Title 21 CFR reference

The procedures in this part apply when: (a) The Commissioner is considering any regulatory action, including a refusal to act, and concludes, as a matter of discretion, on the Commissioner's initiative or at the suggestion of any person, to offer an opportunity for a regulatory hearing to obtain additional information before making a decision or taking action. (b) The act or a regulation provides a person with an opportunity for a hearing on a regulatory action, including proposed action, and the act or a regulation either specifically provides an opportunity for a regulatory hearing under this part or provides an opportunity for a hearing for which no procedures are specified by regulation. Listed below are the statutory and regulatory provisions under which regulatory hearings are available: (1) Statutory provisions: (2) Regulatory provisions: [44 FR 22367, Apr. 13, 1979] Federal Register04www.govinfo.gov.For citations affecting § 16.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at

After any final administrative action that is the subject of a hearing under this part, any party may petition the Commissioner for reconsideration of any part or all of the decision or action under § 10.33 or may petition for a stay of the decision or action under § 10.35. [44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]

Section 10.45 governs the availability of judicial review concerning any regulatory action which is the subject of a hearing under this part

(a) A regulatory hearing is initiated by a notice of opportunity for hearing from FDA. The notice will— (1) Be sent by mail, telegram, telex, personal delivery, or any other mode of written communication; (2) Specify the facts and the action that are the subject of the opportunity for a hearing; (3) State that the notice of opportunity for hearing and the hearing are governed by this part; and (4) State the time within which a hearing may be requested, and state the name, address, and telephone number of the FDA employee to whom any request for hearing is to be addressed. (5) Refer to FDA's guideline on electronic media coverage of its administrative proceedings (21 CFR part 10, subpart C). (b) A person offered an opportunity for a hearing has the amount of time specified in the notice, which may not be less than 3 working days after receipt of the notice, within which to request a hearing. The request may be filed by mail, telegram, telex, personal delivery, or any other mode of written communication, addressed to the designated FDA employee. If no response is filed within that time, the offer is deemed to have been refused and no hearing will be held. (c) If a hearing is…

(a) A regulatory hearing required by the act or a regulation under § 16.1(b) will be initiated in the same manner as other regulatory hearings subject to the additional procedures in this section. (b) [Reserved] (c) The notice will state whether any action concerning the matter that is the subject of the opportunity for hearing is or is not being taken pending the hearing under paragraph (d) of this section. (d) The Commissioner may take such action pending a hearing under this section as the Commissioner concludes is necessary to protect the public health, except where expressly prohibited by statute or regulation. A hearing to consider action already taken, and not stayed by the Commissioner, will be conducted on an expedited basis. (e) The hearing may not be required to be held at a time less than 2 working days after receipt of the request for hearing. (f) Before the hearing, FDA will give to the party requesting the hearing reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the decision or action taken or proposed that is the subject of the hearing and a general summary of the information that will be…

(a) A request for a hearing may be denied, in whole or in part, if the Commissioner or the FDA official to whom authority is delegated to make the final decision on the matter determines that no genuine and substantial issue of fact has been raised by the material submitted. If the Commissioner or his or her delegate determines that a hearing is not justified, written notice of the determination will be given to the parties explaining the reason for denial. (b) After a hearing commences, the presiding officer may issue a summary decision on any issue in the hearing if the presiding officer determines from the material submitted in connection with the hearing, or from matters officially noticed, that there is no genuine and substantial issue of fact respecting that issue. For the purpose of this paragraph, a hearing commences upon the receipt by FDA of a request for hearing submitted under § 16.22(b). (c) The Commissioner or his or her delegate may review any summary decision of the presiding officer issued under paragraph (b) of this section at the request of a party or on the Commissioner's or his or her delegate's own initiative. [53 FR 4615, Feb. 17, 1988, as amended at 69…

Whenever the Commissioner has delegated authority on a matter for which a regulatory hearing is available under this part, the functions of the Commissioner under this part may be performed by any of the officials to whom the authority has been delegated, e.g., a center director. [69 FR 17290, Apr. 2, 2004]

