The Food and Drug Administration (FDA or we) is proposing to issue an order that would repeal the color additive regulation that allows for the use of Citrus Red No. 2 for coloring the skins of mature oranges. Based on certification data, it appears that Citrus Red No. 2 is no longer used for coloring the skins of oranges and has not been certified for use as a color additive in food marketed in the United States since 2020. Because the authorized use of Citrus Red No. 2 appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.
Comments close Aug 24, 2026
This proposed rule would revise standards for determining whether an indirect hold harmless arrangement exists for a health care- related tax. This proposed rule is necessary to implement a provision in the "One Big Beautiful Bill Act," herein referred to as the "Working Families Tax Cut (WFTC) legislation," which established new indirect hold harmless thresholds for health care-related taxes. Currently, the threshold for a State's collection of tax revenues is no more than 6 percent of net patient revenue attributable to the assessed permissible class of health care items or services. Effective October 1, 2026, the WFTC legislation generally sets the threshold equal to the applicable percent of net patient revenue attributable to taxes imposed as of July 4, 2025. Effective October 1, 2027, the WFTC legislation also requires a phase down of the hold harmless threshold in expansion States. Apart from establishing the new threshold in regulation and proposing related changes and enhancements to existing processes, we propose to sunset a secondary prong to the indirect hold harmless determination to ensure the thresholds determined as of July 4, 2025, serve as the maximum permissible level. Finally, this rule proposes to add a new permissible class to enhance CMS oversight of health care- related taxes.
Comments close Sep 21, 2026
Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks input from the public regarding various topics related to the CLIA regulations, including: breath testing; laboratory processes and procedures; emergency preparedness, biosafety and biosecurity, and cybersecurity; and specialty testing areas. Responses to this RFI may be used to help inform CMS and the CDC as to what types of action, if any, should be taken to update the existing CLIA regulations through future notice and comment rulemaking.
Comments close Sep 14, 2026
This proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2026 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the Medicare Promoting Interoperability Program.
Comments close Sep 14, 2026
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment registration and drug listing regulations applicable to foreign drug establishments with statutory changes made by the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).
Comments close Sep 11, 2026
The Department of Health and Human Services (HHS), in consultation with the National Institutes of Health (NIH), is proposing to rescind the existing regulation concerning grants under the National Cancer Institute (NCI) Clinical Cancer Education Program because the regulation is obsolete and no longer necessary.
Comments close Sep 8, 2026
This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There are no changes to the Rural Emergency Hospital Quality Reporting Program. We propose to expand the prior authorization requirement to include additional Botulinum Toxin Injection services. We also propose to implement certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. This rule also requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the HPT information reported in machine- readable files and consumer-friendly displays. We propose hospital AOs with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. Finally, we are soliciting comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines.
Comments close Aug 31, 2026
This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule discusses the behavior adjustment and proposes a temporary behavior adjustment and proposes to recalibrate the case-mix weights and update the functional impairment levels; comorbidity subgroups; and low- utilization payment adjustment (LUPA) thresholds for CY 2027. Additionally, this proposed rule discusses the provision of home health palliative care services and includes a request for information (RFI) on a home health specific wage index. This rule would also propose changes to the Home Health Quality Reporting Program (HH QRP) and summarizes potential initiatives to improve alignment between the HH QRP and expanded Home Health Value Based Purchasing (HHVBP) Model. Lastly, the rule would--clarify the application of the DMEPOS face-to- face encounter requirements for the replacement of DMEPOS items; make changes to the provider and supplier enrollment requirements; make changes regarding DME benefit expansion for infusion pumps and drugs; and discuss collection of information requirement changes regarding the DMEPOS Competitive Bidding Program (CBP) country of origin.
Comments close Aug 31, 2026
The Food and Drug Administration (FDA, the Agency, or we) is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing. Complete and accurate establishment registration and product listing information is important to accomplish statutory, regulatory, and public health objectives. Currently, only domestic owners and operators are required to register their establishments and list their tobacco products with FDA while foreign owners and operators are not subject to these requirements, creating significant gaps in Agency information. This action, if finalized, would extend registration and listing requirements to include owners and operators of foreign establishments.
Comments close Sep 14, 2026
This notice of proposed rulemaking (NPRM, or proposed rule) would establish certain additional requirements for sponsor suitability assessments related to proof of identity, proof of income, and other information required for background checks to promote the safe placement of unaccompanied alien children (UAC). This NPRM proposes acceptable documentation for proof of identity and would require proof of income from potential sponsors of UAC in ORR custody by reason of their immigration status, as described in the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA). This NPRM also proposes amendments to background check requirements for sponsor suitability assessments and the conduct of examinations of UAC related to considerations of UAC dangerousness to self or others that align with the One Big Beautiful Bill Act. Finally, this NPRM proposes certain administrative updates to align numbering and terminology between proposals and existing regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM.
Comments close Aug 25, 2026
This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update the requirements for the ESRD Quality Incentive Program.
Comments close Aug 24, 2026
This request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the "Beneficiary Inducements CMP") for remuneration provided to individuals in connection with their participation in clinical trials.
Comments close Aug 24, 2026
This proposed rule would codify the Medicare Drug Price Negotiation Program ("Negotiation Program") and would establish certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program as required by the Inflation Reduction Act of 2022. This proposed rule would also propose a modification to the fixed combination drug policy.
