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

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31 rows where docket_id = "FDA-2009-D-0137" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-D-0137-0045 FDA None FDA-2009-D-0137 Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability Notice Notice of Availability 2017-12-06T05:00:00Z 2017 12 2017-12-06T05:00:00Z   2017-12-06T15:20:12Z 2017-26226 0 0 0900006482ce90a2
FDA-2009-D-0137-0046 FDA None FDA-2009-D-0137 Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components Guidance for Industry Other Guidance 2017-12-06T05:00:00Z 2017 12 2017-12-06T05:00:00Z   2024-11-07T01:13:38Z   1 0 0900006482ce9dc0
FDA-2009-D-0137-0028 FDA None FDA-2009-D-0137 Amendment to Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-11-10T05:00:00Z 2016 11 2016-11-10T05:00:00Z 2017-02-09T04:59:59Z 2017-02-07T02:02:05Z 2016-27107 0 0 0900006482387508
FDA-2009-D-0137-0036 FDA None FDA-2009-D-0137 Reference 7 Donors deferred for self-reported Chagas disease history: does it reduce risk? Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:11Z   0 0 09000064823877ec
FDA-2009-D-0137-0031 FDA None FDA-2009-D-0137 Reference 2-Autochthonous Transmission of Trypanosoma cruzi, Louisiana Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:30:56Z   0 0 0900006482387a72
FDA-2009-D-0137-0038 FDA None FDA-2009-D-0137 Reference 9 Trypanosoma cruzi (E. coli Recombinant) Antigen ABBOTT PRISM Chagas Package Insert (2010) Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:17Z   0 0 09000064823877ee
FDA-2009-D-0137-0029 FDA None FDA-2009-D-0137 Amendment to “Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion” Other Guidance 2016-11-10T05:00:00Z 2016 11 2016-11-10T05:00:00Z 2017-02-09T04:59:59Z 2024-11-12T06:15:55Z   1 0 0900006482387a6f
FDA-2009-D-0137-0039 FDA None FDA-2009-D-0137 Reference 10 FDA Blood Products Advisory Committee T. cruzi Incidence Study in Blood Donors and its Implications for One-time Testing of Blood Donors August 2 2011 Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:20Z   0 0 09000064823877ef
FDA-2009-D-0137-0042 FDA None FDA-2009-D-0137 Reference 13 Trypanosoma cruzi (E coli) Recombinant Antigen ABBOTT ESA Chagas Package Insert 2011 Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:29Z   0 0 09000064823877f2
FDA-2009-D-0137-0035 FDA None FDA-2009-D-0137 Reference 6-Epidemiology of American Trypanosomiasis (Chagas Disease) Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:08Z   0 0 09000064823877eb
FDA-2009-D-0137-0037 FDA None FDA-2009-D-0137 Reference 8 Trypanosoma cruzi (T cruzi) Whole Cell Lysate Antigen ORTHO T cruzi ELISA Test System Package Insert 2009 Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:15Z   0 0 09000064823877ed
FDA-2009-D-0137-0032 FDA None FDA-2009-D-0137 Reference 3-Case Report: Evidence of Autochthonous Chagas Disease in Southeastern Texas Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:30:58Z   0 0 0900006482387a73
FDA-2009-D-0137-0033 FDA None FDA-2009-D-0137 Reference 4-An Estimate of the Burden of Chagas Disease in the United States Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:02Z   0 0 0900006482387a74
FDA-2009-D-0137-0034 FDA None FDA-2009-D-0137 Reference 5-Trypanosoma cruzi infection in North America and Spain: evidence in support of transfusion transmission Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:05Z   0 0 09000064823877ea
FDA-2009-D-0137-0040 FDA None FDA-2009-D-0137 Reference 11 FDA Blood Products Advisory Committee Reentry of blood donors deferred on the basis of screening test results for antibodies to T. cruzi July 31 2014 Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:23Z   0 0 09000064823877f0
FDA-2009-D-0137-0030 FDA None FDA-2009-D-0137 AMENDMENT TO “GUIDANCE FOR INDUSTRY: USE OF SEROLOGICAL TESTS TO REDUCE THE RISK OF TRANSMISSION OF TRYPANOSOMA CRUZI INFECTION IN WHOLE BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION” DRAFT GUIDANCE FOR INDUSTRY Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:30:52Z   0 0 0900006482387a71
