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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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655,934 rows where document_type = "Other" sorted by posted_date descending

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  • Other · 655,934 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
DOT-OST-2002-12555-0308 DOT None DOT-OST-2002-12555 American Airlines, Inc. Other Correspondence 2026-12-13T05:00:00Z 2026 12 2025-10-28T04:00:00Z   2026-02-14T13:14:34Z   1 0 09000064b9056fb2
EPA-HQ-OW-2026-2575-0001 EPA Clean Water Act Section 312 Uniform National Discharge Standards Pre-Proposal Recommendations EPA-HQ-OW-2026-2575 Memo Opening Docket for Comments Other Memorandum to Open a Docket 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z 2026-07-15T03:59:59Z 2026-05-15T16:15:09Z   1 0 09000064b92d6152
FDA-2025-V-0353-0004 FDA Laser Light Show FDA-2025-V-0353 Amendment to variance from Something Good Other Amendment 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T20:51:22Z   0 0 09000064b92da646
FDA-2026-H-5254-0001 FDA DAB Civil Money Penalty; Gondal Enterprises LLC, d/b/a Exxon FDA-2026-H-5254 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T19:53:37Z   0 0 09000064b92da640
FDA-2026-H-5253-0001 FDA DAB Civil Money Penalty; Runlands LLC d/b/a Runland’s Grocery FDA-2026-H-5253 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T21:37:53Z   0 0 09000064b92da628
FDA-2025-P-7006-0009 FDA Requests that FDA declare that Dicyclomine Hydrochloride Tablets, 10 mg, is suitable for submission as an ANDA FDA-2025-P-7006 Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C. Other Grant of Petition 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T16:56:08Z   0 0 09000064b92d515d
FDA-2026-H-5252-0001 FDA DAB Civil Money Penalty; Rudraunsh, Inc., d/b/a United Mart FDA-2026-H-5252 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T18:15:10Z   0 0 09000064b92da5cd
FDA-2026-H-5255-0001 FDA DAB Civil Money Penalty; 6002 Gas Corp. d/b/a BP FDA-2026-H-5255 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T19:33:46Z   0 0 09000064b92db377
FDA-2026-H-5250-0001 FDA DAB Civil Money Penalty; Tornado 2 Tobacco and Vape Inc., d/b/a Tornado Tobacco & Vape FDA-2026-H-5250 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T21:35:08Z   0 0 09000064b92dadef
FDA-2026-H-5248-0001 FDA DAB Civil Money Penalty; Prayosha Inc. of Live Oak, d/b/a Live Oak Liquors FDA-2026-H-5248 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T22:57:37Z   0 0 09000064b92db36c
FDA-2025-P-6262-0052 FDA Requests that FDA, under FDCA §505G(b) (OTC monograph administrative order process), amend OTC Monograph M013 to update Drug Facts labeling for all over-the-counter acetaminophen-containing products. In the alternative, Petitioner asks FDA to initiate such an order on its own FDA-2025-P-6262 Interim Response Other Letter(s) 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T20:28:02Z   0 0 09000064b92dbaa6
FDA-2026-H-5251-0001 FDA DAB Civil Money Penalty; Chevron Stations Inc., d/b/a Chevron / Extra Mile FDA-2026-H-5251 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T18:18:45Z   0 0 09000064b92da5f9
FDA-2026-H-5249-0001 FDA DAB Civil Money Penalty; Antler Lake Store & Motel, Inc., d/b/a Antler Lake Store & Motel FDA-2026-H-5249 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T18:10:17Z   0 0 09000064b92da5b9
FDA-2026-H-5256-0001 FDA DAB Civil Money Penalty; Mahadeva Inc. d/b/a Friendly Food Mart FDA-2026-H-5256 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T21:26:05Z   0 0 09000064b92db9f3
FDA-2026-H-5257-0001 FDA DAB Civil Money Penalty; Food Town Investments LLC d/b/a Food Town IGA FDA-2026-H-5257 Complaint Other Complaint 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T23:01:41Z   0 0 09000064b92dadf5
FDA-2025-P-6024-0008 FDA Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA FDA-2025-P-6024 Final Response Other Denial 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-16T01:50:33Z   0 0 09000064b92dc6f6