Comments close Aug 17, 2026
The Office of Child Support Enforcement proposes to rescind the Employment and Training Services for Noncustodial Parents in the Child Support Program final rule, published in the Federal Register on December 13, 2024. The final rule allowed child support agencies to utilize Federal Financial Participation under title IV-D of the Social Security Act for providing specific, optional, and non-duplicative employment and training services to eligible noncustodial parents.
Comments close Aug 10, 2026
This request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers ("PBMs") and their affiliates to inform implementation of recent legislation. It specifically focuses on gathering information to inform two specific legislative requirements that are effective beginning calendar year 2028: restrictions on the remuneration that PBMs and their affiliates may receive for services in connection with the utilization of covered Part D drugs; and data reporting requirements.
Comments close Jul 20, 2026
The Administration for Children and Families proposes to amend the Child Support regulations to eliminate unnecessary and obsolete regulations in the following sections: State Plan Approval and Grant Procedures, State Plan Requirements, Standards for Program Operations, Federal Financial Participation, Program Performance Measures, Standards, Financial Incentives, and Penalties, Computerized Support Enforcement Systems, Annual State Self-Assessment Review and Report, Tribal Child Support Enforcement (IV-D) Program, and Computerized Tribal IV-D Systems and Office Automation. A plain language summary of this proposed rule is available at https://www.regulations.gov.
Comments close Jul 20, 2026
This request for information (RFI) seeks public input to support CMS' comprehensive review of the Essential Health Benefits (EHB) framework and the requirement under the Patient Protection and Affordable Care Act (Affordable Care Act) that the scope of EHB be equal to the scope of benefits provided under a typical employer plan. CMS seeks comment on current interpretations of EHB, State approaches to selecting and updating EHB-benchmark plans, and methodologies used to determine the scope of benefits included as EHB, as well as how these approaches relate to access and market stability under the Affordable Care Act. CMS also seeks comment on variation across States in the scope of benefits included as EHB, cost pressures affecting EHB, processes for updating State EHB-benchmark plans, limitations in available data used to evaluate EHB, and potential impacts of possible future policy changes. The information gathered will inform CMS' evaluation of whether revisions or additions to the current EHB regulations through future notice and comment rulemaking may be appropriate.
Comments close Jul 15, 2026
The Office of Management and Budget (OMB) proposes to revise the Guidance for Federal Financial Assistance to improve government- wide policies and requirements related to the management of grants, cooperative agreements, and other forms of assistance. OMB is proposing revisions that would improve transparency, accountability, and oversight for Federal awards across the Federal Government. This includes ensuring that American tax dollars are not wasted or misused, activities performed under Federal awards are consistent with law and policy, and recipients are held accountable when they fail to meet relevant standards. The revisions also aim to ensure that basic American principles of equality and equal opportunity are upheld throughout all stages of the award making process and that unlawful discrimination is no longer permitted. Proposed changes also include providing further clarification on the regulatory status of the OMB requirements and on the process for future updates to the government- wide requirements. Finally, OMB also proposes changes to reduce recipient burden. The listed Federal grant-making agencies propose conforming changes to their respective adopting regulations, or, in the case of some agencies and other entities, establishing new adopting regulations or policies. The proposed changes reflect the administration's commitment to transparency, accountability, and proper oversight for the Federal grantmaking process. The proposed regulations seek to ensure that American tax dollars are ultimately used to serve the needs of the American public.
Comments close Jul 13, 2026
The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of January 11, 2024, announcing that we filed a food additive petition proposing that the food additive regulations be amended to remove four specified solvents. FDA is reopening the comment period to allow for the submission of any updated data and other information over the last two years.
Comments close Jun 29, 2026
The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of January 11, 2024, announcing that we filed a color additive petition proposing that the color additive regulations be amended to remove three specified solvents. FDA is reopening the comment period to allow for the submission of any updated data and other information over the last two years.
Comments close Jun 29, 2026
The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) issues this interim final rule with request for comments to amend its Foreign Quarantine Regulations. This interim final rule provides a procedure for the Secretary acting through the CDC Director or other delegate to suspend the introduction of persons from designated countries or places, if required, in the interest of public health.
Comments close Jun 26, 2026
The Administration for Children and Families proposes to amend the Grants to States for Public Assistance Programs regulations, the General Administration--State Plans and Grant Appeals regulations, the General Administration--Public Assistance Programs regulations, the Training and Use of Subprofessionals and Volunteers regulations, the Coverage and Conditions of Eligibility in Financial Assistance Programs regulations, the Financial Assistance to Individuals regulations, the Administration of Financial Assistance Programs regulations, the Fiscal Administration of Financial Assistance Programs regulations, the General Temporary Assistance for Needy Families (TANF) Provisions regulations, the Ensuring That Recipients Work regulations, the Accountability Provisions--General regulations, the Expenditures of State and Federal TANF Funds regulations, the Other Accountability Provisions regulations, the Data Collection and Reporting Requirements regulations, the High Performance Bonus Awards regulations, the Implementation of Section 403(a)(2) of the Social Security Act Bonus to Reward Decrease in Illegitimacy Ratio regulations, the Methodology for Determining Whether an Increase in a State or Territory's Child Poverty Rate Is the Result of the TANF Program regulations, the Tribal TANF Provisions regulations, and The Native Employment Works (NEW) Program regulations to eliminate unnecessary or obsolete regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM.
