FY21 VENDOR RFP QUESTIONS.docx

Vendor Questions FDA Response

1) Not compete nor assist anyone in competing for any competitive acquisition of the requirements or services described in the documents which the contractor has been provided access to or delivers under this contract and task orders thereof.

2) Not furnish either as a prime contractor or subcontractor the requirements or services described in paragraph 1) above.

The above prohibitions shall also apply to the contractor's employees, subcontractors, consultants or any other person who participates in the performance of this contract. The contractor shall require such persons to sign the Organizational Conflict of Interest Statement agreeing to the above restrictions. An executed Organizational Conflict of Interest Statement shall be provided to the Contracting Officer, prior to a person beginning work under this contract/order.

Noncompliance with the above restrictions and conditions shall be a cause for: termination of this contract for default; and/or, disqualification of any proposal submitted for a competition

2. The RFP Instructions require submission of the past performance questionnaires to Michael Gemmill. However, the questionnaire itself (Attachment D) has instructions to submit to Noah Wills and provides his contact information on the last page of the questionnaire. Also, the RFP and Attachment D have differing solicitation numbers (75F40121R00003 on the RFP, and RFQ No. FDA-SOL-20-1227442 on Attachment D). Would FDA please clarify/correct these discrepancies?

Updated to reflect all communication be sent to Michael Gemmill at michael.gemmill@fda.hhs.gov

3. There is no Attachment 13 provided with the solicitation. Would FDA please provide the missing attachment?

Updated to Attachment F and included

HHSF223201610014I

18. In order to fully respond to FDA’s requirements, will the Government increase the page limitation to 30 pages?

The technical volume is limited to 20 pages. This includes information related to experience. A page in the technical volume that contains a table, chart, graph, etc., not otherwise excluded below, is subject to the page limitation.

The following items are not included in the 20 pages limit:

· Cover Page

· Table of Contents

· Dividers

· Resumes (limited to 5 pages)

22. Will the government accept past performance references from offeror's proposed subcontractor(s)?

These may be submitted in addition to Past Performance of the offeror

23. Is it the intent of the Government to ask offerors for copies of teaming agreements with proposed subcontractors, as subcontract agreements aren’t established until after contract award?

Yes, this is acceptable to send after the contract award.

24. Could the government please clarify the statement “Experience described in the Past Performance Volume will not be considered”? Does this requirement mean the Past Performance references and projects described in Relevant Experience should be different?

This is to clarify that anything included in the Past Performance Volume will not be considered as part of the Technical Volume to try and add information beyond the page limit.

25. Section 12 refers to conducting a full PIA if the results of the PTA show that a full PIA is needed. Can you please confirm if the PTA has been performed on the current contract? If so, what was the outcome?

Full PIA has been performed.

26. If a full PIA is required, would you consider having Offerors submit a separate price line item for conducting a PIA?

NO. Full PIA has been performed.

27. Based on the Do Not Compete clause. Is it possible for you to let Tobacco Retailer Inspection contractors know if we are excluded from competing as either a prime or subcontractor on this solicitation?

See question 1

28. Are the Relevant Experience contracts required to be the same as those used in the Past Performance volume?

No. It is not required

29. Could the government clarify whether projects or BPA and IDIQs should be listed in the Past Performance Volume?

This is the offeror’s discretion

30. In order to allow government customers time to respond to required PPQs and provide offerors sufficient time to develop proposals for FDA, will the Government extend the due date of the proposal to April 5th, 2021

Proposal due date has been extended to April 5, 2021.

31. The RFQ mentions a Sample Task Order but the Sample Task Order is not mentioned in the RFQ instructions or evaluation criteria. Will offerors be expected to create a proposed solution for the Sample Task Order? If so, will this response be separate and apart from the 20-page limit for the overall technical volume?

The sample Task Order is for soliciting and comparing quote purposes. Once the IDIQ is awarded, the winning vendor will propose on the Task Order SOW which will not differ much from the sample Task Order.

32. There is no reference to the sample task order in the RFP document (i.e., the instructions and evaluation criteria). Is this provided for informational purposes? Or is the offeror to address this somewhere in our proposal?

The sample Task Order is for soliciting and comparing quote purposes. Once the IDIQ is awarded, the winning vendor will propose on the Task Order SOW which will not differ much from the sample Task Order.

33. Attachment D to the solicitation is the Past Performance Questionnaire. Attachment E provided with the solicitation is the Sample Task Order. Would the FDA please confirm this is correct?

Confirmed - Attachment D is Past Performance Questionnaire. Attachment E is Sample Task Order.

34. On Page 16 of the Solicitation the following appears to imply that a facilities clearance is NOT a pre-requisite for this award but could be obtained post award.

Certification from the Defense Contract Administration Services/Defense Logistics Agency (DCAS/DLA) as a secret or higher classification is not a pre-requisite for this award but is a requirement before contract performance.

35. The FDA Physical Security Staff may review the contractor's facility and assess the contractor's compliance. Recommendations for bringing noncompliant areas into compliance will be provided to the contractor by the FDA Physical Security Office. Are we to assume the implication is true?

Yes. The contractor shall make any changes necessary within thirty (30) days after written notice from the FDA Physical Security Office in order to comply with the FDA security requirements.

36. Does FDA want the Contractor to provide a separate cost proposal for Transition-In?

Yes.

37. What Quality Control tools, if any, are currently in use for the RFP’s scope of work?

N/A. The government is not allowed to provide the Quality Control tools, if any, currently in use for the RFP’s scope of work by the current contractor. We recommend the offeror provide Quality Control tools in alignment with their proposed method to complete the work described in the scope of work.

38. The STO states: “This will require the Contractor to review all inspection records for completeness, consistency, and accuracy.” What is the size of the current backlog, if any, of inspection records to review?

