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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

16 rows where docket_id = "FDA-2003-N-0313" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 16 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-N-0313-0023 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Tab A Initial Draft (FRN) Submitted to OMB and OIRA for Review re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-08T05:00:00Z 2016 2     2016-02-08T16:27:09Z   0 0 0900006480494f03
FDA-2003-N-0313-0025 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Tab C Recommendations of from OIRA for Review and Action re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-08T05:00:00Z 2016 2     2016-02-08T16:28:40Z   0 0 0900006480494f0b
FDA-2003-N-0313-0022 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Regulations Policy and Management Staff re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products OMB and OIRA Review Supporting & Related Material Background Material 2016-02-08T05:00:00Z 2016 2     2016-02-08T16:26:32Z   0 0 0900006480494f08
FDA-2003-N-0313-0024 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Tab B Changes of Initial Draft (FRN) Submitted to OIRA for Review and Action re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-08T05:00:00Z 2016 2     2016-02-08T16:28:03Z   0 0 0900006480494efe
FDA-2003-N-0313-0014 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 3 "Sources of Receipts or Revenue, 1997 Economic Census, Health Care and Social Assistance, Subject Series," U.S. Dept of Commerce Publication No. EC97S62S-LS, August 2000 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:06:29Z   0 0 0900006480494ede
FDA-2003-N-0313-0012 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 1 "2001 Industry Facts-at-a-Glance," National Association of Chain Drug Stores, http://www.nacds.org re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T17:35:09Z   0 0 0900006480494ed6
FDA-2003-N-0313-0020 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 13 Pharmaceutical Preparation Manufacturing, 1997 Economic Census, Manufacturing, Industry Series," U.S. Dept of Commerce, Publication No. EC97M-3254B, November 1999 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:09:06Z   0 0 0900006480494ecc
FDA-2003-N-0313-0021 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 14 Statistics of U.S. Businesses: 1999, Pharmaceutical Preparation Manufacturing, U.S. Dept of Commerce, www.census.gov/epcd/susb/1999/us/US325412.htm re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:09:28Z   0 0 0900006480494ed9
FDA-2003-N-0313-0016 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 5 "2000 National Occupational Employment and Wage Estimates," U.S. Dept of Labor, Bureau of Labor Statistics, http://www.bls.gov.oes/2OOO/oes292O52.htm re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:06:58Z   0 0 0900006480494ee4
FDA-2003-N-0313-0015 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 4 Svarstad, B. et al., "Evaluation of Written Prescription Information Provided in Community Pharmacies 2001," Final report to FDA, December 21, 2001 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:06:45Z   0 0 0900006480494ee1
FDA-2003-N-0313-0017 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 7 GAO Adverse Drug Events The Magnitude of Health Risk is Uncertain Because of Limited Incidence Data January 2000 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:07:35Z   0 0 0900006480494eea
FDA-2003-N-0313-0013 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 2 "'Summary 1997 Economic Census, Retail Trade," U.S. Dept of Commerce Publication No. EC97R44S-SM, January 2001 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T17:35:39Z   0 0 0900006480494eb9
FDA-2003-N-0313-0018 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 11 Establishment and Firm Size, 1997 Economic Census, Retail Trade," U.S. Dept of Commerce Publication No. EC97R44S-SZ October 2000 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:07:54Z   0 0 0900006480494edb
FDA-2003-N-0313-0019 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 Reference 12 Establishment and Firm Size, 1997 Economic Census, Health Care and Social Assistance, Subject Series," Dept of Commerce, Publication EC97S62S-SZ, October 2000 re: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:08:51Z   0 0 0900006480494ecf
FDA-2003-N-0313-0011 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 List of References - Table of Contents re: Toll-free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-05T05:00:00Z 2016 2     2016-02-05T18:06:00Z   0 0 0900006480494ed4
FDA-2003-N-0313-0010 FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products FDA-2003-N-0313 References for Proposed Rule: Toll-free Number for Reporting Adverse Events on Labeling for Human Drug Products Supporting & Related Material Background Material 2016-02-04T05:00:00Z 2016 2     2016-02-05T18:05:42Z   0 0 0900006480494ed1

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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;