Sol_Doc_FDA-22-RFP-1249967_Questions 7-29-22.pdf

Attachment No: 1 RFP Questions Template

Solicitation No: FDA-22-RFP-1249967

Offeror: Industry Date: 7-29-2022

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 G: Instructions to Offerors and Part H: Evaluation of Award

Question: Page 85 of 90 states that Volume I – Technical Quote should be broken out by

i. Factor 1 – Technical Understanding and Approach

ii. Factor 2 – Management Staff Plan

iii. Factor 3 – Relevant Experience

Part H: Evaluation of Award states that Volume I should be organized into the following sections:

Factor 1 – Technical Approach Factor 2 – Management Approach Staff Plan Factor 3 – Relevant Experience and Past Performance

While similar, please confirm how the contents of Volume I should be organized

Government Response: Please use

Factor 1 – Technical Approach

Factor 2 – Management Approach Staff Plan

Factor 3 – Relevant Experience and Past Performance

(For Government use only)

2.

Solicitation Section/Subsection Number: Part G: Instructions to Offerors

Question: Beginning on page 84 of 90, the Instructions to Offerors provides page, font size, and formatting but does not provide the page limits for Volume I – Technical Quote or Volume II – Price Quote. Please confirm the page limits for both Volumes

Government Response: Please limit your response to 40 pages

3.

Solicitation Section/Subsection Number: Part H: Evaluation of Award

Question: Page 87 of 90 specifies that the Key Personnel are considered the Program/Project Manager and Principal Investigator; however, Page 6 of 90 states that the PI, Pharmacist, and PM are considered Key for Performance Area A and the Lab Technician and PM are considered Key for Performance Area B. Please confirm the personnel that offerors should propose as Key.

Government Response: Offers should use the Key Personnel listed on Page 6 of 90 for Performance Area A and Performance Area B.

Solicitation Section/Subsection Number: C.2 Objectives

Question: Page 8 of 90 of the RFP states that “the scope of activities FDA may require of the contractor shall include the capability to conduct multiple Phase I clinical trials within a year and at times in parallel, and the provision of a full range of services to support the clinical trials and reporting of the results.” Please clarify what “a full range of services to support the clinical trials and reporting of the results” may require.

4. Government Response: Offers should provide a list of the services they would provide to support clinical trials and reporting of results. The services should demonstrate a high likelihood and capability of successfully conducting Phase I clinical trials and reporting of results.

5.

Solicitation Section/Subsection Number: Attachment 5 – Sample Study 1

Question: Sample Study 1 includes a table of events column for Day 1 24 hours and for Day

2. If dose is in the morning of Day 1, then 24 hours post-dose is Day 2. Is Day 1 24 hours and Day 2 the same timepoint or should they be counted separately?

Government Response: The Day 1, 24 hour and Day 2 timepoints can be considered as the same timepoint. The Day 2 timepoint can be ignored.

6.

Question: Sample Study 1 includes physical exams at serial timepoints on Day 1 (0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24 hours) in addition to the other timepoints listed in the table. Is the intent to perform physical exams for all subjects at all those serial timepoints on Day 1?

Government Response: The abbreviated physical examination assessments at serial timepoints on Day 1 (0.5, 1, 2, 3, 4, 6, 9, 12, and 18 hours) can be ignored.

7.

Question: Sample Study 1 includes a line item for “Telemetered ECG monitoring” with timepoints marked as Day1 (0, 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24 hours). Is this intended to be holter monitoring type collection with extractions at those specific timepoints? Or is this standard telemetry that would be performed from predose through 24 hours postdose (no extraction timepoints; live monitoring)?

Government Response: The intent is Holter monitoring collection with extraction at the specified timepoints.

8.

Question: Can any additional information be provided regarding flow cytometry needs for Sample Study 1?

Government Response: Samples will need to be processed within 24 hours. Costs for assay validation should be included. Can propose pricing based on 8 phenotypes and 9 phenotypic markers.

9.

Question: The schedule of activities notes PK and flow cytometry daily through Day 14;

however, it seems domiciling is only through Day 1/24 hours (possibly Day 2). Should the assumption be, subjects will return daily from Day 3 to Day 14 for these assessments?

Government Response: Yes

10.

Solicitation Section/Subsection Number: Attachment 5 – Sample Study 2

Question: Sample Study 2 includes a line item for FSH (females only) at screening and on Day -1. Is this test to be performed for all females at both timepoints? Or is it only required to confirm reports of postmenopausal status?

Government Response: FSH testing can be performed at screening and would not need to be repeated at Day -1.

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

11.

Question: Sample Study 2 includes a line item for estrogen and progesterone. Are these tests to be performed for all subjects (both males and females)?

Government Response: Female subjects only.

Question: Can additional detail be provided for what is needed for the pupillometry assessments?

12.

Government Response This relates to performing an assessment using a commercially available pupillometer to determine pupillary size measures. It is not a physical evaluation.

13.

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.

14.

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.