Questions And Responses- Solicitation 75F40125R00018- Final.pdf

Number Document Page Section Question FDA Response 1 RFP 7 1 Table shows only two inspection types: undercover buy and advertising and labeling. Are those the only two inspection type contractors should propose?

Please confirm contractors do not also need to quote for both FDA Directed UBs and Contractor Directed UBs.

Please confirm the types of inspections required to be performed and which should be priced.

The Contractor shall arrange tobacco compliance check inspections of retailers that sell or advertise tobacco products to determine whether those retailers are complying with the Tobacco Control Act and the implementing regulations (See Section B.1.C.).

Generally, the Contractor shall carry out two (2) types of tobacco compliance check inspection assignments: (1) undercover buy assignments, to determine a retailer's compliance with age and photo identification requirements; and (2) advertising and labeling, to cover other provisions of the Tobacco Control

Act. In some instances, FDA may request, in advance, that both types of assignments be conducted within a short timeframe of each other at a particular retail outlet. (See Section C.1.6) Each Task order will state the estimated number of Undercover Buy (UB) inspections for each jurisdiction. The Contractor may be responsible for identifying retailers to inspect in each jurisdiction. The Contractor may determine the date of assignment and retailer location. The Contractor shall not assign the UB inspections at a retailer location where a retailer inspection has been completed within 365 days from the prior inspection unless otherwise directed by

FDA.

2 RFP 8 1 Are contractors allowed to quote other positions besides Program Coordinator and Backup Program Coordinator? (i.e. Program Manager, Program Analyst, Evidence Custodian, etc.) If so, please add guidance on how to submit this information.

Yes, you are allowed to propose other positions. The PC and BPC are the only Key Personnel that will be considered for the task orders. See Volume I- Technical Proposal Instructions B. Program Management/Staffing on p.112 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 and the number of hours proposed for each position for the task orders included in the solicitation.

3 RFP 8 1 Are the costs associated with locating UPs and Inspectors that have left the program to be issued as a separate, future task order?

No. Costs associated with locating inspectors and UPs will not be issued as a separate task order.

This is covered under Program Management.

Information regarding Witness testimony compensation is located on page 9 under Witness Testimony Compensation.

4 RFP 9 Witness Testimony Compensation

The RFP states, "Compensation for witness testimony costs will be reimbursed based on inspection rates." Later, it states "Compensation is based on the amount of time testifying." These two criteria are at odds with each other. Can the Government clarify if it is FFP at the cost of an inspection (if so, at UB or A&L rate) or based on the amount of time to testify (If so, at Inspector rate built into the Inspection cost)?

These two criteria are not at odds with one another. To clarify, compensation for Witness Testimony costs will be in reimbursed based on the inspection rate and the length of time spent testifying.

5 RFP 12 C.1 Scope of Work Should the regional table show the quantity of inspections anticipated per region, per year?

No. The table on page 11 on the RFP will be populated with the minimum inspection numbers from the sample Task Orders.

This number is intended to be the minimum for all 5 years of the IDIQ.

6 RFP 12 B. Background Investigations/ Commissioning Process

Please define the how the contractor shall 'certify' candidates meet the commissioning requirements.

Language has been updated.

7 RFP 14 C. Key Personnel The RFP states, "The PC and BPC together shall equal one

(1) FTE." However, the slides during the Pre-Proposal conference stated the PC/BPC should at least meet 2080 hours. Please confirm if PC/BPC hours are capped in 2080 or if that is the minimum allowed to be proposed, collectively. (Note:

PC/BPC equal to 2080 hours per jurisdiction will greatly impact larger jurisdictions with high retailer and inspection volumes.)

For the purposes of this contract, The PC and BPC together shall equal one (I) Full Time Equivalent (FTE).

8 RFP 14 C. Key Personnel The RFP states, "Other program management hours not to exceed 500 hours."

Please confirm this is per Task Order. If this is a contract-wide requirement, it greatly impacts larger jurisdictions with high retailer and inspection volumes.

The “Other program management hours not to exceed 500 hours.” language will be removed.

