FDA Response to FY20 RFP Questions.pdf

FY20 RFP Questions:

1. Am I allowed to ask you a question regarding the number listed under the state of

Mississippi column FDA Directed UB inspections.? It says 2000 and I am wondering is this number including Routine Undercover UB inspections and FDA Directed UB follow-up inspections (the one after a buy)? Normally, we have done 3,120 routine UB and then approximately another 450 of the FDA Directed UB inspections on top of the

3,120.

2. Connecticut’s main question revolves around the change from Contractor directed routine

UBs to FDA directed routine UBs. Currently we (Connecticut) set parameters of the queue for routine UBs (using a 365-day window so as to avoid inspecting an establishment twice). Will that continue under the new contract or will you (FDA) now fill the queue for routine UBs much like what is currently done for compliance follow ups and complaint UBs?

3. Page 7-8 shows a chart of the FDA-directed Inspections (700 UB and 200 A&L). How many UB Routines (Contractor-driven)? And I suspect, like our current contract) will won’t have any A&L Routines (Contractor-driven)?

4. The solicitation lists FDA inspection expectations for our state of 8000 FDA-directed UB inspections and 1000 FDA- directed A&L inspections. Will states also be expected to assign and conduct additional routine UB and A&L inspections during each performance period? If so, are there any guidelines pertaining to the number to be conducted?

5. We would like clarification on FDA Directed UB Inspections (C.1 and C.1.6). Will this consist of inspections created by both the contractor and FDA? If the number of inspections listed as FDA Directed UB Inspections includes both contractor created and

FDA created inspections is there an estimated percentage of how the UB inspections will be divided between the two?

6. Can you please explain the breakdown of FDA-Directed UB inspections and FDA-

Directed A&L inspections listed in the chart on pages 7-8? Does the number of inspections listed include what would be considered Routine or Contractor Directed UBs as well as FDA Directed Follow-Up inspections? Section C.1, Pages 7/8 – The scope of work lists FDA-Directed UBs and FDA-Directed A&Ls, but does not list Contractor-

Directed UBs. Does this mean contractor-directed “Routine” UBs are not included in this

RFP?

7. Under the current contract, the FDA directs the Compliance Follow-Up UB’s and the

Complaint UB’s, while the Contractor directs the Routine UB’s. The language in the new RFP indicates that ALL UB inspections under the new contract will be FDA-

Directed.

8. Section C.1, Pages 7/8 – The scope of work lists FDA-Directed UBs and FDA-Directed

A&Ls but does not list Contractor-Directed UBs. Does this mean contractor-directed

“Routine” UBs are not included in this RFP?

9. Historically our state has been inspecting 100% routine inspections of our retail establishments. Will the FDA directed areas (by zip code) still apply to our program?

10. If those inspections are truly FDA directed routine inspections, how much flexibility would we have in assigning them? We have areas in our state that extremely difficult to get to due to various weather conditions like snow, rain/flooding, wildfires.

11. Under the new FDA-directed undercover buys, will the Contractor have the flexibility to schedule inspections by season (for example, scheduling more inspections in the summer months when UPs are out of school)?

12. Pg. 20, C.1.6 Compliance Check Inspections, The RFP states “FDA will require the contractor to ensure compliance check inspections are conducted in specific areas of certain times of day.” Does this mean states will receive direction to conduct inspections during certain periods of day (for example, direction that an inspection must be conducted between 2:00pm-4:00pm?)

13. Does this mean that the FDA will be directing ALL Routine UB’s under the new contract?

14. Page 18 #3 Selection of Retailer Undercover Buy (UB) Inspections Under item 2: For inspections where FDA requests that certain retail outlets or geographic areas be inspected, the Contractor shall assign or conduct UB inspections only within the area or areas specifically designated by FDA. The FDA will request that certain retail outlets or areas be inspected.

Please explain what this means. Will the FDA direct the contractor which zip codes to assign routine UB’s in and when to assign them?

15. Section C.1, Pages 7/8 – The scope of work lists FDA-Directed UBs and FDA-Directed

A&Ls but does not list Contractor-Directed UBs. Does this mean contractor-directed

“Routine” UBs are not included in this RFP?

16. Page 18 – Paragraph 3, Part 1, “FDA may specify the number and location of retailer inspections to be completed during a contract period, and the Contractor shall comply with these requirements”

17. Will FDA require the Contractor to complete more than the listed number of inspections for their State from Section C.1, page 7?

18. Unlike previous Contract, will there be any Contractor Directed Inspections?

FDA Response for Questions 1 – 18:

All inspections under this contract will be directed by FDA. The FDA Directed estimated inspection numbers provided in the table include Routine, Follow-Up, and

Complaint Inspection assignments. Inspections numbers listed in the RFP are an estimate.

FDA will request that certain retail outlets or areas be inspected. For UBs, the Contractor may determine the date of assignment, retailer location (selected from the retailer list), and timeframe for completion of retailer inspections, subject to certain additional requirements. See Section C.1.4.3 for more information.

For FDA directed A&L inspections FDA will assign all inspections and will provide a timeframe for completion of assignments. See C.1.6.2 for more information.