FDA-2009-D-0137-0041 FDA None FDA-2009-D-0137 Reference 12 FDA Blood Products Advisory Committee Potential Testing Strategies for T. cruzi Infection in Blood Donors April 1 2009 Supporting & Related Material Background Material 2016-11-10T05:00:00Z 2016 11     2016-11-10T15:31:26Z   0 0 09000064823877f1
FDA-2009-D-0137-0027 FDA None FDA-2009-D-0137 Guidance for Industry Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion Other Guidance 2010-12-06T05:00:00Z 2010 12 2010-12-06T05:00:00Z   2024-11-07T22:30:35Z   1 0 0900006480bafc56
FDA-2009-D-0137-0025 FDA None FDA-2009-D-0137 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry; Use of Serological Tests to Reduce Risk of Transmission of Trypanosoma cruzi Infection, etc. Notice 30 Day Proposed Information Collection 2010-12-06T05:00:00Z 2010 12 2010-12-06T05:00:00Z 2011-01-06T04:59:59Z 2016-10-28T18:34:06Z 2010-30404 0 0 0900006480bafe83
FDA-2009-D-0137-0026 FDA None FDA-2009-D-0137 Guidance for Industry: Use of Serological Tests to Reduce Riskof Transmission of Trypanosoma cruzi Infection, etc. Notice Notice of Availability 2010-12-06T05:00:00Z 2010 12 2010-12-06T05:00:00Z   2016-10-28T18:39:30Z 2010-30405 0 0 0900006480baff0b
FDA-2009-D-0137-0011 FDA None FDA-2009-D-0137 Tab 27 - PubMed Results - "Chagas Disease & The U. S. Blood Supply" - Reference [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-04-10T04:00:00Z 2009 4     2009-04-10T16:00:00Z   0 0 090000648092ff9e
FDA-2009-D-0137-0009 FDA None FDA-2009-D-0137 Reference 26 - "Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments, October 2006" - [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-03-30T04:00:00Z 2009 3     2011-06-29T19:45:14Z   0 0 090000648092ff42
FDA-2009-D-0137-0010 FDA None FDA-2009-D-0137 Reference 29 - "FDA Blood Products Advisory Committee Meeting, September 12, 2002" - [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-03-30T04:00:00Z 2009 3     2011-06-29T19:49:33Z   0 0 090000648092ffba
FDA-2009-D-0137-0006 FDA None FDA-2009-D-0137 Reference 15 - CDC/MMWR , "Chagas Disease After Organ Transplantation - Los Angeles, California, 2006" - [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-03-30T04:00:00Z 2009 3     2011-06-29T19:37:58Z   0 0 090000648092fd18
FDA-2009-D-0137-0005 FDA None FDA-2009-D-0137 Reference 14 - CDC/MMWR , "Chagas Disease After Organ Transplantation - United States, 2001" - [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-03-30T04:00:00Z 2009 3     2011-06-29T19:35:35Z   0 0 090000648092fd07
FDA-2009-D-0137-0007 FDA None FDA-2009-D-0137 Reference 24 - CDC/MMWR, "Blood Donor Screening for Chagas Disease - United States, 2006-2007" - [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-03-30T04:00:00Z 2009 3     2011-06-29T19:39:42Z   0 0 090000648092ff2c
FDA-2009-D-0137-0008 FDA None FDA-2009-D-0137 Reference 25 - "FDA Blood Products Advisory Committee, 89th Meeting, April 27, 2007 (Concept Paper)" - [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-03-30T04:00:00Z 2009 3     2011-06-29T19:43:30Z   0 0 090000648092ff3a
FDA-2009-D-0137-0004 FDA None FDA-2009-D-0137 Reference 1 - "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), August 2007" - [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-03-29T04:00:00Z 2009 3     2011-06-29T19:14:36Z   0 0 090000648092fa11
FDA-2009-D-0137-0002 FDA None FDA-2009-D-0137 Guidance for Industry - Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Guidance Other Guidance 2009-03-26T04:00:00Z 2009 3 2009-03-26T04:00:00Z   2011-06-29T17:49:54Z   0 0 0900006480930814
FDA-2009-D-0137-0003 FDA None FDA-2009-D-0137 Table of Contents - References [re FDA-2009-D-0137-0002] Supporting & Related Material REF-Reference (internal unless indicated) 2009-03-26T04:00:00Z 2009 3     2011-06-29T19:10:28Z   0 0 0900006480931787
FDA-2009-D-0137-0001 FDA None FDA-2009-D-0137 Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products Notice NAD-Notice of Availability of Data 2009-03-26T04:00:00Z 2009 3 2009-03-26T04:00:00Z 2009-06-25T03:59:59Z 2011-06-29T17:38:37Z E9-06684 0 0 0900006480930640

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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;