[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR12.1] [Page 125] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 12--FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents Subpart A--General Provisions Sec. 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 Sec. 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.