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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

comment_end_date
A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
comment_start_date
A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)

9 rows where docket_id = "FDA-2026-N-10429" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 8
  • Notice 1

posted_year 1

  • 2026 9

agency_id 1

  • FDA 9
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2026-N-10429-0002 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Reference 1 - Alper, K.R., Stajic´, M., and J.R. Gill, ‘‘Fatalities temporally associated with the ingestion of ibogaine,’’ J. Forensic Sci., 57(2):398–412 (2012), available at doi:10.1111/j.1556-4029.2011.02008.x. Supporting & Related Material Background Material 2026-10-06T04:00:00Z 2026 10     2026-10-06T20:44:11Z   0 0 09000064b9635d74
FDA-2026-N-10429-0003 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Reference 2 - Brunt, T.M., ‘‘Rare but relevant: ibogaine and cardiovascular complications— prolonged QT interval and ventricular arrhythmias,’’ Addiction, 121(6):1616– 1621 (2026), available at doi:10.1111/add.70319. Supporting & Related Material Background Material 2026-10-06T04:00:00Z 2026 10     2026-10-06T20:44:30Z   0 0 09000064b9635d75
FDA-2026-N-10429-0005 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Reference 4 - Knuijver, T., ter Heine, R., Schellekens, A.F.A., Heydari, P., Lucas, L., et al., ‘‘The pharmacokinetics and pharmacodynamics of ibogaine in opioid use disorder patients,’’ J. Psychopharmacol., 38(5):481–488 (2024), available at doi:10.1177/02698811241237873. Supporting & Related Material Background Material 2026-10-06T04:00:00Z 2026 10     2026-10-06T20:44:37Z   0 0 09000064b9635d77
FDA-2026-N-10429-0004 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Reference 3 - Knuijver, T., Schellekens, A., Belgers, M., Donders, R., van Oosteren, T., et al., ‘‘Safety of ibogaine administration in detoxification of opioid-dependent individuals: a descriptive open-label observational study,’’ Addiction, 117(1):118–128 (2022), available at doi:10.1111/add.15448. Supporting & Related Material Background Material 2026-10-06T04:00:00Z 2026 10     2026-10-06T20:44:33Z   0 0 09000064b9635d76
FDA-2026-N-10429-0009 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Reference 8 - Rocha, J.M., Reis, J.A.S., Bouso, J.C., Hallak, J.E.C., and R.G. Dos Santos, ‘‘Identifying setting factors associated with improved ibogaine safety: a systematic review of clinical studies,’’ Eur. Arch. Psychiatry Clin. Neurosci., 273(7):1527–1542 (2023), available at doi:10.1007/s00406-023-01590-1. Supporting & Related Material Background Material 2026-10-06T04:00:00Z 2026 10     2026-10-06T20:44:48Z   0 0 09000064b9637d4e
FDA-2026-N-10429-0008 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Reference 7 - Roden, D.M., ‘‘Drug-induced prolongation of the QT interval,’’ N. Engl. J. Med., 350(10):1013–1022 (2004), available at doi:10.1056/NEJMra032426. Supporting & Related Material Background Material 2026-10-06T04:00:00Z 2026 10     2026-10-07T23:57:35Z   0 0 09000064b9637d4d
FDA-2026-N-10429-0006 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Reference 5 - Kock, P., Froelich, K., Walter, M., Lang, U., and K.M. Du¨ rsteler, ‘‘A systematic literature review of clinical trials and therapeutic applications of ibogaine,’’ J. Subst. Abuse Treat., 138:108717 (2022), available at doi:10.1016/j.jsat.2021.108717. Supporting & Related Material Background Material 2026-10-06T04:00:00Z 2026 10     2026-10-06T20:44:40Z   0 0 09000064b9635d78
FDA-2026-N-10429-0007 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Reference 6. - Ona, G., Rocha, J.M., Bouso, J.C., Hallak, J.E.C., Borra`s, T., et al., ‘‘The adverse events of ibogaine in humans: an updated systematic review of the literature (2015–2020),’’ Psychopharmacology, 239(6):1977–1987 (2022), available at doi:10.1007/s00213-021-05964-y. Supporting & Related Material Background Material 2026-10-06T04:00:00Z 2026 10     2026-10-06T20:44:43Z   0 0 09000064b9635d79
FDA-2026-N-10429-0001 FDA Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information FDA-2026-N-10429 Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information Notice Requests for Information (RFI) 2026-10-06T04:00:00Z 2026 10 2026-10-06T04:00:00Z 2026-11-21T04:59:59Z 2026-10-15T09:00:40Z 2026-20427 1 0 09000064b962e7b9

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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