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# Info Collection on Time and Extent Filings
- URL: https://www.fdaweb.com/info-collection-on-time-and-extent-filings/
- Published: 2023-08-09T12:00:00.000Z
- Updated: 2026-09-14T18:49:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155057

*Federal Register* notice: FDA is seeking comments on an information collection entitled “Time and Extent Applications for Nonprescription Drug Products.” The collection supports agency regulations that establish additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective. They provide that OTC drug products introduced into the U.S. market after the OTC drug review began in 1972 and OTC drug products without any marketing experience can be evaluated under the monograph process if the conditions (e.g., active ingredients) meet certain “time and extent” criteria. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-08-08/pdf/2023-16922.pdf?ref=fdaweb.com).