[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: 21CFR16.42]

[Page 177-178]
 
                        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 C--Commissioner and Presiding Officer
 
Sec. 16.42  Presiding officer.

    (a) An FDA employee to whom the Commissioner delegates such 
authority, or any other agency employee designated by an employee to 
whom such authority is delegated, may serve as the presiding officer and 
conduct a regulatory hearing under this part.
    (b) In a regulatory hearing required by the act or a regulation, the 
presiding officer is to be free from bias or prejudice and may not have 
participated in the investigation or action that is the subject of the 
hearing or be subordinate to a person, other than the Commissioner, who 
has participated in such investigation or action.
    (c)(1) The Commissioner or the delegate under Sec. 16.40 is not 
precluded by this section from prior participation in the investigation 
or action that is the subject of the hearing. If there has been prior 
participation, the Commissioner or the delegate should, if feasible, 
designate a presiding officer for the hearing who is not a subordinate. 
Thus, if the Commissioner's authority to make a final decision has been 
delegated to a center director, the presiding officer may be an official 
in another center or the office of the Commissioner. The exercise of 
general supervisory responsibility, or the designation of the presiding 
officer, does not constitute prior participation in the investigation or 
action that is the subject of the hearing so as to preclude the 
Commissioner or delegate from designating a subordinate as the presiding 
officer.
    (2) The party requesting a hearing may make a written request to 
have the Commissioner or the delegate under Sec. 16.40 be the presiding 
officer, notwithstanding paragraph (c)(1) of this section. If accepted, 
as a matter of discretion, by the Commissioner or the delegate, the 
request is binding upon the party making the request.
    (3) A different presiding officer may be substituted for the one 
originally

[[Page 178]]

designated under Sec. 16.22 without notice to the parties.

[44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]