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HHS/FDA | RIN: 0910-AH94 | Publication ID: Spring 2018 |
Title: ●Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments Regarding "Intended Uses" "Delay of Effective Date" | |
Abstract:
FDA is delaying the effective date of amendments to the existing medical product ‘‘intended uses’ regulations, contained in the final rule of January 9, 2017, until further notice. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Other | |
CFR Citation: 21 CFR 201 21 CFR 801 | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 353 21 U.S.C. 371(a) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Related RINs: Previously reported as 0910-AH19 | |
Agency Contact: Kelley Nduom Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6221, Silver Spring, MD 20993 Phone:301 796-8597 Email: kelley.nduom@fda.hhs.gov |