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💊FDA Guidance on Chemotherapy-Induced Peripheral Neuropathy Available

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." Chemotherapy-induced peripheral neuropathy (CIPN), a painful, disabling, and potentially irreversible condition commonly affecting patients receiving neurotoxic chemotherapies, could diminish survival by potentially increasing chemotherapy treatment interruptions, dose reductions, and discontinuations. This guidance provides recommendations to sponsors for the clinical development of drug and biological products intended for the prevention and treatment of CIPN in oncology patient populations.

📋FDA Adverse Event Reporting

The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA's adverse event reports and product experience reports for FDA-regulated products.

🚫FDA Withdraws Notice on Treatment Center Program Data Collection

The Food and Drug Administration (FDA) is announcing the withdrawal of a notice that was published in the Federal Register of October 18, 2023.

🏥Extension of Flexibility in Evaluating Healthcare Claims to 2029

We are extending the flexibility in the "close proximity of time" standard, as defined in two prior temporary final rules (TFR), through May 11, 2029. We issued a TFR providing the "close proximity of time" flexibility on July 23, 2021, because the COVID-19 national public health emergency (PHE) caused many individuals to experience barriers that prevented them from timely accessing in-person healthcare. On September 29, 2023, we extended the flexibility to evaluate evolving healthcare practices and consumption in a post-PHE environment. We determined that we need additional time to fully evaluate still-evolving healthcare practices after the PHE. We are therefore issuing this TFR to extend the "close proximity of time" flexibility until May 11, 2029, so we can continue to evaluate changes in healthcare practices and determine the proper "close proximity of time" standard for the musculoskeletal disorders listings.

📋Medicaid and CHIP Information Collection

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low-burden, and uncontroversial collections," do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

⚖️HHS Issues New Drug Testing Guidelines for Federal Workplaces

The Department of Health and Human Services ("HHS" or "Department") herein publishes the panels of Schedule I and II drugs and biomarkers authorized for testing in Federal workplace drug testing programs. The Department has revised the drug testing panels for both urine and oral fluid, and revised required nomenclature for laboratory and Medical Review Officer Reports.

⚖️RRB Updates Acceptable Medical Sources for Disability Claims

The Railroad Retirement Board (RRB) amends its regulations to designate additional acceptable medical sources in disability claims under the Railroad Retirement Act. This change recognizes the evolution of how medical care and treatment are delivered and aligns the RRB's acceptable medical sources with recently amended regulations of the Social Security Administration (SSA). Additionally, the changes clarify existing RRB policy regarding how evidence from medical sources, other than those designated as acceptable medical sources, will be evaluated.

🚫FDA Withdraws Approval of 23 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

💼Notice of Closed Meeting for National Institute of Mental Health Grants

🏥OSHA Terminates COVID-19 Rulemaking for Healthcare Settings

OSHA is terminating its COVID-19 rulemaking.