QA for Follow-On Stockpile - Additional Questions - 8-16-21 FINAL .pdf

BARDA Date: 8/16/2021

Question No. Reference Question

Category Question Response

1 Section B Contractual

The period of performance specified in section B of the continuation sheet for the SF 33 reads “Period of Performance: 08/25/2021 to 08/24/2025” however, that does not correspond with the time period covering the requested option periods (Per Section B.2.f. page 8 of the Solicitation reads – “OPTION PERIOD II: (August xx, 2025 through August xx, 2026)”. Request that the period of performance be revised to reflect the intended end date of the extended current contracts (to 02/25/2022 to 02/24/2026)

The Period of Performance (POP) will be 60 months from contract award (with the option to extend services for 6 months). The RFP will be updated to reflect this change. The option period dates will be updated at time of award.

2 Section L.1 Contractual Requests an extension to the submission for the final proposal to 09 OCT 2021 Proposal due date remains at 9-13-2021

3 Section B.1; p.2; first paragraph Technical

As one of the stated goals of the RFP is to produce vaccines and adjuvants to support 2019 Executive Order (EO) for the modernization of influenza virus vaccines, can the USG confirm the assumption that any subsequent development work using procured stockpiled antigens and adjuvants to support the EO would be performed by the Contractor that manufactured the materials and by mutual agreement?

Please clarify the question and define "development." So-called mix-and-match clinical trials must still be completed to ensure pandemic preparedness.

4 Section B.2; p.4-5; CLINs 0008-0014 Contractual

We propose CPFF rather than COST for these CLINs as per FAR 16.306, the activities will be for the performance of research or preliminary exploration or study and the level of effort at this time required is unknown. Additionally, BARDA has historically included these CLINs as TBD to ensure appropriate incentive to Contractors to perform these activities.

Establishment of the CLIN structure will be determined during negotiations.

5 Section B.2; p5; CLIN 0017 Related Contracts: Storage and Stability Technical Can BARDA define the term “Related Contracts” and confirm it is to replace “Prior

Contracts” (CLIN 0017, p.21)?

Confirmed. The term "related contracts" is simply to include contracts that feed into the US National Pre-pandemic Influenza Vaccine Stockpile (NPIVS).

6 Section C.2.1; p.17; CLIN 0004 Commercial Scale Bulk Lots Technical

Note that stability is the only assay that BARDA requires Contractors to perform.

However, container closure integrity and leachables/extractables data are also critical considerations. Does BARDA want to also include such testing in the Contract to ensure that there's sufficient data to support use?

The Offeror may propose to perform such testing, and the USG will evaluate costs.

7 Section C.2.1; p.17; CLIN 0004 Commercial Scale Bulk Lots Technical

CLIN 0004 currently indicates that HHS is to approve selection of lots for stability testing after manufacturing has been completed. Note that typically, stability retains are taken during the manufacturing process. As such, we propose that the relevant text be removed from the RFP.

Agreed. The following will be deleted from CLIN0004 - Selection of lots for stability testing will be determined after manufacture is complete and should be approved by HHS.

8 Section C.2.1; p.19,21; CLIN 0007/0017 Storage and Stability Technical

CLINs 0007 and 0017 currently state that Contractors are to "make appropriate updates to regulatory documentation supporting the continued use of the stored material for pre-pandemic preparation, pandemic response, and where appropriate, manufacture of licensed doses." What updates to regulatory documentation would be anticipated to support continued use of the stored antigen and adjuvant?

It is expected that the vaccine manufacturer will make appropriate updates to the regulatory documentation to support the use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses. This may include updates to the drug master file for example.

9 Section C.2.1; p.22; CLIN 0018 Emerging Pathogens Technical How does BARDA define an Emerging Pathogen? Can BARDA confirm that any activities proposed under CLIN 0018 would be completed per mutual agreement?

The activities proposed under CLIN0018 can be agreed mutually by contractor and

USG.

10 Section F.3.2.K; p.29;

Pandemic Facility Plan Administrative Can BARDA provide more clarity on what should be included in a pandemic facility and/or operational management plan (due 15 days following award)?

A draft operational plan to continue operations in the event of a declared pandemic emergency should be submitted within 15 days of award, and the final operational plan should be submitted within 30 days of award. This is a contractor-defined format.

Additional Questions & Answer s RFP # 75A50121R00013 for the requirement “Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

No. Reference Question

Category Question Response

Additional Questions & Answer s RFP # 75A50121R00013 for the requirement “Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

11 Section F.3.2.N; p.29;

Manufacturing Campaign Reports Technical Please clarify what manufacturing campaign reports would be required by FDA, which BARDA would like to review prior to submission?

