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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

27 rows where docket_id = "FDA-2000-P-0133" and posted_year = 2011 sorted by posted_date descending

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document_type 3

  • Other 13
  • Supporting & Related Material 12
  • Proposed Rule 2

posted_year 1

  • 2011 · 27 ✖

agency_id 1

  • FDA 27
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2000-P-0133-0050 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the Comment Period Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-08-11T04:00:00Z 2011 8 2011-08-11T04:00:00Z 2011-10-26T03:59:59Z 2011-08-11T14:44:41Z 2011-20406 0 0 0900006480eddb33
FDA-2000-P-0133-0047 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 List of References 31-69 - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease] Supporting & Related Material BKG- Background Material (internal references) 2011-03-25T04:00:00Z 2011 3     2011-03-25T21:03:47Z   0 0 0900006480befe54
FDA-2000-P-0133-0046 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Acknowledgement Letter to Botanical Laboratories, Inc. (Kleinfeld Kaplan and Becker, LLP) Other ACK-Acknowledgement Letter 2011-03-24T04:00:00Z 2011 3 2011-03-24T04:00:00Z   2013-07-27T23:48:11Z   0 0 0900006480c0df46
FDA-2000-P-0133-0045 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Botanical Laboratories, Inc. (Kleinfeld Kaplan and Becker, LLP) - Petition for Stay Other PSA-Petition for Stay 2011-03-24T04:00:00Z 2011 3 2011-03-24T04:00:00Z   2013-08-11T03:13:44Z   0 0 0900006480c0ba3b
FDA-2000-P-0133-0043 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Exhibit D - "Kevin C. Maki, Ph.D. - Curriculum Vitae" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2000-P-0133-0040 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-03-04T05:00:00Z 2011 3     2011-03-04T23:33:59Z   0 0 0900006480c0111d
FDA-2000-P-0133-0040 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition Other CP-Citizen Petition 2011-03-04T05:00:00Z 2011 3 2011-03-04T05:00:00Z   2024-11-07T22:28:35Z   1 0 0900006480bfae26
FDA-2000-P-0133-0044 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Acknowledgement Letter to Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) Other ACK-Acknowledgement Letter 2011-03-04T05:00:00Z 2011 3 2011-03-04T05:00:00Z   2013-07-27T23:46:13Z   0 0 0900006480bfae28
FDA-2000-P-0133-0041 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Exhibit A - "Container and Carton Label for Nature Made® Cholestoff®" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2000-P-0133-0040 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-03-04T05:00:00Z 2011 3     2011-03-04T23:33:56Z   0 0 0900006480c0084b
FDA-2000-P-0133-0042 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Exhibit C - "Maki, et al., A Plant Sterol/Stanol Supplement in Tablet Form Lowers LDL and Non-HDL Cholesterol in Men and Woman with Primary Hypercholesterolemia (Poster)" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2000-P-0133-0040 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-03-04T05:00:00Z 2011 3     2011-03-04T23:33:57Z   0 0 0900006480c0084d
FDA-2000-P-0133-0038 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Exhibit D - "Kevin C. Maki, Ph.D. - Curriculum Vitae" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2000-P-0133-0035 Supporting & Related Material PSA- Petition for Stay (Supporting and Related Material) 2011-03-02T05:00:00Z 2011 3     2011-03-02T20:23:58Z   0 0 0900006480bfd1d7
FDA-2000-P-0133-0035 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Petition for Stay of Action Other PSA-Petition for Stay 2011-03-02T05:00:00Z 2011 3 2011-03-02T05:00:00Z   2013-08-11T01:40:09Z   0 0 0900006480bfa3f2
FDA-2000-P-0133-0037 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Exhibit C - "Maki, et al., A Plant Sterol/Stanol Supplement in Tablet Form Lowers LDL and Non-HDL Cholesterol in Men and Woman with Primary Hypercholesterolemia (Poster)" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2000-P-0133-0035 Supporting & Related Material PSA- Petition for Stay (Supporting and Related Material) 2011-03-02T05:00:00Z 2011 3     2011-03-02T20:24:25Z   0 0 0900006480bfa43b
FDA-2000-P-0133-0039 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Acknowledgement Letter to Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) Other ACK-Acknowledgement Letter 2011-03-02T05:00:00Z 2011 3 2011-03-02T05:00:00Z   2013-08-11T01:40:09Z   0 0 0900006480bfa423
