**UPDATE (10/25/2023) : A copy of the questions submitted by industry and all CDC answers has been posted to the Attachments/Links section of this notice -- please see the Excel sheet titled "RFI 75D301-24-R-72876 - Questions and Answers FINAL" below. Any other immediate or general questions should be directed via e-mail to Liz Cole-Greenblatt at
[email protected] before the submission deadline. Final Responses continue to be due on Friday, November 3, 2023, at 5:00pm ET . (All vendors, whether they submitted questions or not, are welcome to participate). Further instructions can be found in the actual RFI document included below as an attachment to this notice. This is a Request for Information (RFI). It is NOT a solicitation for proposals, proposal abstracts, or quotations. Release of this information should not be construed as a commitment to procure items discussed or to incur costs for which reimbursement would be required or sought. As permitted by Federal Acquisition Regulation (FAR) Part 10, this is a market research tool being utilized for informational and planning purposes only. Responses will assist the Government in the development of its acquisition strategy, definition of any future requirements, and assessment of available capabilities, capacities, technical methods, processes, and practices being utilized in the current marketplace. TARGET AUDIENCE: Diagnostic Testing Services Industry (Private Sector Clinical Laboratories) I. BACKGROUND To improve the efficiency and accuracy of lab testing during and out of a public health emergency (PHE), the Centers for Disease Control and Prevention (CDC) aims to enhance laboratory quality, safety, and science by improving key laboratory processes and coordination between internal and external partners. Depending on the type and scale of an outbreak or PHE, laboratory testing could be performed entirely at CDC, expanded to include public health laboratories (PHL), or enhanced by partnering with private sector clinical laboratories to achieve widespread national capacity. Engagement with the clinical laboratory community has been used for surge testing support in different capacities for three (3) recent PHE responses: the Zika response utilized regional clinical laboratories; the Mpox response utilized a set of commercial clinical laboratories with nationwide reach; and the COVID response utilized broad nationwide testing in commercial and hospital clinical laboratories and many non-traditional testing sites, such as pharmacies. These recent experiences have proven that engaging with private sector laboratories significantly increases the nation’s resources and diagnostic capacity beyond what is available between CDC and the PHL system. Commercial laboratories leverage sophisticated, nationwide logistical operations that can move specimens from anywhere in the United States to a site with expertise and/or capacity, and can accession and process large volumes of tests performed on high-throughput instrumentation. Additionally, there are other laboratories, such as those affiliated with academic medical centers, that have specialized expertise, high containment facilities, and unique capabilities that may be useful depending on the emergency. In learning from previous PHE responses, CDC would like to better prepare for future responses by enhancing the state of readiness for high-volume diagnostic testing. To do this, CDC would like to partner with private sector laboratories that have the capability, scalability (i.e., capacity), and willingness to collaborate with CDC to develop and rapidly scale-up testing when a pathogen of concern emerges, even before a PHE would be declared. Such a formalized collaboration, once established, would ensure that mechanisms are in place before a PHE exists to facilitate coordination between the federal government (CDC) and private partners, thereby accelerating the implementation of private-sector surge diagnostic testing ideally to tamp down an outbreak before it becomes a widespread emergency and certainly during a PHE. II. PURPOSE The purpose of this RFI is to ascertain the level of interest and capacities of private sector clinical laboratories for coordinating with the CDC to establish pre-event collaborations. Responses to this RFI may be used to inform potential pre-event agreements and strategies that can be used to support activities for these public-private partnerships. III. OBJECTIVE The primary objective of this RFI is to understand the type of support, cost, and resources needed for private sector laboratories to provide test development and surge diagnostic testing support prior to and during a PHE, as well as to determine what method, such as formal agreements via Memorandums of Understanding (MOUs), contracts, or otherwise, would be best to execute this arrangement with private sector laboratories to meet response needs depending on the type and scale of the emergency. IV. REQUIREMENTS CDC seeks information from organizations about their capability, proven experience, and capacity to develop and implement solutions to enable pre-positioned partnerships between private sector laboratories and public health and federal laboratories for enhancing surge diagnostic testing capacity in the event of a PHE. The agency asks for a summary response of no more than 10 pages, with three sections: (1) cover page; (2) approach; and (3) business information. Section 1: Cover Page Company Name Company Address Unique Entity Identification Number Point of Contact information (email addresses, phone numbers, and mailing 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 / End-to End Solutions for Private Sector Partnerships with the PHL system and/or CDC Describe what would be your organization’s approach to preparing to support test development and surge testing capacity, in collaboration with the CDC, to be leveraged when a pathogen of concern emerges that may become a PHE. Please consider providing details on the following and adding any other information you believe the CDC should recognize about your organization’s expertise and capacity, such as: Time frames necessary to develop tests for a new pathogen of concern, assuming CDC can or cannot provide to your organization clinical or contrived samples containing the pathogen Lead time to move from test development to ramping up capacity to 10,000 tests per week and beyond, while maintaining your capacity to continue to serve patients testing needs for other healthcare concerns. The geographic coverage for testing that your organization has in place now, including information on logistical mechanisms used to ensure rapid turnaround times of 2 days or less within that geographic area. Your organization’s expertise in infectious disease testing—immunoassay, molecular, etc.—and optimizing tests for improved throughput and performance. Your processes for ensuring appropriate biosafety. Your workforce, supply, logistical, and other potential costs and constraints that would challenge a rapid test development and response effort. (e.g., partnership costs, inventory, staff retention, appointment availability, automated reporting to submitter and public health, forecasting demand, etc.). Existing relationships with local, state, territorial and/or tribal public health laboratories and agencies (e.g., department of health) in areas where you operate. Describe preferred type of agreements (e.g., MOU, contract, other) that could be established with CDC in advance of a PHE to expedite emergency response efforts and enable a more efficient scale up for surge testing. Please include any liability issues, constraints, and/or concerns to be considered. Provide any additional suggestions for improving partnerships between public and private laboratories. Provide testimonial(s) or proof of successful past performance of these capabilities, including volume of tests processed. Section 3: Business and Pricing Model Considerations To establish a warm-base test development and surge capacity agreement, describe your organization’s requirements for what you would consider a feasible minimum capacity level kept warm to sustain preparedness to rapidly develop and expand testing. Describe coding, coverage, test payment, and other anticipated funding needs for long-term sustainability of surge testing support. Describe the preferred mechanism for partnership (e.g., MOU, grant, contract). V. INSTRUCTIONS FOR SUBMISSION Questions Due : Questions about this RFI must be in the "Questions & Answer Template" provided below (see attached excel sheet) via e-mail to Liz Cole-Greenblatt at
[email protected] by 5:00pm ET on Wednesday, October 18, 2023 . Responses Due : Final Responses to this RFI should be sent via email to Liz Cole-Greenblatt at
[email protected] by 5:00pm ET on Friday, November 3, 2023. Further instructions on formatting can be found in the actual RFI document attached to this posting.