[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.84]

[Page 84-85]
 
                        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

[[Page 85]]

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
    (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]