19. With only two inspection types this funding cycle, FDA-directed UBs and FDA-directed

A&Ls, we need clarification on how UBs will be assigned. In the past, we have assigned

UBs based not only on inspection dates but geographic location to make it more cost-effective for inspectors who cover large territories. Will we have this same flexibility in the new funding cycle or will all UBs come directly from FDA? Is there a percentage of

FDA-directed UBs we should hold specifically for FDA assignment?

FDA Response:

The Contractor may determine the date of issuance, retailer location (selected from the retailer list), and timeframe for completion of retailer inspections in approximately 80% of undercover buy inspections.

20. American Samoa’s legal age to purchase tobacco products is 18 years old. A proposal has been submitted to increase the purchasing tobacco product(s) age limit to 21 which is still under review. What rule is to be followed?

For the FDA program the legal age is 21.

21. Page 8 – Paragraph 1, “Non-commissioned Contractor personnel shall assume only administrative, planning, and logistical functions that may be performed. This encompasses all functions except performing inspections.”

Will FDA accept in-kind for administrative, planning and logistical functions that is needed for this contract? Other than PC, BPC and Inspectors who else is required to have an administrative commission (no credential issued) at the Contractor and Subcontractor

Level?

All individuals working under this contract will be subject to a background check. Only individuals that conduct inspections are required to be commissioned. Underage purchasers are not required to be commissioned. In-kind services are not allowed for work performed on this program

22. Page 11 – Paragraph 9, “Underage Tobacco Purchasers who are 16 or 17 years-old are also minors, and as such, have special protections that are discussed below.”

The paragraph only refers to 16 or 17 years-old. Do the special protections discussed in the subsequent paragraphs in the RFP not pertain to Under Aged Purchasers 18-20 years-old?

Per the solicitation, the special protections are provided to age 16 – 17 as minors.

23. Page 14 – C.1.2 Bullet Point 9, “Ensuring that an inventory of all FDA-issued equipment assigned to the Contractor (including mobile devices) is completed and submitted to FDA quarterly and within ten (10) business days of FDA’s request. The inventory should include who is assigned the equipment. FDA must be alerted within one (1) business day if FDA-issued equipment is lost or stolen (C.1.2);”

To whom should the Contractor submit the quarterly inventory log and report any lost or stolen equipment?

Quarterly inventory log and the report of any lost or stolen equipment should be sent to

COR.

24. Page 19 – Paragraph 1, “For FDA Directed UB Inspections, the Contractor shall focus on inspecting areas that have not been inspected in prior years before returning to retailers that have been inspected under this contract.”

Does this mean the Contractor cannot re-inspect an establishment that has been inspected outside of the 12-month rolling requirement if there are establishments that have not yet been inspected for this contract unless directed by FDA?

The contractor should inspect establishments that have never been inspected prior to returning to a previously inspected retailer.

25. Pg. 18 Selection of Retailer Undercover Buy (UB) Inspections, The RFP states

“Contractor shall utilize FDA TIMS System to issue inspection assignments.” Does this mean states will no longer have to create assignments but will only have to issue assignment for the 4-year contract?

Contractors will create assignments in TIMS based on FDA direction for routine inspection assignments.

26. Page 22 under number 2. FDA Directed Advertising and Labeling (A&L) Inspections; “If both an A&L and a UB inspection have been assigned by FDA, the A&L assignment should be completed first.

Will states once again have the latitude to write in their proposal that we intend to conduct the FDA Directed UB first since it is more likely the Inspector will be recognized during the UB if the A&L is conducted first.

27. Page 22 – Paragraph 3, “If both an A&L and a UB inspection have been assigned by

FDA, the A&L assignment should be completed first.”

28. If it is not logistically possible, will it be allowable to conduct the UB before the A&L?

FDA Response to Questions 26 - 28:

Requests for exceptions will be considered on a case by case basis.

29. Page 22 – Paragraph 3, “All inspections shall be completed within 90 days. Additionally, 15% shall be completed within 15 calendar days and 10% shall be completed within 5 calendar days of assignment.”

Who determines which of the stores are in the 15% 15-day completion deadline and 10%

5-day deadline? How far in advance do we have for the stores with shortened completion deadline? What if it is not possible for us to complete A&L inspections within 5 calendar days depending on establishment selected?

FDA will determine the completion date.

30. Page 22 – Paragraph 3, “Up to 20% of all A&L inspections require the contractor to develop a system to allow an Inspector to purchase a potentially violative tobacco product.”

Will the purchases be processes/bagged/labeled the same way as UB evidence? Will written protocols to be provided?

FDA will provide written protocol.

31. Pg. 28 – C 1.1 – “Underage Tobacco Purchaser information – “Fourteen (14) calendar days before the Underage Tobacco Purchasers begins inspecting.” Does this mean that the UP cannot work until 2 weeks after receiving completed paperwork? Can’t train until

14 days after the completed paperwork? Please clarify.

