[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR15.1]
[Page 163]
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-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.
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