OIRA Conclusion of EO 12866 Regulatory Review


RIN: 0910-AH99         View EO 12866 Meetings Received Date: 01/05/2022 
Title: Harmonizing and Modernizing Regulation of Medical Device Quality Systems 
Agency/Subagency: HHS / FDA   Stage: Proposed Rule 
Concluded Action: Consistent with Change  Concluded Date: 02/08/2022 
Section 3(f)(1) Significant *: No 
Legal Deadline: None  Economically Significant **: Yes 
Publication Date: 02/23/2022  Unfunded Mandates: No 
Major: Yes  Related To Homeland Security: No 
Regulatory Flexibility Analysis Required: Undetermined  Small Entities Affected: No 
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  




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Following the issuance of E.O. 14094 on April 6, 2023, which amended Section 3(f)(1) of E.O. 12866, OIRA has designated regulatory actions as "Section 3(f)(1) Significant" if under that newly amended section of E.O. 12866 they are likely to result in a rule that may have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of OIRA for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities. After April 6, 2023, OIRA no longer designated regulatory actions as "Economically Significant."

Between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when E.O. 14094 was issued, OIRA designated regulatory actions as "Economically Significant" if under Section 3(f)(1) of E.O. 12866 they were likely to result in a rule that may have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.