Healthcare & Life Sciences

CMS Agency Information Collection Activities: OMB Review Comment Request

The Centers for Medicare & Medicaid Services (CMS) has submitted an agency information collection activity for review by the Office of Management and Budget (OMB). This notice requests public comments on the proposed collection, with a deadline of April 16, 2026.

DEA Seizes Over Half a Million Vape Cartridges and Drugs in San Diego

The DEA announced a massive seizure in San Diego, confiscating over half a million vape cartridges and other illicit drugs. This action highlights the ongoing threat posed by illegal substances to public health and safety, with multiple law enforcement agencies collaborating in the operation.

DEA Seattle Fentanyl Enforcement and Awareness Initiative

The DEA's Seattle Division is launching a "Fentanyl-Free America" initiative in the Pacific Northwest, focusing on increased enforcement, education, and awareness. This initiative aims to combat the fentanyl crisis through collaborative efforts.

CDC Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has submitted the Maritime Illness Database and Reporting System (MIDRS) information collection request to the Office of Management and Budget (OMB) for review. This notice allows an additional 30 days for public comments on the proposed extension of this surveillance system.

CDC Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has submitted an information collection request titled “Aviation-related Public Health Activities” for review by the Office of Management and Budget. This notice provides an additional 30-day period for public comment on the proposed data collection.

CDC Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Land travel-related Public Health Activities” to the Office of Management and Budget (OMB) for review. This notice allows an additional 30 days for public and affected agency comments on the proposed data collection.

CDC Seeks Nominations for Advisory Committee on Breast Cancer

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on its Advisory Committee on Breast Cancer in Young Women. The committee comprises 15 experts in various fields related to breast cancer. Nominations must be received by April 20, 2026.

Ryan White HIV/AIDS Program Forms Submission to OMB for Review

The Health Resources and Services Administration (HRSA) has submitted revisions to the Ryan White HIV/AIDS Program: Allocations Report Forms to the Office of Management and Budget (OMB) for review and approval. A public comment period is open until April 16, 2026.

Court Blocks HHS Vaccine Policy Changes

A court has blocked changes to HHS vaccine policy, a decision praised by the American Medical Association (AMA). The AMA emphasized the importance of science-based immunization policies for public health and patient safety.

FDA Complaint Document

The FDA has posted a complaint document related to its activities, with the comment period closing on March 16, 2026. The document is available for public review and input.

FDA Complaint Document Details

The FDA has posted details regarding a complaint document, with the information made available on March 16, 2026. The document is related to a complaint filed with the agency.

FDA Acknowledgment Letter to J.M.W. Entertainment Group

The FDA issued an acknowledgment letter to The J.M.W. Entertainment Group, LLC, regarding a submission. This notice confirms receipt of documentation by the FDA's Center for Devices and Radiological Health (CDRH).

FDA Complaint Document Posted

The FDA has posted a complaint document related to its regulatory activities. The document was made available on March 16, 2026, and was open for public comment. No specific details about the complaint's content or the nature of the comment period are provided.

FDA Variance Application from Audio Source, Inc

The FDA has posted a variance application from Audio Source, Inc. This document is available for review on the Regs.gov platform. The application pertains to medical device regulations.

FDA Variance Amendment from J.M.W. Entertainment Group

The FDA has posted a variance amendment from J.M.W. Entertainment Group, LLC. The document was made available on March 16, 2026, via the Regs.gov portal. No further details on the amendment's content are provided.

FDA Complaint Posted for Public Comment

The FDA has posted a complaint for public comment, with the comment period closing on March 16, 2026. This action allows for public input on a specific complaint filed with the agency.

FDA Guidance on Progestins as Endocrine Disruptors

The FDA has issued new guidance concerning progestins and their potential role as endocrine disruptors. This document outlines the agency's current thinking and provides information relevant to manufacturers and public health authorities.

FDA Study on Oral Contraception and HIV Risk in Africa

The FDA has published a notice regarding a study on the relationship between oral contraception and HIV risk in Africa. This notice is associated with docket number FDA-2026-P-2641-0031.

FDA Study on Contraceptives, Herpes, and HIV Risk

The FDA has posted a study concerning the relationship between contraceptives, herpes, and HIV risk. The study details are available through the agency's regulatory portal.

