Federal Register #2026-21908

FDA Seeks Comments on Electronic Records and Signatures Information Collection

The U.S. Food and Drug Administration is seeking public comments on its electronic records and electronic signatures information collection, not purchasing products or services. - Government buyer: Department of Health and Human Services, Food and Drug Administration (FDA). - Scope: Extension of the information collection under 21 CFR Part 11, OMB Control Number 0910-0303, covering electronic records and electronic signatures, including nonrepudiation letters and controls for electronic systems and signatures. - Estimated annual burden: 5,000 nonrepudiation letters, 5,000 reporting hours, and 300,000 recordkeeping hours. - No OEMs, vendors, products, or services are identified; this is a public-comment notice rather than a procurement solicitation or award.

Description

The Food and Drug Administration (FDA) is requesting public comment on an information collection concerning electronic records and electronic signatures under 21 CFR part 11. The collection supports requirements for electronic records and signatures to be accepted as equivalent to paper records, including submission of nonrepudiation letters and controls for electronic systems and signatures. The notice is an extension of OMB Control Number 0910-0303 and estimates 5,000 annual nonrepudiation-letter submissions and 300,000 annual recordkeeping hours. Comments are due by December 28, 2026.

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