32. Page 28 – Deliverables (3rd item)

C.1.1 Underage Tobacco

Purchaser information

Fourteen (14) calendar days before the Underage Tobacco

Purchaser begins inspecting See

Description 2 below

33. Question: Does this mean that we have to wait fourteen (14) calendar day after the volunteer information has been entered into TIMS or after completing Minor Training before they can go out on inspections?

FDA Response to Questions 31 - 33:

Underage Purchaser information must be provided fourteen days prior to beginning inspection.

34. Page 31 – Description 8, “Description 8: Plan for Retailers to be Inspected - The

Contractor shall supply FDA with an explanation of how it complied with its plan to ensure that compliance check inspections are conducted at a variety of different locations

(urban, suburban, rural, and racial and ethnic minority communities) and outlet types throughout its jurisdiction, while complying to the requirements of C.1.4. The Contractor shall also provide any changes to its plan.”

Does the one routine inspection in a 12-month period mean one inspection within a contract year or calendar year? If the definition is 12 months minimum between routine inspections, we feel that our inspections would fall in the same time of year which would give retailers a rough guess to when we are planning our next inspection.

35. Page 18 #3 Selection of Retailer Undercover Buy (UB) Inspections: Under item 1: The

Contractor shall not assign the UB inspections at a retailer location where a retailer inspection has been completed within a year from the prior inspection unless otherwise directed by FDA.

Can the state indicate that they will only conduct a routine UB inspection once during the contract year in response to this directive?

FDA Response to Questions 34 - 35:

Inspections should occur one time in a 12-month (365-day) period, unless otherwise directed by FDA. The Contractor cannot conduct a routine inspection more frequently than one time in a 12-month (365 day) period. It is the responsibility of the Contractor to manage their program in a way to ensure this requirement is met.

36. Pg. 43 – Role Based Training – we are not familiar with this training and need more guidance. Does this training only need to be those with an FDA laptop?

37. Pg. 44 – Rules of Behavior - we are not familiar with this training and need more guidance. Does this training only need to be those with an FDA laptop?

38. Training Requirements, Page 43 – Paragraph 4 and 5, Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable FDA

Contractor Information Security Awareness, Privacy, and Records Management training

(provided upon contract award) before performing any work under this contract.

Thereafter, the employees shall complete FDA Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS and FDA training policies.

Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy and FDA Role-Based Training (RBT) of

Personnel with Significant Security...”

Are subcontractors now required to attend these mandatory trainings? HHS/FDA sends out multiple emails throughout the year regarding multiple trainings. Will FDA provide a list of all Contractor/Subcontractor required trainings to ensure we complete all trainings relative to our roles?

FDA Response to Question 36 - 38:

This applies to all individuals who have an FDA laptop and PIV badge.

39. Page 46 – Paragraph 2, “Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, email address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or

CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes shall be submitted within a timeline as directed by the COR and/or CO. The

COR will notify the Contractor of the appropriate level of investigation required for each staff member.”

Is this roster only for Commissioned Officers or anyone who signs FDA Form 3398?

Anyone who has been submitted for an FDA background check, commissioning, and has signed an FDA Form 3398.

40. Page 74 – Paragraph 1 (Technical Proposal), “This limitation excludes resumes, commitment documentation, and supporting documentation. The technical proposal shall include a table of contents for each section described below.”

Do we need to include resumes of the subcontractor’s employees with the technical proposal?

Resumes are required for individuals identified as key personnel.

41. Pg. 19 Qualified Adult Only Facility:

What business types are being classified as Adult Only Facilities for this 4-year contract?

Does this mean “Adult Only Facilities” like gentlemen clubs will need to be added to the

Master Retailer List for inspection purposes since we now utilize 18-20-year old as

Underage purchases?

The Contractor shall also provide the FDA COR with any information, as it becomes available, regarding any entities or events that may be considered a “Qualified Adult Only

Facility” or any entities that are distributing free samples of smokeless tobacco products or other tobacco products for advertising, marketing or promotional purposes as defined in 21

CFR Part 1140.16(d)(2)(iii).

42. Pg. 29, Description 14, Indicates there’s a Description 15 to be referenced but there is no

#15 Description on page 32.

The RFP has been updated to reflect this discrepancy

43. Pg. 43 B. Training

Mandatory training & 2) Role-Based Training

Michigan has one subcontractor (Dial Help) whose only function is to employ the

Underage Purchasers of the program. Dial Help does not recruit, train, or work with any of the Underage Purchasers except for the role of acting as their employer and processing payroll for the Underage Purchasers. In addition, Dial Help does not have access to FDA program material. Is Dial Help required to take these trainings?

The Prime Contractor is responsible for ensuring the requirements within the contract are met.

44. Pg. 74 B. Program Management (first bullet referencing Grant of Immunity)

• How do you define jurisdiction?

• Will a letter from the State of Michigan’s, Attorney General Office of the

Criminal Division meet this requirement?

• Will a letter from the Prosecutor’s Association (representing all county prosecuting agencies within the state) meet this requirement?

• If not, what specifically are states expected to do to meet this requirement of securing a grant of immunity?

45. My state currently has regulations related to the sale of tobacco products to minors. Does

FDA require a grant of immunity to cover UPs age 18-20?

