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withdrawn,object_id FDA-2016-D-3401-0050,FDA,FDA-2016-D-3401,Reference 2 Guidance -- Evidence-Based Review System for the Scientific Evaluation of Health Claims re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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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