{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled \"Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).\" The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health.","action":"Notification of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/11/23/2016-27949.html","cfr_references":[{"chapter":null,"citation_url":null,"part":101,"title":21}],"citation":"81 FR 84516","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on this document by January 23, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-3401"],"dockets":[],"document_number":"2016-27949","effective_on":null,"end_page":84517,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/11/23/2016-27949.xml","html_url":"https://www.federalregister.gov/documents/2016/11/23/2016-27949/scientific-evaluation-of-the-evidence-on-the-beneficial-physiological-effects-of-isolated-or","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-27949?publication_date=2016-11-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-11-23/2016-27949/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2574,"last_updated":"2026-10-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-11-23/pdf/2016-27949.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-27949.pdf?1479822325","publication_date":"2016-11-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/11/23/2016-27949.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"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 Indust","document_id":"FDA-2016-D-3401-0064"},{"title":"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","document_id":"FDA-2016-D-3401-0062"},{"title":"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 Pet","document_id":"FDA-2016-D-3401-0061"},{"title":"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","document_id":"FDA-2016-D-3401-0060"},{"title":"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 Petitio","document_id":"FDA-2016-D-3401-0056"},{"title":"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): Guid","document_id":"FDA-2016-D-3401-0055"},{"title":"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 Indu","document_id":"FDA-2016-D-3401-0053"},{"title":"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 Indu","document_id":"FDA-2016-D-3401-0052"},{"title":"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 (2","document_id":"FDA-2016-D-3401-0051"},{"title":"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 Cit","document_id":"FDA-2016-D-3401-0050"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-3401","supporting_documents_count":32,"docket_id":"FDA-2016-D-3401","regulation_id_number":null,"title":"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)","checked_regulationsdotgov_at":"2017-01-24T05:00:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":84516,"subtype":null,"title":"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","toc_doc":"Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition","toc_subject":"Guidance:","topics":[],"type":"Proposed Rule","volume":81}