A22 Questions Responses 07312024.pdf

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Traveler-based Genomic Surveillance Program
Solicitation number
RFP75D30124R72969
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This document contains questions and responses related to a Request for Proposal (RFP) for the Traveler-based Genomic Surveillance (TGS) program, solicitation number RFP75D30124R72969, issued by the Department of Health and Human Services Centers for Disease Control and Prevention (CDC) Office of Acquisition Services.

The TGS program aims to detect new SARS-CoV-2 variants and other pathogens, and fill gaps in global biosurveillance, by utilizing samples from travelers (clinical and environmental). Key details include: the program is voluntary and prioritizes flights based on factors like travel volume and disease prevalence; it leverages various sampling modalities including individual testing, pooled testing, wastewater testing, and air sampling; positive samples undergo RT-PCR testing and genetic sequencing with a 10-day turnaround; the program can surge capacity as needed. The responses address questions related to small business set-asides, platform requirements, pathogen testing, sample collection locations and hours, sequencing, data reporting and dashboards, and security requirements.

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QUESTIONS & RESPONSES

RFP 75D301-24-R-72969

1. Why was the small business set aside, as outlined in Section A.1.d, removed as a requirement?

RESPONSE: The reference to small business set-aside was an error. CDC conducted market research including a sources sought notice. Two or more capable small businesses did not submit responses to support a small business set-aside.

2. Are companies allowed to apply to certain parts of the RFP, or is an entire solution expected?

RESPONSE: An entire solution is expected.

3. Is d-PCR the platform of choice for wastewater testing or is dd-PCR also acceptable?

RESPONSE: Yes.

4. “No more than 10 targets including pathogens such as SARS-CoV-2, RSV, Flu A and B and Mpox and other important pathogens”- how much advance notice for additional pathogens will be given?

a. Will pricing be updated to account for additional pathogen testing?

RESPONSE: CDC will endeavor to provide at least 30 days notice for additional pathogens to allow for lab validation etc. Pricing will not be updated in the event additional pathogens are added.

5. (Subsection A - Place of Performance) How much advance notice for additional airports will be given?

RESPONSE: CDC will endeavor to provide at least 30 days advance notice in the form of a contract task order award for the implantation of new additional airports.

6. (Subsection B - Contract Support Hours) Will weekend and/or holiday support / sample collection be required?

RESPONSE: Sample collection will occur 5-days per week. Holiday support hours are not required under the base CLIN, but may be required with the exercise of one of the surge CLINs.

7. “The contractor shall conduct genetic sequencing of all positive samples for the pathogen of interest using appropriate methodologies.”- Can we confirm that this means MPOX, Flu A, Flu B, and RSV sequencing methods must be available?

a. Is this to say that every sample needs genetic sequencing, or only positive samples? If only positive samples, what is the added cost structure for follow-up genomic sequencing on samples?

RESPONSE: Contractor shall maintain sequencing capabilities for SARS-CoV-2, Flu A, and Flu B. Only positive samples should be processed for sequencing. Offerors are encouraged to estimate positivity based on global prevalence.

8. Is Wastewater TGS data subject to a weekly report TAT as mentioned in the RFP or is there another TAT?

RESPONSE: Wastewater data shall be reported weekly, and TAT for PCR should be within 48 hours;

wastewater sequencing data may have a 14 day turn around times (TAT) .

9. What details are available regarding the expected nature of the internal dashboard for data dissemination specified in Task 4?

a. Are details available regarding the public-facing dashboard that the CDC may direct contractors to upload data to?

RESPONSE: Internal dashboard shall include participant counts and programmatic operational metrics included in Section 7, Subsection A – Performance Matrix. Vendor shall provide datasets to an Azure Data

Factory, or via API to DCIPHER. Vendor shall support seamless data transfer to CDC servers, and work with

CDC data managers to resolve data transfer issues.

10. Is the 10 day TAT for sequencing 10 business days or 10 days including non-business?

RESPONSE: 10 calendar days (including non-business days).

11. There is mention of air sampling in aircrafts and airplanes, but air sampling is not included in the performance matrix table. Is air sampling a requirement of this SOW?

RESPONSE: No, air sampling is not a requirement of this SOW

12. The contractor shall secure any necessary contractual agreements with airports and aircraft operators to obtain wastewater sample collection in airport and aircraft facilities.

a. Will new contractors be provided contact information to existing program points of contact at participating airports?