In the event that FDA requires manufacturing campaign reports, BARDA expects to review prior to submission to FDA. Please refer to Section F.3.2.c: In the event of a Public Health Emergency, HHS may require daily reporting of manufacturing campaigns during response operations. BARDA may provide a table in tabular format for Contractor to be used to submit such data which would include but not be limited to the following:

• Manufacturing locations

• Seed development or other starting material manufacturing

• Critical materials, consumables, and components

• Manufacturing production projections

• Bulk drug substance actuals and/or adjuvant production actuals

• Fill, finish, and release of product or adjuvant

• Storage/inventory of starting materials, bulk substance, or filled/final product or adjuvant

• Stability information of bulk substance and/or finished product

• Shipment of bulk substance or final finished product

• Disposal of bulk substance or final product

12 Section F.3.2.P; p.30;

Risk Mgmt Plan Administrative

Currently the RFP requires a Risk Management Plan to be submitted within 90 days of contract award. Note that since it's unlikely that there will be any activity within 90 days of award, other than ongoing storage/stability, would BARDA consider revising this requirement to be provided only as part of a response to an RTOR, when a SOW for a new activity is clearly defined?

Agreed. Within 90 days of a RTOR award.

Section F.4; p.32; Item 1 Bi- Weekly/Monthly Meetings and Meeting Minutes

Administrative Would BARDA please clarify anticipated teleconference schedule and deadline to provide meeting minutes? Dates listed in table are in conflict with Section F.3.2.B on p.26 and CDRLs #10 on p.34.

Teleconference (Reference F.3.2.A) - Contractor shall participate in biweekly or monthly teleconferences. CDRL# 10 Description will be updated FROM "The Contractor shall participate in teleconferences every two weeks with the CO and the COR to discuss the performance of the contract.

To - "The Contractor shall participate in teleconferences biweekly or monthly with the CO and the COR to discuss the performance of the contract".

14 Section F.4; p.32; Item 3 Annual Progress Report Administrative Would BARDA clarify why an Annual Report is required, when all TO require final reports?

An annual progress report should include concise and current status of all activities over the past year.

15 Section F.4; p.32; Items 4 and 5 Draft and Final Progress Report Administrative Can BARDA clarify the delivery schedule for such reports? Dates listed in table are in conflict with F.3.2.J on p.28-29

Section F.3.2.J (page 29) will be updated - The Draft Technical Progress Report shall be submitted 75 45 calendar days before the end of the PoP.

Section F.3.2.J (page 29) Final Technical Progress Report shall be submitted no later than 30 calendar days after the completion date of the PoP.

Section F.4; p.34; CDRL Table, Item 10 Weekly/Biweekly Teleconference Meetings/Minutes

Administrative

Note that monthly reports are provided in advance of teleconferences with BARDA, which serve as the agenda for such calls. Please confirm that submission of monthly reports satisfies the requirement to provide an agenda in advance of teleconferences with BARDA.

Confirmed. The monthly reports satisfies the requirement to provide an agenda in advance of teleconferences with BARDA.

Section F.4; p.35; CDRL Table, Item 11 Go/No-Go In-Process Review (IPR) or Decision Gate Presentation

Administrative Please clarify which types of activities require IPR reporting and review.

The following will be removed from the RFP

- CDRL 11 Go/No-Go In- Process Review (IPR) or Decision Gate Presentation (Page 35)

- H.40. IN-PROCESS REVIEW (page 66)

No. Reference Question

Category Question Response

Additional Questions & Answer s RFP # 75A50121R00013 for the requirement “Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

18 Section F.4; p.35; CDRL Table, Item 12 Incident Report Administrative

Can you please examples of incidents that would require reporting incidents and the timelines associated Dates listed in table are in conflict with dates in CLIN 0016 on p.21.

This can include a security incident or incident including any involving critical deviations, such as out of specification (OOS) results, or other product issues.

Reporting should include what happened, what was the impact, if there are any available corrective actions and a time line for when the corrective actions would be in place.

B.2.d.-f. SUPPLIES OR SERVICES AND

PRICES/COSTS; CONTRACT LINE ITEM

NUMBERS (CLINs) pg. 8-12 of 140, CLINs 0006E, 1006E, 2006E

SOW Please clarify the packing expectations and requirements for CLIN 0006E. Does BARDA expect 10 or 25 dose packing?

Packing expectations and requirements will be provided by BARDA at the time of request for task order response or in the event of a Public Health Emergency.

20 C.2.1. STATEMENT OF WORK; Detailed Description of Contract Line Item Numbers (CLINs), CLIN 0006, pg. 22 of 140, 6th & 7th bullets

SOW

Please clarify the serialization and labeling requirements for CLIN 0006; are HHS-approved labels intended to be fixed to individual filled final container vials or whether packed boxes are to receive HHS-specific labeling? Additionally, as adjuvant is not a stand-alone product and serialization is applied to the unit of sale, does the response to the aforementioned question, specifically the serialization requirement, apply to the labeling and cartoning of adjuvant as well? If so, can you please provide an explanation as to why serialization applies to adjuvant?

Expectations and requirements will be provided by BARDA at the time of request for task order response or in the event of a Public Health Emergency.