Civil money penalties hearings (21 CFR 17.1-17.54)

233 Food and Drug Administration, HHS § 17.1 § 16.85 Examination of administrative record. Part 20 governs the availability for public disclosure of each document that is a part of the administrative record of a regulatory hearing. § 16.95 Administrative decision and record for decision. (a) With respect to a regulatory hear ing at the Commissioner’s initiative under § 16.1(a), the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) to gether with all other relevant informa tion and views available to FDA in de termining whether regulatory action should be taken and, if so, in what form. (b) With respect to a regulatory hear ing required by the act or a regulation under § 16.1(b)— (1) The administrative record of the hearing specified in § 16.80(a) con stitutes the exclusive record for deci sion; (2) On the basis of the administrative record of the hearing, the Commis sioner shall issue a written decision stating the reasons for the Commis sioner’s administrative action and the basis in the record; and (3) For purposes of judicial review under § 10.45, the record of the adminis trative proceeding consists of the record of the hearing and the Commis sioner’s decision. Subpart F—Reconsideration and Stay § 16.119 Reconsideration and stay of action. 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] Subpart G—Judicial Review § 16.120 Judicial review. Section 10.45 governs the availability of judicial review concerning any regu latory action which is the subject of a hearing under this part PART 17—CIVIL MONEY PENALTIES HEARINGS Sec. 17.1 Scope. 17.2 Maximum penalty amounts. 17.3 Definitions. 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. AUTHORITY: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c, 360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa–28; 5 U.S.C. 554, 555, 556, 557. 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. § 17.1 Scope. This part sets forth practices and procedures for hearings concerning the administrative imposition of civil money penalties by FDA. Listed below are the statutory provisions that au thorize civil money penalties that are governed by these procedures. (a) Section 303(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00243 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 234 21 CFR Ch. I (4–1–16 Edition) § 17.2 (the act) authorizing civil money pen alties for certain violations of the act that relate to prescription drug mar keting practices. (b) Section 303(f)(1) of the act author izing civil money penalties for certain violations of the act that relate to medical devices and section 303(f)(2) of the act authorizing civil money pen alties for certain violations of the act that relate to pesticide residues. (c) Section 303(f)(3) of the act author izing civil money penalties for certain violations relating to the submission of certifications and/or clinical trial in formation to the clinical trial data bank and section 303(f)(4) of the act au thorizing civil money penalties for cer tain violations of the act relating to postmarket studies, clinical trial re quirements, and risk evaluation and mitigation strategies for drugs. (d) Section 303(g)(1) of the act author izing civil money penalties for certain violations of the act that relate to dis semination of direct-to-consumer ad vertisements for approved drugs or bio logical products. (e) Section 307 of the act authorizing civil money penalties for certain ac tions in connection with an abbre viated 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 author izing 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) au thorizing civil money penalties for vio lations 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 pen alties 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, fal sifying, or concealing any record or re port required to be prepared, main tained, or submitted by vaccine manu facturers under section 2128 of the PHS Act. (j) Section 303(f) of the act author izing civil money penalties for any per son who violates a requirement of the Family Smoking Prevention and To bacco Control Act which relates to to bacco products. [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] § 17.2 Maximum penalty amounts. The following table shows maximum civil monetary penalties associated with the statutory provisions authorizing civil monetary penalties under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act. CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS U.S.C. Section Former maximum penalty amount (in dollars) Assessment method Date of last penalty figure or adjust ment Adjusted maximum penalty amount (in dollars) 21 U.S.C. 333(b)(2)(A) ....... 60,000 ....................... For each of the first two violations in any 10-year period. 2013 ...................... 65,000. 333(b)(2)(B) ....... 1,200,000 .................. For each violation after the second conviction in any 10-year period. 2013 ...................... 1,275,000. 333(b)(3) ............ 120,000 ..................... Per violation ..................................... 2013 ...................... 130,000. 333(f)(1)(A) ........ 16,500 ....................... Per violation ..................................... 2008 ...................... 16,500 (not adjusted). 333(f)(1)(A) ........ 1,200,000 .................. For the aggregate of violations ........ 2013 ...................... 1,275,000. 333(f)(2)(A) ........ 55,000 ....................... Per individual ................................... 2013 ...................... 60,000. 333(f)(2)(A) ........ 300,000 ..................... Per ‘‘any other person’’ .................... 2013 ...................... 325,000. 