[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.41]

[Page 191]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 17--CIVIL MONEY PENALTIES HEARINGS--Table of Contents
 
Sec. 17.41  The administrative record.

    (a) The hearing will be recorded and transcribed. Witnesses, 
participants, and counsel have 30 days from the time the transcript 
becomes available to propose corrections in the transcript of oral 
testimony. Corrections are permitted only for transcription errors. The 
presiding officer shall promptly order justified corrections. 
Transcripts may be obtained following the hearing from the Dockets 
Management Branch at a cost not to exceed the actual cost of 
duplication.
    (b) The transcript of testimony, exhibits, and other evidence 
admitted at the hearing and all papers and requests filed in the 
proceeding constitute the administrative record for the decision by the 
presiding officer and the entity designated by the Commissioner of Food 
and Drugs to decide the appeal, currently the DAB.
    (c) The administrative record may be inspected and copied (upon 
payment of a reasonable fee) by anyone unless otherwise ordered by the 
presiding officer, who shall upon motion of any party order otherwise 
when necessary to protect trade secrets or confidential commercial 
information, as defined in Sec. 20.61 of this chapter, information the 
disclosure of which would constitute a clearly unwarranted invasion of 
personal privacy, or other information that would be withheld from 
public disclosure under part 20.