Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
other · Food and Drug Administration · Rule · Published 2016-11-23 · Effective 2016-12-23 · 81 FR 84465
Document
Document number
2016-28120
Federal Register citation
81 FR 84465
CFR reference
21 CFR 330
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.