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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

39 rows where docket_id = "FDA-2016-D-3401" sorted by posted_date descending

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document_type 4

  • Supporting & Related Material 32
  • Other 4
  • Notice 2
  • Proposed Rule 1

posted_year 3

  • 2018 19
  • 2016 18
  • 2017 2

agency_id 1

  • FDA 39
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-D-3401-0050 FDA None FDA-2016-D-3401 Reference 2 Guidance -- Evidence-Based Review System for the Scientific Evaluation of Health Claims re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:27:10Z   0 0 0900006482f88636
FDA-2016-D-3401-0055 FDA None FDA-2016-D-3401 Reference 7 Dietary Supplements A Framework for Evaluating Safety re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:27:49Z   0 0 0900006482f8863b
FDA-2016-D-3401-0056 FDA None FDA-2016-D-3401 02-08 DRIs for Energy Carbohydrate Fiber Fat Fatty Acids Cholesterol Protein Amino Acids re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:28:00Z   0 0 0900006482f8863c
FDA-2016-D-3401-0048 FDA None FDA-2016-D-3401 Reference List re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:26:48Z   0 0 0900006482f8812d
FDA-2016-D-3401-0053 FDA None FDA-2016-D-3401 Reference 5 A practical approach to evidence grading re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:27:34Z   0 0 0900006482f88639
FDA-2016-D-3401-0064 FDA None FDA-2016-D-3401 Reference 16 An Introduction to Scientific Research re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:29:11Z   0 0 0900006482f8864f
FDA-2016-D-3401-0049 FDA None FDA-2016-D-3401 Reference 1 Dietary Guidelines for Americans 2015-202 re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:27:03Z   0 0 0900006482f88635
FDA-2016-D-3401-0051 FDA None FDA-2016-D-3401 Reference 3 The normal range and simple diagram for recording whole gut transit time re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:27:19Z   0 0 0900006482f88637
FDA-2016-D-3401-0060 FDA None FDA-2016-D-3401 Reference 12 Diet and Health- Implications for Reducing Chronic Disease Risk re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:28:36Z   0 0 0900006482f8864b
FDA-2016-D-3401-0061 FDA None FDA-2016-D-3401 Reference 13 Food and nutrient exposures what to consider when evaluating epidemiologic data re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:28:45Z   0 0 0900006482f8864c
FDA-2016-D-3401-0062 FDA None FDA-2016-D-3401 Reference 14 Guide to Clinical Studies re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:28:54Z   0 0 0900006482f8864d
FDA-2016-D-3401-0054 FDA None FDA-2016-D-3401 Reference 6 The environment and disease association or causation re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:27:42Z   0 0 0900006482f8863a
FDA-2016-D-3401-0057 FDA None FDA-2016-D-3401 Reference 9 Dietary Reference Intakes. Proposed Definition of Dietary Fiber re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:28:08Z   0 0 0900006482f8863d
FDA-2016-D-3401-0058 FDA None FDA-2016-D-3401 Reference 10 To Your Health How to Understand What Research Tell Us About Risk re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:28:17Z   0 0 0900006482f8863e
FDA-2016-D-3401-0059 FDA None FDA-2016-D-3401 Reference 11 Design criteria for studies re fatty acid effects on cardiovascular disease risk factors re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:28:26Z   0 0 0900006482f8864a
FDA-2016-D-3401-0063 FDA None FDA-2016-D-3401 Reference 15 Cereal complex carbohydrates and their contribution to human health re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:29:05Z   0 0 0900006482f8864e
FDA-2016-D-3401-0052 FDA None FDA-2016-D-3401 Reference 4 Reference Manual on Scientific Evidence re Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Supporting & Related Material Background Material 2018-03-05T05:00:00Z 2018 3     2018-03-05T19:27:26Z   0 0 0900006482f88638
FDA-2016-D-3401-0047 FDA None FDA-2016-D-3401 Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Other Guidance 2018-03-02T05:00:00Z 2018 3 2018-03-02T05:00:00Z   2024-11-07T01:22:26Z   1 0 0900006482f88125
FDA-2016-D-3401-0046 FDA None FDA-2016-D-3401 Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Guidance for Industry; Availability Notice Notice of Availability 2018-03-02T05:00:00Z 2018 3 2018-03-02T05:00:00Z   2018-03-02T16:32:04Z 2018-04280 0 0 0900006482f851cb
