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29 rows where docket_id = "FDA-2011-N-0103" sorted by posted_date descending

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  • 2016 11
  • 2019 11
  • 2011 6
  • 2015 1

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  • Supporting & Related Material 26
  • Proposed Rule 2
  • Rule 1

agency_id 1

  • FDA 29
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-N-0103-0025 FDA None FDA-2011-N-0103 Reference 6 Specific Identification of Bacillus anthracis Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:03Z   0 0 0900006483b53a23
FDA-2011-N-0103-0023 FDA None FDA-2011-N-0103 Reference 8 Phage Isolated from Lysogenic Bacillus anthracis Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:01Z   0 0 0900006483b53a25
FDA-2011-N-0103-0028 FDA None FDA-2011-N-0103 Reference 3 Regulatory Flexibility Analysis Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:05Z   0 0 0900006483b53976
FDA-2011-N-0103-0026 FDA None FDA-2011-N-0103 Reference 5 Production and Validation of the Use of Gamma Phage Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:04Z   0 0 0900006483b53978
FDA-2011-N-0103-0027 FDA None FDA-2011-N-0103 Reference 4 Abshire T.G. et at Validation ofthe use of gamma phage for identifying Bacillus anthracis Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:04Z   0 0 0900006483b53977
FDA-2011-N-0103-0024 FDA None FDA-2011-N-0103 Reference 7 Differential Diagnosis of Bacillus cereus Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:02Z   0 0 0900006483b53a24
FDA-2011-N-0103-0030 FDA None FDA-2011-N-0103 Reference 1 Class II Special Controls Guideline Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:06Z   0 0 0900006483b53974
FDA-2011-N-0103-0031 FDA None FDA-2011-N-0103 Index to References FR Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:07Z   0 0 0900006483b53d58
FDA-2011-N-0103-0029 FDA None FDA-2011-N-0103 Reference 2 Transcript of the FDA Microbiology Devices Panel Meeting March 7 2002 Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:06Z   0 0 0900006483b53975
FDA-2011-N-0103-0021 FDA None FDA-2011-N-0103 Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection Rule Final Rule 2019-04-01T04:00:00Z 2019 4 2019-04-01T04:00:00Z   2019-04-01T15:56:15Z 2019-06026 0 0 0900006483b512a0
FDA-2011-N-0103-0022 FDA None FDA-2011-N-0103 Reference 9 A colour Atlas of Bacillus Species Supporting & Related Material Background Material 2019-04-01T04:00:00Z 2019 4     2019-04-01T16:17:00Z   0 0 0900006483b53a26
FDA-2011-N-0103-0016 FDA None FDA-2011-N-0103 Reference 6 - Phage Isolated From Lysogenic Bacillus Anthracis Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:37Z   0 0 0900006481e03459
FDA-2011-N-0103-0017 FDA None FDA-2011-N-0103 Reference 7 - A Colour Atlas of Bacillus Species Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:45Z   0 0 0900006481e0345a
FDA-2011-N-0103-0018 FDA None FDA-2011-N-0103 Reference 8 - Draft Guideline for Industry and FDA Staff Class II Special Controls Guidline: In Vitro Diagnostic Devices for Bacillus spp. Detection Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:51Z   0 0 0900006481e0345e
FDA-2011-N-0103-0015 FDA None FDA-2011-N-0103 Reference 5 - Differential Diagnosis of Bacillus Cereus Bacillus Anthracis and Bacillus Cereus Var. Mycoides Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:33Z   0 0 0900006481e032e5
FDA-2011-N-0103-0012 FDA None FDA-2011-N-0103 Reference 2 - Validation of the use of Gamma Phage for Identifying Bacillus Anthracis Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:19Z   0 0 0900006481e032b1
