Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=pt21.1.17&rgn=div5
Timestamp: 2020-02-25 22:40:11
Document Index: 628383823

Matched Legal Cases: ['art 17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', 'art 17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§17', '§20', 'art 20', '§20', 'art 20', '§17', '§17', '§17', '§20', 'art 20', '§10']

Title 21 → Chapter I → Subchapter A → Part 17
§17.1 Scope.
§17.2 Maximum penalty amounts.
§17.5 Complaint.
§17.7 Service of complaint.
§17.9 Answer.
§17.11 Default upon failure to file an answer.
§17.13 Notice of hearing.
§17.15 Parties to the hearing.
§17.17 Summary decisions.
§17.18 Interlocutory appeal from ruling of presiding officer.
§17.19 Authority of the presiding officer.
§17.20 Ex parte contacts.
§17.21 Prehearing conferences.
§17.23 Discovery.
§17.25 Exchange of witness lists, witness statements, and exhibits.
§17.27 Hearing subpoenas.
§17.28 Protective order.
§17.29 Fees.
§17.30 Computation of time.
§17.31 Form, filing, and service of papers.
§17.32 Motions.
§17.33 The hearing and burden of proof.
§17.34 Determining the amount of penalties and assessments.
§17.35 Sanctions.
§17.37 Witnesses.
§17.39 Evidence.
§17.41 The administrative record.
§17.43 Posthearing briefs.
§17.45 Initial decision.
§17.47 Appeals.
§17.48 Harmless error.
§17.51 Judicial review.
§17.54 Deposit in the Treasury of the United States.
Source: 60 FR 38626, July 27, 1995, unless otherwise noted.
Editorial Note: Nomenclature changes to part 17 appear at 68 FR 24879, May 9, 2003.
(c) Section 303(f)(3) of the act authorizing civil money penalties for certain violations relating to the submission of certifications and/or clinical trial information to the clinical trial data bank and section 303(f)(4) of the act authorizing civil money penalties for certain violations of the act relating to postmarket studies, clinical trial requirements, and risk evaluation and mitigation strategies for drugs.
(d) Section 303(g)(1) of the act authorizing civil money penalties for certain violations of the act that relate to dissemination of direct-to-consumer advertisements for approved drugs or biological products.
(e) Section 307 of the act authorizing civil money penalties for certain actions in connection with an abbreviated new drug application or certain actions in connection with a person or individual debarred under section 306 of the act.
(f) Section 539(b)(1) of the act authorizing civil money penalties for certain violations of the act that relate to electronic products.
(g) Section 351(d)(2) of the Public Health Service Act (the PHS Act) authorizing civil money penalties for violations of biologic recall orders.
(h) Section 354(h)(3) of the PHS Act, as amended by the Mammography Quality Standards Act of 1992 and the Mammography Quality Standards Act of 1998, authorizing civil money penalties for failure to obtain a certificate and failure to comply with established standards, among other things.
(i) Section 2128(b)(1) of the PHS Act authorizing civil money penalties for intentionally destroying, altering, falsifying, or concealing any record or report required to be prepared, maintained, or submitted by vaccine manufacturers under section 2128 of the PHS Act.
[60 FR 38626, July 27, 1995, as amended at 69 FR 43301, July 20, 2004; 73 FR 66752, Nov. 12, 2008; 75 FR 73953, Nov. 30, 2010]
[81 FR 62358, Sept. 9, 2016]
[60 FR 38626, July 27, 1995, as amended at 82 FR 34402, July 25, 2017]
(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.
(d) The presiding officer will be assigned to the case upon the filing of the complaint under this part.
[60 FR 38626, July 27, 1995, as amended at 79 FR 6091, Feb. 3, 2014]
(a) The respondent may request a hearing by filing an answer with the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, within 30 days of service of the complaint. Unless stated otherwise, an answer shall be deemed to be a request for hearing.
(b) In the answer, the respondent:
(1) Shall admit or deny each of the allegations of liability made in the complaint; allegations not specifically denied in an answer are deemed admitted;
(2) Shall state all defenses on which the respondent intends to rely;
(3) Shall state all reasons why the respondent contends that the penalties and assessments should be less than the requested amount; and
(4) Shall state the name, address, and telephone number of the respondent's counsel, if any.
