The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services seeks approval of the Personal Responsibility Education Program (PREP) Innovative Strategies (PREIS) Local Evaluation Support: Final Evaluation Report Template for PREIS grantees. PREIS grant recipients are required to carry out local evaluations of their programs and submit a final evaluation report to ACF documenting their analyses and findings. This request includes guidance for grant recipi

Original title: “Submission for Office of Management and Budget Review; Personal Responsibility Education Program (PREP) Innovative Strategies (PREIS) Local Evaluation Support: Final Evaluation Report Template (New Collection)”

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services published a notice in the Federal Register on September 30, 2025 inviting public comments on a request to extend approval of forms approved for the Placement and Transfer of Unaccompanied [Alien] Children into ORR Care Provider Facilities. Prior to publishing the notice, ORR received emergency approval from the Office of Management and Budget (OMB) for revisions

Original title: “Correction to Published Federal Register Notice; Office of Management and Budget Review Placement and Transfer of Unaccompanied [Alien] Children Into Office of Refugee Resettlement Care Provider Facilities”

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Original title: “Submission for OMB Review; 30-Day Comment Request; Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director)”

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is soliciting nominations for membership on the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC). The BSC, NCIPC consists of 18 experts in fields associated with surveillance, basic epidemiologic research, intervention research, and implementation, dissemination, and evaluation of promi

Original title: “Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Center for Injury Prevention and Control”

This document corrects typographical and technical errors in the final rule that appeared in the August 5, 2025, Federal Register entitled "Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program" (hereinafter referred to as the "FY 2026 IRF final rule"). The effective date was October 1, 2025.

Original title: “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program; Correction”

Referred to the House Committee on Ways and Means.

Original title: “HR 6799: BRIDGE for Young-Onset Alzheimer’s Disease Act of 2025”

The Office of Planning, Research, and Evaluation (OPRE) and the Family and Youth Services Bureau (FYSB) in the Administration for Children and Families (ACF) request approval for a temporary extension of currently approved information collection activities and revisions to be implemented in 2026 for the Sexual Risk Avoidance Education (SRAE) Program Performance Analysis Study (PAS)(Office of Management and Budget (OMB) #: 0970-0536; expiration date December 31, 2025). The goal of the study is to

Original title: “Submission for Office of Management and Budget Review; Sexual Risk Avoidance Education Program Performance Analysis Study”

The U.S. Department of Health and Human Services has added Duchenne muscular dystrophy and Metachromatic Leukodystrophy (MLD) to the federal Recommended Uniform Screening Panel (RUSP)! The RUSP is a list of disorders […] The post HHS Adds Duchenne Muscular Dystrophy and MLD to the Federal Recommended Uniform Screening Panel (RUSP) appeared first on EveryLife Foundation for Rare Diseases.

Original title: “HHS Adds Duchenne Muscular Dystrophy and MLD to the Federal Recommended Uniform Screening Panel (RUSP)”

The CDC today adopted individual-based decision-making for hepatitis B immunization

Original title: “CDC Adopts Individual-Based Decision-Making for Hepatitis B Immunization for Infants Born to Women Who Test Negative for Hepatitis B Virus”

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Sponsor Responsibilities--Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies." The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailabil

Original title: “Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for investigators, industry, and institutional review boards (IRBs) entitled "Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices." The guidance is intended to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies. As such, recommendati

Original title: “Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability”

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold public meetings for calendar year (CY) 2025. Information about the ACCV, agendas, and materials for these meetings can be found on the ACCV website at https://www.hrsa.gov/advisory- committees/vaccines/index.html.

Original title: “Meeting of the Advisory Commission on Childhood Vaccines”

The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation

Original title: “FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula”

The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews.

Original title: “FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Monitoring and Reporting for the Overdose Data to Action (OD2A) Cooperative Agreemen

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health 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; A Generic Submission for Formative Research, Pretesting and Customer Satisfaction of NIH Communication and Education Resources (OD/OER)”

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

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

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union. According to EMA, with this reform, the development and authorization of drugs will be modernized and procedures will be simplified. Current regulations that will be impacted will include Regulation 726/2004 and Directive 2001/83/EC, Regulation 1901/2006 and Regulation 141/2000/EC (medicines for children and rare diseases, respectively), and the advanced therapy medicinal products (ATMP) Regulation 1394/2007. “Today marks a historic milestone for European medicines regulation and for patients across the EU,” said EMA’s Executive Director Emer Cooke in a press release (1). The agency’s committee structure will be made leaner and will be complemented by increased patient and healthcare professional representation. This includes the Committee for Human Medicinal Products and the Pharmacovigilance Risk Assessment Committee. Assessment times will be reduced from 210 days to 180 days, freeing up scientific resources for pre-authorization support for drug companies. Adapted frameworks may also be created for certain non-standard drug categories, and process inefficiency improvements for pediatric medications can be established, such as the formalization of a new process from iterative pediatric investigation plans. The agreement is subject to formal approval by the European Parliament and the Council and may take months to years to be finalized. During that time, EMA will work with the EC and EU Member States to develop guidance documents to help drug developers comply with the new rules.

Original title: “EMA Calls New EU Pharma Legislation Most Significant in Two Decades | Pharmaceutical Technology”

This Policy establishes expectations for ensuring the security of human biospecimens whose collection, obtainment, storage, use, or distribution are supported by NIH funds. The policy ensures protections for human participants and vital national security interests, consistent with Executive Order 14117 (see: https://www.govinfo.gov/ content/pkg/FR-2024-03-01/pdf/2024-04573.pdf) and 28 CFR 202 "Preventing Access to U.S. Sensitive Personal Data and Government- Related Data by Countries of Concern

Original title: “NIH Policy on Enhancing Security Measures for Human Biospecimens”