At OMB: HHS rules under review

Before a significant rule can publish, the agency must send it to the Office of Information and Regulatory Affairs for review under Executive Order 12866. This page tracks what HHS has sitting there now and what has cleared recently. It is the earliest public signal that a rule is coming, usually weeks or months ahead of the Federal Register.

HHS actions at OMB
48
Arrived in last 30 days
17
Concluded in 90 days
53
Longest under review
266d
Withdrawn
1

At OMB now

Longest-running first. A rule that has sat for months is usually contested; one that arrives and leaves in days usually is not.

266d at OMB
Cannabidiol (CBD) Products Compliance and Enforcement Policy
FDA · 0910-ZC82 · Notice · received 2026-03-13
217d at OMB
197d at OMB
Exchange Pre-Enrollment Eligibility Verification (CMS-9873)
CMS · 0938-AW03 · Proposed Rule · received 2026-04-22
177d at OMB
157d at OMB
Short-Term, Limited-Duration Insurance (CMS-9881)
CMS · 0938-AV92 · Proposed Rule · received 2026-05-30
139d at OMB
135d at OMB
127d at OMB
127d at OMB
Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546)Legal deadline
CMS · 0938-AV74 · Final Rule · received 2026-06-15
123d at OMB
Cutting Administrative Requirements for Excellence in Patient Care (CMS-3484)
CMS · 0938-AW04 · Proposed Rule · received 2026-07-02
106d at OMB
Administrative Detention of Tobacco Products
FDA · 0910-AI05 · Proposed Rule · received 2026-07-09
99d at OMB
U.S.-Origin Statements on Seafood; Draft Guidance for Industry
FDA · 0910-ZD48 · Notice · received 2026-07-10
98d at OMB
80d at OMB
White Paper: Proposed Definition of Ultra-Processed Food
FDA · 0910-ZD60 · Notice · received 2026-08-03
74d at OMB
Ensuring Program Integrity for Head Start Programs
ACF · 0970-AD47 · Proposed Rule · received 2026-08-05
72d at OMB
Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) (CMS-6098)
CMS · 0938-AV97 · Proposed Rule · received 2026-08-07
70d at OMB
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409)Legal deadline
CMS · 0938-AU54 · Final Rule · received 2026-08-20
57d at OMB
Reducing Bureaucracy and Burden for Block Grants
ACF · 0970-AD49 · Proposed Rule · received 2026-09-03
43d at OMB
Sunlamp Products; Amendment to the Performance Standard
FDA · 0910-AG30 · Final Rule · received 2026-09-09
37d at OMB
Medicare Drug Price Negotiation Program (CMS-4215)
CMS · 0938-AV90 · Final Rule · received 2026-09-09
37d at OMB
Restoring Flexibility to Support Head Start Program Access
ACF · 0970-AD21 · Final Rule · received 2026-09-10
36d at OMB
2026 NIH Research Plan on Rehabilitation
NIH · 0925-ZA21 · Notice · received 2026-09-11
35d at OMB
Reducing Bureaucracy and Burden in Part 1370
ACF · 0970-AD45 · Proposed Rule · received 2026-09-15
31d at OMB
29d at OMB
29d at OMB
Reducing Bureaucracy and Burden in the Child Care and Development Fund (CCDF)
ACF · 0970-AD29 · Proposed Rule · received 2026-09-17
29d at OMB
25d at OMB
Request for Information: Developing Menopause Common Data Elements
NIH · 0925-ZA22 · Notice · received 2026-09-28
18d at OMB
Reducing Bureaucracy and Burden for Child Support Enforcement
ACF · 0970-AD39 · Final Rule · received 2026-09-28
18d at OMB
17d at OMB
17d at OMB
National Institute on Aging Strategic Directions 2026-2030
NIH · 0925-ZA27 · Notice · received 2026-10-02
14d at OMB
Expanding Access to Individual Coverage Health Reimbursement Arrangements (CMS-9876)
CMS · 0938-AW00 · Proposed Rule · received 2026-10-05
11d at OMB
10d at OMB
Infant Formula Nutrient Requirements
FDA · 0910-AJ34 · Proposed Rule · received 2026-10-14
2d at OMB
Interim Access Policy for Compounding Using Certain Peptides
FDA · 0910-ZD94 · Notice · received 2026-10-14
2d at OMB

Concluded in the last 90 days

OIRA records an outcome for every review. Consistent with Change means the rule was altered during review. Withdrawn means the agency pulled it, which is rare and usually the more significant event. Publication normally follows a conclusion within days.

Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments
FDA · 0910-ZD93 · Notice · received 2026-10-09 · concluded 2026-10-13 after 4d
Consistent with Change
Further Reducing Bureaucracy and Burden from the Administration for Native Americans
ACF · 0970-AD50 · Proposed Rule · received 2026-09-30 · concluded 2026-10-09 after 9d
Consistent with Change
Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition
FDA · 0910-AI91 · Proposed Rule · received 2026-06-05 · concluded 2026-10-08 after 125d
Consistent with Change
Consistent with Change
Request for Information (RFI): Strategies to Advance RAPIDs and Real-World Evidence for Serious Mental Illnesses
NIH · 0925-ZA23 · Notice · received 2026-09-28 · concluded 2026-10-08 after 10d
Consistent with Change
Consistent with Change
Opportunities to Reduce Administrative Burden in NIH Extramural Research Request for Information
NIH · 0925-ZA24 · Notice · received 2026-09-29 · concluded 2026-10-07 after 8d
Consistent with Change
Consistent without Change
Transparency in Coverage (CMS-9882)
CMS · 0938-AV64 · Final Rule · received 2026-07-27 · concluded 2026-10-01 after 66d
Consistent with Change
Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545)Legal deadline
CMS · 0938-AV66 · Final Rule · received 2026-06-26 · concluded 2026-09-30 after 96d
Consistent with Change
Reforming Federal Reporting and Assessments in Child Welfare
ACF · 0970-AD32 · Proposed Rule · received 2026-07-28 · concluded 2026-09-30 after 64d
Consistent with Change
Consistent with Change
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry
FDA · 0910-ZD09 · Notice · received 2026-05-22 · concluded 2026-09-25 after 126d
Consistent with Change
Consistent with Change
Updates to the Children's Bureau Child Welfare Policy Manual
ACF · 0970-ZA25 · Notice · received 2026-08-14 · concluded 2026-09-25 after 42d
Consistent with Change
Modification of Living Organ Donation Reimbursement Program Eligibility Guidelines in Response to Honor Our Living Donors Act
HRSA · 0906-ZA25 · Notice · received 2026-08-28 · concluded 2026-09-24 after 27d
Consistent with Change
Consistent with Change
Period for Refugee Cash Assistance and Refugee Medical Assistance; Correction
ACF · 0970-ZA26 · Notice · received 2026-09-08 · concluded 2026-09-23 after 15d
Consistent without Change
Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information
FDA · 0910-ZD79 · Notice · received 2026-09-15 · concluded 2026-09-21 after 6d
Consistent without Change
Patient Protection and Affordable Care Act; Temporary Moratorium on Certain Agent and Broker Participation in the Exchanges (CMS-9872)
CMS · 0938-AW26 · Interim Final Rule · received 2026-09-16 · concluded 2026-09-21 after 5d
Consistent with Change
FY 2026-2030 NIH Strategic Plan for HIV and HIV-Related Research
NIH · 0925-ZA20 · Notice · received 2026-08-20 · concluded 2026-09-17 after 28d
Consistent with Change
Request for Information: Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards (CMS-4217)Legal deadline
CMS · 0938-AW08 · Notice · received 2026-08-19 · concluded 2026-09-16 after 28d
Consistent with Change
Private Health Insurance; New Agent/Broker Registrations for Plan Year 2027 Moratorium Guidance
CMS · 0938-ZC07 · Notice · received 2026-09-04 · concluded 2026-09-16 after 12d
Withdrawn
Consistent with Change
Consistent without Change
Dear Colleague Letter: Combating Discrimination Rooted in Antisemitism in HHS-Funded Programs and Activities
OCR · 0945-ZA12 · Notice · received 2026-08-07 · concluded 2026-09-02 after 26d
Consistent with Change
Reducing Bureaucracy and Burden for the Repatriation of Mentally Ill Nationals
ACF · 0970-AD48 · Proposed Rule · received 2026-08-20 · concluded 2026-09-01 after 12d
Consistent with Change
Nonclinical Testing Terminology
FDA · 0910-AJ27 · Final Rule · received 2026-07-28 · concluded 2026-08-31 after 34d
Consistent with Change
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry
FDA · 0910-ZD64 · Notice · received 2026-08-11 · concluded 2026-08-28 after 17d
Consistent without Change
