§117.280. Revocation of an order to withdraw a qualified facility exemption.
21 C.F.R. § 117.280
An order to withdraw a qualified facility exemption is revoked if:
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
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
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
Source
Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.