Open for industry feedback

Proposed rules, draft specs, ballots and RFIs with an open comment window. Tracked proceedings keep their full history — from proposal to final decision — so you can follow where a requirement is heading.

Tracked — open for comment

Closing soon Health and Human Services Department, Children and Families Administration

HHS Proposes Updated Mental Health and Health Intervention Forms for Refugee Children with DHS Data Sharing

💬 Comments close in 2 days (Nov 4)

4 updates · 2 briefs · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration, Health Resources and Services Administration

HHS Seeks Input on Regulating Deceased Donor Islet Cells for Type 1 Diabetes Treatment

💬 Comments close in 7 days (Nov 9)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration

FDA Seeks OMB Clearance for Medical Device Adverse Event Reporting Program (MedSun)

💬 Comments close in 7 days (Nov 9)

3 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration

FDA Seeks Public Comment on Pregnancy Exposure Registry Survey of Healthcare Providers

💬 Comments close in 7 days (Nov 9)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration

FDA Seeks Public Comment on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulation

💬 Comments close in 7 days (Nov 9)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration

FDA Seeks Comment on Proposed Medical Device Tracking Information Collection

💬 Comments close in 8 days (Nov 10)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration

FDA Seeks Public Input on Statistical Design of Rare Disease Clinical Trials

💬 Comments close in 11 days (Nov 13)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration

FDA Seeks Comment on Infant Formula Information Collection Requirements

💬 Comments close in 11 days (Nov 13)

3 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Requests Input on Ibogaine Clinical Trial Design for Opioid Use Disorder and PTSD

💬 Comments close in 18 days (Nov 20)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Disease Control and Prevention

CDC seeks public comment on using data intermediaries for public health data exchange

💬 Comments close in 18 days (Nov 20)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Proposes Information Collection for ASCA Accreditation Program

💬 Comments close in 21 days (Nov 23)

3 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Issues Draft Guidance on Premarket Submissions for Robotically-Assisted Surgical Devices

💬 Comments close in 22 days (Nov 24)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Children and Families Administration

HHS Proposes Consolidation and Revision of ORR Unaccompanied Alien Child Health Forms with DHS Data Sharing Updates

💬 Comments close in 23 days (Nov 25)

4 updates · 2 briefs · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA seeks public input on Biosimilar User Fee Act reauthorization for FY 2028-2032

💬 Comments close in 23 days (Nov 25)

8 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department RIN 0938-AW03

HHS Proposes Exchange Pre-Eligibility Verification Updates Under Working Families Tax Cut Legislation

💬 Comments close in 25 days (Nov 27)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Proposes Information Collection for Tracking Medical Devices

💬 Comments close in 28 days (Nov 30)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV89

CMS Proposes Virtual Access to CLIA Data & Digital Images for Gynecologic Cytology PT

💬 Comments close in 35 days (Dec 7)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration RIN 0910-AJ02

FDA Proposes Mandatory GRAS Notice Submission for Food Substances

💬 Comments close in 37 days (Dec 9)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV88

CMS proposes rule to implement Medicare Part D low-income cost-sharing, REAL Act, and PBM accountability provisions of 2026 Appropriations Act

💬 Comments close in 43 days (Dec 15)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Seeks Comment on Electronic Records and Signatures Collection Under PRA

💬 Comments close in 56 days (Dec 28)

5 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Determines Regulatory Review Period for Andembry to Support Patent Extension

💬 Comments close in 126 days (Mar 8)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services

CMS renews DNV Healthcare USA Inc.'s hospital accreditation approval

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services

HHS Publishes Secretarial Comments on Battelle/CBE 2025 Annual Quality Measures Report to Congress

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Announces Medical Device User Fee Rates for FY 2027 Effective October 2026

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Announces Microbiology Devices Panel Meeting on Pathogen-Agnostic Sequencing for Emergency Preparedness

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services

CMS renews NCQA's deeming authority for MA HMOs and PPOs for 6 years

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Closed — awaiting final decision

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA Seeks Public Comment on Proposed Information Collection for Medical Device Voluntary Improvement Program

💬 Comments close in 0 days (Nov 2)

3 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA Seeks Comment on Proposed Information Collection for Medical Device Removals and Corrections Reporting

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Disease Control and Prevention

CDC Seeks Public Comment on National Death Index Data Collection Renewal

💬 Comment window closed

4 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA seeks public comment on proposed information collection for allegations of regulatory misconduct submitted to CDRH

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA proposes Class I classification for specific medical device accessories under FDARA

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA Proposes Downgrading Bladder Cancer Detection Endoscopes from Class III to Class II

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services

CMS proposes RAPID coverage pathway for accelerated Medicare device coverage

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class II

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Children and Families Administration RIN 0970-AD30

HHS Proposes Revised Head Start Standards to Reduce Federal Burden

💬 Comment window closed

3 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV93

CMS Proposes Revised Medicaid Hold Harmless Threshold for Health Care-Related Taxes

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department,

HHS Requests Input on Vaccine Recommendation Categories and Shared Decision-Making Framework

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA Proposes New Information Collection for Investigational New Drug Application Requirements

