[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: 21CFR12.50]
[Page 121-122]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 12 FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart C Appearance and Participation
Sec. 12.50 Advice on public participation in hearings.
(a) Designated agency contact. All inquiries from the public about
scheduling, location, and general procedures should be addressed to the
Deputy Commissioner for Policy (HF-22), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, or telephone 301-443-3480. The
staff of the Associate Commissioner for Regulatory Affairs will attempt
to respond promptly to all inquiries from members of the public, as well
as to simple requests for information from participants in hearings.
(b) Hearing schedule changes. Requests by hearing participants for
changes in the schedule of a hearing or for filing documents, briefs, or
other pleadings should be made in writing directly to the Administrative
Law Judge (HF-3), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857.
(c) Legal advice to individuals. FDA does not have the resources to
provide legal advice to members of the public concerning participation
in hearings. Furthermore, to do so would compromise the independence of
the Commissioner's office and invite charges of improper interference in
the hearing process. Accordingly, the Deputy Commissioner for Policy
(HF-22) will not answer questions about the strengths or weaknesses of a
party's position at a hearing, litigation strategy, or similar matters.
(d) Role of the office of the Chief Counsel. Under no circumstances
will the office of the Chief Counsel of FDA directly provide advice
about a hearing to any person who is participating or may participate in
the hearing. In every hearing, certain attorneys in the office are
designated to represent the center or centers whose action is the
subject of the hearing. Other members of the office, including
ordinarily the Chief Counsel, are designated to advise the Commissioner
on a final decision in the matter. It is not compatible with these
functions, nor would it be professionally responsible, for the attorneys
[[Page 122]]
in the office of the Chief Counsel also to advise other participants in
a hearing, or for any attorney who may be called on to advise the
Commissioner to respond to inquiries from other participants in the
hearing, for such participants may be urging views contrary to those of
the center involved or to what may ultimately be the final conclusions
of the Commissioner. Accordingly, members of the office of the Chief
Counsel, other than the attorneys responsible for representing the
center whose action is the subject of the hearing, will not answer
questions about the hearing from any participant or potential
participant.
(e) Communication between participants and attorneys. Participants
in a hearing may communicate with the attorneys responsible for
representing the center whose action is the subject of the hearing, in
the same way that they may communicate with counsel for any other party
in interest about the presentation of matters at the hearing. It would
be inappropriate to bar discussion of such matters as stipulations of
fact, joint presentation of witnesses, or possible settlement of hearing
issues. Members of the public, including participants at hearings, are
advised, however, that all such communications, including those by
telephone, will be recorded in memoranda that can be filed with the
Division of Dockets Management.
[44 FR 22329, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54
FR 9035, Mar. 3, 1989; 58 FR 17096, Apr. 1, 1993]
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