[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: 21CFR15.21]
[Page 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. 15.21 Notice of participation; schedule for hearing.
(a) The notice of hearing will provide persons an opportunity to
file a written notice of participation with the Division of Dockets
Management within a specified period of time containing the information
specified in the notice, e.g., name of participant, address, phone
number, affiliation, if any, topic of presentation and approximate
amount of time requested for the presentation. If the public interest
requires, e.g., a hearing is to be conducted within a short period of
time or is to be primarily attended by individuals without an
organizational affiliation, the notice may name a specific FDA employee
and telephone number to whom an oral notice of participation may be
given or provide for submitting notices of participation at the time of
the hearing. A written or oral notice of participation must be received
by the designated person by the close of business of the day specified
in the notice.
(b) Promptly after expiration of the time for filing a notice, the
Commissioner will determine the amount of time allotted to each person
and the approximate time that oral presentation is scheduled to begin.
If more than one hearing is held on the same subject, a person will
ordinarily be allotted time for a presentation at only one hearing.
(c) Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and to request time for a
joint presentation. The Commissioner may require joint presentations by
persons with common interests.
(d) The Commissioner will prepare a hearing schedule showing the
persons making oral presentations and the time alloted to each person,
which will be filed with the Division of Dockets Management and mailed
or telephoned before the hearing to each participant.
(e) The hearing schedule will state whether participants must be
present by a specified time to be sure to be heard in case the absence
of participants advances the schedule.
Back to Top
© 2007 Betterchem Corp.
|
