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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)

4 rows where docket_id = "FDA-2026-P-6538" sorted by posted_date descending

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document_type 2

  • Other 3
  • Notice 1

posted_year 1

  • 2026 4

agency_id 1

  • FDA 4
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-6538-0003 FDA Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-6538 Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2026-09-01T04:00:00Z 2026 9 2026-09-01T04:00:00Z   2026-09-01T17:17:13Z 2026-17812 0 0 09000064b94b119a
FDA-2026-P-6538-0004 FDA Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-6538 Final Response Letter Other Response(s) 2026-09-01T04:00:00Z 2026 9 2026-09-01T04:00:00Z   2026-09-01T22:09:59Z   0 0 09000064b94ba5b8
FDA-2026-P-6538-0001 FDA Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-6538 Citizen Petition from Newcastle Bioscience LLC Other Citizen Petition 2026-06-08T04:00:00Z 2026 6 2026-06-08T04:00:00Z   2026-09-01T21:14:35Z   0 0 09000064b931c7e8
FDA-2026-P-6538-0002 FDA Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-6538 Acknowledgement Letter from FDA DMB to Newcastle Bioscience LLC Other Acknowledgement Letter/Receipt 2026-06-08T04:00:00Z 2026 6 2026-06-08T04:00:00Z   2026-06-08T23:18:08Z   0 0 09000064b931c7eb

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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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