FDA seeks comments on paperwork for good laboratory practice rules in nonclinical studies
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This notice asks the public to comment on FDA's paperwork requirements for good laboratory practice records and reports used in nonclinical studies that support product approvals. It mainly affects sponsors and testing facilities working on drugs, biologics, animal drugs, food additives, and medical devices. FDA is not changing the rule here; it is reviewing whether the existing information collection should continue and whether the burden estimates are right. Businesses in scope should review the comment period if they want to challenge the workload, suggest simpler recordkeeping, or flag problems with the current reporting system. Comments are due by June 29, 2026.
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Key Changes
- FDA is opening a 60-day public comment period on the paperwork burden for Good Laboratory Practice records and reports.
- The notice covers an extension of existing information collection under OMB Control No. 0910-0119, not a new rule.
- Companies can comment on necessity, burden estimates, clarity, and ways to reduce recordkeeping effort.
Obligations
What this law requires
Sponsors of nonclinical laboratory studies that support or are intended to support FDA research or marketing permit applications should submit public comments on the proposed information collection if they believe the reporting or recordkeeping burden is unnecessary, inaccurate, unclear, or could be reduced.
Sponsors of nonclinical laboratory studies should submit public comments if they wish to challenge FDA's proposed information-collection burden, suggest ways to simplify recordkeeping, or raise issues with the reporting system for Good Laboratory Practice requirements.
Comments submitted to FDA on this notice must include the docket number FDA-2026-N-3532.
Any electronic or written comment on the collection of information must be submitted by the stated comment deadline to be considered timely.
All comment submissions must include Docket No. FDA-2026-N-3532.