Comments close Jun 25, 2026
This proposed rule describes alternatives to modify the limit on the total payment rate and other requirements for State directed payments in Medicaid managed care. We propose these changes based on our authority to interpret and implement section 1902(a)(4) of the Social Security Act (the Act) with respect to prepaid inpatient health plans and prepaid ambulatory health plans, and section 1903(m)(2)(A)(iii) of the Act, which require that contracts between States and managed care organizations to provide payments under a risk- based contract for services and associated administrative costs that are actuarially sound. This rule also proposes to set a limit for certain targeted Medicaid payments in Medicaid fee-for-service. We propose this change based on our authority to interpret and implement section 1902(a)(30)(A) of the Act with respect to certain targeted Medicaid payments which require that payments be consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.
Comments close Jul 21, 2026
This document contains proposed rules that would amend the regulations regarding excepted benefits under the Employee Retirement Income Security Act of 1974, the Internal Revenue Code, and the Public Health Service Act to establish certain fertility benefits as a new category of limited excepted benefits. Excepted benefits are generally exempt from the market requirements that were added to those laws by the Health Insurance Portability and Accountability Act, the Patient Protection and Affordable Care Act, the No Surprises Act, and certain other Federal laws specifically related to group health plans and group and individual health insurance coverage.
Comments close Jul 13, 2026
In this notice of proposed rulemaking (NPRM), the Administration for Children and Families (ACF) proposes to remove requirements from the Head Start Program Performance Standards (Performance Standards) to restore local flexibility to Head Start programs and improve access to quality services. Specifically, this NPRM proposes to remove requirements related to wages and benefits that the Administration believes are not in line with the plain language of the Head Start Act and are costly and overly prescriptive for Head Start programs and staff. ACF estimates these proposed changes, if finalized, will result in over $2 billion in future cost savings for Head Start programs. The proposed rescissions in this NPRM, if finalized, would impact the costliest parts of the final rule published by the Office of Head Start (OHS) in 2024, Supporting the Head Start Workforce and Consistent Quality Programming.\1\ ---------------------------------------------------------------------------
Comments close Jun 11, 2026
The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order (E.O.) 14168, "Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government," issued on January 20, 2025. Specifically, this proposed rule, if finalized, will remove the term "gender" wherever it appears and either replace it with the term "sex," or delete reference to gender, as applicable, along with other editorial changes to improve readability.
Comments close Jul 6, 2026
These proposals are intended to improve the electronic exchange of health care data and streamline processes related to prior authorization by increasing the interoperability of systems used across the health care industry. We are proposing new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), including issuers that offer small group market QHPs on the Federally-facilitated Small Business Health Options Program (FF- SHOP) Exchanges (hereinafter referred to as "small group market QHP issuers on the FF-SHOPs") (collectively "impacted payers"), to make available electronic prior authorization for drugs. We are also proposing to extend many existing interoperability requirements for the prior authorization of non-drug items and services to include prior authorizations for drugs to further reduce patient and provider burden. We are also proposing to require impacted payers to report their application programming interfaces (API) endpoints and related information for the Patient Access, Provider Directory, Provider Access, Payer-to-Payer, and Prior Authorization APIs to CMS. To help assess the impact of our policies, we are proposing to collect API usage metrics. In addition, we are proposing to apply the existing interoperability requirements to small group market QHP issuers on the FF-SHOPs as impacted payers. To improve impacted payers' ability to exchange health information while continuing CMS's drive toward interoperability, we are proposing to require certain Health Level Seven (HL7[supreg]) Fast Healthcare Interoperability Resources (FHIR[supreg]) implementation guides (IGs) that are currently recommended. In addition, HHS is proposing to adopt the HL7 FHIR base standard and certain associated specifications and IGs as the Health Insurance Portability and Accountability Act of 1996 (hereinafter referred to as "HIPAA") (Pub. L. 104-191, enacted Aug. 21, 1996) standards for dental, professional, and institutional "referral certification and authorization" transactions and "eligibility for a health plan" transactions associated with prior authorization. We are proposing to add a definition for "failure to report," which would allow CMS to impose a civil monetary penalty (CMP) on applicable manufacturers or applicable group purchasing organizations (GPOs) if those entities fail to grant CMS timely access to documents for the purposes of an audit. Finally, ONC is using this rulemaking to propose to adopt updated versions of certain health information technology (health IT) standards and specifications for HHS use, such as CMS's interoperability requirements, to support a more robust health IT infrastructure.
Comments close Jun 15, 2026
This proposed rule would revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital- related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy-related changes.
Comments close Apr 10, 2026
The Department of Health and Human Services, Administration for Children and Families proposes to amend the Block Grants regulations, the Individual Development Account Reserve Funds Established Pursuant to Grants for Assets for Independence regulations, and the Emergency Community Services Homeless Grant Program regulations to eliminate unnecessary or obsolete regulations. The docket on https:/ /www.regulations.gov will include a plain language summary of the NPRM as required.
