Questions_and_Responses_for_3rd_Party_RFP_17-223-SOL-00040_program.pdf

Solicitation Number: 17-223-SOL-00040 Clarification Questions

Proposal Name: Tobacco Retailer Inspections (3rd party)

1. If the contractor elects to travel to the state to conduct onsite training and quality control checks or participate in FDA site visits, are these acceptable expenses (provided these costs are included in the budget)?

FDA Response: Travel costs to conduct onsite training and quality control checks are acceptable expenses that should be included in the budget. FDA site visits will occur at the location where the Program Coordinator, Backup Program Coordinator, and evidence are located.

2. Is it acceptable to send additional management personnel to onsite FDA trainings in the D.C. area?

FDA Response: Only the Program Coordinator and Backup Program Coordinator will participate in the FDA training in the D.C. metro area.

3. Page 9 of the RFP lists specific quantities of inspections. However, on pages 61–62, the number of inspections referenced is at least 20% of total retailers and up to 100%. Which standards are we to respond to?

FDA Response: FDA has provided the number of contractor directed inspections to be performed in the jurisdiction, the number of inspections to be proposed should match the numbers on page 9.

4. Can management staff (PC, BPC, or other) who are not commissioned participate on UB or A&L inspections for quality control and training purposes?

FDA Response: If the intention is to enter the retail establishment and observe the inspection, everyone on the inspection must be commissioned and credentialed.

5. The RFP indicates the PC role must account for the majority percentage of the 1.0 FTE.

Can contractor management staff be designated as the point of contact for communicating with the FDA if they are not identified as the PC? Page 13 of the RFP indicates the primary point of contact for the FDA could be “designated administrative personnel.”

FDA Response: Page 10, of the RFP states, The Program Coordinator shall be responsible for all aspects of the program management work described herein. This position should be the main point of contact for FDA. The Contractor shall also designate a backup/alternate Program Coordinator so the Government will always have a point of contact. In the event the PC and BPC are unavailable, the Contractor shall designate and notify the COR of a point of contact with the authority to make decisions on behalf of the PC/BPC.

6. Please clarify/expand on the description of a “commissionable” inspector. Please define “political subdivision.” Do state university employees or retired law enforcement qualify?

FDA Response: As provided in the RFP, “In order to be commissionable, the inspector must be a health, food, or drug officer/employee of any State, Territory, or political subdivision thereof.” The determination if an individual meets these requirements must be made by the contractor prior to submission and will be reviewed on a case-by-case basis during the commissioning review.

7. Would the FDA consider an individual who has retired (in good standing) from a state or local jurisdiction to be considered an eligible inspector?

FDA Response: See response to number 6.

8. If the Program Coordinator In-Person Training will occur approximately every 3 years, how do we account for this in the budget? Specifically, which year should include these costs?

FDA Response: Travel costs should include estimates for 2 people for each year (Base, Option year 1, and Option Year 2).

9. Page 15 of the RFP indicates the FDA will provide a list of retailers. However, page 62 of the RFP indicates that, if the contractor does not have a list of retailers, it must describe how one will be compiled. Is the FDA providing a list of retailers? If so, is the expectation that the contractor works only from the FDA list, or is the contractor to compile an additional list?

FDA Response: FDA will provide a list of retailers it currently has record of in a specific jurisdiction. The Contractor must provide updates to the list, including obtaining a list of any new retailers not contained in the FDA list and provide it to FDA to update the Tobacco Inspection Management System (TIMS).

10. Page 19 of the RFP describes “potentially violative tobacco product.” For budgetary purposes, can you provide examples so that we can estimate costs?

FDA Response: Any tobacco product within the regulatory purview of the FDA fall under the category of “potentially violative tobacco product.”

11. Page 40 of the RFP references fingerprinting and obtaining security badges and equipment.

• If costs are associated with these activities such as travel to obtain these items, are the travel costs reimbursable within program management and/or non-inspection-related travel?

FDA Response: Costs to travel to obtain fingerprinting and FDA badges are reimbursable under non-inspection related travel.

• Can you provide details on where the travel destination for security badges and equipment would be for each jurisdiction? For example, is it a regional FDA office?

FDA Response: The location to obtain FDA PIV badges would be the closest FDA badging office to the Program Coordinator and Backup Program Coordinator.

