{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled \"Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--Small Entity Compliance Guide.\" The small entity compliance guide (SECG) is being issued for a final rule and an interim final rule published in the Federal Register of June 25, 2007, and is intended to set forth in plain language the requirements of that final rule and interim final rule and to help small businesses understand the regulations. In addition, the SECG includes several recommendations made by FDA in that final rule so that the guidance in those recommendations will be readily accessible to small businesses.","action":"Notice.","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/2010/12/16/2010-31613.html","cfr_references":[],"citation":"75 FR 78715","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the SECG at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0605"],"dockets":[{"supporting_documents":[{"title":"Reference 3 - FDA. Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, http://www.fda.gov/FoodGuidances","document_id":"FDA-2010-D-0605-0005"},{"title":"Reference 2 - FDA. Report a Problem. How to Report Problems With Products Regulated by FDA, http://www.fda.gov/AboutFDA/ContactFDA/ReportaProblem/default.htm.","document_id":"FDA-2010-D-0605-0004"},{"title":"Reference 1 - FDA. Guidance for Industry: Product Recalls, Including Removals and Corrections, http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm","document_id":"FDA-2010-D-0605-0003"}],"agency_name":"FDA","documents":[{"comment_count":2,"comment_start_date":"2010-12-16","updated_at":"2023-03-01T13:06:55.557-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2010-D-0605-0001","allow_late_comments":null,"id":"FDA-2010-D-0605-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":3,"id":"FDA-2010-D-0605","title":"Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Availability"}],"document_number":"2010-31613","effective_on":null,"end_page":78716,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2010/12/16/2010-31613.xml","html_url":"https://www.federalregister.gov/documents/2010/12/16/2010-31613/small-entity-compliance-guide-current-good-manufacturing-practice-in-manufacturing-packaging","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2010-31613?publication_date=2010-12-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2010-12-16/2010-31613/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":5228,"last_updated":"2026-05-23 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-12-16/pdf/2010-31613.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2010-12-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2010/12/16/2010-31613.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 - FDA. Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, http://www.fda.gov/FoodGuidances","document_id":"FDA-2010-D-0605-0005"},{"title":"Reference 2 - FDA. Report a Problem. How to Report Problems With Products Regulated by FDA, http://www.fda.gov/AboutFDA/ContactFDA/ReportaProblem/default.htm.","document_id":"FDA-2010-D-0605-0004"},{"title":"Reference 1 - FDA. Guidance for Industry: Product Recalls, Including Removals and Corrections, http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm","document_id":"FDA-2010-D-0605-0003"}],"comments_count":2,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2010-D-0605","supporting_documents_count":3,"docket_id":"FDA-2010-D-0605","document_id":"FDA-2010-D-0605-0001","regulation_id_number":null,"title":"Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Availability","checked_regulationsdotgov_at":"2023-03-01T18:06:54Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":78715,"subtype":null,"title":"Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Availability","toc_doc":"Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements","toc_subject":"Small Entity Compliance Guides; Availability, etc.:","topics":[],"type":"Notice","volume":75}