United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-05-10 article Rules and Regulations D09002ee1c7f6350c D09002ee1c7f63610 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or we) is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA recently expanded its authority by issuing a final rule, "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" (Deeming rule), deeming all products that meet the statutory definition of "tobacco product," except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act's user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA. 81 FR 28707 https://www.govinfo.gov/app/details/FR-2016-05-10/2016-10688 2016-10688 fr10my16-2 RIN 0910-AG81 4164-01-P Docket No. FDA-2012-N-0920 https://www.govinfo.gov/app/details/FR-2016-05-10/2016-10688 https://www.govinfo.gov/content/pkg/FR-2016-05-10/html/2016-10688.htm https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10688.pdf Tobacco Products User Fees 10 p. 28707 28716 81 FR 28707 Title 21 Part 1150 21 CFR Part 1150 RIN 0910-AG81 Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco; Federal Register Vol. 81, Issue RULE 2016-10688 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-08-08 Docket No. FDA-2012-N-0920 4164-01-P 2016-10688 Final rule.

The Food and Drug Administration (FDA or we) is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA recently expanded its authority by issuing a final rule, "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" (Deeming rule), deeming all products that meet the statutory definition of "tobacco product," except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act's user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA.

This rule is effective August 8, 2016. Domestic manufacturers and importers of cigars and pipe tobacco must begin submitting data required by Sec. 1150.5 (21 CFR 1150.5) to FDA no later than the 20th day of August, 2016. Paul Hart, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002; 1-877-287-1373, CTPRegulations@fda.hhs.gov. Tobacco Products User Fees Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco , CTPRegulations@fda.hhs.gov http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.regulations.gov Vol. 81, no. 90 Office of the Federal Register, National Archives and Records Administration 2016-05-10 continuing daily deposited born digital 433 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-05-10 P0b002ee18f662de2 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10my16 https://www.govinfo.gov/app/details/FR-2016-05-10 https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/FR-2016-05-10.pdf https://www.govinfo.gov/content/pkg/FR-2016-05-10/xml/FR-2016-05-10.xml fdlp 28687 29109 DGPO 2016-05-10 2024-06-02 FR-2016-05-10 machine generated eng FR FR-2016-05-10 81 90