FDA Response to Questions 44 - 45:

The Contractor within the jurisdiction (State/Territory) is responsible for obtaining immunity for all underage purchasers with the appropriate entity within the jurisdiction

(state/territory) with the authority to provide immunity related to purchase and possession of tobacco products. The written immunity must be provided to FDA upon request.

46. We want to confirm that the FDA is moving to a 4-year contract term as opposed to the previous 3-year term.

The contract will be a 12-month base period and three (3) 12-month option periods.

47. B-2 Contract Type and Price Schedule – Authorized/required non-inspection travel

(travel outside of conducting inspections). We are a state government agency and have certain events/training that we must conduct as a requirement of being a state employee.

Does this fall into the non-inspection travel that must be preapproved by the COR?

These costs referenced are state specific and are not allowable costs under this contract.

48. What are the requirements for background check for Underage Purchasers 18-20-year-old participants?

49. What documentation is needed for the underage purchaser’s background check?

FDA Response to Questions 48 - 49:

Background checks for Underage Purchasers 18 – 20-year-old should be in line with the jurisdictions requirements to hire state employees.

50. Will inspectors be required to complete the trainings that are required by individuals that are issued FDA laptops such as Security Awareness Training and Records Management

Training?

Inspectors are not issued FDA laptops and therefore are not required to take Security

Awareness and Records Management Training.

51. Currently, American Samoa is in possession of verification of Minor’s Immunity dated

03/2016 and Minor’s Liability Insurance dated 08/2016. Are these documents sufficient to use for new contract?

No, updated documents are required.

52. Page 4 under bullet 1: Age and Photo Identification Restrictions – Retailers: Must verify that any person under age 27 purchasing regulated tobacco products is at least 21 years old or older by means of photo identification containing the bearer’s date of birth.

Shouldn’t this read; “Must verify that any person under age 30….”

53. Page 4 under bullet 2: Advertising and Labeling Restrictions – Retailers: May not sell regulated tobacco products using vending machines (except in facilities where the retailer ensures no person younger than 18 is permitted to enter); o May not sell cigarettes, cigarette tobacco, or smokeless tobacco using self-service displays (except in facilities where the retailer ensures no person younger than 18 is permitted to enter);

Shouldn’t these read; “younger than 21”

FDA Response to Question 52 – 53: On December 20, 2019, the FD&C Act was amended by law to raise the minimum age for tobacco product sales to 21. This means that as of December 20, 2019, it became illegal to sell tobacco products to anyone under

21. There are no exceptions to this requirement. This law applies to sales of all tobacco products – including cigarettes, smokeless tobacco, hookah tobacco, cigars, pipe tobacco, electronic nicotine delivery systems including e-cigarettes and e-liquids – to anyone under 21 years of age. In addition to increasing the federal minimum age of sale for tobacco products to 21, this law also directs FDA to update its current regulations. FDA’s current regulations on the sale and distribution of tobacco products require retailers to verify a tobacco product purchaser’s age by means of photographic identification that contains their date of birth if that individual is under the age of 27. FDA fully intends to make appropriate changes to its regulations, and we will provide additional details as they become available.

54. Section E, Page 11, Underage Tobacco Purchasers - With the federal (and in many states), legal purchasing age now being 21 years. What is the justification for continuing to hire 16-17-year-old minors? Can jurisdictions decide that they only want to move forward with 18-20 years old? Our agency maybe going to 18-20-year investigative aides for the tobacco unit which may create an issue for our program.

FDA’s program will continue to use 16 and 17-year-old individuals pursuant to FDA program requirements. The Contractor shall employ 16, 17, 18, 19, and 20-year-old underage purchasers. It is the Contractor’s responsibility to meet the FDA requirement for this contract in order to receive an award.

55. What positions are we permitted to subcontract under this contract? Page 8 C.1.1.A implies we are only able to subcontract inspectors.

FDA only requires that key personnel be employed by the Prime Contractor.

56. If Contractor-directed UBs are no longer going to be conducted and all UBs are FDA-directed, then why are Contractors responsible for identifying retailers to inspect per pages 18-20?

The Contractor in each jurisdiction has access to resources that identify retailers who sell regulated tobacco products within its jurisdiction; therefore, FDA requires the Contractor to provide updates to those retailers within their jurisdiction

57. Pg. 22 – Can you please give us more detail about what items might be purchased during an A&L, 20% of the time. How will this be tracked?

Regulated tobacco products might purchase during an A&L assignment.

58. Pg. 46 – Sanitization of Government Files and Information – “all electronic and paper records are appropriately returned or disposed of…” – we have A&L and UB evidence that have been collected since 2011, does this mean we need to ship these materials to the

FDA by the end of September?

59. Pg. 23 – “If the tobacco compliance check inspection contract expires or is not continued before the one based and three option -year period of performance end date, the COR will provide instructions for transfer of these records and evidence” – does this mean we need to send you all evidence from prior grant years? We have evidence dating back 2011.

FDA Response to Questions 58- 59:

If the Contractor currently holds an FDA contract, they should reach out to their COR on returning evidence held on current or prior contracts.

