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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

19 rows where docket_id = "FDA-2016-D-3401" and posted_year = 2018 sorted by posted_date descending

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document_type 3

posted_year 1

  • 2018 · 19 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-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

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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;