FDA Glucocorticoid Receptor Gene Expression Study

The FDA has posted a study concerning Glucocorticoid Receptor gene expression. This notice is for informational purposes and does not introduce new regulatory requirements.

FDA Acknowledgment Letter to Audio Source, Inc

The FDA has issued an acknowledgment letter to Audio Source, Inc. regarding a submission. This notice confirms receipt of the document by the agency.

FDA Background Material on Contraceptive Use and HIV-1 Transmission Risk

The FDA has posted background material concerning contraceptive use and the risk of HIV-1 transmission. This notice provides scientific information relevant to public health discussions and regulatory considerations.

Hormonal Contraceptive Eligibility for Women at High HIV Risk

The FDA has issued draft guidance regarding the eligibility of hormonal contraceptives for women at high risk of HIV. This guidance aims to clarify recommendations and ensure appropriate access to contraceptive methods while considering HIV prevention strategies.

FDA Progestins Classification and Pharmacology

The Food and Drug Administration (FDA) has published a document detailing the classification and pharmacology of progestins. This guidance provides information for manufacturers and pharmaceutical companies regarding these substances.

FDA Document on Contraceptive Status Among Females 15-49

The Food and Drug Administration (FDA) has issued a document concerning contraceptive status among females aged 15-49. This notice provides information on the topic without introducing new regulatory requirements.

FDA Variance Application from J.M.W. Entertainment Group

The FDA has posted a variance application from The J.M.W. Entertainment Group, LLC. This document is available for review on the Regs.gov platform. No further details on the nature of the variance or its implications are provided in the notice.

EMA CHMP Agenda: Hetlioz for Smith-Magenis Syndrome

The European Medicines Agency (EMA) has published the agenda for an extraordinary CHMP meeting on March 16, 2026. The agenda includes discussions on the re-examination procedure for Hetlioz (Tasimelteon) for Smith-Magenis Syndrome, involving oral explanations and variations to marketing authorisations.

COVID-19 Vaccines: Safety Profile Confirmed

The French National Agency for the Safety of Medicines and Health Products (ANSM) has confirmed the safety profile of COVID-19 vaccines. The agency stated that no new safety signals have been identified, reinforcing the established safety of these vaccines.

HHS OIG Audit of Gateway Health Plan Medicare Advantage Compliance

The HHS Office of Inspector General (OIG) audited Gateway Health Plan, Inc.'s submission of diagnosis codes to CMS for Medicare Advantage risk adjustment. The audit found that most sampled diagnosis codes were not supported by medical records, leading to an estimated $4.3 million in net overpayments for 2018 and 2019.

Neonatal incubator safety alert: Lifetherm 2000

The ANSM has issued a safety alert regarding the Lifetherm 2000 neonatal incubator manufactured by Löwenstein Medical GmbH & Co. KG. The alert, registered under number R2607231, concerns a specific healthcare facility and includes a letter from the manufacturer detailing the safety action.

Impella AIC consoles with software <10.1 and Impella 5.5 first-gen safety alert

The ANSM has been informed of a safety action by Abiomed concerning Impella AIC consoles with software versions prior to 10.1, when used with first-generation Impella 5.5 ventricular assist devices. Healthcare providers using these devices have received specific instructions from Abiomed.

Stryker Osteosynthesis Screws Recalled Due to Safety Concerns

The French ANSM has announced a recall of Stryker osteosynthesis screws (7.0 mm Darco headless screws, 16x60 mm) due to safety concerns. This action, registered under recall number R2606623, affects pharmacies and users who have received direct communication from Stryker Instruments.

Product Recall: Mako Surgical Corp. MICS3 Fixation Device

The ANSM has announced a product recall for the Mako Surgical Corp. MICS3 fixation device, registered under recall number R2606434. The recall targets pharmacies and healthcare facilities, with two identified users having received direct communication from the manufacturer.

Polysilane UPSA gel oral recall notice

The ANSM has issued a recall notice for specific lots of Polysilane UPSA oral gel due to the potential presence of food-grade joint particles. The recall is a precautionary measure affecting the distribution chain, and the product will be unavailable until the issue is resolved.

FDA Mammography Standards Quality Act Requirements Comment Request

The FDA has submitted a proposed collection of information related to Mammography Quality Standards Act requirements to the Office of Management and Budget (OMB) for review. The agency is requesting public comments on this information collection, with a deadline of April 13, 2026.

