum Qualification - Commissioning and another 25 pages for Program Management/Staffing, Inspection Plan, and Corporate Experience (Tradeoff Evaluation Factors 1-3) with a 12-point font. This limitation excludes resumes, commitment documentation, and supporting documentation. The technical proposal shall include a table of contents.
43 Terms and Conditions/Provisions/Clauses K.4 / 352.239-78 (p.131–132); I.13 / 352.239-74 (p.124); L.3–L.5 (p.138–150) Provision 352.239-78 (K.4) states offerors "must submit" a Section 508 Checklist or ACR/VPAT with their proposal, but Section L does not request one.
1. Please confirm if this is required, since this is a services acquisition in which the contractor uses FDA's TIMS system and delivers electronic content (reports, photos, data) rather than offeror-developed ICT products.
| 2. If required, where it should be placed and does it count against the volume's page limit? | No, a Section 508 checklist or ACR/VPAT is not required for this solicitation. | ||||
| 44 | Proposal Instructions | L.2 | Will the government accept PDF files for the submission of narrative volumes? (With the exception of the excel pricing spreadsheet.) Or is Microsoft Office Suite (Word) submission required? | Yes. Offerors may submit the narrative proposal volumes in PDF format. The pricing spreadsheet shall be submitted in the required Excel format, as specified in the solicitation. | |
| 45 | Proposal Instructions | 1. Program Management/Staffing (Volume 1 - Technical Proposal) | Section L.3 (Factor 1) requires the Offeror to submit a Quality Control Plan with its Technical Proposal, while Section C.3.1 and the Section F.3 deliverables table require the QCP to be submitted within ten (10) business days of award. Please confirm whether the QCP is required both at proposal submission (for evaluation) and again after award? Or whether the proposal-stage QCP satisfies the requirement. If required at proposal submission, please confirm whether it counts against the technical volume page limit? | Submit with Technical Proposal. The QCP does not count against the technical page limit. | |
| 46 | Proposal Instructions | Page 144. (A. Price per inspection) | Can the government define the Program Analyst labor category mentioned on page 145? Would this be a key personnel role? What tasks do they perform for jurisdictions over 5,000 inspections? | The reference to the Program Analyst labor category has been removed on page 144. For this IDIQ, the key personnel are the Program Coordinator and Back Up Program Coordinator. |
| 47 | Proposal Instructions | D. Additional document to be submitted with business proposal | If a subcontractor is does not meet the FDA's determination of 'significant' (page 149), is it required to submit subcontractor information and pricing as for Volume III? | No. Section L.5 (Volume III – Past Performance Information) requires past performance information only for the Offeror and, if applicable, one significant teaming partner or significant subcontractor. As stated in Section L.5, references for proposed subcontractors that are not considered significant are not desired and will not be considered relevant. |
| 48 | Proposal Instructions | L.5, Volume III – Past Performance (p.149) | Section L.5 permits no more than three (3) total past performance efforts and notes that "individual task orders under an IDIQ contract are each considered to be one (1) past/present performance effort." For an offeror whose relevant experience may include IDIQ contracts spanning multiple task orders, please clarify whether an offeror may cite an entire IDIQ contract (encompassing multiple task orders) as a single past performance effort to show IDIQ management capability, or if that would be deemed non-complaint and this restricts to only the submission of individual Task Orders as compliant? | Offerors shall submit past performance efforts in accordance with Section L.5 of the solicitation. As stated in Section L.5, individual task orders under an IDIQ contract are each considered one (1) past/present performance effort. Accordingly, offerors shall submit individual task orders as past performance efforts rather than the IDIQ contract as a single past performance effort. |
| 49 | Basis for Award and Evaluation Factors | Evaluation Factor 3- Corporate Experience | Can the government please define the evaluation factors for Corporate Experience? There are no factors 'listed below'. | Please see section L.3.A.3 - Corporate Experience page 142- 143 |
| 50 | Basis for Award and Evaluation Factors | Evaluation Factor 5- Price | Please confirm which provided excel workbook is required to be submitted with the price proposal? Attachment 5 or Attachment 13? Or Both? Please specify. | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing. |
| 51 | Attachments | Attachments 5 and 13 | Attachment 5 (Initial Task Order) and Attachment 13 (Pricing Spreadsheet) both request pricing for Program Management, UB and A&L unit prices, ODC, non-inspection travel, and witness testimony across Years 1–5, however are inherently conflicting documents. Please confirm whether offerors are to complete both workbooks, and, where a value or rate differs between the two, which document controls for evaluation and award? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing. |
