Department of Health and Human Services October 18, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Core Patient-Reported Outcomes in Cancer Clinical Trials." This final guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes (herein referred to as core patient-reported outcomes) in cancer clinical trials and related considerations for instrument selection and trial design. This final guidance focuses on patient-reported outcome (PRO) measures and is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry." This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful in supporting a determination of safety of an FDA-regulated "medical product" (i.e., drug, biological product, or medical device) for use in neonates. Although short-term safety evaluations may be appropriate for adults or other populations, such evaluations may not identify important adverse events in the neonatal population, as medical treatment during the neonatal period coincides with a time of critical growth and physiologic development and latent effects may not be evident until later in life following early-life exposures. Consideration of the potential for long-term neurologic, sensory, and developmental effects in the neonatal population early in a development program is important for establishing safety of a medical product intended for use in neonates. This guidance finalizes the draft guidance of the same title issued on February 13, 2023.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205851 and the new animal drug application (NADA) 141-389 for the designated medical gas Helium, USP held by Linde, Inc., 175 East Park Dr., Tonawanda, NY 14150-7844. Linde, Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.

The Food and Drug Administration (FDA, Agency, or we) has determined that TAVIST (clemastine fumarate) tablet, 2.68 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Department of Health and Human Services is hereby giving notice that the charter for the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) has been renewed.

The Food and Drug Administration (FDA, Agency, or we) is correcting a final rule entitled "Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments" that appeared in the Federal Register of September 20, 2024. The final rule inadvertently omitted the effective date for a provision in the regulatory text. This document corrects the error in the DATES portion.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of September 23, 2024. In the notice of availability, FDA requested comments on three draft guidance documents for industry and FDA staff entitled "The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff"; "Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical EquipmentStandards Specific Information for the ASCA Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff"; and "Biocompatibility Testing of Medical DevicesStandards Specific Information for the ASCA Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.