60. Pg. 31 – Annual Update of Inspector/Underage Tobacco Purchaser Information – we have been told for many years that the FDA only wants to know minor/UTP number, date of birth, and gender. Description 13 states the FDA wants all contact information for both inspectors and minors/UTP that have been employed during the last 5 years. Is this correct, you want names, address and phone numbers?

FDA will provide guidance on the required information.

61. My question is regarding TIMS. Mississippi has had a contract with CTP since

2010. The SPC frequently adds new retailer names into TIMS. The Previous RFP in

2017 did not ask us to submit a retailer list if we already had an existing one in

TIMS. Does this still apply? If the answer is no, do we have to submit the entire list over again in a spreadsheet? Trying to figure out to convert the TIMS list into a spreadsheet.

FDA currently possesses a list of the tobacco retailers located in the subject jurisdiction(s) which will be provided to the contractor upon award. The Contractor shall confirm that the retail outlet list does not contain any retail outlets that are located on

Tribal Land. The retail outlet list must contain, at a minimum, the retail outlet name, physical address (including city, state or territory, and zip code), and unique ID number

(assigned by FDA when added to TIMS). The Contractor is responsible for making changes to their retail outlet list contained in the TIMS system, according to FDA guidance.

1. Entities Not Included on Retail Outlet Lists

The Contractor shall be responsible for adding new establishments to TIMS, after verifying that the retail establishment is not already in TIMS. The Contractor shall contact FDA to coordinate the upload of a large list of establishments once a quarter, if needed. See Attachment 2 for the current required format for the retail outlet list. The format is subject to change based on program needs.

62. Currently, all background checks for the program are conducted by the subcontractor.

According to the presentation, the Primary Contractor will have to conduct the background checks. To clarify, do you mean the Primary Contractor has to conduct the background check or is responsible for making sure the background check is completed?

And if a third party is allowed to conduct the background check, will the FDA reimburse the state for time and monies?

63. Are the costs of background checks for Underage Purchasers 18-20-year-old volunteers an allowable cost?

64. We currently bill FDA per inspection, is this acceptable for situations where we deliver warning letters, civil money penalty, or NTSO?

FDA Response to Questions 62 - 64:

This is a cost reimbursement type contract which means that the costs incurred associated with this program will be reimbursed with the appropriate supporting documentation.

65. Page 13 under F. Conflicts of Interest it states; (paragraph 3) In addition, a covered person shall not participate personally or substantially in any matter under the Contract that may significantly affect that person's own financial interests or the financial interests of: His or her spouse or minor child.

Does this mean a child or relative of a covered person cannot be paid to conduct undercover buy tobacco inspections even if they are supervised by someone other than his/her relative.

A child or relative of a covered person can be paid to conduct undercover buy tobacco inspections if the covered person did not participate personally or substantially in decisions that affect the financial interests (including payment) of that child or relative. For example, the covered person may not be involved in the decision to hire, set payment rates, supervise, or evaluate performance of a child or other relative covered in this section of the contract.

66. When referencing using a mix of 16-20 year olds, does this mean that inspection teams must be comprised of either a 16 or 17 year and a 18-20 year old or will we be able to have teams comprised of 16 and 17 year olds and different teams comprised of 18-20 year olds?

UB inspections shall be conducted by teams comprised of an Inspector and an undercover tobacco purchaser, age 16, 17, 18, 19, or 20 at the time of the inspection; the purchaser must be supervised at all times.

67. SYNAR: With the changes to the possible next 4-year contract, are there recommendations regarding the coordination with the Synar program? Illinois’ Synar is based on a random sampling formula to determine counties and areas of inspection, which seems inconsistent with FDA directed routine inspections. Has there been coordination with SAMHSA to explore the impact and possible resolution?

SYNAR and FDA are two separate programs. No coordination has occurred with

SAMHSA.

68. If states can no longer conduct inspections in areas based on its own assessment (in keeping with FDA stated requirements) should this be described in the internal Risk

Management section as potentially creating staffing/coverage challenges?

The proposal should include a risk management plan that identifies potential issues or challenges that could occur in your jurisdiction and how you will address these issues.

69. Pg. 9, “The Contractor shall submit contact information for the person(s) or entity most with their organization’s background investigation procedure (if any) as well as that of the Subcontractor(s). FDA’s Office of Security Operations (OSO) will discuss the

Contractor’s or Subcontractor’s background clearance requirements with the respective security contact to assess whether the entity’s existing background investigation is equivalent to the FDA’s requirement which is a Federal Level 2 Minimum Background

Investigation (MBI), Public Trust Background Investigation. Additionally, OSO will evaluate the clearances currently held by each individual required to have a background check under the Contract. If OSO determines that any additional element or information is needed to complete the required clearances, OSO will facilitate this process.”

In the next contract, is the Contractor (State) responsible for conducting the commission-related background check on Inspectors (and other state staff) in addition to the background check that will be conducted for Underage Purchasers?

Inspectors, along with all other employees under the contract and subcontract, excluding underage purchasers, will be subject to background investigation conducting by FDA.

