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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2013]
[CITE: 21CFR7.85]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 7 -- ENFORCEMENT POLICY

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 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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