21 CFR 117.280

§ 117.280 Revocation of an order to withdraw a qualified facility exemption.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 117.280, § 117.280 Revocation of an order to withdraw a qualified facility exemption, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84423
Permanent ID: ys:prov:84423@1
SHA-256: c74f60396a3d409ed14c24917367d6192220522766ba44245ad72513352bd9ef

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Full text

An order to withdraw a qualified facility exemption is revoked if: (a) You appeal the order and request an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10-calendar days after the hearing, or issues a decision revoking the order within that time; or (b) You appeal the order and request an informal hearing, FDA denies the request for an informal hearing, and FDA does not confirm the order within the 10-calendar days after the appeal is filed, or issues a decision revoking the order within that time; or (c) You appeal the order without requesting an informal hearing, and FDA does not confirm the order within the 10-calendar days after the appeal is filed, or issues a decision revoking the order within that time.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.