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

47 rows where agency_id = "FDA", document_type = "Proposed Rule" and posted_year = 2011 sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: subtype, posted_month, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 1

  • 2011 · 47 ✖

document_type 1

  • Proposed Rule · 47 ✖

agency_id 1

  • FDA · 47 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0467-0008 FDA FDA-2011-N-0467 Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products; Extension of Comment Period Proposed Rule Notice of Extension 2011-12-06T05:00:00Z 2011 12 2011-12-06T05:00:00Z 2012-01-20T04:59:59Z 2012-02-02T20:27:07Z 2011-31225 0 0 0900006480f7c538
FDA-1997-P-0417-0009 FDA Harmonize the agency's acceptable document delivery methods. FDA-1997-P-0417 New Drugs for Human Use; Clarification of Requirements for Patent Holder Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-11-21T05:00:00Z 2011 11 1998-03-08T05:00:00Z 1998-06-05T03:59:59Z 2025-01-31T21:08:23Z 98 5800 0 0 09000064805d4291
FDA-2011-N-0493-0001 FDA FDA-2011-N-0493 Restrictions on the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-11-17T05:00:00Z 2011 11 2011-11-17T05:00:00Z 2012-02-01T04:59:59Z 2011-11-17T18:26:10Z 2011-29702 0 0 0900006480f6e64c
FDA-2011-N-0729-0001 FDA FDA-2011-N-0729 Microbiology Devices: Classification of In Vitro Diagnostic Device for Yersinia Species Detection Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-11-07T05:00:00Z 2011 11 2011-11-07T05:00:00Z 2012-02-07T04:59:59Z 2011-11-07T16:35:32Z 2011-28724 0 0 0900006480f6709f
FDA-2011-N-0583-0001 FDA FDA-2011-N-0583 Orphan Drug Regulations Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-10-19T04:00:00Z 2011 10 2011-10-19T04:00:00Z 2012-01-18T04:59:59Z 2011-10-19T20:37:45Z 2011-27037 0 0 0900006480f55c83
FDA-2011-N-0650-0001 FDA FDA-2011-N-0650 Cardiovascular Devices: Reclassification of External Pacemaker Pulse Generator Devices Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-10-17T04:00:00Z 2011 10 2011-10-17T04:00:00Z 2012-01-18T04:59:59Z 2011-10-17T13:19:24Z 2011-26625 0 0 0900006480f54001
FDA-1978-N-0018-0706 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Sunscreen Drug Products for Over-the-Counter Human Use: Request for Data and Information Regarding Dosage Forms; Extension of Comment Period Proposed Rule Notice of Extension 2011-09-14T04:00:00Z 2011 9 2011-09-14T04:00:00Z 2011-10-18T03:59:59Z 2012-03-24T19:28:47Z 2011-23479 0 0 0900006480f19657
FDA-2011-N-0467-0001 FDA FDA-2011-N-0467 Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2011-09-09T04:00:00Z 2011 9 2011-09-09T04:00:00Z 2011-12-09T04:59:59Z 2011-09-09T14:09:10Z 2011-23096 0 0 0900006480f14d3c
FDA-2011-S-0009-0002 FDA FDA-2011-S-0009 Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of Comment Period Proposed Rule Extension of Comment Period 2011-09-01T04:00:00Z 2011 9 2011-09-01T04:00:00Z   2011-09-01T14:11:29Z 2011-22341 0 0 0900006480f0df90
FDA-2011-N-0505-0002 FDA FDA-2011-N-0505 Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode; Correction Proposed Rule Correction 2011-08-30T04:00:00Z 2011 8 2011-08-30T04:00:00Z   2012-03-24T19:28:48Z 2011-22107 0 0 0900006480f09106
FDA-2000-P-0102-0055 FDA Health Claim: Vegetable Oil Sterol Esters & Coronary Heart Disease CLOSED 05/26/2020 FDA-2000-P-0102 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 2011-08-11T14:38:52Z 2011-20406 0 0 0900006480eddf11
