[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR15.1]

[Page 171-172]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 15--PUBLIC HEARING BEFORE THE COMMISSIONER--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 15.1  Scope.


    The procedures in this part apply when:
    (a) The Commissioner concludes, as a matter of discretion, that it 
is in the public interest to permit persons to present information and 
views at a public hearing on any matter pending before the Food and Drug 
Administation.
    (b) The act or regulation specifically provides for a public hearing 
before the Commissioner on a matter, e.g., Sec. 330.10(a)(8) relating to 
over-the-

[[Page 172]]

counter drugs and sections 520 (b) and (f)(1)(B), and 521 of the act 
relating to proposals to allow persons to order custom devices, to 
proposed device good manufacturing practice regulations, and to proposed 
exemptions from preemption of State and local device requirements under 
Sec. 808.25(e).
    (c) A person who has right to an opportunity for a formal 
evidentiary public hearing under part 12 waives that opportunity and 
instead requests under Sec. 12.32 a public hearing before the 
Commissioner, and the Commissioner, as a matter of discretion, accepts 
the request.