75A50125R00006 QA.pdf
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- Solicitation number
- 75A50125R00006
About this file
This document is a Questions and Answers (Q&A) file for Solicitation Number 75A50125R00006 regarding Marburg virus (MARV) and Sudan virus (SUDV) Vaccines. The Q&A provides clarifications on multiple technical and procedural aspects of the solicitation, including proposal submission requirements, deliverable timelines, and contract expectations. Key clarifications include: offerors should submit proposals aligned with the existing CLIN structure, with alternate structures potentially discussable during negotiations; vaccine stability goals are 4 years for initial FDA licensure with potential extension to 5 years; and Program Management and Risk Management Plan summaries are expected in the proposal, with final versions due 60 days after award. The Q&A also addresses administrative details such as using UEI instead of DUNS numbers, Section 508 compliance approaches, and confirms that sub-offerors and subcontractors are considered equivalent. The solicitation allows flexibility in proposal preparation, with guidance on document formatting, deliverable templates, and additional technical attachments.
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Other files
| File | Type | Posted |
|---|---|---|
| 75A50125R00006 Amendment 2.pdf | ||
| 75A5012R00006 Amendment 001.pdf | ||
| 75A50125R00006.pdf |
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75A50125R00006 Questions and Answers
1. May offerors propose alternative CLIN structures or is the CLIN structure in the Solicitation mandatory?
All Offerors should submit a proposal and budget that aligns with the CLIN structure in the RFP.
Alternate CLIN structures may be discussed in negotiations.
2. Is a proposed Base period of longer than five years acceptable or is five years a strict limitation?
All Offerors should submit a proposal and budget that aligns with the CLIN structure in the RFP. A base period longer than 5 years can be discussed in negotiations.
3. For the Security Plan requirement, may we include our own security plan in the proposal and then provide Security Plans for subcontractors as a Master Plan due 30 days after award?
Yes
4. The Solicitation mentions both 4 year and 5 year stability. Can you clarify which duration is expected?
Goal is a 4 year expiry for both MARV and SUDV vaccines for initial FDA licensure. After FDA licensure, expectations are for expiry studies to extend past 4 years to a minimum of 5 years.
5. Can you confirm timeline for QMS plan submission? Listed as 60 days after award in E.IV.7. and 30 days after award in F.4. Item No. 19. E.IV.7 (p32) in RFP.
60 days after award. F.4. has been updated.
6. Can you confirm F.4. Item No. 27deliverable is a VMI Storage plan?
Confirmed that this is a VMI Storage Plan.
7. Can you confirm if the Program Management Plan and Risk Management Plan are expected as a component of the proposal submission or are expected as a 60 day deliverable after award?
Summary of the Program Management Plan and Risk management Plan are expected in proposal. Final versions using templates are due 60 days after award.
8. Does the Table of Figures count towards the total page count?
Per the solicitation, the total technical proposal submission, including appendices, shall not exceed 250 pages.
9. Do we need to include a copy of the SOW in both the business and technical proposals?
Please include a copy of the SOW in both in accordance with Section L.2.4
10. Can we include additional technical attachments beyond what is listed in Section L.4.2. or is this limited to the exact items listed?
Yes, L.4.2. allows other supporting documents as necessary.
11. Is there a more updated version of the Small Business Subcontracting Plan template that we should be using? The link provided s a template from 2017 with FY17 goals listed.
There is no updated template, but the FY 25 goals can be found here:
https://www.sba.gov/document/support-agency-contracting-goals
12. If we have previous BARDA contracts do we need to request Past Performance Questionnaires for those contracts or only for contracts with other agencies?
The Offeror(s) shall submit a completed questionnaire for each of the contracts listed.
13. Where DUNS number is referenced, should UEI be used instead?
Yes, please use UEI number.
14. For the required plans where templates are provided (e.g. Risk Mitigation Matrix) or do we need to use the specific templates? If the latter, can you confirm that all links are active and accurate (e.g. broken link in F.3.2.E.III)
For final deliverables after award, templates should be used. For proposal submission, Offeror can use any format to fit into proposal.
15. Can you clarify the Quality Agreements required and the timings? B.3.3. states that a quality agreement is required within 90 days of contract award while E.IV. states that a quality agreement is required within 30 days of first delivery to VMI or SNS.
B.3.3 has been updated to reflect 30 days before first delivery to VMI storage or SNS.
16. Could you clarify if a PMBR is required for this contract? There is no description or requirement for one other than a brief mention in Section E.b.
No, reference to PMBR removed.
17. In the deliverables schedule there are two references to risk mitigation plans, one as a component of deliverable 10 (Integrated Master Project Plan) and a second as deliverable 28.
Deliverable 10 is due within 90 days of award and deliverable 28 is due within 60 days of award.
Could you clarify if these are two separate deliverables and the timing of when they are due?
These should be two separate deliverables. Removed risk mitigation plan in deliverable 10.
18. Could you please clarify the IMS requirements? L.2.3. mentions Microsoft Project but F.4. Row 10 lists the IMS as a 90-day deliverable. Is it acceptable to provide a Gantt and IMS visual in the proposal and provide the full IMS as a 90-day deliverable or does BARDA anticipate receiving the full IMS as part of the proposal?
Yes, Gantt and IMS visual OK for proposal with full IMS as a 90 day deliverable.
19. Are “subcontractors” and “sub-offerors” considered the same?
Yes.
https://www.sba.gov/document/support-agency-contracting-goals
20. There does not appear to be a reference to Quad Charts in the solicitation. Can you please confirm that a Quad Chart is not required to be included in proposal submissions.
No Quad Chart required for this RFP.
21. Section I.2.HHSAR Clauses 352.239-73 and 352.239-79; Section J Attachment 5: From our review, it appears the HHS Section 508 Product Assessment Template referenced in 352.239-73 and Attachment 5 is obsolete and HHS's current form is either a VPAT ACR or Accessibility Conformance Checklist. As there are no ICT system deliverables under this Solicitation, Section 508 compliance would instead be focused on electronic documents. As there are a broad range of deliverables that would fall into this category, completing a VPAT ACR or Accessibility Conformance Checklist to cover all of the potential formats and document types is not feasible.
May we instead provide a summary of our approach to meeting Section 508 requirements in preparing the proposed deliverables?
Yes, this is acceptable.
22. Has BARDA considered the role alternative and newly developed technologies in fill-finish can play in supporting the policy objectives of the U.S. Government for the Marburg Virus and Sudan Ebolavirus Vaccines projects?
This RFP was written with a statement of objectives to allow Offerors to propose their own solutions to meet the stated objectives.
File details come from the government source that posted it. Updated .