[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: 21CFR15.30]

[Page 164-165]
 
                        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.  15.30  Conduct of a public hearing before the Commissioner.

    (a) The Commissioner or a designee may preside at the hearing, 
except where a regulation provides that the Commissioner will preside 
personally. The presiding officer may be accompanied by other FDA 
employees or other Federal Government employees designated by the 
Commissioner, who may serve as a panel in conducting the hearing.
    (b) The hearing will be transcribed.
    (c) Persons may use their alloted time in whatever way they wish, 
consistent with a reasonable and orderly hearing. A person may be 
accompanied by any number of additional persons, and may present any 
written information or views for inclusion in the record of the hearing, 
subject to the requirements of Sec.  15.25. The presiding officer may 
allot additional time to any person when the officer concludes that it 
is in the public interest, but may not reduce the time allotted for any 
person without the consent of the person.
    (d) If a person is not present at the time specified for the 
presentation, the persons following will appear in order, with 
adjustments for those appearing at their scheduled time. An attempt will 
be made to hear any person who is late at the conclusion of the hearing. 
Other interested persons attending the hearing who did not request an 
opportunity to make an oral presentation will be given an opportunity to 
make an oral presentation at the conclusion of the hearing, in the 
discretion of the

[[Page 165]]

presiding officer, to the extent that time permits.
    (e) The presiding officer and any other persons serving on a panel 
may question any person during or at the conclusion of the presentation. 
No other person attending the hearing may question a person making a 
presentation. The presiding officer may, as a matter of discretion, 
permit questions to be submitted to the presiding officer or panel for 
response by them or by persons attending the hearing.
    (f) The hearing is informal in nature, and the rules of evidence do 
not apply. No motions or objections relating to the admissibility of 
information and views may be made or considered, but other participants 
may comment upon or rebut all such information and views. No participant 
may interrupt the presentation of another participant at any hearing for 
any reason.
    (g) The hearing may end early only if all persons scheduled for a 
later presentation have already appeared or it is past the time 
specified in the hearing schedule, under Sec.  15.21(e), by which 
participants must be present.
    (h) The Commissioner or the presiding officer may, under Sec.  
10.19, suspend, modify, or waive any provision of this part.