Where the Clinic Meets the Movement: Does Gender Ideology Arm Left-Wing Authoritarian Psychology?
OS · 0937-ZA01 · Notice · received 2026-08-24 · concluded 2026-08-25 after 1d
Consistent without Change
Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making
OS · 0991-ZA62 · Notice · received 2026-08-18 · concluded 2026-08-20 after 2d
Consistent with Change
Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability
FDA · 0910-ZD61 · Notice · received 2026-08-06 · concluded 2026-08-17 after 11d
Consistent without Change
Consistent without Change
Request for Information: Draft NIH Biosafety Policy for Research Involving Biohazards
NIH · 0925-ZA13 · Prerule · received 2026-06-17 · concluded 2026-08-12 after 56d
Consistent with Change
NIH Policy on Sharing Summary Level Results with Clinical Research Participants
NIH · 0925-ZA19 · Notice · received 2026-08-04 · concluded 2026-08-12 after 8d
Consistent without Change
Consistent with Change
Request for Information (RFI) on Proposed Changes to Reporting Outcomes from NIH Peer Review
NIH · 0925-ZA16 · Notice · received 2026-07-23 · concluded 2026-08-07 after 15d
Consistent with Change
Recent Updates: Supporting a Safe and Respectful Workplace at Institutions that Receive NIH Funding
NIH · 0925-ZA17 · Notice · received 2026-07-23 · concluded 2026-08-07 after 15d
Consistent with Change
Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway (CMS-3487)
CMS · 0938-ZC05 · Notice · received 2026-07-23 · concluded 2026-08-07 after 15d
Consistent with Change
Substances Generally Recognized as Safe
FDA · 0910-AJ02 · Proposed Rule · received 2025-12-01 · concluded 2026-07-31 after 242d
Consistent with Change
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2027 Rates (C…Legal deadline
CMS · 0938-AV79 · Final Rule · received 2026-06-24 · concluded 2026-07-31 after 37d
Consistent with Change
Modernize the Head Start Program by Reducing Requirements and Enhancing Alignment with State and Local Systems
ACF · 0970-AD30 · Proposed Rule · received 2026-05-22 · concluded 2026-07-31 after 70d
Consistent with Change
FY 2027 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1851)Legal deadline
CMS · 0938-AV78 · Final Rule · received 2026-07-09 · concluded 2026-07-30 after 21d
Consistent with Change
FY 2027 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1845)Legal deadline
CMS · 0938-AV76 · Final Rule · received 2026-07-09 · concluded 2026-07-29 after 20d
Consistent with Change
FY 2027 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1847)Legal deadline
CMS · 0938-AV77 · Final Rule · received 2026-06-24 · concluded 2026-07-29 after 35d
Consistent with Change
Notice Regarding 340B Rebate Model Pilot Program
HRSA · 0906-ZA23 · Prerule · received 2026-05-27 · concluded 2026-07-28 after 62d
Consistent with Change
FY 2027 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Rep…Legal deadline
CMS · 0938-AV75 · Final Rule · received 2026-06-18 · concluded 2026-07-28 after 40d
Consistent with Change
Request for Information: Inviting Input on NIDA's Strategic Plan for 2027-2031
NIH · 0925-ZA11 · Notice · received 2026-06-15 · concluded 2026-07-27 after 42d
Consistent with Change
Consistent with Change
NIH Is Replacing Letters of Support with Letters of Collaboration to Reduce Administrative Burden
NIH · 0925-ZA15 · Notice · received 2026-07-09 · concluded 2026-07-24 after 15d
Consistent with Change
Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods
FDA · 0910-AI72 · Final Rule · received 2026-04-20 · concluded 2026-07-23 after 94d
Consistent with Change
Determining Whether to Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability
FDA · 0910-ZD49 · Notice · received 2026-07-10 · concluded 2026-07-21 after 11d
Consistent without Change
Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes (CMS-2452)Legal deadline
CMS · 0938-AV93 · Proposed Rule · received 2025-12-31 · concluded 2026-07-21 after 202d
Consistent with Change

Source: reginfo.gov EO 12866 review data, regenerated each weekday morning. Pending actions from the rules-under-review file; conclusions from the completed-reviews file for the current calendar year.