documents

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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

15 rows where docket_id = "FDA-2009-D-0137" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 15 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0137-0028 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the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-11-10T05:00:00Z 2016 11 2016-11-10T05:00:00Z 2017-02-09T04:59:59Z 2017-02-07T02:02:05Z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

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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;