FDA Asks for Lab Safety Paperwork Feedback
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 no new costs but a chance to improve paperwork. You’ve got until June 29, 2026, to share your comments and help shape the future of lab safety rules!
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
GLP Recordkeeping and Retention Duty
If you sponsor nonclinical laboratory studies, the GLP rules (21 CFR part 58) require your testing facility to retain and make available records to regulatory officials and to prepare final study reports. The rules specify record types such as personnel training summaries, SOPs, equipment maintenance and calibration, test article accountability, animal care documentation, and study raw data. The agency estimates an annual recordkeeping burden of 786,308 hours across 300 respondents.
Reporting Requirements and Time Burden
For each nonclinical study, sponsors must prepare final reports documenting quality assurance inspections, test/article characterization, and overall interpretation of study results. FDA estimates annual reporting activity totaling 517,849 hours across respondents, including 18,075 total annual responses for reporting nonclinical laboratory study results (average 27.65 hours per response).
No Capital or O&M Costs Declared
FDA states there are no capital costs or operating and maintenance (O&M) costs associated with this collection of information (OMB Control No. 0910-0119, extension). This means FDA did not estimate additional monetary equipment or ongoing O&M expenses tied to the paperwork burden.
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Key Dates
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