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413 rows where docket_id = "FDA-2016-N-3389" sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 410
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  • 2016 390
  • 2017 23

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  • FDA 413
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-3389-0463 FDA None FDA-2016-N-3389 Table of Contents Appendix of Copyrighted Footnote and Endnote Materials Copyrighted Materials Cited in Footnotes re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-28T05:00:00Z 2017 2     2017-02-28T16:59:26Z   0 0 09000064824e1800
FDA-2016-N-3389-0459 FDA None FDA-2016-N-3389 Expert Panel Report on the Intrinsic and Intact Dietary Fiber Status of Grain Millers Oat Fiber January 23, 2017 re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-24T05:00:00Z 2017 2     2017-02-24T20:04:27Z   0 0 09000064824db147
FDA-2016-N-3389-0460 FDA None FDA-2016-N-3389 Exhibit D List of Technical Materials Provided to Expert Panel re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-24T05:00:00Z 2017 2     2017-02-24T20:38:48Z   0 0 09000064824db0b2
FDA-2016-N-3389-0461 FDA None FDA-2016-N-3389 Exhibit E Grain Millers' Proprietary Production Process that Retains All Lignin and Other Plant Components Intrinsic and Intact re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-24T05:00:00Z 2017 2     2017-02-24T20:45:35Z   0 0 09000064824db0b3
FDA-2016-N-3389-0462 FDA None FDA-2016-N-3389 Reference Materials for Endnotes 1-26 Supporting Expert Panel Report on the Intrinsic and Intact Dietary Fiber Status of Grain Millers Oat Fiber re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-24T05:00:00Z 2017 2     2017-02-24T21:46:22Z   0 0 09000064824db0b4
FDA-2016-N-3389-0458 FDA None FDA-2016-N-3389 Table of Contents for Attachment "B" Expert Panel Report on the Intrinsic and Intact Dietary Fiber Status of Grain Millers Oat Fiber re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-24T05:00:00Z 2017 2     2017-02-24T19:49:56Z   0 0 09000064824db146
FDA-2016-N-3389-0457 FDA None FDA-2016-N-3389 Reference Materials for Endnotes 1-11 Supporting Attachment "A" re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-23T05:00:00Z 2017 2     2017-02-23T17:32:05Z   0 0 09000064824d8012
FDA-2016-N-3389-0454 FDA None FDA-2016-N-3389 Reference Materials for Footnotes 1-20 Contained in The Food Lawyers Comment Supporting & Related Material Background Material 2017-02-23T05:00:00Z 2017 2     2017-02-23T17:25:46Z   0 0 09000064824d8139
FDA-2016-N-3389-0456 FDA None FDA-2016-N-3389 Attachment "A" Grain Millers Milling Process vs. Patented Hydrogen Peroxide and Similar Methods re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-23T05:00:00Z 2017 2     2017-02-23T17:22:25Z   0 0 09000064824d8011
FDA-2016-N-3389-0453 FDA None FDA-2016-N-3389 Table of Contents re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-23T05:00:00Z 2017 2     2017-02-23T16:43:41Z   0 0 09000064824d8138
FDA-2016-N-3389-0455 FDA None FDA-2016-N-3389 Table of Contents for Attachment "A" Grain Millers Milling Process vs. Patented Hydrogen Peroxide and Similar Methods re: Comment from The Food Lawyers® Supporting & Related Material Background Material 2017-02-23T05:00:00Z 2017 2     2017-02-23T17:20:29Z   0 0 09000064824d7fd3
FDA-2016-N-3389-0448 FDA None FDA-2016-N-3389 Appendix V: Nutrient Analysis of Gum Acacia re: Comment from Keller and Heckman LLP on behalf of Nexira, TIC Gums, et al Supporting & Related Material Background Material 2017-02-17T05:00:00Z 2017 2     2017-02-17T17:15:03Z   0 0 09000064824caff0
FDA-2016-N-3389-0445 FDA None FDA-2016-N-3389 Appendix II: Article on Gummosis re: Comment from Keller and Heckman LLP on behalf of Nexira, TIC Gums, et al Supporting & Related Material Background Material 2017-02-17T05:00:00Z 2017 2     2017-02-17T17:08:44Z   0 0 09000064824cafed
FDA-2016-N-3389-0444 FDA None FDA-2016-N-3389 Appendix I: Manufacturing Process of Gum Acacia re: Comment from Keller and Heckman LLP on behalf of Nexira, TIC Gums, et al Supporting & Related Material Background Material 2017-02-17T05:00:00Z 2017 2     2017-02-17T17:07:03Z   0 0 09000064824cafda
FDA-2016-N-3389-0450 FDA None FDA-2016-N-3389 Appendix VII: English Translation of Torres et al. 2006 re: Comment from Keller and Heckman LLP on behalf of Nexira, TIC Gums, et al Supporting & Related Material Background Material 2017-02-17T05:00:00Z 2017 2     2017-02-17T17:20:41Z   0 0 09000064824caff2