12. Page 61 of the RFP requires a draft schedule for the completion of the work.

• When can training commence for the PC, BPC, inspectors, and minors?

• How do those activities relate to NPI forms and commissioning?

FDA Response: Training for the PC and BPC can commence once FDA has received the NPI form and the background check has been completed. Inspectors must complete NPI forms and be commissioned in order to begin training.

Minors must complete and pass training before conducting inspections.

13. Page 64 of the RFP describes the price per inspection. If inspections are completed by a subcontractor, can the subcontractor’s program management and training costs be included in the fixed price for the inspections?

FDA Response: All subcontractor cost must be broken out and clearly shown in the proposal. No training cost for the subcontractor should not be included in price for inspections.

14. Are MNRs completed by hand in hard copy or electronically within the iPhone? If hard copy, who is responsible for attaching the document to the inspection—the inspector or

PC/BPC?

FDA Response: Currently, Minor Narrative Reports (MNR) are completed in hard copy by the minor. The Inspector provides the MNR as a part of the inspection documentation.

15. Considering the processes involved with startup and states with a large number of required contractor-directed inspections, can fewer inspections be proposed in the base year with the expectation of increasing the number in the option years?

FDA Response: FDA has provided the number of contractor directed inspections to be performed in the jurisdiction; this number applies to each year of the contract the number of inspections to be proposed should match the numbers on page 9.

16. The RFP indicates inspectors must complete 10 inspections each month or may be deactivated. For rural areas with harsh winter conditions, this may be a challenge for some inspectors. Can FDA allow some flexibility to accommodate these circumstances?

The 10 inspections per month can be considered an average if there are times where inspectors will be conducting more or fewer inspections due to limits of the jurisdiction.

If fewer than 10 inspections per month is expected for some months, the contractor should provide justification for this within their response.

17. On page 60, the RFP states: “Together the Program Coordinator and backup/alternate Program Coordinator shall equal at least one (1) FTE.” However, the required level of effort varies significantly in terms of number of retailers across states and territories. To increase cost-effectiveness, would the FDA consider a more flexible approach to determining FTE percentages for proposed key personnel where the percentage of FTE would be determined by the number of retailers for each specific state?

FDA Response: The Program Coordinator shall be responsible for all aspects of the program management work described herein. This position should be the main point of contact for FDA. The Contractor shall also designate a backup/alternate Program Coordinator so the Government will always have a point of contact. The Program

Coordinator shall be available at all times within the 40 hour work week to communicate with the FDA.

18. For Past Performance, the RFP reads “…a list of the last three (3) contracts completed during the last five years.” Please clarify:

• Is it acceptable to use a current contract for which the contractor has completed an obligation year?

• Is it acceptable to use the last three (3) most relevant contracts?

FDA Response: Per RFP, contracts currently in process that are similar in work scope may be included in past performance. All contracts included in past performance must have been completed in the last five (5) years.

19. To enhance presentation of proposal material, please confirm that 10-point font is permissible for charts, graphs, graphic elements, tables, and other visual elements that will assist reviewers in their evaluation of proposals.

FDA Response: A 10-point font is permissible for charts, graphs, graphic elements and tables only. All other material should be submitted in 12-point font as outlined in the

RFP.

20. Will the Government please clarify its intent regarding the requirements for C.1.2, Program Management Tasks (page 13) which is to be covered in the Technical Approach section of the proposal and Chapter D, Program Management (page 61)? Both proposal sections appear to require the same information. What information does the Government expect to see under C.1.2. in the Technical Approach vs. Chapter D?

FDA Response: Page 13 is the technical requirement. Page 61 is a part of the technical proposal instructions which is a under section L.4. This provides the criteria that an Offeror’s proposal will be evaluated.

21. Will the Government please clarify its intent regarding the requirements for C.1.8, Quality Control Plan (page 21) which is to be covered in the Technical Approach section of the proposal and Chapter H, Quality Control Plan (page 63)? Both sections appear to require the same information. What information does the Government expect to see under C.1.8 in the Technical Approach vs. Chapter H?

FDA Response: Page 21 is the technical requirement. Page 63 is a part of the technical proposal instructions which is a under section L.4. This provides the criteria that an Offeror’s proposal will be evaluated.