FDA-2011-N-0103-0014 FDA None FDA-2011-N-0103 Reference 4 - Specific Identification of Bacillus Anthracis by Means of a Variant Bacteriophage Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:29Z   0 0 0900006481e032e4
FDA-2011-N-0103-0011 FDA None FDA-2011-N-0103 Reference 1 - Transcript of Microbiology Devices Panel meeting March 7 2002 Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:15Z   0 0 0900006481e02ead
FDA-2011-N-0103-0010 FDA None FDA-2011-N-0103 List of References Supporting & Related Material List 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:10Z   0 0 0900006481e031a7
FDA-2011-N-0103-0013 FDA None FDA-2011-N-0103 Reference 3 - Production and Validation of the Use of Gamma Phage for the Identification of Bacillus Anthracis Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:25Z   0 0 0900006481e032b2
FDA-2011-N-0103-0019 FDA None FDA-2011-N-0103 Reference 9 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection - Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:39:55Z   0 0 0900006481e0345f
FDA-2011-N-0103-0020 FDA None FDA-2011-N-0103 Reference 10 - Laboratory Response Network LRN Level A laboratory procedures for identification of Bacillus Anthracis Supporting & Related Material Background Material 2016-01-12T05:00:00Z 2016 1     2016-01-12T18:40:02Z   0 0 0900006481e034a8
FDA-2011-N-0103-0008 FDA None FDA-2011-N-0103 Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-11-17T05:00:00Z 2015 11 2015-11-17T05:00:00Z 2016-02-17T04:59:59Z 2015-12-10T22:00:47Z 2015-29275 0 0 0900006481d4d5ce
FDA-2011-N-0103-0004 FDA None FDA-2011-N-0103 Reference 2 - Abshire, T.G. et at, "Validation ofthe use of gamma phage for identifying Bacillus anthracis,It 102nd American Society for Microbiology Annual Meeting poster #C 122, 2001 [5/18/2011 Notice of Proposed Rule] Supporting & Related Material BKG-Background Material 2011-05-18T04:00:00Z 2011 5     2011-05-18T16:06:05Z   0 0 0900006480d4366e
FDA-2011-N-0103-0002 FDA None FDA-2011-N-0103 List of References Supporting & Related Material BKG-Background Material 2011-05-18T04:00:00Z 2011 5     2016-01-12T16:29:28Z   0 0 0900006480d43669
FDA-2011-N-0103-0005 FDA None FDA-2011-N-0103 Reference 3 - Brown, Eric R. and William B. Cherry, "Specific identification ofBacillus anthracis by means of a variant bacteriophage," vol. 96, Journal of Infectious Disease, p. 34, 2001 [5/18/2011 Notice of Proposed Rule] Supporting & Related Material BKG-Background Material 2011-05-18T04:00:00Z 2011 5     2011-05-18T16:06:07Z   0 0 0900006480d4366f
FDA-2011-N-0103-0006 FDA None FDA-2011-N-0103 Reference 4 - Brown, Eric R. et aI., "Differential diagnosis of Bacillus cereus, Bacillus anthracis and Bacillus cereus var. ,nycoides," vol. 75, Journal of Bacteriology, p. 499, 1957 [5/18/2011 Notice of Proposed Rule] Supporting & Related Material BKG-Background Material 2011-05-18T04:00:00Z 2011 5     2011-05-18T16:06:09Z   0 0 0900006480d43a26
FDA-2011-N-0103-0001 FDA None FDA-2011-N-0103 Microbiology Devices: Classification of In Vitro Diagnostic Device for Bacillus Species Detection Proposed Rule NPR-Notice of Proposed Rule-Making 2011-05-18T04:00:00Z 2011 5 2011-05-18T04:00:00Z 2011-08-17T03:59:59Z 2011-05-18T13:52:27Z 2011-12088 0 0 0900006480d4154e
FDA-2011-N-0103-0003 FDA None FDA-2011-N-0103 Reference 1 -Transcript of the FDA Microbiology Devices Panel meeting, March 7. 2002, at: http://www.accessdata.fda.gov/scripts/cdrhlcfdocs/cfAdvisory/details.cfm?mtg=348 [5/18/2011 Notice of Proposed Rule] Supporting & Related Material BKG-Background Material 2011-05-18T04:00:00Z 2011 5     2011-05-18T16:06:03Z   0 0 0900006480d4366b

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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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