FDA-2016-N-3389-0447 FDA None FDA-2016-N-3389 Appendix IV: Article on Traditional Food Use of Gum Acacia re: Comment from Keller and Heckman LLP on behalf of Nexira, TIC Gums, et al Supporting & Related Material Background Material 2017-02-17T05:00:00Z 2017 2     2017-02-17T17:12:48Z   0 0 09000064824cafef
FDA-2016-N-3389-0449 FDA None FDA-2016-N-3389 Appendix VI: Akeo Paper- Japanese and English Translation re: Comment from Keller and Heckman LLP on behalf of Nexira, TIC Gums, et al Supporting & Related Material Background Material 2017-02-17T05:00:00Z 2017 2     2017-02-17T17:18:40Z   0 0 09000064824caff1
FDA-2016-N-3389-0446 FDA None FDA-2016-N-3389 Appendix III: Letter from Health Canada regarding Gum Acacia as Dietary Fiber re: Comment from Keller and Heckman LLP on behalf of Nexira, TIC Gums, et al Supporting & Related Material Background Material 2017-02-17T05:00:00Z 2017 2     2017-02-17T17:10:23Z   0 0 09000064824cafee
FDA-2016-N-3389-0451 FDA None FDA-2016-N-3389 Appendix VIII: Unpublished Australian Study- Confidential re: Comment from Keller and Heckman LLP on behalf of Nexira, TIC Gums, et al Supporting & Related Material Background Material 2017-02-17T05:00:00Z 2017 2     2017-02-17T17:22:37Z   0 0 09000064824caff3
FDA-2016-N-3389-0440 FDA None FDA-2016-N-3389 Attachment I Chemical Equivalence re: Comment from Keller and Heckman LLP on behalf of Roquette Supporting & Related Material Background Material 2017-02-16T05:00:00Z 2017 2     2017-02-16T15:42:36Z   0 0 09000064824c7516
FDA-2016-N-3389-0441 FDA None FDA-2016-N-3389 Attachment 2 Unpublished Studies on Nutriose (#1-8) re: Comment from Keller and Heckman LLP on behalf of Roquette Supporting & Related Material Background Material 2017-02-16T05:00:00Z 2017 2     2017-02-16T15:45:18Z   0 0 09000064824c7517
FDA-2016-N-3389-0408 FDA None FDA-2016-N-3389 Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request For Scientific Data, Information, and Comments; Reopening of Comment Period Notice Extension of Comment Period 2017-01-13T05:00:00Z 2017 1 2017-01-13T05:00:00Z 2017-02-14T04:59:59Z 2017-03-04T02:01:35Z 2017-00725 0 0 090000648247042b
FDA-2016-N-3389-0407 FDA None FDA-2016-N-3389 List of Cited References re: Comment from Anonymous Supporting & Related Material Background Material 2017-01-12T05:00:00Z 2017 1     2017-01-12T19:57:52Z   0 0 0900006482466678
FDA-2016-N-3389-0394 FDA None FDA-2016-N-3389 Request to Extend Comment Period from Grocery Manufacturers Association Other Electronic Regulation from Form 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T17:19:26Z   0 0 0900006482432fb6
FDA-2016-N-3389-0008 FDA None FDA-2016-N-3389 Reference 02-05 Evaluation of satiety enhancement, including compensation, by blends of gum arabic. A methodological approach re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:52:51Z   0 0 090000648239903a
FDA-2016-N-3389-0023 FDA None FDA-2016-N-3389 Reference 02-20 In vivo imaging of intragastric and its effect on satiety in humans re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:57:02Z   0 0 09000064823990d7
FDA-2016-N-3389-0151 FDA None FDA-2016-N-3389 Reference 02-148 Effects of consumption a bread contains agave or chicory inulin on lipids and blood pressure in patients with cardiovascular risk factors re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:17:56Z   0 0 09000064823996bd
FDA-2016-N-3389-0154 FDA None FDA-2016-N-3389 Reference 02-151 Inulin and oligofructose What are they re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:18:36Z   0 0 09000064823996c2
FDA-2016-N-3389-0158 FDA None FDA-2016-N-3389 Reference 02-155 Gut hormone release and appetite regulation in healthy non-obese participants following oligofructose intake A dose-escalation study re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:19:10Z   0 0 09000064823996ef
FDA-2016-N-3389-0189 FDA None FDA-2016-N-3389 Reference 02-186 Microbiota benefits after inulin and partially hydrolized guar gum supplementation – a randomized clinical trial in constipated women re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:24:44Z   0 0 0900006482399739
FDA-2016-N-3389-0330 FDA None FDA-2016-N-3389 Reference 02-328 Suppressive effect of resistant maltodextrin on postprandial blood triglycerol elevation re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:46:42Z   0 0 090000648239986a
