Sec. 4. Report on ALS and other rare neurodegenerative disease action plans
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Section 4 of the Accelerating Access to Critical Therapies for ALS Act ( 21 U.S.C. 360aa note) is amended by adding at the end the following: Not later than one year 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— an updated action plan, including— 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); a description of the resources necessary to implement each section of the plan within such 5-year period; and 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 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— the actions taken by the Food and Drug Administration under the 2022 Action Plan; the effect of the implementation of the 2022 Action Plan on the development of therapies and regulatory consideration of therapies for ALS and other rare neurodegenerative diseases; any programs and initiatives that established or carried out as part of the implementation of the 2022 Action Plan; and the extent to which the 2022 Action Plan was implemented with respect to rare neurodegenerative diseases that are not amyotrophic lateral sclerosis. .
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Sec. 4
Report on ALS and other rare neurodegenerative disease action plans
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