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 2017_register executive 2017-03-18 article Rules and Regulations D09002ee1c7f2482a D09002ee1c7f24b10 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 further delaying the effective date of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. This action further delays the effective date of the rule until March 19, 2018. FDA has received a petition from affected parties which raises questions about the amendments to the regulations regarding "intended uses" and requests that FDA reconsider these amendments. FDA is further delaying the effective date to invite public comment on the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments. FDA is seeking input on some specific questions, and is also interested in any other pertinent information or comments stakeholders would like to provide regarding any aspect of the final rule, or with respect to issues relating to "intended uses" generally. 82 FR 14319 https://www.govinfo.gov/app/details/FR-2017-03-20/2017-05526 2017-05526 fr20mr17-1 RIN 0910-AH19 4164-01-P Docket No. FDA-2015-N-2002 https://www.govinfo.gov/app/details/FR-2017-03-20/2017-05526 https://www.govinfo.gov/content/pkg/FR-2017-03-20/html/2017-05526.htm https://www.govinfo.gov/content/pkg/FR-2017-03-20/pdf/2017-05526.pdf 6 p. 14319 14324 82 FR 14319 Title 21 Part 1100 21 CFR Part 1100 Title 21 Part 201 21 CFR Part 201 Title 21 Part 801 21 CFR Part 801 RIN 0910-AH19 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments; Federal Register Vol. 82, Issue RULE 2017-05526 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-01-09 Docket No. FDA-2015-N-2002 4164-01-P 2017-05526 Final rule; further delay of effective date; request for comments.

The Food and Drug Administration (FDA or we) is further delaying the effective date of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. This action further delays the effective date of the rule until March 19, 2018. FDA has received a petition from affected parties which raises questions about the amendments to the regulations regarding "intended uses" and requests that FDA reconsider these amendments. FDA is further delaying the effective date to invite public comment on the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments. FDA is seeking input on some specific questions, and is also interested in any other pertinent information or comments stakeholders would like to provide regarding any aspect of the final rule, or with respect to issues relating to "intended uses" generally.

Effective date: The effective date for the rule amending 21 CFR chapter 1 published at 82 FR 2193 on January 9, 2017, delayed at 82 FR 9501 on February 7, 2017, is further delayed until March 19, 2018. Robert Berlin, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4238, Silver Spring, MD 20993, 301-796-8828. Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products , http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm489499.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.justice.gov/usao-ndga/pr/atlanta-man-convicted-illegally-importing-and-distributing-male-enhancement-products https://www.regulations.gov Vol. 82, no. 52 Office of the Federal Register, National Archives and Records Administration 2017-03-20 continuing daily deposited born digital 107 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-03-20 P0b002ee194034f09 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20mr17 https://www.govinfo.gov/app/details/FR-2017-03-20 https://www.govinfo.gov/content/pkg/FR-2017-03-20/pdf/FR-2017-03-20.pdf https://www.govinfo.gov/content/pkg/FR-2017-03-20/xml/FR-2017-03-20.xml fdlp 14319 14417 DGPO 2017-03-18 2024-06-01 FR-2017-03-20 machine generated eng FR FR-2017-03-20 82 52