16-100-SOL-00015-Q A.pdf

RFP 16-100-SOL-00015 Questions and Answers

Next Generation Anthrax Vaccine

16-100-SOL-00015

QUESTIONS AND ANSWERS

The following are answers to questions received from potential Offerors:

Q1: Section L.2.1 Instructions, Conditions, and Notices to Offerors, General (page 52)—

Instructions state, “The proposal must be prepared in three parts, ‘Mandatory Criteria,’ a ‘Technical Proposal’ and a ‘Business Proposal.’ Each of the parts shall be separate and complete in itself.” In the Evaluation Factors on page 63, instructions state, “The Offeror(s) shall provide a dedicated section in the technical proposal that addresses the mandatory criteria for eligibility...”

Can BARDA please confirm if the Mandatory Evaluation Criteria should be in a separate volume (binder), or incorporated in the Technical Proposal?

A1: The Mandatory Evaluation Criteria shall be submitted in a separate volume or folder.

Please submit two separate packages for Mandatory and Technical submissions.

Q2: Section L.2.3 Packaging of Proposal (page 53)—Can BARDA please confirm whether the

Technical Appendices should be included as a separate section within the Technical Volume binder, or as a separate binder?

A2: Please submit the technical appendices separately from the technical proposal itself.

Q3: Section L.2.2 Delivery of Proposal, Mail Submission (page 52)—Can BARDA please confirm that only one (1) CD-ROM or USB Drive total, to include all of the proposal components, is required upon hard copy submission?

A3: Yes, only one CD-ROM or USB Drive is required.

Q4: Section L.2.2 Delivery of Proposal, Mail Submission (page 52)— Instructions state submission of CD-ROM or USB Drive material “MS Office Word format.” May we submit the CD- ROM or USB in Adobe PDF format, since MS Office Word is not a publishing program?

A4: Yes, Adobe PDF format is acceptable.

Q5: Section L.5.3 Business Proposal – Other Information (6) Required Forms (page 58) –

Starting with item #2 (Breakdown of Proposed Costs with Excel Spreadsheet), the references to attachment #’s are inconsistent with Section J List of Attachments (page 42). They appear to be off by one number. Please advise if BARDA will issue an amendment to update the attachment #s, or if we should reference attachments by the number listed in Section J (page 42).

A5: Section J has the correct attachment numbers. The updated list on page 58 is now accurate (Please see amendment #1).

Q6: Section J List of Attachments (page 42) — Attachment #6, Protection of Human Subjects, is not referenced specifically within the RFP. The attachment form includes elements related to cost. Can BARDA please provide clarification if this attachment form should be included with the Protection of Human Subjects section in the technical appendices, or if this attachment form should be included as a supporting document in the cost volume?

A6: Please submit Attachment #6 as part of the technical appendices.

Q7: Section H.16 Electronic Information and Technology Accessibility Notice (page 30) –

Contractor believes this requirement is not applicable under the proposed scope of work, as it is not a technology product, but rather a vaccine candidate. Do we still need to provide Attachment #7 and indicate non-applicable? Or should we submit the HHS Section 508 Product Assessment Template (Attachment #7) as instructed under Section H.16.c.? If so, can BARDA please indicate which volume this Attachment #7 should be included in?

A7: Yes it is required; please include this under appendices with the technical proposal.

Q8: Section B.2.2. Firm Fixed Price, CLIN 0003 (Option Quantity) (page 4)—Will BARDA consider

Cost + Fixed Fee (CPFF) for Phase IV post-marketing commitments/requirements?

A8: No, please submit CLIN 0003 as a fixed price CLIN.

Q9: Section J List of Attachments (page 42)—We could not find Attachment #10 ACH

Vendor/Misc. Payment Enrollment Form referenced in the RFP. Can BARDA please indicate which volume this form should be included in?

A9: Please see page 82 of the solicitation. Please this attachment should be submitted under technical appendices.

Q10: Section K Representations, Certifications, and Other Statements of Offerors, number 2

(page 43)—The RFP instructs the contractor to “Complete and INCLUDE as part of your BUSINESS PROPOASAL: SECTION K- REPRESENTATIONS AND CERTIFICATIONS.” Is this still required if the Contractor completed the Online Reps and Certs Application (ORCA) at sam.gov and provided confirmation of this in the Business Proposal?

A10: No, the reps and certs in SAM are acceptable.

Q11: Section C.1.3.3 Chemistry, Manufacturing, Control (CMC) Objectives (page 7) and Section

C.1.3.4 Procurement and Delivery of Product Objectives (page 8)— Target deliveries requested in the CMC and Procurement objectives include 2 million doses, 12 million doses, and up to 25 million dose regimens. Can BARDA please define dose regimen? Is dose regimen the number of doses required for complete vaccination of one person? This number would vary depending on a single or two dose vaccine.

A11: Correct. A dose regimen is the number of doses required for complete vaccination of one person with the proposed vaccine.

Q12: Does the business proposal cost spreadsheet require that the proposed costs within each CLIN be segregated by the Work Breakdown Structure (WBS)?

A12: Yes, please include a spreadsheet within the business proposal that includes costs broken out by Work Breakdown Structure (WBS).

Q13: In some paragraphs of the NGAV RFP the term “Integrated Master Project Plan” (IMPP) is referenced and in other paragraphs the term used is “Integrated Master Plan (IMP)”. We believe that these names are for the same document, The following examples are listed below:

Section C-5.1 – Refers to the Integrated Master Plan (IMP) Section C-5.1.1 – Refers to the Integrated Master Project Plan (IMPP) Section F.3.2-E – Refers to the Integrated Master Project Plan (IMPP)

There are many more examples; most of them are for the IMPP requirement.

It should be noted that the DOD has FARs, DIDs, and 1423s that define the IMP and the IMP/IMS relationship to the WBS and OBS. There is no record of the IMPP in Government Procurement.

The IMP/IMS are one of the primary foundations of the EVMS. Is it the intent of the RFP author to replace the requirements for the IMP with the IMPP? If the answer is yes, then should we treat the IMPP the same as the IMP and show the Events, Accomplishments, and Criteria as the top three levels of the IMS and export them to an excel spread sheet for submittal?

A13: Please assume IMP and IMPP are synonymous for proposal submission purposes.

Q14: Given that the following list of plans and documents are required as Appendices to the Technical

Proposal:

Security Plan Curriculum Vitae of Key Personnel Risk Management Plan Protection of Human Subjects

Other supporting Documents:

Draft Target Product Profile Quality Management System Plan Quality Control and Quality Assurance Plan Integrated Master Project Plan (In both Gantt and Tabular form) Performance Measurement Baseline Review Plan Statement of Work (suitable for inclusion in the contract)

We request that the 100 Page limit on Appendices to the Technical Proposal be deleted and replaced with "No Page Limit".

A14: No. Please keep the page limit to 100 pages for technical appendices.