Comments close May 8, 2026
This rulemaking proposes to update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rulemaking also proposes refinement of the IPF PPS outlier policy. These changes would be effective for IPF discharges occurring during the fiscal year beginning October 1, 2026, through September 30, 2027. We are also proposing the implementation of a standardized IPF patient assessment instrument, and the removal of two measures used in the Inpatient Psychiatric Facilities Quality Reporting Program.
Comments close Jun 1, 2026
This rule proposes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year 2027. This proposed rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program.
Comments close Jun 1, 2026
The Department of Health and Human Services, Administration for Children and Families proposes to remove duplicative or unnecessary sections from the Runaway and Homeless Youth Program regulations (45 CFR part 1351). These amendments will streamline the Runaway and Homeless Youth Program regulations to make them more accessible to the public. The docket on https://www.regulations.gov will include a plain language summary of the NPRM.
Comments close May 6, 2026
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2027. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2027. It also continues the third year of the 3-year phaseout of the rural adjustment, which began in FY 2025. This proposed rule includes a solicitation for public comments on alternative data sources for the IRF PPS wage index; proposes to require all therapy treatments or therapy evaluations to begin within 36-hours from midnight on the day of admission; proposes to require a patient's current functional status be documented on the preadmission screening; proposes requirements for the initial Interdisciplinary Team meeting; and includes a request for information on potential future IRF PPS payment reform. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program. Furthermore, the proposed rule includes changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program.
Comments close Jun 1, 2026
The Department of Health and Human Services, Administration for Children and Families, proposes to remove duplicative or unnecessary Sections from the Family Violence Prevention and Services program regulations (45 CFR part 1370). These amendments will streamline the Family Violence Prevention and Services regulations and make them more accessible to the public. The docket on https:// www.regulations.gov will include a plain language summary of the NPRM.
Comments close May 6, 2026
ACF proposes to make changes to the Temporary Assistance for Needy Families (TANF) program regulations to reset the base year of the caseload reduction credit from fiscal year (FY) 2005 to the new year established by Congress, which is currently FY 2015, and to exclude from the TANF work participation rate calculations certain cases that receive assistance payments benefits of less than $35 for a month. These changes are required by the Fiscal Responsibility Act (FRA) of 2023. The docket on https://www.regulations.gov will include a plain language summary of the NPRM as required by 5 U.S.C. 553(b)(4).
Comments close May 6, 2026
This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2027. This proposed rule also includes an analysis of Medicare non-hospice spending, including details regarding a hospice service and spending variation index (SSVI), and proposes to require that hospices provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Additionally, this rule proposes conforming regulation text changes to discharge from hospice care regulations; regulation text changes to the face-to-face encounter regulations; and includes requests for information on community palliative care services; the construction of a hospice specific wage index; and the overlap between hospice and medical aid in dying (MAID). Finally, this rule proposes changes to the Hospice Quality Reporting Program.
Comments close Jun 1, 2026
The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by the International Association of Color Manufacturers (IACM or petitioner), proposing that we amend the color additive regulations to no longer provide for the use of three specified solvents (methylene chloride, trichloroethylene, and ethylene dichloride) for preparing certain color additives because these uses have been permanently abandoned.
Comments close Jun 1, 2026
The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.
Comments close May 29, 2026
The Department of Health and Human Services, Administration for Children and Families rescinds obsolete provisions of the State Legalization Impact Assistance Grants regulations (45 CFR part 402). The Administration for Children and Families has undertaken a sweeping review aimed at eliminating outdated rules and reducing unnecessary regulatory burdens to streamline, simplify, and efficiently deregulate across multiple fronts simultaneously to better serve the public. The docket on https://www.regulations.gov will include a plain language summary of the direct final rule as required by 5 U.S.C. 553(b)(4).
Comments close May 26, 2026
The Department of Health and Human Services, Administration for Children and Families proposes to amend the Care and Treatment of Mentally Ill Nationals of the United States, Returned from Foreign Countries regulations and the Assistance for United States Citizens Returned from Foreign Countries regulations to eliminate unnecessary or obsolete regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM.
Comments close Apr 27, 2026
The Department of Health and Human Services, Administration for Children and Families proposes to amend the Native American Programs Act regulations (45 CFR part 1336) to eliminate unnecessary or obsolete regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM as required by 5 U.S.C. 553(b)(4).
Comments close Apr 27, 2026
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) for blood irradiators intended to irradiate intraoperatively salvaged blood for cancer patients undergoing surgery to assist in prevention of metastasis, which are unclassified, preamendments devices. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from use of the devices.
Comments close May 18, 2026
The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.
Comments close May 18, 2026
The Administration for Children and Families (ACF) proposes to remove the requirements issued in the final rule Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children (89 FR 34818) that was published on April 30, 2024. The final rule required title IV-E/IV-B agencies to ensure that a Designated Placement is available for all children who self-identify with an alternative sexual orientation or self-identify as something other than their sex in foster care who request or would benefit from such a placement. On June 13, 2025, the U.S. District Court for the Eastern District of Texas vacated the final rule in its entirety, State of Texas v. United States Department of Health & Human Services, 770 F. Supp. 3d 940 (E.D. Tex. 2025), concluding that the final rule exceeded the Department of Health and Human Services' statutory authority and conflicted with the text of title IV-E. As a result of the court's decision, the final rule is no longer in effect or enforceable, and to ensure clarity for the public and regulated entities, ACF proposes to remove the provisions from the Code of Federal Regulations.