333(f)(2)(A) ........ 600,000 ..................... For all violations adjudicated in a single proceeding. 2013 ...................... 650,000. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00244 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 235 Food and Drug Administration, HHS § 17.2 CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS—Continued U.S.C. Section Former maximum penalty amount (in dollars) Assessment method Date of last penalty figure or adjust ment Adjusted maximum penalty amount (in dollars) 333(f)(3)(A) ........ 10,000 ....................... For all violations adjudicated in a single proceeding. 2013 ...................... 11,000. 333(f)(3)(B) ........ 10,000 ....................... For each day the violation is not corrected after a 30-day period following notification until the vio lation is corrected. 2013 ...................... 11,000. 333(f)(4)(A)(i) ..... 250,000 ..................... Per violation ..................................... 2013 ...................... 275,000. 333(f)(4)(A)(i) ..... 1,000,000 .................. For all violations adjudicated in a single proceeding. 2013 ...................... 1,075,000. 333(f)(4)(A)(ii) .... 250,000 ..................... For the first 30-day period (or any portion thereof) of continued vio lation following notification. 2013 ...................... 275,000. 333(f)(4)(A)(ii) .... 1,000,000 .................. For any 30-day period, where the amount doubles for every 30-day period of continued violation after the first 30-day violation. 2013 ...................... 1,075,000. 333(f)(4)(A)(ii) .... 10,000,000 ................ For all violations adjudicated in a single proceeding. 2013 ...................... 10,850,000. 333(f)(9)(A) ........ 15,000 ....................... Per violation ..................................... 2009 ...................... 15,000 (not adjusted). 333(f)(9)(A) ........ 1,000,000 .................. For all violations adjudicated in a single proceeding. 2013 ...................... 1,050,000. 333(f)(9)(B)(i)(I) .. 250,000 ..................... Per violation ..................................... 2013 ...................... 275,000. 333(f)(9)(B)(i)(I) .. 1,000,000 .................. For all violations adjudicated in a single proceeding. 2013 ...................... 1,050,000. 333(f)(9)(B)(i)(II) 250,000 ..................... For the first 30-day period (or any portion thereof) of continued vio lation following notification. 2013 ...................... 275,000. 333(f)(9)(B)(i)(II) 1,000,000 .................. For any 30-day period, where the amount doubles for every 30-day period of continued violation after the first 30-day violation. 2013 ...................... 1,050,000. 333(f)(9)(B)(i)(II) 10,000,000 ................ For all violations adjudicated in a single proceeding. 2013 ...................... 10,525,000. 333(f)(9)(B)(ii)(I) 250,000 ..................... Per violation ..................................... 2013 ...................... 275,000. 333(f)(9)(B)(ii)(I) 1,000,000 .................. For all violations adjudicated in a single proceeding. 2013 ...................... 1,050,000. 333(f)(9)(B)(ii)(II) 250,000 ..................... For the first 30-day period (or any portion thereof) of continued vio lation following notification. 2013 ...................... 275,000. 333(f)(9)(B)(ii)(II) 1,000,000 .................. For any 30-day period, where the amount doubles for every 30-day period of continued violation after the first 30-day violation. 2013 ...................... 1,050,000. 333(f)(9)(B)(ii)(II) 10,000,000 ................ For all violations adjudicated in a single proceeding. 2013 ...................... 10,525,000. 333(g)(1) ............ 250,000 ..................... For the first violation in any 3-year period. 2013 ...................... 275,000. 333(g)(1) ............ 500,000 ..................... For each subsequent violation in any 3-year period. 2013 ...................... 550,000. 333 note ............. 250 ............................ For the second violation (following a first violation with a warning) with in a 12-month period by a retailer with an approved training pro gram. 2009 ...................... 250 (not adjusted). 333 note ............. 500 ............................ For the third violation within a 24 month period by a retailer with an approved training program. 2009 ...................... 500 (not adjusted). 333 note ............. 2,000 ......................... For the fourth violation within a 24 month period by a retailer with an approved training program. 2009 ...................... 2,000 (not adjusted). 333 note ............. 5,000 ......................... For the fifth violation within a 36 month period by a retailer with an approved training program. 2009 ...................... 5,000 (not adjusted). 333 note ............. 10,000 ....................... For the sixth or subsequent violation within a 48-month period by a re tailer with an approved training program. 2013 ...................... 11,000. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00245 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 236 21 CFR Ch. I (4–1–16 Edition) § 17.3 CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS—Continued U.S.C. Section Former maximum penalty amount (in dollars) Assessment method Date of last penalty figure or adjust ment Adjusted maximum penalty amount (in dollars) 333 note ............. 250 ............................ For the first violation by a retailer without an approved training pro gram. 2009 ...................... 250 (not adjusted). 333 note ............. 500 ............................ For the second violation within a 12 month period by a retailer without an approved training program. 