21 CFR 17.5 – Complaint
(a) The Center with principal jurisdiction over the matter involved shall begin all administrative civil money penalty actions by serving on the respondent(s) a complaint signed by the Office of the Chief Counsel attorney for the Center and by filing a copy of the complaint with the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For a civil money penalty action against retailers of tobacco products, the complaint may be signed by any Agency employee designated by the Chief Counsel.
Terms Used In 21 CFR 17.5
- Answer: The formal written statement by a defendant responding to a civil complaint and setting forth the grounds for defense.
- Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
- Presiding officer: A majority-party Senator who presides over the Senate and is charged with maintaining order and decorum, recognizing Members to speak, and interpreting the Senate's rules, practices and precedents.
(b) The complaint shall state:
(1) The allegations of liability against the respondent, including the statutory basis for liability, the identification of violations that are the basis for the alleged liability, and the reasons that the respondent is responsible for the violations;
(2) The amount of penalties and assessments that the Center is seeking;
(3) Instructions for filing an answer to request a hearing, including a specific statement of the respondent’s right to request a hearing by filing an answer and to retain counsel to represent the respondent; and
(4) That failure to file an answer within 30 days of service of the complaint will result in the imposition of the proposed amount of penalties and assessments, as provided in § 17.11.
(c) The Center may, on motion, subsequently amend its complaint to conform with the evidence adduced during the administrative process, as justice may require.
(d) The presiding officer will be assigned to the case upon the filing of the complaint under this part.