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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

55 rows where docket_id = "FDA-2021-N-0862" sorted by posted_date descending

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document_type 5

  • Supporting & Related Material 44
  • Other 5
  • Rule 3
  • Proposed Rule 2
  • Notice 1

posted_year 4

  • 2024 21
  • 2022 17
  • 2025 10
  • 2023 7

agency_id 1

  • FDA 55
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2021-N-0862-0237 FDA None 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     2025-09-25T18:07:52Z 2025-18621 0 0 09000064b8fdca45
FDA-2021-N-0862-0236 FDA None FDA-2021-N-0862 Nonprescription Drug Product With an Additional Condition for Nonprescription Use Rule Final Rule 2025-03-25T04:00:00Z 2025 3     2025-03-25T14:47:53Z 2025-04978 0 0 0900006486a2a7ed
FDA-2021-N-0862-0235 FDA None FDA-2021-N-0862 Nonprescription Drug Product With an Additional Condition for Nonprescription Use Rule Final Rule 2025-01-27T05:00:00Z 2025 1     2025-01-27T14:30:42Z 2025-01840 0 0 0900006486900454
FDA-2021-N-0862-0228 FDA None 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   2025-01-23T14:51:11Z   0 0 09000064868c21c5
FDA-2021-N-0862-0229 FDA None FDA-2021-N-0862 TAB A-2023-142-ACNU-Final Rule-Original Supporting & Related Material Background Material 2025-01-15T05:00:00Z 2025 1     2025-01-15T18:59:12Z   0 0 09000064868c2151
FDA-2021-N-0862-0234 FDA None FDA-2021-N-0862 TAB C-2023-142-ACNU-FRIA-Final Supporting & Related Material Background Material 2025-01-15T05:00:00Z 2025 1     2025-01-15T19:11:26Z   0 0 09000064868c2155
FDA-2021-N-0862-0232 FDA None 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     2025-01-15T19:10:30Z   0 0 09000064868c21cb
FDA-2021-N-0862-0231 FDA None 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     2025-01-15T19:04:00Z   0 0 09000064868c2153
FDA-2021-N-0862-0230 FDA None FDA-2021-N-0862 TAB A-2023-142-ACNU-FRIA-Original Supporting & Related Material Background Material 2025-01-15T05:00:00Z 2025 1     2025-01-15T19:02:02Z   0 0 09000064868c2152
FDA-2021-N-0862-0233 FDA None FDA-2021-N-0862 TAB C-2023-142-ACNU-Final Rule-Final Supporting & Related Material Background Material 2025-01-15T05:00:00Z 2025 1     2025-01-15T19:08:03Z   0 0 09000064868c2154
FDA-2021-N-0862-0219 FDA None FDA-2021-N-0862 Reference 10 - FDA Combination Products web page Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:38Z   0 0 090000648688c405
FDA-2021-N-0862-0226 FDA None 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     2024-12-26T20:00:49Z   0 0 090000648688c497
FDA-2021-N-0862-0227 FDA None 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     2024-12-26T20:00:54Z   0 0 090000648688c4a8
FDA-2021-N-0862-0215 FDA None 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     2024-12-26T19:59:19Z   0 0 090000648688c3cb
FDA-2021-N-0862-0218 FDA None FDA-2021-N-0862 Reference 9 - FDA eCTD Resources web page Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:38Z   0 0 090000648688c403
FDA-2021-N-0862-0223 FDA None FDA-2021-N-0862 Reference 15 - 83 FR 13394_Docket FDA-2008-N-0549_04-02-2018 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T20:00:19Z   0 0 090000648688c490
FDA-2021-N-0862-0225 FDA None FDA-2021-N-0862 Reference 17 - 87 FR 68702_Docket FDA-2022-N-2673_11-16-2022 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T20:00:41Z   0 0 090000648688c493
FDA-2021-N-0862-0220 FDA None FDA-2021-N-0862 Reference 11 - MOU Between the FTC and FDA Concerning the Exchange of Information (FDA-225-71-8003)_April 1971 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:59:53Z   0 0 090000648688c406
FDA-2021-N-0862-0217 FDA None FDA-2021-N-0862 Reference 8 - 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     2024-12-26T19:59:32Z   0 0 090000648688c402
FDA-2021-N-0862-0208 FDA None 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     2024-12-26T19:58:28Z   0 0 090000648688c868
FDA-2021-N-0862-0207 FDA None 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   2024-12-26T15:41:32Z 2024-30261 0 0 090000648688bfbc
FDA-2021-N-0862-0216 FDA None 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     2024-12-26T19:59:23Z   0 0 090000648688c3cc
FDA-2021-N-0862-0209 FDA None FDA-2021-N-0862 Reference 1 - FDA Guidance for Industry_Label -Comprehension-Studies-for-Nonprescription-Drug-Products_Aug2010 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:58:33Z   0 0 090000648688c8ae
FDA-2021-N-0862-0212 FDA None FDA-2021-N-0862 Reference 4 - FDA Guidance for Industry and FDA Staff_Policy for Device Software Functions and Mobile Medical Applications Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:58:49Z   0 0 090000648688c8b3
