Scalable Wastewater Questions and Answers.pdf

Scalable Wastewater Surveillance for Routine and Emerging Infectious Disease Pathogens

Questions & Answers

1. Would a state government public health laboratory, such as a laboratory operating within a state department of public health, be eligible to submit an offer and serve as the prime contractor under this solicitation, provided that the laboratory meets all applicable technical, responsibility, registration, contractual, and performance requirements?

Answer:

There are no restrictions on the request for proposals. State government public health laboratories, such as a laboratory operating within a state department of public health, are eligible to submit an offer.

2. If state government public health laboratories are not eligible to serve as the prime contractor, could you please clarify whether they may participate as a subcontractor or teaming partner to an eligible prime contractor?

Answer:

State government public health laboratories are eligible to participate as a subcontractor.

3. When developing the ddPCR price per test in the pricing table under B.13 (and reproduced on page 67), should we assume that “test” refers to a single pathogen target or that it refers to the entire panel of pathogen targets tested in a given sample?

Answer:

A test would refer to the entire panel of pathogen targets tested in a given sample. In other words, a test refers to all of the ddPCR targets tested per one sample.

4. Technical proposal: sequencing - What are CDC’s selected genomic regions for MeV sequencing?

MeV sequencing is required in Task 3: “The contractor shall conduct targeted sequencing on samples for genetic characterization of Measles virus including subclade identification, and other relevant genomic assessments as directed by CDC. Sequencing shall include selected genomic regions.” (page 8, emphases added).

Answer:

Genotyping of MeV targeting 450 nucleotides of the nucleoprotein (N) gene remains the global standard in MeV genetic analyses. CDC recommends offerors include N450 as an MeV target.

5. The URL provided on p. 22 (RFP IDIQ) or page 19 (RFTOP) in Special Considerations (https://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) does not resolve (and appears to be an internal CDC URL). If this is required to prepare our response, please provide a copy?

https://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf Katz, Samantha S. (CDC/NCEZID/DIDRI/OAMD) At this time, N450 is going to be the most informative. Realistically, it alone is not going to be sufficient in providing enough resolution for finer analyses; but given what we know of MeV genomes currently N450 is going to be sufficient.

Separately, the measles program would agree with this choice of target. For other assays, if program input has not been solicited then this would be something I recommend pursuing in future. You may have already done this, so if so then disregard :)

The link is not essential for responding to the solicitation. Following award, if out processing is needed, the form will be provided.

6. Does the RFP allow for a vendor to bid as both “Primary” and “Subcontractor”? If so, does NCEZID have any trepidations or concerns regarding such?

Answer:

A vendor may propose as both the primary contractor and subcontractor. NCEZID has no concerns with this approach.

7. Please confirm the applicable NAICS code (541380, Testing Laboratories) and the $19M size standard, and whether the Government will accept an offeror’s self-certified small-business representation in SAM for this unrestricted acquisition?

Answer:

NAICS code (541380, Testing Laboratories) confirmed.

To be considered small businesses, the organization has to be registered in SAM.gov as such and with the Small Business Administration.

8. For an offeror that is a small business concern, is a Small Business Subcontracting Plan required, given that FAR 52.219-9 does not apply to small business concerns?

If the offeror is a small business, then a subcontracting plan is not required?

9. Will the Government provide a pricing template or defined CLIN structure for the Task Order 1 price proposal? Should sampling kits, shipping, and biorepository shipbacks be priced within the per-sample line items or under the separate program-implementation line (item 0010)?

Answer:

The defined CLIN structure is found on pages 3-5 of the task order solicitation document (A19. RFTOP – Task 1). The program implementation line could cover the sampling kits, shipping, and biorepository shipping.

10. At the IDIQ level (up to 500 facilities, up to 25 pathogen targets, metagenomic sequencing), is any pricing required at this time, or is all pricing limited to Sample Task Order 1?

Answer:

See page seven of IDIQ solicitation. Section B.13 Ordering List by Ordering Period.

11. For Similar Experience and Past Performance, may offerors cite work performed as a subcontractor, and how should offerors reference confidential commercial engagements where the client relationship is subject to a non-disclosure agreement?

Yes, offerors may cite work performed as a subcontractor. Additional information, such as testing volume or number of sites served would be valuable. References to confidential engagements could use generic company names to preserve anonymity, with as much detail provided on the tasks completed without any violation of the NDA.

12. Are the AI Compliance & Risk Management Plan and the Public Health Data Management Plan submitted as separate volumes, and are they excluded from the 35-page IDIQ and 20-page Task Order 1 technical page limits?

Answer:

Yes, the AI Compliance & Risk Management Plan and the Public Health Data Management Plan are separate documents, and they are not included in the page limit.

13. Does the Government have a preferred sample-return logistics model (e.g., utility drop-off at a carrier location versus scheduled courier pickup at the facility)? May offerors propose a hybrid approach that defaults to courier retrieval for any facility that requests it or that is more than a specified distance from a carrier drop point?

