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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

28 rows where docket_id = "FDA-2009-N-0592" sorted by posted_date descending

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document_type 4

  • Supporting & Related Material 25
  • Other 1
  • Proposed Rule 1
  • Rule 1

posted_year 2

  • 2011 23
  • 2009 5

agency_id 1

  • FDA 28
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0592-0091 FDA None FDA-2009-N-0592 OMB Review, Executive Order 12866 (E.O.)[Informed Consent Elements, January 4, 2011 (76 FR 256) ] - Reference Other REF-Reference 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2013-08-11T04:44:17Z   0 0 0900006480bf16bc
FDA-2009-N-0592-0076 FDA None FDA-2009-N-0592 Reference 9a - "Mayo Clinic Informed Consent, IRB Consent Form..." - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:17Z   0 0 0900006480bc2082
FDA-2009-N-0592-0084 FDA None FDA-2009-N-0592 Reference 9i - "American College of Radiology Imaging Network (ACRIN), Protocol Development & Regulatory Resources, Sample Consent Research Study" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:13Z   0 0 0900006480bc3de2
FDA-2009-N-0592-0079 FDA None FDA-2009-N-0592 Reference 9d - "University of Michigan Consent To Be Part of a Research Study" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:15Z   0 0 0900006480bc208f
FDA-2009-N-0592-0081 FDA None FDA-2009-N-0592 Reference 9f - "Children's Hospital Boston, Research Consent Form" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:15Z   0 0 0900006480bc2095
FDA-2009-N-0592-0077 FDA None FDA-2009-N-0592 Reference 9b - "Stanford University Research Consent Form" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:17Z   0 0 0900006480bc2083
FDA-2009-N-0592-0078 FDA None FDA-2009-N-0592 Reference 9c - "Duke University Health System Consent to Participate in a Research Study" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:10Z   0 0 0900006480bc208e
FDA-2009-N-0592-0087 FDA None FDA-2009-N-0592 Reference 13 - "FDA: A Guide to Informed Consent--Information Sheet" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:17Z   0 0 0900006480bc3e0d
FDA-2009-N-0592-0074 FDA None FDA-2009-N-0592 Reference 4 - "Trials of War Criminals, Nuernberg Military Tribunals, Nuernberg Code" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:13Z   0 0 0900006480bc207b
FDA-2009-N-0592-0085 FDA None FDA-2009-N-0592 Reference 9j - "National Cancer Institute Templates, Informed Consent Template for Cancer Treatment Trials, August 2009" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:16Z   0 0 0900006480bc3de5
FDA-2009-N-0592-0071 FDA None FDA-2009-N-0592 Reference 1 - "Protection of Human Subjects;Informed Consent, Federal Register Volume 46 Number 17, Tuesday. January 27, 1981" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:12Z   0 0 0900006480bc1ee7
FDA-2009-N-0592-0072 FDA None FDA-2009-N-0592 Reference 2 - "The Belmont Report..., April 18, 1979" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:12Z   0 0 0900006480bc1ee9
FDA-2009-N-0592-0080 FDA None FDA-2009-N-0592 Reference 9e - "Informed Consent to Participate in Research, University of Texas at Austin" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:16Z   0 0 0900006480bc2094
FDA-2009-N-0592-0089 FDA None FDA-2009-N-0592 Reference 15 - "Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable, April 25, 2006" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:11Z   0 0 0900006480bc3e0f
FDA-2009-N-0592-0090 FDA None FDA-2009-N-0592 Reference 16 - "NIH: ClinicalTrials.gov “Basic Results Data Element Definitions (DRAFT), February 2010" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:14Z   0 0 0900006480bc3e10
FDA-2009-N-0592-0075 FDA None FDA-2009-N-0592 Reference 6 - "World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:14Z   0 0 0900006480bc207f
FDA-2009-N-0592-0070 FDA None FDA-2009-N-0592 Reference List, (References 1-16) - [Informed Consent Elements; Final Rule] re FDA-2009-N-0592-0069 Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:11Z   0 0 0900006480bc480b
FDA-2009-N-0592-0073 FDA None FDA-2009-N-0592 Reference 3 - "National Research Act PL93-348" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:15Z   0 0 0900006480bc207a
FDA-2009-N-0592-0086 FDA None FDA-2009-N-0592 Reference 12 - "FDA, Office of Planning, Risk Communication Staff, Analysis Note, July 30, 2010, Informal Testing of Clinical Trials Informed Consent Statement" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:12Z   0 0 0900006480bc3e0c
FDA-2009-N-0592-0088 FDA None FDA-2009-N-0592 Reference 14 - "NIH-PRS Information: U.S. Public Law 110-85" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:11Z   0 0 0900006480bc3e0e
FDA-2009-N-0592-0083 FDA None FDA-2009-N-0592 Reference 9h - "Walter Reed Army Medical Center, NCA Templates "Informed Consent Form" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:13Z   0 0 0900006480bc2f0e
FDA-2009-N-0592-0069 FDA None FDA-2009-N-0592 Informed Consent Elements Rule NFR-Notice of Final Rule 2011-01-04T05:00:00Z 2011 1 2011-01-04T05:00:00Z   2011-06-11T16:28:13Z 2010-33193 0 0 0900006480bc4ae4
FDA-2009-N-0592-0082 FDA None FDA-2009-N-0592 Reference 9g - "Partners HealthCare System Research Consent Form, February 2010" - [Informed Consent Elements; Final Rule] Supporting & Related Material BKG-Background Material 2011-01-04T05:00:00Z 2011 1     2011-06-11T16:28:16Z   0 0 0900006480bc2096
FDA-2009-N-0592-0004 FDA None FDA-2009-N-0592 Reference 3 - ‘‘National Research Act, Title II (Public Law 93–348, July 12, 1974)" - [Informed Consent Elements] Supporting & Related Material BKG-Background Material 2009-12-30T05:00:00Z 2009 12     2010-03-04T04:00:30Z   0 0 0900006480a733d4
FDA-2009-N-0592-0002 FDA None FDA-2009-N-0592 Reference 1 - ‘‘Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, Vol. 2, pp. 181–182. Office, 1949" - [Informed Consent Elements] Supporting & Related Material BKG-Background Material 2009-12-30T05:00:00Z 2009 12     2010-03-04T03:57:45Z   0 0 0900006480a7336d
FDA-2009-N-0592-0003 FDA None FDA-2009-N-0592 Reference 2 - "World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects" - [Informed Consent Elements] Supporting & Related Material BKG-Background Material 2009-12-30T05:00:00Z 2009 12     2010-03-04T03:59:28Z   0 0 0900006480a733cd
FDA-2009-N-0592-0005 FDA None FDA-2009-N-0592 Reference 4 - ‘‘National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, ‘‘The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research’’ - [Informed Consent Elements] Supporting & Related Material BKG-Background Material 2009-12-30T05:00:00Z 2009 12     2010-03-04T04:01:40Z   0 0 0900006480a7340b
FDA-2009-N-0592-0001 FDA None FDA-2009-N-0592 Informed Consent Elements Proposed Rule NPR-Notice of Proposed Rule-Making 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z 2010-03-02T04:59:59Z 2011-06-11T16:28:10Z E9-30751 0 0 0900006480a7316e

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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;
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