2009 ...................... 500 (not adjusted). 333 note ............. 1,000 ......................... For the third violation within a 24 month period by a retailer without an approved training program. 2013 ...................... 1,100. 333 note ............. 2,000 ......................... For the fourth violation within a 24 month period by a retailer without an approved training program. 2009 ...................... 2,000 (not adjusted). 333 note ............. 5,000 ......................... For the fifth violation within a 36 month period by a retailer without an approved training program. 2009 ...................... 5,000 (not adjusted). 333 note ............. 10,000 ....................... For the sixth or subsequent violation within a 48-month period by a re tailer without an approved training program. 2013 ...................... 11,000. 335b(a) .............. 300,000 ..................... Per violation for an individual .......... 2013 ...................... 325,000. 335b(a) .............. 1,200,000 .................. Per violation for ‘‘any other person’’ 2013 ...................... 1,275,000. 360pp(b)(1) ........ 1,100 ......................... Per violation per person .................. 2008 ...................... 1,100 (not adjusted). 360pp(b)(1) ........ 355,000 ..................... For any related series of violations 2013 ...................... 375,000. 42 U.S.C. 263b(h)(3) .......... 11,000 ....................... Per violation ..................................... 2008 ...................... 11,000 (not adjusted). 300aa–28(b)(1) .. 120,000 ..................... Per occurrence ................................ 2013 ...................... 130,000. [79 FR 6090, Feb. 3, 2014] § 17.3 Definitions. The following definitions are applica ble in this part: (a) For specific acts giving rise to civil money penalty actions brought under 21 U.S.C. 333(g)(1): (1) Significant departure, for the pur pose of interpreting 21 U.S.C. 333(g)(1)(B)(i), means a departure from requirements that is either a single major incident or a series of incidents that collectively are consequential. (2) Knowing departure, for the pur poses of interpreting 21 U.S.C. 333(g)(1)(B)(i), means a departure from a requirement taken: (a) With actual knowledge that the action is such a de parture, or (b) in deliberate ignorance of a requirement, or (c) in reckless dis regard of a requirement. (3) Minor violations, for the purposes of interpreting 21 U.S.C. 333(g)(1)(B)(ii), means departures from requirements that do not rise to a level of a single major incident or a series of incidents that are collectively consequential. (4) Defective, for the purposes of inter preting 21 U.S.C. 333(g)(1)(B)(iii), in cludes any defect in performance, man ufacture, construction, components, materials, specifications, design, in stallation, maintenance, or service of a device, or any defect in mechanical, physical, or chemical properties of a device. (b) Person or respondent includes an individual, partnership, corporation, association, scientific or academic es tablishment, government agency or or ganizational unit thereof, or other legal entity, or as may be defined in the act or regulation pertinent to the civil penalty action being brought. (c) Presiding officer means an admin istrative law judge qualified under 5 U.S.C. 3105. (d) Any term that is defined in the act has the same definition for civil money penalty actions that may be brought under that act. (e) Any term that is defined in Title 21 of the Code of Federal Regulations VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00246 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 237 Food and Drug Administration, HHS § 17.9 has the same definition for civil money penalty actions that may arise from the application of the regulation(s). (f) Any term that is defined in the PHS Act has the same definition for civil money penalty actions that may be brought under that act. (g) Departmental Appeals Board (DAB) means the Departmental Appeals Board of the Department of Health and Human Services. § 17.5 Complaint. (a) The Center with principal juris diction over the matter involved shall begin all administrative civil money penalty actions by serving on the re spondent(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 Division of Dockets Management (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. (b) The complaint shall state: (1) The allegations of liability against the respondent, including the statutory basis for liability, the identi fication of violations that are the basis for the alleged liability, and the rea sons that the respondent is responsible for the violations; (2) The amount of penalties and as sessments that the Center is seeking; (3) Instructions for filing an answer to request a hearing, including a spe cific statement of the respondent’s right to request a hearing by filing an answer and to retain counsel to rep resent the respondent; and (4) That failure to file an answer within 30 days of service of the com plaint will result in the imposition of the proposed amount of penalties and assessments, as provided in § 17.11. (c) The Center may, on motion, sub sequently amend its complaint to con form with the evidence adduced during the administrative process, as justice may require. (d) The presiding officer will be as signed 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] § 17.7 Service of complaint. (a) Service of a complaint may be made by: (1) Certified or registered mail or similar mail delivery service with a re turn receipt record reflecting receipt; or (2) Delivery in person to: (i) An individual respondent; or (ii) An officer or managing or general