Office of Information and Regulatory Affairs (OIRA)

Executive Order Submissions Under Review

April 20, 2024

Department of Health and Human Services


AGENCY: HHS-ACF RIN: 0970-AD03 Status: Pending Review
TITLE:Safe and Appropriate Foster Care Placement Requirements for Titles IV–E and IV–B Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/06/2024 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AC96 Status: Pending Review
TITLE:Parentage Establishment in the Child Support Services Program Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/07/2024 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AC97 Status: Pending Review
TITLE:Strengthening Temporary Assistance for Needy Families (TANF) as a Safety Net Program Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/07/2024 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AC89 Status: Pending Review
TITLE:Foster Care Legal Representation Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/22/2024 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD04 Status: Pending Review
TITLE:Temporary Assistance for Needy Families Work Outcomes Measures Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Interim Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 04/02/2024 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CDC RIN: 0920-AA82 Status: Pending Review
TITLE:Control of Communicable Diseases; Foreign Quarantine Importation of Dogs and Cats Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/11/2024 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AU91 Status: Pending Review
TITLE:Healthcare System Resiliency and Modernization (CMS-3426) Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Proposed Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 10/25/2023 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AU51 Status: Pending Review
TITLE:Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535) Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Proposed Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 11/09/2023 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AU28 Status: Pending Review
TITLE:Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/22/2024 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV23 Status: Pending Review
TITLE:Clarifying Eligibility for a Qualified Health Plan Through an Exchange, Advance Payments of the Premium Tax Credit, Cost-sharing Reductions, A Basic Health Program and Medicaid and CHIP (CMS-9894) Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 04/10/2024 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV27 Status: Pending Review
TITLE:CY 2025 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1805) Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Proposed Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
** RECEIVED DATE: 04/18/2024 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AV33 Status: Pending Review
TITLE:CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1807) Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Proposed Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
** RECEIVED DATE: 04/18/2024 LEGAL DEADLINE: Statutory  


AGENCY: HHS-FDA RIN: 0910-AI28 Status: Pending Review
TITLE:Tobacco Product Standard for Characterizing Flavors in Cigars Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 10/13/2023 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AI60 Status: Pending Review
TITLE:Tobacco Product Standard for Menthol in Cigarettes Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 10/13/2023 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AI82 Status: Pending Review
TITLE:Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Proposed Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 01/02/2024 LEGAL DEADLINE: Statutory  


AGENCY: HHS-FDA RIN: 0910-AI49 Status: Pending Review
TITLE:Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 02/13/2024 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZB92 Status: Pending Review
TITLE:Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Notice Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 02/26/2024 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AI85 Status: Pending Review
TITLE:Medical Devices; Laboratory Developed Tests Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/01/2024 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZB94 Status: Pending Review
TITLE:Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564. Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Notice Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/05/2024 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZB95 Status: Pending Review
TITLE:Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Notice Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/07/2024 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZB96 Status: Pending Review
TITLE:Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Notice Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 04/10/2024 LEGAL DEADLINE: None  


AGENCY: HHS-IHS RIN: 0917-AA24 Status: Pending Review
TITLE:Removal of Outdated Regulations Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/26/2024 LEGAL DEADLINE: None  


AGENCY: HHS-OCR RIN: 0945-AA15 Status: Pending Review
TITLE:Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Final Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/04/2024 LEGAL DEADLINE: None  


AGENCY: HHS-ONC RIN: 0955-AA06 Status: Pending Review
TITLE:Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. Yes
STAGE: Proposed Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 01/18/2024 LEGAL DEADLINE: Statutory  


AGENCY: HHS-SAMHSA RIN: 0930-AA33 Status: Pending Review
TITLE:Mandatory Guidelines for Federal Workplace Drug Testing Programs--Hair Section 3(f)(1) Significant: As defined in Section 3(f)(1) of E.O. 12866, as amended by the Modernizing E.O., a regulatory action that is likely to 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. These rules are generally included in the agency's regulatory plan, which appears only in the fall editions of the Unified Agenda. No
STAGE: Proposed Rule Economically Significant: This term was used for regulatory actions reviewed between September 30, 1993, when E.O. 12866 was issued, and April 6, 2023, when the Modernizing E.O. was issued. The term referred to a regulatory action as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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. No
RECEIVED DATE: 03/31/2023 LEGAL DEADLINE: None