Federal Register #2026-21712

FDA seeks comments on ASCA Program information collection

The U.S. Food and Drug Administration is seeking public input on information collection for its Accreditation Scheme for Conformity Assessment Program. - Government offices: Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS); the collection was submitted to the Office of Management and Budget (OMB) for review. - Purpose: The information collection concerns accreditation bodies and testing laboratories applying for or maintaining participation in the ASCA Program, as well as laboratories preparing summary test reports. - Estimated annual burden: 795 hours for reporting, 733 hours for recordkeeping, and 7,995 hours for third-party disclosures. - Procurement status: This is a public comment notice, not a solicitation or contract award. No products, services, quantities, OEMs, or vendors are identified.

Description

The FDA submitted a proposed information collection concerning the Accreditation Scheme for Conformity Assessment (ASCA) Program to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act. The collection covers information associated with accreditation bodies and testing laboratories applying to and maintaining participation in the program, as well as testing laboratories completing summary test reports. FDA estimates the annual burden at 795 reporting hours, 733 recordkeeping hours, and 7,995 third-party disclosure hours. Written comments are due by November 23, 2026.

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