FDA Requests Comments on Lab Study Info Collection Process
Published Date: 4/30/2026
Notice
Summary
The FDA wants your thoughts on how it collects info about lab rules for nonclinical studies, which help keep research safe and reliable. This affects labs and companies doing these studies, with a chance to comment by June 29, 2026. No big cost changes yet, just a heads-up to keep things clear and smooth.
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Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
GLP Recordkeeping and Reporting Burden
If you run or sponsor nonclinical laboratory studies under 21 CFR Part 58, you must keep Good Laboratory Practice (GLP) records and prepare a final report for each study that documents quality assurance inspections, test and control article characterization, personnel training, SOPs, equipment maintenance/calibration, animal care, and test article accountability. FDA estimates 300 respondents will incur 517,849 annual reporting hours and 786,308 annual recordkeeping hours in total; you can submit comments on this information collection by June 29, 2026.
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Key Dates
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