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

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30 rows where docket_id = "FDA-2012-D-0307" sorted by posted_date descending

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posted_year 5

document_type 3

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2012-D-0307-0071 FDA None FDA-2012-D-0307 Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components Other Guidance 2022-05-24T04:00:00Z 2022 5 2022-05-24T04:00:00Z   2024-11-07T00:39:23Z   1 0 09000064850df573
FDA-2012-D-0307-0070 FDA None FDA-2012-D-0307 Recommendations To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry; Availability Notice Notice of Availability 2022-05-24T04:00:00Z 2022 5 2022-05-24T04:00:00Z 2022-05-25T03:59:59Z 2022-05-25T01:01:14Z 2022-11119 0 0 09000064850dbd5c
FDA-2012-D-0307-0064 FDA None FDA-2012-D-0307 Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components Other Guidance 2020-06-17T04:00:00Z 2020 6 2020-06-17T04:00:00Z   2024-11-06T23:37:22Z   1 0 09000064846f63b5
FDA-2012-D-0307-0063 FDA None FDA-2012-D-0307 Recommendations To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components; Guidance for Industry; Availability; Notice Notice of Availability 2020-06-17T04:00:00Z 2020 6 2020-06-17T04:00:00Z   2020-06-17T12:33:02Z 2020-13055 0 0 09000064846f5d22
FDA-2012-D-0307-0055 FDA None FDA-2012-D-0307 Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components Guidance for Industry Other Guidance 2020-04-03T04:00:00Z 2020 4 2020-04-03T04:00:00Z   2024-11-06T23:34:05Z   1 0 090000648448596f
FDA-2012-D-0307-0056 FDA None FDA-2012-D-0307 29 Reference 29 Holmquest et al. No evidence of transfusion transmitted sporadic CJD Supporting & Related Material Background Material 2020-04-03T04:00:00Z 2020 4     2020-04-03T14:35:47Z   0 0 09000064844859c1
FDA-2012-D-0307-0037 FDA None FDA-2012-D-0307 Reference 26- Development of Dose-Response Models of Creutzfeldt-Jakob Disease Infection in Nonhuman Primates re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2020-02-25T05:00:00Z 2020 2     2020-02-25T16:03:56Z   0 0 09000064843ae6d8
FDA-2012-D-0307-0038 FDA None FDA-2012-D-0307 Reference 33- The New England Journal of Medicine re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2020-02-25T05:00:00Z 2020 2     2020-02-25T16:04:02Z   0 0 09000064843ae6d7
FDA-2012-D-0307-0031 FDA None FDA-2012-D-0307 Recommendations To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-01-31T05:00:00Z 2020 1 2020-01-31T05:00:00Z 2020-04-01T03:59:59Z 2020-02-25T13:29:12Z 2020-01815 0 0 0900006484315e30
FDA-2012-D-0307-0032 FDA None FDA-2012-D-0307 Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry Other Guidance 2020-01-30T05:00:00Z 2020 1 2020-01-30T05:00:00Z   2024-11-12T23:16:48Z   1 0 0900006484317192
FDA-2012-D-0307-0023 FDA None FDA-2012-D-0307 Reference 37-Regulation (EC) No 999_2001 of EU Parliament re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:38:29Z   0 0 0900006482d5883c
FDA-2012-D-0307-0013 FDA None FDA-2012-D-0307 Reference 01 - Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by blood and blood products re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:24:28Z   0 0 0900006482d5882c
FDA-2012-D-0307-0010 FDA None FDA-2012-D-0307 Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Notice Notice of Availability 2017-12-22T05:00:00Z 2017 12 2017-12-22T05:00:00Z 2018-03-23T03:59:59Z 2018-01-06T02:01:16Z 2017-27569 0 0 0900006482d56ac6