FDA-2016-N-3389-0343 FDA None FDA-2016-N-3389 Reference 02-342 A double-blind placebo-controlled clinical trial compares the cholesterol lowering effects of two different soy protein preparations re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:48:15Z   0 0 090000648239989c
FDA-2016-N-3389-0350 FDA None FDA-2016-N-3389 Reference 02-349 Effects of some cereal brans and textured vegetable protein on plasma lipids re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:48:59Z   0 0 09000064823998b4
FDA-2016-N-3389-0120 FDA None FDA-2016-N-3389 Reference 02-117 Acute effects of a herb extract formulation and inulin fibre on appetite, energy intake and food choice re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:14:07Z   0 0 0900006482399943
FDA-2016-N-3389-0050 FDA None FDA-2016-N-3389 Reference 02-46 Alteration of the fiber and lipid components of a defined-formula diet effects on stool characteristics, nutrient digestibility, mineral balance re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:02:34Z   0 0 0900006482399510
FDA-2016-N-3389-0111 FDA None FDA-2016-N-3389 Reference 02-108 Effect of inulin and fructo-oligosaccharide on the prevention of acute radiation enteritis in patients with gynecological cancer and impact on quality-of-life re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:13:11Z   0 0 090000648239964b
FDA-2016-N-3389-0213 FDA None FDA-2016-N-3389 Reference 02-209 Long-term blood cholesterol-lowering effects of a dietary fiber supplement re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:28:32Z   0 0 09000064823999f6
FDA-2016-N-3389-0215 FDA None FDA-2016-N-3389 Reference 02-211 Decreased postprandial thermogenesis and fat oxidation but increased fullness after a high-fiber meal compared with a low-fiber meal re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:28:52Z   0 0 09000064823999f8
FDA-2016-N-3389-0238 FDA None FDA-2016-N-3389 Reference 02-235 Volume of food consumed affect satiety in men re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:32:49Z   0 0 0900006482399a31
FDA-2016-N-3389-0242 FDA None FDA-2016-N-3389 Reference 02-239 Attenuated response of the serum triglyceride concentration to ingestion of a chocolate containing polydextrose and lactitol in place of sugar re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:33:24Z   0 0 0900006482399a35
FDA-2016-N-3389-0259 FDA None FDA-2016-N-3389 Reference 02-256 Effect of carbohydrate digestibility on appetite and its relationship to postprandial blood glucose and insulin levels re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:36:16Z   0 0 0900006482399a66
FDA-2016-N-3389-0272 FDA None FDA-2016-N-3389 Reference 02-269 Acute ingestion of resistant starch reduces food intake in healthy adults re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:38:48Z   0 0 0900006482399a97
FDA-2016-N-3389-0276 FDA None FDA-2016-N-3389 Reference 02-273 Interaction between physical structure and amyloseamylopectin ratio of foods on postprandial glucose and insulin responses in healthy subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:39:16Z   0 0 0900006482399a9b
FDA-2016-N-3389-0227 FDA None FDA-2016-N-3389 Reference 02-224 Effects of polydextrose supplementation on different faecal parameters in healthy volunteers re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:30:30Z   0 0 0900006482399790
FDA-2016-N-3389-0266 FDA None FDA-2016-N-3389 Reference 02-263 Effect of long-term consumption of amylose vs amylopectin starch on metabolic variables in human subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:37:50Z   0 0 09000064823997db
FDA-2016-N-3389-0308 FDA None FDA-2016-N-3389 Reference 02-305 Design criteria for studies examining individual fatty acid effects on cardiovascular disease risk factors human and animal studies re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:43:49Z   0 0 0900006482399827
FDA-2016-N-3389-0304 FDA None FDA-2016-N-3389 Reference 02-301 Physiological effects of resistant starches on fecal bulk, short chain fatty acids, blood lipids and glycemic index re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:43:19Z   0 0 0900006482399ad7
FDA-2016-N-3389-0367 FDA None FDA-2016-N-3389 Reference 02-366 Serum lipid and fecal bile acid changes with cereal, vegetable, and sugar-beet fiber feeding re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:51:48Z   0 0 0900006482399bb2
FDA-2016-N-3389-0372 FDA None FDA-2016-N-3389 Reference 02-371 The effects of two dietary fiber supplements on gastrointestinal transit, stool weight and frequency re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:53:25Z   0 0 0900006482399bb7
