75A50122R00021 Thrombocytopenia PBS Question and Responses 12 August 2022.pdf

Question 1:

The delivery schedule as presented in the following table provides conflicting information as it pertains to procurement. The RFP state ‘In each option period additional pharmaceutical doses shall be procured to reach the 170,000 level.’ Option Period 5 Dosing Regimen VMI of 60,000 totals

190,0000 doses. Please clarify quantity for Option Period 5.

Response:

The USG has revised Dosing Regimen VMI under option 5 from 60,000 to 40,000 to be consistent with the Dosing Regimen Procurement.

Contract Line-

Item

Description

BASE

PERIOD

CLIN 0001-

0003 Initial

Procurement

OPTION

PERIOD 1

CLIN 0004-

Additional

Procurement

OPTION

PERIOD 2

CLIN 0007-

Additional

Procurement

OPTION

PERIOD 3

CLIN

0010-0012

Additional

Procurement

OPTION

PERIOD 4

CLIN 0013-

Additional

Procurement

OPTION

PERIOD 5

CLIN 0016-

Additional

Procurement

Estimated

Period of

Performance

30 September

2022 - 29

September 2027

30 September 2027

- 29 September

30 September

2028 - 29

September 2029

30 September

2029 - 29

September 2030

30 September 2030

– 29 September

30 September 2031

– 29 September

Quantity

(doses)

Quantity

(doses)

Quantity

(doses)

Quantity

(doses)

Quantity

(doses)

Quantity

(doses)

Dosing

Regimen

Procurement

51,000 20,000 20,000 20,000 20,000 40,000

Dosing

Regimen VMI 51,000 20,000 20,000 20,000 20,000 40,000

Question 2:

The last sentence in Section C 1.3 Scope states ‘The packaging shall be the same as a non-commercial product. Please confirm the USG is interested in commercial product packaging.

The USG is interested in the commercially packaged product.

Question 3:

Section L.5.3.d Past Performance states ‘For the purposes of this solicitation, a “major subcontract” is defined as a subcontract in excess of $500,000.00. The Offeror(s) shall provide a list of the last five (5) contracts completed during the past three years and all contracts currently being performed that are similar in nature to the solicitation work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers. Any previous activities with BARDA must be included in the submitted past performance list.’ We are assuming BARDA is only interested in contracts specifically related to VMI procurement activities. Please confirm.

BARDA is interested in USG contracts/subcontracts related to the production of pharmaceutical drugs and vendor-managed inventory and storage.

Question 4:

For the Inventory Management and Distribution/Shipping Service CLINs, we plan to submit the information as a service cost per each unit of pharmaceutical drug. Please confirm alignment.

CLIN Description of Service or Supply Units Unit Price

Total ($)

Initial procurement of pharmaceutical drug to be held as vendor managed inventory (VMI) or delivered to the Strategic

National Stockpile (SNS).

Each

0002 Inventory Management as described in Section C.1.4.1.

for Base Period of the Contract

Each

0003 Distribution and Shipping Services as described in Section D for Years 1 -5 of the Contract

(F.O.B. Origin, Contractor’s Facility)

Each

The offeror may submit the information as a service cost per each unit of pharmaceutical drug or they may propose an alternate inventory management plan.

Question 5:

Section B.3.3 requires the contractor to negotiate and enter into a Quality Agreement with HHS, and Section F.4 provides for 90 days after contract signature for the submission of the Quality

Agreement and states a “template” will be provided by the ASPR Quality Unit. Will the government provide the Quality Agreement “template” prior to the proposal submission due date to enable offerors to begin preparation of their Quality Agreement (which would expedite submission and negotiation of a final Agreement post-award)? If we have an existing Quality

Agreement in place with HHS, can the existing Quality Agreement be expanded to include this procurement effort?

We will provide a template after contract award.

Question 6:

Sections C.1.4 (final paragraph), C.1.4.1.11 and C.1.4.2.7 address the disposition of product in

VMI upon expiration or termination of the contract and contain conflicting information/requirements.