FDA Variance Approval for North Bay Productions

The FDA has issued a variance approval letter to North Bay Productions. This document, originating from the CDRH, signifies an approval related to a specific variance request.

FDA Variance Application from Low Frequency Productions

The FDA is accepting comments on a variance application submitted by Low Frequency Productions. This application pertains to medical device regulations. The comment period for this application closed on March 13.

FDA Variance Application from William Moore - Public Comment

The FDA is accepting public comments on a variance application submitted by William Moore. The comment period is open until March 13. This action pertains to a specific application for a variance.

Proposed Rule for State Long-Term Care Ombudsman Program

The Administration on Aging (AoA) has issued a proposed rule to implement provisions of the Older Americans Act for the State Long-Term Care Ombudsman program. This rulemaking provides the first regulatory guidance for these programs, aiming to clarify implementation and reduce state-level variations. Comments are due by August 19, 2013.

State Long-Term Care Ombudsman Programs Correction

The Administration on Aging (AOA) has published a correction to a final rule concerning State Long-Term Care Ombudsman programs. This document addresses minor technical and typographical errors identified in the original rule published on February 11, 2015. The corrections are effective December 19, 2016.

Agency Collection Notice for Older Americans Act Recipients Study

The Administration on Aging (AoA) has submitted a proposed collection of information for the Older Americans Act Recipients study to the Office of Management and Budget (OMB) for review. The study aims to collect data on service usage and satisfaction from recipients of various AoA-funded programs.

DEA Notice: Stepan Company Application for Bulk Controlled Substance Manufacturer

The DEA has published a notice regarding Stepan Company's application to be registered as a bulk manufacturer of cocaine and ecgonine. Interested parties can submit comments or requests for a hearing by May 12, 2026.

DEA Designates Propionyl Chloride as List I Chemical

The DEA has finalized a rule designating propionyl chloride as a List I chemical under the Controlled Substances Act. This action subjects handlers of propionyl chloride to regulatory provisions due to its use in the illicit manufacture of fentanyl and its analogues. The rule becomes effective on April 9, 2026.

DEA Notice: Patheon API Services Controlled Substance Application

The DEA has published a notice regarding an application from Patheon API Services Inc. to be registered as a bulk manufacturer of controlled substances, including Dimethyltryptamine, Psilocybin, Psilocyn, Amphetamine, and Methadone. Interested parties can submit comments or requests for a hearing by May 12, 2026.

DEA Notice: Lonza Tampa LLC Application for Controlled Substance Importer Registration

The DEA has published a notice regarding an application from Lonza Tampa, LLC to be registered as an importer of psilocybin (Schedule I controlled substance). Interested parties can submit comments or requests for a hearing by April 13, 2026.

ACA Benefit Parameters and Basic Health Program Correction Proposed Rule

The Department of Health and Human Services (HHS) is issuing a correction to a proposed rule concerning the Affordable Care Act (ACA) benefit parameters and the Basic Health Program. This correction addresses technical errors, specifically the omission of column headings in several tables within the original proposed rule published on February 11, 2026.

NIH Terminates Minority Biomedical Research Support Program

The Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), is repealing the regulation for the Minority Biomedical Research Support (MBRS) program. This action is effective September 25, 2025, and aligns with recent Supreme Court decisions and executive orders concerning discrimination and DEI programs.

NIH Amends Clinical Trials Registration and Results Submission Rule

The National Institutes of Health (NIH) has issued a final rule making a technical amendment to its clinical trials registration and results submission regulation. This amendment updates the URL for accessing information on formatting and submission procedures from the old prsinfo.clinicaltrials.gov to the new clinicaltrials.gov website. The change is effective December 9, 2024.

NIH Privacy Act Implementation Final Rule

The National Institutes of Health (NIH) has published a final rule implementing exemptions for a new Privacy Act system of records, 'NIH Police Records.' This rule exempts certain law enforcement investigatory materials from specific Privacy Act requirements to protect ongoing investigations and sources.

NIH Delays Effective Date for Privacy Act Rule

The National Institutes of Health (NIH) has delayed the effective date of a final rule concerning a new Privacy Act system of records. The rule, originally set to take effect on February 18, 2025, is now delayed until March 21, 2025, in accordance with a presidential memorandum.