Currently, there is no backlog of inspection records to review.

39. The STO states: “The Contractor shall anticipate on average 300 -600 inspection assignments to be processed as Reply Letters per week.” What is the volume of Reply Letters received electronically? What is the volume received in other forms such as mailings/paper?

The Contractor receives a list and the letters electronically. All letters will need to be processed, including preparing the letters for mailing and accurately uploading the documents and information into the appropriate FDA computer systems.

40. Does the pricing worksheet depict the expected level of effort for this contract?

Yes.

41. The transition-in period is listed as 60 – 90 days. What factors does FDA CTP believe would make the transition-in 60 versus 90 days?

Transition-in period may be up to 60-90 days. The length of the transition-in period may be affected by the Contractor’s transition-in plan, on boarding process/activities, and practical knowledge and past experience.

42. The RFP states that “the transition out period is thirty (30) days.” How does the 30-day transition out being called for here relate to the 60-90 days of transition in?

Transition out period, which occurs at the end of the contract period of performance, is designated to ensure the Contractor completes all task order activities prior to the end of the contract per page 9 of the SOW.

43. Section 14 - The contractor and all of its present and future affiliates and subsidiaries agree to:

Not compete nor assist anyone in competing for any competitive acquisition of the requirements or services described in the documents which the contractor has been provided access to or delivers under this contract and task orders thereof. Given the requirements of this opportunity, the successful Offeror will not be exposed to or in possession of procurement sensitive information. Please consider deleting this requirement or if boilerplate and required in all contracts, provide confirmation that it does not apply to this contract.

See question 1

44. May Offerors submit more than three past performance questionnaires?

At least three past performance references are required for this contract.

45. In regard to the Project Director- Understanding that our goal is always to offer the Government the best, most qualified candidates possible, would the Government consider making the position degree requirements consistent with other FDA IDIQ requirements (example: an individual with a bachelor’s degree in a technical, business, information management discipline)?

The expected education requirements are listed in the RFP. The offeror should provide the Government the best, most qualified candidates to meet the performance of the work described in the IDIQ.

46. In regard to Project/Task Manager- would the Government consider making the position degree requirements consistent with other FDA IDIQ requirements (example: an individual with a bachelor’s degree in a technical, business, information management discipline)?

The expected education requirements are listed in the RFP. The offeror should provide the Government the best, most qualified candidates to meet the performance of the work described in the IDIQ.

47. The Government provided an amount in the ODC line for pricing. Please explain what costs are included so that we can ensure our proposed contractor facility cost as a rate per square foot and courier expenses are able to be covered or provide instructions on how you would like for us to propose those costs.

The amount provided on ODC line is for estimation purposes.

48. Are the dollars listed in the various ODC line items in Attachment C provided for evaluation and estimation purposes only or will those amount form ceilings for ODC’s in each year of performance of the contract?

The amount provided on ODC line is for estimation purposes.

50. What is the ceiling of this IDIQ?

Sixty-five Million Dollars ($65,000,000.00)

52. For future Task Order requests under this IDIQ, will the offeror be able to propose additional labor categories as needed?

No. Task Order labor categories must mirror the IDIQ labor categories.

53. The Sample Task Order references additional key personnel, "The key personnel for this task order are the Project/Task Manager, and all designated alternates."

The key personnel are the Project Director and the Project Manager.

54. Please confirm we are providing Key Personnel resumes at the IDIQ level only

Key personnel resumes will be provided at the IDIQ and Task Order level

55. Would the Government provide a schedule of the planned release of all anticipated task orders?

No.

56. Will the Government clarify the average number of days from the date a Task Order is posted to the date of Task Order award? In order to ensure key personnel are available to work immediately after Task Order award we need to complete the badging process which may be as long as 30 days to complete.

Badging process will occur during the transition in period.

58. Security Requirements: Att. A, Personnel Security Requirements, section 13, page 64, states the "Position Risk Designation for this contract is Tier 2." Att. E, Sample Task Order, 13, Personnel Security Requirements, states "the security risk level for this task order is 5." Can the government please clarify the personnel security level for this contract?

Position risk designation for this contract is Tier 2.

61. What is the government looking from the Offeror in regard to: "Association of LCATs with Roles and Responsibilities to be performed by Each LCAT" section? In other words, can the government kindly elaborate on what specifics they are looking for from the Offeror in that section?

Under Task 5.3, “As asked, the Contractor shall provide services supporting the reception and review of inspection results to recommend administrative or enforcement action as necessary.”

Is this task in person at the location or tracked via a system

Please provide the roles and responsibilities to be performed by each LCATs.

This will be tracked via a system and not performed in person at the location.

62. Under Task 5.3, 3rd bullet, “Processing documents may include, data entry, uploading documents and creating cases in databases identified by the FDA. Documents associated with the Tobacco Retailer Compliance Check Inspection Program include, but are not limited to: inspection reports, administrative or enforcement notices and follow-ups, and details regarding tobacco retail establishments. These documents vary in length; however, the typical range is from one (1) page to twenty-five (25) pages.”

Is this task in person at the location or tracked via a system?

This will be tracked via a system and not performed in person at the location.

63. Under Task 5.3, “Certain tasks under Task 5.3 will require delivery of documents to FDA’s White Oak campus in Silver Spring, Maryland, once a week. Couriered documents must be delivered to the contractor’s physical location so that they are processed the same day.” Does the government have an estimation of the volume of envelopes and the weight of the packages?

The Contractor shall provide for delivery and pickup of documents, via courier, between FDA’s White Oak campus in Silver Spring, Maryland and the Contractor’s facility (off-site), upon request no more than twice per week. The volume of documents included in each pickup/delivery will vary.