Program management costs will be negotiated based on proposed hours on a per jurisdiction basis.

Other program management hours may not be needed for smaller jurisdictions.

9 RFP 14 C. Key Personnel It is recommended a Program Manager (PM) be added as a required key personnel role for each IDIQ.

As a third party charged with operating an IDIQ of various task orders, or jurisdictions within a region, a PM maintains consistency of processes, provides overall team oversight, allocates resources, and manages budgets—all critical aspects to project success. A designated PM role is consistent with industry standards and best practices for an IDIQ contract of this

The government has determined not to amend the key personnel listed in the RFP. The Contractor shall designate the key personnel:

Program Coordinator (PC) and the Backup Program Coordinator (BPC). See Volume I - Technical Proposal Instructions B.

Program Management/Staffing on p.112 of the solicitation, please provide the size, scope, and especially considering the ceiling values anticipated per region for this work. Other similar contracts recently released by FDA CTP require a PM role, especially for inspections, surveillance, and IDIQ management.

organizational structure of the personnel and a description of their role in the inspection retail program including tasks that will be performed and the number of hours proposed for each position for the task orders included in the solicitation.

10 RFP 14 C. Key Personnel It is recommended that FDA CTP consider an Evidence Specialist (ES) as an allowable role for this program. Third party contractors are charged with managing various states within a Region and storing their evidence accordingly. A designated ES would provide consistent evidentiary chain of custody knowledge across multiple jurisdictions, and regions if applicable.

The government has determined not to amend the key personnel listed in the RFP. See Volume I - Technical Proposal Instructions B.

Program Management/Staffing on p.112 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 and the number of hours proposed for each position for the task orders included in the solicitation. Any costs associated with conducting inspections may be included in the fixed price per inspections.

11 RFP 14 D. Inspectors As inspectors are overwhelmingly off-duty Police Officers as a result of jurisdictional/commissioning requirements, would the Government consider using the Labor Category of 27132 POLICE OFFICER II for the Wage Determination?

This category includes occupations concerned with providing protection against fire, fighting fires, and detecting fire hazards;

maintaining law and order to protect individuals and property, directing ,and controlling traffic and maintaining order in court; and guarding property to prevent illegal entry, fire, theft, and vandalism, to ensure safety of people. Based on previously awarded state contracts and invoicing thus far, a Inspector does not appear to perform the duties of a police officer. A Police Officer enforces laws established for the protection of persons and property, by detaining, arresting, interrogating, and incarcerating suspected violators, and appearing as a witness at trials.

Work is performed in uniform or civilian clothes, and officers are typically armed.

- Excluded are:

- a. Supervisory positions.

- b. Criminal investigators.

- c. Police detectives and specialists performing duties above those described for Police Officer II.

- d. Positions requiring the operation of aircraft.

- e. Police academy cadets and positions receiving on-the-job training and experience in basic police activities

12 RFP 14 D. Inspectors The RFP states, "due to logistics and associated expenses, the Contractor shall have no more than thirty (30) Inspectors." Will the Government please clarify if this is per task order/jurisdiction, or region?

Larger jurisdictions may require more than 30 inspectors to operate at capacity. Conversely, it may be unrealistic for smaller jurisdictions to require a minimum of 10 inspections per inspector per month.

Flexibility with these requirements may be needed and may be better stipulated at the task order level.

This language is intended for each Task Order/jurisdiction.

13 RFP 16 E. Information Regarding Underage Purchasers

The RFP states "Contractor shall update TIMS with each UP's unique ID number, gender, and date of birth at least 14 calendar days prior to the UP-beginning work."

What is the value or purpose of a 14-day waiting period? If all necessary paperwork has been received, a 14-day waiting period creates an unnecessary barrier to work.

(Also reference table on page 34). Please consider removing this requirement.

(DSP)

The language pertaining to the 14-day waiting period requirement has been removed from the solicitation.

14 RFP 19 2. Communication and Data Transmission

Is it anticipated that PC/BPC will also be issued an iPhone for training and communication purposes?

Yes, the PC and BPC will be issued a laptop and mobile device.

