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withdrawn,object_id DOT-OST-2002-12555-0308,DOT,DOT-OST-2002-12555,"American Airlines,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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