Comments close Apr 6, 2026
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Kemin Industries, Inc., proposing that we amend our food additive regulations to provide for the safe use of chromium propionate as a source of chromium in food for layer and breeding chickens.
Comments close Apr 3, 2026
This request for information (RFI) solicits stakeholder feedback on potential regulatory changes that might be included in a potential upcoming CRUSH proposed rule, as well as other programmatic changes that could be implemented to make CMS more effective in crushing fraud to protect taxpayer dollars and the Americans we serve.
Comments close Mar 30, 2026
This document extends the comment period for the proposed rule that appeared in the Federal Register on December 23, 2025, titled "Transparency in Coverage". The comment period for the proposed rule, which would end on February 23, 2026, is extended until March 2, 2026.
Comments close Mar 2, 2026
This proposed rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also includes provisions related to civil money penalties (CMPs) for noncompliant issuers and other responsible entities; standards governing agents, brokers, and web-brokers; the expansion and codification of hardship exemption eligibility; implementation of the State Exchange Improper Payment Measurement (SEIPM); provider access standards and essential community provider standards for QHP certification; QHP certification of non-network plans; a prohibition on issuers from including routine non-pediatric dental services as an Essential Health Benefit (EHB); cost-sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive years; QHP issuer quality improvement strategies (QISs); revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to States; and seeks comment on potential adjustments to other Federal standards, including the Federal medical loss ratio (MLR) standard in the individual market. This proposed rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation.
Comments close Mar 13, 2026
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally (except for infant formula, certain foods subject to regulation by the U.S. Department of Agriculture, and foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards) at levels consistent with good manufacturing practice (GMP), to lower the heavy metal specifications for lead, arsenic, and mercury, and to add a specification for cadmium. We are taking this action in response to a color additive petition (CAP) submitted by GNT USA, LLC (GNT or petitioner).
Comments close Mar 9, 2026
The Department of Health and Human Services (HHS or Department) published a notice of proposed rulemaking (NPRM) in the Federal Register on December 19, 2025. As a result of administrative technical issues, HHS is re-opening the public comment period for the public to submit comments. The purpose of the NPRM is to limit ambiguity by clarifying that the statutory exclusion of "gender identity disorders not resulting from physical impairments" from the scope of what constitutes discrimination includes "gender dysphoria not resulting from a physical impairment."
Comments close Feb 20, 2026
This request for information (RFI) seeks input from the public regarding the potential adoption of diagnostic imaging technical standards and certification criteria for health information technology (IT) under the ONC Health IT Certification Program (Certification Program) to better enable the access, exchange, and use of diagnostic images by health care providers and patients. Responses to this RFI will be used to inform potential future rulemaking.
Comments close Mar 16, 2026
This proposed rule would revise the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and enable OPOs to make better informed decisions to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This rule would revise definitions, add new Quality Assessment Performance Improvement (QAPI) requirements related to medically complex organs and donors, revise the designation requirements for OPOs, clarify when an OPO's service area is open for competition, and update the process for appeals. It also includes a discussion of factors we would consider when selecting a successor OPO during a competition under the tiered approach to re-certification. We are committed to holding all OPOs accountable for their performance and this proposed rule does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re- certification and de-certification of OPOs.
Comments close Mar 31, 2026
This request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the "Beneficiary Inducements CMP") for emerging direct-to-consumer ("DTC") sales programs established by pharmaceutical manufacturers, including those that will be available through TrumpRx.
Comments close Mar 30, 2026
This advance notice of proposed rulemaking solicits public comment on potential options we may consider for Medicare participating hospitals to help foster a more resilient supply chain for American- made personal protective equipment and essential medicines to secure our nation's health and safety and to reflect the additional resource costs incurred when procuring these domestically manufactured items. We seek input on a possible new "Secure American Medical Supplies" friendly designation that could be earned by hospitals that demonstrate their commitment to domestic procurement. In addition, we seek input on potential ways such a designation could facilitate the creation of new, streamlined payment policies to support hospitals in their efforts. We are also seeking input on a potential new structural quality measure as part of the Hospital Inpatient Quality Reporting (IQR) Program that could promote hospital commitments to invest in domestic procurement to secure our nation's health and safety.
Comments close Mar 30, 2026
The Department of Health and Human Services, Administration for Children and Families proposes to amend the Child Care and Development Fund (CCDF) regulations (45 CFR part 98) to reduce costs and burden for states and territories administering the CCDF program. It proposes rescinding the requirements to limit family co-payments to 7 percent of family income, to provide some direct services through grants or contracts, to pay providers based on child's enrollment, and to pay providers prospectively that were added to the CCDF regulations in the March 2024 final rule, Improving Child Care Access, Affordability, and Stability in the Child Care and Development Fund (CCDF) (89 FR 15366). The docket on https://www.regulations.gov will include a plain language summary of the NPRM as required by 5 U.S.C. 553(b)(4).
Comments close Feb 4, 2026
This proposed rule focuses on deregulatory actions identified in HHS regulations regarding Health information technology standards, implementation specifications, and certification criteria and certification programs for health information technology, and information blocking. This proposed rule seeks to reduce burden, offer flexibility to both developers and providers, and support innovation through the removal and revisions of certain certification criteria and regulatory provisions. This proposed rule also seeks to address reported misuse and abuse of information blocking definitions and exceptions.
