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 2011_register executive 2011-07-05 article Rules and Regulations D09002ee1c7ffa4d2 D09002ee1c7ffa5c2 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) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision. 76 FR 38961 https://www.govinfo.gov/app/details/FR-2011-07-05/2011-16766 2011-16766 fr05jy11-1 RIN 0910-AG39 4160-01-P Docket No. FDA-2010-N-0646 https://www.govinfo.gov/app/details/FR-2011-07-05/2011-16766 https://www.govinfo.gov/content/pkg/FR-2011-07-05/html/2011-16766.htm https://www.govinfo.gov/content/pkg/FR-2011-07-05/pdf/2011-16766.pdf Tobacco Products Substantial Equivalence Exemptions Administrative Practice and Procedure 15 p. 38961 38975 76 FR 38961 Title 21 Part 1107 21 CFR Part 1107 Title 21 Part 16 21 CFR Part 16 RIN 0910-AG39 Tobacco Products, Exemptions From Substantial Equivalence Requirements; Federal Register Vol. 76, Issue RULE 2011-16766 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2011-08-04 Docket No. FDA-2010-N-0646 4160-01-P 2011-16766 Final rule.

The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.

This rule is effective August 4, 2011. Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373, annette.marthaler@fda.hhs.gov. Tobacco Products Substantial Equivalence Exemptions Administrative Practice and Procedure Tobacco Products: Exemptions From Substantial Equivalence Requirements , annette.marthaler@fda.hhs.gov smallbiz.tobacco@fda.hhs.gov http://data.bls.gov/cgi-bin/print.pl/oes/current/naics4_312200.htm http://factfinder.census.gov/ http://www.fda.gov/TobaccoProducts/default.htm Vol. 76, no. 128 Office of the Federal Register, National Archives and Records Administration 2011-07-05 continuing daily deposited born digital 291 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-07-05 P0b002ee180d91000 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05jy11 https://www.govinfo.gov/app/details/FR-2011-07-05 https://www.govinfo.gov/content/pkg/FR-2011-07-05/pdf/FR-2011-07-05.pdf https://www.govinfo.gov/content/pkg/FR-2011-07-05/xml/FR-2011-07-05.xml fdlp 38961 39244 DGPO 2011-07-05 2024-06-04 FR-2011-07-05 machine generated eng FR FR-2011-07-05 76 128