FDA-2006-P-0033-0055 FDA Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 FDA-2006-P-0033 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 2011-08-11T14:47:58Z 2011-20406 0 0 0900006480eddb34
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-2011-N-0505-0001 FDA FDA-2011-N-0505 Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-08-08T04:00:00Z 2011 8 2011-08-08T04:00:00Z 2011-11-08T04:59:59Z 2011-08-08T13:56:21Z 2011-19959 0 0 0900006480ed9ebf
FDA-2011-N-0504-0001 FDA FDA-2011-N-0504 Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-08-08T04:00:00Z 2011 8 2011-08-08T04:00:00Z 2011-11-08T04:59:59Z 2011-08-24T16:36:04Z 2011-19957 0 0 0900006480ed9ea7
FDA-2011-N-0526-0001 FDA FDA-2011-N-0526 Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-08-04T04:00:00Z 2011 8 2011-08-04T04:00:00Z 2011-11-03T03:59:59Z 2011-08-04T15:12:53Z 2011-19733 0 0 0900006480ed6ee5
FDA-2005-N-0404-0135 FDA Food Labeling; Gluten-Free Labeling of Foods-CLOSED FDA-2005-N-0404 Food Labeling: Gluten-Free Labeling of Foods; Reopening of Comment Period Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-08-03T04:00:00Z 2011 8 2011-08-03T04:00:00Z 2011-10-04T03:59:59Z 2011-09-21T21:41:05Z 2011-19620 0 0 0900006480ed4ad8
FDA-2011-N-0522-0001 FDA FDA-2011-N-0522 Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-07-27T04:00:00Z 2011 7 2011-07-27T04:00:00Z 2011-10-26T03:59:59Z 2011-07-27T16:47:13Z 2011-18957 0 0 0900006480ecd3f2
FDA-2011-S-0009-0001 FDA FDA-2011-S-0009 Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2011-07-26T04:00:00Z 2011 7 2011-07-26T04:00:00Z 2011-09-27T03:59:59Z 2012-07-30T15:07:20Z 2011-18792 0 0 0900006480ecb7f2
FDA-2011-N-0446-0001 FDA FDA-2011-N-0446 Removal of Certain Requirements Related to Prescription Drug Marketing Act: Opportunity for Public Comment Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-07-14T04:00:00Z 2011 7 2011-07-14T04:00:00Z 2011-09-13T03:59:59Z 2011-07-14T13:29:56Z 2011-17696 0 0 0900006480ec1bf6
FDA-2011-F-0171-0113 FDA FDA-2011-F-0171 Food Labeling: Calorie Labeling of Articles of Food in Vending Machines; Correction Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-06-27T04:00:00Z 2011 6 2011-06-27T04:00:00Z   2015-02-20T20:10:55Z 2011-15983 0 0 0900006480eb4100
FDA-2011-N-0080-0001 FDA FDA-2011-N-0080 Sterility Test Requirements for Biological Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-06-21T04:00:00Z 2011 6 2011-06-21T04:00:00Z 2011-09-20T03:59:59Z 2011-06-21T13:35:14Z 2011-15346 0 0 0900006480e6a0e9
FDA-1990-N-0025-0004 FDA Food Labeling, Declaration of Ingredients FDA-1990-N-0025 Food Labeling, Declaration of Ingredients (See FDA-1990-N-0025-0002) Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-06-17T04:00:00Z 2011 6 2011-06-17T04:00:00Z   2024-11-07T22:30:55Z   1 0 0900006480e51f8b
FDA-1978-N-0018-0697 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-06-17T04:00:00Z 2011 6 2011-06-17T04:00:00Z 2011-09-16T03:59:59Z 2011-08-12T15:28:51Z 2011-14768 0 0 0900006480e51fc3
FDA-1978-N-0018-0699 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-06-17T04:00:00Z 2011 6 2011-06-17T04:00:00Z 2011-09-16T03:59:59Z 2012-02-08T21:51:20Z 2011-14769 0 0 0900006480e52098
