1. Regulations
  2. title 21
  3. chapter I-i1
  4. part 117
  5. subpart E
  6. § 117.280

View all text of Subpart E [§ 117.251 - § 117.287]

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

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.

AUTHORITY: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

SOURCE: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.

CITE AS: 21 CFR 117.280