EPA-HQ-OPP-2025-0177-0006 EPA Application for Section 3 Registration of Three new Active Ingredients Containing Spinach Defensin Proteins for use in Citrus EPA-HQ-OPP-2025-0177 Public Participation for the new active ingredients collectively referred to as CTV-SoD2 variants. Other Public Participation 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z 2026-05-30T03:59:59Z 2026-05-14T16:37:50Z   1 0 09000064b92d6cc7
EPA-HQ-OPPT-2025-3358-0006 EPA Science Advisory Committee on Chemicals (SACC); Request for Nominations of Ad hoc Peer Reviewers EPA-HQ-OPPT-2025-3358 Memo to Docket to Open Docket for Comment on Available Candidates (15-day public comment period) Other Memorandum to Open a Docket 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z 2026-05-30T03:59:59Z 2026-05-15T02:12:13Z   1 0 09000064b92d9d6f
FDA-2022-V-0385-0004 FDA Laser Light Show FDA-2022-V-0385 Variance Renewal Application from Brant Parrish Other Application for Variance (VAR) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T18:02:11Z   0 0 09000064b92d6cc8
FDA-2026-P-5454-0002 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Acknowledgment Letter from FDA DMB to Americans for Scientific Integrity Other Acknowledgement Letter/Receipt 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T17:41:43Z   0 0 09000064b92d4fe9
FDA-2026-P-5454-0001 FDA Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 Citizen Petition from Americans for Scientific Integrity Other Citizen Petition 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T17:41:38Z   1 0 09000064b92d4fe7
FDA-2025-P-6350-0004 FDA Requests that the FDA initiate notice-and-comment rulemaking to amend 21 CFR § 1271.90 to extend the existing regulatory exception for surplus cryopreserved embryos to surplus cryopreserved oocytes originally recovered for a woman’s own reproductive use FDA-2025-P-6350 Interim Response Letter from FDA CBER to Jack Weis Other Response(s) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T18:12:30Z   0 0 09000064b92d7d0a
FDA-2026-P-5578-0001 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Suitability Petition from Appco Pharma LLC Other Petition(s) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:17:53Z   1 0 09000064b92d8f5b
FDA-2026-H-5193-0001 FDA DAB Civil Money Penalty; Semo Gas Stations LLC d/b/a Cooter Browns / Exxon FDA-2026-H-5193 Complaint Other Complaint 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-15T00:35:04Z   0 0 09000064b92d79e2
FDA-2026-H-5184-0001 FDA DAB Civil Money Penalty; Tobacco Zone Inc., d/b/a Tobacco Zone FDA-2026-H-5184 Complaint Other Complaint 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T19:33:28Z   0 0 09000064b92d6ce9
FDA-2026-H-5191-0001 FDA DAB Civil Money Penalty; Nafii Group LLC d/b/a Morning Star Market / Marathon FDA-2026-H-5191 Complaint Other Complaint 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T20:05:30Z   0 0 09000064b92d6cee
FDA-2020-V-0476-0004 FDA Laser Light Show FDA-2020-V-0476 Variance Renewal Application from Andrew Stuart Other Application for Variance (VAR) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T18:05:51Z   0 0 09000064b92d76f8
FDA-2026-P-5578-0002 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. FDA-2026-P-5578 Acknowledgement Letter from FDA DMB to Appco Pharma LLC Other Acknowledgement Letter/Receipt 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:17:57Z   0 0 09000064b92d8f63
FDA-2026-P-5611-0002 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc Other Acknowledgement Letter/Receipt 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:37:28Z   0 0 09000064b92d7cce
FDA-2026-P-3630-0006 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules, USP 0.8 mg FDA-2026-P-3630 Completeness Assessment Correspondence Other Assessment Document or Analysis 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T15:19:06Z   0 0 09000064b92d613f
FDA-2026-P-5611-0001 FDA Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-5611 Suitability Petition from Senores Pharmaceuticals, Inc Other Petition(s) 2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T23:37:18Z   1 0 09000064b92d9592
