Amd_0001_NCBI_-_Consolidated_Questions_-_Answers.pdf

# Question Section of RFP Page # Government Response 1 Deliverable # 25: The contract is slated to begin on January 1, 2020, but this item states that the first reports are for October 2019, due by December 1. October through December 2019 are dates in advance of the stated start date of the contract.

1) If the contract is signed and the site approved by HRSA, can collections begin as soon as the contact is fully accepted, with billing to be accepted beginning Jan 1, 2020?

2) If the report for October is due on Dec 1, that only allows 30 days for the collection of CBU reports from the end of the month, especially HLA typing, which often batched and not that prompt. Was your intent 30 days, or 60 days? Do you require a status on all collected CBUs intended for the contract, or final upload? Does the October report refer to units collected the previous month, September, for example?

F.4 25 The contract start date has not been specified as January 1, 2020. The contract period of performance will be specified in the contract and is expected to begin on or before September 30, 2019. If the contract period of performance begins after September 30, 2019, the initial reporting period will be adjusted and align with the period of performance.

1) No. See 4.3.4 Maintain a CBU Collection Schedule. Collection dates outside of the timeframe specified for each contract year, as shown in Section 4.3.4, shall not be accepted. For Year 1, the CBU Collection Start Date begins on or after the effective date of CLIN award for the contract year and not before January 1, 2020.

2) Per Deliverable 25, all reports are due the first day of the month, two months after the end of the reporting period. The deliverable table will be corrected to reflect a two‐month period. Beyond this correction, there are several reports that make up Deliverable #25 and the content is specified by report. For example, Progress Report #2, CBU Collection Schedule, covers CBUs collected by month; collections for a given month would be reported in that month's report. For progress reports on contracted CBU deliveries, the CBUs must meet contract requirements for CBU delivery; per PWS Task 4.3.5, registration of licensed CBUs with HRSA's C.W. Bill Young Cell Transplantation Program Single Point of Access is a requirement for CBU delivery.

2 The requested submission is described as having four volumes, but lists sections I, II, and III, with Section III defined as the business proposal. No Section IV is described.

On page 56 in L6, the Business Proposal is referred to as Section IV. What is Section

IV?

L.1 L.6

Section L.6 was corrected to reference the Business Proposal as Volume III. There is no Volume IV.

3 Is the expected start date of the contract the date after the contract is signed and start of collections is approved by HRSA, expected to be around October 1, 2019?

F.4 14 & 15 The contract period of performance will be specified in the contract. Cord blood unit collections (CBU) shall begin as specified in the Performance Work Statement (PWS), Task 4.3.4, Maintain a CBU Collection Schedule. Per the task, for the first year of the contract, the CBU collection start date begins on or after the effective date of the contract line item number (CLIN) award for the contract year and not before January 1, 2020; however, HRSA retains the right to negotiate earlier collection start dates with awardees.

4 Do units qualify for the funding year based on collection date or SPAR upload date? Schedule of Deliverables #25

14 The Government is unfamiliar with "SPAR". Performance Work Statement (PWS) Task 4.3.4 specifies the CBU collection dates for each contract year. Prior to cord blood units being eligible for billing, the CBUs must meet contract requirements.

5 Can units collected prior to October 1, 2019 and not uploaded to SPAR as of October 1, 2019, be funded through this award?

Schedule of Deliverables #25

14 The contract period of performance will be specified in the contract. Cord blood unit collections (CBU) shall begin as specified in the Performance Work Statement (PWS), Task 4.3.4, Maintain a CBU Collection Schedule. Per the task, for the first year of the contract, the CBU collection start date begins on or after the effective date of the contract line item number (CLIN) award for the contract year and not before January 1, 2020; however, HRSA retains the right to negotiate earlier collection start dates with awardees.

6 We currently have goals through Sept 2020. How do we reconcile these goals with our response to this new solicitation?

Per Section G.6, Invoices under this contract must not contain units that could be invoiced under the other contract. That is, if a Race/Ethnicity target from the previously awarded contract has not been met, the Contractor may not include units from that Race/Ethnicity category on invoices under this contract. If awarded a new contract under this solicitation, vendors should take into account completing goals, with funding lines already exercised, from existing NCBI contracts in proposing CBU schedule and delivery for the new contract. The proposals for the new contract should only apply to CBUs collected and delivered for the new contract.

7 Do you think it make sense for us to forward our proposal if we do not have BLA and are not planning to apply for in the near future?

Per Technical Factor 1, Mandatory Requirements, Proposals not meeting the mandatory requirements specified below will not be evaluated for consideration under this solicitation. Per Factor 1, 2. The Offeror must have an approved U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) for the biological product, Hematopoietic Progenitor Cell (HPC), Cord Blood, for use in unrelated donor hematopoietic progenitor cell transplantation procedures. The Offeror must submit verification of its FDA BLA for Hematopoietic Progenitor Cell (HPC), Cord Blood, for use in unrelated donor hematopoietic progenitor cell transplantation procedures.

8 We perform manual processing and found this equivalent to any automated process. The Performance Work Statement does not specify processing type.

9 Are unlicensed cord blood banks eligible to apply to this solicitation? Per Technical Factor 1, Mandatory Requirements, Proposals not meeting the mandatory requirements specified below will not be evaluated for consideration under this solicitation. Per Factor 1, 2. The Offeror must have an approved U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) for the biological product, Hematopoietic Progenitor Cell (HPC), Cord Blood, for use in unrelated donor hematopoietic progenitor cell transplantation procedures. The Offeror must submit verification of its FDA BLA for Hematopoietic Progenitor Cell (HPC), Cord Blood, for use in unrelated donor hematopoietic progenitor cell transplantation procedures.