13. Can resumes be submitted as an appendix outside of the 30-page limit?

14. The RFP (Task 4 b) indicates a deliverable is to “maintain an internal dashboard and pipeline of data that flows to CDC. As directed by CDC SMEs, the contractor shall provide data to a public-facing dashboard.”

a. Is an appropriate pipeline for PCR and sequencing results, both wastewater and nasal samples, an API to DCIPHER or does the CDC have another modality in mind. If so, what modality?

RESPONSE: Yes, an API to DCIPHER would be an acceptable pipeline. Data transfers to a CDC Azure Data Factory from AWS or a similar service would be acceptable.

b. What are the specific requirements for the internal dashboard?

RESPONSE: Internal dashboard shall include participant counts and programmatic operational metrics included in Section 7, Subsection A – Performance Matrix.

15. The program description includes “wastewater and air samples from airports” but the deliverables do not include air samples. How is this modality contemplated to be included in the project?

RESPONSE: Air sampling is an example of a modality that could be included under an “pilot of novel modalities” and exercised separately under of the novel modality pilot CLINs.

16. For the purpose of the TGS program, is the data that a contractor is being asked to collect, transmit, or access in this project considered "controlled unclassified information" as described in Baseline Security Requirements section e?

RESPONSE: Some information under this contract may be controlled unclassified. Vendor will receive guidance from CDC POC or COR regarding information that is sensitive in nature.

17. Will you confirm that this RFP does not involve PII and therefore does not require security provisions as described in Section 10 Additional Requirements, Standard 2?

RESPONSE: No, PII is not involved. Security provisions are applicable.

18. Does this RFP involve government information processed on GOCO or COCO systems (and therefore require security provisions as described in Section 10 Additional Requirements, Standard 3)?

RESPONSE: The security provisions included in the solicitation are applicable.

19. Does this RFP involve the use of cloud services (and therefore require security provisions as described in Section 10 Additional Requirements, Standard 4) ?

RESPONSE: The security provisions in the solicitation are applicable.

20. Should "Sequencing data: consensus genome, VCF, BAM files for each sample (sequences with ≥90% coverage and ≥10% read depth)" be updated to read "Sequencing data: consensus genome, VCF, BAM files for each sample (sequences with ≥90% coverage and ≥10X read depth)" (emphasis added)?

RESPONSE: Yes, “Sequencing data: consensus genome, VCF, BAM files for each sample (sequences with ≥90% coverage and ≥10X read depth)” is correct.

21. Are positive pools expected to be sequenced given that the constituent positive samples will be sequenced?

RESPONSE: Positive pools should not be sequenced, only positive individual samples.

22. What is the turnaround time expectation for reporting to CDC from identification of a positive pool to results for the individual samples that make up the pool?

RESPONSE: Vendor shall provide PCR results for pool and positive individual samples within 48 hours.

23. Question 7 refers to maintaining sequencing capabilities for SARS-CoV-2, Flu A, and Flu B. Does this response apply to sequencing of both nasal samples and wastewater samples?

RESPONSE: Yes, both nasal and wastewater samples should be sequenced for SARS-CoV-2, Flu A, and Flu B.

24. Question 5 refers to Subsection A, Place of Performance. Page 8, Section 3, of the RFP states "The contractor shall collect biological and environmental samples at designated airports. The contractor shall establish nasal sample collection sites in six (6) major international airports located in the U.S., and environmental (e.g., wastewater and air) sampling at seven (7) U.S. airports." However, only six airports are listed on page 12, Subsection A. Will CDC provide notice in the form of a contract task order award for the implementation of the seventh airport?

RESPONSE: Vendor should maintain wastewater collection capabilities (either aircraft wastewater or triturator) at each airport at which they operate. Vendor should obtain 1250 wastewater samples per year from flights/triturators which capture geographically diverse points of flight origin. Places of performance for wastewater collection will be finalized at time of award based in part on vendor’s capabilities. In addition to the six airports listed on page 11 Subsection A, wastewater sampling, options for increased quantity, and pilots of new technologies or modalities may require performance at various additional locations to be specified at time of award based on agreement between the CDC and contractor, including:

1. Hartsfield Jackson Atlanta International Airport (ATL)

2. Los Angeles International Airport (LAX)

3. Boston Logan International Airport (BOS)

4. Chicago O’Hare International Airport (ORD)

5. Dallas Fort Worth International Airport (DFW)

6. Other US-based international airports as identified by CDC SMEs

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