22. Regarding Section L.4, Volume I – Technical Proposal Instructions, this section identifies requirements A, B, C, D, E, F, and H. There is no requirement G. Please confirm this was just an error and that requirement H will become requirement G.

FDA Response: There is no requirement G.

23. To enhance presentation of proposal material, please confirm that 10-point font is permissible for charts, graphs, graphic elements, tables, and other visual elements that will assist reviewers in their evaluation of proposals.

FDA Response: See question 19.

24. Please confirm the table of contents for the Technical Proposal is not included in the page limits.

FDA Response: The table of contents for the Technical Proposal is not included in the page limits.

25. The name and address of the Contract Specialist for proposal submission is unclear. The RFP indicates an unnamed Contract Specialist with a partial address (no room number) at the Parklawn Building on Fishers Lane in Rockville. SF-33, however, identifies Lisa Jackson and Lisa T. Oneill with a Silver Spring address. Please clarify to whose attention and at what address proposals should be submitted.

FDA Response: The proposals should be addressed to:

Lisa Jackson 5630 Fishers Lane. Rm 2022 Rockville, MD 20857

26. Please confirm no Proposal Intent Form is required for this solicitation.

FDA Response: There is no Proposal Intent Form required for this solicitation

27. Two requirements in Section C are labeled Section C.1.2—one is Program Management

Tasks while the other is Tobacco Retail Inspection Program Training. Please clarify. Is it acceptable if offerors address Program Management Tasks as C.1.2.A and Tobacco Retail Inspection Program Training as C.1.2.B?

FDA Response: Please label C.1.2 Program Management Tasks and C.1.2.A as Tobacco Retail Inspection Program Training per the RFP.

28. Regarding Page 1; 53, Solicitation Section SF44, Section K – Reps and Certs, Paragraph SF 33; Section K.1(a)(1):The SF33 does not list a NAICS code; however, the Reps and

Certs in Section K.1(a)(1) lists NAICS code 923120, which applies to the States. The FBO site, however, lists NAICS code 541990. Would FDA please confirm the NAICS code and small business size standard that applies to this solicitation?

FDA Response: The NAICS code for this solicitation is 541990, the small business standard is 15M.

29. Regarding Page 1; 66, Solicitation Section SF-33; L.9 – Proposal Submission, Block 9;

Para. 1:

Block 9 of the SF-33 indicates 17:00 ET (5 PM ET) as the NLT time for submission of proposals. This conflicts with Section L.9, which states that offerors should submit their proposals NLT 1 PM ET. May the government please confirm the NLT time for submission of proposals?

FDA response: The proposals are due June 23, 2017 by 3:00 pm ET.

30. Regarding Page 5; 68, Solicitation Section B.2 – Contract Price; M.3 – Price Evaluation, Tables; Para. 1: Section M.3 Price Evaluation, states that, “[t]he estimated quantities for all items shall be multiplied by the proposed unit price in calculating the price of said items.” Given this statement, the total evaluated price, using the tables in B.2 Contract price, will likely result in significant pricing variances given the wide range in terms of the percentage of outlets to be inspected (i.e. min 20% all the way up to 100%).

We recommend the government revise the solicitation to provide a fixed number of inspections per jurisdiction (and seek pricing at the associated level) so that costs can be fairly and accurately analyzed amongst bidders.

FDA Response: See question 3, above. FDA has provided the number of contractor directed inspections to be performed in the jurisdiction. The number of inspections to be proposed should match the numbers on page 9.

31. Regarding Page 8, Solicitation Section B.4 – Travel and Other Direct Costs, Paragraph Para. A:

Please confirm that offerors will be allowed to include indirect burdens on travel and ODC’s in accordance with their established accounting practices.

FDA Response: No indirect burdens and ODC’s should be included in travel cost. Travel costs should be in accordance with federal travel regulations.

32. Regarding Page 9, Solicitation Section C.1 – Scope of Work, Table:

Can the FDA clarify if the numbers contained in the table on page 9 represent the FDA’s estimate of the number of inspections based on current number of retailers in each state?

directed inspections to be performed in the jurisdiction. Pages 61- 62 are being amended to reflect that the number of inspections to be proposed should match the numbers on page 9.