15 RFP 27 D. Special Considerations

Reducing staffing requirements for one jurisdiction will create staffing difficulties for a third-party contractor as it creates an imbalance in FTE assignments. Please reconsider this requirement.

After reviewing the requirement, the government has decided not to make any changes.

16 RFP 27 Region V- Puerto Rico The RFP states, “The PC and BPC shall conduct their work in the Commonwealth of Puerto Rico.” Please clarify if this means the PC and BPC

The PC and BPC shall be physically located in Puerto Rico.

are to be physically located full time in Puerto Rico?

17 RFP 31 Section D - Packaging and Marking

Please clarify what deliverables this section applies to?

This applies to all appropriate deliverables provided to the COR.

18 RFP 77 Organizational Conflicts of Interest

The RFP states, "The contractor shall perform lab analysis of tobacco products and provide that analysis to FDA to inform regulatory decision making." This does not appear to align with the scope of work. Can the Government please clarify how this fits within the scope of the contract?

This language has been deleted.

18 RFP 110 L.3.3 - Proposal Instructions

In order to increase readability and to align to proposal best practices, will the Government allow Offerors to use 10-point font for graphics and tables?

For purpose of uniformity, use 12-point font.

19 RFP 110 L.3.3 - Proposal

The RFP states, "no more than 15 pages of supporting documentation will be allowed." Please confirm this does not include resumes and commitment documentation.

Confirmed, it does not include resumes and commitment documentation.

20 RFP 110; 111 L.3.3 - Proposal

The RFP states, "no more than 15 pages of supporting documentation will be allowed." To allow Offerors the opportunity to fully document their solution and knowledge of the requirements, will the Government remove the page limit for supporting documentation?

No, the Government will not remove the page limit for supporting

21 RFP 110 L3.3 - Proposal

Will the Government please extend the page count for Volume I to 35 pages to enable Offerors to provide sufficient detail to meet all required elements?

No, the Government will not extend the page Count for Volume I.

22 RFP 110; 111 L.3.3 - Proposal

The RFP states, "This limitation excludes resumes, commitment documentation, and supporting documentation."

There does not otherwise appear to be a requirement for commitment documentation to be included in the proposal.

Please confirm what commitment documentation is required to submit, if any.

There are no requirements for Commitment Documentation. This is optional.

23 RFP 110;

114-115

L.4 Volume I - Technical Proposal Instructions;

L.5 Volume II - Business Proposal Instructions

Please confirm the "transmission and cover letter" mentioned at the bottom of page 110 should include all the information outlined in Section L.5 (pages 114-115). Further, please confirm the "transmission and cover letter" is excluded from the Volume I page count.

The transmission and cover letter are separate from the cover page for the business proposal.

Both are excluded from the page count.

24 RFP 111 L.4.A - Commissioning Given the requirement to provide evidence of nine proposed inspectors, please confirm the proof required (copy of a pay stub or letter from current employer) can be included as supporting documentation?

Yes, this information can be submitted as supporting

25 RFP 111 L.4 Volume I - Technical Proposal Instructions

Please confirm the table of contents is excluded from page count.

No, the Table of Contents will be included in the page count.

26 RFP 112 B. Program Management/ Staffing

RFP states, "The Offeror shall describe their approach to secure a grant of immunity from the proper authorities, as described in Section C.1.1.E in the RFP. The vendor will provide a specific approach to securing grant of immunity specifically for region 1 (New York, Delaware), Region 2 (Nebraska, Ohio), Region 3 (Florida, USVI), and Region 5 (Puerto Rico) 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 of each jurisdiction’s requirements and submit a plan on how it will obtain a grant of immunity in writing from each applicable jurisdiction." Please confirm the last sentence that states "each jurisdiction's" is specific to the seven referenced jurisdictions in

Confirmed, this refers to the specific jurisdictions that are listed.

the paragraph, not ALL jurisdictions in each Region?