FDA-2016-N-3389-0018 FDA None FDA-2016-N-3389 Reference 02-15 Fiber and prebiotics mechanism and health benefits re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:56:23Z   0 0 09000064823990d2
FDA-2016-N-3389-0021 FDA None FDA-2016-N-3389 Reference 02-18 Ascophyllum nodosum enriched bread reduces subsequent energy intake with no effect on post-prandial glucose and cholesterol in healthy, overweight males re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:56:47Z   0 0 09000064823990d5
FDA-2016-N-3389-0024 FDA None FDA-2016-N-3389 Reference 02-21 Can alginate-based preloads increase weight loss beyond calorie restriction A pilot study in obese individuals re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:57:08Z   0 0 09000064823990d8
FDA-2016-N-3389-0036 FDA None FDA-2016-N-3389 02-33 Differences in satiety effects of alginate- and whey protein-based foods re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:59:04Z   0 0 09000064823990f2
FDA-2016-N-3389-0039 FDA None FDA-2016-N-3389 02-35 The effects of bulking, viscous and gel-forming dietary fibres on satiation re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:00:20Z   0 0 09000064823990f5
FDA-2016-N-3389-0011 FDA None FDA-2016-N-3389 Reference 02-08 Role of water-soluble dietary fiber in the management of elevated plasma cholesterol in healthy subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:53:16Z   0 0 09000064823993af
FDA-2016-N-3389-0028 FDA None FDA-2016-N-3389 Reference 02-25 Effect of sodium alginate addition to chocolate milk on glycemia, insulin, appetite and food intake in healthy adult men re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:57:38Z   0 0 09000064823993eb
FDA-2016-N-3389-0033 FDA None FDA-2016-N-3389 Reference 02-30 Daily ingestion of alginate reduces energy intake in free-living subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:58:12Z   0 0 09000064823993f0
FDA-2016-N-3389-0100 FDA None FDA-2016-N-3389 Reference 02-96 Inulin controls inflammation and metabolic endotoxemia in women with type 2 diabetes mellitus a randomized-controlled clinical trial re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:09:26Z   0 0 09000064823994e2
FDA-2016-N-3389-0135 FDA None FDA-2016-N-3389 Reference 02-132 Effects of inulin and lactose on fecal microflora, microbial activity, and bowel habit in elderly constipated persons re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:15:40Z   0 0 0900006482399695
FDA-2016-N-3389-0137 FDA None FDA-2016-N-3389 Reference 02-134 Effects of inulin on faecal bifidobacteria in human subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:16:03Z   0 0 0900006482399697
FDA-2016-N-3389-0334 FDA None FDA-2016-N-3389 Reference 02-332 Design criteria for studies examining individual fatty acid effects on cardiovascular disease risk factors human and animal studies re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:47:08Z   0 0 0900006482399882
FDA-2016-N-3389-0346 FDA None FDA-2016-N-3389 Reference 02-345 Effect of soya and cellulose fibers on postprandial glycemic response in type II diabetic patients re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:48:34Z   0 0 090000648239989f
FDA-2016-N-3389-0356 FDA None FDA-2016-N-3389 Reference 02-355 Effects of soy polysaccharide on postprandial plasma glucose, insulin, glucagon, pancreatic polypeptide, somatostatin, and triglyceride in obese diabetic patients re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:50:32Z   0 0 09000064823998ba
FDA-2016-N-3389-0363 FDA None FDA-2016-N-3389 Reference 02-362 Reduced glycemic response to beet-fibre meal in non-insulin-dependent diabetics and its relation to plasma levels of pancreatic and gastrointestinal hormones re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:51:18Z   0 0 09000064823998d1
FDA-2016-N-3389-0178 FDA None FDA-2016-N-3389 Reference 02-175 Chicory inulin does not increase stool weight or speed up intestinal transit time in healthy male subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:23:09Z   0 0 0900006482399994
FDA-2016-N-3389-0381 FDA None FDA-2016-N-3389 Reference 02-380 Metabolic characteristics of healthy adult males as affected by ingestion of a liquid nutritional formula re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:57:36Z   0 0 0900006482399bc9
