Description
Potential criminal cases are frequently preceded by an opportunity for proposed defendants to present their views on whether a criminal action should be forwarded to the United States Attorney. It is not unusual for prospective defendants, their attorney, and/or their representative to contact district headquarters offices subsequent to the Section 305 meeting to inquire about the agency decision and status of the case. The following policy applies to such inquiries from such persons.
Scope & Applicability
Stakeholders
5notify the Office of General Counsel of the communications
Decision maker in expedited withdrawal procedures; Provides opportunity for a meeting or written appeal during withdrawal procedures.; FDA Commissioner or their designee presiding over appeals
unless FDA's Office of Chief Counsel has confirmed that the referral may be revealed
whether a criminal action should be forwarded to the United States Attorney
opportunity for proposed defendants to present their views
Related CFR Sections (1)
- 21CFR7.85§ 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.Read full regulation →