Request for Information- Mechanisms for Public-Private Partnerships to Support Diagnostic Test Development and Production for Emergency Response

This posting has been amended to extend the response date to 5:00 PM ET on November 30, 2023. This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. This posting should not be interpreted as a commitment to purchase services or supplies discussed or to incur costs for which reimbursement would be expected due to responding to this RFI. In accordance with Federal Acquisition Regulation (FAR) Part 10, this is a market research tool being utilized for informational and planning purposes only. Responses to this RFI will assist the Government in the development of its future requirements, and assessment of available capabilities, capacities, technical methods, processes, and practices being utilized in the current marketplace. Title: Mechanisms for Public-Private Partnerships to Support Diagnostic Test Development and Production for Emergency Response Request for Information (RFI) No. 81580 TARGET AUDIENCE: Diagnostic Test Developers and Manufacturers (Private Sector) Background When there is an outbreak of new emerging disease (e.g., COVID-19), or a re-emerging disease that lacks a commercial diagnostic test (e.g., mpox), there is a need to rapidly develop and validate diagnostic tests for Emergency Use Authorization (EUA) or 510(k) clearance that can be manufactured at scale and are suitable for high-throughput testing on automated clinical laboratory platforms. Rapid and large-scale production of the reagents, kits, or cartridges that are used to run tests for clinical or surveillance purposes on these instruments is necessary to enable adequate response to large outbreaks of epidemic or pandemic scale. In learning from previous public health emergency responses, CDC would like to better prepare for future responses by enhancing the state of readiness for high-volume diagnostic test development and production. To do this, CDC would like to partner with private sector diagnostic test manufacturers that have the capability, scalability (i.e., capacity), compatibility with a large installed base of automated, high-throughput clinical laboratory equipment, and willingness work with the U.S. government to provide surge test production in the event of a public health emergency (PHE). The goal of this partnership is to contribute to overall laboratory response system that can more quickly and more efficiently respond to PHEs. This system, once established, would ensure that mechanisms are in place before a PHE exists to allow collaborations between the federal government (CDC) and private partners, thereby decreasing downtime for establishing funding mechanisms or agreements during the PHE for the immediate or expedited delivery of services. Purpose The purpose of this request for information is to determine the level of interest that exists for partnering with the CDC and other public health agencies to rapidly develop, validate and manufacture diagnostic tests for a new emerging infectious disease during a PHE, or to proactively develop diagnostic tests against identified pathogens of pandemic potential to the point of having an EUA or 510(k) data package ready in advance of a PHE; to obtain information, needs, capabilities, constraints, capacities, and requirements of these potential public-private partnerships; and to make use of this information to inform potential acquisition strategies that may be used to support activities for these public-private partnerships. Objective The primary objective of this RFI is to understand the kind of support, cost, and resources needed for private sector test manufacturers to develop, validate, obtain regulatory approval (pre=EUA, EUA or 510(k)), and manufacture at scale diagnostic tests (including all required reagents) for emerging infectious diseases during a PHE, or for pathogens of pandemic potential in advance of an outbreak, as well as to determine how to best accomplish this collaborative effort through developing and executing formal agreements via Memorandums of Understanding (MOUs), contracts, or otherwise, for partnering with private sector test manufacturers to meet response needs depending on the type and scale of the emergency. Requirements CDC seeks information from organizations about their capability, proven experience, and capacity to develop and implement a solution to enable pre-positioned partnerships between private sector diagnostic test developers and manufacturers and public health and federal laboratories for enhancing diagnostic test production capacity in advance of or in response to a PHE. The agency requests a brief summary of no more than 10 pages, with three sections: (1) cover page, (2) approach, and (3) business information. Section 1: Cover page Respondents are asked to provide a cover page that contains the following information: Unique Entity Identification Number Point of Contact information (email addresses, phone numbers, and mailing address) Company Name Company Address Type of company under North American Industry Classification System (NAICS), as validated via the SAM. Additional information on NAICS codes can be found at www.sba.gov. Any potential government contractor must be registered on the SAM located at http://www.sam.gov/index.asp Identification as a large or small business. If small, indicate any additional classification. Identification of services on any Federal Supply Schedules, if any, and the relevant schedule numbers. Section 2: Approach Describe end-to-end solutions for proactively establishing private sector partnerships with the CDC to rapidly develop and manufacture high-throughput diagnostic tests that can be run on an installed base of clinical diagnostic automated high-throughput instrumentation in the public health and/or private, including commercial, clinical laboratory space in response to an emerging infectious disease, as well as how to engage with public health experts to develop diagnostic tests to the pre-EUA or pre-510(k) stage for identified pathogens of pandemic potential in advance of an actual public health emergency. Describe how test development, validation, and regulatory approval can be best supported early in a PHE or in advance of a PHE and what services you can provide. Include For which automated high throughput platform(s) can you develop tests? What information, materials (e.g. validation samples), and support you would need from CDC or other federal agencies (FDA, etc.) to support rapid test development, validation, and regulatory approval? Any additional support needed for manufacturing? The estimated time expected for test development and validation up to the point of submitting a data package for regulatory review, assuming you receive the required information and materials in (ii) above. The time to establish a manufacturing line and the capacity of that line (i.e. how many test kits per week. Please indicate how many tests are included in a typical test kit your company manufactures). Broad geographic coverage of a minimal testing footprint of installed testing platforms in (i) above. Estimates of the costs for test development and validation up to the point of generating the data package for regulatory review for a new diagnostic test in response to a new emerging public health emergency. Estimates of the costs for test development and validation up to the point of generating the data package for regulatory review for a disease of pandemic potential in advance of an actual public health emergency. Estimates of the cost per test result of a newly developed diagnostic test on your platform assuming that demand would support production on the scale of orders of 1,000,000 tests per bulk order. Describe what agreements (e.g., MOU, contract, other) could be established with CDC in advance of a PHE to expedite emergency response efforts and enable a more efficient development and production of a new test, or the modification of an existing test, so that it could be used to support a high demand for diagnostic testing. Additional suggestions of improving partnerships between the public and private on IVD test development, production, and distribution. Any liability issues, constraints, and/or concerns to be considered. Testimonials or proof of successful past performance of these capabilities including volume of tests produced. Section 3: Business and pricing model considerations Describe anticipated funding requirements for long-term sustainability costs for providing surge manufacturing capacity. Explain test pricing model, and what level of production is possible. Describe anticipated funding requirements for prepositioning assays for surge manufacturing. Explain test pricing model, and what level of prepositioning (e.g., FDA Pre-submission packet, 510(k) submission packet). Describe any business arrangement models that clarify the costs for CDC and other stakeholders and scalability. Explain ability to use a GSA schedule or other government-wide vehicle. Submission Instructions Respondents are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability in line with this notice. Proprietary information, if any, should be minimized and marked as proprietary. Please submit your final responses to this RFI no later than 5:00 PM ET on November 30, 2023. Submit responses electronically, with subject - RFI Response Mechanisms for Public-Private Partnerships to Support Diagnostic Test Development and Production for Emergency Response: [Company Name] to TJustice@cdc.gov. Submit general questions relating to the RFI via email to TJustice@cdc.gov, Attn: Tonya S. Justice, Contracting Officer. Disclaimer In accordance with FAR 15.201 (e), this RFI is for market research only and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this RFI. The information submitted in all responses will be utilized to help the Government further define its requirements and develop acquisition strategies. All submitted information shall remain with the Government and will not be returned.