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29 rows where docket_id = "FDA-2011-N-0103" sorted by posted_date descending
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document_type 3
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- 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;