Answer:

While there is not a required courier model, the Government prefers scheduled courier pickup at the facility or location of the utility’s choosing. The suggested approach of defaulting to courier retrieval for any facility that requests it or that is more than a specified distance from a carrier drop point, would certainly be acceptable. Ultimately, CDC prefers a courier option that allows for flexibility so that utilities have minimal burden on shipping logistics.

14. Does the Government have any preference or restriction regarding the assignment of the Program Manager role (e.g., full-time dedicated individual versus a dual-hatted senior executive)?

Answer:

The Government prefers that the Program Manager role be a “Key Personnel” who is a full-time dedicated individual. The government would have to be notified before a “Key Personnel” change occurs.

15. Does CDC anticipate that specialized technology partners or subcontractors could be added by the IDIQ prime after award, subject to the contract terms and applicable Contracting Officer approval?

Answer:

Pending discussion with and approval by CDC's Contracting Office and the Contract Officer of record, it may be possible to add a subcontractor as indicated on p. 24 section f of the solicitation.

West, Rachel (CDC/NCEZID/DIDRI/RRRSB) @Hudson, Amy (CDC/NCEZID/DIDRI/RRRSB) I tried my best here!

Hudson, Amy (CDC/NCEZID/DIDRI/RRRSB) Fantastic response. :)

West, Rachel (CDC/NCEZID/DIDRI/RRRSB) @Hudson, Amy (CDC/NCEZID/DIDRI/RRRSB)defer to you but this would be our preference I would imagine

Katz, Samantha S. (CDC/NCEZID/DIDRI/OAMD) Personally, I think you may want a firmer statement but I will defer to you all as you obviously know what you need here.

West, Rachel (CDC/NCEZID/DIDRI/RRRSB) @Hudson, Amy (CDC/NCEZID/DIDRI/RRRSB)for your review

Katz, Samantha S. (CDC/NCEZID/DIDRI/OAMD) Suggestion:

Pending discussion with and approval by CDC's Contracting Office and the Contract Officer of record, it may be possible to add a subcontractor as indicated on p. 24 section f of the solicitation.

Hudson, Amy (CDC/NCEZID/DIDRI/RRRSB) Suggestion taken. Thank you!

16. Could future task orders potentially accommodate validated alternative sample-preparation, targeted-detection, or sequencing technologies where those technologies meet CDC-defined performance, quality, throughput, reporting, and data requirements?

Answer:

Yes, though the offeror must fulfill requirements for methods written in the RFP. This includes that samples must be of liquid wastewater influent, quantitative testing must be performed by dPCR, and all genomic data must be filtered of human reads (filter human reads out of any datasets using the sra-human-scrubber (https://github.com/ncbi/sra-human-scrubber) human read removal tool (HRRT), or a tool with equivalent or better performance) prior to submission of any raw sequences to NCBI. Alternative methods should be discussed with CDC prior to implementation, with validation data shared to assess CDC defined requirements.

17. If discussion of the technical capability would be more appropriate with a CDC program or technical representative, would you be willing to direct me to the appropriate contact or industry-engagement mechanism?

Technical capabilities should be discussed in the RFP.

18. IDIQ, page 12 – Does the 30-Day Requirement include design & manufacturing timelines or does the 30-Day development timeline start once the materials are received at the lab?

Answer:

The 30-day requirement for assay adaptability referenced in Requirement Four, section 4.1 is 30 calendar days from the request to update the hybrid capture panel.

19. Task Order 1, page 7: Can you clarify if the first 10 positive samples mean only the first 10 positive measles samples or if the first 10 positive samples mean the first 10 positive samples for ANY of the targets listed in Section 2?

The first 10 positives refer to positive measles samples only.

20. Task Order 1, page 8: Is there flexibility in the 10-day TAT if we need to modify batching to meet the sequencing depth requirement of Section 4.2.1?

Answer:

The 10-day TAT should be met for routine testing. However, if modification needs arise, they shall be communicated to CDC and documented to ensure the exceptions are agreed upon and no penalty on the deliverables are assigned.

West, Rachel (CDC/NCEZID/DIDRI/RRRSB) I can't find the section this person is referencing. I think that yes, it is included in that 30 days.

Katz, Samantha S. (CDC/NCEZID/DIDRI/OAMD) Random question - did you clarify anywhere "calendar" vs "business" days? Do you anticipate any issue? We recently did with an IDIQ task order, and if possible here then I'd be as explicit as can be.

Hudson, Amy (CDC/NCEZID/DIDRI/RRRSB) This question is at the bottom of pg. 12 and rolls to page 13. It is about assay adaptability in Requirement Four section 4.1. We ask for ability to update panel within 30 days. They're asking if it's 30 days from request or receiving the materials. But what if they don't order the materials for two months? Also, Samantha is correct, we need to specify 30 calendar days or business days. Thoughts?

@Welsh, Rory (CDC/NCEZID/DIDRI/RRRSB) @Katz, Samantha S. (CDC/NCEZID/DIDRI/OAMD) @West, Rachel (CDC/NCEZID/DIDRI/RRRSB)