💬 Comment window closed

3 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AW01

CMS Issues RFI to Update CLIA Regulations for 1988 Clinical Laboratory Standards

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration RIN 0910-AH59

FDA Proposes Extending Tobacco Establishment Registration and Product Listing to Foreign Facilities

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV82

CMS Proposes CY 2027 Physician Fee Schedule: Interoperability, Quality, and Payment Updates Open for Comment

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration RIN 0910-AI94

FDA Proposes Streamlined Registration for Distributed Manufacturing Establishments

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV80

CMS Proposes CY 2027 Home Health Payment Rates, Case-Mix Recalibration, and QRP/HHVBP Alignment Changes

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV83

CMS Proposes 2027 OPPS/ASC Payment Updates, Expands Prior Auth, and Issues HPT Standardization RFI

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV81

CMS proposes CY 2027 updates to ESRD PPS, AKI dialysis payment, and Quality Incentive Program

💬 Comment window closed

3 updates · 2 briefs · view timeline →

Closed — awaiting decision Health and Human Services Department, RIN 0936-AA16

HHS Seeks Input on Anti-Kickback Safe Harbors and Beneficiary Inducements Exceptions for Clinical Trial Remuneration

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department

ONC Opens 60-Day Comment Window on Proposed Information Collection Under Paperwork Reduction Act

💬 Comment window closed

5 updates · 1 brief · view timeline →

Other open comment items

Comment opportunities from non–Federal Register sources — no lifecycle tracking.

Notable HHS 💬 Comments close in 2 days (Nov 4)

AHRQ Seeks OMB Approval for Revised CAHPS Database for Health Plans Collection

AHRQ requests public comment on a proposed revision to its CAHPS Database for Health Plans information collection, with the comment period closing November 4, 2026. The Agency for Healthcare Research and Quality (AHRQ) has announced its intention to request Office of Management and Budget (OMB)...

Sources

Health and Human Services Department, Agency for Healthcare Research and Quality · Agency Information Collection Activities: Proposed Collection; Comment Request · Oct 5
Notable HHS 💬 Comments close in 7 days (Nov 9)

HRSA Seeks Public Comment on OMB Submission for Organ Transplant Data System

HRSA requests public feedback on its revised information collection request for the Organ Procurement and Transplantation Network data system before OMB review concludes. The Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of...

Sources

Health and Human Services Department, Health Resources and Services Administration · Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision · Oct 9
Notable CMS HHS 💬 Comments close in 18 days (Nov 20)

CMS Announces Privacy Act Matching Program with VA to Identify Duplicate Payments

CMS and VA will match beneficiary data to recover duplicate payments and improve payment accuracy under the Privacy Act of 1974, with public comment open until November 20, 2026. The Centers for Medicare & Medicaid Services (CMS), in coordination with the Department of Veterans Affairs (VA)...

Sources

Health and Human Services Department, Centers for Medicare & Medicaid Services · Privacy Act of 1974; Matching Program · Oct 21
Notable HHS 💬 Comments close in 18 days (Nov 20)

SAMHSA Proposes New Data Security Requirements for Confidential Mental Health Data Access

SAMHSA seeks OMB clearance for updated security requirements governing access to confidential substance abuse and mental health data, with public comment open until November 20, 2026. The Substance Abuse and Mental Health Services Administration (SAMHSA) has submitted a proposed information...

Sources

Health and Human Services Department, Substance Abuse and Mental Health Services Administration · Agency Information Collection Activities: Proposed Collection; Public Comment Request; Information Collection Request Title: SAMHSA Data Security Requirements for Accessing Confidential Data (OMB No. 0930-0396) · Oct 21
Notable HHS 💬 Comments close in 21 days (Nov 23)

HRSA Seeks Public Comment on NPDB Regulations and Forms Revision (OMB No. 0906-0081)

The Health Resources and Services Administration requests input on proposed updates to the National Practitioner Data Bank regulations and forms under the Paperwork Reduction Act. The Health and Human Services Department's Health Resources and Services Administration (HRSA) has submitted an...

Sources

Health and Human Services Department, Health Resources and Services Administration · Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-45 CFR Part 60 Regulations and Forms, OMB No. 0906-0081-Revision · Oct 23
High FDA 💬 Comments close in 22 days (Nov 24)

FDA Issues Draft Guidance on Pre-Market Testing for Surgical Robot Systems

FDA's new draft guidance expands pre-market testing requirements for robotic-assisted surgical devices to include cybersecurity, human factors, and operating room integration, with comments due November 24. The FDA has published draft guidance on pre-market testing for robotically-assisted...

Sources

MedCity News · Are Hospital Operating Rooms Ready For FDA’s Expectations for Surgical Robots? · Oct 12
Notable CMS HHS 💬 Comments close in 28 days (Nov 30)

CMS Announces Privacy Act Matching Program for State Health Subsidy Eligibility Verification

CMS launches a computer matching program to verify eligibility for ACA subsidy programs and prevent duplicate Medicaid enrollment across states, with public comment open until November 30, 2026. The Centers for Medicare & Medicaid Services (CMS) has issued a notice under the Privacy Act of 1974...

Sources

Health and Human Services Department, Centers for Medicare & Medicaid Services · Privacy Act of 1974; Matching Program · Oct 29

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