{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-2021-N-0862\" sorted by posted_date descending", "rows": [["FDA-2021-N-0862-0237", "FDA", "FDA-2021-N-0862", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2025-09-25T04:00:00Z", 2025, 9, null, null, "2025-09-25T18:07:52Z", "2025-18621", 0, 0, "09000064b8fdca45"], ["FDA-2021-N-0862-0236", "FDA", "FDA-2021-N-0862", "Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Rule", "Final Rule", "2025-03-25T04:00:00Z", 2025, 3, null, null, "2025-03-25T14:47:53Z", "2025-04978", 0, 0, "0900006486a2a7ed"], ["FDA-2021-N-0862-0235", "FDA", "FDA-2021-N-0862", "Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Rule", "Final Rule", "2025-01-27T05:00:00Z", 2025, 1, null, null, "2025-01-27T14:30:42Z", "2025-01840", 0, 0, "0900006486900454"], ["FDA-2021-N-0862-0228", "FDA", "FDA-2021-N-0862", "Memorandum re Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Final Rule)", "Other", "Memo", "2025-01-23T05:00:00Z", 2025, 1, "2025-01-23T05:00:00Z", null, "2025-01-23T14:51:11Z", null, 0, 0, "09000064868c21c5"], ["FDA-2021-N-0862-0229", "FDA", "FDA-2021-N-0862", "TAB A-2023-142-ACNU-Final Rule-Original", "Supporting & Related Material", "Background Material", "2025-01-15T05:00:00Z", 2025, 1, null, null, "2025-01-15T18:59:12Z", null, 0, 0, "09000064868c2151"], ["FDA-2021-N-0862-0234", "FDA", "FDA-2021-N-0862", "TAB C-2023-142-ACNU-FRIA-Final", "Supporting & Related Material", "Background Material", "2025-01-15T05:00:00Z", 2025, 1, null, null, "2025-01-15T19:11:26Z", null, 0, 0, "09000064868c2155"], ["FDA-2021-N-0862-0232", "FDA", "FDA-2021-N-0862", "TAB B-2023-142-ACNU-FRIA-TRACK CHANGE FROM ORIGINAL TO FINAL", "Supporting & Related Material", "Background Material", "2025-01-15T05:00:00Z", 2025, 1, null, null, "2025-01-15T19:10:30Z", null, 0, 0, "09000064868c21cb"], ["FDA-2021-N-0862-0231", "FDA", "FDA-2021-N-0862", "TAB B-2023-142-ACNU-Final Rule-TRACK CHANGE FROM ORIGINAL TO FINAL", "Supporting & Related Material", "Background Material", "2025-01-15T05:00:00Z", 2025, 1, null, null, "2025-01-15T19:04:00Z", null, 0, 0, "09000064868c2153"], ["FDA-2021-N-0862-0230", "FDA", "FDA-2021-N-0862", "TAB A-2023-142-ACNU-FRIA-Original", "Supporting & Related Material", "Background Material", "2025-01-15T05:00:00Z", 2025, 1, null, null, "2025-01-15T19:02:02Z", null, 0, 0, "09000064868c2152"], ["FDA-2021-N-0862-0233", "FDA", "FDA-2021-N-0862", "TAB C-2023-142-ACNU-Final Rule-Final", "Supporting & Related Material", "Background Material", "2025-01-15T05:00:00Z", 2025, 1, null, null, "2025-01-15T19:08:03Z", null, 0, 0, "09000064868c2154"], ["FDA-2021-N-0862-0219", "FDA", "FDA-2021-N-0862", "Reference 10 - FDA Combination Products web page", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2025-02-23T18:35:38Z", null, 0, 0, "090000648688c405"], ["FDA-2021-N-0862-0226", "FDA", "FDA-2021-N-0862", "Reference 18 - 73 FR 63491_Docket FDA-2008-N-0549_10-24-2008", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T20:00:49Z", null, 0, 0, "090000648688c497"], ["FDA-2021-N-0862-0227", "FDA", "FDA-2021-N-0862", "Reference 19 - 83 FR 40973_Docket FDA-2017-N-6730_08-17-2018", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T20:00:54Z", null, 0, 0, "090000648688c4a8"], ["FDA-2021-N-0862-0215", "FDA", "FDA-2021-N-0862", "Reference 7a - NPSA_Guide to Graphic Design of Medication Packaging 2nd Ed_2007", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T19:59:19Z", null, 0, 0, "090000648688c3cb"], ["FDA-2021-N-0862-0218", "FDA", "FDA-2021-N-0862", "Reference 9 - 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USP_Recommendations to the Safe Medication Use Expert Committee by the Health Literacy and Prescription Container Labeling Advisory Panel_2010", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T19:59:32Z", null, 0, 0, "090000648688c402"], ["FDA-2021-N-0862-0208", "FDA", "FDA-2021-N-0862", "Reference List - Nonprescription Drug Product With an Additional Condition for Nonprescription Use - Final Rule", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T19:58:28Z", null, 0, 0, "090000648688c868"], ["FDA-2021-N-0862-0207", "FDA", "FDA-2021-N-0862", "Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Rule", "Final Rule", "2024-12-26T05:00:00Z", 2024, 12, "2024-12-26T05:00:00Z", null, "2024-12-26T15:41:32Z", "2024-30261", 0, 0, "090000648688bfbc"], ["FDA-2021-N-0862-0216", "FDA", "FDA-2021-N-0862", "Reference 7b - NPSA_Guide to Labelling and Packaging of Injectable Medicines_1st Ed_2007", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T19:59:23Z", null, 0, 0, "090000648688c3cc"], ["FDA-2021-N-0862-0209", "FDA", "FDA-2021-N-0862", "Reference 1 - 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FDA Guidance for Industry_Application of Human Factors Engineering Principles for Combination Products QA_Sept2023", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T19:58:45Z", null, 0, 0, "090000648688c8b1"], ["FDA-2021-N-0862-0222", "FDA", "FDA-2021-N-0862", "Reference 14 - 87 FR 38313_Docket FDA-2021-N-0862_06-28-2022", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T20:00:08Z", null, 0, 0, "090000648688c986"], ["FDA-2021-N-0862-0224", "FDA", "FDA-2021-N-0862", "Reference 16 - 70 FR 52050_Docket 2005N-0345_09-01-2005", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T20:00:32Z", null, 0, 0, "090000648688c491"], ["FDA-2021-N-0862-0210", "FDA", "FDA-2021-N-0862", "Reference 2 - FDA Guidance for Industry_Self-Selection-Studies-for-Nonprescription-Drug-Products_April2013", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2024-12-26T19:58:41Z", null, 0, 0, "090000648688c8b0"], ["FDA-2021-N-0862-0214", "FDA", "FDA-2021-N-0862", "Reference 6 - FDA Consumer Complaint Coordinators web page", "Supporting & Related Material", "Background Material", "2024-12-26T05:00:00Z", 2024, 12, null, null, "2025-02-23T18:35:38Z", null, 0, 0, "090000648688c3c8"], ["FDA-2021-N-0862-0206", "FDA", "FDA-2021-N-0862", "TAB C-NSURE-ProposedRule-Final RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022", "Supporting & Related Material", "Background Material", "2023-01-20T05:00:00Z", 2023, 1, null, null, "2023-01-20T20:02:50Z", null, 0, 0, "09000064855fd2fe"], ["FDA-2021-N-0862-0203", "FDA", "FDA-2021-N-0862", "TAB B-2017-723-NSURERULE-TRACK CHANGE FROM ORIGINAL TO FINAL RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022", "Supporting & Related Material", "Background Material", "2023-01-20T05:00:00Z", 2023, 1, null, null, "2023-01-20T20:02:31Z", null, 0, 0, "09000064855fd148"], ["FDA-2021-N-0862-0201", "FDA", "FDA-2021-N-0862", "TAB A-2017-723-NSURE-PRIA RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022", "Supporting & Related Material", "Background Material", "2023-01-20T05:00:00Z", 2023, 1, null, null, "2023-01-20T20:02:18Z", null, 0, 0, "09000064855fd2fb"], ["FDA-2021-N-0862-0204", "FDA", "FDA-2021-N-0862", "TAB B-NSURE-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022", "Supporting & Related Material", "Background Material", "2023-01-20T05:00:00Z", 2023, 1, null, null, "2023-01-20T20:02:37Z", null, 0, 0, "09000064855fd149"], ["FDA-2021-N-0862-0205", "FDA", "FDA-2021-N-0862", "TAB C-NSURE-PRIA-Final RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022", "Supporting & Related Material", "Background Material", "2023-01-20T05:00:00Z", 2023, 1, null, null, "2023-01-20T20:02:44Z", null, 0, 0, "09000064855fd2fd"], ["FDA-2021-N-0862-0200", "FDA", "FDA-2021-N-0862", "Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022", "Other", "Memorandum", "2023-01-20T05:00:00Z", 2023, 1, "2023-01-20T05:00:00Z", null, "2023-01-20T20:01:00Z", null, 0, 0, "09000064855fd0c5"], ["FDA-2021-N-0862-0202", "FDA", "FDA-2021-N-0862", "TAB A-2017-723-NSURERULE RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022", "Supporting & Related Material", "Background Material", "2023-01-20T05:00:00Z", 2023, 1, null, null, "2023-01-20T20:02:25Z", null, 0, 0, "09000064855fd147"], ["FDA-2021-N-0862-0177", "FDA", "FDA-2021-N-0862", "FDA