FDA-2016-N-3389-0001 FDA None FDA-2016-N-3389 Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Notice Request for Comments 2016-11-23T05:00:00Z 2016 11 2016-11-23T05:00:00Z 2017-01-10T04:59:59Z 2017-01-13T02:00:53Z 2016-27950 0 0 09000064823b9adb
FDA-2016-N-3389-0114 FDA None FDA-2016-N-3389 Reference 02-111 Selective stimulation of bifidobacteria in the human colon by oligofructose and inulin re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:13:31Z   0 0 0900006482399900
FDA-2016-N-3389-0115 FDA None FDA-2016-N-3389 Reference 02-112 Prebiotics consumption modifies diastolic blood pressure, but does not affect serum lipids concentratoin in volunteers with ischemic heart disease re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:13:38Z   0 0 0900006482399901
FDA-2016-N-3389-0144 FDA None FDA-2016-N-3389 Reference 02-141 Fructooligosaccharide (FOS) supplementation in type 2 diabetic adults improves systolic blood pressure, serum lipid, and gut microbiota re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:16:54Z   0 0 090000648239995d
FDA-2016-N-3389-0163 FDA None FDA-2016-N-3389 Reference 02-160 Effects of oligofructose-enriched inulin prebiotic supplementation on the lipid profile and inflammation in women with type 2 diabetes re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:20:49Z   0 0 0900006482399976
FDA-2016-N-3389-0080 FDA None FDA-2016-N-3389 Reference 02-76 Metabolic characteristics of healthy adult males as affected by ingestion of a liquid nutritional formula containing fish oil, oligosaccharides, gum Arabic re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:07:03Z   0 0 0900006482399563
FDA-2016-N-3389-0093 FDA None FDA-2016-N-3389 Reference 02-89 Consuming foods with added oligofructose improves stool frequency a randomized trial in healthy young adults re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:08:39Z   0 0 090000648239958d
FDA-2016-N-3389-0107 FDA None FDA-2016-N-3389 Reference 02-103 GRAS Notification 44 re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:10:56Z   0 0 09000064823995af
FDA-2016-N-3389-0110 FDA None FDA-2016-N-3389 Reference 02-107 Tolerance and the effect of high doses of wheat bran extract, containing arabinoxylan-oligosaccharides, and oligofructose on faecal output re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:11:22Z   0 0 090000648239964a
FDA-2016-N-3389-0247 FDA None FDA-2016-N-3389 Reference 02-244 Glycemic responses to sweetened dried and raw cranberries in human with type 2 diabetes re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:34:09Z   0 0 0900006482399a4a
FDA-2016-N-3389-0220 FDA None FDA-2016-N-3389 Reference 02-217 Snacks containing whey protein and polydextrose induce a sustained reduction in daily energy intake over 2 wk under free-living conditions re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:29:37Z   0 0 0900006482399789
FDA-2016-N-3389-0223 FDA None FDA-2016-N-3389 Reference 02-220 The effects of oligofructose and polydextrose on metabolic control parameters in type-2 diabetes re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:29:57Z   0 0 090000648239978c
FDA-2016-N-3389-0228 FDA None FDA-2016-N-3389 Reference 02-225 Consuming polydextrose in a mid-morning snack increases acute satiety measurements and reduces subsequent energy intake at lunch in healthy human subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:30:38Z   0 0 0900006482399791
FDA-2016-N-3389-0322 FDA None FDA-2016-N-3389 Reference 02-319 Fermentable fibers do not affect satiety or food intake by women who do not practice restrained eating re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:45:30Z   0 0 090000648239984c
FDA-2016-N-3389-0388 FDA None FDA-2016-N-3389 02-320 Resistant starch type 4-enriched diet lowered blood cholesterols and improved body composition in a double blind cross-over intervention re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:58:30Z   0 0 090000648239984d
FDA-2016-N-3389-0287 FDA None FDA-2016-N-3389 Reference 02-284 Combining wheat bran with resistant starch has more beneficial effects on fecal indexes than does wheat bran alone re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:40:58Z   0 0 0900006482399ab4
FDA-2016-N-3389-0293 FDA None FDA-2016-N-3389 Reference 02-290 Comparative study of the acute effects of resistant starch and dietary fibers on metabolic indexes in men re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:41:45Z   0 0 0900006482399ac4
