[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.80]

[Page 201]
 
                        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 E_Administrative Record and Decision
 
Sec. 16.80  Administrative record of a regulatory hearing.


    (a) The administrative record of the regulatory hearing consists of 
the following:
    (1) The notice of opportunity for hearing and the response.
    (2) All written information and views submitted to the presiding 
officer at the hearing or after if specifically permitted by the 
presiding officer.
    (3) Any transcript of the hearing.
    (4) The presiding officer's report of the hearing and comments on 
the report under Sec. 16.60(e).
    (5) All letters and memoranda of meetings or communications between 
participants and the presiding officer or the Commissioner referred to 
in Sec. 16.44(c).
    (b) The record of the regulatory hearing is closed to the submission 
of information and views, at the close of the hearing, unless the 
presiding officer specifically permits additional time for a further 
submission.