[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: 21CFR16.60]

[Page 178-179]
 
                        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 D--Procedures for Regulatory Hearing
 
Sec. 16.60  Hearing procedure.


    (a) A regulatory hearing is public, except when the Commissioner 
determines that all or part of a hearing should be closed to prevent a 
clearly unwarranted invasion of personal privacy; to prevent the 
disclosure of a trade secret or confidential commercial or financial 
information that is not available for public disclosure under 
Sec. 20.61; or to protect investigatory records complied for law 
enforcement purposes that are not available for public disclosure under 
Sec. 20.64.
    (1) The Commissioner may determine that a regulatory hearing is 
closed either on the Commissioner's initiative or on a request by the 
party asking for a regulatory hearing, in the request for the hearing.
    (2) If the hearing is a private hearing, no persons other than the 
party requesting the hearing, counsel and witnesses, and an employee or 
consultant or other person subject to a commercial arrangement as 
defined in Sec. 20.81(a) and FDA representatives with a direct 
professional interest in the subject matter of the proceeding are 
entitled to attend.
    (3) If the hearing is a public hearing, it will be announced on the 
public calendar described in Sec. 10.100(a) whenever feasible, and any 
interested person who attends the hearing may participate to the extent 
of presenting relevant information.
    (b) A regulatory hearing will be conducted by a presiding officer. 
Employees of FDA will first give a full and complete statement of the 
action which is the subject of the hearing, together with the 
information and reasons supporting it, and may present any oral or 
written information relevant to the hearing. The party requesting the 
hearing may then present any oral or written information relevant to the 
hearing. All parties may confront and conduct reasonable cross-
examination of any person (except for the presiding officer and counsel 
for the parties) who makes any statement on the matter at the hearing.
    (c) The hearing is informal in nature, and the rules of evidence do 
not apply. No motions or objections relating to the admissibility of 
information and views will be made or considered, but any other party 
may comment upon or rebut all such data, information, and views.
    (d) The presiding officer may order the hearing to be transcribed. 
The party requesting the hearing may have the hearing transcribed, at 
the party's expense, in which case a copy of the transcript is to be 
furnished to FDA. Any transcript of the hearing will be included with 
the presiding officer's report of the hearing.
    (e) The presiding officer shall prepare a written report of the 
hearing. All written material presented at the hearing will be attached 
to the report. Whenever time permits, the parties to

[[Page 179]]

the hearing will be given the opportunity to review and comment on the 
presiding officer's report of the hearing.
    (f) The presiding officer shall include as part of the report of the 
hearing a finding on the credibility of witnesses (other than expert 
witnesses) whenever credibility is a material issue, and shall include a 
recommended decision, with a statement of reasons, unless the 
Commissioner directs otherwise.
    (g) The presiding officer has the power to take such actions and 
make such rulings as are necessary or appropriate to maintain order and 
to conduct a fair, expeditious, and impartial hearing, and to enforce 
the requirements of this part concerning the conduct of hearings. The 
presiding officer may direct that the hearing be conducted in any 
suitable manner permitted by law and these regulations.
    (h) The Commissioner or the presiding officer has the power under 
Sec. 10.19 to suspend, modify, or waive any provision of this part.

[44 FR 22367, Apr. 13, 1979, as amended at 66 FR 6469, Jan. 22, 2001; 66 
FR 12850, Mar. 1, 2001]

    Effective Date Note: At 66 FR 12850, Mar. 1, 2001, Sec. 16.60 was 
amended by adding paragraph (a)(3), effective Jan. 22, 2001, to Apr. 22, 
2001.