27 RFP 112 B. Program Management/ Staffing

RFP states, "Provide a brief description of the qualifications and experience of the proposed key personnel, i.e., the Program Coordinator and Backup Program Coordinator for the task orders included in the solicitation." and "Resumes must be included for all proposed key personnel." What jurisdictions are anticipated to be issued upon contract award for each Region? This information is needed in

Provide your response specific to New York, Delaware for region 1, Nebraska, Ohio for region 2, Florida, USVI for region 3, and Puerto Rico for region 5.

order to properly staff and provide resumes.

28 RFP 112 L.4.B - Grant of Immunity

This RFP states, "The Offeror shall provide a copy of each jurisdiction's requirements and submit a plan on how it will obtain a grant of immunity in writing from each applicable jurisdiction."

Can the copies of each jurisdiction's requirements be submitted as supporting documentation?

No. Requirements can be summarized rather than listed out in its entirety. References may also be provided.

For example, hyperlinks for publicly available documents.

29 RFP 113 L.4.C This RFP states, "If the jurisdiction requires individuals conducting tobacco compliance check inspections to possess specialized credentials or approval […] the Offeror shall provide a copy of the jurisdiction's requirements."

Can the copies of the jurisdiction's requirements be submitted as supporting documentation?

No. Requirements can be summarized rather than listed out in its entirety. References may also be provided.

For example, hyperlinks for publicly available documents.

30 RFP 113 L.4.C The RFP states, "If the jurisdiction requires individuals conducting tobacco compliance check inspections to possess specialized credentials or approval […] the Offeror shall provide a copy of the jurisdiction's requirements" While the Attachment 11 Wage Determination for Inspectors provides the Service Contract Act minimum pay, many jurisdictions require that the inspector be a Law Enforcement Officer in order to grant the minor immunity.

Would the Government consider changing the Inspector Labor Category to one that provides a pay rate more applicable to Law Enforcement and/or Police Officers? Otherwise, the Government is at risk of receiving proposal submissions with pricing that will not support program performance as Law Enforcement Officers require substantially above the listed wage determination to perform on the program.

These are the posted minimum wage rates for the corresponding Inspector Labor Category. The Law Enforcement and/or police officer labor category is not applicable.

31 RFP 115 A. Price Per Inspection The RFP states, "Proposed hourly rates shall be supported by the submission of the employee's most recent payroll stub or leave and earnings statement.

Documentation to verify salaries for new hires shall consist of written offers of employment, employment agreements or contracts, which indicate the position, annual salary, and hourly rate for each new hire."

Please clarify what this is in regard to? (i.e. All roles, only Inspectors, etc.?)

The following language has been removed from the solicitation as it will not be applicable for this section.

32 RFP 115 A. Price Per Inspection The RFP states, "Proposed hourly rates shall be supported by the submission of the employee's most recent payroll stub or leave and earnings statement.

Documentation to verify salaries for new hires shall consist of written offers of employment, employment agreements or contracts, which indicate the position, annual salary, and hourly rate for each new hire."

Please define 'new hire'.

The following language will be removed from the solicitation as it will not be applicable for this section.

33 RFP 115 A. Price Per Inspection The RFP states, "Proposed hourly rates shall be supported by the submission of the employee's most recent payroll stub or leave and earnings statement.

Documentation to verify salaries for new hires shall consist of written offers of employment, employment agreements or contracts, which indicate the position, annual salary, and hourly rate for each new hire." Are other sources of salary documentation, including but not limited to BLS information, industry salary information, and GSA rates, acceptable?

The following language will be removed from the solicitation as it will not be applicable for this section.

34 RFP 116 A. Direct Labor RFP states, "Offerors must submit supporting schedules indicating types or categories of labor, together with person-hours." Can the Government please provide further clarification on the definition of a supporting schedule? In addition, can the Government please define categories of labor?

Language revised in the solicitation.

35 RFP 116 A. Direct Labor RFP states, "If you use anything other than actual hours, state the basis of the full-time equivalency, i.e., 2,000 hours, etc." However, section C. Key Personnel (pg.

14) states, "For the purposes of this contract, an FTE is equal to 2080 hours." Please confirm if contractors are to price based on FT equivalency at 2080 as stated, or if that basis can be determined by the contractor?

