75F40125Q00401-SafeMedUse-QA.pdf

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Attached to
Safe Medication Use
Solicitation number
75F40125Q00401
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This document is a Questions and Answers (Q&A) file for a federal contract opportunity with the Food and Drug Administration (FDA). The procurement is a Firm Fixed Price (FFP) purchase order conducted under simplified acquisitions procedures, with a total contract value up to $7.5 million and a potential contract duration of 5 years. Key requirements include technical support services from 8am-6pm, virtual meetings, analytics platform licenses for 25 users with a minimum of 10 concurrent users, and training services utilizing FDA University and a Learning Management System. The solicitation requires contractors to submit a technical volume, past performance volume, and pricing worksheet, with specific guidelines on attachments, page limits, and past performance documentation. Notably, travel outside the Washington DC metropolitan area is not permitted, and all training sessions will be conducted virtually.

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Other files

File Type Posted
Att A - Records management cert.pdf PDF
Att D - FDA Form 3398.pdf PDF
Att F - Data Disclosure Clearance Form.docx DOCX document
Att B - Records management training.pdf PDF
Att E - Data Disclosure Clearance Procedures.docx DOCX document
SOL_RFQ (75F40125Q00401) SafeMedUse.docx DOCX document
Att C - Pricing Worksheet.xlsx XLSX spreadsheet

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Question No. Page number / Section Question FDA Response 1 Page 1. i.

Is the total contract funding limited to up to $7.5 million?

This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 in conjunction with Part 13.

2 Page 1 v., SCOPE / Work Statement and task Areas This is a Firm Fixed purchase order and there are tasks ad hoc meeting, ad hoc reports, emergency requests with safety issues, and ad hoc trainings.

Please clarify how the ad hoc work will be compensated? Compensation will be included in the Firm Fixed Price (FFP)

3 Page 3, SOW Task Areas table What is the estimate level of effort per period of performance? Since this is a FFP contract the contractor will have to determine that 4 General

Due to the answers in travel questions and place of performance frequency of meeting / visits, the budget will be impacted. Can there be additional time to address the answers in the RFQ response? No

5 Page 8, Technical Support & Services , pp pp required 8a-6p or 9a-5p? 8 am - 6 pm 6 Page 16, Place of Performance What is the anticipated frequency of visits to the Sponsor per year? What is the location of the Sponsor site visit? We anticipate meeting virtually 7 Page 16, Travel Is travel for Contractor staff that is outside the Washington DC metropolitan area permissible? No

Page 6, Task 2 User Access & Page 24 ix.

The requirements analytics platform licenses for up to 25 FDA users, unlimited subscriptions, but allow a maximum of 10 concurrent users at a given time. Can the government clarify the number of Users / Subscribers? Is it the government intension to limit the number of users at a given time?

The requirement is for 25 users or unlimited subscribed users; corrected to state a minium of 10 concurrent users to access the analytic platform at a given time.

Page 7, Training Services Can the government examples of training platforms currently in use in the F

Primary Training Platforms

• FDA University (FDAU) - The agency's primary learning management system that provides comprehensive training programs for FDA employees across all centers and offices

• Learning Management System (LMS) - An integrated platform that hosts mandatory training modules, compliance courses, and professional development programs

Page 7 & 8, Training Services

There appears is a contradiction between the requirement and the deliverable (page 7 & 8, respectively) on virtual vs in-person training. Can the government confirm that the training sessions are virtual or should contractors account for in-person as well? Virtual

Page 14, Schedule of Deliverables

Can the government confirm that the Schedule of Deliverables on page 14 will be superseded by the winner Offeror's proposed Deliverable and Schedule? No

Page 25, Order of Importance Can the government provide a definition of Phase 1 and Phase 2?

The government is only evaluating in one phase. Any reference to phase 2 is not applicable to this requirement. Phase 1 is the Technical evaluation of the proposal.

Page 31, FAR 52.217-9 c Can the government confirm that c should read "not exceed five (5) years" this is correct, the total number of potential years of the contract will be 5.

Page 21, RFQ Attachment Table

Are we required to attach any of these forms as attachments to our technical proposal? They seem to be post-contract award forms. (We will include the Pricing Worksheet as part of the Price volume).

The following are to be included with the quote. All others Attachments A, B, E and F are post award attachments.

Attachment C. Pricing worksheet should be completed and submitted Attachment D. NDA can be completed by key personnel and submitted

Page 21, RFQ Attachment Table If any of the forms should be attached to the Technical volume, would those forms count towards the technical volume’s page limit? No, those that are to be included are not a part of the page limit.

16 Page 31, Key Personnel Table Should this table be inserted anywhere in the Technical volume? Yes (may also include statement of qualifications).

Past Performance volume Are we required to provide CPARS for each past performance project as attachments to the past performance volume?

No, the government will be able to go into CPARS and review/download if a reportable contract is provided.

Past Performance volume

May we provide past performance projects that are not government contracts? If so, we would not be able to provide CPARS, so would a different form of feedback be accepted, or none at all?

Yes, you may provide past performance projects that are non-governmental contracts. If non-governmental contract, please provide as much information as possible.

75F40125Q00401

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