FDA-2000-P-0133-0036 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Exhibit A - "Container and Carton Label for Nature Made® Cholestoff®" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2000-P-0133-0035 Supporting & Related Material PSA- Petition for Stay (Supporting and Related Material) 2011-03-02T05:00:00Z 2011 3     2011-03-02T20:24:48Z   0 0 0900006480bfa428
FDA-2000-P-0133-0028 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Reference - "Letter of Enforcement Discretion From FDA to Cargill Health & Food Technologies" - [Health Claim; Phytosterols and Risk of Coronary Heart Disease] re FDA-2000-P-0133-0025 Supporting & Related Material REF-Reference (internal unless indicated) 2011-02-28T05:00:00Z 2011 2     2011-02-28T21:01:53Z   0 0 0900006480bf13be
FDA-2000-P-0133-0029 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Attachment 4 - "On Nutrition and Health Claims Made on Food" - [Innoceutics bvba-llC University of Ghent - Comment] re FDA-FDA-2000-P-0133-0027 Supporting & Related Material C-Comment (Supporting and Related Material) 2011-02-28T05:00:00Z 2011 2     2011-02-28T22:02:59Z   0 0 0900006480bfad82
FDA-2000-P-0133-0030 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Attachment 5 - "On the Authorisation of Certain Health Claims Made on Food and Referring to the Reduction of Disease Risk an to Children's Development and Health " - [Innoceutics bvba-llC University of Ghent - Comment] re FDA-2000-P-0133-0027 Supporting & Related Material C-Comment (Supporting and Related Material) 2011-02-28T05:00:00Z 2011 2     2011-02-28T22:04:12Z   0 0 0900006480bfad83
FDA-2000-P-0133-0031 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Attachment 6 - "Amending Regulation (EC) No. 983/2009 on the Authorisation and Refusal of Authorisation of Certain Health Claims Made on Food and Referring to the Reduction of Disease Risk and to Children's Development and Health" - [Innoceutics bvba-llC University of Ghent - Comment] re FDA-2000-P-0133-0027 Supporting & Related Material C-Comment (Supporting and Related Material) 2011-02-28T05:00:00Z 2011 2     2011-02-28T22:05:12Z   0 0 0900006480bfad84
FDA-2000-P-0133-0026 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Reference - "Letter of Enforcement Discretion From FDA to Cargill Health & Food Technologies, February 14, 2003" - [Extension of Enforcement Discretion: Health Claim, Phytosterols and Risk of Coronary Heart Disease] Supporting & Related Material BKG-Background Material 2011-02-18T05:00:00Z 2011 2     2011-02-18T23:19:29Z   0 0 0900006480bf251f
FDA-2000-P-0133-0025 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Health Claim; Phytosterols and Risk of Coronary Heart Disease Proposed Rule NEC-Notice of Extension 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z 2011-04-20T03:59:59Z 2011-02-28T20:59:23Z 2011-3678 0 0 0900006480bf251c
FDA-2000-P-0133-0023 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Venable LLP - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2011-02-15T05:00:00Z 2011 2 2011-02-15T05:00:00Z   2013-07-27T23:45:23Z   0 0 0900006480befd94
FDA-2000-P-0133-0022 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Venable, LLP - Request for Extension of Comment Due Date Other EXT-Request for Extension Comment Due Date 2011-02-14T05:00:00Z 2011 2 2010-12-08T05:00:00Z 2011-02-12T04:59:59Z 2013-07-27T23:44:52Z   0 0 0900006480bec04f
FDA-2000-P-0133-0019 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Fommer Lawrence & Haug LLP (Pharmachem Laboratories, Inc.) - Petition for Stay Other PSA-Petition for Stay 2011-02-01T05:00:00Z 2011 2 2011-02-01T05:00:00Z   2013-08-11T01:39:31Z   0 0 0900006480bd6ec6
FDA-2000-P-0133-0020 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Acknowledgement Letter to Fommer Lawrence & Haug LLP (Pharmachem Laboratories, Inc.) Other ACK-Acknowledgement Letter 2011-02-01T05:00:00Z 2011 2 2011-02-01T05:00:00Z   2013-07-27T23:43:59Z   0 0 0900006480bd6f6b
FDA-2000-P-0133-0018 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Acknowledgement Letter to Covington & Burling (Cargill Inc.) Other ACK-Acknowledgement Letter 2011-01-10T05:00:00Z 2011 1 2011-01-10T05:00:00Z   2013-07-27T23:42:02Z   0 0 0900006480bc81d6
FDA-2000-P-0133-0017 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Covington & Burling (Cargill Inc.) - Petition for Stay of Action Other PSA-Petition for Stay 2011-01-10T05:00:00Z 2011 1 2011-01-10T05:00:00Z   2024-11-12T04:58:05Z   1 0 0900006480bc81d4
FDA-2000-P-0133-0016 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 Council for Responsible Nutrition - Letter Other LET-Letter 2011-01-10T05:00:00Z 2011 1 2011-01-10T05:00:00Z   2013-07-27T23:42:02Z   0 0 0900006480bc81d2

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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);
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