(c) If the respondent is unable to file an answer meeting the requirements of paragraph (b) of this section within the time provided, the respondent shall, before the expiration of 30 days from service of the complaint, file a request for an extension of time within which to file an answer that meets the requirements of paragraph (b) of this section. The presiding officer may, for good cause shown, grant the respondent up to 30 additional days within which to file an answer that meets the requirements of paragraph (b) of this section.
(d) The respondent may, on motion, amend its answer to conform with the evidence as justice may require.
(a) If the respondent does not file an answer within the time prescribed in §17.9 and if service has been effected as provided in §17.7, the presiding officer shall assume the facts alleged in the complaint to be true, and, if such facts establish liability under the relevant statute, the presiding officer shall issue an initial decision within 30 days of the time the answer was due, imposing:
(1) The maximum amount of penalties provided for by law for the violations alleged; or
(2) The amount asked for in the complaint, whichever amount is smaller.
(b) Except as otherwise provided in this section, by failing to file a timely answer, the respondent waives any right to a hearing and to contest the amount of the penalties and assessments imposed under paragraph (a) of this section, and the initial decision shall become final and binding upon the parties 30 days after it is issued.
(c) If, before such a decision becomes final, the respondent files a motion seeking to reopen on the grounds that extraordinary circumstances prevented the respondent from filing an answer, the initial decision shall be stayed pending a decision on the motion.
(d) If, on such motion, the respondent can demonstrate extraordinary circumstances excusing the failure to file an answer in a timely manner, the presiding officer may withdraw the decision under paragraph (a) of this section, if such a decision has been issued, and shall grant the respondent an opportunity to answer the complaint as provided in §17.9(a).
(e) If the presiding officer decides that the respondent's failure to file an answer in a timely manner is not excused, he or she shall affirm the decision under paragraph (a) of this section, and the decision shall become final and binding upon the parties 30 days after the presiding officer issues the decision on the respondent's motion filed under paragraph (c) of this section.
After an answer has been filed, the Center shall serve a notice of hearing on the respondent. Such notice shall include:
(a) The date, time, and place of a prehearing conference, if any, or the date, time, and place of the hearing if there is not to be a prehearing conference;
(b) The nature of the hearing and the legal authority and jurisdiction under which the hearing is to be held;
(c) A description of the procedures for the conduct of the hearing;
(d) The names, addresses, and telephone numbers of the representatives of the government and of the respondent, if any; and
(e) Such other matters as the Center or the presiding officer deems appropriate.
(e) Except as provided in §17.18, a party may not obtain interlocutory review by the entity deciding the appeal (currently the DAB) of a partial summary decision of the presiding officer. A review of final summary decisions on all issues may be had through the procedure set forth in §17.47.
(a) Except as provided in paragraph (b) of this section, rulings of the presiding officer may not be appealed before consideration on appeal of the entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory appeal to the entity deciding the appeal (currently the DAB) if the presiding officer certifies on the record or in writing that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest.
(c) When an interlocutory appeal is made, a participant may file a brief on the appeal only if specifically authorized by the presiding officer or the entity deciding the appeal (currently the DAB), and if such authorization is granted, only within the period allowed by the presiding officer or the entity deciding the appeal. If a participant is authorized to file a brief, any other participant may file a brief in opposition, within the period allowed by the entity deciding the appeal (currently the DAB). The deadline for filing an interlocutory appeal is subject to the discretion of the presiding officer.
