[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.24]

[Page 176-177]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
 
                  Subpart B--Initiation of Proceedings
 
Sec. 16.24  Regulatory hearing required by the act or a regulation.

    (a) A regulatory hearing required by the act or a regulation under 
Sec. 16.1(b) will be initiated in the same manner as other regulatory 
hearings subject to the additional procedures in this section.
    (b) [Reserved]
    (c) The notice will state whether any action concerning the matter 
that is the subject of the opportunity for hearing is or is not being 
taken pending the hearing under paragraph (d) of this section.
    (d) The Commissioner may take such action pending a hearing under 
this section as the Commissioner concludes is necessary to protect the 
public health, except where expressly prohibited by statute or 
regulation. A hearing to consider action already taken, and not stayed 
by the Commissioner, will be conducted on an expedited basis.
    (e) The hearing may not be required to be held at a time less than 2 
working days after receipt of the request for hearing.
    (f) Before the hearing, FDA will give to the party requesting the 
hearing reasonable notice of the matters to be considered at the 
hearing, including a comprehensive statement of the basis for the 
decision or action taken or proposed that is the subject of the hearing 
and a general summary of the information that will be presented by FDA 
at the hearing in support of the decision or action. This information 
may be given orally or in writing, in the discretion of FDA.
    (g) FDA and the party requesting the hearing will, if feasible, at 
least 1 day before the hearing provide to each other written notice of 
any published articles or written information to be

[[Page 177]]

presented at or relied on at the hearing. A copy will also be provided 
in advance if the other participant could not reasonably be expected to 
have or be able to obtain a copy. If written notice or a copy is not 
provided, the presiding officer may, if time permits, allow the party 
who did not receive the notice or copy additional time after the close 
of the hearing to make a submission concerning the article or 
information.

[44 FR 22367, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982; 
54 FR 9037, Mar. 3, 1989]