RFP 75N95022R00091 Questions and Answers.pdf

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Biological Specimens' Receipt, Storage, Management and Distribution
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75N95022R00091
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Attachment 5 - GFP revised 2-16-2023.pdf PDF
75N95022R00091 Solicitation.pdf PDF

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1. This evaluation factor requires the inclusion of a completed HHS Section 508 Product Assessment Template. Can offerors submit the template either as a separate document or as an appendix/attachment to the technical or business proposal?

The HHS Section 508 Product Assessment Template can be submitted as a separate document or as an appendix/attachment of the technical proposal.

2. Also please verify our assumption that this (VPAT2.4Rev508(March2022)) is the correct template.

Yes. the VPAT2.4Rev508(March2022) is the correct template.

3. Can the government please exclude the HHS Section 508 Product Assessment Template from the page limitations.

The HHS Section 508 Product Assessment Template will not count towards the page limitations.

4. Will the government please exclude CVs/Resumes from the page limitations for the technical proposal and allow offerors to provide CVs/Resumes in an attachment/appendix to the technical proposal?

CVs/Resumes will not count towards the page limitations of the technical proposal and can be submitted as a separate document or as an appendix/attachment of the technical proposal.

5. Is the BSI‐II system included as GFP/GFE?

BSI-II is available for licensing. Potential offerors should budget for BSI-II licensing.

6. Of the 15‐20 outgoing shipment per year, have any of them been to international sites in the past? If so, how many?

Yes, there have been 4 international shipments over the last 4 years.

7. Will the aliquoting be covered under the fee schedule or paid for by the contract?

Aliquoting is paid for by the researcher according to the fee schedule.

8. Are all outgoing shipments paid for by researchers based off the ancillary fee schedule or do we need to include a certain number in our cost assumptions?

All outgoing shipments are paid for by researchers.

9. The requirement indicates that an offeror should budget for travel related to physical transfer of biospecimens. Is it the intention that the sites currently holding the specimens would not pack up the specimens and ship them, even if shipping containers and instructions were provided and that the contractor would need to physically retrieve the samples?

Generally, shipping containers and instructions are sent out to researchers/institutions to retrieve, pack and ship their samples to the AgingResearchBiobank. Decisions to travel related to physical transfer of biospecimens are made on a case by case basis depending on value and needs of the collection to be transferred.

10. For optional tasks, are we able to send shippers and instructions or do we have to go and pack materials for shipment?

Yes, shippers and instructions can be sent out to researchers/institutions so they can pack their materials and ship them to the AgingResearchBiobank.

11. Will the culling of 30k samples be done over the 5yr period or annually? Will Certificates of

Destruction be required?

The culling of 30K samples is just an estimate to be conducted over the five year period. Yes, certificates of destruction or comprehensive/clear documentation of destruction are required.

12. For the BSI remote hosting option, is there a current license that is transferrable to a new contractor or a uniform cost assumption that should be used for the cost of the license?

Potential offerors are expected to budget for BSI-II licensing.

13. The RFP indicates that aliquots shall not be performed as a routine or on a retrospective fashion;

however, Task Area 1, section F references larger requests or those involving aliquoting, and Task Area 3, Section A indicates the necessary facility to aliquot. For the purposes of proposal costs, how many parent vials and subsequent child vials should be assumed? This would feed into not only the materials and supplies and labor needed for aliquoting, but also the potential impact on the number of freezers that may be required.

Aliquoting decisions are dependent on investigator needs (volume requested and thaw status), total volume available, and the impact of each vial. To date the minimum numbers include 346 parents aliquoted and 1047 children created in one year; maximum numbers include 3852 parents aliquoted and 26044 children created in one year.

14. Is the current sample collection being housed at 1 location or 2?

The current samples are housed in one location.

15. How many aliquots are expected to be performed on outgoing samples per year?

Aliquoting decisions are dependent on investigator needs (volume requested and thaw status), total volume available, and the impact of each vial. To date the minimum numbers include 346 parents aliquoted and 1047 children created in one year; the maximum numbers include 3852 parents aliquoted and 26044 children created in one year.

16. Are the aliquots currently being stored in separate freezers or are they mixed in with regular samples? If stored separately, how many freezers account for aliquots?

Existent aliquots received from studies are kept in the same freezers, but can also be stored in separate freezers.

17. It is noted that about 1/2 of the mechanical freezers are chest freezers. Is there a preference for chest freezers versus upright freezers? If so, will the Government expand on why there is a preference for chest freezers?

The Government does not have a preference.

18. The same model number (MDF‐U76VC‐PA) is listed as a ‐80 Mechanical Chest Freezer and as a ‐80 Mechanical Upright Freezer. Can the government please provide the correct model numbers?

Chest freezers model C80-27S. Upright freezers models MDF-U76VC-PA and MDF-DU702VH-PA.

See Amendment 01 for a revised Attachment 5 – Government Furnished Property.

19. In the RFP, a number of transfers of samples are described. Will any freezers or racks be transferred along with these studies or should the contract holder budget for the provision of the necessary freezer units and associated racks?

See Attachment 5 – Government Furnished Property for a list of freezers that would be transferred from the existing contract to the new contract. If any additional freezers or racks are required, the contractor should include this in their business proposal.

20. For planning purposes is there a way to estimate the number of incoming samples that will require LN2 storage vs ‐80C storage? For instance, in Attachment 3, page 7, Optional task 5 PBMCs are called out as a sample type, what proportion of overall samples do the PBMCs represent?

It is impossible at this point to estimate the number of incoming samples that will require LN2 storage. Currently, PBMCs represent approximately 15% of the overall samples in the LN2 storage.

21. In the RFP, it is stated that “BSI Systems offers three options for hosting BSI data; Multi‐tenant Cloud, Private Cloud, and Remote. The remote hosting option shall be used unless and until such time as BSI systems obtains FedRAMP authorization for their Cloud‐based hosting options”. It is our understanding that BSI is a managed service and not a cloud offering. Please confirm that a FedRAMP instance is applicable to a managed service.

Managed services are generally considered Software as a Service (SaaS). SaaS falls under the FedRAMP requirements.

22. Aliquot preparation is mentioned for offsite storage, is there a specific range of expected aliquots that we should plan to perform and to budget for accordingly? Will aliquoting be required for any other tasks under this contract?

Aliquoting is not a routine task. Aliquoting decisions are dependent on investigator needs (volume requested and thaw status), total volume available, and the impact of each vial. To date the minimum numbers include 346 parents aliquoted and 1047 children created in one year; the maximum numbers include 3852 parents aliquoted and 26044 children created in one year.

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