Comments close Feb 27, 2026
This proposed rule would implement the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model to test a new Medicare payment model under section 1115A of the Social Security Act. The model proposes a test of an alternative payment method for calculating inflation rebates for certain Part D drugs and biological products. The proposed GUARD Model would test whether changing the calculation of the Part D inflation rebate would reduce costs for the Medicare program while preserving or enhancing quality of care for Part D enrollees.
Comments close Feb 23, 2026
This proposed rule proposes to implement the Global Benchmark for Efficient Drug Pricing Model ("GLOBE Model"), a new Medicare payment model under section 1115A of the Social Security Act (the Act). The GLOBE Model would test whether a payment model that uses an alternative method for calculating Part B inflation rebate amounts for certain separately payable Part B drugs and biologicals products reduces costs for Medicare fee-for-service (FFS) beneficiaries and the Medicare program while preserving quality of care.
Comments close Feb 23, 2026
These proposed rules set forth proposed requirements that would amend the regulations under the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code regarding price transparency reporting requirements for non-grandfathered group health plans and health insurance issuers offering non-grandfathered group and individual health insurance coverage. Specifically, these proposed rules would improve the standardization, accuracy, and accessibility of public pricing disclosures in line with the goals of the Executive Order 14221. With respect to the in-network rate and out-of-network allowed amount machine-readable files, these proposed rules would achieve these goals by adding new contextual files and additional data elements like product type, network name, and enrollment counts; changing the reporting level for aggregation of data; removing in-network rates for unlikely provider-to-service mappings; increasing the reporting period and lowering the claims threshold for out-of-network historical data; and reducing the reporting cadence. These proposed rules would also improve the findability of all of the publicly disclosed machine- readable files required under the Transparency in Coverage rules, including the prescription drug file, by requiring a text file and footer with website URLs and contact information for the files. These proposed rules would also require pricing information that is made available through an online consumer tool and paper (upon request), to also be made available by phone, and establish that the satisfaction of such requirement also satisfies the requirements of section 114 of the No Surprises Act (including for grandfathered group health plans and health insurance issuers offering grandfathered group and individual health insurance coverage that are not otherwise subject to these proposed rules).
Comments close Feb 23, 2026
The Department of Health and Human Services (HHS or Department) issues this Notice of Proposed Rulemaking (NPRM) to revise 45 CFR 84.4(g) in the regulation implementing section 504 of the Rehabilitation Act of 1973 (section 504) as it applies to recipients of HHS funding (entitled "Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance," 89 FR 40066 ("2024 Final Rule")), published on May 9, 2024. This rule clarifies that the Department interprets the statutory exclusion of "gender identity disorders not resulting from physical impairments" from the definitions of "individual with a disability" and "disability" set forth at 29 U.S.C. 705(9) & (20)(F)(i), 42 U.S.C. 12211(b), to encompass "gender dysphoria not resulting from a physical impairment" for purposes of part 84. This clarification is necessary to resolve ambiguity introduced in the preamble to the 2024 Final Rule and to ensure compliance with the best reading of the plain language of the governing statute.
Comments close Jan 20, 2026
This proposed rule would revise the requirements that Medicare and Medicaid certified hospitals must meet to participate in the Medicare and Medicaid programs. These changes are necessary to protect the health and safety of children and reflect HHS' review of recent information on the safety and efficacy of sex-rejecting procedures (SRPs) on children. The revisions to the requirements would prohibit hospitals from performing sex-rejecting procedures on children.
Comments close Feb 17, 2026
This proposed rule would require that a State Medicaid plan must provide that the Medicaid agency will not make payment under the plan for sex-rejecting procedures for children under 18 and prohibit the use of Federal Medicaid dollars to fund sex-rejecting procedures for individuals under the age of 18. In addition, it would require that a separate State Children's Health Insurance Program (CHIP) plan must provide that the CHIP agency will not make payment under the plan for sex-rejecting procedures for children under 19 and prohibit the use of Federal CHIP dollars to fund sex-rejecting procedures for individuals under the age of 19.
Comments close Feb 17, 2026
This direct final rule (DFR) removes the requirement that Head Start programs have a COVID-19 mitigation policy. This requirement was included in the final rule titled "Mitigating the Spread of COVID-19 in Head Start Programs," which ACF published on January 6, 2023. Specifically, this rescission removes the requirement from the Head Start Program Performance Standards (Performance Standards) that Head Start programs have a COVID-19 mitigation policy developed in consultation with their Health and Mental Health Services Advisory Committee (HMHSAC), formerly the Health Services Advisory Committee (HSAC). This DFR meets the deregulatory requirements of Executive Order 14192, Unleashing Prosperity Through Deregulation, and is aligned with Executive Order 14148, Initial Rescissions of Harmful Executive Orders and Actions.
Comments close Jan 20, 2026
This proposed rule would update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2.
Comments close Feb 9, 2026
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute, as well as developing new OIG Special Fraud Alerts.
Comments close Feb 9, 2026
This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), and Medicare cost plan regulations to implement changes related to Star Ratings, marketing and communications, drug coverage, enrollment processes, special needs plans, and other programmatic areas.
