[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: 21CFR12.32]
[Page 118.119]
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 B Initiation of Proceedings
Sec. 12.32 Request for alternative form of hearing.
(a) A person with a right to request a hearing may waive that right
and request one of the following alternatives:
(1) A hearing before a Public Board of Inquiry under part 13.
(2) A hearing before a public advisory committee under part 14.
(3) A hearing before the Commissioner under part 15.
(b) The request--
[[Page 119]]
(1) May be on the person's own initiative or at the suggestion of
the Commissioner.
(2) Must be submitted in the form of a citizen petition under Sec.
10.30 before publication of a notice of hearing under Sec. 12.35 or a
denial of hearing under Sec. 12.28; and
(3) Must be--
(i) In lieu of a request for a hearing under this part; or
(ii) If submitted after or with a request for hearing, in the form
of a waiver of the right to request a hearing conditioned on an
alternative form of hearing. Upon acceptance by the Commissioner, the
waiver becomes binding and may be withdrawn only by waiving any right to
any form of hearing unless the Commissioner determines otherwise.
(c) When more than one person requests and justifies a hearing under
this part, an alternative form of hearing may by used only if all the
persons concur and waive their right to request a hearing under this
part.
(d) The Commissioner will determine whether an alternative form of
hearing should be used, and if so, which alternative is acceptable,
after considering the requests submitted and the appropriateness of the
alternatives for the issues raised in the objections. The Commissioner's
acceptance is binding unless, for good cause, the Commissioner
determines otherwise.
(e) The Commissioner will publish a notice of an alternative form of
hearing setting forth the following information:
(1) The regulation or order that is the subject of the hearing.
(2) A statement specifying any part of the regulation or order that
has been stayed by operation of law or in the Commissioner's discretion.
(3) The time, date, and place of the hearing, or a statment that
such information will be contained in a later notice.
(4) The parties to the hearing.
(5) The issues at the hearing. The statement of issues determines
the scope of the hearing.
(6) If the hearing will be conducted by a Public Board of Inquiry,
the time within which--
(i) The parties should submit nominees for the Board under Sec.
13.10(b);
(ii) A notice of participation under Sec. 12.45 should be filed;
and
(iii) Participants should submit written information under Sec.
13.25. The notice will list the contents of the portions of the
administrative record relevant to the issues at the hearing before the
Board. The portions listed will be placed on public display in the
office of the Division of Dockets Management before the notice is
published. Additional copies of material already submitted under Sec.
13.25 need not be included with any later submissions.
(f)(1) The decision of a hearing before a Public Board of Inquiry or
a public advisory committee under this section has legal status of and
will be handled as an initial decision under Sec. 12.120.
(2) The decision of a public hearing before the Commissioner under
this section will be issued as a final order. The final order will have
the same content as an initial decision, as specified in Sec. 12.120
(b) and (c).
(3) Thereafter, the participants in the proceeding may pursue the
administrative and court remedies specified in Sec. Sec. 12.120 through
12.159.
(g) If a hearing before a public advisory committee or a hearing
before the Commissioner is used as an alternative form of hearing, all
submissions will be made to the Division of Dockets Management, and
Sec. 10.20(j) governs their availability for public examination and
copying.
(h) This section does not affect the right to an opportunity for a
hearing before a public advisory committee under section 515(g)(2) of
the act regarding device premarket approval applications and product
development protocols. Advisory committee hearing procedures are found
in part 14.
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