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-2004-N-0061" sorted by posted_date descending

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posted_year 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2004-N-0061-0056 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 See FDA-2004-N-0061-0002 Rule Final Rule 2011-08-22T04:00:00Z 2011 8 2011-08-22T04:00:00Z   2011-08-22T17:51:39Z   0 0 0900006480ee8af2
FDA-2004-N-0061-0031 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Citizen Petition et al Denial Response from FDA CDER to Robert Reinhard Other Denial of Petition 2008-10-27T04:00:00Z 2008 10 2008-10-27T04:00:00Z   2016-02-04T20:24:29Z   0 0 090000648077f414
FDA-2004-N-0061-0014 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Letter from Robert Reinhard Other Electronic Letter 2008-07-13T04:00:00Z 2008 7 2008-07-13T04:00:00Z   2016-02-04T17:59:13Z   0 0 0900006480657958
FDA-2004-N-0061-0012 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Acknowlegement Letter from FDA DDM to Robert Reinhard re: Petition for Stay of Action Other Acknowledgement Letter/Receipt 2008-06-30T04:00:00Z 2008 6 2008-06-30T04:00:00Z   2016-02-05T14:15:19Z   0 0 090000648061cf34
FDA-2004-N-0061-0013 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Letter from Robert Reinhard to FDA DDM Other Letter(s) 2008-06-30T04:00:00Z 2008 6 2008-06-30T04:00:00Z   2016-02-04T17:57:07Z   0 0 090000648061cf4c
FDA-2004-N-0061-0009 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Citizen Petition from Robert Reinhard Other Citizen Petition 2008-06-30T04:00:00Z 2008 6 2008-06-30T04:00:00Z   2016-02-04T19:43:39Z   0 0 090000648061ce38
FDA-2004-N-0061-0004 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Tab A Initial Draft (FRN) Submitted to OMB OIRA for Review re: Human Subject Protection; Foreign Clinical Studies not Conducted under an Investigational New Drug Application Supporting & Related Material Background Material 2008-06-30T04:00:00Z 2008 6     2016-02-05T15:43:31Z   0 0 090000648046ec02
FDA-2004-N-0061-0007 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Regulations Policy and Management Staff [Human Subject Protection; Foreign Clinical Studies not Conducted Under an Investigational New Drug Application] OMB/OIRA Review Supporting & Related Material Background Material 2008-06-30T04:00:00Z 2008 6     2016-02-04T17:00:34Z   0 0 0900006480607c8d
FDA-2004-N-0061-0010 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Acknowledgement Letter from FDA DDM to Robert Reinhard re: Citizen Petition Other Acknowledgement Letter/Receipt 2008-06-30T04:00:00Z 2008 6 2008-06-30T04:00:00Z   2016-02-05T14:13:26Z   0 0 090000648061cede
FDA-2004-N-0061-0011 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Petition for Stay of Action from Robert Reinhard Other Petition(s) 2008-06-30T04:00:00Z 2008 6 2008-06-30T04:00:00Z   2016-02-04T19:55:18Z   0 0 090000648061cf0a
FDA-2004-N-0061-0008 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Objection to Rule and Request for a Hearing from Robert Reinhard Other Objection(s) 2008-06-30T04:00:00Z 2008 6 2008-06-30T04:00:00Z   2016-02-05T14:11:17Z   0 0 090000648061ce08
FDA-2004-N-0061-0005 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Tab B Changes of Initial Draft (FRN) Submitted to OIRA for Review and Action re: Human Subject Protection; Foreign Clinical Studies not Conducted under an Investigational New Drug Application Supporting & Related Material Background Material 2008-06-30T04:00:00Z 2008 6     2016-02-05T15:48:34Z   0 0 090000648046ec03
FDA-2004-N-0061-0003 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Regulations Policy and Management Staff [Human Subject Protection; Foreign Clinical Studies not Conducted Under an Investigational New Drug Application] OMB/OIRA Review Supporting & Related Material Background Material 2008-06-30T04:00:00Z 2008 6     2016-02-05T15:36:02Z   0 0 090000648046ec01
FDA-2004-N-0061-0002 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule Rule Final Rule 2008-04-28T04:00:00Z 2008 4 2008-04-28T04:00:00Z   2016-02-04T16:49:48Z E8-09200 0 0 0900006480537f08
FDA-2004-N-0061-0001 FDA Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application FDA-2004-N-0061 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Proposed Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2004-06-14T04:00:00Z 2004 6 2004-06-09T04:00:00Z 2004-09-09T03:59:59Z 2016-02-05T22:00:35Z   0 0 090000648046ebfe

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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);