[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: 21CFR16.44]

[Page 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. 16.44  Communication to presiding officer and Commissioner.

    (a) Regulatory hearings are not subject to the separation of 
functions rules in Sec. 10.55.
    (b) Those persons who are directly involved in the investigation or 
presentation of the position of FDA or any party at a regulatory hearing 
that is required by the act or a regulation should avoid any off-the-
record communication on the matter to the presiding officer or the 
Commissioner or their advisors if the communication is inconsistent with 
the requirement of Sec. 16.95(b)(1) that the administrative record be 
the exclusive record for decision. If any communication of this type 
occurs, it is to be reduced to writing and made part of the record, and 
the other party provided an opportunity to respond.
    (c) A copy of any letter or memorandum of meeting between a 
participant in the hearing and the presiding officer or the 
Commissioner, e.g., a response by the presiding officer to a request for 
a change in the time of the hearing, is to be sent to all participants 
by the person writing the letter or the memorandum.