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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)

7 rows where docket_id = "FDA-2026-N-8361" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 6
  • Notice 1

posted_year 1

  • 2026 7

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-8361-0002 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications FDA-2026-N-8361 Reference 1 - Gelperin, K., H. Hammad, K. Leishear, et al., ‘‘A Systematic Review of Pregnancy Exposure Registries: Examination of Protocol-Specified Pregnancy Outcomes, Target Sample Size, and Comparator Selection,’’ Pharmacoepidemiology and Drug Safety, 2017 Feb;26(2):208–214. doi: 10.1002/pds.4150. Epub 2016 Dec 27. PMID: 28028914. Supporting & Related Material Background Material 2026-09-09T04:00:00Z 2026 9     2026-09-09T23:01:30Z   0 0 09000064b9503f4d
FDA-2026-N-8361-0004 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications FDA-2026-N-8361 Reference 6 - Hartman, R.I. and A.B. Kimball, ‘‘Performing Research in Pregnancy: Challenges and Perspectives,’’ Clinics in Dermatology, 2016 May–Jun;34(3):410–415. doi: 10.1016/j.clindermatol.2016.02.014. Epub 2016 Feb 11. PMID: 27265080. Supporting & Related Material Background Material 2026-09-09T04:00:00Z 2026 9     2026-09-09T23:01:43Z   0 0 09000064b9503f4f
FDA-2026-N-8361-0005 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications FDA-2026-N-8361 Reference 7 - Krueger, W.S., M.S. Anthony, C.W. Saltus, et al., ‘‘Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis,’’ Drugs Real World Outcomes, 2017 Sep;4(3):139–149. doi: 10.1007/s40801–017–0114–9. PMID: 28756575; PMCID: PMC5567459. Supporting & Related Material Background Material 2026-09-09T04:00:00Z 2026 9     2026-09-09T23:01:46Z   0 0 09000064b9503f50
FDA-2026-N-8361-0006 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications FDA-2026-N-8361 Reference 8 - Sarker A., P. Chandrashekar, A. Magge, et al., ‘‘Discovering Cohorts of Pregnant Women From Social Media for Safety Surveillance and Analysis,’’ Journal of Medical internet Research, 2017 Oct 30;19(10):e361. doi: 10.2196/jmir.8164. PMID: 29084707; PMCID: PMC5684515. Supporting & Related Material Background Material 2026-09-09T04:00:00Z 2026 9     2026-09-09T23:01:49Z   0 0 09000064b9503f51
FDA-2026-N-8361-0003 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications FDA-2026-N-8361 Reference 5 - Daniels, J.L., D.A. Savitz, C. Bradley, et al., ‘‘Attitudes Toward Participation in a Pregnancy and Child Cohort Study,’’ Paediatric and Perinatal Epidemiology, 2006 May;20(3):260–266. doi: 10.1111/j.1365–3016.2006.00720.x. PMID: 16629701. Supporting & Related Material Background Material 2026-09-09T04:00:00Z 2026 9     2026-09-09T23:01:39Z   0 0 09000064b9503f4e
FDA-2026-N-8361-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications FDA-2026-N-8361 Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications Notice 60 Day Proposed Information Collection 2026-09-09T04:00:00Z 2026 9 2026-09-09T04:00:00Z 2026-11-10T04:59:59Z 2026-10-03T09:00:40Z 2026-18299 1 0 09000064b9506ef8
FDA-2026-N-8361-0007 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications FDA-2026-N-8361 Reference 9 - Sinclair S., M. Cunnington, J. Messenheimer, et al., ‘‘Advantages and Problems With Pregnancy Registries: Observations and Surprises Throughout the Life of the International Lamotrigine Pregnancy Registry,’’ Pharmacoepidemiology and Drug Safety, 2014 Aug;23(8):779–786. doi: 10.1002/ pds.3659. Epub 2014 Jun 27. PMID:24974947; PMCID: PMC4406353. Supporting & Related Material Background Material 2026-09-09T04:00:00Z 2026 9     2026-09-09T23:01:52Z   0 0 09000064b9503f52

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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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