The Contractor shall provide the information for the available employees and

Subcontractors to be commissioned/receive background investigations, and subsequently, immediately upon identifying new staff it wishes to have commissioned directly to FDA.

Key Personnel (PC/BPC)

70. Pertaining to the Technical Requirements Section of the solicitation - C1.1.C Key

Personnel, Texas has operated successfully since the inception of the FDA program in our state (continuously since 2012) with the PC employed by the Prime Contractor, and the BPC employed by the Subcontractor. We are extremely concerned that the state would not be able carry out the requirements and deliverables of the FDA program due to the requirement that both the PC and BPC must be employed directly by the Prime

Contractor. Therefore, we would like to inquire about the possibility of Texas receiving approval to continue to operate under our current structure (PC at Prime and BPC at

Subcontractor) moving forward in the new funding period under this solicitation.

The Department of Health Services is currently the Prime Contractor but does not have position authority to hire staff. Page 10 states “the PC and BPC must be employed directly by the Prime Contractor and shall not be employed by a subcontractor”, what happens if the Prime Contractor is unable to hire the PC and BPC due to not having position authority?

71. What is the rationale behind the PC and BPC both being employed by a Prime

Contractor?

FDA Response to Questions 70 - 71:

The prime contractor is responsible for ensuring successful performance of all contracts awarded by FDA and is therefore responsible for staffing key personnel positions that will manage the tobacco retail inspection program in a jurisdiction. It is not feasible for

FDA to contract with prime contractors that are not able to staff the key positions of the

PC and BPC because responsibility of managing overall performance of the requirement may not be delegated to a subcontractor. Therefore, FDA will not consider proposals to staff those positions with subcontractor staff to be technically acceptable for award do to the essential functions the PC and BPC managing overall contract performance. No exceptions will be made to this requirement.

72. In the case the PC/BPC are unavailable, please clarify how the alternate POC will be communicated with as they do not have access to an FDA issued laptop?

FDA will communicate with the alternate POC through the contact information provided by the Contractor.

73. The alternate point of contact is only contacted if the PC and BPC are not available, do we need to include salary costs for this individual?

Costs should be included for the estimated amount of time that the alternate POC may be needed to work on the contract.

74. Page 10 – Paragraph 5, “The PC shall be the main point of contact (POC) for FDA. The

Contractor shall also designate a BPC as an alternate POC to allow the Government consistent communication.”

Does the designated POC need to be Commissioned?

All individuals working under this contract will be subject to a background check. Only individuals that conduct inspections are required to be commissioned. Underage purchasers are not required to be commissioned.

75. Please clarify what is meant by the PC/BPC must be available anytime during the 40-hour work week to specify what timeframe during the week this involves?

A business work week is defined as Monday – Friday. An example of business hours is

8:00 a.m. – 5:00 p.m.; however, this may fluctuate based on each jurisdiction’s agency requirements.

PC Conference and Travel Related Questions

76. For budget-development-purposes, what Option Year shall we add the FDA PC

Conference too? Or have a 5th tab perhaps entitled “PC Conference Expenses”.

77. Do we include travel costs associated with the in-person conference for each contract year?

78. Should states budget for Program Coordinator’s conference attendance for each year of the 4-year contract? If, not what year of the 4-year contract should conference attention be budgeted for?

79. Should travel for the PC conference be included for each budget year?

80. What year should we budget for travel for the PC/BPC to attend the PC Conference in the

Washington, D.C. area, would it be OY 2 or OY 3

FDA Response to Questions 76 - 80:

PC Conference travel cost should be included in the Base Year and Option Year 3.

81. Do we include travel costs associate with PIV renewal and laptop refresh for each contract year?

Due to uncertainty with key personnel changes within a specific jurisdiction, travels costs associated with PIV and laptops should be included for each contract year.

82. B-3 Options, page 7, Unallowable Costs – Would FDA related quarterly training at our

HQ be considered as non-inspection related travel?

Yes, this is considered non-inspection related travel.

83. What positions are we permitted to subcontract under this contract? Page 8 C.1.1.A implies we are only able to subcontract inspectors.

FDA only requires that key personnel be employed by the Prime Contractor.

84. If Contractor-directed UBs are no longer going to be conducted and all UBs are FDA-directed, then why are Contractors responsible for identifying retailers to inspect per pages 18-20?

The Contractor in each jurisdiction has access to resources that identify retailers who sell regulated tobacco products within its jurisdiction; therefore, FDA requires the Contractor to provide updates to those retailers within their jurisdiction

85. Pg. 22 – Can you please give us more detail about what items might be purchased during an A&L, 20% of the time. How will this be tracked?

Regulated tobacco products might be purchased during an A&L assignment.

86. Pg. 46 – Sanitization of Government Files and Information – “all electronic and paper records are appropriately returned or disposed of…” – we have A&L and UB evidence that have been collected since 2011, does this mean we need to ship these materials to the

FDA by the end of September?

