[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: 21CFR12.35]
[Page 119-120]
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. 12.35 Notice of hearing; stay of action.
(a) If the Commissioner determines upon review of the objections and
requests for hearing that a hearing is justified on any issue, the
Commissioner will publish a notice setting forth the following:
(1) The regulation or order that is the subject of the hearing.
[[Page 120]]
(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 parties to the hearing.
(4) The issues of fact on which a hearing has been justified.
(5) A statement of any objections or requests for hearing for which
a hearing has not been justified, which are subject to Sec. 12.28.
(6) The presiding officer, or a statement that the presiding officer
will be designated in a later notice.
(7) The time within which notices of participation should be filed
under Sec. 12.45.
(8) The date, time, and place of the prehearing conference, or a
statement that the date, time, and place will be announced in a later
notice. The pre-hearing conference may not commence until after the time
expires for filing the notice of participation required by Sec.
12.45(a).
(9) The time within which participants should submit written
information and views under Sec. 12.85. The notice will list the
contents of the portions of the administrative record relevant to the
issues at the hearing. 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. 12.85 need not be included with any later submissions.
(b) The statement of the issues determines the scope of the hearing
and the matters on which evidence may be introduced. The issues may be
revised by the presiding officer. A participant may obtain interlocutory
review by the Commissioner of a decision by the presiding officer to
revise the issues to include an issue on which the Commissioner has not
granted a hearing or to eliminate an issue on which a hearing has been
granted.
(c) A hearing is deemed to begin on the date of publication of the
notice of hearing.
[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]
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