Comments close Jan 26, 2026
The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.
Comments close Jan 26, 2026
This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this final rule with comment period announces the closure of a teaching hospital and the opportunity to apply for available slots, and updates and refines the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency, as well as summarizes comments received in response to a request for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for the OQR, REHQR, and ASCQR programs.
Comments close Jan 20, 2026
The Food and Drug Administration (FDA or we) is proposing to issue an order that would remove the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. Based on certification data, it appears that Orange B is no longer used for coloring the casings or surfaces of frankfurters and sausages and has not been certified for use as a color additive in food marketed in the United States since 1978. Because the authorized use of Orange B appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.
Comments close Oct 17, 2025
The Food and Drug Administration (FDA or we) is amending the food additive regulation to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. We are taking this action in response to a food additive petition filed by Cargill, Inc. (Cargill or petitioner).
Comments close Oct 3, 2025
This document corrects typographical and technical errors in the proposed rule that appeared in the July 16, 2025 Federal Register (90 FR 32352) titled "Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program" (hereinafter referred to as the CY 2026 PFS proposed rule), specifying proposed changes to the Medicare physician fee schedule (PFS) that is applicable for calendar year (CY) 2026, and other changes to Medicare Part B payment policies, as well as proposals regarding other Medicare payment policies.
Comments close Sep 12, 2025
The Food and Drug Administration is proposing to extend the compliance date for the final rule, "Requirements for Additional Traceability Records for Certain Foods," due to concerns about the amount of time affected entities will need to implement the requirements of the rule. If finalized, this rule would extend the compliance date by 30 months from January 20, 2026, to July 20, 2028.
Comments close Sep 8, 2025
The Food and Drug Administration (FDA or we) is proposing to amend the standard of identity for pasteurized orange juice (POJ) by lowering the minimum orange juice soluble solids content from 10.5[deg] to 10[deg] Brix. We tentatively conclude that this proposed amendment will promote honesty and fair dealing in the interest of consumers and provide industry greater flexibility in the manufacture of pasteurized orange juice. This action, if finalized, will respond to a citizen petition submitted by the Florida Citrus Processors Association Inc. and Florida Citrus Mutual Inc.
Comments close Nov 4, 2025
The Food and Drug Administration (FDA or we) is proposing to revoke 18 standards of identity for dairy products. FDA is taking this action as we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
Comments close Sep 15, 2025
The Food and Drug Administration (FDA or we) is proposing to revoke 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as we tentatively conclude these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action, if finalized, will remove obsolete rules to possibly reduce unnecessary regulatory requirements.
Comments close Aug 18, 2025
The Food and Drug Administration (FDA or we) revokes 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action will remove obsolete rules to reduce unnecessary regulatory requirements.
Comments close Aug 18, 2025
The Food and Drug Administration (FDA or we) is proposing to revoke 23 standards of identity for food. FDA is taking this action because we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
Comments close Sep 15, 2025
This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. This proposed rule would also update and refine the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency. This rule also contains requests for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for all three programs (OQR, REHQR, and ASCQR; expanding the method to control for unnecessary increases in the volume of covered OPD services to on- campus clinic visits; software as a service; and adjusting payment under the OPPS for services predominately performed in the ambulatory surgical center or physician office settings.
Comments close Sep 15, 2025
This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.
Comments close Sep 12, 2025
This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update requirements for the ESRD Quality Incentive Program and to terminate and modify requirements for the ESRD Treatment Choices Model.
Comments close Aug 29, 2025
This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule proposes permanent and temporary behavior adjustments and proposes to recalibrate the case-mix weights and update the functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for CY 2026. Lastly, this proposed rule proposes policy changes to the face-to-face encounter policy. It also proposes changes to the Home Health Quality Reporting Program (HH QRP) and the expanded Health Value-Based Purchasing (HHVBP) Model requirements. In addition, it would update the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). Lastly it proposes: a technical change to the HH conditions of participation; updates to DMEPOS supplier conditions of payment; updates to provider and supplier enrollment requirements; and changes to DMEPOS accreditation requirements.
Comments close Aug 29, 2025
The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.
Comments close Aug 11, 2025
This document is a request for information (RFI) regarding the prescription drug machine-readable file disclosure requirements in the Transparency in Coverage final rules. The Departments of Labor, Health and Human Services (HHS), and the Treasury (the Departments) are issuing this RFI to gather input regarding implementation of the prescription drug machine-readable file disclosure requirements under the Transparency in Coverage final rules, including what modifications to the disclosure requirements or additional technical implementation guidance might be necessary to better ensure the accurate and timely completion of the prescription drug file.
Comments close Jul 2, 2025
The Food and Drug Administration (FDA or we) is reopening the comment period for a draft guidance entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Guidance for Industry," which was announced in the Federal Register of January 7, 2025. We are taking this action in response to requests to allow interested persons additional time to submit comments before FDA begins work on the final guidance.
Comments close Jul 28, 2025
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of zinc L- selenomethionine as a source of selenium in complete feed for broiler chickens. This action is in response to a food additive petition filed by Zinpro Corp.