Listening Session with APhA Stakeholders--High-Level Notes", "Other", "Meeting Exhibits", "2022-11-22T05:00:00Z", 2022, 11, "2022-11-22T05:00:00Z", "2022-11-26T04:59:59Z", "2022-11-22T20:15:53Z", null, 0, 0, "09000064854fc3fd"], ["FDA-2021-N-0862-0140", "FDA", "FDA-2021-N-0862", "Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period", "Proposed Rule", "Extension of Comment Period", "2022-10-24T04:00:00Z", 2022, 10, "2022-10-24T04:00:00Z", null, "2022-11-22T18:58:05Z", "2022-23033", 0, 0, "090000648544cb97"], ["FDA-2021-N-0862-0043", "FDA", "FDA-2021-N-0862", "Request for Extension from Consumer Healthcare Products Association", "Other", "Request for Extension", "2022-10-06T04:00:00Z", 2022, 10, "2022-10-06T04:00:00Z", null, "2022-11-22T18:57:53Z", null, 0, 0, "09000064853bd957"], ["FDA-2021-N-0862-0039", "FDA", "FDA-2021-N-0862", "Request for Extension from American Pharmacists Association", "Other", "Request for Extension", "2022-09-26T04:00:00Z", 2022, 9, "2022-09-26T04:00:00Z", null, "2022-11-22T18:57:40Z", null, 0, 0, "090000648536e90d"], ["FDA-2021-N-0862-0001", "FDA", "FDA-2021-N-0862", "Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Proposed Rule", "Notice of Proposed Rulemaking (NPRM)", "2022-06-28T04:00:00Z", 2022, 6, "2022-06-28T04:00:00Z", "2022-11-26T04:59:59Z", "2024-08-23T01:00:37Z", "2022-13309", 0, 0, "09000064851a6c55"], ["FDA-2021-N-0862-0008", "FDA", "FDA-2021-N-0862", "Reference 6- Engelberg Expert Workshop--Exploring Implications of the Nonprescription Drug Safe Use Regulatory Expansion Initiative on Reimbursement and Access_2013  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:48:58Z", null, 0, 0, "09000064851a6e08"], ["FDA-2021-N-0862-0011", "FDA", "FDA-2021-N-0862", "Reference 9 - 70 FR 52050  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:46:47Z", null, 0, 0, "09000064851a6e05"], ["FDA-2021-N-0862-0004", "FDA", "FDA-2021-N-0862", "Reference 2-  Journal of Research in Pharmacy Practice re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:32:38Z", null, 0, 0, "09000064851a6e07"], ["FDA-2021-N-0862-0010", "FDA", "FDA-2021-N-0862", "Reference 8- 83 FR 13394  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:45:35Z", null, 0, 0, "09000064851a6e03"], ["FDA-2021-N-0862-0009", "FDA", "FDA-2021-N-0862", "Reference 7- FDA Preliminary Regulatory Impact Analysis_Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:43:52Z", null, 0, 0, "09000064851a6e04"], ["FDA-2021-N-0862-0005", "FDA", "FDA-2021-N-0862", "Reference 3- Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:34:10Z", null, 0, 0, "09000064851a56d6"], ["FDA-2021-N-0862-0007", "FDA", "FDA-2021-N-0862", "Reference 5- Engelberg Expert Workshop--Innovative Technologies and Nonprescription Medications--Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:39:56Z", null, 0, 0, "09000064851a6e0a"], ["FDA-2021-N-0862-0003", "FDA", "FDA-2021-N-0862", "Reference 1- Guidance for Industry Self-Selection Studies for Nonprescription Drug\nProducts  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:30:20Z", null, 0, 0, "09000064851a56d8"], ["FDA-2021-N-0862-0013", "FDA", "FDA-2021-N-0862", "Reference 11 - 83 FR 33938  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:49:29Z", null, 0, 0, "09000064851a6e02"], ["FDA-2021-N-0862-0002", "FDA", "FDA-2021-N-0862", "Reference List re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:28:40Z", null, 0, 0, "09000064851a56d7"], ["FDA-2021-N-0862-0006", "FDA", "FDA-2021-N-0862", "Reference 4- Engleberg Expert Workshop--Nonprescription Medications With Conditions of Safe Use as a Novel Solution for Undertreated Diseases or conditions  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use", "Supporting & Related Material", "Background Material", "2022-06-28T04:00:00Z", 2022, 6, null, null, "2022-06-28T13:38:18Z", null, 0, 0, "09000064851a6e06"], ["FDA-2021-N-0862-0012", "FDA", "FDA-2021-N-0862", "Reference 10 - 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