Home / Agencies / HHS / 2026-14358
Proposed Rule

Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations

Agency
HHS
Document Number
2026-14358
Published
July 16, 2026
Effective Date
-

Abstract

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.

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

View Full Text on FederalRegister.gov →

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Frequently Asked Questions

What is the 2026-14358 Federal Register document?
Document 2026-14358 is a Proposed Rule published by the Department of Health and Human Services in the Federal Register on July 16, 2026. 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. View the original at https://www.federalregister.gov/documents/2026/07/16/2026-14358/request-for-information-clinical-laboratory-improvement-amendments-of-1988-clia-regulations.
Is document 2026-14358 an economically significant rule?
No. Document 2026-14358 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

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