§ 12.1 - Scope.

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§ 12.1 Scope.

The procedures in this part apply when -

(a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or

(b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.

                    
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§ 12.1 - Scope.

§ 12.1 Scope.