FDA Collects Data on Nonprescription Drug Timelines
Published Date: 6/26/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about nonprescription drug applications, especially about timing and usage. This affects drug makers and anyone interested in over-the-counter meds. You’ve got until August 25, 2026, to share your comments—no fees, just your voice helping shape the process!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
OTC Time-and-Extent Applications Ending
If you make or sponsor over-the-counter (OTC) drug products, the FDA says it anticipates no submissions under 21 CFR 330.14 and plans to withdraw the TEA regulations and discontinue the related guidance. When FDA takes those actions it will also request discontinuation of the information collection approved under OMB control number 0910-0688; the notice lists an estimated burden of 861.78 hours per response and a total of 1,112 hours (placeholder) for the collection. The CARES Act added section 505G (21 U.S.C. 355h) on March 27, 2020, and comments on this collection are due by August 25, 2026.
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Key Dates
Department and Agencies
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