documents

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)

7 rows where docket_id = "FDA-2017-P-7034" sorted by posted_date descending

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posted_year 2

document_type 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-P-7034-0007 FDA Requests that the FDA determine that the drug product, Valacyclovir Hydrochloride Oral Tablet EQ 250 mg and 750 mg base are suitable for consideration in an Abbreviated New Drug Application. FDA-2017-P-7034 Response Letter from FDA CDER to Jubilant Generics Limited Other Letter(s) 2025-07-31T04:00:00Z 2025 7 2025-07-31T04:00:00Z   2025-07-31T18:24:31Z   0 0 09000064b8ebc5b5
FDA-2017-P-7034-0003 FDA Requests that the FDA determine that the drug product, Valacyclovir Hydrochloride Oral Tablet EQ 250 mg and 750 mg base are suitable for consideration in an Abbreviated New Drug Application. FDA-2017-P-7034 Exhibit 1 Orange Book Listing re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:20Z   0 0 0900006482d84d72
FDA-2017-P-7034-0005 FDA Requests that the FDA determine that the drug product, Valacyclovir Hydrochloride Oral Tablet EQ 250 mg and 750 mg base are suitable for consideration in an Abbreviated New Drug Application. FDA-2017-P-7034 Exhibit 3 Proposed Product Draft Label re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:46Z   0 0 0900006482d84d74
FDA-2017-P-7034-0001 FDA Requests that the FDA determine that the drug product, Valacyclovir Hydrochloride Oral Tablet EQ 250 mg and 750 mg base are suitable for consideration in an Abbreviated New Drug Application. FDA-2017-P-7034 Citizen Petition from Jubilant Generics Limited Other Citizen Petition 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-06-28T03:59:59Z 2018-01-02T16:52:40Z   0 0 0900006482d84d2a
FDA-2017-P-7034-0006 FDA Requests that the FDA determine that the drug product, Valacyclovir Hydrochloride Oral Tablet EQ 250 mg and 750 mg base are suitable for consideration in an Abbreviated New Drug Application. FDA-2017-P-7034 Exhibit 4 Valtrex Tablets 250 mg re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:57Z   0 0 0900006482d84d75
FDA-2017-P-7034-0004 FDA Requests that the FDA determine that the drug product, Valacyclovir Hydrochloride Oral Tablet EQ 250 mg and 750 mg base are suitable for consideration in an Abbreviated New Drug Application. FDA-2017-P-7034 Exhibit 2 RLD Label re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:34Z   0 0 0900006482d84d73
FDA-2017-P-7034-0002 FDA Requests that the FDA determine that the drug product, Valacyclovir Hydrochloride Oral Tablet EQ 250 mg and 750 mg base are suitable for consideration in an Abbreviated New Drug Application. FDA-2017-P-7034 Acknowledgment Letter from FDA DDM to Jubilant Generics Limited Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2018-01-02T16:53:05Z   0 0 0900006482d84d2c

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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;