Health and Human Services Department, Centers for Medicare & Medicaid Services
Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks input from the public regarding various topics related to the CLIA regulations, including: breath testing; laboratory processes and procedures; emergency preparedness, biosafety and biosecurity, and cybersecurity; and specialty testing areas. Responses to this RFI may be used to help inform CMS and the CDC as to what types of action, if any, should be taken to update the existing CLIA regulations through future notice and comment rulemaking.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Part 493 [CMS-3485-NC] RIN 0938-AW01 AGENCY: Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Request for information. SUMMARY: Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks input from the public regarding various topics related to the CLIA regulations, including: breath testing; laboratory processes and procedures; emergency preparedness, biosafety and biosecurity, and cybersecurity; and specialty testing areas. Responses to this RFI may be used to help inform CMS and the CDC as to what types of action, if any, should be taken to update the existing CLIA regulations through future notice and comment rulemaking. DATES: To be assured consideration, comments must be received at one of the addresses provided below, by September 14, 2026. ADDRESSES: In commenting, refer to file code CMS-3485-NC. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation at https://www.regulations.gov/​docket/​CMS-2026-2345 . Follow the “Submit a comment” …
Citation: 91 FR 43586
