Attachment C - Questions and Answers.pdf

Request for Quotation (RFQ) No. FDA-SOL-23-1267862, Amendment 1 Attachment C – Questions and Answers

Vendors’ Questions and the Government’s Answers regarding RFQ No. FDA-SOL-23-1267862

1. Would you consider pursing this effort via a direct 8(a) award?

a. No, we have already decided to pursue a competitive small business set aside.

2. Would you kindly confirm if this is an entirely new effort or is there an incumbent currently providing these services? If so, would you please provide the incumbent contract details? Please also provide their Contract number.

a. This is an entirely new effort.

3. What will be the contract value for this opportunity?

a. The government will not be providing this information to potential offerors.

4. Is this a new requirement, if not, would the government please provide the incumbent details, with the contract number and total contract value?

a. This is an entirely new effort.

5. Does Attachment B "Commitment to Protect Non-Public Information (NPI) Employee Agreement Form FDA 3398" need to be a part of our response?

a. No, it is required prior to the applicable employee performing work and is not required to be submitted with the quote.

6. Does the government require only 2 resumes, one each for the key personnel mentioned in the solicitation?

a. Yes.

7. Is being a U.S. Citizen a mandatory requirement for the key personnel?

a. Please see RFQ pages 26-30 for Personnel Security requirements / Contractor Personnel Security Clearance Standards and Residency Requirements

8. What are the annual hours for each key personnel?

a. The government does not have an annual hour estimate to provide to potential offerors.

9. RFQ p.2, Pricing - Please confirm that the contractor should budget by the methods in the table on page 2 rather than by Task.

a. Correct, contractor should budget by the pricing table on page 2 of the RFQ.

10. RFQ p.4 Scope—Description of Work - What approvals (e.g., OMB, FDA’s IRB) will be required for the planned data collection? Does FDA consider the data collection to be research?

a. Center approval will be required. Employee union approval may also be required for non-survey methods. Technical Experts will help with gaining necessary approvals. Does the FDA consider the data collection to be research? No.

11. RFQ, p.5, Task 1 Project Management - Can the Government please advise on how to account for the cost of meetings and project planning in this FFP effort, which are not covered in the pricing table on page 2?

a. You are able to build meeting/ price costs as deemed necessary per the pricing table’s item description. This action is not a labor hour type contract.

12. RFQ, p.5, Monthly Invoices - Can the Government confirm if monthly invoices are applicable to the FFP contract?

a. This action will be invoiced based upon deliverable found in the pricing table.

13. RFQ, p.8, Qualified Personnel - Can the Government confirm the role and evaluation of the 2 key personnel?

a. We have no information to add beyond the RFQ

14. RFQ p.8, Qualified Key Personnel - In lieu of a bachelor’s degree and 15 years of experience, would the Government consider a master’s degree and a lower number of years of experience, for both positions?

a. Yes, we will consider it.

15. RFQ p.8, Deliverables - If the Government requires paper copies of deliverables, is it acceptable to budget for printing and postage costs?

a. Electronic copies are acceptable

16. RFQ., p.10, Government Furnished Property - Can the Government confirm how many laptops and associated IT will be provided?

a. As many as required to complete the assessment team.

17. RFQ., p.10, Government Furnished Property - Can the Government confirm it is acceptable to budget for labor and travel costs associated with obtaining a Personal Identity Verification (PIV) card?

a. Contractor is responsible for all travel costs associated with obtaining PIV and laptops. Build costs into the pricing table.

18. RFQ p.11 Government Points of Contact - Can the Government further elaborate on the roles of the Technical Experts and how contractors will collaborate with them?

a. Technical experts are subject matter experts on CDRH internal communications, social science, and data collection conducted to date. They will also assist in getting needed approvals for internal data collection.

19. RFQ., p.12, Compliance - The link listed does not work, can the Government send the correct link?

a. The RFQ has been revised accordingly on page 13.