| 52 | Attachments | Attachment 13 | Based on 'unit' data pre-populated into Attachment 13, please clarify if following jurisdictions are anticipated to be Year 1 task orders: Idaho, Nevada, Oregon, New Mexico, Utah, Alaska, Wyoming? | Task Orders for Utah, Oregon, Idaho, Alaska, Nevada, New Mexico and Wyoming may be awarded in Year 1. |
Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing
| 53 | Attachments | Attachments 5 and 13 | Please confirm inspection figures for the initial task order of Alaska. Attachment 5 shows 250/100 and Attachment 13 shows 1000/500. Which document will be evaluated for price? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing |
| 54 | Attachments | Attachments 5 and 13 | Other Direct Cost (ODC) Not-to-Exceed amounts conflict across documents- B.3.3.3, Attachment 13, Attachment 5. Please confirm amounts at 100,000 or 10,000 and if they are designated per region or jurisdiction? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing |
| 55 | Proposal Instructions | L.4.A–B (p.144–145); L.8 / M (p.152, 159); Attachment 13 | Section L instructs offerors to make an "independent assessment of the resources required" and to propose the labor categories, hours, and rates needed to perform, but Section L.4.A (p.145) states that a "Program Analyst will be proposed for jurisdictions with more than 5,000 inspections only." Please clarify: (a) whether offerors retain discretion to propose the labor categories they determine necessary, or whether the 5,000-inspection threshold is a firm restriction on proposing a 'Program Analyst'; and (b) if firm, whether it applies only to the "Program Analyst" title or also limits other additional (non-PC/BPC) labor categories offerors may propose to support the work? | The reference to the Program Analyst has been removed from the solicitation. Offerors retain discretion to propose labor categories they determine necessary for government review. |
| 56 | Attachments | B.3.2 (p.6); L.4.B (p.145); Attachments 5 and 13 | Program Management pricing is represented three different ways: (a) Sections B.3.2 and L.4.B require a monthly FFP price plus fully burdened hourly rates for the PC and BPC; (b) Attachment 5 requests Program Management as 2,080 NTE hours multiplied by an hourly rate ("NTE Program Management (PC & BPC)"); and (c) Attachment 13 requests Program Management as a dollar amount per jurisdiction (YR tabs, column B), with the "PM and Unit Pricing Assumptions" tab building a single Region 4 "PM TOTAL" that is then applied to each jurisdiction row. Please clarify how offerors should present Program Management pricing so that the monthly FFP price, the 2,080-hour annual labor-hour basis, and the per-jurisdiction PM amount are reconciled. | The solicitation has been revised to clarify the Program Management pricing requirements. Attachment 13 has been removed. Offerors shall use Attachment 5 to prepare and submit Program Management pricing. The monthly fixed-price Program Management amount shall be supported by the fully burdened hourly rates for the Program Coordinator (PC) and Backup Program Coordinator (BPC) using the Government-provided pricing assumptions. |
| 57 | Attachments | Attachment 13, Pricing Table - Yearly Tabs | Based on the formulas on the Year 5 tab for Program Management and Undercover Buy unit costs, an annual escalation of 4% per year has been included. May offerors propose a different escalation if justification is provided, and adjust the formulas to their proposed escalation? | Yes, Offerors may propose a different escalation rate and adjust the formulas accordingly. |
| 58 | Attachments | Attachment 13 | The Regional Total (cell M2) in each yearly tab only captures the costs for row 2, to include the plug figure of $100,000 for ODCs and $10,0000 for Witness Testimony Compensation. Should the costs for each individual jurisdiction be captured in the Region Total, or is M2 meant to only include costs that are shared across the entire region? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing |
| 59 | Attachments | Attachment 5 | Formulas site external references not included in other government provided forms. Please confirm if offerors may correct the formulas across all provided workbooks. | The Government has revised the affected workbook to correct the formulas. Offerors shall use the revised Government-provided Attachment 5 issued on the amendment when preparing and submitting their proposals. |
| 60 | Attachments | Attachment 5 & 13 | Please confirm if additional tabs can be added to the provided spreadsheets to portray offeror pricing details? | Yes, Offerors may add additional tabs to the pricing workbook as necessary to support their proposed pricing. |
| 61 | Attachments | Attachment 13 | Arizona and Montana are not included in the list of states in Attachment 13, but are included in the solicitation in sections B.2.3 and C.1.3. |
| Will FDA reissue a version of Attachment 13 to include Arizona and Montana? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing | |||
| 62 | Attachments | Attachment 13 | California, Colorado, Hawaii, and Washington do not include any formulas on the yearly tab, nor do they include the plug figures for Non-Inspection Travel per Jurisdiction or the units in columns G and J. |
Should these states, with the addition of Arizona and Montana, include the same plug figures as the other states?