FDA-2012-D-0307-0016 FDA None FDA-2012-D-0307 Referecne 28-Gregori_et_al-2011-Transfusion re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:36:55Z   0 0 0900006482d58830
FDA-2012-D-0307-0021 FDA None FDA-2012-D-0307 Reference 35-Schlicter S.J. (1997)TRAP Study re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:37:58Z   0 0 0900006482d58838
FDA-2012-D-0307-0015 FDA None FDA-2012-D-0307 Reference 25-Yang_et_al-2017-Transfusion re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:36:39Z   0 0 0900006482d5882e
FDA-2012-D-0307-0020 FDA None FDA-2012-D-0307 Reference 34-King_LR reduced RBC rxn_Tx_'04 re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:37:48Z   0 0 0900006482d58835
FDA-2012-D-0307-0011 FDA None FDA-2012-D-0307 Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Other Guidance 2017-12-22T05:00:00Z 2017 12 2017-12-22T05:00:00Z 2018-03-23T03:59:59Z 2024-11-07T01:15:24Z   1 0 0900006482d58385
FDA-2012-D-0307-0019 FDA None FDA-2012-D-0307 Reference 32-Transfusion-medicine-epidemiology-review-tmer re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:37:39Z   0 0 0900006482d58833
FDA-2012-D-0307-0018 FDA None FDA-2012-D-0307 Reference 31-McCutcheon_et_al-2011-PloSOne re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:37:23Z   0 0 0900006482d58832
FDA-2012-D-0307-0022 FDA None FDA-2012-D-0307 Referenec 36-Bowden_LR v seroneg_Blood '95 re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:38:22Z   0 0 0900006482d5883b
FDA-2012-D-0307-0024 FDA None FDA-2012-D-0307 Reference 38-FDA Transmissible Spongiform Encephalopathies Advisory Committee re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:38:38Z   0 0 0900006482d5883d
FDA-2012-D-0307-0014 FDA None FDA-2012-D-0307 Reference 19-Swiss Med Wkly re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:24:59Z   0 0 0900006482d5882d
FDA-2012-D-0307-0017 FDA None FDA-2012-D-0307 Reference 29-Harvey_et_al-2015-Transfusion re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2020-02-25T15:37:08Z   0 0 0900006482d58831
FDA-2012-D-0307-0012 FDA None FDA-2012-D-0307 Reference List re Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:24:07Z   0 0 0900006482d587fd
FDA-2012-D-0307-0009 FDA None FDA-2012-D-0307 References List - Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products Supporting & Related Material Background Material 2016-01-15T05:00:00Z 2016 1     2016-01-15T16:03:51Z   0 0 0900006481e0d8a6
FDA-2012-D-0307-0008 FDA None FDA-2012-D-0307 Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry Other Guidance 2016-01-14T05:00:00Z 2016 1 2016-01-14T05:00:00Z   2024-11-11T21:21:28Z   1 0 0900006481e0dc4c
FDA-2012-D-0307-0007 FDA None FDA-2012-D-0307 Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry; Availability Notice Notice of Availability 2016-01-14T05:00:00Z 2016 1 2016-01-14T05:00:00Z   2016-01-14T15:19:15Z 2016-00536 0 0 0900006481e0d2aa
FDA-2012-D-0307-0002 FDA None FDA-2012-D-0307 Draft Guidance for Industry: Revised Preventive Measures to Reduce Possible Risk of Transmission of Creutzfeldt-Jakob Disease, etc. Other Guidance 2012-06-12T04:00:00Z 2012 6 2012-06-12T04:00:00Z   2012-06-12T16:37:12Z   0 0 09000064810413e8
FDA-2012-D-0307-0001 FDA None FDA-2012-D-0307 Draft Guidance for Industry: Revised Preventive Measures to Reduce Possible Risk of Transmission of Creutzfeldt-Jakob Disease, etc.; Amendment Notice Notice of Availability 2012-06-11T04:00:00Z 2012 6 2012-06-11T04:00:00Z 2012-09-11T03:59:59Z 2012-09-20T02:01:13Z 2012-14034 0 0 0900006481040b4c

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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;