87. Pg. 23 – “If the tobacco compliance check inspection contract expires or is not continued before the one based and three option -year period of performance end date, the COR will provide instructions for transfer of these records and evidence” – does this mean we need to send you all evidence from prior grant years? We have evidence dating back 2011.

FDA Response to Question 86 - 87:

If the Contractor currently holds an FDA contract, they should reach out to their COR on returning evidence held on current or prior contracts.

88. Pg. 31 – Annual Update of Inspector/Underage Tobacco Purchaser Information – we have been told for many years that the FDA only wants to know minor/UTP number, date of birth, and gender. Description 13 states the FDA wants all contact information for both inspectors and minors/UTP that have been employed during the last 5 years. Is this correct, you want names, address and phone numbers?

FDA will provide guidance on the required information.

89. Currently, all background checks for the program are conducted by the subcontractor.

According to the presentation, the Primary Contractor will have to conduct the background checks. To clarify, do you mean the Primary Contractor has to conduct the background check or is responsible for making sure the background check is completed?

And if a third party is allowed to conduct the background check, will the FDA reimburse the state for time and monies?

90. Are the costs of background checks for Underage Purchasers 18-20-year-old volunteers an allowable cost?

FDA Response to Question 89 - 90:

This is a cost reimbursement type contract which means that the costs incurred associated with this program will be reimbursed with the appropriate supporting documentation.

DSP Questions

91. Page 19 – Paragraph 2, “For FDA Directed UB Inspections, the Contractor shall focus on inspecting areas that have not been inspected in prior years before returning to retailers that have been inspected under this contract.”

Does this mean that the FDA will provide us with a full list of all stores at the beginning of the contract year? Will we still get to pick which stores to do for each inspection day?

Does this also mean that we will have to do inspections in remote areas that are hard to access and presence of anyone outside of the area is known immediately upon arrival, if those have never been inspected as a UB?

The Contractor will have the ability to create the assignments which should be completed based on the criteria provided by FDA. The Contractor is expected to conduct inspections in all areas of the state.

92. Safety: We are very diligent as a program to verify areas that are deemed unsafe. Our inspectors prescreen areas of inspection to determine if any safety issues arise. This includes matching the demographics of the area with the ethnicity of the minor. If you are assigning counties/areas to inspect how will this affect the inspection teams concerns regarding safety? We assume that unsafe establishments will still be allowed to be deemed unsafe, even if they are part of directed FDA inspections?

The Contractor will have the ability to create the assignments which should be completed based on the criteria provided by FDA. Alternatively, the Contractor may be responsible for identifying retailers to inspect in each jurisdiction.

93. Can we use FDA issued phone to contact Underage Purchasers?

FDA issued phones may be utilized for FDA inspection related activities.

94. The FDA has published in the RFP that Mississippi should do 2000 FDA Directed UB inspections. I am assuming this 2000 number reflects both UB routines and FDA

Directed UB follow-ups. If approximately 400 of the 2000 number are FDA Directed

UB follow-up inspections, then only 1600 would be UB routines. Am I understanding this correctly? Currently, Mississippi only has 3, 287 available retailer stores. If we only do 1,600 routine UBs then that would only be approximately 50% of all stores getting a

UB routine check per year. This seems really low. Is it ok for Mississippi to suggest that we inspect 80% of all available stores for a routine UB inspection per year?

95. Our state plans on submitting different inspection numbers than what is listed under the scope of work chart. As long as we provide justification for our numbers, will the FDA consider our alternative proposal?

FDA Response to Questions 93 -94:

The number of FDA Directed UB inspections are negotiable, as long as they are within the requirements of the contract. Offerors proposing different inspection numbers must include a justification in their proposals with support for the numbers proposed by the state/jurisdiction.

96. Section C.1.6.2, page 22, FDA Directed A&L Inspections – Clarification on inspectors purchasing a potentially violative tobacco product during an A&L inspection and up to

20% of all A&L inspections making such purchases.

Contractors should develop a system to allow an Inspector to purchase a potentially violative tobacco product on up to 20% of all A&L inspections.

97. Pg. 22, FDA Directed A&L Inspections, can you provide more specific information regarding what types of assignments (UB, A&L, NTSO, NTSO Follow Up) correspond to the percentages provided in this section? What specific type of assignments are the percentages referencing?

As the RFP states “Additionally, 15% shall be completed within 15 calendar days and10% shall be completed within 5 calendar days of assignment. The Contractor may need to coordinate these A&L inspections so that they are conducted within 14 days of a corresponding FDA Directed UB assignment. The Contractor may be required to conduct hand delivery of documents to a retailer rather than conduct a compliance check inspection.” The percentages relate to the timeframe for performing A&L inspections, as noted, some of these may involve delivery of documents rather than a full inspection.

These FDA Directed A&L inspections would not be an Undercover Buy inspection.

98. Page 18 – Paragraph 1, “The Contractor is responsible for making changes to their retail outlet list contained in the TIMS system, according to FDA guidance.”

Will FDA provide written reference guidelines for retailer updates?

FDA can provide guidelines on updates to the retail outlet list once a contract has been awarded.

