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

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16 rows where docket_id = "FDA-2015-N-1355" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-N-1355-0026 FDA None FDA-2015-N-1355 Use of Ozone-Depleting Substances Rule Direct Final Rule 2017-02-28T05:00:00Z 2017 2 2017-02-28T05:00:00Z   2017-02-28T14:41:22Z 2017-03866 0 0 09000064824e0d15
FDA-2015-N-1355-0017 FDA None FDA-2015-N-1355 Attachment 2 Redacted Cetylite adverse drug experience reports re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2017-01-13T17:09:39Z   0 0 090000648243807b
FDA-2015-N-1355-0016 FDA None FDA-2015-N-1355 Attachment 1 Redacted History of Cetylite's DESI proceeding re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2017-01-13T17:06:29Z   0 0 090000648243807a
FDA-2015-N-1355-0022 FDA None FDA-2015-N-1355 Exhibit D A Guidance on the Use of Topical Anesthetics for Naso/Oropharyngeal and Laryngotracheal Procedures Feb. 2006 www.pbm.va.gov re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2016-12-27T18:21:59Z   0 0 09000064824380ec
FDA-2015-N-1355-0023 FDA None FDA-2015-N-1355 Exhibit E Current Cetacaine® Spray label from DailyMed database re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2016-12-27T18:24:02Z   0 0 09000064824380ed
FDA-2015-N-1355-0024 FDA None FDA-2015-N-1355 Exhibit F Current Laryng-0-Jet kit label from DailyMed database re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2016-12-27T18:27:37Z   0 0 09000064824380ee
FDA-2015-N-1355-0018 FDA None FDA-2015-N-1355 Attachment 3 Redacted Information about Cetylite's business status re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2017-01-13T17:12:15Z   0 0 09000064824380e7
FDA-2015-N-1355-0020 FDA None FDA-2015-N-1355 Exhibit A Guidance for FDA Staff and Industry Marketed Unapproved Drugs Compliance Policy Guide Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs Sept 9, 2011 re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2016-12-27T19:41:10Z   0 0 09000064824380e9
FDA-2015-N-1355-0019 FDA None FDA-2015-N-1355 Attachment 4 Redacted List of Cetylite's communications with DAAAP re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2017-01-13T17:14:30Z   0 0 09000064824380e8
FDA-2015-N-1355-0021 FDA None FDA-2015-N-1355 Exhibit C Greenfield, Hittelman, and Glickman Evaluation of Anesthetic Agents on Human Mucous Membrane: An Illustration Experimental Protocol Using Computers NYS Dental Journal (1986): 22-28. re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.) Supporting & Related Material Background Material 2016-12-27T05:00:00Z 2016 12     2017-01-13T16:51:34Z   0 0 09000064824380eb
FDA-2015-N-1355-0003 FDA None FDA-2015-N-1355 Use of Ozone-Depleting Substances Rule Direct Final Rule 2016-10-26T04:00:00Z 2016 10 2016-10-26T04:00:00Z 2016-12-28T04:59:59Z 2016-12-28T02:02:24Z 2016-25851 0 0 090000648234d51a
FDA-2015-N-1355-0007 FDA None FDA-2015-N-1355 Reference 1 -More methemoglobin is produced by benzocaine treatment than lidocaine treatment in human in vitro systems Supporting & Related Material Background Material 2016-10-26T04:00:00Z 2016 10     2016-10-26T20:08:17Z   0 0 09000064823547dd
FDA-2015-N-1355-0004 FDA None FDA-2015-N-1355 Use of Ozone-Depleting Substances Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-10-26T04:00:00Z 2016 10 2016-10-26T04:00:00Z 2016-12-28T04:59:59Z 2016-12-01T14:00:46Z 2016-25850 0 0 090000648234d577
FDA-2015-N-1355-0005 FDA None FDA-2015-N-1355 Use of Ozone-Depleting Substances Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-10-26T04:00:00Z 2016 10 2016-10-26T04:00:00Z 2016-12-28T04:59:59Z 2017-01-31T02:02:25Z 2016-25852 0 0 090000648234d5d1
FDA-2015-N-1355-0006 FDA None FDA-2015-N-1355 Reference 1 - Bryan Corporation (httplistings.findthecompany.coml12165972Bryan-Corporation-in-Woburn-MA Supporting & Related Material Background Material 2016-10-26T04:00:00Z 2016 10     2016-10-26T20:06:21Z   0 0 09000064823547dc
FDA-2015-N-1355-0001 FDA None FDA-2015-N-1355 Use of Ozone-Depleting Substances; Request for Comment Concerning Essential-Use Designations Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-06-29T04:00:00Z 2015 6 2015-06-29T04:00:00Z 2015-08-29T03:59:59Z 2015-08-22T01:30:54Z 2015-15902 0 0 0900006481b5acc4

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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;