(b) The presiding officer has the authority to:
(1) Set and change the date, time, and place of the hearing on reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a reasonable time;
(3) Require parties to attend conferences for settlement, to identify or simplify the issues, or to consider other matters that may aid in the expeditious disposition of the proceeding;
(5) Issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation;
(7) Regulate the scope and timing of discovery consistent with §17.23;
(8) Regulate the course of the hearing and the conduct of the parties;
(10) Upon motion of a party for good cause shown, the presiding officer may allow a witness to be recalled for additional testimony;
(11) Receive, rule on, exclude, or limit evidence;
(12) Upon motion of a party or on the presiding officer's own motion, take official notice of facts;
(13) Upon motion of a party, decide cases, in whole or in part, by summary decision when there is no genuine issue of material fact;
(14) Conduct any conference, argument, or hearing on motions in person or by telephone;
(15) Consolidate related or similar proceedings or sever unrelated matters;
(16) Limit the length of pleadings;
(17) Waive, suspend, or modify any rule in this part if the presiding officer determines that no party will be prejudiced, the ends of justice will be served, and the action is in accordance with law;
(18) Issue protective orders pursuant to §17.28; and
(19) Exercise such other authority as is necessary to carry out the responsibilities of the presiding officer under this part.
(c) The presiding officer does not have the authority to find Federal statutes or regulations invalid.
No party or person (except employees of the presiding officer's office) shall communicate in any way with the presiding officer on any matter at issue in a case, unless on notice and opportunity for all parties to participate. This provision does not prohibit a person or party from inquiring about the status of a case or asking routine questions concerning administrative functions or procedures.
(a) The presiding officer may schedule prehearing conferences as appropriate.
(b) Upon the motion of any party, the presiding officer shall schedule at least one prehearing conference at a reasonable time in advance of the hearing.
(c) The presiding officer may use a prehearing conference to discuss the following:
(8) Discovery and scheduling dates for completion of discovery;
(9) The date, time, and place for the hearing; and
(d) The presiding officer shall issue an order containing all matters agreed upon by the parties or ordered by the presiding officer at a prehearing conference.
(a) No later than 60 days prior to the hearing, unless otherwise ordered by the presiding officer, a party may make a request to another party for production, inspection, and copying of documents that are relevant to the issues before the presiding officer. Documents must be provided no later than 30 days after the request has been made.
(b) For the purpose of this part, the term documents includes information, reports, answers, records, accounts, papers and other data and documentary evidence. Nothing contained in this section may be interpreted to require the creation of a document, except that requested data stored in an electronic data storage system must be produced in a form readily accessible to the requesting party.
(c) Requests for documents, requests for admissions, written interrogatories, depositions, and any forms of discovery, other than those permitted under paragraphs (a) and (e) of this section, are not authorized.
(d)(1) Within 10 days of service of a request for production of documents, a party may file a motion for a protective order.
(2) The presiding officer may grant a motion for a protective order, in whole or in part, if he or she finds that the discovery sought:
(i) Is unduly costly or burdensome,
(ii) Will unduly delay the proceeding, or
(3) The burden of showing that a protective order is necessary shall be on the party seeking the order.
(4) The burden of showing that documents should be produced is on the party seeking their production.
(e) The presiding officer shall order depositions upon oral questions only upon a showing that:
(1) The information sought cannot be obtained by alternative methods, and
(2) There is a substantial reason to believe that relevant and probative evidence may otherwise not be preserved for presentation by a witness at the hearing.
(b)(1) If a party objects to the proposed admission of evidence not exchanged in accordance with paragraph (a) of this section, the presiding officer will exclude such evidence if he or she determines that the failure to comply with paragraph (a) of this section should result in its exclusion.
(a) A party wishing to procure the appearance and testimony of any individual at the hearing may, when authorized by law, request that the presiding officer issue a subpoena.
(c) A party seeking a subpoena shall file a written request therefor not less than 20 days before the date fixed for the hearing unless otherwise allowed by the presiding officer, upon a showing by the party of good cause. Such request shall specify any documents to be produced and shall designate the witnesses and describe the address and location thereof with sufficient particularity to permit such witnesses to be found.
(e) The party seeking the subpoena shall serve it in the manner prescribed for service of a complaint in §17.7.
(f) If a party or the individual to whom the subpoena is directed believes a subpoena to be unreasonable, oppressive, excessive in scope, or unduly burdensome, or if it wishes to raise any other objection or privilege recognized by law, the party or individual may file a motion to quash the subpoena within 10 days after service or on or before the time specified in the subpoena for compliance if it is less than 10 days after service. Such a filing will state the basis for the motion to quash. The presiding officer may quash or modify the subpoena or order it implemented, as justice may require.
