Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 201, 801 and 1100 [Docket No. FDA-2015-N-2002] RIN 0910-AH19 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; further delay of effective date; request for comments. SUMMARY: 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. DATES: 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 …
Other Federal Register documents from the same docket.
Regulations Regarding “Intended Uses”
Regulations Regarding “Intended Uses”
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Partial Delay of Effective Date
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Proposed Partial Delay of Effective Date
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; Extension of Comment Period
Citation: 82 FR 14319
