Rules and Regulations. Final rule; extension of comment period

Agency: Food and Drug Administration, HHS
Action: Final rule; extension of comment period
Citation: FR Doc. 2017-10036 · RIN 0910-AH19 · Docket No. FDA-2015-N-2002 · 21 CFR 201, 801, 1100

Summary

In the Federal Register of January 9, 2017, the Food and Drug Administration (FDA or the Agency) issued a final rule entitled “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses' ” (Final Rule). On March 20, 2017, FDA published a document in the Federal Register (Final Rule Extension) to delay the effective date of the Final Rule until March 19, 2018, and requested comments on particular issues raised in a petition for reconsideration and stay of action of the Final Rule. The petition for reconsideration raised questions about the amendments to the regulations regarding “intended uses” that are set forth in the Final Rule. In the Final Rule Extension FDA also requested comments regarding any aspect of the Final Rule, or with respect to issues relating to “intended uses” generally, and on whether the delay in the effective date should be modified or revoked. FDA is now issuing this document to extend the comment period. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Dates

FDA is extending the comment period on the document delaying the effective date and seeking comment on the final rule published March 20, 2017 (82 FR 14319). Submit either electronic or written comments by July 18, 2017. For additional information on the comment date, see ADDRESSES and SUPPLEMENTARY INFORMATION .

Supplementary Information

In the Federal Register of March 20, 2017, FDA published a document delaying the effective date of the January 9, 2017 (82 FR 2193), final rule entitled “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses' ” until March 19, 2018, with a 60-day comment period. FDA requested comments on particular issues raised in a petition for reconsideration and stay of action of the Final Rule, as well as regarding any aspect of the Final Rule, or with respect to issues relating to “intended uses” generally. FDA also requested comments on whether the delay in the effective date of the Final Rule should be modified or revoked. Comments on these issues will inform FDA's thinking and next steps on these issues. The Agency has received a request for a 30-day extension and another request for a 90-day extension of the comment period for the Final Rule Extension. The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to issues FDA raised in the Final Rule Extension. FDA has considered the requests and is extending the comment period for 60 days, until July 18, 2017. The Agency believes that a 60-day extension allows additional time for interested persons to submit comments on these important issues. Dated: May 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-10036 Filed 5-17-17; 8:45 am]