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21CFR112.211

§ 112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked?

Regulation Text

An order to withdraw a qualified exemption applicable to a farm under § 112.5 is revoked if: (a) The owner, operator, or agent in charge of the farm appeals the order and requests 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) The owner, operator, or agent in charge of the farm appeals the order and requests 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) The owner, operator, or agent in charge of the farm appeals 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. (d) Confirmation of a withdrawal order by the presiding officer is considered a final Agency action for purposes of 5 U.S.C. 702 .

Authority

21 U.S.C. 321,331,342,350h,371;42 U.S.C. 243,264,271.

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21CFR112.211 — § 112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked? | CFR Explorer | BioRegHub