• Section C.1.4 states that when the contract “is considered dead” the government and the contractor “shall negotiate the disposition of the product including the buyback of the product” and that the government “shall have the final approval of the disposition of the product.” This section makes contractor buyback of the product negotiable, with final approval of product disposition vested in the government.

• Section C.1.4.1.11 states that upon contract expiration the contractor “must rotate all units to their commercial business and credit the Government for the sale of those units” and that the “credit price” shall be reviewed and approved by the government. This section appears to make return of product remaining in VMI to the contractor’s commercial business mandatory, with a credit price for the sale of those units subject to review and approval of the government.

• Section C.1.4.2.7 gives the government three options for disposition of product remaining in VMI upon contract expiration or termination, one of which is the government offering the product to the contractor for repurchase at the original purchase price and specifically stating that the contractor “is under no obligation to repurchase the product.” This section makes repurchase by the contractor of product remaining in VMI completely optional.

We believe that Section C.1.4.2.7 reflects the intended language whereas the contractor “is under no obligation to repurchase the product.” We request clarity that BARDA is in agreement that the contractor should not be required to repurchase product remaining in VMI upon contract termination/expiration, but that such repurchase should be optional and negotiable consistent with C.1.4.2.7. The government is requested to revise Sections C.1.4 and C.1.4.1.11 to be consistent with Section C.1.4.2.7, and to make repurchase by the contractor of product remaining in VMI optional and subject to negotiation with the government.

Prior to contract closeout, a discussion will be held on disposition of remaining USG property and a bilateral agreement will be reached. C.1.4.1.11 has been revised to state “Reserved”.

Question 7:

Section C.1.4.2.3 requires the contractor to provide their “FDA approved quality control/quality assurance monitoring plan to the government. Additionally in the same section there is a reference to a Quality Agreement that will be executed by the Contractor and BARDA. Please clarify if this requirement is intended to refer to an offeror’s pre-existing plan or if this section is only referring to the Quality Agreement that is to be executed post award. If the offeror’s pre-existing plan is also required, when is the plan required to be submitted to the government?

Section C.1.4.2.3 refers to the Offeror’s preexisting plan with the FDA for the commercially approved product. The FDA approved plan shall be submitted in response to the RFP. The contractor shall enter into a quality agreement with SNS quality control and ASPR no later than 90 days after contract award.

See section B.3.3

Question 8:

Section F.2.1, Deliveries, provides that the “place and method of delivery for Product will be determined at the time of award of each Order by the inclusion of VMI or shipping in that Order.”

• Does the government anticipate issuing an initial Order at the time of contract award and will the Order include the quantity of product to be delivered?

• If not, when does the government estimate that the initial Order will be issued?

• Does the government anticipate issuing a single Order, or successive Orders, for product to be delivered in each contract period of performance?

The Offeror shall propose a delivery schedule that will be considered as part of the technical evaluation.

This will not be an IDIQ contract; no task orders will be issued. This is a firm-fixed price standalone contract with potential to exercise options due to USG need. Refer to section C.1.2 Objective, for the procurement objectives.

Question 9:

Does the government anticipate making a contract award in response to the RFP prior to September 30, 2022? Also, is the government able to provide clarity regarding timelines or plans for having product delivered to VMI or Stockpile and if so, is it anticipated that this will occur prior to September 30, 2022? If not, when does the government realistically believe a contract award will be made, and will the government need to secure new appropriated FY 2023 funds for an award made after October 1, 2022?

The USG anticipates awarding by September 30, 2022. See response on schedule for clarity regarding timelines for product delivery.

Question 10:

Section B.1.1, defines a dose as 'an adult or pediatric daily dose of the pharmaceutical product.’ For the purposes of responding to this proposal, please advise what should be the assumed average adult and pediatric patient weights

The USG assumes an average adult weight of 80kg. The offeror shall propose how they would dose for the pediatric populations.

Question 11:

The link provided in the subject RFP for “HHS Section 508 Product Assessment Template”, Attachment #2, results in a “Page not Found”.

Complete form available here:

http://www.hhs.gov/web/508/contracting/technology/vendors.html

The revised link for Attachment #2 is: https://www.itic.org/policy/accessibility/vpat.

No Additional Questions or Responses.

https://www.itic.org/policy/accessibility/vpat