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# Comments on Criteria for OTC Drugs Seen as GRASE
- URL: https://www.fdaweb.com/comments-on-criteria-for-otc-drugs-seen-as-grase/
- Published: 2017-05-30T12:00:00.000Z
- Updated: 2026-09-14T22:26:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138810

*Federal Register* notice: FDA is seeking comments on an information collection revision to “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded.” Recently FDA revised its regulations at 21 CFR part 330 to add six hours to the agency’s estimated annual reporting burden for the information collection. Specifically, it clarifies the requirements on content and format criteria for a safety and effectiveness data submission, and provides procedures for FDA’s review of the submissions and determination of whether a submission is sufficiently complete to permit a substantive review. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-05-30/pdf/2017-11008.pdf?ref=fdaweb.com).