(b) When issuing a protective order, the presiding officer may make any order which justice requires to protect a party or person from oppression or undue burden or expense, or to protect trade secrets or confidential commercial information, as defined in §20.61 of this chapter, information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, or other information that would be withheld from public disclosure under 21 CFR part 20. Such orders may include, but are not limited to, one or more of the following:
The party requesting a subpoena shall pay the cost of the fees and mileage of any witness subpoenaed in the amounts that would be payable to a witness in a proceeding in a United States District Court. A check for witness fees and mileage shall accompany the subpoena when served.
(a) In computing any period of time under this part or in an order issued thereunder, the time begins with the day following the act or event, and includes the last day of the period, unless either such day is a Saturday, Sunday, or Federal holiday, in which event the time includes the next business day.
(b) When the period of time allowed is less than 7 days, intermediate Saturdays, Sundays, and Federal holidays shall be excluded from the computation.
(c) When a document has been served or issued by placing it in the mail, an additional 5 days will be added to the time permitted for any response.
(a) Form. (1) Documents filed with the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, shall include an original and two copies.
(2) The first page of every pleading and paper filed in the proceeding shall contain a caption setting forth the title of the action, the case number assigned by the Office of the Chief Counsel, and designation of the pleading or paper (e.g., “motion to quash subpoena”).
(3) Every pleading shall be signed by, and shall contain the address and telephone number of, the party or the person on whose behalf the pleading was filed, or his or her counsel.
(4) Pleadings or papers are considered filed when they are received by the Division of Dockets Management.
(b) Service. A party filing a document with the Division of Dockets Management under this part shall, no later than the time of filing, serve a copy of such document on every other party. Service upon any party of any document, other than service of a complaint, shall be made by delivering a copy personally or by placing a copy of the document in the United States mail or express delivery service, postage prepaid and addressed, to the party's last known address. When a party is represented by counsel, service shall be made on such counsel in lieu of the actual party.
(c) Proof of service. A certificate of the individual serving the document by personal delivery or by mail, setting forth the time and manner of service, shall be proof of service.
(a) Any application to the presiding officer for an order or ruling shall be by motion. Motions shall state the relief sought, the authority relied upon, and the facts alleged, and shall be filed with the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, delivered to the presiding officer, and served on all other parties.
(d) The hearing shall be open to the public unless otherwise ordered by the presiding officer, who may order closure only to protect trade secrets or confidential commercial information, as defined in §20.61 of this chapter, information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, or other information that would be withheld from public disclosure under part 20 of this chapter.
(a) When determining an appropriate amount of civil money penalties and assessments, the presiding officer and the Commissioner of Food and Drugs or entity designated by the Commissioner to decide the appeal (currently the DAB) shall evaluate any circumstances that mitigate or aggravate the violation and shall articulate in their opinions the reasons that support the penalties and assessments imposed.
(b) The presiding officer and the entity deciding the appeal shall refer to the factors identified in the statute under which the penalty is assessed for purposes of determining the amount of penalty.
(c) Nothing in this section shall be construed to limit the presiding officer or the entity deciding the appeal from considering any other factors that in any given case may mitigate or aggravate the offense for which penalties and assessments are imposed.
(a) The presiding officer may sanction a person, including any party or counsel for:
(1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding;
(b) Any such sanction, including, but not limited to, those listed in paragraphs (c), (d), and (e) of this section, shall reasonably relate to the severity and nature of the failure or misconduct.
(c) When a party fails to comply with a discovery order, including discovery and subpoena provisions of this part, the presiding officer may:
(2) Prohibit the party failing to comply with such order from introducing evidence concerning, or otherwise relying upon, testimony relating to the information sought; and
(3) Strike any part of the pleadings or other submissions of the party failing to comply with such request.
(d) The presiding officer may exclude from participation in the hearing any legal counsel, party, or witness who refuses to obey an order of the presiding officer. In the case of repeated refusal, the presiding officer may grant judgment to the opposing party.
(e) If a party fails to prosecute or defend an action under this part after service of a notice of hearing, the presiding officer may dismiss the action or may issue an initial decision imposing penalties and assessments.
(f) The presiding officer may refuse to consider any motion, request, response, brief, or other document that is not filed in a timely fashion or in compliance with the rules of this part.
