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Federal regulatory documents currently open for public comment. ⚠ Derive comment deadlines from comment_end_datetime converted to America/New_York, never from comment_end_date, which is mid-correction and may be one day late (DataDawn queue #498).

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

perpetual_docket
1 = a standing/perpetual docket carrying a sentinel comment-end date (2050 or later; in practice 2099/2100 — agency guidance and exemption dockets that never close). 0 = an ordinary docket with a real deadline. NULL = no end date reported. The site's Open-for-Comment surface EXCLUDES perpetual_docket = 1 by default, so the site count and the bulk dump answer the same question differently: the dump is complete and includes them.
comment_end_date
The comment deadline as an Eastern (America/New_York) calendar date — CORRECTED in the 2026-09-06 daily snapshot (DataDawn queue #498): a snapshot whose _metadata row comment_end_date_grain reads 'eastern' carries the Eastern date; the pre-correction snapshots (through 2026-09-05) held the UTC-rolled day, one day LATE on every end-of-day close. Federal comment periods close at 11:59:59 PM Eastern and the source publishes that instant in UTC ('2026-08-26T03:59:59Z' = the 2026-08-25 deadline). Prefer comment_end_datetime for any arithmetic and convert it to America/New_York yourself; never 'subtract a day' from this column.
comment_end_datetime
AUTHORITATIVE. The full UTC instant of the comment deadline ('2026-08-26 03:59:59' == 11:59:59 PM Eastern on 2026-08-25). Convert to America/New_York for the official date; prefer this column over comment_end_date for anything computed.

71 rows where agency_id = "FDA" and document_type = "Notice" sorted by comment_end_datetime descending

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document_type 1

  • Notice · 71 ✖

agency_id 1

  • FDA · 71 ✖
id agency_id docket_id title document_type subtype posted_date posted_year posted_month comment_start_date comment_end_date comment_end_datetime ▲ perpetual_docket last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2015-N-3469-0001 FDA FDA-2015-N-3469 Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket Notice Notice of Availability 2015-10-27 2015 10 2015-10-27 2050-02-21 2050-02-22 04:59:59 1 2026-08-11 09:00:50 2015-27270 1 0 0900006481cf17b1
FDA-2015-N-3534-0001 FDA FDA-2015-N-3534 Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket Notice Notice of Availability 2015-10-27 2015 10 2015-10-27 2050-02-21 2050-02-22 04:59:59 1 2026-09-20 09:00:16 2015-27271 1 0 0900006481cf1710
FDA-2011-N-0655-0041 FDA FDA-2011-N-0655 Animal Generic Drug User Fee Act; Public Meeting; Request for Comments Notice Request for Comments 2026-04-17 2026 4 2026-04-17 2027-12-01 2027-12-02 04:59:59 0 2026-07-01 09:00:24 2026-07497 1 0 09000064b928930a
FDA-2011-N-0656-1315 FDA FDA-2011-N-0656 Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate Notice General Notice 2026-05-11 2026 5 2026-05-11 2027-12-01 2027-12-02 04:59:59 0 2026-08-13 14:40:33 2026-09283 1 0 09000064b92cacd0
FDA-2011-N-0655-0042 FDA FDA-2011-N-0655 Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate Notice Notice of Intent 2026-05-11 2026 5 2026-05-11 2027-12-01 2027-12-02 04:59:59 0 2026-08-13 14:41:39 2026-09284 1 0 09000064b92cf91b
