AMENDMENTs: PLEASE SEE THREE ATTACHMENTS CONTAINING QUESTIONS AND ANSWERS. Uploaded 4/2, 4/3 and 4/4 Title: Request for Information – Collection of Serum Samples from Patients Infected With SARS-CoV-2 Synopsis: This is a request for information. It is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to: Determine the level of interest which exists in the open market for providing the needed services; Obtain information, needs, capabilities, constraints, capacities, and requirements of those potential providers of the needed service; and Make use of this information to inform potential acquisition strategies that may be used to support a) emergency public health response activities, b) on-going assay development, and c) research. Background: The Centers for Disease Control and Prevention (CDC) is a public health organization which operates within the Department of Health and Human Services. The CDC requires access to freshly drawn whole blood, blood products, and other unique sample types and materials to enable rapid assay development during infectious disease outbreaks. In addition to CDC, many commercial manufacturers and research laboratories are developing serological tests for diagnostic purposes in response to the COVID-19 pandemic. Fundamental to the development and implementation of serologic procedures, and the evaluation of these procedures, is the availability of positive control samples (i.e., serum or plasma from patients with well-documented, laboratory-confirmed disease). The only source of positive control samples for assays for human samples originates from individuals who have had recent COVID-19 illnesses. Traditionally, positive controls for serologic test procedures are identified from patient samples submitted to the CDC laboratory for routine diagnostic testing. However, these samples are typically small volume (1 ml or less) and cannot serve as standardized controls. Similarly, uniform panels of positive control serum are generally unavailable, limiting the ability of CDC and other laboratories to standardize and calibrate their assays. Requirement: CDC is seeking information from companies and other organizations about their capability and capacity to deploy to the site of a domestic SARS-CoV-2 outbreak, obtain informed consent, collect whole blood specimens (~20 ml) from individuals infected with SARS-CoV-2 who are at least 14-28 days after the onset of symptoms, and safely ship these specimens to CDC in accordance with all applicable local, state, and federal and/or international laws, and regulations. Additionally, the agency is seeking information on the following: To obtain information, needs, capabilities, constraints, capacities, and requirements of those vendors and companies who do have an interest (or potential interest) in providing the needed services; Information provided should include: Name, location and size of company Service and/or coverage area (e.g. throughout the United States and/or internationally). Description of sites used to collect patient samples. Availability of IRB and ability to develop IRB approved protocols and consent documents. Ability to explain the reason for the sample collection and the informed consent document to prospective patients, obtain consent, and transfer the consent documents to CDC. Ability to obtain required patient meta data (age, gender, results of clinical testing, etc), complete the required sample data forms, and securely transmit the information to CDC. Ability to safely collect whole blood and prepare serum prior to shipment to CDC. Description of safety measures used for blood collection. Ability to perform testing to determine the titer of antibodies against SARS-CoV-2 Current ability to collect, and details of prior experience collecting, specimens from patients in a medical setting (e.g., hospital, clinic, physician office) and/or in patient’s homes or other locations. Information about time it would take to deploy personnel to the site of the outbreak and begin collecting samples. Methods of sample transport and shipping which may be utilized, and measures to assure shipping conditions, such as temperature, to preserve sample integrity. Ability to track items in transit and provide exact locations of samples at all times Ability to adhere to all applicable hazardous materials transportation regulations Any liability issues, constraints and/or concerns to be considered 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. Respondents are asked to provide a cover page that contains the following information: All Point of Contact information (email addresses, phone numbers, and mailing address) DUNS number All relevant NAICS Codes Identification as a large or small business. If small, indicate the classification. Identification of services on any Federal Supply Schedules, if any, and the relevant schedule numbers. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid HHS, please segregate and clearly mark proprietary information. Please be advised that all submissions become the property of the Government and will not be returned. This REQUEST FOR INFORMATION is in accordance with FAR 52.215-3 Request for Information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only. Responses to this REQUEST FOR INFORMATION notice, along with a firm’s capability statement referencing “Request for Information – Serum from COVID-19 Patients” may be submitted electronically via email to the points of contact listed below NO LATER THAN 5PM EST on 6 April 2020. Point of Contact: Eric Sullivan, Contracting Officer
[email protected] (412) 386-5290