Health and Human Services Department Docket FDA-2016-N-0011 Final Rule

2016-18787: Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment

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Summary

The Food and Drug Administration (FDA) is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing so that the lists correctly reference the statutory and regulatory provisions that provide such an opportunity in connection with a ban of a device. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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