[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: 21CFR16.22]

[Page 167]
 
                        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 
 
                   Subpart B_Initiation of Proceedings
 
Sec.  16.22  Initiation of regulatory hearing.


    (a) A regulatory hearing is initiated by a notice of opportunity for 
hearing from FDA. The notice will--
    (1) Be sent by mail, telegram, telex, personal delivery, or any 
other mode of written communication;
    (2) Specify the facts and the action that are the subject of the 
opportunity for a hearing;
    (3) State that the notice of opportunity for hearing and the hearing 
are governed by this part; and
    (4) State the time within which a hearing may be requested, and 
state the name, address, and telephone number of the FDA employee to 
whom any request for hearing is to be addressed.
    (5) Refer to FDA's guideline on electronic media coverage of its 
administrative proceedings (21 CFR part 10, subpart C).
    (b) A person offered an opportunity for a hearing has the amount of 
time specified in the notice, which may not be less than 3 working days 
after receipt of the notice, within which to request a hearing. The 
request may be filed by mail, telegram, telex, personal delivery, or any 
other mode of written communication, addressed to the designated FDA 
employee. If no response is filed within that time, the offer is deemed 
to have been refused and no hearing will be held.
    (c) If a hearing is requested, the Commissioner will designate a 
presiding officer, and the hearing will take place at a time and 
location agreed upon by the party requesting the hearing, the FDA, and 
the presiding officer or, if agreement cannot be reached, at a 
reasonable time and location designated by the presiding officer.
    (d) A notice of opportunity for hearing under this section will not 
operate to delay or stay any administrative action, including 
enforcement action by the agency unless the Commissioner, as a matter of 
discretion, determines that delay or a stay is in the public interest.

[44 FR 22367, Apr. 13, 1979, as amended at 49 FR 32173, Aug. 13, 1984]