Healthcare & Life Sciences

Proposed Collection for Child Care Fund Consumer Education

The Administration for Children and Families is proposing to collect information for the Child Care and Development Fund (CCDF) consumer education website and reports of serious injuries and death. The Office of Management and Budget (OMB) number for this collection is 0970-0473.

Proposed Information Collection: Income Withholding for Support

The Administration for Children and Families has proposed a new information collection activity related to income withholding for support. This notice opens a public comment period for stakeholders to provide feedback on the proposed collection.

Medicare Program Deeming Authority Renewal for NCQA

The Centers for Medicare & Medicaid Services (CMS) has issued a notice regarding the renewal of deeming authority for the National Committee for Quality Assurance (NCQA). This notice is open for public comment until April 9, 2026.

CMS Agency Information Collection Activities Proposed Collection Comment Request

The Centers for Medicare & Medicaid Services (CMS) has published a notice requesting public comment on proposed information collection activities. The comment period is open until May 11, 2026.

CMS Agency Information Collection Activities Proposed Collection Comment Request

The Centers for Medicare & Medicaid Services (CMS) is requesting public comment on its intention to collect information from the public. This notice is part of the process required by the Paperwork Reduction Act of 1995. The comment period closes on May 11, 2026.

CMS Approves Rural Health Clinic Accreditation Program

The Centers for Medicare & Medicaid Services (CMS) has approved the American Association for Accreditation of Ambulatory Surgery Facilities' (AAAASF) Rural Health Clinic (RHC) accreditation program. This approval allows AAAASF to accredit RHCs for Medicare and Medicaid participation.

Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has published a notice regarding agency forms undergoing review under the Paperwork Reduction Act. This notice initiates a 30-day review period for specific forms to assess their continued necessity and burden on respondents.

Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has published a notice regarding agency forms undergoing review under the Paperwork Reduction Act. This notice initiates a 30-day review period for specific forms to assess their information collection requirements.

Proposed Data Collection for Public Comment

The Centers for Disease Control and Prevention (CDC) has submitted a proposed data collection for public comment. The comment period closes on May 8, 2026. This notice initiates a consultation period for a new data collection initiative.

Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has published a notice regarding agency forms undergoing review under the Paperwork Reduction Act. This notice initiates a 30-day review period for public comment on the forms.

Proposed Data Collection for Public Comment

The Centers for Disease Control and Prevention (CDC) has submitted a proposed data collection for public comment. The comment period for this proposed collection ends on May 8, 2026. This action is part of the CDC's ongoing efforts to gather information for public health initiatives.

HOPE for Homeowners Program: Board of Directors Organization and Functions

The Board of Directors of the HOPE for Homeowners Program has published its adopted bylaws detailing the organization, staffing, and operational procedures for the Program. These bylaws were established to oversee the Program's implementation and facilitate its operations.

HOPE for Homeowners Program: Program Regulations

The Board of Directors of the Hope for Homeowners Program published final regulations for the HOPE for Homeowners Program. These regulations establish the framework for the program aimed at assisting struggling homeowners.

HOPE for Homeowners Program: Payment Incentive Changes

The Board of Directors of the Hope for Homeowners Program issued a final rule amending program regulations. These changes specifically address the upfront payment incentive for subordinate mortgage lien holders and introduce other program modifications. The rule was published in the Federal Register on January 7, 2009.

HOPE for Homeowners Program: Rules for Access to Information Under FOIA

The Board of Directors of the HOPE for Homeowners Program has issued an interim rule establishing regulations for access to its records under the Freedom of Information Act (FOIA). The rule is effective immediately, and the public has until April 21, 2009, to submit comments.

State Long-Term Care Ombudsman Report Data Collection Proposed

The Administration on Aging is proposing revised data collection for the State Annual Long-Term Care Ombudsman Report to the National Ombudsman Reporting System. This notice requests public comment on the proposed changes.

Agency Information Collection Activities; Long-Term Care Ombudsman Report

The Department of Health and Human Services, through the Administration for Community Living and the Administration on Aging, is requesting public comment on proposed changes to the State Annual Long-Term Care Ombudsman Report data collection. The comment period closes on August 29, 2016.

State Long-Term Care Ombudsman Programs Rule

The Administration on Aging published a correction to the State Long-Term Care Ombudsman Programs rule. This document clarifies existing regulations under 45 CFR Part 1324.