20. RFQ, p.17, Task 6 - The RFQ mentions a virtual summit. Should offerors budget for meeting logistics planning and coordination?

a. The summit is intended to be a virtual meeting with the CDRH Technical Experts and other CDRH leadership. The contractor is expected to prepare and present at this meeting, so yes, offerors should budget accordingly.

21. RFQ, p.34, OCI statement - Can the Government clarify if it would like signed statements submitted with the proposal?

a. This requirement has been removed from the RFQ.

22. RFQ, p.38, FAR 52.212-3 - Can the Government confirm which Volume the answers to this clause should be included in?

a. This can be included with Volume III – Business Quote.

23. RFQ p.49 Electronic and Information Technology Accessibility Notice - Would the Government accept the completed HHS Section 508 Product Assessment post-award?

a. No, this should be established prior to award as a determination to whether the contractor is able to comply.

24. RFQ, p.52, Volume III Business Quote - Is the Government willing to consider progress payments versus milestone payments?

a. No.

25. RFQ, p.52, Volume III Business Quote - Would the Government allow for Volume III to include both a Word/PDF narrative and an Excel document?

a. Yes.

26. RFQ, p.52, Volume III Business Quote - The Government states "underlying cost information" should be provided. Can the Government confirm that fully loaded labor rates and its associated level of effort is sufficient?

a. The Offeror shall submit a business quote fully supported by underlying cost information (i.e., price breakdown) adequate for the Government to determine the reasonableness of the unit pricing proposed, and to evaluate whether the proposed costs are consistent with the technical quote and the Offeror’s effort to perform the requirement. The Offeror shall fill out the pricing table contained in Section 6 “Pricing” of this Solicitation. The Offeror shall not alter/change the quantities contained in the pricing table. Offerors who fail to provide pricing for each price category may be considered non-responsive.

27. Attachment A, 52.222-41 Service Contract Labor Standards - can the Government please confirm which LCATs are applicable under this clause?

a. The type of work for this contract is expected to be of a professional/consultant type and is considered SCA Exempt. See changes on pages 7-8 of Attachment A

– FAR 52.212-5 Contract Terms and Conditions (SEP 2023) (Updated).

28. Attachment B - Can the Government confirm if this is supposed to be submitted with the proposal?

a. Attachment B – Commitment to Protect Non-Public Information (NPI) Employee Agreement, Form FDA 3398 is required prior to commencement of work by an applicable contractor employee and is not required to be submitted with the quote.

29. Can the Government please provide the name of the incumbent for this work, if applicable?

a. Not applicable. New requirement.

30. Will the contractor be given access to CDRH’s intranet and other pertinent internal communication channels?

a. By receiving laptops and badges, the contractor will have access to the applicable/ required pertinent internal communication channels.

31. Would the Government provide a funding range for this opportunity?

a. No.

32. Can the Government share how many employees are in CDRH?

a. The CDRH has about 2,000 employees.

33. Can FDA provide an estimated total level of effort in terms of total labor hours for this scope of work?

a. No.

34. Please confirm that the stakeholders referenced in the pricing table, “Stakeholder Interviews,” are internal to FDA (i.e. FDA employees).

a. Yes, the stakeholders are internal to FDA.

35. Please confirm that the implementation of the research methodologies (surveys, focus groups, interviews, etc.) is to be conducted under Task 4.

a. The offeror should propose where research methodologies will be used to accomplish the tasks included in the SOW.

36. Please confirm that a separate Excel spreadsheet accompaniment is permitted as part of Volume III Business Quotation?

a. Confirmed

37. What is the actual place of performance?

a. All services shall be provided off-premises. The Contractor shall work remotely using FDA-furnished property on the FDA network. See page 11 of the RFQ.

38. We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services. If not brand new, could you please provide the current / previous contract number?

a. This is a new effort.

39. Would the Government consider removing the Do Not Compete language on pages 33 thru 34 of

55?

a. Yes, we have removed the language on Organizational Conflicts of Interest from the RFQ.