FFMN__Pre_Proposal_QuestionsResponses.pdf

Is a list of commercial products (with

NDC

codes) sufficient as “evidence” that commercial product is being manufactured at the facility?

If not, can you suggest other documentation? Please provide the product name, license date, license and date of last fill in the facility.

2 Please confirm if the following information is required to be submitted for both Prime and Subcontractors:

(1) Disclosure of Lobbying activities (2) Small Business Subcontracting Plan

Disclosure of Lobby activities should be submitted by the Prime and Subcontractors.

Small Business

Subcontracting Plans only need to be submitted by the Prime.

3 Please define the difference between the Integrated Master Project Plan as described on pg.

69, item iii (4) vs.

Integrated Master Schedule as described on pg.

and 80.

The Integrated Master project Plan

(IPP)

is the narrative text describing plans, strategy, assumptions and rationale for decisions.

The Integrated Master Schedule

(IMS)

is the Gantt Chart with dates, durations, predecessors, critical path.

4 Please explain how Security is to be evaluated, since it's not currently addressed under Technical Evaluation

Criteria.

Security is evaluated under Evaluation Factor Sub factor “E” using the same color coded ratings as the other Sub-‐factors within that evaluation factor.

5 Does the Gantt requirement on pg.

59, item iii, fall under Evaluation Factor 1, sub-‐factor on pg.

or under Evaluation Factor on pgs.

79-‐80?

Requirement iii is for

EF1

Sub-‐factor

With respect to surge capacity, Pg.

of the

RFP

says “up to 50M” vs.

pg.

“Outstanding rating if mds”.

Can mds be proposed for surge capacity?

If so, does any/all proposed surge capacity mds also need to be filled within the same week window?

Yes, the Offeror can propose 50M doses for Surge Capacity.

The Offeror should provide details on what quantity can be provided within the week time frame as surge capacity during a pandemic.

Additional doses that could be provided after that weeks should also be described and include the additional time requirement for providing these additional doses.

The additional doses (exceeding the

12weeks timeline) will be considered as funding allows, if technically acceptable and if determined to be of best value to the

USG.

HHS

uses the terms “Pandemic vaccine” and “Influenza vaccine” interchangeably throughout the

RFP.

Can

HHS

clarify which pandemic and/or seasonal influenza vaccine candidates would be eligible candidates for the surge component of the

FFMN?

A monovalent component of an

FDA

licensed seasonal tri-‐valent influenza vaccine is the preferred technical transfer candidate.

A surge response to a pandemic would likely be a monovalent influenza vaccine.

Alternatively, a pre-‐pandemic influenza vaccine may be considered.

Unlicensed vaccine candidates must be at least at Phase Clinical testing to be eligible for consideration.

8 How will

HHS

address potentially overlapping requirements between

FFMN

and

CIADM?

HHS

expects potential overlapping requirements to be executed individually and completed per the terms of each contract.

If a contractor recognizes a potential overlap in a

T/DOR

they should address the overlap in their proposal.

The

RFP

indicates that “funding for future T/DORs is separate from the funding being allocated to establish

FFMN”

(pg.

10, line 15).

Can

HHS

explain what that means?

In recent years, all non-‐influenza funding for

ASPR/BARDA

has been provided by the BioShield Special Reserve Fund which is reported to be depleted by

September 2013.

What funding is anticipated be available to support the

FFMN

beyond its establishment?

The base period funding for the

FFMN

is Influenza money.

Task orders will be determined and issued based on availability of funding.

In Amendment

HHS

removed the following from Section C-‐4, CLIN

Contract Management

(FFP)…

“Additionally, monthly meetings, periodic site visit and quarterly site visits shall be included”.

In light of this change, how should Offerors include costs related to participating in quarterly site meetings in proposals, since such meetings would be a contractual obligation?

Amendment no.

deleted/replaced only the first sentence of this paragraph, the sentence referenced has not been deleted.

Questions-‐

FFMN

Pre-‐Proposal Conference BARDA Responses

In the scenario where

HHS

purchases bulk drug substance (under a

TO

with company A) and has it converted to drug product (under a

TO

with company B), which entity is responsible for covering the cost for replacing the bulk drug substance should there be an issue with significant product/batch loss during the drug product manufacturing process (at company B)?

Responsibility will be dependent on Root Cause analysis and investigation regarding the loss of product.

Replacement costs will be negotiated at/prior to contract award.