Comments close Jun 18, 2025
This proposed rule is intended to address a loophole in a regulatory statistical test applied to State proposals for Medicaid tax waivers. The test is designed to ensure, as required by statute, that non-uniform or non-broad -based health care-related taxes, authorized under a waiver, are generally redistributive. The inadvertent loophole currently allows some health care-related taxes, especially taxes on managed care organizations, to be imposed at higher tax rates on Medicaid taxable units than non-Medicaid taxable units, contrary to statutory and regulatory intent for health care-related taxes to be generally redistributive. The proposed provisions would better implement the statutory requirements by adding additional safeguards to ensure that tax waivers that exploit the loophole because they pass the current statistical test, but are not generally redistributive, are not approvable.
Comments close Jul 14, 2025
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria), in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Fermentalg (Fermentalg or petitioner).
Comments close Jun 11, 2025
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition (CAP) filed by Innophos, Inc. (Innophos or petitioner).
Comments close Jun 11, 2025
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Sensient Colors, LLC (Sensient or petitioner).
Comments close Jun 11, 2025
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule entitled "Food Labeling: Front- of-Package Nutrition Information" that appeared in the Federal Register of January 16, 2025. We are taking this action in response to requests for an extension to allow interested parties additional time to submit comments.
Comments close Jul 15, 2025
This proposed rule would change and update policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for FY 2026. This rulemaking also proposes to update the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program.
Comments close Jun 10, 2025
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2026. As required by statute, this proposed rule includes the proposed classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2026. It also continues the second year of the 3-year phaseout of the rural adjustment, which began in FY 2025. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program (QRP).
Comments close Jun 10, 2025
This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2026. This rule also proposes changes to the admission to hospice regulations and the hospice face-to-face attestation requirements under the certification of terminal illness regulations. This proposed rule also includes a technical correction to the regulatory text and provides updates to the Hospice Quality Reporting Program requirements. Finally, this proposed rule solicits comments regarding requests for information surrounding future measure concepts for Hospice Quality Reporting Program.
Comments close Jun 10, 2025
This rulemaking proposes to update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rulemaking also proposes to revise the payment adjustment factors for teaching status and for IPFs located in rural areas. These proposed changes would be effective for IPF discharges occurring during the fiscal year beginning October 1, 2025 through September 30, 2026. We are proposing to make changes to measures used in the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program, to update and codify the Extraordinary Circumstances Exception policy, and to solicit feedback through requests for information on future changes to the IPFQR Program.
Comments close Jun 10, 2025
This proposed rule would revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital- related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy-related changes.
Comments close Jun 10, 2025
ORR is amending a regulation so that it comports with the express language of the governing legislation. That regulation relates to key aspects of the placement, care, and services provided to unaccompanied alien children (UACs) referred to ORR, pursuant to ORR's responsibilities for coordinating and implementing the care and placement of UACs who are in Federal custody by reason of their immigration status under the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA).
Comments close May 27, 2025
This proposed rule would revise standards relating to past-due premium payments; exclude Deferred Action for Childhood Arrivals recipients from the definition of "lawfully present"; the evidentiary standard HHS uses to assess an agent's, broker's, or web-broker's potential noncompliance; failure to file and reconcile; income eligibility verifications for premium tax credits and cost-sharing reductions; annual eligibility redetermination; the automatic reenrollment hierarchy; the annual open enrollment period; special enrollment periods; de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements and for income-based cost-sharing reduction plan variations; and the premium adjustment percentage methodology; and prohibit issuers of coverage subject to EHB requirements from providing coverage for sex-trait modification as an EHB.
Comments close Apr 11, 2025
The Department of Health and Human Services (HHS or Department) published a direct final rule entitled "Name Change From Office of Child Support Enforcement to Office of Child Support Services" in the Federal Register on December 31, 2024, which was to become effective March 3, 2025. HHS is reopening the public comment period and delaying the effective date for the purpose of reviewing any questions of fact, law, and policy that the rule may raise.
Comments close Mar 31, 2025
In the January 17, 2025, issue of the Federal Register, the Drug Enforcement Administration and the Department of Health and Human Services published two final rules related to the practice of telemedicine, titled "Expansion of Buprenorphine Treatment via Telemedicine Encounter" and "Continuity of Care via Telemedicine for Veterans Affairs Patients." These final rules were scheduled to become final on February 18, 2025. In accordance with the Presidential Memorandum of January 20, 2025, titled "Regulatory Freeze Pending Review," the Drug Enforcement Administration and the Department of Health and Human Services are delaying the effective dates of these two final rules to March 21, 2025, and are soliciting public comments specifically regarding this delayed effective date.
Comments close Feb 28, 2025
The Department of Health and Human Services (HHS or Department) published a direct final rule in the Federal Register on December 23, 2024, which was to become effective February 6, 2025. As a result of administrative technical issues, including an incorrect email address, HHS is reopening the public comment period with a new email address for the public to submit comments and delaying the effective date to March 21, 2025. The purpose of the direct final rule was to exempt a new Privacy Act system of records maintained by the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), Unaccompanied Children Bureau (UCB), System No. 09- 80-0323, "ORR Unaccompanied Children Bureau (UCB) Child Abuse or Neglect Investigation Records and Central Registry," from certain requirements of the Privacy Act, in accordance with subsection (k)(2) of the Privacy Act.
Comments close Mar 5, 2025