FDA-2016-D-3401-0023 FDA None FDA-2016-D-3401 Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment Period Proposed Rule Extension of Comment Period 2017-01-13T05:00:00Z 2017 1 2017-01-13T05:00:00Z 2017-02-14T04:59:59Z 2017-02-17T02:03:51Z 2017-00724 0 0 0900006482470477
FDA-2016-D-3401-0020 FDA None FDA-2016-D-3401 Request for Extension from Grocery Manufacturers Association (GMA) Other Request for Extension 2017-01-05T05:00:00Z 2017 1 2017-01-05T05:00:00Z   2017-01-05T15:25:42Z   0 0 090000648243355c
FDA-2016-D-3401-0019 FDA None FDA-2016-D-3401 Request for Extension from Council for Responsible Nutrition Other Electronic Regulation from Form 2016-12-16T05:00:00Z 2016 12 2016-12-16T05:00:00Z   2016-12-16T21:59:59Z   0 0 09000064823e58a0
FDA-2016-D-3401-0006 FDA None FDA-2016-D-3401 Reference 02-03 Guidance for Industry Evidence-Based Review System for the Scientific Evaluation of Health Claims Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:33Z   0 0 09000064823ab5a1
FDA-2016-D-3401-0010 FDA None FDA-2016-D-3401 Reference 02-07 Dietary Reference Intakes for Energy Carbohydrate Fiber Fat Fatty Acids Cholesterol Protein and Amino Acids Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:09Z   0 0 09000064823ab5a5
FDA-2016-D-3401-0011 FDA None FDA-2016-D-3401 Reference 02-08 Dietary Reference Intakes. Proposed Definition of Dietary Fiber Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:01Z   0 0 09000064823ab5b0
FDA-2016-D-3401-0004 FDA None FDA-2016-D-3401 Reference 02-01 Dietary Guidelines for Americans 2015-202 Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:47Z   0 0 09000064823ab59f
FDA-2016-D-3401-0014 FDA None FDA-2016-D-3401 Reference 02-11 Food and nutrient exposures what to consider when evaluating epidemiologic data Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:46:44Z   0 0 09000064823ab5b4
FDA-2016-D-3401-0003 FDA None FDA-2016-D-3401 List of References Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:52Z   0 0 09000064823ab59e
FDA-2016-D-3401-0005 FDA None FDA-2016-D-3401 Reference 02-02 Health claims fruits vegetables and grain products that contain fiber Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:39Z   0 0 09000064823ab5a0
FDA-2016-D-3401-0017 FDA None FDA-2016-D-3401 Reference 02-14 Wilson Intro to Sci Res Dover Pub 1990 Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:46:24Z   0 0 09000064823ab5b7
FDA-2016-D-3401-0007 FDA None FDA-2016-D-3401 Reference 02-04 A practical approach to evidence grading Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:27Z   0 0 09000064823ab5a2
FDA-2016-D-3401-0012 FDA None FDA-2016-D-3401 Reference 02-09 To Your Health How to Understand What Research Tell Us About Risk Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:46:55Z   0 0 09000064823ab5b1
FDA-2016-D-3401-0008 FDA None FDA-2016-D-3401 Reference 02-05 The environment and disease association or causation Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:20Z   0 0 09000064823ab5a3
FDA-2016-D-3401-0009 FDA None FDA-2016-D-3401 Reference 02-06 Dietary Supplements A Framework for Evaluating Safety Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:47:14Z   0 0 09000064823ab5a4
FDA-2016-D-3401-0015 FDA None FDA-2016-D-3401 Reference 02-12 Guide to Clinical Studies Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:46:37Z   0 0 09000064823ab5b5
FDA-2016-D-3401-0016 FDA None FDA-2016-D-3401 Reference 02-13 Cereal complex carbohydrates and their contribution to human health Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:46:30Z   0 0 09000064823ab5b6
FDA-2016-D-3401-0002 FDA None FDA-2016-D-3401 Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry Other Guidance 2016-11-23T05:00:00Z 2016 11 2016-11-23T05:00:00Z 2017-01-24T04:59:59Z 2024-11-07T23:52:58Z   1 0 09000064823bc1a5
FDA-2016-D-3401-0001 FDA None FDA-2016-D-3401 Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-11-23T05:00:00Z 2016 11 2016-11-23T05:00:00Z 2017-01-24T04:59:59Z 2017-01-17T02:01:15Z 2016-27949 0 0 09000064823b991e
FDA-2016-D-3401-0013 FDA None FDA-2016-D-3401 Reference 02-10 Reference Manual on Scientific Evidence Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T15:46:50Z   0 0 09000064823ab5b2

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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;
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