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 2014_register executive 2014-07-10 article Rules and Regulations D09002ee1c7f91c05 D09002ee1c7f91c75 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 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, the final rule requires the submission of this information to FDA instead of USDA. 79 FR 39302 https://www.govinfo.gov/app/details/FR-2014-07-10/2014-16153 2014-16153 fr10jy14-3 RIN 0910-AG81 4164-01-P Docket No. FDA-2012-N-0920 https://www.govinfo.gov/app/details/FR-2014-07-10/2014-16153 https://www.govinfo.gov/content/pkg/FR-2014-07-10/html/2014-16153.htm https://www.govinfo.gov/content/pkg/FR-2014-07-10/pdf/2014-16153.pdf Tobacco Products User Fees 10 p. 39302 39311 79 FR 39302 Title 21 Part 1150 21 CFR Part 1150 RIN 0910-AG81 Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Federal Register Vol. 79, Issue RULE 2014-16153 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-08-11 Docket No. FDA-2012-N-0920 4164-01-P 2014-16153 Final rule.

The Food and Drug Administration (FDA or we) is issuing a final rule that requires 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, the final rule requires the submission of this information to FDA instead of USDA.

This rule is effective August 11, 2014. Nancy Boocker or Annette Marthaler, 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 Tobacco Products: User Fees for Domestic Manufacturers and Importers; Requirements for Submission of Data to Calculate , CTPRegulations@fda.hhs.gov http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/tobaccoproducts http://www.regulations.gov Vol. 79, no. 132 Office of the Federal Register, National Archives and Records Administration 2014-07-10 continuing daily deposited born digital 671 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-07-10 P0b002ee1897aad6d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10jy14 https://www.govinfo.gov/app/details/FR-2014-07-10 https://www.govinfo.gov/content/pkg/FR-2014-07-10/pdf/FR-2014-07-10.pdf https://www.govinfo.gov/content/pkg/FR-2014-07-10/xml/FR-2014-07-10.xml fdlp 39289 39951 DGPO 2014-07-10 2024-06-02 FR-2014-07-10 machine generated eng FR FR-2014-07-10 79 132