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withdrawn,object_id FDA-2021-N-1333-0032,FDA,FDA-2021-N-1333,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2025-07-03T04:00:00Z,2025,7,2025-07-03T04:00:00Z,,2025-07-03T16:44:04Z,2025-12415,0,0,09000064b8e4e2bd FDA-2021-N-1333-0028,FDA,FDA-2021-N-1333,Reference 3--Medical Gas CPGM,Supporting & Related Material,Background Material,2024-06-18T04:00:00Z,2024,6,,,2024-06-18T15:24:17Z,,0,0,09000064865bd76c FDA-2021-N-1333-0031,FDA,FDA-2021-N-1333,Reference 6--FRIA Medical Gases,Supporting & Related Material,Background Material,2024-06-18T04:00:00Z,2024,6,,,2024-06-18T15:24:39Z,,0,0,09000064865bd771 FDA-2021-N-1333-0025,FDA,FDA-2021-N-1333,"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases",Rule,Final Rule,2024-06-18T04:00:00Z,2024,6,2024-06-18T04:00:00Z,,2024-06-20T12:33:21Z,2024-13190,0,0,09000064865bc84f FDA-2021-N-1333-0027,FDA,FDA-2021-N-1333,Reference 2--Med Gas - Container Closure - OMQ White Paper,Supporting & Related Material,Background Material,2024-06-18T04:00:00Z,2024,6,,,2024-06-18T15:24:14Z,,0,0,09000064865bd76b FDA-2021-N-1333-0026,FDA,FDA-2021-N-1333,Reference 1--Certification Process Draft Guidance,Supporting & Related Material,Background Material,2024-06-18T04:00:00Z,2024,6,,,2024-06-18T15:24:11Z,,0,0,09000064865bd76a FDA-2021-N-1333-0029,FDA,FDA-2021-N-1333,Reference 4--Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application,Supporting & Related Material,Background Material,2024-06-18T04:00:00Z,2024,6,,,2024-06-18T15:24:22Z,,0,0,09000064865bd76f FDA-2021-N-1333-0030,FDA,FDA-2021-N-1333,Reference 5--Postmarketing Safety Reporting Draft Guidance,Supporting & Related Material,Background Material,2024-06-18T04:00:00Z,2024,6,,,2024-06-18T15:24:36Z,,0,0,09000064865bd770 FDA-2021-N-1333-0020,FDA,FDA-2021-N-1333,"Reference18 -Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases",Supporting & Related Material,Background Material,2022-05-23T04:00:00Z,2022,5,,,2022-05-23T18:25:47Z,,0,0,09000064850c9a83 FDA-2021-N-1333-0019,FDA,FDA-2021-N-1333,"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2022-05-23T04:00:00Z,2022,5,2022-05-23T04:00:00Z,2022-08-23T03:59:59Z,2022-08-19T01:00:30Z,2022-10458,0,0,09000064850c48ea FDA-2021-N-1333-0003,FDA,FDA-2021-N-1333,Reference 3-E-cigarette use in patients receiving home oxygen therapy,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T13:55:31Z,,0,0,0900006485039c94 FDA-2021-N-1333-0001,FDA,FDA-2021-N-1333,Reference 1-Certification Process for Designated Medical Gases Guidance for Industry,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T13:53:54Z,,0,0,090000648503a1f0 FDA-2021-N-1333-0017,FDA,FDA-2021-N-1333,Reference 17-Veterinary Adverse Event Reporting for Manufacturers,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T13:49:00Z,,0,0,0900006485039cb3 FDA-2021-N-1333-0013,FDA,FDA-2021-N-1333,Reference 13-Field Alert Report Submission Questions and Answers Guidance for Industry,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:07:37Z,,0,0,0900006485039caf FDA-2021-N-1333-0007,FDA,FDA-2021-N-1333,Reference 7-CP Response,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T13:58:42Z,,0,0,0900006485039c98 FDA-2021-N-1333-0012,FDA,FDA-2021-N-1333,Reference 12-Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:06:41Z,,0,0,0900006485039c9d FDA-2021-N-1333-0016,FDA,FDA-2021-N-1333,Reference 16-Medical Dictionary for Regulatory Activities,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:11:43Z,,0,0,0900006485039cb2 FDA-2021-N-1333-0005,FDA,FDA-2021-N-1333,Reference 5-Fire research report E-Cigarette Fire Risks and Reported Incidents,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T13:56:48Z,,0,0,0900006485039c96 FDA-2021-N-1333-0014,FDA,FDA-2021-N-1333,Reference 14-FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:08:06Z,,0,0,0900006485039cb0 FDA-2021-N-1333-0002,FDA,FDA-2021-N-1333,Reference 2- Medical Gas Regulation Public Workshops,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T13:54:43Z,,0,0,090000648503a1f1 FDA-2021-N-1333-0009,FDA,FDA-2021-N-1333,Reference 9-Preventing Patients From Receiving Leaking or Empty Containers of Medical Gas: A Review of Inspectional Findings from 2003 to 2021,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:04:06Z,,0,0,0900006485039c9a FDA-2021-N-1333-0015,FDA,FDA-2021-N-1333,Reference 15- Guidance for Industry Providing Submissions in Electronic Formal— Postmarketing Safety ReportsDRAFT GUIDANCE,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:09:00Z,,0,0,0900006485039cb1 FDA-2021-N-1333-0004,FDA,FDA-2021-N-1333,Reference 4-E-cigarette Explosion in a Patient Room _ PSNet,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T13:56:07Z,,0,0,0900006485039c95 FDA-2021-N-1333-0008,FDA,FDA-2021-N-1333,"Reference 8-Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities FDA PUBLIC HEALTH ADVISORY",Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:02:54Z,,0,0,0900006485039c99 FDA-2021-N-1333-0006,FDA,FDA-2021-N-1333,"Reference 6-Electronic nicotine delivery systems: overheating,fires and explosions",Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T13:57:45Z,,0,0,0900006485039c97 FDA-2021-N-1333-0010,FDA,FDA-2021-N-1333,Reference 10-Office of Pharmaceutical Quality Acceptability of Standards from Alternative Compendia (BP/EP/JP),Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:05:01Z,,0,0,0900006485039c9b FDA-2021-N-1333-0011,FDA,FDA-2021-N-1333,Reference 11-Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration Guidance for Industry,Supporting & Related Material,Background Material,2022-04-27T04:00:00Z,2022,4,,,2022-05-23T14:05:47Z,,0,0,0900006485039c9c FDA-2021-N-1333-0018,FDA,FDA-2021-N-1333,"Reference18-Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases",Supporting & Related Material,,2022-04-27T00:00:00Z,2022,4,,,2022-05-23T18:17:22Z,,0,1,0900006485039cb4