[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: 21CFR7.85]
[Page 74-75]
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. 7.85 Conduct of a presentation of views before report of criminal
violation.
(a) The presentation of views shall be heard by a designated Food
and Drug Administration employee. Other Food and Drug Administration
employees may be present.
(b) A presentation of views shall not be open to the public. The
agency employee designated to receive views will permit participation of
other persons only if they appear with the respondent or the
respondent's designated representative, and at the request of, and on
behalf of, the respondent.
(c) A respondent may present any information of any kind bearing on
the Commissioner's determination to recommend prosecution. Information
may include statements of persons appearing on the respondent's behalf,
letters, documents, laboratory analyses, if applicable, or other
relevant information or arguments. The opportunity to present views
shall be informal. The rules of evidence shall not apply. Any
information given by a respondent, including statements by the
respondent, shall become part of the agency's records concerning the
matter and may be used for any official purpose. The Food and Drug
Administration is under no obligation to present evidence or witnesses.
(d) If the respondent holds a ``guaranty or undertaking'' as
described in section 303(c) of the act (21 U.S.C. 333(c)) that is
applicable to the notice, that document, or a verified copy of it, may
be presented by the respondent.
(e) A respondent may have an oral presentation recorded and
transcribed at his or her expense, in which case a copy of the
transcription shall be furnished to the Food and Drug Administration
office from which the notice issued. The employee designated to receive
views may order a presentation of views recorded and transcribed at
agency expense, in which case a copy of such transcription shall be
provided to each respondent.
(f) If an oral presentation is not recorded and transcribed, the
agency employee designated to receive views shall dictate a written
summary of the presentation. A copy of the summary shall be provided to
each respondent.
(g) A respondent may comment on the summary or may supplement any
response by additional written or documentary evidence. Any comment or
addition shall be furnished to the Food and Drug Administration office
where the respondent's views were presented. If materials are submitted
within 10 calendar days after receipt of the copy of the summary or
transcription of the presentation, as applicable, they will
[[Page 75]]
be considered before a final decision as to whether or not to recommend
prosecution. Any materials received after the supplemental response
period generally will be considered only if the final agency decision
has not yet been made.
(h)(1) When consideration of a criminal prosecution recommendation
involving the same violations is closed by the Commissioner with respect
to all persons named in the notice, the Commissioner will so notify each
person in writing.
(2) When it is determined that a person named in a notice will not
be included in the Commissioner's recommendation for criminal
prosecution, the Commissioner will so notify that person, if and when
the Commissioner concludes that notification will not prejudice the
prosecution of any other person.
(3) When a United States attorney informs the agency that no persons
recommended will be prosecuted, the Commissioner will so notify each
person in writing, unless the United States attorney has already done
so.
(4) When a United States attorney informs the agency of intent to
prosecute some, but not all, persons who had been provided an
opportunity to present views and were subsequently named in the
Commissioner's recommendation for criminal prosecution, the
Commissioner, after being advised by the United States attorney that the
notification will not prejudice the prosecution of any other person,
will so notify those persons eliminated from further consideration,
unless the United States attorney has already done so.
[44 FR 12168, Mar. 6, 1979]
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