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.

Original title: “Reducing Bureaucracy and Burden for Human Services and Emergency Response Programs-Repatriation Program”

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).

Original title: “Reducing Bureaucracy and Burden for Native American Programs”

Referred to the Subcommittee on Conservation, Research, and Biotechnology.

Original title: “HR 8149: Agricultural Access to Addiction and Mental Health Care Act”

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 The Administration for Children and Families has undertaken a sweeping review aimed at eliminating outdated rules and reducing unnecessary regulatory burdens to streamline, simplify, and efficiently deregulate across multiple fronts simultaneously to better serve the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.r

Original title: “Reducing Bureaucracy and Burden for Refugee Resettlement Programs”

The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) is requesting a 3-year extension with revisions to the information collection activities approved by the Office of Management and Budget (OMB): ACF Congressionally Directed Community Projects--Universal Project Description (CDCP-UPD)(OMB#: 0970-0604, expiration March 31, 2026). Revisions are based on lessons learned from previous years. Language is simplified for application requirements. This

Original title: “Submission for Office of Management and Budget Review; Administration for Children and Families Congressionally Directed Community Projects-Uniform Project Description”

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for the new Temporary Assistance for Needy Families (TANF) Pilot Evaluation.

Original title: “Proposed Information Collection Activity; Temporary Assistance for Needy Families (TANF) Pilot Evaluation”

This is to notify the public that pursuant to the preliminary order issued on March 16, 2026, in American Academy of Pediatrics et al. v. Kennedy et al., No. 1:25-cv-11916 (D. Mass.), the ACIP meeting previously scheduled for March 18-19, 2026, has been stayed until further notice.

Original title: “Advisory Committee on Immunization Practices; Cancellation of Meeting”

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Lead Exposure and Prevention Advisory Committee (LEPAC).

Original title: “Lead Exposure and Prevention Advisory Committee; Notice of Charter Renewal”

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 Institutes of Health, 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: 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)”

This report describes kratom-related exposures in the United States from 2015-2024.

Original title: “Increases in Kratom-Related Reports to Poison Centers — National Poison Data System, United States, 2015–2025”

This report describes vaccination coverage by age 2 among children born in 2021 and 2022.

Original title: “Vaccination Coverage by Age 24 Months Among Children Born in 2021 and 2022 — National Immunization Survey-Child, United States, 2022–2024”

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on September 24, 2025 (90 FR 183), appearing on page 45942 in FR Doc. 2025-18453. The document announced the withdrawal of approval of 72 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of October 23, 2025. The document indicated that FDA was withdrawing approval of the ANDA 070631 for valproic acid, capsule, 250 milligrams, held by Upsher-Smith Laboratories, LLC,

Original title: “Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction”

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF-204: Annual Temporary Assistance for Needy Families (TANF) and State Maintenance-of-Effort (MOE) Report (Office of Management and Budget #0970-0248, expiration March 31, 2026). There are no substantive changes requested to the form, but instructions have been updated, and burden estimates adjusted.

Original title: “Submission for OMB Review; Annual Report on Temporary Assistance for Needy Families Programs and State Maintenance-of-Effort Programs-ACF-204 (Annual TANF and MOE Report)”

This year's catalysts in the space include a near-term FDA decision on Eli Lilly’s oral challenger to the new Wegovy pill. Looking further ahead, Novo Nordisk is expecting more clinical data for next-gen weight loss asset CagriSema, which recently lost a head-to-head battle with Lilly’s Zepbound.

Original title: “Despite Novo's Robust Oral Wegovy Launch, Access Remains a Challenge for Obesity Drugs”

The Food and Drug Administration (FDA) is issuing a final order reclassifying optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), both postamendments class III device types, into class II (special controls), subject to premarket notification. FDA is also renaming and codifying these devices under the new classification regulation named "software-aided adjunctive diagnostic devices for use on skin lesions by physicians tr

Original title: “General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer”

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Original title: “National Vaccine Injury Compensation Program; List of Petitions Received”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 1818: Prescription Drug Price Relief Act of 2025”

Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.

Original title: “FDA Blueprint Aims To Cut Regulatory Risk for Alternatives to Animal Testing”

If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit.

Original title: “Japan's Drug Prices Are Creating Problems for Washington and Tokyo Alike”

In the first months of 2026, the FDA has moved on multiple fronts to modernize how drugs are developed, evaluated, and approved, signaling a broader regulatory shift toward flexibility, mechanism-based evidence, and human-centric science. framework is designed for individualized therapies targeting ultra-rare diseases where patient populations are too small to support traditional randomized controlled trials. It allows sponsors to build a regulatory case using clinical, nonclinical, and manufacturing data anchored in the therapy's direct biological mechanism, and applies most clearly to genome editing and RNA-based approaches. Editor’s note: This FAQ article was created based on four previous pieces of Applied Clinical Trials content— · FDA Removes Two Study Requirement for New Drug Approval Process, FDA Introduces New Framework to Advance Individualized Therapies for Ultra-Rare Diseases, Applications include adaptive trial designs, dose selection, subgroup analyses, and incorporation of external data sources such as prior clinical studies, real-world evidence, or external controls when scientifically justified. FDA highlighted rare disease and pediatric trials as areas of particular value, given the limited patient populations that constrain traditional Single-trial standard: One adequate and well-controlled study, supported by confirmatory evidence, is now the default requirement for new drug approval. Plausible mechanism framework: A new pathway allows sponsors of individualized ultra-rare disease therapies to build approval cases from mechanistic data when traditional trials are not feasible.

Original title: “Four FDA Actions Reshaping Drug Development in 2026 | Applied Clinical Trials Online”