documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
20 rows where docket_id = "FDA-2021-N-1333" and posted_year = 2022 sorted by posted_date descending
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Suggested facets: subtype, posted_date, posted_month, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-1333-0020 | FDA | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 |
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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;