Open FDA comment periods, with countdowns

56 FDA documents in the Federal Register are open for public comment (4 close within 7 days). Sorted by deadline. Filter by topic, subscribe to the calendar feed, or see 7 upcoming effective dates.

Closes	Document
closes today Oct 17, 2026	Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments Notice · published Aug 11, 2026 · FDA-2025-N-0873 Other FDA topics
closes in 2 days Oct 19, 2026	Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability Notice · published Aug 18, 2026 · FDA-2017-D-5974 Other FDA topics
closes in 4 days Oct 21, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs Notice · published Sep 21, 2026 · FDA-2026-N-3400 Other FDA topics
closes in 6 days Oct 23, 2026	Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice · published Aug 24, 2026 · FDA-2007-D-0369 CMC (chemistry, manufacturing & controls)
closes in 9 days Oct 26, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health Notice · published Aug 26, 2026 · FDA-2026-N-8482 Medical devices
closes in 9 days Oct 26, 2026	Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast Rule · published Sep 25, 2026 · FDA-2021-F-1157 Food & dietary supplements
closes in 9 days Oct 26, 2026	Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments Notice · published May 29, 2026 · FDA-2026-N-5057 Clinical
closes in 10 days Oct 27, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration Notice · published Aug 28, 2026 · FDA-2026-N-8087 Other FDA topics
closes in 10 days Oct 27, 2026	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 · published Aug 28, 2026 · FDA-2026-N-8691 GMP / manufacturing Food & dietary supplements
closes in 10 days Oct 27, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery Notice · published Aug 28, 2026 · FDA-2026-N-8898 Other FDA topics
closes in 12 days Oct 29, 2026	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 · published Sep 29, 2026 · FDA-2026-N-2743 Food & dietary supplements
closes in 13 days Oct 30, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections Notice · published Aug 31, 2026 · FDA-2026-N-9349 Medical devices
closes in 13 days Oct 30, 2026	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 · published Aug 31, 2026 · FDA-2026-N-8690 GMP / manufacturing
closes in 16 days Nov 2, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program Notice · published Oct 1, 2026 · FDA-2026-N-6876 Other FDA topics
closes in 17 days Nov 3, 2026	Advancing Development of Botanical Drug Products; Request for Information Notice · published Sep 4, 2026 · FDA-2026-N-9550 Other FDA topics
closes in 17 days Nov 3, 2026	Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information Notice · published Aug 5, 2026 · FDA-2026-N-7605 Other FDA topics
closes in 23 days Nov 9, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products Notice · published Sep 9, 2026 · FDA-2026-N-9638 Vaccines / biologics
closes in 23 days Nov 9, 2026	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 · published Sep 9, 2026 · FDA-2026-N-8361 Other FDA topics
closes in 23 days Nov 9, 2026	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 · published Oct 8, 2026 · FDA-2026-N-7129 Medical devices
closes in 23 days Nov 9, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements Notice · published Oct 9, 2026 · FDA-2026-N-6667 Vaccines / biologics
closes in 23 days Nov 9, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use Notice · published Oct 9, 2026 · FDA-2026-N-7426 Other FDA topics
closes in 23 days Nov 9, 2026	Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information Notice · published Sep 24, 2026 · FDA-2026-N-10738 Vaccines / biologics
closes in 24 days Nov 10, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking Notice · published Sep 11, 2026 · FDA-2026-N-9350 Medical devices
closes in 27 days Nov 13, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements Notice · published Oct 14, 2026 · FDA-2026-N-7131 Food & dietary supplements
closes in 27 days Nov 13, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products Notice · published Oct 14, 2026 · FDA-2026-N-6739 Other FDA topics
closes in 27 days Nov 13, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards Notice · published Oct 14, 2026 · FDA-2026-N-7338 Food & dietary supplements
closes in 27 days Nov 13, 2026	Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate Rule · published Oct 14, 2026 · FDA-2026-F-2048 Food & dietary supplements
closes in 27 days Nov 13, 2026	Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments Notice · published Sep 15, 2026 · FDA-2026-N-10165 Clinical
closes in 31 days Nov 17, 2026	Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document Notice · published Sep 18, 2026 · FDA-2025-N-2787 Vaccines / biologics
