Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a manufacturer of a critical food (which includes infant formula) must notify FDA of a permanent discontinuance or an interruption of the manufacture of a critical food that is likely to lead to a meaningful disruption in the supply of the food in the United States. The draft guidance, when finalized, is intended to help the infant formula industry comply with this notification requirement as it pertains to infant formula.