| Will FDA reissue a version of Attachment 13 to include formulas and plug figures? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing | |||
| 63 | Attachments | Attachment 13 | Year 5 includes formulas to pull the Program Management and Undercover Buy unit costs from the PM and Unit Pricing Assumptions tab. |
| Can FDA kindly confirm that all unit costs (Program Management, Undercover Buy, and Advertising and Labeling) should pull through to all years to generate the detailed annual pricing on the Yearly tabs? Will FDA reissue a version of Attachment 13 with all these formulas added to each tab? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing | ||||
| 64 | Attachments | Attachment 13 | Rows 6 and 7 of the PM and Unit Pricing Tab assume that Overhead is based on a percentage of direct labor, and Fringe and G&A are based on a percentage of direct labor and overhead. Please confirm that if an offeror's standard accounting practices apply indirect differently (for example, fringe on direct labor, Overhead on fringe and direct labor, etc.) that they may adjust these rows or insert additional rows to account for their standard practice? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing | |
| 65 | Attachments | Attachment 13 | Can offerors adjust the cost build up table for cost per inspection to include additional direct cost inputs into the price per inspection build up table included in Attachment 13? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing | |
| 66 | Attachments | Attachment 13 | The "Cost Ceilings by Year" table pulls the Total IDIQ cost from the "Grand Total Year X" cell in row 38 while the Region 4 total pulls from the "Region 4" totals in row 14. As the spreadsheet is currently built, these totals are the same. Can FDA please clarify how, if at all, these totals should differ? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing | |
| 67 | Attachments | Attachment 13 | On the Total Cost tab in the Yearly cost tables, the Jurisdiction totals pull from each yearly tab and include the total cost per state. However, on the Total Cost tab, these Jurisdiction costs are not factored into the totals. |
1. Can FDA please clarify if the Jurisdiction costs should be replicated in the "Region Total" column so as to be captured in the "Grand Total" by Year in row 38?
| 2. If not, please clarify how the Jurisdiction costs will be factored into the Cost Ceilings by Year table? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing | ||||
| 68 | Attachments | Attachment 13 | California, Colorado, Hawaii, and Washington do not include any formulas on the Total Cost tab. Will FDA reissue a version of Attachment 13 to include formulas for these states, as well as adding Arizona and Montana, to the Total Cost tab? | Attachment 13 has been removed from the solicitation. Offerors shall use Attachment 5 as the Government-provided Excel workbook for submitting pricing | |
| 69 | Proposal Instructions | L.6.2 Question Submittal Process and Attachment Reference page 150 | Two solicitation numbers are referenced: 75F40125R00040 and 75F40125R00046. Kindly confirm that all proposal materials and correspondence should reference 75F40126R00040? | The solicitaiton number is 75F40126R00040 | |
| 70 | Terms and Conditions/Provisions/Clauses | I.1 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998), page 104 | FAR 52.219-9, Small Business Subcontracting Plan, is included on page 104. Given that this is a small business set aside, would FDA consider removing this clause from the solicitation? | Yes. FAR 52.219-9 has been removed from the solicitation. | |
| 71 | Proposal Instructions | L.2 Proposal Instructions page 138 | L.2.2 states that Technical Proposal supporting documentation is limited to 15 pages. Can FDA please clarify what specific information is expected to be included in this 15 page limit? | The 15-page limit applies to supporting documentationsubmitted with the technical proposal. Supporting documentation may include evidence, justification or additional details to support the Offeror's proposed approach. | |
| 72 | Proposal Instructions | SF 33 and L.4 VOLUME II – BUSINESS PROPOSAL INSTRUCTIONS page 144 | Block 12 of the SF 33 has a pre-filled "0" calendar days for minimum bid acceptance, while Section L.4 states that the Business Proposal cover letter should include "proposal expiration date (shall remain valid six (6) months after proposal submission)." Please confirm the required offer/proposal acceptance period. Should offerors revise Block 12 of the SF 33 to align with this information? | Offerors shall keep their proposals valid for six (6) months after proposal submission date. | |
| 73 | Terms and Conditions/Provisions/Clauses | Section C.2.9 COMMUNICATION AND DATA TRANSMISSION pages 26-27 and Section H.1 SECURITY AND PRIVACY REQUIREMENTS pages 69-89 | Section C.2.9 appears to require use of FDA-provided systems only, while Section H.1 includes broader security, SA&A, ATO, PTA/PIA, and contractor-system requirements. Please confirm which Section H.1 security/ATO/PTA/PIA requirements apply if the Contractor uses only FDA-furnished equipment and FDA systems and does not operate a contractor-owned system containing FDA data? | The solicitation clarifies the applicability of these requirements in Section H.2. Contractors using only FDA-furnished equipment and FDA-provided systems shall comply with the applicable security and privacy requirements of the solicitation. The contractor-owned information system requirements in Section H.2 apply only if the Contractor uses contractor-owned information systems to store, process, or transmit FDA information. | |