Under Organizational Competency on pgs.

and 62, please clarify how requirements under items and

(names, capabilities and approximate percentage of time each individual could be available for a

T/DOR)

differs from item (names and capabilities of personnel available for assignment to fill and finish manufacturing services

T/DOR)

other than time availability.

The two line items are the same and redundant-‐ the

RFP

will be amended to remove.

Please clarify why "Timeline to product availability (meets

FDA

requirements for use) is included under

Technical Evaluation Criteria, Evaluation Factor 2, Sub-‐factor Organizational Competency, item

c. This requirement will be evaluated under Evaluation Factor Sub-‐factor 1-‐ the

RFP

will be amended to make the correction.

14 Please clarify HHS/BARDA's expectations/position around long lead time items… glass, stoppers, etc.

FFMN

to secure

20MM

vials and stoppers and store to be ready?

Expectation is for the Offeror to work with suppliers to develop cost effective strategy to ensure dose delivery requirements are met during a surge/pandemic.

15 Does the Govt have room temperature storage capacity for primary container closure at a Govt location or should the

FFMN

assume this cost?

Please provide details if the

FFMN

contractor was to assume this cost.

16 Does the Govt have cold storage capacity for

BDS

or finished product at a Govt location or should the

FFMN

assume this cost?

Please provide details if the

FFMN

contractor was to assume this cost.

Would temperature controlled mobile storage (trailers) be acceptable to store finished product? Temporary storage in non-‐ mobile, validated trailers may be acceptable but will need to be approved prior to implementation.

18 Should Serilization be included? All

FDA

requirements must be met as are requirement to this solicitation.

19 What

BSL

(Bio-‐Safety Hazard Level) should be assumed? BSL2 is the minimum requirement.

Offerors should propose their capabilities.

Are Controlled substances in scope?

Schedule class 2-‐5 drugs are within scope.

The Offeror should propose their capabilities.

21 Are Sterile Cytotoxic products in scope? Yes, the Offeror should propose their capabilities.

22 Are Sterile potent products in scope? Yes, the Offeror should propose their capabilities.

23 What inco term is required for shipment?

Should we assume

CIP?

Assume

FFMN

would need to provide insurance coverage on product until reaches destination.

INCO

terms are

FOB

Destination for

BARDA

contracts.

Refer to section F in the solicitation.

24 How many

USG

sites to ship to? TBD 25 Shipping costs for Non-‐surge products for other customers, we will assume

FOB

(FCA

Free carrier) INCO terms are

FOB

Destination for

BARDA

contracts.

Refer to section F.

26 What's the release cycle time anticipated by the USG? Please refer to section L.

11.2.c.ii.1 in the solicitation regarding the requirement for providing released doses for this solicitation.

27 Are electronic batch records a requirement? No.

28 Are there certain max rates/allowed for Validation, Engineering in capital bids? No.

How do you anticipate the

BDS

to be delivered to the

FFMN?

(tanks, bags ,etc) What size?

How many? This is dependent upon the chosen vaccine candidate.

The Offeror should make an assumption and justify the chosen delivery container in order to provide appropriate information in the Offeror's proposal.

What is the

BDS

batch size?

Can we combine two or more

BDS

lots to maximize equipment capacity? This is dependent upon the chosen vaccine candidate.

The Offeror should make an assumption and justify the chosen delivery container in order to provide appropriate information in the Offeror's proposal.

Under Proposal Formatting on pg.

of the

RFP,

item (3), it's stated that "text shall be printed using a font size of no less than cpi", whereas on pg.

under Proposal Page Limitations, it's stated that "Text shall be presented as single-‐spaced, or 12-‐point font..."

Please clarify the required font size for the submission.

Proposals should be as described on page 55.

"10 or 12-‐point font…" The

RFP

will be amended to make correction.

Please clarify if the Technical Appendix should be included with the Technical Proposal or submitted as a separate volume in a different binder. Using separate binders is at the Offerors discretion.

Please confirm if electronic copies of Mandatory Criteria, Technical Proposal, Technical Appendix can be contained on the same

CD,

with Business Proposal and Business Appendix submitted on a separate

CD.

Yes, Business and Technical proposals must be separate CDs for distribution to the different evaluation panels

34 Please clarify who should receive Past Performance Questionnaires.

Pg.

of the

RFP

indicates Quintin

Hackshaw, while Attachment #9 indicates Kyle Roberts.

Submit to Quintin Hackshaw.

The

RFP

will be amended to make correction.