{"abstract":"The Food and Drug Administration (FDA, we, or Agency) is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products, to assure that the public health is protected and that tobacco products are in compliance with chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).","action":"Proposed rule.","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/2023/03/10/2023-04591.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1120,"title":21}],"citation":"88 FR 15174","comment_url":null,"comments_close_on":"2023-09-06","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submitted by September 6, 2023. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by April 10, 2023 (see section \"VI. Paperwork Reduction Act of 1995\" of this document). See section V of this document for the proposed effective date of a final rule based on this proposed rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0227"],"dockets":[{"supporting_documents":[{"title":"TAB C TPMP NPRM as Cleared by OMB","document_id":"FDA-2013-N-0227-0307"},{"title":"Memorandum to FDA DMS on TPMP NPRM (Docket No. FDA-2013-N-0227)","document_id":"FDA-2013-N-0227-0302"},{"title":"Reference 183 Ding Determination of 14 Polycyclic Aromatic Hydrocarbons 2006","document_id":"FDA-2013-N-0227-0252"},{"title":"Reference 173 Ding Determination of 14 Polycyclic Aromatic Hydrocarbons 2005","document_id":"FDA-2013-N-0227-0242"},{"title":"Reference 170 Carter Product Standards Raw Material Contamination 1988","document_id":"FDA-2013-N-0227-0239"},{"title":"Reference 158 Reasor Residual Solvent Task Force Meeting Brown and Williamson 1991","document_id":"FDA-2013-N-0227-0227"},{"title":"Reference 146 ISO 2859 1 Sampling Procedures for Inspection by Attributes Part 1 1999","document_id":"FDA-2013-N-0227-0215"},{"title":"Reference 143 Smith Composite Multivariate Quality Control Using a System 1991","document_id":"FDA-2013-N-0227-0212"},{"title":"Reference 138 Rose CORESTA Technical Report Tobacco Moisture Water and Oven Volatiles 2014","document_id":"FDA-2013-N-0227-0207"},{"title":"Reference 124 ISO 3951 Sampling Procedures for Inspection by Variables Part 1 2013","document_id":"FDA-2013-N-0227-0192"}],"agency_name":"FDA","documents":[{"comment_count":129,"comment_start_date":"2023-03-10","updated_at":"2023-11-03T01:01:22.717-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-N-0227-0066","allow_late_comments":null,"id":"FDA-2013-N-0227-0066","comment_end_date":"2023-10-07","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":236,"id":"FDA-2013-N-0227","title":"Tobacco Product Manufacturing Practice; Establishment of a Public Docket"}],"document_number":"2023-04591","effective_on":null,"end_page":15263,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/03/10/2023-04591.xml","html_url":"https://www.federalregister.gov/documents/2023/03/10/2023-04591/requirements-for-tobacco-product-manufacturing-practice","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-04591?publication_date=2023-03-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-03-10/2023-04591/mods.xml","not_received_for_publication":null,"page_length":90,"page_views":{"count":17734,"last_updated":"2026-04-25 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-10/pdf/2023-04591.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-04591.pdf?1678283117","publication_date":"2023-03-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/03/10/2023-04591.txt","regulation_id_number_info":{"0910-AH91":{"issue":"202404","html_url":"https://www.federalregister.gov/regulations/0910-AH91/requirements-for-tobacco-product-manufacturing-practice","title":"Requirements for Tobacco Product Manufacturing Practice","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&RIN=0910-AH91&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH91"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"TAB C TPMP NPRM as Cleared by OMB","document_id":"FDA-2013-N-0227-0307"},{"title":"Memorandum to FDA DMS on TPMP NPRM (Docket No. FDA-2013-N-0227)","document_id":"FDA-2013-N-0227-0302"},{"title":"Reference 183 Ding Determination of 14 Polycyclic Aromatic Hydrocarbons 2006","document_id":"FDA-2013-N-0227-0252"},{"title":"Reference 173 Ding Determination of 14 Polycyclic Aromatic Hydrocarbons 2005","document_id":"FDA-2013-N-0227-0242"},{"title":"Reference 170 Carter Product Standards Raw Material Contamination 1988","document_id":"FDA-2013-N-0227-0239"},{"title":"Reference 158 Reasor Residual Solvent Task Force Meeting Brown and Williamson 1991","document_id":"FDA-2013-N-0227-0227"},{"title":"Reference 146 ISO 2859 1 Sampling Procedures for Inspection by Attributes Part 1 1999","document_id":"FDA-2013-N-0227-0215"},{"title":"Reference 143 Smith Composite Multivariate Quality Control Using a System 1991","document_id":"FDA-2013-N-0227-0212"},{"title":"Reference 138 Rose CORESTA Technical Report Tobacco Moisture Water and Oven Volatiles 2014","document_id":"FDA-2013-N-0227-0207"},{"title":"Reference 124 ISO 3951 Sampling Procedures for Inspection by Variables Part 1 2013","document_id":"FDA-2013-N-0227-0192"}],"comments_count":129,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0227","supporting_documents_count":236,"docket_id":"FDA-2013-N-0227","document_id":"FDA-2013-N-0227-0066","regulation_id_number":null,"title":"Tobacco Product Manufacturing Practice; Establishment of a Public Docket","checked_regulationsdotgov_at":"2023-11-04T01:00:07Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":15174,"subtype":null,"title":"Requirements for Tobacco Product Manufacturing Practice","toc_doc":"Requirements for Tobacco Product Manufacturing Practice","toc_subject":null,"topics":["Reporting and recordkeeping requirements","Smoking","Tobacco"],"type":"Proposed Rule","volume":88}