FDA-2011-N-0656-1314 FDA FDA-2011-N-0656 Animal Drug User Fee Act; Public Meeting; Request for Comments Notice Request for Comments 2026-04-17 2026 4 2026-04-17 2027-12-01 2027-12-02 04:59:59 0 2026-08-20 09:01:12 2026-07498 1 0 09000064b928948d
FDA-2026-N-0131-0001 FDA FDA-2026-N-0131 FDA Rare Disease Innovation Hub Future Programming; Request for Comments Notice Request for Comments 2026-01-30 2026 1 2026-01-30 2026-12-31 2027-01-01 04:59:59 0 2026-07-08 09:00:11 2026-01903 1 0 09000064b91893ee
FDA-2020-E-1882-0005 FDA FDA-2020-E-1882 Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC Notice Determinations 2026-10-09 2026 10 2026-10-09 2026-12-08 2026-12-09 04:59:59 0 2026-10-09 18:22:03 2026-20766 1 0 09000064b9657798
FDA-2020-E-1892-0005 FDA FDA-2020-E-1892 Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC Notice Determinations 2026-10-09 2026 10 2026-10-09 2026-12-08 2026-12-09 04:59:59 0 2026-10-09 18:23:55 2026-20766 1 0 09000064b965705e
FDA-2026-N-10605-0001 FDA FDA-2026-N-10605 Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations Notice 60 Day Proposed Information Collection 2026-10-08 2026 10 2026-10-08 2026-12-07 2026-12-08 04:59:59 0 2026-10-08 17:22:43 2026-20663 1 0 09000064b9651d3d
FDA-2014-N-0053-1398 FDA FDA-2014-N-0053 Challenges and Solutions in Lot-Level Food Traceability; Public Meeting Notice Public Meetings 2026-10-09 2026 10 2026-10-09 2026-12-06 2026-12-07 04:59:59 0 2026-10-09 18:53:04 2026-20720 1 0 09000064b9653e73
FDA-2026-D-8693-0001 FDA FDA-2026-D-8693 Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability Notice Notice of Availability 2026-09-02 2026 9 2026-09-02 2026-12-01 2026-12-02 04:59:59 0 2026-09-03 18:40:25 2026-17961 1 0 09000064b94bf507
FDA-2026-N-10132-0001 FDA FDA-2026-N-10132 Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards Notice 60 Day Proposed Information Collection 2026-09-29 2026 9 2026-09-29 2026-11-30 2026-12-01 04:59:59 0 2026-09-29 17:15:35 2026-19849 1 0 09000064b95e7083
FDA-2018-D-4533-2363 FDA FDA-2018-D-4533 Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Notice Notice of Availability 2026-08-28 2026 8 2026-08-28 2026-11-27 2026-11-28 04:59:59 0 2026-08-28 16:31:49 2026-17580 1 0 09000064b94a6448
FDA-2015-N-3326-0056 FDA FDA-2015-N-3326 Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments Notice Request for Comments 2026-09-25 2026 9 2026-09-25 2026-11-25 2026-11-26 04:59:59 0 2026-10-06 09:00:35 2026-19660 1 0 09000064b95c53b7
FDA-2026-N-9505-0001 FDA FDA-2026-N-9505 Robotically-Assisted Surgical Devices—Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2026-09-25 2026 9 2026-09-25 2026-11-24 2026-11-25 04:59:59 0 2026-09-25 19:21:13 2026-19704 1 0 09000064b95c549b
FDA-2026-N-10100-0001 FDA FDA-2026-N-10100 FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics Notice Meeting 2026-08-31 2026 8 2026-09-23 2026-11-22 2026-11-23 04:59:59 0 2026-08-31 22:10:19   1 0 09000064b94b538f
FDA-2026-N-10363-0001 FDA FDA-2026-N-10363 Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications Notice 60 Day Proposed Information Collection 2026-09-21 2026 9 2026-09-21 2026-11-20 2026-11-21 04:59:59 0 2026-09-21 17:16:01 2026-19283 1 0 09000064b959db67
FDA-2026-N-10430-0001 FDA FDA-2026-N-10430 Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption Notice 60 Day Proposed Information Collection 2026-09-21 2026 9 2026-09-21 2026-11-20 2026-11-21 04:59:59 0 2026-09-21 17:21:17 2026-19282 1 0 09000064b959db5f
FDA-2026-N-10033-0001 FDA FDA-2026-N-10033 Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Notice 60 Day Proposed Information Collection 2026-09-21 2026 9 2026-09-21 2026-11-20 2026-11-21 04:59:59 0 2026-09-22 09:00:47 2026-19281 1 0 09000064b959dbae