(g) Sanctions imposed under this section may be the subject of an interlocutory appeal as allowed in §17.18(b), provided that no such appeal will stay or delay a proceeding.
(b) Direct testimony shall be admitted in the form of a written declaration submitted under penalty of perjury. Any such written declaration must be provided to all other parties along with the last known address of the witness. Any prior written statements of witnesses proposed to testify at the hearing shall be exchanged as provided in §17.25(a).
(b) Except as provided in this part, the presiding officer shall not be bound by the “Federal Rules of Evidence.” However, the presiding officer may apply the “Federal Rules of Evidence” when appropriate, e.g., to exclude unreliable evidence.
(c) The presiding officer shall exclude evidence that is not relevant or material.
(d) Relevant evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or by considerations of undue delay or needless presentation of cumulative evidence.
(f) Evidence of furnishing or offering or promising to furnish, or accepting or offering or promising to accept, a valuable consideration in settling or attempting to settle a civil money penalty assessment which was disputed as to either validity or amount, is not admissible to prove liability for or invalidity of the civil money penalty or its amount. Evidence of conduct or statements made in settlement negotiations is likewise not admissible. This rule does not require the exclusion of any evidence otherwise discoverable merely because it is presented in the course of settlement negotiations. This rule also does not require exclusion when the evidence is offered for another purpose, such as proving bias or prejudice of a witness or opposing a contention of undue delay.
(g) The presiding officer may in his or her discretion permit the parties to introduce rebuttal witnesses and evidence.
(h) All documents and other evidence offered or taken for the record shall be open to examination by all parties, unless otherwise ordered by the presiding officer pursuant to §17.28.
(a) The hearing will be recorded and transcribed. Witnesses, participants, and counsel have 30 days from the time the transcript becomes available to propose corrections in the transcript of oral testimony. Corrections are permitted only for transcription errors. The presiding officer shall promptly order justified corrections. Transcripts may be obtained following the hearing from the Division of Dockets Management at a cost not to exceed the actual cost of duplication.
(b) The transcript of testimony, exhibits, and other evidence admitted at the hearing and all papers and requests filed in the proceeding constitute the administrative record for the decision by the presiding officer and the entity designated by the Commissioner of Food and Drugs to decide the appeal, currently the DAB.
(c) The administrative record may be inspected and copied (upon payment of a reasonable fee) by anyone unless otherwise ordered by the presiding officer, who shall upon motion of any party order otherwise when necessary to protect trade secrets or confidential commercial information, as defined in §20.61 of this chapter, information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, or other information that would be withheld from public disclosure under part 20.
(b)(1) A notice of appeal may be filed at any time within 30 days after the presiding officer issues an initial decision or decision granting summary decision.
No error in either the admission or the exclusion of evidence, and no error or defect in any ruling or order or in any act done or omitted by the presiding officer or by any of the parties is grounds for vacating, modifying, or otherwise disturbing an otherwise appropriate ruling or order or act, unless refusal to take such action appears to the presiding officer or the Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB) to be inconsistent with substantial justice. The presiding officer and the entity deciding the appeal at every stage of the proceeding will disregard any error or defect in the proceeding that does not affect the substantial rights of the parties.
(a) The final decision of the Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB) constitutes final agency action from which a respondent may petition for judicial review under the statutes governing the matter involved. Although the filing of a petition for judicial review does not stay a decision under this part, a respondent may file a petition for stay of such decision under §10.35 of this chapter.
(b) The Chief Counsel of FDA has been designated by the Secretary of Health and Human Services as the officer on whom copies of petitions for judicial review are to be served. This officer is responsible for filing the record on which the final decision is based. The record of the proceeding is certified by the entity deciding the appeal (currently the DAB).
(c) Exhaustion of an appeal to the entity deciding the appeal (currently the DAB) is a jurisdictional prerequisite to judicial review.
All amounts assessed pursuant to this part shall be delivered to the Director, Division of Financial Management (HFA-100), Food and Drug Administration, rm. 11-61, 5600 Fishers Lane, Rockville, MD 20857, and shall be deposited as miscellaneous receipts in the Treasury of the United States.