{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled \"Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide\" for the final user fees rule published July 10, 2014, and for the new user fees regulation. This revised guidance, a small entity compliance guide (SECG), replaces the SECG of the same name published on July 16, 2014. The revised SECG is intended to set forth in plain language the requirements of the user fee regulations and to help small businesses understand and comply with the regulations.","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/2016/05/10/2016-10689.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1150,"title":21}],"citation":"81 FR 28783","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0917"],"dockets":[],"document_number":"2016-10689","effective_on":null,"end_page":28784,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/05/10/2016-10689.xml","html_url":"https://www.federalregister.gov/documents/2016/05/10/2016-10689/requirements-for-the-submission-of-data-needed-to-calculate-user-fees-for-domestic-manufacturers-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-10689?publication_date=2016-05-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-05-10/2016-10689/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":346,"last_updated":"2026-10-24 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10689.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-10689.pdf?1462452417","publication_date":"2016-05-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/05/10/2016-10689.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-0917","supporting_documents_count":0,"docket_id":"FDA-2014-D-0917","regulation_id_number":null,"title":"Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products","checked_regulationsdotgov_at":"2016-05-30T06:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28783,"subtype":null,"title":"Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide; Availability","toc_doc":"Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide","toc_subject":"Guidance:","topics":[],"type":"Proposed Rule","volume":81}