FDA-2026-N-10429-0001 FDA FDA-2026-N-10429 Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information Notice Requests for Information (RFI) 2026-10-06 2026 10 2026-10-06 2026-11-20 2026-11-21 04:59:59 0 2026-10-10 09:00:58 2026-20427 1 0 09000064b962e7b9
FDA-2026-D-8561-0001 FDA FDA-2026-D-8561 Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2026-08-20 2026 8 2026-08-20 2026-11-18 2026-11-19 04:59:59 0 2026-08-20 17:54:40 2026-16960 1 0 09000064b946c7f3
FDA-2026-D-9429-0001 FDA FDA-2026-D-9429 Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2026-09-18 2026 9 2026-09-18 2026-11-17 2026-11-18 04:59:59 0 2026-09-18 18:00:19 2026-19181 1 0 09000064b958f5ee
FDA-2026-D-7233-0001 FDA FDA-2026-D-7233 Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2026-09-18 2026 9 2026-09-18 2026-11-17 2026-11-18 04:59:59 0 2026-09-18 18:09:09 2026-19141 1 0 09000064b958f536
FDA-2025-N-2787-0007 FDA FDA-2025-N-2787 Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document Notice Notice of Availability 2026-09-18 2026 9 2026-09-18 2026-11-17 2026-11-18 04:59:59 0 2026-09-18 18:37:52 2026-19166 1 0 09000064b958ecea
FDA-2026-N-10165-0001 FDA FDA-2026-N-10165 Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments Notice Request for Comments 2026-09-15 2026 9 2026-09-15 2026-11-13 2026-11-14 04:59:59 0 2026-09-16 09:00:44 2026-18805 1 0 09000064b955afbc
FDA-2026-N-8692-0001 FDA FDA-2026-N-8692 Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Pathogen-Agnostic Sequencing Notice Request for Comments 2026-09-16 2026 9 2026-09-16 2026-11-12 2026-11-13 04:59:59 0 2026-10-04 09:00:20 2026-18920 1 0 09000064b956b6a9
FDA-2026-N-9350-0001 FDA FDA-2026-N-9350 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking Notice 60 Day Proposed Information Collection 2026-09-11 2026 9 2026-09-11 2026-11-10 2026-11-11 04:59:59 0 2026-09-30 09:00:20 2026-18529 1 0 09000064b951dd42
FDA-2024-E-4125-0005 FDA FDA-2024-E-4125 Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA Notice Determinations 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-09 17:47:05 2026-18297 1 0 09000064b9506ef3
FDA-2024-E-4128-0005 FDA FDA-2024-E-4128 Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA Notice Determinations 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-09 17:49:59 2026-18297 1 0 09000064b94cc9f8
FDA-2024-E-4129-0005 FDA FDA-2024-E-4129 Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA Notice Determinations 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-09 17:52:57 2026-18297 1 0 09000064b94cc9f9
FDA-2024-E-4130-0005 FDA FDA-2024-E-4130 Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA Notice Determinations 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-09 17:56:33 2026-18297 1 0 09000064b94cc9fa
FDA-2024-E-4131-0005 FDA FDA-2024-E-4131 Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA Notice Determinations 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-09 18:01:24 2026-18297 1 0 09000064b94cc9fb
FDA-2025-E-3595-0005 FDA FDA-2025-E-3595 Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY Notice Determinations 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-09 18:09:30 2026-18300 1 0 09000064b9506ef2
FDA-2025-E-3596-0005 FDA FDA-2025-E-3596 Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY Notice Determinations 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-09 18:12:58 2026-18300 1 0 09000064b94cc9fc