FDA-2026-H-4962-0001 FDA DAB Civil Money Penalty; Lincolnway, Inc. d/b/a Lincolnway Liquor & Bar FDA-2026-H-4962 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T16:11:53Z   0 0 09000064b92d2875
FDA-2018-N-4626-1057 FDA List of Bulk Drug Substances That May be Used to Compound Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations FDA-2018-N-4626 Nomination from Stokes Pharmacy Other Nomination 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T22:53:42Z   0 0 09000064b92a502f
FDA-2019-D-1536-0037 FDA Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework; Draft Guidance for Industry; Availability FDA-2019-D-1536 Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:23:30Z   1 0 09000064b92d0c28
FDA-2026-H-4964-0001 FDA DAB Civil Money Penalty; Central Park Food, Corp. d/b/a Shell FDA-2026-H-4964 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T20:07:19Z   0 0 09000064b92d474c
FDA-2026-H-5121-0001 FDA DAB Civil Money Penalty; R & E Meat Market LLC d/b/a Ruben's Meat Market 3 FDA-2026-H-5121 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-14T00:04:07Z   0 0 09000064b92d4ee4
FDA-2026-H-5050-0001 FDA DAB Civil Money Penalty; RIA 24 LLC d/b/a Smoke City 3 FDA-2026-H-5050 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-14T00:06:15Z   0 0 09000064b92d4ce2
FDA-2026-H-5126-0001 FDA DAB Civil Money Penalty; Natural Food Deli, Inc. d/b/a Gourmet Deli FDA-2026-H-5126 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T20:18:06Z   0 0 09000064b92d58d5
FDA-2023-D-0608-0005 FDA Development of Local Anesthetic Drug Products With Prolonged Duration of Effect; Draft Guidance for Industry; Availability FDA-2023-D-0608 Development of Local Anesthetic Drug Products With Prolonged Duration of Effect; Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:22:13Z   1 0 09000064b92d0c40
FDA-2026-H-4823-0001 FDA DAB Civil Money Penalty; HotSpot Stores LLC d/b/a Ozark Hot Spot FDA-2026-H-4823 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T18:56:10Z   0 0 09000064b92d46ee
FDA-2026-H-4794-0001 FDA DAB Civil Money Penalty; Commerce Puff Zone Tobacco & Vape LLC d/b/a Puff Zone Tobacco & Vape FDA-2026-H-4794 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T20:54:18Z   0 0 09000064b92d44cd
FDA-2026-H-5053-0001 FDA DAB Civil Money Penalty; Grab 'N Go Mart LLC d/b/a Grab 'N Go Mart Smoke Shop FDA-2026-H-5053 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:02:35Z   0 0 09000064b92d4bbf
FDA-2021-N-0556-0026 FDA Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry; Availability FDA-2021-N-0556 Development of Non-Opioid Analgesics for Acute Pain; Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:20:57Z   1 0 09000064b92d0c73
FDA-1995-S-0036-0241 FDA Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 FDA-1995-S-0036 Public Disclosure from Boston Children's Hospital Other Public Disclosure 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T17:49:22Z   0 0 09000064b92d4423
FDA-2026-H-4965-0001 FDA DAB Civil Money Penalty; Super Deli 617, LLC d/b/a Super Delicatessen FDA-2026-H-4965 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T20:09:56Z   0 0 09000064b92d40a7
FDA-2026-R-5127-0001 FDA DAB No Tobacco Sale Order; Rapid Management Inc. d/b/a Roadrunner FDA-2026-R-5127 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T22:53:38Z   0 0 09000064b92d4bbc
FDA-2026-H-5052-0001 FDA DAB Civil Money Penalty; LTHQ LLC d/b/a HQ Vape & Smoke FDA-2026-H-5052 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T20:19:23Z   0 0 09000064b92d4ce8
FDA-2023-D-1848-0023 FDA Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability FDA-2023-D-1848 Stimulant Use Disorders: Developing Drugs for Treatment; Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:18:07Z   1 0 09000064b92d0c8f
FDA-2025-D-0610-0125 FDA Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability FDA-2025-D-0610 Development of Non-Opioid Analgesics for Chronic Pain; Guidance for Industry; Draft Guidance Other Guidance 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T15:19:21Z   1 0 09000064b92d0c87
