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About Docket Clock: method and sources

Docket Clock is a free, independent countdown calendar of FDA documents that are open for public comment or have upcoming effective dates. It does not comment on, summarize beyond the official abstract, or rate any document or company.

Data source

All documents come from the free Federal Register API (https://www.federalregister.gov/api/v1/documents.json), filtered to the agency food-and-drug-administration. Each refresh runs three queries: comment date on or after today (open), effective date on or after today (upcoming), and comment date in the last 180 days (recently closed). Previously seen documents stay in the archive. Docket links point to Regulations.gov, using the docket IDs and comment links published in the Federal Register data.

Latest refresh: 2026-10-17T14:51:45+00:00: 56 open comment periods, 7 upcoming effective dates, 158 closed in the last 180 days, 219 documents in the archive.

Federal Register content is a work of the U.S. government and is not subject to copyright in the United States. This site is not an official legal edition of the Federal Register; only the official edition provides legal notice.

How topics are assigned

Topics are automatic: a document is tagged by the 21 CFR parts it amends (for example parts 210–212 for GMP, 312 and 50/56 for clinical, 600–680 and 1271 for biologics, 800–898 for devices, 100–199 and 500–599 for food and animal food, 1100+ for tobacco) and by keywords in its title, abstract and action line. A document can have several topics; documents that match none are listed under "Other FDA topics". Tagging is a convenience and can be wrong. It is not a judgment about the document.

Countdowns

"Closes in X days" is recalculated in your browser from the closing date, so it stays current between refreshes. FDA comment deadlines are generally 11:59 p.m. Eastern on the closing date, but check the DATES section of each document. Extensions and reopenings appear as new Federal Register documents and show up after the next refresh.

What is not included (and why)

EMA and ICH consultations are not included (decision reviewed October 2026):

• EMA: EMA's legal notice allows reproduction with acknowledgment, but its conditions for linking say linked EMA information should not be displayed alongside advertising, which conflicts with this site's planned sponsor slot, and EMA offers no structured API for consultations. Skipped for now.
• ICH: ICH guideline documents carry a reuse license with acknowledgment, but ICH draft guidelines are put out for comment through regional regulators. FDA typically announces ICH drafts for comment in the Federal Register, so those appear here as FDA documents.

FDA dockets opened without a Federal Register notice (for example some citizen petitions) are not covered.

Corrections

If a date or link is wrong, the Federal Register document is the authority. A contact address for corrections is being set up.