FDA-2025-E-3939-0005 FDA FDA-2025-E-3939 Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO Notice Determinations 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-09 18:26:41 2026-18298 1 0 09000064b9506dda
FDA-2026-N-9638-0001 FDA FDA-2026-N-9638 Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products Notice 60 Day Proposed Information Collection 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-09-29 09:00:25 2026-18333 1 0 09000064b9506ea0
FDA-2026-N-8361-0001 FDA 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 2026-09-09 2026 9 2026-09-09 2026-11-09 2026-11-10 04:59:59 0 2026-10-03 09:00:40 2026-18299 1 0 09000064b9506ef8
FDA-2026-N-7129-0005 FDA FDA-2026-N-7129 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) Notice 30 Day Proposed Information Collection 2026-10-08 2026 10 2026-10-08 2026-11-09 2026-11-10 04:59:59 0 2026-10-08 17:19:42 2026-20661 1 0 09000064b9651f14
FDA-2026-N-7426-0003 FDA FDA-2026-N-7426 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use Notice 30 Day Proposed Information Collection 2026-10-09 2026 10 2026-10-09 2026-11-09 2026-11-10 04:59:59 0 2026-10-09 18:12:21 2026-20765 1 0 09000064b96577e0
FDA-2026-N-10738-0001 FDA FDA-2026-N-10738 Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information Notice Requests for Information (RFI) 2026-09-24 2026 9 2026-09-24 2026-11-09 2026-11-10 04:59:59 0 2026-10-10 09:00:57 2026-19563 1 0 09000064b95b6b07
FDA-2026-N-6667-0002 FDA FDA-2026-N-6667 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements Notice 30 Day Proposed Information Collection 2026-10-09 2026 10 2026-10-09 2026-11-09 2026-11-10 04:59:59 0 2026-10-10 09:00:59 2026-20768 1 0 09000064b9657794
FDA-2026-N-7605-0001 FDA FDA-2026-N-7605 Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information Notice Requests for Information (RFI) 2026-08-05 2026 8 2026-08-05 2026-11-03 2026-11-04 04:59:59 0 2026-10-03 09:00:26 2026-15887 1 0 09000064b93ff4d4
FDA-2026-N-9550-0001 FDA FDA-2026-N-9550 Advancing Development of Botanical Drug Products; Request for Information Notice Requests for Information (RFI) 2026-09-04 2026 9 2026-09-04 2026-11-03 2026-11-04 04:59:59 0 2026-10-10 09:00:42 2026-18133 1 0 09000064b94cc083
FDA-2026-N-6876-0005 FDA FDA-2026-N-6876 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program Notice 30 Day Proposed Information Collection 2026-10-01 2026 10 2026-10-01 2026-11-02 2026-11-03 04:59:59 0 2026-10-01 17:10:26 2026-20085 1 0 09000064b95fa835
FDA-2026-N-8690-0001 FDA FDA-2026-N-8690 Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees Notice 60 Day Proposed Information Collection 2026-08-31 2026 8 2026-08-31 2026-10-30 2026-10-31 03:59:59 0 2026-08-31 17:28:32 2026-17676 1 0 09000064b94afcfe
FDA-2026-N-9349-0001 FDA FDA-2026-N-9349 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections Notice 60 Day Proposed Information Collection 2026-08-31 2026 8 2026-08-31 2026-10-30 2026-10-31 03:59:59 0 2026-08-31 17:33:15 2026-17675 1 0 09000064b94afbd8
FDA-2026-N-2743-0003 FDA FDA-2026-N-2743 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 Notice 30 Day Proposed Information Collection 2026-09-29 2026 9 2026-09-29 2026-10-29 2026-10-30 03:59:59 0 2026-09-29 17:13:03 2026-19850 1 0 09000064b95e920c
FDA-2026-N-10606-0001 FDA FDA-2026-N-10606 Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application (NDA) 219694 for Atropine Sulfate Ophthalmic Solution, 0.01% Notice Request for Comments 2026-09-25 2026 9 2026-09-25 2026-10-29 2026-10-30 03:59:59 0 2026-10-10 09:00:57 2026-19700 1 0 09000064b95c540b