33. Regarding Page 9; 62, C.1 – Scope of Work; Section L.4 – Volume I - Technical Proposal Instructions, Para. 2; Table; Section F(A) and (B):

Paragraph 2 states: “The number and types of inspections required to be conducted for the base period and option year for each jurisdiction are listed below.” However, Section L.F(A) and (B) state that the contractor is required to provide the number of tobacco retail outlets in the jurisdiction and update the retailer list for all retail outlets in the State for a minimum of 20% of the retail outlets in the State and up to 100% if practicable.

Q1: If the Table at Section C.1 represents the total number of inspections and contractors must inspect them one time (unless there is a violation), what percentage of the totals in the Table are indicative of the re-inspections?

Q2: If contractors are to provide the number of tobacco retail outlets and are required to inspect at least 20% of the retail outlets, what do the “required” numbers provided for Contractor Directed Inspections in the table on page 9 represent?

directed inspections to be performed in the jurisdiction. Pages 61- 62 are being amended to reflect that the number of inspections to be proposed should match the numbers on page 9.

34. Regarding Page 16; Attach. 1, C.1.4 – FDA’s TIMS; Materials List, Para. 1:

Paragraph 1 provides: “FDA will not consider contractor provided devices…The handheld device currently provided to Inspectors by FDA is an iPhone.”

If the iPhone is the only device that the Inspectors can use, would FDA please explain the need for contractors to provide cameras, computers, and CDs as indicated in the Materials List in Attach 1?

FDA Response: These materials may be needed in specific limited circumstances.

35. Regarding Page 21; C.1.7 – Contractor Transition Out; Materials List, 4th bullet:

This bullet point notes that “Regulatory notebooks, properly labeled based on FDA provided protocol and procedures” are subject to transition at the end of the contract. The Materials List at Attachment 1 also includes a Regulatory notebook (bound) as an item provided/purchased by the Contractor.

Would FDA please clarify what the regulatory notebook is and how it is used on this project?

FDA Response:

A regulatory notebook is a bound notebook used to document the observations of the inspector. Additional detail on how the notebook will be used will be provided after contract award.

36. Regarding Page 22, Section C.1.9 – Monthly Report, Section I, Number 5:

This section requires the contractor to report on “[m]edia coverage, contact, and/or inquiries, if any” in the monthly report.

Would FDA please expand on how the contractor should address these media situations if encountered?

FDA Response: All media requests that the contractor may receive must be sent to FDA.

37. Regarding Page 26, Section F.3 – Deliverables, Table, 3rd row, middle cell:

This section references Administrative Assistants, which has an associated SCA labor category as provided in the SCA Dictionary of Occupations and acknowledged in other FDA solicitations.

Please confirm that the Administrative Assistant SCA labor category should be used for purposes of this solicitation as well.

FDA Response: If the Offeror identifies a need for Administrative Assistants to work on this project then the SCA labor category should be used for the purposes of this solicitation.

38. Regarding Page 58, Section L.3 – Proposal Instructions, Para. 2:

Consistent with other FDA solicitations, would FDA allow a smaller font (i.e., 10 pt.) for the following:

• Headers and footers,

• Graphics, and

• Tables?

FDA Response: See response to question 19.

39. Regarding Page 58, Section L.3 – Proposal Instructions; Section L.4 – Volume I -

Technical Proposal Instructions, Para. 2; L.4(C), and L.4(H):

This section allows for a 50-page limit with the following being excluded: “resumes, commitment documentation, and supporting documentation”

Q1: Given the page limitation, would FDA consider excluding the Quality Control Plan required at Section L.4(H)?

FDA Response: All required items must be submitted as requested by RFP including the Quality Control Plan.

Q2: Given the page limitation and given that each State could have up to 30 inspectors, would FDA consider either providing a sample of the Inspector names (1 – 2 with proof) for the proposal as required in Section L.4(C), 1st and 2nd bullet point, OR allowing submitters to provide the information to the proposal as an excluded attachment?

FDA Response: Specify the commissionable employees as requested and any additional information required can be included as part of your supporting documentation.

Q3: Would FDA consider excluding the following from the page count:

• Cover;

• Cover Page;

• Table of Contents;

• Executive Summary; and a

• Compliance Matrix?

FDA Response: The cover, cover page and Table of Contents maybe excluded from the page count; The Executive Summary and Compliance matrix are included as part of the 50 page count limit.