OMB Review for State Long-Term Care Ombudsman Report NORS

The Department of Health and Human Services is submitting the State Long-Term Care Ombudsman Report, also known as the National Ombudsman Reporting System (NORS) and Instructions, for Office of Management and Budget (OMB) review. The public is invited to comment on this information collection activity.

Public Comment Request: State Annual Long-Term Care Ombudsman Report

The Department of Health and Human Services, through the Administration for Community Living and Administration on Aging, is requesting public comment on an information collection activity concerning the State Annual Long-Term Care Ombudsman Report and Instructions. The comment period closes on November 18, 2016.

Proposed Data Collection for Public Comment

The Agency for Toxic Substances and Disease Registry (ATSDR) is proposing a new data collection and is seeking public comment. The comment period closes on February 20, 2026.

Agency Forms Undergoing Paperwork Reduction Act Review

The Agency for Toxic Substances and Disease Registry has submitted forms for review under the Paperwork Reduction Act. This notice informs the public about the agency's intent to collect information and allows for public comment on the necessity and burden of these forms.

Availability of Draft Toxicological Profiles; Comment Period Extended

The Agency for Toxic Substances and Disease Registry (ATSDR) has extended the public comment period for five draft toxicological profiles. The original notice was published on November 8, 2024, and the new deadline for comments is February 13, 2025.

Agency Forms Undergoing Paperwork Reduction Act Review

The Agency for Toxic Substances and Disease Registry (ATSDR) has published a notice regarding agency forms undergoing review under the Paperwork Reduction Act. This notice informs the public about the forms that are subject to review and potential revision.

Availability of Five Draft Toxicological Profiles

The Agency for Toxic Substances and Disease Registry (ATSDR) has made five draft toxicological profiles available for public comment. These profiles address potential health risks associated with various substances. Comments are due by February 6, 2025.

Agency Information Collection Activities: Proposed Collection; Comment Request

The Agency for Healthcare Research and Quality (AHRQ) has published a notice requesting public comment on proposed new agency information collection activities. The comment period is open until April 10, 2026.

Patient Safety Organizations: Voluntary Relinquishment for Vizient PSO

The Agency for Healthcare Research and Quality (AHRQ) has published a notice delisting the Vizient TM PSO (PSO number P0007) from its list of Patient Safety Organizations. This action is effective January 7, 2026, following the PSO's voluntary relinquishment of its status.

Patient Safety Organizations: Expired Listing for MedExpress PSO

The Agency for Healthcare Research and Quality (AHRQ) has issued a notice regarding the expired listing of MedExpress PSO as a Patient Safety Organization. This notice serves to inform the public and relevant parties of this administrative change.

Agency Information Collection Activities Proposed Collection Comment Request

The Agency for Healthcare Research and Quality (AHRQ) has published a notice requesting public comment on proposed information collection activities. This notice outlines the specific data collection efforts for which AHRQ is seeking input from stakeholders.

Agency Information Collection Activities: Proposed Collection Comment Request

The Federal Register is requesting public comment on a proposed collection of information by a government agency. The document indicates a server error and is not currently accessible.

FDA Approves Wellcovorin for Cerebral Folate Deficiency

The FDA has approved Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed FOLR1 gene variant. This marks the first FDA-approved treatment for this rare genetic condition.

FDA Streamlines Biosimilar Development Guidance

The FDA issued draft guidance to streamline biosimilar development by recommending the reduction of unnecessary clinical pharmacokinetic testing when scientifically justified. This initiative aims to save developers up to 50% in PK study costs, potentially lowering drug prices and increasing patient access to affordable biologic treatments.

FDA Meeting on State Drug Importation Program

The FDA held a meeting with several states to discuss the Section 804 Importation Program (SIP), which allows states to import certain prescription drugs from Canada. This meeting is part of the FDA's implementation of an executive order aimed at lowering drug prices for American consumers.

FDA Approves Tec-Dara for Relapsed Multiple Myeloma

The FDA has approved Tec-Dara (teclistamab and daratumumab hyaluronidase-fihj) for relapsed or refractory multiple myeloma. This approval was granted under the Commissioner's National Priority Voucher (CNPV) pilot program, marking a significant acceleration in the review process.