Language revised in the solicitation.

36 RFP 116 B. Overhead, General and Administrative Expense. C. Brief Direct Labor/Staffing Narrative

RFP states, "If not provided in volume 1 Technical proposal, please include the following in your business proposal: …" However, that bullet of information is also included for the technical response. If both Tech and Business Volume are to be reviewed separately, should the requirement be for the information to be included in both volumes? If there are page count considerations, can the offeror choose which volume to include this information in?

Yes, the offeror does not include information in both volumes. However, some narratives may need to accompany specific business proposal information that is not included in the technical proposal.

37 RFP 117 D. Travel Non-Inspection related travel is included at the task order level at a Not to Exceed (NTE) amount. If a travel schedule is proposed, will that be included in the overall price evaluation? Or will all offerors accept the NTE provided for each task order?

Non-inspection travel has a maximum amount per region per year and will be included in Task Orders as appropriate. The offeror need not propose any cost related to non-inspection travel.

38 RFP 118 H.) Service Contract Act Information

The Wage Determination No.: 1988-0407, Revision 58 (Attachment 11: Wage Determination- Single Rate for Inspectors) appears to be applicable nationwide, however the Wage Determination No.: 2024- 0024, Revision 5 (Attachment 12: Wage Determination- Single rate for Underage Purchasers) only lists 4 of the potential 40 jurisdictions available for task orders. Please clarify and provide additional applicable wage determinations for Underage Purchasers in all jurisdictions/Regions.

Additional applicable wage determination for Underage Purchasers in all Jurisdictions/Regions are forthcoming.

39 RFP 120 L.6 PAST

PERFORMANCE

INFORMATION

Please provide the due date for Past Performance Questionnaires.

The due date for Past Performance Questionnaires is equivalent to the final proposal deadline

40 RFP 120 L.9 Proposal Submission If contractors propose to more than one region, please confirm each region should be submitted through individual emails.

Yes, please submit proposals for each region through separate individual emails. Please identify the region in the subject line.

41 RFP 120 L.9 Proposal Submission Would the government consider extending the due date to appropriately account for any changes made to the RFP as a result of the Q&A?

Yes, the RFP will be extended as an amendment.

42 RFP 121 Evaluation Factor 2 - Program Management/Staffing, Confidence Ratings

The confidence ratings (High, Some, Low) mention the contractor's understanding of the "protocol requirement", however there is no other mention of a protocol requirement in the solicitation. Please confirm what will be reviewed to determine the contractor's rating for Factor 2.

The “protocol” language has been removed from the confidence rating language for Evaluation Factor 2.

43 RFP 122 Evaluation Factor 3 - Inspection Plan, Confidence Ratings

The confidence ratings (High, Some, Low) mention the contractor's understanding of the "Data Analysis Plan requirement", however there is no other mention of a Data Analysis Plan in the solicitation. Please confirm what will be reviewed to determine the contractor's rating for Factor 3.

The “Data Analysis Plan requirement language has been removed from the confidence rating

Evaluation Factor 3.

44 RFP 122 Evaluation Factor 4 - Corporate Experience, Confidence Ratings

The confidence ratings (High, Some, Low) mention the contractor's ability to provide an "adequate number of key personnel".

Key personnel quantity does not seem relevant to the evaluation of Corporate Experience and may be better suited for Factor 2's evaluation. Please confirm what will be reviewed to determine the contractor's rating for Factor 4.

Key Personnel quantity language has beenremoved from the confidence rating

Evaluation Factor 2.

45 RFP 124 Evaluation Factor 6 - Price

RFP states, "For source selection purposes, the prices contained in the business proposal and the task order proposal will be evaluated for price to determine the best value to the Government." Please define 'best value' and

Please refer to M.2 Basis for Award. The sample Task Order proposal will be used evaluate price. The selection for award will consist of a Best Value source selection process based on describe what the Government will evaluate to determine best value.

evaluation of the technical proposal and Business Proposal. FDA will evaluate the capability of each offeror on each of the evaluation factors, Program management, Inspection plan, corporate experience, and Past Performance. The offeror will receive an overall technical proposal rating. The technical and business proposal will be evaluated to determine the offeror who provides the best value to the government.