FDA-1998-N-1016-0001 FDA General Requirements for Blood, Blood Components and Derivati FDA-1998-N-1016 Notice of Proposed Rule-Making re General Requirements for Blood, Blood Components, and Blood Derivatives; Notification of Deferred Donors Proposed Rule NPR-Notice of Proposed Rule-Making 2011-06-03T04:00:00Z 2011 6 2011-06-03T04:00:00Z 1999-11-18T04:59:59Z 2015-12-07T15:01:57Z   0 0 09000064805a29f6
FDA-2011-F-0172-0235 FDA FDA-2011-F-0172 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Proposed Rule NEC-Notice of Extension 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z 2011-07-06T03:59:59Z 2011-07-13T20:31:42Z 2011-12736 0 0 0900006480e30f32
FDA-2011-F-0172-0234 FDA FDA-2011-F-0172 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Correction Proposed Rule NCR-Notice of Correction 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2011-06-11T16:30:33Z 2011-12735 0 0 0900006480e30f4a
FDA-1993-N-0065-0012 FDA Safe Processing & Importing of Fish & Fishery Products FDA-1993-N-0065 Proposal to Establish Procedures for the Safe Processing & Importing of Fish & Fishery Products Proposed Rule NCR-Notice of Correction 2011-05-18T04:00:00Z 2011 5 2011-05-18T04:00:00Z 1994-04-29T03:59:59Z 2011-05-18T19:05:29Z   0 0 09000064804fcb70
FDA-2011-N-0103-0001 FDA FDA-2011-N-0103 Microbiology Devices: Classification of In Vitro Diagnostic Device for Bacillus Species Detection Proposed Rule NPR-Notice of Proposed Rule-Making 2011-05-18T04:00:00Z 2011 5 2011-05-18T04:00:00Z 2011-08-17T03:59:59Z 2011-05-18T13:52:27Z 2011-12088 0 0 0900006480d4154e
FDA-2011-N-0121-0001 FDA FDA-2011-N-0121 Further Amendments to General Regulations of Food and Drug Administration to Incorporate Tobacco Products Proposed Rule NPR-Notice of Proposed Rule-Making 2011-04-14T04:00:00Z 2011 4 2011-04-14T04:00:00Z 2011-06-14T03:59:59Z 2011-06-11T16:30:42Z 2011-09044 0 0 0900006480c2c60e
FDA-2011-N-0079-0001 FDA FDA-2011-N-0079 Disqualification of a Clinical Investigator Proposed Rule NPR-Notice of Proposed Rule-Making 2011-04-13T04:00:00Z 2011 4 2011-04-13T04:00:00Z 2011-07-13T03:59:59Z 2011-06-11T16:30:42Z 2011-08786 0 0 0900006480c25e36
FDA-2011-F-0171-0001 FDA FDA-2011-F-0171 Food Labeling: Calorie Labeling of Articles of Food in Vending Machines Proposed Rule NPR-Notice of Proposed Rule-Making 2011-04-06T04:00:00Z 2011 4 2011-04-06T04:00:00Z 2011-07-06T03:59:59Z 2011-06-11T16:30:00Z 2011-08037 0 0 0900006480c1cfbc
FDA-2011-F-0172-0001 FDA FDA-2011-F-0172 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Proposed Rule NPR-Notice of Proposed Rule-Making 2011-04-06T04:00:00Z 2011 4 2011-04-06T04:00:00Z 2011-06-07T03:59:59Z 2015-02-20T20:05:04Z 2011-07940 0 0 0900006480c1cf20
FDA-1976-N-0519-0031 FDA Over-the-Counter (OTC) General Comments & Combinations - OPEN FDA-1976-N-0519 Notice of Proposed Rule-Making re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use, Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride; Correction Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-03-23T04:00:00Z 2011 3 2011-03-23T04:00:00Z   2016-03-02T16:28:24Z   0 0 090000648053bcee
FDA-1976-N-0519-0032 FDA Over-the-Counter (OTC) General Comments & Combinations - OPEN FDA-1976-N-0519 Notice of Extension re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use; Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride; Extension Of Comment Period Proposed Rule Extension of Comment Period 2011-03-23T04:00:00Z 2011 3 2011-03-23T04:00:00Z 1990-05-30T03:59:59Z 2016-03-02T18:53:21Z   0 0 090000648053bcf1