40. Regarding Page 59, Section L.4 – Volume I – Technical Proposal Instructions – A.

Technical Approach Including Physical Security Plan, Para. 1:

This section provides: “In order to be commissionable, the inspector must be a health, food, or drug officer/employee of any State, Territory, or political subdivision thereof.

Note: This definition of commissionable applies throughout.”

Would FDA please explain how broadly this provision has been interpreted at FDA for recruiting purposes?

FDA Response: See Question 6, above, as provided in the RFP, “In order to be commissionable, the inspector must be a health, food, or drug officer/employee of any State, Territory, or political subdivision thereof.” The determination if an individual meets these requirements must be made by the contractor prior to submission and will be reviewed on a case-by-case basis during the commissioning review.

41. Regarding Page 65, Section L.6 – Volume III – Past Performance, Para. 2:

The RFP states that Offeror’s should provide “[a] list of the last three (3) contracts completed during the last five (5) years and all contracts currently in process that are similar in nature…”

Please confirm that Offerors are limited to 3 past performance references total, combined between the Offeror and any major subcontractor?

FDA Response: Offerors are limited to 3 past performance references total.

42. Regarding Attachment 1, 3rd Column – Provided/Purchased by Contractor, 3rd bullet and

8th bullet:

This list requires contractors to purchase printers/faxes/scanners (including ink cartridges) and small labels to place on evidence.

Q1: Would FDA please confirm that the printers/faxes/scanners may be connected to FDA-GFP as long as they are on the MAT list? If not, would FDA consider providing them as GFP?

FDA Response: Local printers on the MAT List may be connected to FDA GFP.

Q2: Would FDA please confirm that the small labels for the evidence are provided by

FDA?

FDA Response: Contractors shall use FDA provided evidence storage bags for all evidence storage.

43. Reference Section L.3 Proposal Instructions, B. Corporate Experience, “The Offeror shall provide information for three projects that are similar to this effort in terms of type, scope, complexity and size…” Our team includes a prime/subcontractor relationship.

Would the government consider a subcontractor’s contract as one of three Corporate Experience projects required in this section? And if so, would the presentation of two contracts from the prime offeror and one contract from the subcontractor to the offeror be evaluated the same as three projects from the offeror?

FDA Response: Per the RFP the offeror shall submit 3 projects that are similar in type, scope and complexity and size and include the degree of their involvement (prime or subcontractor). All three projects will be evaluated as part of the offerors Corporate Experience.

44. Reference Section C.1 Scope of Work, “The number and type of inspections required to be conducted for the base period and option year for each jurisdiction are listed below…” AND Section L.3 Proposal Instructions, F. Inspection Plan for Retailers, Including Proposed List of Retail Outlets, “In order to accurately understand and evaluate the number and type of retail inspections being proposed, please provide… the number of routine inspection assignments to be completed in each contract year.”

Are the inspection quantities identified in Section C an absolute constraint, or can Offerors proposed additional inspection quantities for the respective state? Please clarify.

FDA Response: See question 3, above. FDA has provided the number of contractor directed inspections to be performed in the jurisdiction, the number of inspections to be proposed should match the numbers on page 9.

45. Is it possible for Inspectors to serve in multiple states with a Federal Commissioning status? If so, could a state employee from Georgia do inspections in Florida if they were commissioned in either Florida or Georgia?

For the purposes of our program, Offerors should plan to have inspectors conduct inspections the state in which they are employed as a health, food, or drug officer/employee.

46. If you are a small business are you required to submit a subcontracting plan as required in Section M:

FDA Response: No you are not required to submit a subcontracting plan if you are a small business. All small business should submit a statement stating they are a small business.

47. RFP Page 9 in Section C.1 states “The Contractor may be required to coordinate the work under this Contract with other tobacco enforcement activities.” Can FDA provide detail as to what these additional enforcement activities entail?

FDA Response: These activities would be on a limited case-by-case basis, but may include coordination with enforcement activities such as manufacturing enforcement at a location that conducts both manufacturing and retail activities.

48. Will the Contractor be reimbursed for costs accrued due to these “other tobacco enforcement activities”?

FDA Response: Costs to complete activities assigned by FDA for completion by the contractor under this contract are reimbursable.

