[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
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]