[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: 21CFR15.20]
[Page 163.164]
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 B Procedures for Public Hearing Before the Commissioner
Sec. 15.20 Notice of a public hearing before the Commissioner.
(a) If the Commissioner determines that a public hearing should be
held on a matter, the Commissioner will publish a notice of hearing in
the Federal Register setting forth the following information:
(1) If the hearing is under Sec. 15.1 (a) or (b), the notice will
state the following:
(i) The purpose of the hearing and the subject matter to be
considered. If a written document is to be the subject matter of the
hearing, it will be published as part of the notice, or reference made
to it if it has already been published in the Federal Register, or the
notice will state that the document is available from an agency office
identified in the notice.
(ii) The time, date, and place of the hearing, or a statement that
the information will be contained in a subsequent notice.
(2) If the hearing is in lieu of a formal evidentiary public hearing
under Sec. 15.1(c), all of the information described in Sec. 12.32(e).
(b) The scope of the hearing is determined by the notice of hearing
and any regulation under which the hearing is held. If a regulation,
e.g., Sec. 330.10(a)(10), limits a hearing to review of an existing
administrative record, information not already in the record may not be
considered at the hearing.
(c) The notice of hearing may require participants to submit the
text of their presentations in advance of the hearing if the
Commissioner determines that advance submissions are necessary for the
panel to formulate useful questions to be posed at the hearing under
Sec. 15.30(e). The notice may provide for
[[Page 164]]
the submission of a comprehensive outline as an alternative to the
submission of the text if the Commissioner determines that submission of
an outline will be sufficient.
[44 FR 22366, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]
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