OIRA Conclusion of EO 12866 Regulatory Review


RIN: 0910-ZB66         View EO 12866 Meetings Received Date: 06/12/2023 
Title: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability 
Agency/Subagency: HHS / FDA   Stage: Notice 
Concluded Action: Consistent with Change  Concluded Date: 07/20/2023 
Legal Deadline: None  Economically Significant: No 
Publication Date:   Unfunded Mandates: No 
Major: No  Related To Homeland Security: No 
Regulatory Flexibility Analysis Required: No  Small Entities Affected:  
Federalism Implications: No  Affordable Care Act [Pub. L. 111-148 & 111-152]: No
International Impacts: No Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No
Pandemic Response: No