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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

19 rows where docket_id = "FDA-2005-D-0140" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2005-D-0140-0012 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 1 FDA Memorandum to All Registered Blood Establishments: “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products,” Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:42Z   0 0 0900006482d7ee3f
FDA-2005-D-0140-0015 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 4 Busch MP. Closing the windows on viral transmission by blood transfusion. In Stramer SL ed. Blood Safety in the New Millenium. Bethesda, MD: American Association of Blood Banks, 2001: Chapter 2, p.36. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:28Z   0 0 0900006482d7ee42
FDA-2005-D-0140-0010 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry: Guidance for Industry Other Guidance 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2024-11-07T01:15:24Z   1 0 0900006482d7ee3c
FDA-2005-D-0140-0016 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 5 Glynn SA, Kleinman SH, Wright DJ, Busch MP. International application of the incidence rate/window period model. Transfusion 42:966-972 (2002). Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:23Z   0 0 0900006482d7ee43
FDA-2005-D-0140-0022 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 11 Alter HJ. To C or not to C: These are the questions. Blood 85:1681-1695 (1995). Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:39:54Z   0 0 0900006482d7ee52
FDA-2005-D-0140-0011 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 001 - List of References - Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry Guidance for Industry Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:50Z   0 0 0900006482d7ee3e
FDA-2005-D-0140-0021 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 10 Blood Products Advisory Committee, 69th Meeting, June 14, 2001 Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:39:59Z   0 0 0900006482d7ee51
FDA-2005-D-0140-0019 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 8 Federal Register, December 14, 1999 (64 FR 71147), Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2, December 1999. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:08Z   0 0 0900006482d7ee4f
FDA-2005-D-0140-0020 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 9 Federal Register, August 24, 2007 (72 FR 48765), Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”); Final Rule. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:03Z   0 0 0900006482d7ee50
FDA-2005-D-0140-0018 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 7 Fiebig EW, Wright DJ, Rawal BD, et. al. Dynamics of HIV-1 viremia and antibody seroconversion in plasma donors: Implications for diagnosis and staging of primary HIV-1 infection. AIDS 17:1871-1879 (2003). Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:13Z   0 0 0900006482d7ee4e
FDA-2005-D-0140-0014 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 3 FDA Memorandum to All Registered Blood Establishments: “Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),” August 5, 1993. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:33Z   0 0 0900006482d7ee41
FDA-2005-D-0140-0017 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 6 (final) - Zou S, Dorsey KA, Notari EP, Foster GA, et al. Prevalence, incidence and residual risk of human immunodeficiency virus and hepatitis C virus infections among United States blood donors since the introduction of nucleic acid testing. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:18Z   0 0 0900006482d7ee44
FDA-2005-D-0140-0013 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 2 FDA Memorandum to All Registered Blood and Plasma Establishments: “Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen,” Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:38Z   0 0 0900006482d7ee40
FDA-2005-D-0140-0023 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 12 Centers for Disease Control, Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR 47; (RR-19) (1998). Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:39:49Z   0 0 0900006482d7ee53
FDA-2005-D-0140-0007 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV), etc. Notice NAD-Notice of Availability of Data 2010-04-30T04:00:00Z 2010 4 2010-04-30T04:00:00Z   2024-11-07T22:14:16Z 2010-10048 1 0 0900006480ae4312
FDA-2005-D-0140-0009 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 9 - Federal Register, August 24, 2007 (72 FR 48765), Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfussion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection ("Lookback"); Final Rule Supporting & Related Material BKG-Background Material 2010-04-30T04:00:00Z 2010 4     2010-04-30T15:18:15Z   0 0 0900006480ae387b
FDA-2005-D-0140-0008 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV), etc. Other GDL-Guidance (Supporting and Related Materials) 2010-04-30T04:00:00Z 2010 4 2010-04-30T04:00:00Z   2024-11-12T04:52:51Z   1 0 0900006480ae3879
FDA-2005-D-0140-0002 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Guideline Supporting & Related Material GDL-Guidance 2005-07-27T04:00:00Z 2005 7     2008-04-11T23:46:41Z   0 0 090000648043fe9b
FDA-2005-D-0140-0001 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 FDA Notice NAD-Notice of Availability of Data 2005-07-27T04:00:00Z 2005 7 2005-07-26T04:00:00Z 2005-10-26T03:59:59Z 2008-04-11T23:46:40Z   0 0 090000648043fe9a

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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);