FDA-2026-P-5453-0002 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Acknowledgement Letter from FDA DMB to Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS) Other Acknowledgement Letter/Receipt 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:04:37Z   0 0 09000064b92d5159
FDA-2026-H-5054-0001 FDA DAB Civil Money Penalty; State Street Mobil Incorporated d/b/a Mobil / State Street Car Care FDA-2026-H-5054 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:14:35Z   0 0 09000064b92d4ee9
FDA-2026-H-5125-0001 FDA DAB Civil Money Penalty; 2034 Best Gourmet Deli Inc. d/b/a Best 2034 Gourmet Deli FDA-2026-H-5125 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-14T00:06:58Z   0 0 09000064b92d599b
FDA-2026-H-4827-0001 FDA DAB Civil Money Penalty; Big Boss IV, LLC, d/b/a Big Boss Stores / 76 FDA-2026-H-4827 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T19:16:50Z   0 0 09000064b92d4469
FDA-2026-H-4955-0001 FDA DAB Civil Money Penalty; All Thingz Exotic South, LLC d/b/a All Thingz Exotic South FDA-2026-H-4955 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T18:58:41Z   0 0 09000064b92d443b
FDA-2025-H-3115-0002 FDA DAB Civil Money Penalty; Sehgal Enterprises LLC, d/b/a AJ's One-Stop FDA-2025-H-3115 Amended Complaint Other Amendment 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T18:31:59Z   0 0 09000064b92d2a7a
FDA-2026-H-4952-0001 FDA DAB Civil Money Penalty; Zaidal Blue Sky Investments Corp d/b/a I Lava You Smoke Shop FDA-2026-H-4952 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T19:14:34Z   0 0 09000064b92d445b
FDA-2026-P-5453-0001 FDA Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption FDA-2026-P-5453 Citizen Petition from Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS) Other Citizen Petition 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:00:37Z   1 0 09000064b92d5158
FDA-2026-H-5051-0001 FDA DAB Civil Money Penalty; Dollar Treat & More, Inc. d/b/a Dollar Treat & More FDA-2026-H-5051 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T20:57:05Z   0 0 09000064b92d44db
FDA-2026-H-4992-0001 FDA DAB Civil Money Penalty; Jusbelinda Grocery Corp. d/b/a Grocery Corp. FDA-2026-H-4992 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T19:45:07Z   0 0 09000064b92d3805
FDA-2026-H-5120-0001 FDA DAB Civil Money Penalty; Excellent LT, LLC, d/b/a Marathon / Excellent Food Mart FDA-2026-H-5120 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:42:26Z   0 0 09000064b92d1f55
FDA-2026-H-5124-0001 FDA DAB Civil Money Penalty; Smokers Paradise Urbana LLC d/b/a Smokers Paradise FDA-2026-H-5124 Complaint Other Complaint 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-14T00:00:28Z   0 0 09000064b92d57b8
EPA-R08-OAR-2025-0230-0022 EPA WBI Energy Transmission, Inc. - Hardin Compressor Station, Minor NSR Permit / Minor Mod of Existing Major Source EPA-R08-OAR-2025-0230 WBI Hardin CS MNSR Final Permit MNSR-C-000001-2025.001 Other   2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-13T00:01:48Z   0 0 09000064b92d1e32
FDA-2026-V-3076-0001 FDA Laser Light Show FDA-2026-V-3076 Variance Application from Ole Red Nashville Other Application for Variance (VAR) 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-13T00:06:06Z   0 0 09000064b92363f7
FDA-2026-H-4796-0001 FDA DAB Civil Money Penalty; SKE Inc. d/b/a Marathon / H&H Sport Shop FDA-2026-H-4796 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T21:11:07Z   0 0 09000064b92d2d04
FDA-2026-H-4990-0001 FDA DAB Civil Money Penalty;111 Corona Candy Store, Inc. d/b/a 111 Corona Discount & Candy Store Inc. FDA-2026-H-4990 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:52:33Z   0 0 09000064b92d40fa
FDA-2026-H-4795-0001 FDA DAB Civil Money Penalty; E Cigs MG Inc. d/b/a E Cig City FDA-2026-H-4795 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:55:11Z   0 0 09000064b92d5100
FDA-2026-H-4789-0001 FDA DAB Civil Money Penalty; SD 2020 Inc., d/b/a Crave Beer Vape & Smoke FDA-2026-H-4789 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:48:22Z   0 0 09000064b92d31ec
FDA-2026-D-5083-0002 FDA Enforcement Policies for Certain Electronic Nicotine Delivery Systems (ENDS) Marketed Without Premarket Authorization; Guidance for Industry; Availability FDA-2026-D-5083 Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization - Guidance for Industry Other Guidance 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T17:54:03Z   1 0 09000064b92d0add
FDA-2025-P-6315-0013 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Interim Response Other Letter(s) 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T18:26:15Z   0 0 09000064b92cfe1a
FDA-2026-H-4831-0001 FDA DAB Civil Money Penalty; Riverside Market LLC d/b/a Cedar Food FDA-2026-H-4831 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T22:44:00Z   0 0 09000064b92ca94e
FDA-2026-H-4970-0001 FDA DAB Civil Money Penalty; Yonkers Grocery & Convenience Store, Inc. d/b/a Yonkers Dan's Tobacco Cigar & Convenience FDA-2026-H-4970 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:50:58Z   0 0 09000064b92d307b
FDA-2026-H-4966-0001 FDA DAB Civil Money Penalty; Express Gas USA LLC d/b/a BP FDA-2026-H-4966 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:30:43Z   0 0 09000064b92d3801
FDA-2026-H-4731-0001 FDA DAB Civil Money Penalty; J P Bar, Inc. d/b/a Big Sky Bar FDA-2026-H-4731 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T21:08:54Z   0 0 09000064b92d18ad
FDA-2025-P-6094-0013 FDA Requests that the FDA require updating the pregnancy safety warnings in the labels of serotonin reuptake inhibitors: selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors. FDA-2025-P-6094 Interim Response Other Letter(s) 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T18:33:39Z   0 0 09000064b92cf88c
FDA-2026-H-4991-0001 FDA DAB Civil Money Penalty; Vista Deli & Grill Inc. d/b/a Vista Deli & Grill Inc. / 111 Super Stop Deli FDA-2026-H-4991 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:53:15Z   0 0 09000064b92d5568
FDA-2026-H-4328-0001 FDA DAB Civil Money Penalty; UN Rosen Enterprise Inc. d/b/a Chevron / Food Mart FDA-2026-H-4328 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:56:11Z   0 0 09000064b92d40fd
FDA-2026-H-4988-0001 FDA DAB Civil Money Penalty; Park Ridge Smokes LLC d/b/a Park Smoke FDA-2026-H-4988 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:51:47Z   0 0 09000064b92d40e3
FDA-2026-H-4967-0001 FDA DAB Civil Money Penalty; Willow Associate Inc. d/b/a Fuel 4 FDA-2026-H-4967 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:37:33Z   0 0 09000064b92d2f43
FDA-2026-V-3076-0003 FDA Laser Light Show FDA-2026-V-3076 Variance Approval Letter to Ole Red Nashville Other Approval for Variance (VRA) 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-13T00:06:16Z   0 0 09000064b92d2807
FDA-2026-H-4728-0001 FDA DAB Civil Money Penalty; Bolla Operating Corp. d/b/a Bolla / Bolla Market FDA-2026-H-4728 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T19:35:36Z   0 0 09000064b92c8eff
FDA-2026-H-4961-0001 FDA DAB Civil Money Penalty; Smoke Scene Plainview LLC d/b/a Smoke Scene FDA-2026-H-4961 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-13T00:23:29Z   0 0 09000064b92d18ff
FDA-2026-V-3076-0002 FDA Laser Light Show FDA-2026-V-3076 Acknowledgment Letter from FDA DMB to Ole Red Nashville Other Acknowledgement Letter/Receipt 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-13T00:06:11Z   0 0 09000064b92363f8
FDA-2026-H-4824-0001 FDA DAB Civil Money Penalty; Royal Smoke and Vape LLC d/b/a Royal Smoke and Vape FDA-2026-H-4824 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T22:57:13Z   0 0 09000064b92d0165
FDA-2026-H-4793-0001 FDA DAB Civil Money Penalty; A & R News & Candy Corp. d/b/a Smoke Shop & Convenience Store FDA-2026-H-4793 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T19:29:33Z   0 0 09000064b92c91b6
FDA-2026-H-4820-0001 FDA DAB Civil Money Penalty; Allen Park One Stop, Inc. d/b/a SNK Fuels / Allen Park One Stop Liquor FDA-2026-H-4820 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T21:13:18Z   0 0 09000064b92d016d
FDA-2026-H-4821-0001 FDA DAB Civil Money Penalty; Graceville Stop Inc. d/b/a Freeway FDA-2026-H-4821 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T22:39:33Z   0 0 09000064b92d015a
FDA-2026-P-4535-0006 FDA Requests that FDA declare that Metformin HCl for Extended-Release Oral Suspension, 500 mg and 750 mg (unit-dose sachets), are suitable for submission as an ANDA FDA-2026-P-4535 Completeness Assessment Correspondence to Hyman, Phelps & McNamara, P.C. Other Assessment Document or Analysis 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T20:51:56Z   0 0 09000064b92d0cec
FDA-2026-H-4968-0001 FDA DAB Civil Money Penalty; Mr RJ Convenience & Smoke Shop Inc. d/b/a Mr. RJ Convenience FDA-2026-H-4968 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-13T00:32:19Z   0 0 09000064b92d2f3b
FDA-2026-H-4969-0001 FDA DAB Civil Money Penalty; To Go Mini Market Deli and Grill Corp. d/b/a To Go Mini Market Deli & Grill FDA-2026-H-4969 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-13T00:34:14Z   0 0 09000064b92d2f3e
FDA-2026-H-4825-0001 FDA DAB Civil Money Penalty; City Mart 21 Corporation, d/b/a City Mart 21 Convenience Shop FDA-2026-H-4825 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T23:01:39Z   0 0 09000064b92d0121
FDA-2026-H-4832-0001 FDA DAB Civil Money Penalty; Sandiha Liquor, LLC d/b/a Langley's Liquor FDA-2026-H-4832 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T23:59:18Z   0 0 09000064b92d0909
FDA-2026-H-4951-0001 FDA DAB Civil Money Penalty; N & D of Jacksonville, Inc. d/b/a Sunoco FDA-2026-H-4951 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T16:04:05Z   0 0 09000064b92d01f9
FDA-2026-H-4989-0001 FDA DAB Civil Money Penalty; Gochmen LLC d/b/a Puff City FDA-2026-H-4989 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:45:06Z   0 0 09000064b92d4748
FDA-2026-H-4963-0001 FDA DAB Civil Money Penalty; Aspen, Inc. d/b/a 7-Eleven FDA-2026-H-4963 Complaint Other Complaint 2026-05-12T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T21:50:02Z   0 0 09000064b92d3f9c
FDA-2026-P-5194-0001 FDA Requests that the FDA declare that the drug product Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-5194 Suitability Petition from Hyman, Phelps & McNamara, P.C. Other Petition(s) 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-11T21:16:58Z   1 0 09000064b92ca97f
FDA-2026-P-5188-0001 FDA Request that the FDA amend its food labeling regulations under 21 C.F.R. Part 101 to establish a Hybrid Digital Labeling Standard that: Requires major food allergies to be declared in large, conspicuous print directly on physical product packaging FDA-2026-P-5188 Citizen Petition from Kirke’s Homemade Ice Cream Other Citizen Petition 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-11T21:47:10Z   1 0 09000064b92cf32d
FDA-2026-V-3796-0002 FDA Laser Light Show FDA-2026-V-3796 Acknowledgment Letter from FDA CDRH to Bernhard Blazier Other Acknowledgement Letter/Receipt 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-11T20:05:28Z   0 0 09000064b9258455
FDA-2026-V-3796-0001 FDA Laser Light Show FDA-2026-V-3796 Variance Application from Bernhard Blazier Other Application for Variance (VAR) 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-11T20:05:22Z   0 0 09000064b9258451
FDA-2026-H-4953-0001 FDA DAB Civil Money Penalty; Vape Valley LLC d/b/a Smoke Valley FDA-2026-H-4953 Complaint Other Complaint 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-11T20:49:00Z   0 0 09000064b92d0153
FDA-2013-D-1319-0016 FDA Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability FDA-2013-D-1319 Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry Other Guidance 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-11T17:31:41Z   1 0 09000064b92cf3cb

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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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