99. Attachment 2: Retail Outlet List Template and Instruction, “States can submit information for all the retail locations they want considered for inspections. This information should be saved to a CD as an Excel file (using the template provided) and submitted to the Center for Tobacco Products.

Do we need to use CD to store Excel files of the retailer list and mail them out to CTP?

No, retail outlet lists can be submitted electronically to CTP. As referenced on p. 18 “The

Contractor shall contact FDA to coordinate the upload of a large list of establishments once a quarter, if needed.”

100. Pg. 24 Apart from FDA enforcement actions for violations of the Tobacco

Control Act and its implementing regulations, jurisdictional enforcement actions may be pursued against retail outlets and are found to have also violated the law of that jurisdiction. These efforts must be coordinated with the FDA COR and not compromise

FDA’s compliance check inspection procedures, data, or evidence. Additionally, the

Contractor shall furnish information regarding retailer compliance with the jurisdiction’s laws, including jurisdictional enforcement actions, where violations are found during

FDA inspections, as soon as practicable after inspections are completed.

Can you provide a specific example of what states can do? For example, does this mean we can share FDA enforcement violation information after an inspection is completed with the law enforcement agency of that jurisdiction for their enforcement purposes? If so, what are ramifications for a state doing so when there is a true possibility that FDA’s compliance check inspections procedures, data, or evidence could be compromised when a Retailer’s defense attorney requests the information under discovery when challenging a violation cited by a city, county, state law enforcement agency?

No, the results of completed FDA compliance check inspections are available on FDA’s website. FDA reviews compliance check inspection information and determines if a violation has occurred. Information on FDA compliance check inspection results is not available until it has been posted to the Compliance Check Inspection Database.

101. Will you provide us a list of FDA-directed routine UBs at once in the beginning of each fiscal year or throughout the contract period?

If FDA will provide direction at the beginning of each contract period on how and where to conduct FDA directed inspections.

102. If CTP is going to tell us the zip code areas where inspections are to be conducted, can states get that information now? Our inspectors are regionally assigned throughout the state, will there be enough inspection activity throughout the state to maintain the Inspector’s regional assignment?

If FDA will provide direction at the beginning of each contract period on how and where to conduct FDA directed inspections.

103. What criteria or guidance will FDA provide to help us determine that we are hitting all the different required locations? We visit establishments Statewide in various locations with mixed racial and ethnic communities, do all the stores then fall within all the categories?

The Contractor should submit its plan for conducting inspections in racial and ethnic.

104. Page 11 – Paragraph 4, “If the Contractor utilizes part-time Inspectors, those inspectors must maintain regular performance of inspections in order to remain active on this contract. Inspectors that do not perform a minimum of 10 inspections each month will be deactivated from the program.”

How much notice will FDA give the PC prior to deactivating an Inspector?

105. The language in the requirement of an Inspector maintaining their commissioning status was change from “may be deactivated” to “will be deactivated” if a minimum of 10 inspections are not completed a month. What direction can you provide states if an

Inspector cannot maintain this requirement? What will the implications be on the state?

106. Will FDA consider not deactivating inspectors that do not perform the minimum

10 inspections each month due to program composition?

FDA Response to Questions 104 - 106:

FDA will work with each Program Coordinator depending on the specific situation.

107. Page 12 – Paragraph 2, “The Contractor shall ensure that the Underage

Tobacco Purchasers are within the required age range by obtaining a copy of their birth certificate and/or other government-issued identification and for Minors, an original parental/legal guardian consent form.”

It states that birth certificate AND/OR other government-issued identification, does this mean that we no longer need birth certificate if the volunteers can provide other government-issued identification (e.g. passport, military ID, drivers permits/license) since we are only using them for age verification?

108. Can an American Samoa Identification Card and Voter’s Registration ID card be acceptable forms of Identification?

FDA Response to Questions 107 - 108:

Either a birth certificate or valid government-issued identification containing the

Underage Purchasers date of birth will serve as sufficient documentation. If the valid government issued identification being used does not contain the date of birth, both the copy of the birth certificate and the government-issued identification would be needed.

109. Page 19 mentions prioritizing geographic areas with a higher risk for regulatory violations – is there a certain percentage of inspections that should be dedicated to these areas?

FDA will provide direction at the beginning of each contract period on where to conduct

FDA directed inspections.

110. Pg. 22 – Can you please give us more detail about what items might be purchased during an A&L, 20% of the time. How will this be tracked?

Regulated tobacco products might be purchased during an A&L.

111. Pg. 23- Besides evidence and copies of 482s, what do you consider “original inspection records”?

Per the RFP, The Contractor shall maintain all original inspection records and evidence in its files for FDA for the length of the contract. Original inspection records may include anything recorded separately from information in the Tobacco Inspection Management

System (TIMS).

112. Pg. 28 – C 1.1 – “Underage Tobacco Purchaser information – “Fourteen (14) calendar days before the Underage Tobacco Purchasers begins inspecting.” Does this mean that the UP cannot work until 2 weeks after receiving completed paperwork? Can’t train until 14 days after the completed paperwork? Please clarify.

No, this language is referencing when the minor should be added to the TIMS…