List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Reopening of the Comment Period

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The Food and Drug Administration (FDA or the Agency) is reopening the comment period for a notice that appeared in the Federal Register of July 31, 2020, in which FDA identified certain bulk drug substances (active pharmaceutical ingredients) that FDA has considered and proposes to include or not include on the list of bulk drug substances for which there is a clinical need (the 503B Bulks List). The Agency is taking this action in response to a request received during the initial comment period, which asked the Agency to allow interested persons additional time to submit comments.