| 74 | Attachments | Attachment 13 | Attachment 13's "PM and Unit Pricing Assumptions" tab lists "PC training in DC" as a Program Management cost input, but the PWS does not appear to require in-person PC training in Washington, DC. Will the Government confirm whether offerors are required to price PC/BPC travel for in-person DC training? | Offerors are not required to price PC/BPC travel for in-person DC training. Attachment 13 has been removed from this solicitation. | |
| 75 | Description of Requirement/Statement of Work | B.3.1–B.3.3.1 (p.6–7); L.7 (p.152); M.1 (p.159); Attachments 5 and 13 | The solicitation's Contract Line Item Numbers are used inconsistently and are not defined in a price schedule. B.3.3.1 assigns Line Item 0003 to Non-Inspection Travel, ODCs, and Witness Testimony, while L.7 and M.1 assign Line Item 0003 to Program Management, and L.7 separately refers to Program Management as Line Item 0002. In addition, the CLINs are not itemized or defined in Section B or in the pricing workbooks (Attachments 5 nor 13). Please provide a definitive CLIN structure identifying each line item (e.g., 0001–000x) and its corresponding scope, and confirm whether the pricing workbooks should include a CLIN breakdown so that proposed prices map to the correct line items? | The correct Contract Line Item Number (CLIN) structure is as follows: |
CLIN 0001 – Inspections CLIN 0002 – Program Management CLIN 0003 – Other Direct Costs (ODCs), including Non-Inspection Travel and Witness Testimony, as applicable.
The references to CLIN 0003 for Program Management and CLIN 0002 in Sections L and M were inadvertent errors. The solicitation will be amended to correct these references and ensure the CLIN structure is used consistently throughout the solicitation.
| 75 | Proposal Instructions | Section L, Volume I, Factor 1 (Program Management/Staffing), pp. 140–141; cross-reference C.2.3 and C.1.2 | For the Key Personnel requirement in Factor 1, it states PC/BPC resumes are required for "the jurisdictions included in the solicitation". Please confirm if this is only for the Alaska Initial Task Order? (If not, please specify which jurisdictions require PC/BPC resumes for submission.) | For evaluation purposes, the Offerosr shall submit resumes for the proposed Program Coordinator and Backup Program Coordinator positions for Alaska and Utah. The Solicitation has been revised accordingly. |
| 76 | Proposal Instructions | N/A | Please confirm the proposal due date of 07/31/2026 at 2:00 PM. SAM.gov currently still lists the date as 07/27/26. | Amednment 0001 and 0002 on SAM.gov lists the due date as 7/31/2026 at 2 PM ET |
| 77 | Proposal Instructions | p.137 | Please confirm that the Technical Proposal page limits are 25 pages for Mandatory Minimum Qualification (Commissioning) and 25 pages for Tradeoff Factors 1–3, and that these limits are separate (i.e., 50 pages total for narrative). | L.2- Techinical proposal Volume 1- Technical proposal volumes shall be limited to 25 pages with a 12-point font for the Mandatory Minimum Qualification - Commissioning and 25 pages with a 12-point font for Tradeoff Evaluation Factor 1-3. Any pages submitted above the 25 page limit will not be evaluated which could negatively impact your technical evaluation. This limitation excludes resumes (no page limit), commitment documentation (no page limit), and supporting documentation (maximum 15 pages). NOTE: No more than 15 pages of supporting documentation will be allowed. The technical proposal shall include a table of contents. |
L.3- The technical proposal shall be limited to 25 pages for Mandatory Minimum Qualification - Commissioning and another 25 pages for Program Management/Staffing, Inspection Plan, and Corporate Experience (Tradeoff Evaluation Factors 1-3) with a 12-point font. This limitation excludes resumes, commitment documentation, and supporting documentation. The technical proposal shall include a table of contents.
78 Proposal Instructions p.137 Please confirm that resumes, pay stubs/employer letters are excluded from the technical page limits and are not intended to be included in the 25-page limit for Mandatory Minimum Qualification. L.2- Techinical proposal Volume 1- Technical proposal volumes shall be limited to 25 pages with a 12-point font for the Mandatory Minimum Qualification - Commissioning and 25 pages with a 12-point font for Tradeoff Evaluation Factor 1-3. Any pages submitted above the 25 page limit will not be evaluated which could negatively impact your technical evaluation. This limitation excludes resumes (no page limit), commitment documentation (no page limit), and supporting documentation (maximum 15 pages). NOTE: No more than 15 pages of supporting documentation will be allowed. The technical proposal shall include a table of contents.
L.3- The technical proposal shall be limited to 25 pages for Mandatory Minimum Qualification - Commissioning…
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