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HHS/FDA | RIN: 0910-AH96 | Publication ID: Fall 2018 |
Title: Updated Regulations for Medical Gases | |
Abstract:
FDA intends to propose revisions to certain regulations with regard to medical gases. These proposed changes are anticipated to include, but are not necessarily limited to, specific changes to current good manufacturing practice (cGMP), labeling, and postmarket reporting regulations applicable to medical gases, generally aiming for less stringent regulation where appropriate. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: Pub. L 115-31, sec. 756 (2017 Consolidated Appropriations Act) |
Legal Deadline:
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Overall Description of Deadline: Section 756 of the 2017 Consolidated Appropriations Act (Pub. L. 115-31) directs FDA to issue final regulations revising the Federal drug regulations with respect to medical gases by July 2017. |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: David Faranda Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-8767 Email: david.faranda@fda.hhs.gov |