Request for Information on CDC Procurement of Clinical Specimens

The Centers for Disease Control and Prevention (CDC), through its Office of Acquisition Services, is conducting market research to identify capable sources for the procurement of clinical specimens or synthetic specimen matrices to support the development and validation of diagnostic tests. This initiative is aligned with the National Biodefense Strategy and Implementation Plan, aiming to strengthen national preparedness for biological threats by building robust specimen procurement capabilities. The effort is formalized through RFI No. 412026, posted on April 23, 2026, with responses due by May 22, 2026. This RFI is strictly for information gathering and does not obligate the government to issue a solicitation, make an award, or reimburse any respondent for costs incurred. All submitted information becomes the property of the government and will not be returned. Respondents must provide detailed proposals limited to 15 pages, submitted exclusively via email to faz9@cdc.gov, with a mandatory cover page in Microsoft Word and supporting metadata in CSV format. Proposals must address key operational requirements including compliance with IATA Packing Instructions 620 and 650, DOT 49 CFR, and OSHA Bloodborne Pathogens Standard for safe specimen handling and transport. Specimens must meet CLSI PRE01, CLSI PRE04, ISO 15189, and ISO 20658 standards, with strict adherence to cold chain protocols, minimization of freeze-thaw cycles, and full traceability through metadata including collection date, volume, and freeze-thaw history. Human subject protections must comply with 45 CFR Part 46 and 21 CFR Parts 50 and 56, and collection facilities must be certified BSL-2. Synthetic matrices must be validated under FDA performance characterization standards. Contractors must demonstrate the ability to mobilize collection efforts within 72 hours during public health emergencies and accept restrictions on third-party use of specimens. The government is evaluating potential contracting vehicles such as IDIQ, BPA, or OTA but has not yet selected a structure. No contract value is available, as this is pre-acquisition research, and no evaluation factors or award criteria are defined at this stage.