46 RFP 124 M.2 Basis for Award RFP states, "A task order has been provided and will be used in combination with the business proposal to evaluate price. A task order will be awarded and funded with the subsequent base contract for each region."

The provided sample task orders for regions 1, 2, and 3 do not specify jurisdictions nor specific inspection quantities for each unique jurisdiction. Will the contractor be able to submit a Request for Task Order Proposal for each jurisdiction after award, assuming the jurisdictions vary in inspection volumes?

Please see the updated RFTOP procedures. Future RFTOPs will include the number of inspections and the fixed price and program management labor rates negotiated for the region. The contractors will be able to propose program management hours in response to the

RFTOP.

47 RFP 126 M.7 Subcontracting Evaluation

As this is a small business solicitation, is a small business subcontracting plan required? This paragraph also mentions 'states' and may not be applicable to a 3rd party contract?

No. Language to be removed.

48 RFP Will FDA/CTP apply an Authorization-To-Operate (ATO) security requirement for Contractor internal system hosting Inspector, Minor, and tobacco evidence information?

All inspection data related to inspections will remain on FDAs internal system and not on the contractor systems. Contractor is responsible for security of information regarding contractor personnel.

49 RFP Can FDA/CTP provide a breakdown of the most current inspection volumes per region/state listed in the solicitation?

No, however offerors can review the Tobacco Compliance Check Outcomes database for inspection data https://timp-ccid.fda.gov/.

50 RFP Will FDA/CTP accept state statues protecting underage Minor tobacco purchases as proof of Minor immunity in lieu of securing letters of immunity from each jurisdictions Attorney General’s office?

Yes, offerors can provide statutes demonstrating an understanding of the minor immunity requirements in the jurisdictions;

however, Offerors only need to provide information necessary to demonstrate minor immunity and would not require submitting letters from the Attorney General's office prior to award.

https://timp-ccid.fda.gov/ https://timp-ccid.fda.gov/

51 RFP Will FDA/CTP allow Contractor to bill for costs associated with prepping evidence and transferring to FDA/CTP custody?

The contractor must submit invoice in accordance with Section B.2 Contract Type and Price Schedule.

52 RFP Will FDA/CTP allow Contractor to bill for Inspector and Minor time to support enforcement hearings virtually?

The contractor must invoice in accordance with Section B.2 Contract Type and Price Schedule for Witness Testimony Compensation.

53 RFP What is the anticipated timeframe to complete Inspector FDA background check?

Timeframes vary.

However, we recommend offerors estimate 60 days to complete background checks.

54 RFP Does FDA/CTP require the Contractor to perform our own internal background checks prior to sending for FDA onboarding?

FDA does not require the Contractor to perform their own internal background checks prior to sending for FDA onboarding.

55 RFP Could you please provide the names of the current incumbents for regions 1, 2, The names of the current incumbents and the more recent

Agreed.

and 3, along with the base year award amounts for their respective contracts award for each jurisdiction can be found at FDA Tobacco Retail Inspection Contracts | FDA.

56 RFP Could you confirm the maximum number of compliance inspections that can be completed monthly? I understand the minimum requirement is 10 inspections to remain eligible.

Individual Task Orders may include monthly limits of total inspections to be conducted by the contractor. Beyond that limitation there is no limitation to how many inspections an inspector can conduct.

57 RFP Can the Program Coordinator and BPC roles also double as Inspectors, or do these positions need to remain separate from inspection duties?

Yes. The Program Coordinator and BPC can also double as inspectors, but the roles should be billed accordingly for work conducted. Please note that the PC and BPC must meet the requirements to be commissionable to conduct inspections.

https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/fda-tobacco-retail-inspection-contracts https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/fda-tobacco-retail-inspection-contracts https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/fda-tobacco-retail-inspection-contracts

58 RFP Could you please confirm whether it is permissible to submit a proposal for only these two states, or if the proposal must encompass all states within region 2?

