FDA rare neurodegenerative disease action plan

Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended amended— (1) in the section heading, by striking ALS and other rare neurodegenerative disease action plan and inserting FDA rare neurodegenerative disease action plan; and (2) by adding at the end the following: (c) Report on ALS and other FDA rare neurodegenerative disease action plans plan (1) In general Not later than one year 18 months after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration an action plan that includes a description of the actions that the Food and Drug Administration intends to take during the 5-year period following publication of the action plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a). (2) Report Not later than 5 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that contains— (1) an updated action plan, including— (A) a description of the actions the Food and Drug Administration intends to take during the 5-year period following publication of the plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a); (B) a description of the resources necessary to implement each section of the plan within such 5-year period; and (C) specific approaches the Commissioner will take to improve coordination of implementation of the plan with rare neurodegenerative disease communities that are not specifically ALS communities; and (2) with respect to the Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) published by the Food and Drug Administration on June 23, 2022 (referred to in this section as the 2022 Action Plan), a description of— (A) describes the actions taken by the Food and Drug Administration under the 2022 Action Plan; (B) the effect of the implementation of the 2022 Action Plan on the development of therapies action plan published under paragraph (1) and regulatory consideration of therapies for ALS and other rare neurodegenerative diseases; (C) any programs and initiatives that established or carried out as part of the implementation of the 2022 Action Plan; and (D) the extent to which such action plan meets the 2022 Action Plan was implemented with respect to rare neurodegenerative diseases that are not amyotrophic lateral sclerosis..requirements specified in paragraph (1)..