Sol_Doc_FDA-22-RFP-1249967_Questions.pdf

Attachment No: 1 RFP Questions Template

Solicitation No: FDA-22-RFP-1249967

Offeror: Industry

Date: 13 July 2022

Instructions:

All questions or requests for clarification related to this solicitation shall be submitted using this attachment. Questions submitted without using this attachment will not be given consideration.

This form shall be submitted electronically to van.nixon@fda.hhs.gov no later than 3:00 PM Eastern Time, July 18, 2022.

PLEASE NOTE: Offerors are instructed to enter only one (1) question per numbered table below and maintain the formatted numbering in the left (blue) cell when adding additional questions tables.

1.

Solicitation Section/Subsection Number: Part C. Section C.3 “Scope of Services” (Page 9 of 90)

FDA-22-SOL-1249967

Question: Section C.3 “Scope of Services” notes “To Qualify for award, organizations must have in-house capabilities in performance Areas A, which represent the majority of the work”. This requirement is unduly restrictive and does not provide full and open competition for the subject RFP. Can the USG explain/justify why an organization must have the “in-house” capability to provide all services, and not be able to subcontract certain services? We strongly request the USG revise the requirement, and allow the prime contractor to “subcontract” services that cannot be performed in house for Performance Area A.

Government Response: C.3 does not require a vendor to have all capabilities in Performance Area A. There should be in-house capabilities for the majority of services in Performance Area A, particularly with regards to operational support and facilities for clinical trial execution in healthy subjects or patients. Any service under Performance Area A that cannot be provided in-house should have a description of how it would be provided by the vendor. In contrast, a vendor does not need to have in-house capabilities for any service under Performance Area B provided they have sub-contracting capability for all services under it.

(For Government use only)

2.

Solicitation Section/Subsection Number: N/A FDA-22-SOL-1249967

Question: Can the USG advise if this is a new requirement, or existing program with a incumbent contractor?

Government Response: This is a new requirement.

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Solicitation Section/Subsection Number:

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Government Response

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*Copy and paste additional tables as necessary, and maintain the formatted numbering in the left (blue) cell when adding additional questions tables.