FDA-2026-N-8691-0001 FDA FDA-2026-N-8691 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers Notice 60 Day Proposed Information Collection 2026-08-28 2026 8 2026-08-28 2026-10-27 2026-10-28 03:59:59 0 2026-08-28 17:30:23 2026-17599 1 0 09000064b94a6404
FDA-2026-N-8087-0001 FDA FDA-2026-N-8087 Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration Notice 60 Day Proposed Information Collection 2026-08-28 2026 8 2026-08-28 2026-10-27 2026-10-28 03:59:59 0 2026-08-28 17:52:27 2026-17598 1 0 09000064b949f63c
FDA-2026-N-8898-0001 FDA FDA-2026-N-8898 Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery Notice 60 Day Proposed Information Collection 2026-08-28 2026 8 2026-08-28 2026-10-27 2026-10-28 03:59:59 0 2026-09-06 09:00:29 2026-17605 1 0 09000064b94a6385
FDA-2026-N-8482-0001 FDA FDA-2026-N-8482 Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health Notice Request for Comments 2026-08-26 2026 8 2026-08-26 2026-10-26 2026-10-27 03:59:59 0 2026-08-27 09:00:24 2026-17377 1 0 09000064b94982b2
FDA-2026-N-5057-0001 FDA FDA-2026-N-5057 Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments Notice Request for Comments 2026-05-29 2026 5 2026-05-29 2026-10-26 2026-10-27 03:59:59 0 2026-09-30 09:00:14 2026-10752 1 0 09000064b92fcf66
FDA-2007-D-0369-2640 FDA FDA-2007-D-0369 Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2026-08-24 2026 8 2026-08-24 2026-10-23 2026-10-24 03:59:59 0 2026-09-29 20:57:56 2026-17222 1 0 09000064b948c1a1
FDA-2026-N-3400-0003 FDA FDA-2026-N-3400 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs Notice 30 Day Proposed Information Collection 2026-09-21 2026 9 2026-09-21 2026-10-21 2026-10-22 03:59:59 0 2026-09-21 17:09:16 2026-19284 1 0 09000064b959dbaf
FDA-2017-D-5974-0012 FDA FDA-2017-D-5974 Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability Notice Determinations 2026-08-18 2026 8 2026-08-18 2026-10-19 2026-10-20 03:59:59 0 2026-08-18 17:24:50 2026-16837 1 0 09000064b9467538
FDA-2026-N-5479-0001 FDA FDA-2026-N-5479 Testosterone Use in Menopausal Women; Public Workshop; Request for Comments Notice General Notice 2026-08-18 2026 8 2026-08-18 2026-10-19 2026-10-20 03:59:59 0 2026-10-10 09:00:38 2026-16829 1 0 09000064b94653e0
FDA-2025-N-0873-0014 FDA FDA-2025-N-0873 Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments Notice Request for Comments 2026-08-11 2026 8 2026-08-11 2026-10-17 2026-10-18 03:59:59 0 2026-09-24 09:00:21 2026-16353 1 0 09000064b942ebed
FDA-2026-N-7757-0001 FDA FDA-2026-N-7757 Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food Notice 60 Day Proposed Information Collection 2026-08-17 2026 8 2026-08-17 2026-10-16 2026-10-17 03:59:59 0 2026-08-17 17:13:22 2026-16714 1 0 09000064b9462da6
FDA-2026-N-8328-0001 FDA FDA-2026-N-8328 Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries Notice 60 Day Proposed Information Collection 2026-08-17 2026 8 2026-08-17 2026-10-16 2026-10-17 03:59:59 0 2026-08-17 17:48:14 2026-16712 1 0 09000064b9462da4
FDA-2025-E-0490-0005 FDA FDA-2025-E-0490 Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Notice Determinations 2026-08-17 2026 8 2026-08-17 2026-10-16 2026-10-17 03:59:59 0 2026-08-17 18:05:29 2026-16713 1 0 09000064b9462d5b
FDA-2025-E-0485-0005 FDA FDA-2025-E-0485 Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Notice Determinations 2026-08-17 2026 8 2026-08-17 2026-10-16 2026-10-17 03:59:59 0 2026-08-17 18:06:12 2026-16713 1 0 09000064b9463d3f