(a) An FDA employee to whom the Commissioner delegates such authority, or any other agency employee designated by an employee to whom such authority is delegated, or, consistent with 5 CFR 930.209(b) or (c), an administrative law judge to whom such authority is delegated, may serve as the presiding officer and conduct a regulatory hearing under this part. (b) In a regulatory hearing required by the act or a regulation, the presiding officer is to be free from bias or prejudice and may not have participated in the investigation or action that is the subject of the hearing or be subordinate to a person, other than the Commissioner, who has participated in such investigation or action. (c)(1) The Commissioner or the delegate under § 16.40 is not precluded by this section from prior participation in the investigation or action that is the subject of the hearing. If there has been prior participation, the Commissioner or the delegate should, if feasible, designate a presiding officer for the hearing who is not a subordinate. Thus, if the Commissioner's authority to make a final decision has been delegated to a center director, the presiding officer may be an official in another…

(a) Regulatory hearings are not subject to the separation of functions rules in § 10.55. (b) Those persons who are directly involved in the investigation or presentation of the position of FDA or any party at a regulatory hearing that is required by the act or a regulation should avoid any off-the-record communication on the matter to the presiding officer or the Commissioner or their advisors if the communication is inconsistent with the requirement of § 16.95(b)(1) that the administrative record be the exclusive record for decision. If any communication of this type occurs, it is to be reduced to writing and made part of the record, and the other party provided an opportunity to respond. (c) A copy of any letter or memorandum of meeting between a participant in the hearing and the presiding officer or the Commissioner, e.g., a response by the presiding officer to a request for a change in the time of the hearing, is to be sent to all participants by the person writing the letter or the memorandum.

(a) This part does not apply to the following: (1) Informal presentation of views before reporting a criminal violation under section 305 of the act and section 5 of the Federal Import Milk Act and § 1210.31. (2) A hearing on a refusal of admission of a food, drug, device, or cosmetic under section 801(a) of the act and § 1.94, or of an electronic product under section 360(a) of the Public Health Service Act and § 1005.20. (3) Factory inspections, recalls (except mandatory recalls of medical devices intended for human use), regulatory letters, and similar compliance activities related to law enforcement. (4) A hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and §§ 101.17(h) and 115.50 of this chapter. (5) A hearing on an order for diversion or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264), and § 118.12 of this chapter. (b) If a regulation provides a person with an opportunity for hearing and specifies some procedures for the hearing but not a comprehensive set of procedures, the procedures in this part apply to the extent that they are…

(a) A regulatory hearing is public, except when the Commissioner determines that all or part of a hearing should be closed to prevent a clearly unwarranted invasion of personal privacy; to prevent the disclosure of a trade secret or confidential commercial or financial information that is not available for public disclosure under § 20.61; or to protect investigatory records complied for law enforcement purposes that are not available for public disclosure under § 20.64. (1) The Commissioner may determine that a regulatory hearing is closed either on the Commissioner's initiative or on a request by the party asking for a regulatory hearing, in the request for the hearing. (2) If the hearing is a private hearing, no persons other than the party requesting the hearing, counsel and witnesses, and an employee or consultant or other person subject to a commercial arrangement as defined in § 20.81(a) and FDA representatives with a direct professional interest in the subject matter of the proceeding are entitled to attend. (b) A regulatory hearing will be conducted by a presiding officer. Employees of FDA will first give a full and complete statement of the action which is the subject…

Any party to a hearing under this part has the right at all times to be advised and accompanied by counsel.

(a) The administrative record of the regulatory hearing consists of the following: (1) The notice of opportunity for hearing and the response. (2) All written information and views submitted to the presiding officer at the hearing or after if specifically permitted by the presiding officer. (3) Any transcript of the hearing. (4) The presiding officer's report of the hearing and comments on the report under § 16.60(e). (5) All letters and memoranda of meetings or communications between participants and the presiding officer or the Commissioner referred to in § 16.44(c). (b) The record of the regulatory hearing is closed to the submission of information and views, at the close of the hearing, unless the presiding officer specifically permits additional time for a further submission.

Part 20 governs the availability for public disclosure of each document that is a part of the administrative record of a regulatory hearing.

(a) With respect to a regulatory hearing at the Commissioner's initiative under § 16.1(a), the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form. (b) With respect to a regulatory hearing required by the act or a regulation under § 16.1(b)— (1) The administrative record of the hearing specified in § 16.80(a) constitutes the exclusive record for decision; (2) On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record; and (3) For purposes of judicial review under § 10.45, the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision.