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

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  • 2018 106,690
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  • 2024 78,228
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  • 2021 71,789
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  • 2025 61,376
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  • …
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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
USDA_FRDOC_0001-3307 USDA Recently Posted USDA Rules and Notices. USDA_FRDOC_0001 Modified Organisms Subject to the Plant Protection Act Proposed Rule   2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z 2026-06-16T03:59:59Z 2026-05-16T09:00:19Z 2026-09833 1 0 09000064b92da9bf
FWS-HQ-IA-2026-0298-0014 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Minnesota Zoo, Apple Valley, MN; Permit No. PER26188753 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:03Z   0 0 09000064b92d95a4
FWS-R5-FAC-2026-1684-0006 FWS Agency Information Collection Activities; Submission to the Office of Management and Budget; Horseshoe Crab and Cooperative Fish Tagging Programs FWS-R5-FAC-2026-1684 FWS Form 3-2494 Snakehead Recapture Data Rev 07-2017 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:48:15Z   0 0 09000064b92d9027
FWS-HQ-IA-2026-0298-0001 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Foreign Endangered Species; Receipt of Permit Applications Notice   2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z 2026-06-16T03:59:59Z 2026-05-15T16:53:53Z 2026-09807 1 0 09000064b92db145
FWS-HQ-IA-2026-0298-0015 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Turtle Survival Alliance, North Charleston, SC; Permit No. PER27332264 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:03Z   0 0 09000064b92d95a5
FWS-HQ-IA-2026-0298-0016 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: John Ball Zoo, Grand Rapids, MN; Permit No. PER27754098 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:04Z   0 0 09000064b92d95a6
FWS-R5-FAC-2026-1684-0002 FWS Agency Information Collection Activities; Submission to the Office of Management and Budget; Horseshoe Crab and Cooperative Fish Tagging Programs FWS-R5-FAC-2026-1684 FWS Form 3-2495 Striped Bass Recapture Data Rev 07-2017 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:48:09Z   0 0 09000064b92d9023
FWS-R5-FAC-2026-1684-0003 FWS Agency Information Collection Activities; Submission to the Office of Management and Budget; Horseshoe Crab and Cooperative Fish Tagging Programs FWS-R5-FAC-2026-1684 FWS Form 3-2496 Sturgeon Recapture Data Rev 07-2017 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:48:11Z   0 0 09000064b92d9024
FWS-R5-FAC-2026-1684-0007 FWS Agency Information Collection Activities; Submission to the Office of Management and Budget; Horseshoe Crab and Cooperative Fish Tagging Programs FWS-R5-FAC-2026-1684 FWS Form 3-2311 Horseshoe Crab Tagging Report Rev 07-2017 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:48:16Z   0 0 09000064b92d9035
FWS-R5-FAC-2026-1684-0005 FWS Agency Information Collection Activities; Submission to the Office of Management and Budget; Horseshoe Crab and Cooperative Fish Tagging Programs FWS-R5-FAC-2026-1684 FWS Form 3-2310 Horseshoe Crab Recapture Report Rev 07-2017 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:48:14Z   0 0 09000064b92d9026
FWS-HQ-IA-2026-0298-0012 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Turtle Conservancy, Ojai, CA; Permit No. PER27229456 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:03Z   0 0 09000064b92d95a2
FWS-HQ-IA-2026-0298-0008 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Vicki Lynn Lee, Ft. Collins, CO; Permit No. PER26618348 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:02Z   0 0 09000064b92d9580
FWS-HQ-IA-2026-0298-0006 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Sam Noble Oklahoma Museum of Natural History, Norman, OK; Permit No. PER25540581 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:01Z   0 0 09000064b92d957e
FWS-HQ-IA-2026-0298-0004 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Charlie Dally, Rathdrum, ID; Permit No. PER27974123 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:00Z   0 0 09000064b92d957c
FWS-R5-FAC-2026-1684-0004 FWS Agency Information Collection Activities; Submission to the Office of Management and Budget; Horseshoe Crab and Cooperative Fish Tagging Programs FWS-R5-FAC-2026-1684 FWS Form 3-2493 American Shad Recapture Data draft Rev 07-2017 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:48:12Z   0 0 09000064b92d9025
FWS-HQ-IA-2026-0298-0013 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Henry Vilas Zoo, Madison, WI; Permit No. PER27541931 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:03Z   0 0 09000064b92d95a3
FWS-HQ-IA-2026-0298-0007 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Brandon Isenhour, Hickory, NC; Permit No. PER26245660 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:01Z   0 0 09000064b92d957f
FWS-HQ-IA-2026-0298-0010 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Collin Griffiths, Missoula, MT; Permit No. PER26935891 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:02Z   0 0 09000064b92d95a0
FWS-HQ-IA-2026-0298-0002 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Stephen Isenhour, Hickory, NC; Permit No. PER26245661 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:00Z   0 0 09000064b92d957a
FWS-R5-FAC-2026-1684-0001 FWS Agency Information Collection Activities; Submission to the Office of Management and Budget; Horseshoe Crab and Cooperative Fish Tagging Programs FWS-R5-FAC-2026-1684 Agency Information Collection Activities; Submission to the Office of Management and Budget; Horseshoe Crab and Cooperative Fish Tagging Programs Notice   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:47:48Z 2026-09751 0 0 09000064b92da381
FWS-HQ-IA-2026-0298-0005 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: Craig Keller, Tunkhannock, PA; Permit No. PER25338256 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:01Z   0 0 09000064b92d957d
FWS-HQ-IA-2026-1915-0001 FWS Agency Information Collection Activities; Submission to the Office of Management and Budget; Federal Fish and Wildlife Permit Applications and Reports—Management Authority FWS-HQ-IA-2026-1915 Agency Information Collection Activities; Submission to the Office of Management and Budget; Federal Fish and Wildlife Permit Applications and Reports-Management Authority Notice   2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T16:50:38Z 2026-09805 0 0 09000064b92da383
FWS-HQ-IA-2026-0298-0011 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: St. Augustine Alligator Farm, St. Augustine, FL; Permit No. PER21244412 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:02Z   0 0 09000064b92d95a1
FWS-HQ-IA-2026-0298-0009 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: St. Augustine Alligator Farm, St. Augustine, FL; Permit No. PER21244411 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:02Z   0 0 09000064b92d9581
FWS-HQ-IA-2026-0298-0003 FWS Receipt of Application Minnesota Zoo, PER26188753 FWS-HQ-IA-2026-0298 Applicant: George Sammut, Morgan Hill, CA; Permit No. PER26821388 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T16:54:00Z   0 0 09000064b92d957b
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
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-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-2025-N-0421-0002 FDA NOOH Proposal to Debar Oscar Bobo FDA-2025-N-0421 Oscar Bobo: Final Debarment Order Notice Statutory Debarment 2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T17:48:54Z 2026-09767 1 0 09000064b92da9bd
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-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-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-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-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-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-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-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-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-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-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
EPA-R01-SFUND-2026-0826-0005 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 FINAL PRE-REMEDIAL DESIGN INVESTIGATION REPORT Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:31Z   0 0 09000064b92d8738
EPA-R01-SFUND-2026-0826-0009 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 ANNUAL REPORT FOR 2008 (03172010 TRANSMITTAL LETTER ATTACHED) Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:31Z   0 0 09000064b92d873c
EPA-R01-SFUND-2026-0826-0013 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 REDACTED FINAL 2024 ANNUAL REPORT Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:32Z   0 0 09000064b92d874a
EPA-R01-SFUND-2026-0826-0015 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 REDACTED FINAL 2010 ANNUAL REPORT - OPERABLE UNIT (OU) 1 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:32Z   0 0 09000064b92d874c
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
EPA-R01-SFUND-2026-0826-0002 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 FINAL PERMEABLE REACTIVE BARRIER CONCEPTUAL DESIGN REPORT Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:30Z   0 0 09000064b92d8735
EPA-R01-SFUND-2026-0826-0012 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 REDACTED REMEDIAL INVESTIGATION (RI) REPORT ADDENDUM FOR TECHNICAL IMPRACTICABILITY (TI) ZONE BEDROCK Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:32Z   0 0 09000064b92d8749
EPA-R01-SFUND-2026-0826-0004 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 FINAL FOCUSED FEASIBILITY STUDY (FFS) REPORT Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:30Z   0 0 09000064b92d8737
EPA-R01-SFUND-2026-0826-0011 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 THIRD FIVE-YEAR REVIEW REPORT Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:32Z   0 0 09000064b92d8748
EPA-R01-SFUND-2026-0826-0007 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 SAVAGE MUNICIPAL WATER SUPPLY OPERABLE UNIT (OU) 1 DRAFT THIRD EXPLANATION OF SIGNIFICANT DIFFERENCES (ESD) FOR P Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:31Z   0 0 09000064b92d873a
EPA-R01-SFUND-2026-0826-0008 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 DRAFT FINAL FOCUSED FEASIBILITY STUDY (FS) REPORT Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:31Z   0 0 09000064b92d873b
EPA-R01-SFUND-2026-0826-0010 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 ROOT CAUSE ANALYSIS AND MONITORIING NETWORK EVALUATION INSTALLATION OF DEEP BEDROCK MONITORING WELLS Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:32Z   0 0 09000064b92d873d
EPA-R01-SFUND-2026-0826-0003 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 FINAL TECHNICAL MEMORANDUM PROPOSED ALTERNATIVE REMEDY Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:30Z   0 0 09000064b92d8736
EPA-HQ-OPPT-2018-0465-0072 EPA trans-1,2- Dichloroethylene; TSCA Review EPA-HQ-OPPT-2018-0465 September 10, 2024 Amended Final Report TDCE Abiotic Feasibility Study submitted by BCCM Supporting & Related Material Report 2026-05-15T04:00:00Z 2026 5     2026-05-16T01:40:23Z   0 0 09000064b92d9dcf
EPA_FRDOC_0001-32815 EPA Recently Posted EPA Rules and Notices from FR Feed. EPA_FRDOC_0001 Environmental Impact Statements; Availability, etc. Notice   2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z   2026-05-15T16:06:05Z 2026-09788 0 0 09000064b92da963
EPA-R01-SFUND-2026-0826-0006 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 FINAL 2025 ANNUAL REPORT Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:31Z   0 0 09000064b92d8739
EPA-R01-SFUND-2026-0826-0014 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 REDACTED 2020 ANNUAL REPORT - OPERABLE UNIT (OU) 1 Supporting & Related Material   2026-05-15T04:00:00Z 2026 5     2026-05-15T17:14:32Z   0 0 09000064b92d874b
EPA-R01-SFUND-2026-0826-0001 EPA Savage Municipal OU1 Draft Explanation of Significant Differences (ESD) EPA-R01-SFUND-2026-0826 DRAFT THIRD EXPLANATION OF SIGNIFICANT DIFFERENCES (ESD) - OPERABLE UNIT (OU) 1 FOR PUBLIC COMMENT Notice   2026-05-15T04:00:00Z 2026 5 2026-05-15T04:00:00Z 2026-05-31T03:59:59Z 2026-05-15T17:14:22Z   1 0 09000064b92d8fff
USDA_FRDOC_0001-3306 USDA Recently Posted USDA Rules and Notices. USDA_FRDOC_0001 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice   2026-05-14T04:00:00Z 2026 5 2026-05-14T04:00:00Z   2026-05-14T16:26:14Z 2026-09645 0 0 09000064b92d8201
FDA-2026-P-5578-0003 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 Attachment 1 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:06Z   0 0 09000064b92d70f0
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-P-5454-0016 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 Reference 14 - Andreasen, S. M., et al. (2025). Maternal urinary paracetamol concentrations and self-reported paracetamol use in mid-gestation: association to reduced anogenital distance in offspring from infancy to 9 years. Reproductive Toxicology, 135, 108946. URL: https://pubmed.ncbi.nlm.nih.gov/40374128/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:22Z   0 0 09000064b92d5033
FDA-2026-P-5454-0012 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 Reference 10 - Liu, F., et al. (2024). Maternal administration of acetaminophen affects meiosis through its metabolite NAPQI targeting SIRT7 in fetal oocytes. Antioxidants & Redox Signaling, 41, 93-109. URL: https://doi.org/10.1089/ars.2023.0270 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:50Z   0 0 09000064b92d502f
FDA-2026-P-5454-0008 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 References 6 - Lecante, L. L., et al. (2022). Acetaminophen interferes with the first trimester human fetal ovary development in an ex vivo model. Journal of Clinical Endocrinology & Metabolism, 107(6), 1647-1661. URL: https://pubmed.ncbi.nlm.nih.gov/35147701/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:35Z   0 0 09000064b92d5010
FDA-2026-P-5454-0019 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 Reference 17 - Zafeiri, A., et al. (2022). Maternal over-the-counter analgesics use during pregnancy and adverse perinatal outcomes: cohort study of 151,141 singleton pregnancies. BMJ Open, 12(5), e048092. URL: https://doi.org/10.1136/bmjopen-2020-048092 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:32Z   0 0 09000064b92d5036
FDA-2026-P-5454-0010 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 References 8 - Nielsen, B. S., et al. (2025). Paracetamol disrupts early embryogenesis by cell cycle inhibition. Human Reproduction, 40(10), 1860-1876. URL: https://doi.org/10.1093/humrep/deaf116 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:42Z   0 0 09000064b92d5012
FDA-2026-P-5454-0022 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 Reference 20 - Kougias, D. G., et al. (2025). A quantitative weight-of-evidence review of preclinical studies examining the potential developmental and reproductive toxicity of acetaminophen. Critical Reviews in Toxicology, 55(2), 179-226. URL: https://doi.org/10.1080/10408444.2024.2446471 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:58Z   0 0 09000064b92d5039
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-5611-0002 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-5454-0020 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 Reference 18 - Rehfeld, A., et al. (2022). Human sperm cells can form paracetamol metabolite AM404 that directly interferes with sperm calcium signalling and function through a CatSper-dependent mechanism. Human Reproduction, 37(5), 922-935. URL: https://doi.org/10.1093/humrep/deac042 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:48Z   0 0 09000064b92d5037
FDA-2026-P-5454-0023 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 Reference 21 - OFIRMEV (acetaminophen) Injection Package Insert. (2018). Mallinckrodt Hospital Products Inc. Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:44:02Z   0 0 09000064b92d503a
FDA-2026-P-5454-0018 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 Reference 16 - Xu, M., et al. (2024). Association of acetaminophen use with perinatal outcomes among pregnant women: a retrospective cohort study with propensity score matching. BMC Pregnancy and Childbirth, 24, 268. URL: https://doi.org/10.1186/s12884-024-06480-5 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:29Z   0 0 09000064b92d5035
FDA-2026-P-5454-0005 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 Reference 3 - Lind, D. V., et al. (2017). Maternal use of mild analgesics during pregnancy associated with reduced anogenital distance in sons. Human Reproduction, 32(1), 149-155. URL: https://pubmed.ncbi.nlm.nih.gov/27852690/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:12Z   0 0 09000064b92d500d
FDA-2026-P-5611-0005 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 attachment-3-test-product-draft-labeling Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:38:07Z   0 0 09000064b92d8751
FDA-2026-P-5611-0004 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 attachment-2-rld-labeling Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:38:03Z   0 0 09000064b92d8750
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-5454-0007 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 References 5 - Górawski, F., et al. (2026). Sex-dependent effects of early-life paracetamol exposure on behavior and monoamines in the rat central nervous system. Chemico-Biological Interactions, 427, 111937. URL: https://doi.org/10.1016/j.cbi.2026.111937 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:31Z   0 0 09000064b92d500f
FDA-2026-P-5454-0006 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 References 4 - Guzmán-Montemayor, A. J., et al. (2026). Prenatal, but not neonatal, paracetamol exposure disrupts neuroendocrine regulation of stress and emotional behavior in adult male rats. Physiology & Behavior, 308, 115261. URL: https://doi.org/10.1016/j.physbeh.2026.115261 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:16Z   0 0 09000064b92d500e
FDA-2026-P-5454-0003 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 References 1 - Ernstsen, C., et al. (2026). Prenatal paracetamol modulates sexually dimorphic behaviour and steroidogenesis in adult male and female mice. Reproduction, 171(2). URL: https://doi.org/10.1093/reprod/xaag007 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:41:54Z   0 0 09000064b92d500b
FDA-2026-P-5454-0021 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 Reference 19 - Eletri, L., et al. (2026). Association between in utero exposure to acetaminophen and external genital tract malformations in boys and girls: a systematic review and meta-analysis. Human Reproduction, 41(3), 427-442. URL: https://doi.org/10.1093/humrep/deaf253 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:53Z   0 0 09000064b92d5038
FDA-2026-P-5611-0003 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 attachment-1-orange-book-page Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:37:59Z   0 0 09000064b92d874f
FDA-2026-P-5454-0017 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 Reference 15 - Lee, C. Y., et al. (2023). Effects of acetaminophen on reproductive activities in male golden hamsters. Development & Reproduction, 27(1), 25-37. URL: https://doi.org/10.12717/DR.2023.27.1.25 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:26Z   0 0 09000064b92d5034
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-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-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-P-5578-0005 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 Attachment 3 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:14Z   0 0 09000064b92d70f2
FDA-2026-P-5578-0004 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 Attachment 2 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T23:18:09Z   0 0 09000064b92d70f1
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-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-P-5454-0013 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 Reference 11 - Wu, T., et al. (2024). Prenatal acetaminophen exposure and the developing ovary: time, dose, and course consequences for fetal mice. Food and Chemical Toxicology, 189, 114679. URL: https://doi.org/10.1016/j.fct.2024.114679 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:53Z   0 0 09000064b92d5030
FDA-2026-P-5454-0004 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 References 2 - Fisher, B. G., et al. (2016). Prenatal paracetamol exposure is associated with shorter anogenital distance in male infants. Human Reproduction, 31(11), 2642-2650. URL: https://pubmed.ncbi.nlm.nih.gov/27609981/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:41:58Z   0 0 09000064b92d500c
FDA-2026-P-5454-0011 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 Reference 9 - Carlsen, L. N., et al. (2024). Overuse of analgesics can affect the fertility biomarker Anti-Müllerian Hormone in females. A translational study. Cephalalgia, 44(11). URL: https://doi.org/10.1177/03331024241290530 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:46Z   0 0 09000064b92d5013
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-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-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-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-5454-0015 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 Reference 13 - Laursen, T. Q., et al. (2024). Maternal intake of paracetamol during pregnancy and biomarkers of male fecundity in young adult sons. Reproductive Toxicology, 127, 108626. URL: https://doi.org/10.1016/j.reprotox.2024.108626 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:43:00Z   0 0 09000064b92d5032
FDA-2026-P-5454-0014 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 Reference 12 - de Araújo-Ramos, A. T., et al. (2026). Differential disruption of gonadal development by DEHP and paracetamol in male and female Wistar rats. Reproductive Toxicology, 141, 109183. URL: https://doi.org/10.1016/j.reprotox.2026.109183 Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:56Z   0 0 09000064b92d5031
FDA-2026-P-5454-0009 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 References 7 - Smarr, M. M., et al. (2016). Urinary paracetamol and time-to-pregnancy. Human Reproduction, 31(9), 2119-2127. URL: https://pubmed.ncbi.nlm.nih.gov/27412248/ Supporting & Related Material Background Material 2026-05-14T04:00:00Z 2026 5     2026-05-14T17:42:39Z   0 0 09000064b92d5011

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