FDA published a final rule on November 23, 2016 establishing timelines for specified non-sunscreen over-the-counter time-and-extent applications, known as TEAs. The rule became effective December 23. Its five review clocks started at different events; none was a universal promise that a product would receive approval after a fixed number of days. [2016-28120][2016-07612]

The first clock allowed 180 days from TEA submission for an eligibility notice or ineligibility letter. The second allowed 90 days from submission of safety and effectiveness data for a filing determination. Filing then started two further clocks: 730 days for feedback if the initial determination was unfavorable, and 1,095 days for a proposed rule. A final rule was due within 912 days after the proposed-rule docket closed. [2016-28120][2016-07612]

The April 4, 2016 proposal had explained why a filing step mattered: FDA would first assess whether the data submission was complete enough to review. It also proposed withdrawal procedures and explicitly separated this non-sunscreen timetable from sunscreen work. The final supplied the operative schedule and annual public metrics. These are successive documents in one agency process, not independent evaluations of its performance. [2016-28120][2016-07612]

The timetable excluded sunscreen conditions and specified non-sunscreen TEAs submitted before November 27, 2014 under the statutory provision. Those boundaries matter when interpreting any headline about faster OTC reviews. Eligibility, completeness, proposed action and final action are distinct decisions. The retained rule establishes their timing framework, but does not show that deadlines were met or that any particular ingredient was found safe and effective. [2016-28120][2016-07612]

Source documents

  1. Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applicationshttps://www.govinfo.gov/content/pkg/FR-2016-11-23/html/2016-28120.htm
  2. Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applicationshttps://www.govinfo.gov/content/pkg/FR-2016-04-04/html/2016-07612.htm