FDA-2021-N-0862-0213 FDA None FDA-2021-N-0862 Reference 5 - FDA Medwatch The FDA Safety Information and Adverse Event Reporting Program Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:38Z   0 0 090000648688c3c7
FDA-2021-N-0862-0221 FDA None FDA-2021-N-0862 Reference 12 - FDA Prescription to Over-the-Counter (OTC) Switch List web page Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:37Z   0 0 090000648688c407
FDA-2021-N-0862-0211 FDA None FDA-2021-N-0862 Reference 3 - 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     2024-12-26T19:58:45Z   0 0 090000648688c8b1
FDA-2021-N-0862-0222 FDA None 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     2024-12-26T20:00:08Z   0 0 090000648688c986
FDA-2021-N-0862-0224 FDA None 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     2024-12-26T20:00:32Z   0 0 090000648688c491
FDA-2021-N-0862-0210 FDA None 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     2024-12-26T19:58:41Z   0 0 090000648688c8b0
FDA-2021-N-0862-0214 FDA None FDA-2021-N-0862 Reference 6 - FDA Consumer Complaint Coordinators web page Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:38Z   0 0 090000648688c3c8
FDA-2021-N-0862-0206 FDA None 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     2023-01-20T20:02:50Z   0 0 09000064855fd2fe
FDA-2021-N-0862-0203 FDA None 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     2023-01-20T20:02:31Z   0 0 09000064855fd148
FDA-2021-N-0862-0201 FDA None 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     2023-01-20T20:02:18Z   0 0 09000064855fd2fb
FDA-2021-N-0862-0204 FDA None 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     2023-01-20T20:02:37Z   0 0 09000064855fd149
FDA-2021-N-0862-0205 FDA None 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     2023-01-20T20:02:44Z   0 0 09000064855fd2fd
FDA-2021-N-0862-0200 FDA None 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   2023-01-20T20:01:00Z   0 0 09000064855fd0c5
FDA-2021-N-0862-0202 FDA None 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     2023-01-20T20:02:25Z   0 0 09000064855fd147
FDA-2021-N-0862-0177 FDA None 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   0 0 09000064854fc3fd
FDA-2021-N-0862-0140 FDA None 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   2022-11-22T18:58:05Z 2022-23033 0 0 090000648544cb97
FDA-2021-N-0862-0043 FDA None 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   2022-11-22T18:57:53Z   0 0 09000064853bd957
FDA-2021-N-0862-0039 FDA None 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   2022-11-22T18:57:40Z   0 0 090000648536e90d
FDA-2021-N-0862-0001 FDA None 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 None 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     2022-06-28T13:48:58Z   0 0 09000064851a6e08
FDA-2021-N-0862-0011 FDA None 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     2022-06-28T13:46:47Z   0 0 09000064851a6e05
FDA-2021-N-0862-0004 FDA None 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     2022-06-28T13:32:38Z   0 0 09000064851a6e07
FDA-2021-N-0862-0010 FDA None 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     2022-06-28T13:45:35Z   0 0 09000064851a6e03
FDA-2021-N-0862-0009 FDA None 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     2022-06-28T13:43:52Z   0 0 09000064851a6e04
FDA-2021-N-0862-0005 FDA None 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     2022-06-28T13:34:10Z   0 0 09000064851a56d6
FDA-2021-N-0862-0007 FDA None 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     2022-06-28T13:39:56Z   0 0 09000064851a6e0a
FDA-2021-N-0862-0003 FDA None FDA-2021-N-0862 Reference 1- Guidance for Industry Self-Selection 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     2022-06-28T13:30:20Z   0 0 09000064851a56d8
FDA-2021-N-0862-0013 FDA None 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     2022-06-28T13:49:29Z   0 0 09000064851a6e02
FDA-2021-N-0862-0002 FDA None 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     2022-06-28T13:28:40Z   0 0 09000064851a56d7
FDA-2021-N-0862-0006 FDA None 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     2022-06-28T13:38:18Z   0 0 09000064851a6e06
FDA-2021-N-0862-0012 FDA None FDA-2021-N-0862 Reference 10 - 77 FR 12059 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use Supporting & Related Material Background Material 2022-06-28T04:00:00Z 2022 6     2022-06-28T13:49:16Z   0 0 09000064851a6e09

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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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