The proposal must include all the states listed in the Region.

The contractor must be able to perform inspections in any of the jurisdictions within the Region.

There is no guarantee to the Contractor that they will receive a task order to conduct inspections or other services listed in the contract in all the states located within a region.

59 RFP Does the entity applying for the contract need to be registered within the states included in the region that I'm looking to apply for? or does the applying entity only needs to be registered within the USA to be able to apply?

As long as the contractor is registered within SAM.Gov, a prospective offeror can submit a proposal for consideration.

60 The solicitation cover page indicates that responses are due 1/21/25 at 1700 ET, however Section L.9 contains a 2:00 PM deadline.

Please clarify.

The solicitation deadline has been updated via an amendment.

61 Considering the potential for offerors to submit multiple different responses, would the government consider extending the deadline for responses?

TBD

62 Will the government allow offerors to use 10-point font for tables and graphics?

No, the Government will not allow offerors to use 10-point font for tables and graphics.

63 Will the government please clarify the page limits for the technical volume and appendices? While "no more than 15 pages of supporting documentation will be allowed," the solicitation also states that " this limitation excludes resumes, commitment documentation, and supporting documentation."

Technical proposal is limited to 25 pages excluding: resumes, commitment documentation, and supporting documentation.

Resumes, commitment documentation, and supporting documentation are limited to 15 pages.

64 How many Program Coordinators and Back-Up Program Coordinators must be submitted for each Region?

As part of the proposal submission, provide your response for Key Personnel specific to New York, Delaware for Region 1, Nebraska, Ohio for Region 2, Florida, USVI for Region 3, and Puerto Rice for Region 5. The PC shall account for at least 51% of the program management effort than the BPC. For the purposes of this contract, an FTE is equal to 2080 hours.

65 Will the government provide wage determinations for the remaining regions/states upon award, or will the wage rates be left to Contractor to set?

Additional applicable wage determination for Underage Purchasers in all Jurisdictions/Regions are forthcoming.

66 Commissioning Process Are there any specific templates or formats required for providing employee information for commissioning?

Yes, there is a template for providing employee information for commissioning. The template will be provided post-award.

Underage Purchasers

What specific protections or guidelines should contractors consider when recruiting and managing underage purchasers in states with restrictive laws regarding minors?

Section E. Information Regarding Underage Purchases pgs. 15-16.

The Contractor shall recruit a mix of Underage Purchasers ages 16 to 20 to participate in the program. The Contractor must recruit Underage Purchasers from each age group. Underage Purchasers who are 16 or 17 years-old are also minors. A unique identification number shall be generated by the Contractor to protect the identity of the Underage Purchaser.

The Contractor shall maintain information cross-referencing each unique identification number to a specific Underage Purchaser. The

Contractor shall secure a grant of immunity from the proper authorities in any jurisdiction where it would be illegal to use Underage Purchasers to conduct undercover buy assignments or where a purchaser’s possession of tobacco products is illegal, prior to using Underage Purchasers in those jurisdictions.

The Executive Order has a separate set of protections and threshold for the minimum executive wage whereas the Fair Labor Standard Act has its own set of protections and threshold that can vary.

The highest applicable minimum wage is enforced by the Department of Labor (DOL), and/or if there is a local agency. The DOL cannot enforce a state law. The Contractor is responsible for following all relevant laws applicable (Service Contract Act (SCA), Fair Labor Standard Act (FLSA), Executive Orders, etc.)

68 Underage Purchasers Are there FDA-preferred insurance providers for covering underage purchasers, or any minimum insurance policy requirements?

The Contractor shall ensure that all Underage Purchasers are insured against accidents or other injuries. It is the vendors responsibility to identify insurance providers and insurance policy requirements for underage purchasers.

69 Retailer Lists and TIMS Can the FDA provide additional details on the format requirements for uploading new retailers into

TIMS?

The retail outlet list must contain, at a minimum, the retail outlet name, physical address (including city, state or territory, and zip code), unique ID number (assigned by FDA when added to TIMS) and the source where the information was obtained. Please see Attachment 2 for the current required format for the retail outlet list.