FDA-2016-N-3389-0314 FDA None FDA-2016-N-3389 Reference 02-311 Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:44:34Z   0 0 0900006482399afd
FDA-2016-N-3389-0365 FDA None FDA-2016-N-3389 Reference 02-364 Blood glucose response to pea fiber comparisons with sugar beet fiber and wheat bran re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:51:33Z   0 0 0900006482399bb0
FDA-2016-N-3389-0376 FDA None FDA-2016-N-3389 Reference 02-375 A novel source of wheat fiber and protein effects on fecal bulk and serum lipids re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:56:07Z   0 0 0900006482399bc4
FDA-2016-N-3389-0378 FDA None FDA-2016-N-3389 Reference 02-377 The dietary effects of xanthan gum in man re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:57:14Z   0 0 0900006482399bc6
FDA-2016-N-3389-0029 FDA None FDA-2016-N-3389 Reference 02-26 Effects of a combination fiber system on appetite and energy intake in overweight humans re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T17:57:44Z   0 0 09000064823993ec
FDA-2016-N-3389-0061 FDA None FDA-2016-N-3389 Reference 02-57 Galactooligosacchraide supplementation reduces stress-induced gastrointestinal dysfunction and days of cold or flu a randomized, double-blind, controlled trial re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:04:28Z   0 0 090000648239941e
FDA-2016-N-3389-0086 FDA None FDA-2016-N-3389 Reference 02-82 The effects of oligofructose on metabolic control parameters in type-2 diabetes. re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:07:45Z   0 0 090000648239943c
FDA-2016-N-3389-0002 FDA None FDA-2016-N-3389 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 2016-11-23T05:00:00Z 2016 11     2016-11-23T16:03:01Z   0 0 09000064823bc576
FDA-2016-N-3389-0051 FDA None FDA-2016-N-3389 Reference 02-47 Therapeutic effects of marine collagen peptides on re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:02:47Z   0 0 0900006482399511
FDA-2016-N-3389-0067 FDA None FDA-2016-N-3389 Reference 02-63 A mixture of trans-galactooligosaccharides reduced markers of metabolic syndrome and modulates the fecal microbiota and immune function of overweight adults. re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:05:15Z   0 0 0900006482399543
FDA-2016-N-3389-0071 FDA None FDA-2016-N-3389 Reference 02-67 Short-term effect of bedtime consumption of fermented milk supplemented with calcium, inulin-type fructans and caseinphosphopetides on bone metabolism re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:05:43Z   0 0 0900006482399547
FDA-2016-N-3389-0073 FDA None FDA-2016-N-3389 Reference 02-69 Bacterial fermentation of fructooligosaccharides and resistant starch in patients with an ileal pouch-anal anastomosis re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:06:01Z   0 0 090000648239955c
FDA-2016-N-3389-0104 FDA None FDA-2016-N-3389 Reference 02-100 Insight into the prebiotic concept lessons from an exploratory, double blind intervention study with inulin type fructans in obese women re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:10:37Z   0 0 09000064823995a8
FDA-2016-N-3389-0237 FDA None FDA-2016-N-3389 Reference 02-234 Polydextrose its impact on short-term food intake and subjective feelings of satiety in males – a randomized controlled cross-over study re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:32:42Z   0 0 0900006482399a30
FDA-2016-N-3389-0249 FDA None FDA-2016-N-3389 Reference 02-246 Digestions and physiological properties of resistant starch in the human large bowel re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:34:27Z   0 0 0900006482399a51
FDA-2016-N-3389-0229 FDA None FDA-2016-N-3389 Reference 02-226 Studies on the effects of polydextrose intake on physiologic functions in Chinese people re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:30:43Z   0 0 09000064823997ae
FDA-2016-N-3389-0235 FDA None FDA-2016-N-3389 Reference 02-232 Postprandial effects of polydextrose on satiety hormone responses and subjective feelings of appetite in obese participants re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments Supporting & Related Material Background Material 2016-11-23T05:00:00Z 2016 11     2016-11-23T18:32:17Z   0 0 09000064823997b4

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    docket_id TEXT REFERENCES dockets(id),
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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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