RFI 75D301-24-R-72876 - Questions and Answers FINAL.xlsx

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Request for Information - Public-Private Lab Partnership Mechanisms to Support Surge Testing during Public Health Emergencies
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75D301-24-R-72876
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This document contains a question and answer template for Request for Information number 75D301-24-R-72876 regarding mechanisms for public-private partnerships to support surge testing during public health emergencies. The Centers for Disease Control and Prevention is seeking information on how respondents can support surge testing capacity outside traditional healthcare settings, including through improving functions like sample collection, transport, and logistical support. Respondents are also invited to describe how they could directly support sample collection efforts such as by establishing, operating, and staffing testing sites. While the primary interest is in diagnostic testing, respondents can describe how sequencing can contribute to a response. This RFI is open to any diagnostic testing method and contemplates roles for respondents in test development, managing sample collection kit inventories, and suggestions for partnerships and consortia to improve coordinated surge testing.

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Sheet1

QUESTION AND ANSWER TEMPLATE
Request for Information (RFI) No. 75D301-24-R-72876
Mechanisms for Public-Private Partnerships to Support Surge Testing During PHEs
Question
NumberRFI Reference
(if applicable)QuestionCDC Response
1GeneralFor testing labs with limited operational capacity and past performance in sample collection, transport and end-to-end logistical support, and particularly when the requirement is to surge testing capacity outside of traditional healthcare settings, does the RFI contemplate the need for partners who can provide these services?The CDC is interested in hearing how respondents can support surge testing in any capacity, and if that support is through improving those functions listed, then we would like to hear about it as well.
2GeneralIs there a contemplated role for direct support of the sample collection effort? Such as standing up, operating and staffing testing sites?Yes, additional consideration should include how to appropriately incorporate testing with the improved/enhanced sample collection.
3GeneralHow does the CDC envision the role of sequencing labs in supporting warm base preparedness infrastructure?While the primary interest is in diagnostic testing, respondents are welcome to describe how sequecing can contribute to a response, whether through active strain surveillance or otherwise. Surveillance sequencing continues to be an important component of response efforts and is being explored by the CDC.
4GeneralWhat type of testing is contemplated in the RFI? Is the expectation that this would be PCR based detection or are other testing modalities within scope such as sequencing?This RFI is not restricted to PCR-based detection methods, but is interested in any diagnostic testing for emergency response.
5GeneralIs creating and managing the inventory of sample collection kits within the expected scope of services the lab partner would provide?Yes, that can be included.
6RFI: Section 2: Approach: a. (Page2)Does "support test development" include the development of a laboratory developed test (LDT), a test under EUA, or something else?Yes, these can include LDTs, EUAs, 510ks, and amendments.
7GeneralDoes the RFI contemplate that the labs will be required to work together in a coordinated fashion, to help improve efficiency of testing capacity, maintain baseline standards, collectively help close gaps in testing capacity, share best practices and learnings, etc.? If so, does the RFI contemplate a (limited, temporary) operating structure or mechanism that would facilitate that, like, for example a corsortium; and, if so, does the RFI contemplate whether CDC or another entity would manage such an operating structure?No, CDC does not plan to require that participants work together in a coordinated fashion managed by a single entity (CDC or otherwise). However, cooperation between entities prior to and during a response is encouraged, and your response should include suggestions on how to best improve surge diagnostic testing etc. through partnerships, consortia, etc., especially if your laboratory structure would require coordinating with another entity.

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