Attachment 3 Industry Questions and Response.docx

ATTACHMENT 3 _ INDUSTRY QUESTIONS & GOVRNMENT RESPONSE

1. NTE 500 Quantity: What is the approximate anticipated breakdown between Healthy Leukopaks and Fresh Healthy Whole Blood within the NTE 500 combined units?

Government Response:

This breakdown is unknown currently, as it depends on SRM production and research needs over the period of performance. A rough estimate would be 60% blood 40% leukopaks, but this may change as needs change.

1. Required Sizes: What Leukopak size is anticipated (tenth, quarter, half, full), and what Whole Blood volume/aliquot size is required?

Government Response:

Half and full leukopaks are acceptable. Whole blood should be >50mL per individual.

1. Ordering Schedule: Is there an estimated number of donors, quantities per shipment/order, or anticipated ordering schedule during the base period?

Government Response:

No current ordering schedule is in place. Goal of approximately 25 donors per shipment/order.

1. Healthy Donor Definition: Can you provide the specific criteria or definition for “clinically confirmed healthy status”, including any required clinical screening or exclusion criteria?

Government Response:

Clinically confirmed healthy status would be defined as donors have been found to present with no evidence of active, chronic, or latent pathology to include: no active acute or chronic illnesses, organ dysfunction, systemic pathologies, or metabolic disorders; no clinical, histological, or radiological evidence of benign or malignant cancer; and/or normal genomic baseline with no clinical manifestation of known pathogenic genetic variants, hereditary syndromes, or inherited metabolic conditions.

1. Viral Testing Timing: The SOW requires a viral testing report with each shipment but also references the possibility of a positive sample being shipped before testing is complete. Please confirm whether samples may be shipped before final infectious-disease testing results are available, with notification/replacement if a reactive result is later identified.

Government Response:

Units may be shipped with a pending viral testing report and final infectious-disease testing results are available. If a unit that was shipped pending viral testing reporting is determined to be positive in testing it will be replaced with another unit which passes viral testing.

1. Anticipated Start Date: Is there an estimated start date for the first sample collections/deliveries following award?

Government Response:

Pending award, first sample collections/deliverers would likely take place within 90-120 days.

1. Sequencing Consent: Does the informed-consent requirement specifically require permission for full genomic sequencing, or would consent allowing genotyping/other sequencing and publication of those results satisfy the requirement?

Government Response:

The informed consent must explicitly require permission for full/whole genome sequencing. Permission for genotyping/other sequencing does not meet this requirement.

1. The RFQ notes a small business set aside with a small business size standard of $41.5 million. Is our organization with revenues of $90-100 million eligible to provide the services requested?

Government Response:

The small business size standard for the designated NAICS code dictates the maximum size a business—including its affiliates and subsidiaries—can be to still be considered small. Limits are based either on average annual receipts (usually averaged over several years) or the number of employees.

1. Is there more detail available on your definition of a Leukopak and Whole Blood Sample? Are you requesting a full leukopak with +-10 billion cells and a 500ml bag of whole blood? Or are you looking for smaller samples? I apologize if I missed any of this information as I read through the documents.

Government Response:

Request is for a leukopak with +- 10 billion cells. A half leukopak would be allowable as well. Whole blood is requested in volumes of > 50 mL per donor.

1. Quantity requested is NTE 500 - is there a scope/limit on how many per week/month the researchers can support?

Government Response:

Goal of approximately 25 donors per shipment/order and spread throughout the year. There is no set shipment schedule.

1. Are you looking for one provider or multiple providers for these products?

We are requesting one blood bank/provider to provide multiple donors. We would like the ability to recall donors, but the vast majority of our samples will need to be individual donors.

1. Are you considering extending the deadline for responses?

Yes