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21CFR112.210

§ 112.210 What is the timeframe for issuing a decision on an appeal?

Regulation Text

(a) If the owner, operator, or agent in charge of a farm appeals the order without requesting a hearing, the presiding officer must issue a written report that includes a final decision confirming or revoking the withdrawal by the 10th calendar day after the appeal is filed. (b) If the owner, operator, or agent in charge of a farm appeals the order and requests an informal hearing: (1) If FDA grants the request for a hearing and the hearing is held, the presiding officer must provide a 2 calendar day opportunity for the hearing participants to review and submit comments on the report of the hearing under § 112.208(c)(4) , and must issue a final decision within 10 calendar days after the hearing is held; or (2) If FDA denies the request for a hearing, the presiding officer must issue a final decision on the appeal confirming or revoking the withdrawal within 10 calendar days after the date the appeal is filed.

Authority

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

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21CFR112.210 — § 112.210 What is the timeframe for issuing a decision on an appeal? | CFR Explorer | BioRegHub