# Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
> **Food and Drug Administration** · Final rule. · Published 2016-11-23 · Effective 2016-12-23 · 81 FR 84465
## Document
- **Document number:** 2016-28120
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 84465
- **CFR reference:** 21 CFR 330
- **Publication date:** 2016-11-23
- **Effective date:** 2016-12-23
- **HHS docket:** Docket No. FDA-2016-N-0543
## Abstract

The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/11/23/2016-28120/food-and-drug-administration-review-and-action-on-over-the-counter-time-and-extent-applications)
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