Q_A__2_-_RFP_75N92025R00003_3.pdf

Questions and Answers #2 Solicitation 75N92025R00003

National Gene Vector Biorepository

1. Is this opportunity actually planned to be solicited for 2025?

The solicitation 75N92025R00003 was posted 11/22/2024 with an original proposal due date of 1/10/2025.

2. What is the anticipated solicitation date?

The solicitation 75N92025R00003 was posted 11/22/2024 with an original proposal due date of 1/10/2025. Per Amendment 1, the proposal due date is revised to be 2:00 PM EST on 1/15/2025.

3. What is the anticipated Award date?

Potentially in FY 2025.

4. Is this a new opportunity or a re-compete?

Recompete.

5. If existing, who is the incumbent for the current contract?

The current contract number is 75N92019D00018 with Trustees of Indiana University.

6. What is the current contract Number?

The current contract number is 75N92019D00018 with Trustees of Indiana University.

7. Are all samples coming in at once? No not at once. If not, what is the shipping frequency of the samples into our labs? Shipping frequency will be at random times. Will these samples be coming in batches? Assume 20 submissions of 40 samples each for a total of 800 samples per year. The Government estimates that a total of 4,000 new samples will be received over the full five year period of performance of the contract.

8. Regarding the 29K samples, we are assuming these are coming from Indianapolis based on RFP.

Yes. For the 4K new samples, will these be coming from Indianapolis as well or from various sites collected in the future? If from sites, can you confirm the number of sites and its country? Will we need to provide kits for the new samples? This would be 4,000 new samples over the life of the contract and they would be coming from various sites collected in the future that are not yet known. No, the awardee does not need to provide kits for the new samples.

9. Can you confirm what type of sample we are receiving for the 29K existing and 4K New? Are these samples blood, urine, plasma, tissue, etc.?

Tissue.

10. How will these samples be shipped to our labs?

Frozen at -70 degrees.

11. You had requested DNA or RNA extracting of samples. Can you confirm the number of samples to perform this extraction on?

Estimate 40 per year.

12. For RCR and RCL Assay, will these assays be run on the new or existing sample? New. Can you confirm if we should perform RCR assay on 5 samples and RCL on 7 samples? Yes, that’s correct.

13. For qPCR, will this assay be run on existing or new samples? Should we assume 80 samples for the assay to be ran?

Mostly new samples. Yes, 80 per year.

14. Attachment 2, 2.1.C.3. “Establish an External Advisory Board (EAB) composed of three (3) or four

(4) experts in the gene therapy field and ex-officio Government representatives from the NIH and FDA.” Do we need to identify these individuals in our proposal?

No.

15. Attachment 2 2.2.8. “provide DNA support services including…in vivo gene editing using CRISPR/Cas9 or other system…” What animal models would be used? Can the Government provide an example of a task?

There are no animal models needed.

16. Please confirm if the web portal is required to be Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101) compliant. Yes, the web portal is required to be Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101) compliant.

17. For costing purposes, can the Government clarify or provide assumptions for the small-scale research and/or development projects as needed to answer scientific questions as they arise and/or to meet the objectives of the NGVB? This research will be discretionary research that NGVB does to keep up with changing FDA requirements and/or regulatory trends as they occur during performance.

18. Can the Government clarify what testing is currently performed by the incumbent under College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA) certifications and/or Good Manufacturing Practices (GMP) standards? All testing in the SOW. Can the Government clarify if animal studies are part of the scope of work for this effort? They are not.

19. Can the government clarify if biologic samples derived from human clinical trials in compliance with Good Clinical Practice guidelines will be deidentified prior to being accessioned by the repository? Some may not be fully de-identified.

20. What type of data is expected under this contract (CUI, PII)? What data will the contractor receive that will be CUI under EO 13556? Assume there may be potential PII and CUI.

21. Can the government clarify if DNA support services under this specific contract include whole genome sequencing of large numbers of human samples and whether the current NGVL Program houses large-scale human genomic data? If whole genome sequencing of large numbers of human samples is not expected under the new contract, is this section applicable in the current application? Large-scale genomic data refers to a vast amount of genetic information collected from a large number of individuals or samples, encompassing the entire genome, including data like DNA sequence, gene expression levels, and genetic variations across the genome (generated through genome-wide association studies, SNP arrays, whole-genome sequencing, transcriptomics, epigenomics, metagenomics). No, DNA support services do not include WGS and are limited to DNA extraction and insertion site analyses.

22. H.13. “An offeror is to submit their respective subcontracting plan electronically using the U.S.

Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system….by the proposal submission deadline.” The SBCX website does not have this solicitation listed. Please clarify if the small business plan should be submitted online or included in the Business Volume. Please submit the Small Business Subcontracting Plan with the Business Volume as well as if possible with SBCX. An Amendment to the RFP will be issued to allow for the submission of the Small Business Subcontracting Plan in the Business Proposal as well as with SBCX.

23. Attachment 3, Model Task Order. “Requests for vectors and/or cell lines: 25. a. Includes clinical-grade reagents that are maintained under GMP.” Can the Government clarify for costing purposes if all shipments will be domestic? Yes.

24. Are there any access restrictions required for users by either biosafety level, product, service, etc.? No.

25. The contractor shall be responsible for the transportation of equipment and materials and other costs required for the transition.” Can you share additional details regarding the types and quantities of the equipment for budgeting purposes? This will be determined in further detail if there is a possible transition from the incumbent to a non-incumbent. As of this moment, please estimate based on what is contained in Task Area B, Model Task Order.