FDA Launches Unified Adverse Event Analysis Platform AEMS

The FDA has launched a new unified platform, the Adverse Event Monitoring System (AEMS), to analyze adverse event reports for all regulated products. This modernization aims to improve data accessibility, transparency, and surveillance capabilities, replacing fragmented legacy systems and is expected to save $120 million over five years.

Medicare Drug Price Negotiation: Manufacturer Participation in Third Cycle

CMS announced that 15 drug manufacturers have chosen to participate in the third cycle of Medicare drug price negotiations. These negotiations, part of the Inflation Reduction Act, will determine prices for selected high-expenditure drugs, with negotiated prices effective beginning in 2028.

SOLTIVE Premium SuperPulsed Laser System Recall

Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System manufactured by Gyrus Acmi, Inc. The recall is due to a defect in the 24V power supply causing sudden power loss or failure to power on. Affected customers will be contacted by Olympus representatives to schedule service.

Health Canada Recalls Nitrous Oxide Chargers

Health Canada has issued a recall for nitrous oxide chargers sold for inhalation without market authorization. Consumers are warned not to inhale these products recreationally and to seek medical attention if side effects occur. The recall affects multiple brands sold by Total Merchandise Ltd.

Instinct Plus Endoscopic Clipping Device Recall

Health Canada has issued a Type II recall for the Instinct® Plus Endoscopic Clipping Device manufactured by Wilson-Cook Medical, Inc. due to 486 reported malfunctions where the clip fails to open. This recall is to withdraw products manufactured prior to corrective actions being implemented.

Arjo Tenor Mobile Lift Recall

Health Canada has issued a Type II recall for the Arjo Tenor Mobile Lift due to a brake defect that can cause uncontrolled descent. All affected units must be removed from service immediately until repaired by authorized personnel.

Monoject Syringe Recall

Health Canada has issued a Type II recall for Monoject 1mL Luer Lock Syringes due to incorrect labeling. The affected products are mislabeled as Tuberculin syringes but contain U-100 Insulin syringes. Healthcare providers are advised to contact the manufacturer for more information.

Kisqali Tablets: Updated Storage Conditions and Shelf Life

Novartis Pharma GmbH has updated the storage conditions and shelf life for Kisqali 200 mg film-coated tablets. The medicine no longer requires refrigeration and now has an authorized shelf life of 2 years. This information letter was issued by the BfArM.

Tegretal Suspension Use Restricted in Newborns

The German Federal Institute for Drugs and Medical Devices (BfArM) has issued a direct healthcare professional communication restricting the use of Tegretal Suspension (carbamazepine) in newborns due to high propylene glycol content. This restriction is to prevent serious side effects in infants.

Arixtra Quality Defect: Needle Discoloration and Iron Particle

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a notice regarding a quality defect in Arixtra pre-filled syringes. Reports indicate brown discoloration and needle blockage due to oxidized iron particles, posing a risk to patients. Healthcare professionals are instructed not to dispense or administer affected products.

Digimerck Tablets Quality Defect: Degradation Products May Exceed Limit

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a Direct Healthcare Professional Communication regarding Digimerck 0.07 mg tablets. A quality defect has been identified where degradation products may slightly exceed the specification limit by the end of the product's shelf life. Distribution was discontinued in 2022.

Melphalan AqVida: Risk of Overdose Due to Higher Concentration

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a communication regarding Melphalan AqVida RTD 90 mg/ml, a new formulation with an 18-fold higher concentration than existing melphalan products. This increased concentration poses a potential risk of overdose for patients.

NY Health Urges Colorectal Cancer Screening for Adults Under 50

The New York State Department of Health is urging adults aged 45 and older to undergo colorectal cancer screening, as it is now a leading cause of cancer death for those under 50. The department highlights that screening can prevent or detect the cancer early, and aims to improve current screening rates.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in their October 2025 meeting. These recommendations are directly actionable by marketing authorisation holders (MAHs) for updates to product information.

PRAC Recommendations on Signals - January 2026 Meeting

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in January 2026. Marketing Authorisation Holders (MAHs) for affected medicinal products are required to update product information within specified timelines.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in February 2026. These recommendations require marketing authorisation holders (MAHs) to provide supplementary information or take regulatory action, such as updating product information.