closes in 31 days Nov 17, 2026	Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice · published Sep 18, 2026 · FDA-2026-D-9429 Vaccines / biologics Medical devices
closes in 31 days Nov 17, 2026	Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability Notice · published Sep 18, 2026 · FDA-2026-D-7233 Other FDA topics
closes in 32 days Nov 18, 2026	Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability Notice · published Aug 20, 2026 · FDA-2026-D-8561 CMC (chemistry, manufacturing & controls) Vaccines / biologics
closes in 34 days Nov 20, 2026	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 · published Sep 21, 2026 · FDA-2026-N-10033 Food & dietary supplements
closes in 34 days Nov 20, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption Notice · published Sep 21, 2026 · FDA-2026-N-10430 Other FDA topics
closes in 34 days Nov 20, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications Notice · published Sep 21, 2026 · FDA-2026-N-10363 Other FDA topics
closes in 34 days Nov 20, 2026	Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information Notice · published Oct 6, 2026 · FDA-2026-N-10429 Clinical
closes in 37 days Nov 23, 2026	Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability Proposed Rule · published Oct 9, 2026 · FDA-2025-D-6952 Food & dietary supplements
closes in 38 days Nov 24, 2026	Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice · published Sep 25, 2026 · FDA-2026-N-9505 Medical devices
closes in 39 days Nov 25, 2026	Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments Notice · published Sep 25, 2026 · FDA-2015-N-3326 Vaccines / biologics
closes in 41 days Nov 27, 2026	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 · published Aug 28, 2026 · FDA-2018-D-4533 GMP / manufacturing
closes in 44 days Nov 30, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards Notice · published Sep 29, 2026 · FDA-2026-N-10132 Clinical Medical devices
closes in 45 days Dec 1, 2026	Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability Notice · published Sep 2, 2026 · FDA-2026-D-8693 Vaccines / biologics
closes in 50 days Dec 6, 2026	Challenges and Solutions in Lot-Level Food Traceability; Public Meeting Notice · published Oct 9, 2026 · FDA-2014-N-0053 Food & dietary supplements
closes in 51 days Dec 7, 2026	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 · published Oct 8, 2026 · FDA-2026-N-10605 Other FDA topics
closes in 51 days Dec 7, 2026	Nonclinical Testing Terminology Proposed Rule · published Sep 22, 2026 · FDA-2026-N-5347 Clinical Vaccines / biologics
closes in 51 days Dec 7, 2026	Nonclinical Testing Terminology Rule · published Sep 22, 2026 · FDA-2026-N-5347 Clinical Vaccines / biologics
closes in 52 days Dec 8, 2026	Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC Notice · published Oct 9, 2026 · FDA-2020-E-1882, FDA-2020-E-1892 Other FDA topics
closes in 53 days Dec 9, 2026	Substances Generally Recognized as Safe Proposed Rule · published Aug 11, 2026 · FDA-2025-N-3262 Food & dietary supplements
closes in 55 days Dec 11, 2026	Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments Notice · published Oct 16, 2026 · FDA-2026-N-12214 Clinical
closes in 72 days Dec 28, 2026	Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV Notice · published Jun 29, 2026 · FDA-2025-E-0162, FDA-2025-E-0163, FDA-2025-E-0164 Other FDA topics
closes in 75 days Dec 31, 2026	FDA Rare Disease Innovation Hub Future Programming; Request for Comments Notice · published Jan 30, 2026 · FDA-2026-N-0131 Clinical
closes in 114 days Feb 8, 2027	Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI Notice · published Aug 10, 2026 · FDA-2025-E-5206 Other FDA topics
closes in 114 days Feb 8, 2027	Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO Notice · published Aug 10, 2026 · FDA-2025-E-0707 Other FDA topics
closes in 142 days Mar 8, 2027	Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY Notice · published Sep 9, 2026 · FDA-2025-E-3595, FDA-2025-E-3596 Vaccines / biologics
closes in 142 days Mar 8, 2027	Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA Notice · published Sep 9, 2026 · FDA-2024-E-4125, FDA-2024-E-4128, FDA-2024-E-4129, FDA-2024-E-4130, FDA-2024-E-4131 Vaccines / biologics
closes in 142 days Mar 8, 2027	Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO Notice · published Sep 9, 2026 · FDA-2025-E-3939 Other FDA topics

Comment periods include proposed rules, notices (guidance documents, information collections, public meetings, requests for information) and some direct final rules. FDA comment deadlines are usually 11:59 p.m. Eastern on the closing date; check each document.