[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: 21CFR7.84]
[Page 73-74]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 7 ENFORCEMENT POLICY--Table of Contents
Subpart E Criminal Violations
Sec. 7.84 Opportunity for presentation of views before report of criminal
violation.
(a)(1) Except as provided in paragraph (a) (2) and (3) of this
section, a person against whom criminal prosecution under the Federal
Food, Drug, and Cosmetic Act is contemplated by the Commissioner of Food
and Drugs shall be given appropriate notice and an opportunity to
present information and views to show cause why criminal prosecution
should not be recommended to a United States attorney.
(2) Notice and opportunity need not be provided if the Commissioner
has reason to believe that they may result in the alteration or
destruction of evidence or in the prospective defendant's fleeing to
avoid prosecution.
(3) Notice and opportunity need not be provided if the Commissioner
contemplates recommending further investigation by the Department of
Justice.
(b) If a statute enforced by the Commissioner does not contain a
provision for an opportunity to present views, the Commissioner need
not, but may in the Commissioner's discretion, provide notice and an
opportunity to present views.
(c) If an apparent violation of the Federal Food, Drug, and Cosmetic
Act also constitutes a violation of any other Federal statute(s), and
the Commissioner contemplates recommending prosecution under such other
statute(s) as well, the notice of opportunity to present views will
include all violations.
(d) Notice of an opportunity to present views may be by letter,
standard form, or other document(s) identifying the products and/or
conduct alleged to violate the law. The notice shall--
(1) Be sent by registered or certified mail, telegram, telex,
personal delivery, or any other appropriate mode of written
communication;
(2) Specify the time and place where those named may present their
views;
(3) Summarize the violations that constitute the basis of the
contemplated prosecution;
(4) Describe the purpose and procedure of the presentation; and
[[Page 74]]
(5) Furnish a form on which the legal status of any person named in
the notice may be designated.
(e) If more than one person is named in a notice, a separate
opportunity for presentation of views shall be scheduled on request.
Otherwise, the time and place specified in a notice may be changed only
upon a showing of reasonable grounds. A request for any change shall be
addressed to the Food and Drug Administration office that issued the
notice and shall be received in that office at least 3 working days
before the date set in the notice.
(f) A person who has received a notice is under no legal obligation
to appear or answer in any manner. A person choosing to respond may
appear personally, with or without a representative, or may designate a
representative to appear for him or her. Alternatively, a person may
respond in writing. If a person elects not to respond on or before the
time scheduled, the Commissioner will, without further notice, decide
whether to recommend criminal prosecution to a United States attorney on
the basis of the information available.
(g) If a respondent chooses to appear solely by designated
representative, that representative shall present a signed statement of
authorization. If a representative appears for more than one respondent,
the representative shall submit independent documentation of authority
to act for each respondent. If a representative appears without written
authorization, the opportunity to present views with respect to that
respondent may be provided at that time only if the authenticity of the
representative's authority is first verified by telephone or other
appropriate means.
[44 FR 12167, Mar. 6, 1979]
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