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Browse 196 rules and proposed rules from the Federal Register.
196
Total Regulations
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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statutory authority and conflicted with the text of title IV-E. As a result of the court's decision, the final rule is no longer in effect or enforceable, and to ensure clarity for the public and regulated entities, ACF proposes to remove the provisions from the Code of Federal Regulations.
This document corrects technical errors in the proposed rule that appeared in the February 11, 2026, Federal Register titled "Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program."
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule.
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Ecoflora Cares, c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in pet foods at levels consistent with good manufacturing practice.
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.
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.
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.
This document corrects two outdated references that should have been deleted and one outdated reference in the final rule that appeared in the February 2, 2024 Federal Register titled "Medications for the Treatment of Opioid Use Disorder," specifying final modified and updated certain provisions related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder with Medications for Opioid Use Disorders in OTPs. The effective date of the final rule was April 2, 2024, and the compliance date was October 2, 2024.
This document corrects technical errors in the final rule with comment period that appeared in the November 25, 2025 issue of the Federal Register titled "Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots" (hereinafter referred to as the "CY 2026 OPPS/ASC final rule with comment period"). The effective date of the CY 2026 OPPS/ASC final rule with comment period was January 1, 2026.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the methods of analysis regulation, which describes an FDA policy to use certain methods of analysis for FDA enforcement programs when the method of analysis is not prescribed in a regulation. FDA is issuing this action because the existing regulation is no longer necessary.
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule revoking the regulations entitled "Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community." FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.
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.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
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).
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice, except in products under the jurisdiction of the United States Department of Agriculture (USDA), infant formula, or foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of the added color is authorized by such standards. We are taking this action in response to a color additive petition (CAP) submitted by Phytolon, Ltd. (Phytolon or petitioner).
This final rule addresses 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 final rule closes the loophole by finalizing the policies in the proposed rule to add 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. By adding these safeguards, the final rule is also implementing recently added statutory requirements for a tax to be considered generally redistributive.
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."
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.
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.
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.
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.
The Department of Health and Human Services (HHS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty (CMP) amounts in its statutes and regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
The U.S. Department of Health and Human Services will conduct a virtual Tribal consultation on the proposed rule "Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement."
This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List. It also announces updates to the HCPCS codes on the Required Face-to-Face and Written Order Prior to Delivery List and the Required Prior Authorization List.
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).
The Drug Enforcement Administration (DEA) jointly with the Department of Health and Human Services (HHS) is issuing a fourth extension of telemedicine flexibilities for the prescribing of controlled medications through December 31, 2026.
ASTP/ONC published in the Federal Register on August 5, 2024, a proposed rule, titled "Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability" (HTI-2), in which it proposed updating and adding regulations regarding health information technology, information blocking, and the Trusted Exchange Framework and the Common Agreement. The comment period closed on October 4, 2024. ASTP/ONC is withdrawing the remaining proposals that have not been finalized from the HTI-2 Proposed Rule.
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.
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).