49 . RFP Page 10 states “The Contractor shall annually verify current contact information for all inspectors and minors who were employed within the past five years but are no longer employed by the Contractor, and the most recent contact information for such inspectors and minors shall be provided to FDA.” Please confirm that FDA expects the Contractor to contact previous Minors and Inspectors directly to update this information.

50. FDA Response: The contractor shall annually verify the information for all inspectors and minors who are or have been employed by the contractor.

51. RFP Page 14 in Section C.1.2 states “The Contractor shall provide FDA with a plan within two business days on how it intends to address inspector errors that are identified” for inspectors that “make multiple and/or repeated procedural errors”. Is this plan for addressing inspector errors required for each identified error?

52. FDA Response: Yes.

53. If not, how does FDA define “multiple and/or repeated procedural errors”?

54. FDA Response: Not applicable, see above at 4.

55. RFP Page 19 states “Within 48 hours of receiving the compliance check inspection assignment results from the Inspector, the Program Coordinator shall submit a recommendation for the inspection results in their queue and make appropriate updates to establishment records electronically through the TIMS system to FDA.” However, this 48-hour deadline may be unfeasible if results are submitted on a Friday, for example. Could FDA confirm whether the requirement is 48 hours or 2 business days?

56. FDA Response: 2 business days will meet this requirement.

57. 7. RFP Page 20 states “Within 48 hours of receiving a request from FDA, the Program

Coordinator shall provide FDA Requestor with information about a compliance check inspection and investigation unless citing extenuating circumstances.” Is this requirement for 48 hours or 2 business days?

58. FDA Response: 2 business days will meet this requirement.

59. 8. RFP Page 20 states “the Contractor shall be responsible for securing prompt and continuing cooperation from witnesses.” However, given that commissionable Inspectors are required by definition to hold other employment, their continued availability and cooperation may require forward notice. How long in advance will FDA notify the Contractor of a need for testimony or other cooperation?

60. FDA Response: As stated in the RFP, the Inspector and Minor must remain available to testify as a witness and provide oral testimony following any compliance check inspection in support of an FDA enforcement action and shall provide such testimony upon request. FDA recognizes that inspectors will be required to hold other employment and will make every effort to provide as much advance notice as possible.

61. 9. RFP Page 22 states that the Monthly Report must be submitted to the COR by the 10th of each following month. However, the RFP Deliverables table states that it should be submitted on the 10th business day of each following month. Please clarify the submission deadline for Monthly Reports.

62. FDA Response: The 10th business day is acceptable.

63. 10. RFP Page 26 states retail outlet list / updates to list should be submitted within 21 days after award; however, RFP Page 15 states that the Contractor shall assess the FDA-supplied list and provide revisions within 60 days. Please clarify whether the Contractor it required to update the retailer list within 21 days or within 60 days of award.

64. FDA Response: Within 60 days of award is acceptable.

65. 11. RFP Page 34 states that “The Government will provide 2 laptops to the Contractor”;

however, in many cases more than two internal staff would be accessing TIMS to complete all tasks in the SOW. Would FDA confirm that they will provide sufficient laptops for the Contractor’s Program Coordinator, Back-Up Program Coordinator, and Program Assistant(s) to access TIMS?

66. FDA Response: At this time, alternative access to TIMS may be provided to individuals beyond the Program Coordinator and Back-up Program Coordinator on a case by case basis. The contractor should make every attempt to limit the number of people who require access to the TIMS web-based interface.

67. 12. Could FDA confirm whether the performance of FDA-directed inspections are the same as compliance follow up inspections on the incumbent contracts?

68. FDA Response: FDA-directed inspections include compliance follow up inspections as well as other inspection related assignments. Please see section C.1.5, Subsections A-1 and A-2, regarding assignment types and timeframes.

69. 13. If not, could FDA clarify the differences between the compliance follow up inspections and the FDA-directed inspections?

70. FDA Response: Compliance follow up inspections are one type of FDA-directed inspection.

71. 14. In C.1.3.2 (p.16) we’re instructed that the contractor is “not to conduct more than two” UB inspections on a non-violative retailer within 12 months, but then in C.1.5.A.1 (p.18) it says no more than one per calendar year… but both sections seem to be talking about the contractor directed undercover buys. Please clarify whether 2 UBs can be performed on a non-violative retailer within 12 months.

