Ombu Comments on Notice of Information Collection for QSR

The US Government’s Paperwork Reduction Act requires Federal Agencies to report collection activities to the Office of Management and Budget for approval and renew the approval every three years.

FDA is seeking public comments on the collection activities related to QSR. The FDA published the notice in the Federal Register as Docket Number FDA-2010-N-0273. You can get a copy and offer comments at

FDA estimates that there are 8,924 firms that must collect information, and that the total number of hours to write and maintain procedures, generate records, etc. The Federal Register Notice describes the activities under the various QSR sections and subsections and estimates the hours per record. For example, “Section 820.22 requires the conduct and documentation of [Quality System] audits and reaudits.” FDA estimates that a firm subject to QSR needs 33 hours per year to satisfy section 820.22.

Ombu commented on the proposed recording keeping requirements, because we believe the estimates are very low. The notice and Ombu’s comments are in the Ombu Library in the FDA Information Section.