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

Original title: “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Withdrawal”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LEQEMBI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; LEQEMBI”

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.

Original title: “Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing”

The Administration for Children and Families (ACF) is requesting revisions and a one-year extension of the currently approved ACF Uniform Project Description (UPD) information collection (UPD; Office of Management and Budget (OMB) # 0970-0139, March 31, 2026 expiration date). This includes transitioning to use one simplified version of the UPD with edits to the language for clarification and plain language purposes. Two versions of the instructions remain in the proposed simplified version to ac

Original title: “Proposed Information Collection Activity; Administration for Children and Families Uniform Project Description”

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Children's Justice Act (CJA) Program Instruction (Office of Management and Budget (OMB) #: 0970- 0425, expiration March 31, 2026). There are no changes requested to the instructions.

Original title: “Proposed Information Collection Activity; Children's Justice Act Program Instruction”

The Administration for Children and Families (ACF) is requesting a 3-year extension of the form Low Income Home Energy Assistance Program (LIHEAP) Quarterly Reports (Office of Management and Budget (OMB) #: 0970-0589, expiration October 31, 2025). Changes are proposed, which would reduce redundancy and administrative burden for respondents.

Original title: “Proposed Information Collection Activity; Low Income Home Energy Assistance Program (LIHEAP) Quarterly Reports”

This notice describes the proposal to extend data collection under the Administration for Children and Families (ACF) Generic Program-Specific Performance Progress Report (PPR) (0970-0490). This overarching generic currently allows ACF program offices to collect performance and progress data from recipients and sub-recipients who receive funding from ACF under a grant or cooperative agreement. This generic mechanism provides the opportunity for ACF program offices to tailor requests for performa

Original title: “Proposed Information Collection Activity; Generic Program-Specific Performance Progress Report”

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 preserv

Original title: “Global Benchmark for Efficient Drug Pricing (GLOBE) Model”

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

Original title: “Transparency in Coverage”

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 enhanc

Original title: “Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model”

The HHS Office of the Deputy Secretary in collaboration with ASTP/ONC has published this Request for Information (RFI) to seek broad public comment on what HHS can do to accelerate the adoption and use of AI as part of clinical care.

Original title: “Request for Information: Accelerating the Adoption and Use of Artificial Intelligence as Part of Clinical Care”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act." This guidance provides recommendations for industry and review staff on the formal dispute resolution (FDR) and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Eva

Original title: “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the NIH will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Proposed Collection; 60-Day Comment Request; Loan Repayment Programs (LRP), (Office of the Director)”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Proposed Collection; 60-Day Comment Request; the Clinical Trials Reporting Program (CTRP) Database (NCI)”

The Health Resources and Services Administration (HRSA) published a Federal Register notice on August 14, 2025 (90 FR 39196), requesting comments from the public on the potential recommendation of adding Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP). After consideration of public comments and evidence-based reports, HRSA recommended to the Secretary of Health and Human Services (HHS) that MLD be added to the RUSP. The Secretary of HHS has accepted the recom

Original title: “Addition of Metachromatic Leukodystrophy to the Recommended Uniform Screening Panel”

HRSA published a Federal Register notice on August 14, 2025 (90 FR 39197), requesting comments from the public on the potential recommendation of adding Duchenne Muscular Dystrophy (DMD) to the Recommended Uniform Screening Panel (RUSP). After consideration of public comments and evidence-based reports, HRSA recommended to the HHS Secretary that DMD be added to the RUSP. The Secretary has accepted the recommendation as detailed in this notice. Conditions listed on the RUSP are part of the eviden

Original title: “Addition of Duchenne Muscular Dystrophy to the Recommended Uniform Screening Panel”

The Centers for Medicare & Medicaid Services (CMS), Center for Medicaid and CHIP Services, Office of Rural Health Transformation, has been established.

Original title: “Statement of Organization, Functions, and Delegations of Authority”

The Office of Refugee Resettlement (ORR) is requesting a 3- year extension of the ORR-2: Cash and Medical Assistance (CMA) Program Quarterly Report on Expenditures and Obligations (Office of Management and Budget (OMB) #0970-0407, expiration February 28, 2026). Minor changes are proposed to the form and instructions.

Original title: “Submission for Office of Management and Budget Review; Office of Refugee Resettlement Cash and Medical Assistance Program Quarterly Report on Expenditures and Obligations (ORR-2)”

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services is requesting a 3-year extension of the Community Economic Development (CED) Performance Progress Report (PPR) (Office of Management and Budget (OMB) #: 0970-0386), expiration date February 28, 2026, with revisions to support a quarterly reporting schedule. This request updates burden estimates to account for new quarterly reporting requirements. While the core CED

Original title: “Submission for Office of Management and Budget Review; Proposed Information Collection Activity; Office of Community Services Community Economic Development Performance Progress Report”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”