72. FDA Response: No more than one contractor-directed undercover buy inspection shall be conducted at a retail establishment within 12 months.

73. 15. Does an Offeror need to submit employment information for Inspectors who are already commissioned?

74. FDA Response: The Offeror should provide general information regarding Inspectors who are already commissioned, including that their current active commissioned status.

75. 16. C.1. SOW page 7 inspection quantity table; the number of contractor directed inspections is substantially lower than what has been completed in prior years in some of the jurisdictions, may the offeror proposed more contractor directed inspections than what has been included in the table?

76. FDA Response: FDA has provided the number of contractor directed inspections to be performed in the jurisdiction, the number of inspections to be proposed should match the numbers on page 9.

77. 17. C.1. SOW page 7 inspection quantity table; if the contractor calculates a different number of FDA directed inspections based on the violation rate in the jurisdiction may the contractor proposed more or less FDA directed inspections than what has been inclu

78. FDA Response: See response to 16.

79. 18. Regarding Section B.1.C – Synar Regulation; Section C.1.9 – Monthly report - Page

4 describes the Synar Regulation as a program coordinated by individual jurisdictions and administered by SAMHSA/CAP and further states that the “annual Synar survey is separate from the FDA inspections under this contract.” Page 22, Section I, #7 states that contractors shall provide a “[d]escription of the jurisdiction’s Synar program and how it is coordinated with work under [the Tobacco Retailer Inspections] Contract per quarter, if at all.”

80. 18(a): May FDA please clarify how the Synar program is associated with this contract?

81. FDA Response: As provided in the RFP, the annual Synar survey is separate from the

FDA inspections under this contract. The requirement on page 22, Section I, #7 specially provides that the information needs to be provided “if at all” and does not apply in most situations.

82. 18(b): May FDA please clarify if awardees have any responsibilities or deliverables related to the Synar regulations and their annual report

83. FDA Response: As provided in the RFP, the annual Synar survey is separate from the FDA inspections under this contract. The requirement on page 22, Section I, #7 specially provides “if at all” and does not apply in most situations.

84. 19. Regarding Section F.3 – Deliverables; Section L.4.C – Organization and Staffing Plan… Page 26 of the RFP states that “[n]ames of individuals for commissioning…[should be provided] within 21 days after award…” Page 70 of the RFP states that Offerors are to “[s]pecify the commissionable contract employees/subcontractors that will be utilized to perform inspection work…” within our proposal submission.

85. Will FDA please clarify if Offerors are required to submit inspector’s names and qualifications with the proposal submission or within 21 days after award?

86. FDA Response: The requirement on page 70 is for evaluation of the RFP and the Offeror should provide the names of all known commissionable contract employees/subcontractors that will be utilized that it would like to be considered as part of their technical proposal. Within 21 days of award, the contractor shall provide to FDA all individuals who will be submitted for commissioning.

87. 20. Regarding Section I.2 – FAR/HHSAR Clauses in Full Text, The small business subcontracting plan requirements seem broad to apply to each individual jurisdiction contract. Would the Government consider reducing the subcontracting plan requirements to limit the number of socioeconomic statuses that must be applied? For example, perhaps only require a minimum of 3 statuses must be met by Offerors?

88. FDA Response: All requirements of the subcontracting plan must be applied in all the individual jurisdictions since each jurisdiction will be awarded individually as a separate contract.

89. 21. Regarding Section L.4.F – Inspection Plan for Retailers… last bullet The RFP states, “Should the ration of inspection types eliminate or significantly reduce the need for employees that the State previously hired for the specific purpose of working on its FDA State Tobacco Compliance Check Inspection Program, the offeror shall explicitly describe how it will be affected and propose alternate plans to attain a mix of inspections as close to the required ratio as feasible.”

90. May FDA please clarify this statement?

91. FDA Response: The RFP has been revised. This bullet is not in the most recent version of the

RFP.

92. 22. Regarding: Section L.6 – Volume III - Past Performance Information, 1st sentence

The RFP states that Offerors shall submit past performance information “for both the Offeror and proposed major subcontractors.”

93. What is FDA’s definition of a major subcontractor?

FDA Response: The evaluation will take into account past performance information regarding subcontractors that will perform major or critical aspects of the requirement when such information is relevant to performance of the contract.