{"abstract":"The Food and Drug Administration (FDA or we) is issuing this proposed rule that would require domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with the data FDA needs to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA intends to cease collecting this information starting in fiscal year 2015 (October 2014). Consistent with the requirements of the FD&C Act, we are proposing to require the submission of this information to FDA instead of USDA. We are taking this action to ensure that FDA continues to have the information we need to calculate, assess, and collect user fees.","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/2013/05/31/2013-12927.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1150,"title":21}],"citation":"78 FR 32581","comment_url":null,"comments_close_on":"2013-08-14","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by August 14, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by July 1, 2013 (see the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0920"],"dockets":[],"document_number":"2013-12927","effective_on":null,"end_page":32594,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/05/31/2013-12927.xml","html_url":"https://www.federalregister.gov/documents/2013/05/31/2013-12927/tobacco-products-user-fees-requirements-for-the-submission-of-data-needed-to-calculate-user-fees-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-12927?publication_date=2013-05-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-05-31/2013-12927/mods.xml","not_received_for_publication":null,"page_length":14,"page_views":{"count":1315,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-05-31/pdf/2013-12927.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-12927.pdf?1369918199","publication_date":"2013-05-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/05/31/2013-12927.txt","regulation_id_number_info":{"0910-AG81":{"issue":"201404","html_url":"https://www.federalregister.gov/regulations/0910-AG81/requirements-for-the-submission-of-data-needed-to-calculate-user-fees-for-domestic-manufacturers-and","title":"Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201404&RIN=0910-AG81&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG81"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 2 Form FDA 3825","document_id":"FDA-2012-N-0920-0019"},{"title":"Reference 1 Regulatory Impact Analysis re Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco","document_id":"FDA-2012-N-0920-0018"},{"title":"User Fee Rule References","document_id":"FDA-2012-N-0920-0017"},{"title":"Reference 2 - Regulatory Impact Analysis re Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products","document_id":"FDA-2012-N-0920-0015"},{"title":"Reference 1 FDA-3852 re Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products","document_id":"FDA-2012-N-0920-0014"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG81/requirements-for-the-submission-of-data-needed-to-calculate-user-fees-for-domestic-manufacturers-and","title":"Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0920","supporting_documents_count":5,"docket_id":"FDA-2012-N-0920","regulation_id_number":"0910-AG81","title":"Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products","checked_regulationsdotgov_at":"2013-06-20T08:06:19Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":32581,"subtype":null,"title":"Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products","toc_doc":"Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers","toc_subject":"Tobacco Products:","topics":["Tobacco"],"type":"Proposed Rule","volume":78}