FDA-2025-E-0486-0005 FDA FDA-2025-E-0486 Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Notice Determinations 2026-08-17 2026 8 2026-08-17 2026-10-16 2026-10-17 03:59:59 0 2026-08-17 18:06:44 2026-16713 1 0 09000064b9463d40
FDA-2025-E-0488-0005 FDA FDA-2025-E-0488 Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Notice Determinations 2026-08-17 2026 8 2026-08-17 2026-10-16 2026-10-17 03:59:59 0 2026-08-17 18:07:20 2026-16713 1 0 09000064b9463d41
FDA-2025-E-0489-0005 FDA FDA-2025-E-0489 Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Notice Determinations 2026-08-17 2026 8 2026-08-17 2026-10-16 2026-10-17 03:59:59 0 2026-08-17 18:07:39 2026-16713 1 0 09000064b9463d42
FDA-2026-N-0027-0003 FDA FDA-2026-N-0027 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing Notice 30 Day Proposed Information Collection 2026-09-16 2026 9 2026-09-16 2026-10-16 2026-10-17 03:59:59 0 2026-09-16 17:00:39 2026-18946 1 0 09000064b956b6ef
FDA-2026-N-8163-0001 FDA FDA-2026-N-8163 Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments Notice Request for Comments 2026-08-14 2026 8 2026-08-14 2026-10-16 2026-10-17 03:59:59 0 2026-10-10 09:00:37 2026-16650 1 0 09000064b94571b0
FDA-2026-N-2740-0003 FDA FDA-2026-N-2740 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Customer Service Satisfaction Surveys Notice 30 Day Proposed Information Collection 2026-09-14 2026 9 2026-09-14 2026-10-14 2026-10-15 03:59:59 0 2026-09-14 17:17:00 2026-18691 1 0 09000064b954b3cf
FDA-2026-N-2917-0002 FDA FDA-2026-N-2917 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed Notice 30 Day Proposed Information Collection 2026-09-11 2026 9 2026-09-11 2026-10-13 2026-10-14 03:59:59 0 2026-09-11 17:20:19 2026-18528 1 0 09000064b951de42
FDA-2016-N-3120-0570 FDA FDA-2016-N-3120 Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets Notice Withdrawal 2026-08-13 2026 8 2026-08-13 2026-10-13 2026-10-14 03:59:59 0 2026-09-19 11:46:00 2026-16536 1 0 09000064b943bc08

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CREATE TABLE documents (
            id TEXT PRIMARY KEY,
            agency_id TEXT,
            docket_id TEXT,
            title TEXT,
            document_type TEXT,
            subtype TEXT,
            posted_date TEXT,
            posted_year INTEGER,
            posted_month INTEGER,
            comment_start_date TEXT,
            comment_end_date TEXT,      -- EASTERN calendar date of the close (queue #498 writer
                                        -- fix, 2026-09-05; was the UTC-rolled day AFTER the ET
                                        -- deadline before that). Display-grade only.
            comment_end_datetime TEXT,  -- full UTC close ("YYYY-MM-DD HH:MM:SS", queue #498):
                                        -- the API expresses the 11:59:59 PM ET deadline as a UTC
                                        -- datetime. AUTHORITATIVE: the predicate, days_left and
                                        -- any timezone-aware render derive from THIS column.
            perpetual_docket INTEGER,   -- 1 = sentinel end date (queue #464); NULL = no end date
            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_comment_end ON documents(comment_end_date);
CREATE INDEX idx_docs_withdrawn ON documents(withdrawn);
CREATE INDEX idx_docs_perpetual ON documents(perpetual_docket);
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