FDA-2011-N-0029-0001 FDA FDA-2011-N-0029 Medical Devices Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions Proposed Rule NPR-Notice of Proposed Rule-Making 2011-03-23T04:00:00Z 2011 3 2011-03-23T04:00:00Z 2011-05-24T03:59:59Z 2011-03-23T19:07:04Z 2011-06621 0 0 0900006480c0eca4
FDA-1976-N-0519-0037 FDA Over-the-Counter (OTC) General Comments & Combinations - OPEN FDA-1976-N-0519 Notice of Proposed Rule-Making re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use, Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-03-23T04:00:00Z 2011 3 2011-03-23T04:00:00Z 1990-01-21T04:59:59Z 2016-03-02T16:15:25Z   0 0 090000648053bcea
FDA-1976-N-0519-0013 FDA Over-the-Counter (OTC) General Comments & Combinations - OPEN FDA-1976-N-0519 Notice of Proposed Rulemaking re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The Counter Human Use; Tentative Final Monograph For Combination Drug Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-03-18T04:00:00Z 2011 3 2011-03-18T04:00:00Z 1988-12-13T04:59:59Z 2018-12-20T02:02:21Z   0 0 090000648053bc8f
FDA-1981-N-0012-0044 FDA OTC Weight Control Drug Products for Human Use FDA-1981-N-0012 Weight Control Drug Products for Over-the-Counter Human Use: Benzocaine; Status Change Proposed Rule NPR-Notice of Proposed Rule-Making 2011-03-09T05:00:00Z 2011 3 2011-03-09T05:00:00Z 2011-06-08T03:59:59Z 2011-06-11T16:25:42Z 2011-05145 0 0 0900006480c03fb5
FDA-2006-P-0033-0027 FDA Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 FDA-2006-P-0033 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 2011-02-28T21:08:27Z 2011-3678 0 0 0900006480bf2522
FDA-2000-P-0102-0028 FDA Health Claim: Vegetable Oil Sterol Esters & Coronary Heart Disease CLOSED 05/26/2020 FDA-2000-P-0102 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 2011-02-18T23:12:37Z 2011-3678 0 0 0900006480bf2393
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-1978-N-0021-0037 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Notice of Proposed Rulemaking re Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use: Amendment to Tentative Final Monograph Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-02-11T05:00:00Z 2011 2 2011-02-11T05:00:00Z 2011-03-15T03:59:59Z 2016-08-22T20:55:33Z 2011-3091 0 0 0900006480becd42
FDA-1978-N-1268-0001 FDA Medical Devices; Procedures for Development of Standards FDA-1978-N-1268 Notice of Proposed Rulemaking- Medical Devices Proposed Procedures for Development of Standards Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-02-10T05:00:00Z 2011 2 2011-02-10T05:00:00Z 1978-09-26T03:59:59Z 2019-05-03T01:01:01Z 70-20370 0 0 09000064805999d5
FDA-1975-N-0017-0055 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Proposal To Establish Monographs For OTC Nighttime Sleep-Aid, Daytime Sedative, And Stimulant Products (Part 1) Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-02-07T05:00:00Z 2011 2 2011-02-07T05:00:00Z 1976-03-09T04:59:59Z 2018-01-24T21:03:21Z 75-32774 0 0 09000064805c22a6
FDA-2010-N-0646-0001 FDA FDA-2010-N-0646 Tobacco Products: Exemptions From Substantial Equivalence Requirements Proposed Rule NPR-Notice of Proposed Rule-Making 2011-01-06T05:00:00Z 2011 1 2011-01-06T05:00:00Z 2011-03-23T03:59:59Z 2011-06-11T16:29:58Z 2011-34 0 0 0900006480bc5f9b

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

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);