[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.60]
[Page 169.170]
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
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.
(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
[[Page 170]]
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 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]
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