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

17 rows where docket_id = "FDA-2011-N-0830" sorted by posted_date descending

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posted_year 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-N-0830-0030 FDA None FDA-2011-N-0830 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:32:16Z 2016-30351 0 0 0900006482423485
FDA-2011-N-0830-0029 FDA None FDA-2011-N-0830 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) Applications Notice Notice of Approval 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2016-11-29T16:14:37Z 2016-28655 0 0 09000064823c607f
FDA-2011-N-0830-0027 FDA None FDA-2011-N-0830 Reference 2-4 - U.S. Dept of Commerce, Bureau of the Census, Economic Census, Manuf Summary Series. General Summary Industry Stats for Subsectors and Industries by Employment Size 2007 re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2016-10-06T04:00:00Z 2016 10     2016-10-06T15:54:27Z   0 0 09000064822a0d51
FDA-2011-N-0830-0024 FDA None FDA-2011-N-0830 Reference 2 -1 - Final Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for ANDAs and 505(b)(2) Apps; Final Rule re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2016-10-06T04:00:00Z 2016 10     2016-10-06T15:46:41Z   0 0 09000064822a0aac
FDA-2011-N-0830-0022 FDA None FDA-2011-N-0830 Abbreviated New Drug Applications and 505(b)(2) Applications Rule Final Rule 2016-10-06T04:00:00Z 2016 10 2016-10-06T04:00:00Z   2016-10-06T15:06:45Z 2016-22690 0 0 090000648229ee69
FDA-2011-N-0830-0028 FDA None FDA-2011-N-0830 Reference 2-5 - U.S. Department of Health & Human Services, “Guidance on Proper Consideration of Small Entities in Rulemakings of the U.S. Department of Health and Human Services,” May 2003 re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2016-10-06T04:00:00Z 2016 10     2016-10-06T16:03:14Z   0 0 09000064822a0d52
FDA-2011-N-0830-0025 FDA None FDA-2011-N-0830 Reference 2-2 - Bureau of Labor Statistics (BLS). 2016. May 2015 National Industry-Specific Occupational Employment and Wage Estimates for NAICS 325400 - Pharmal and Medicine Manufacturing Supporting & Related Material Background Material 2016-10-06T04:00:00Z 2016 10     2016-10-06T15:50:38Z   0 0 09000064822a0d4f
FDA-2011-N-0830-0023 FDA None FDA-2011-N-0830 Reference 1 - Federal Trade Commission, Report on “Generic Drug Entry Prior to Patent Expiration An FTC Study” (July 2002) re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2016-10-06T04:00:00Z 2016 10     2016-10-06T15:45:47Z   0 0 09000064822a0aab
FDA-2011-N-0830-0026 FDA None FDA-2011-N-0830 Reference 2-3 - U.S. Dept of Commerce, Bureau of the Census, Economic Census Manuf Summary Series. General Summary Industry Stats for Subsectors and Industries by Employment Size 2012 re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2016-10-06T04:00:00Z 2016 10     2016-10-06T15:53:02Z   0 0 09000064822a0d50
FDA-2011-N-0830-0008 FDA None FDA-2011-N-0830 Abbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period Proposed Rule Extension of Comment Period 2015-04-24T04:00:00Z 2015 4 2015-04-24T04:00:00Z 2015-06-09T03:59:59Z 2015-06-10T01:30:47Z 2015-09523 0 0 0900006481ab8547
FDA-2011-N-0830-0007 FDA None FDA-2011-N-0830 Request for Extension from Generic Pharmaceutical Association (GPhA) Other Request for Extension 2015-04-03T04:00:00Z 2015 4 2015-04-03T04:00:00Z   2015-04-03T14:28:29Z   0 0 0900006481a4313f
FDA-2011-N-0830-0006 FDA None FDA-2011-N-0830 Request for Extension from Teva Pharmaceuticals Other Request for Extension 2015-04-03T04:00:00Z 2015 4 2015-04-03T04:00:00Z   2015-04-03T14:19:47Z   0 0 0900006481a3f782
FDA-2011-N-0830-0005 FDA None FDA-2011-N-0830 Abbreviated New Drug Applications and 505(b)(2) Applications Proposed Rule Correction 2015-03-13T04:00:00Z 2015 3 2015-03-13T04:00:00Z   2015-03-13T16:28:12Z C1-2015-01666 0 0 0900006481a4296e
FDA-2011-N-0830-0004 FDA None FDA-2011-N-0830 Reference 2 - Pharmaceutical Preparation Manufacturing 2002, Economic Census Manufacturing Industry Series re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2015-02-06T05:00:00Z 2015 2     2015-02-06T16:37:42Z   0 0 09000064819f8606
FDA-2011-N-0830-0002 FDA None FDA-2011-N-0830 List of References re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2015-02-06T05:00:00Z 2015 2     2015-02-06T16:37:25Z   0 0 09000064819f8604
FDA-2011-N-0830-0001 FDA None FDA-2011-N-0830 Abbreviated New Drug Applications and 505(b)(2) Applications Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-02-06T05:00:00Z 2015 2 2015-02-06T05:00:00Z 2015-05-08T03:59:59Z 2015-04-10T02:06:25Z 2015-01666 0 0 09000064819f78d2
FDA-2011-N-0830-0003 FDA None FDA-2011-N-0830 Reference 1 - ANDAs and 505(b)(2) Applications Docket No. FDA-2011-N-0830 Preliminary Regulatory Impact Analysis Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2015-02-06T05:00:00Z 2015 2     2015-02-06T16:37:36Z   0 0 09000064819f8605

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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;