70 Retailer Lists and TIMS Is there a grace period for updating TIMS when new retailers are discovered, and what specific protocol applies for incorrectly entered data?

Updates to the retail outlet lists should be conducted quarterly.

71 Travel Costs Are travel cost approvals processed via the TIMS system or through direct communication with the

COR/CO?

Any required non-inspection travel is Not-to-Exceed (NTE):

$10,000 per year per region. All travel must be reviewed/approved by the Contracting Officer Representative (COR) and the Contracting Officer (CO) prior to traveling and reimbursed in accordance with the Federal Travel Regulations (FTR).

72 Compliance Monitoring What are the penalties or corrective actions for repeated procedural errors identified during the FDA's review of submitted inspection data?

The Offeror shall submit a Quality Control Plan with its Technical Proposal, which must include, at a minimum, viable and comprehensive measures to identify and document problems, determine corrective actions, and determine improvement based upon corrective actions.

FDA does not have penalties for repeated procedural errors identified during the FDA’s review of submitted inspection data.

However, resulting penalties associated with performance would come in the form of a possible CPARS downgrade within a contractor’s performance assessment.

FDA will notify the Contractor of Inspectors that make multiple and/or repeated procedural errors. These updates will also be noted within monthly status reports by the contractor.

The Contractor shall provide FDA with a plan, within two (2) business days of notification, regarding how it intends to address inspector errors that are identified, including the training provided.

73 Subcontracting Restrictions

Is there a maximum percentage of work that can be subcontracted under this contract, and does FDA have specific vetting requirements for subcontractors?

As reflected on Page 119 of the RFP, the maximum percentage of work that can be subcontracted for this requirement would entail the following:

A maximum of one recent and relevant Contract performed by an Offeror’s significant teaming partner or a significant subcontractor may be submitted. The Government considers a significant subcontractor or teaming partner to be a company which:

(1) provides 20% or more of the support required,

(2) provides a critical portion of the effort required, or

(3) influences the results of performance.

References for proposed subcontractors not considered significant are not desired and will not be considered relevant.

Quality Control Plan

(QCP)

Can a draft QCP be submitted for preliminary feedback before final submission after award?

No. The Quality Control Plan should be submitted as part of the proposal and will be reviewed during initial evaluation.

75 Key Personnel Requirements

Are there FDA-provided templates for resumes or certifications required for Program Coordinators or Backup Program Coordinators?

No, there are no FDA-provided templates for resumes or certifications required for Program Coordinators or Backup Program Coordinators.

76 Task Order Allocation Will task orders be completed among IDIQ awardees, or will they be assigned directly by the

FDA?

FDA intends to award IDIQs by regions. Task Orders will be awarded to the regional IDIQ awardees.

77 Region-Specific Considerations

What is the possibility of the FDA Revisiting Region 3 Scope, while it is understandable the FDA may have strong reasons for the current regional structure, can the Contracting Officer consider the following:

What criteria were used to define the states included in region 3, and could these criteria be revisited to better align with workload or geographic consistency

The Government does not intend to revisit Region 3 scope and the included states.

Reevaluation of Region Scope

Has the FDA considered narrowing Region 3 to focus exclusively on Southern states and reassigning other states (e.g., West Virginia, Oklahoma) to neighboring regions?

The Government does not intend to revisit Region 3 scope and the included states.

79 Flexibility in Task Orders

If Region 3 remains unchanged, is it possible to issue smaller, state-specific task orders to focus on high-priority areas within the region?

The Government intends on issuing task orders for jurisdictions in the region. Task orders will indicate the number of inspections to be performed.

80 The Cybersecurity Maturity Model Certification (CMMC) requirement in this solicitation ensures that contractors have the necessary controls in place to protect Controlled Unclassified Information (CUI) and other sensitive data that may be transmitted, processed, or stored during the performance of the contract.

How does the FDA intend to review this requirement as part of the proposal to ensure that a potential contractor is in compliance

This requirement is not listed in the solicitation.

CTP, please advise as to where this question originated.

We will need to this further.

Is this question from a vendor?