agent in the case of a corporation or unincorporated business. (b) Proof of service, stating the name and address of the person on whom the complaint was served, and the manner and date of service, may be made by: (1) Affidavit or declaration under penalty of perjury of the individual serving the complaint by personal de livery; (2) A United States Postal Service or similar mail delivery service return re ceipt record reflecting receipt; or (3) Written acknowledgment of re ceipt by the respondent or by the re spondent’s counsel or authorized rep resentative or agent. § 17.9 Answer. (a) The respondent may request a hearing by filing an answer with the Division of Dockets Management (HFA–305), Food and Drug Administra tion, 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852, within 30 days of serv ice of the complaint. Unless stated oth erwise, 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 admit ted; (2) Shall state all defenses on which the respondent intends to rely; (3) Shall state all reasons why the re spondent 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, be fore the expiration of 30 days from service of the complaint, file a request VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00247 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 238 21 CFR Ch. I (4–1–16 Edition) § 17.11 for an extension of time within which to file an answer that meets the re quirements of paragraph (b) of this sec tion. The presiding officer may, for good cause shown, grant the respond ent 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. § 17.11 Default upon failure to file an answer. (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, impos ing: (1) The maximum amount of pen alties provided for by law for the viola tions alleged; or (2) The amount asked for in the com plaint, 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 assess ments 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 cir cumstances excusing the failure to file an answer in a timely manner, the pre siding officer may withdraw the deci sion under paragraph (a) of this sec tion, if such a decision has been issued, and shall grant the respondent an op portunity 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 ex cused, he or she shall affirm the deci sion under paragraph (a) of this sec tion, and the decision shall become final and binding upon the parties 30 days after the presiding officer issues the decision on the respondent’s mo tion filed under paragraph (c) of this section. § 17.13 Notice of hearing. 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 pre hearing 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 tele phone numbers of the representatives of the government and of the respond ent, if any; and (e) Such other matters as the Center or the presiding officer deems appro priate. § 17.15 Parties to the hearing. (a) The parties to the hearing shall be the respondent and the Center(s) with jurisdiction over the matter at issue. No other person may participate. (b) The parties may at any time prior to a final decision by the entity decid ing any appeal agree to a settlement of all or a part of the matter. The settle ment agreement shall be filed in the docket and shall constitute complete or partial resolution of the administra tive case as so designated by the settle ment agreement. The settlement docu ment shall be effective upon filing in the docket and need not be ratified by the presiding officer or the Commis sioner of Food and Drugs. (c) The parties may be represented by counsel, who may be present at the hearing. § 17.17 Summary decisions. (a) At any time after the filing of a complaint, a party may move, with or without supporting affidavits (which, for purposes of this part, shall include VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00248 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 239 Food and Drug Administration, HHS § 17.19 declarations under penalty of perjury), for a summary decision on any issue in the hearing. The other party may, within 30 days after service of the mo tion, which may be extended for an ad ditional 10 days for good cause, serve opposing affidavits or countermove for summary decision. The presiding officer may set the matter for argument and call for the submission of briefs. (b) The presiding officer shall grant the motion if the pleadings, affidavits, and other material filed in the record, or matters officially noticed, show that there is no genuine issue as to any ma terial fact and that the party is enti tled to summary decision as a matter of law. (c) Affidavits shall set forth only such facts as would be admissible in evidence and shall show affirmatively that the affiant is competent to testify to the matters stated. When a motion for summary decision is made and sup ported as provided in this regulation, a party opposing the motion may not rest on mere allegations or denials or general descriptions of positions and contentions; affidavits or other re sponses must set forth specific facts showing that there is a genuine issue of material fact for the hearing. (d) If, on motion under this section, a summary decision is not rendered on all issues or for all the relief asked, and if additional facts need to be developed, the presiding officer will issue an order specifying the facts that appear with out substantial controversy and direct ing further evidentiary proceedings on facts still at issue. The facts specified not to be at issue shall be deemed es tablished. (e) Except as provided in § 17.18, a party may not obtain interlocutory re view by the entity deciding the appeal (currently the DAB) of a partial sum mary decision of the presiding officer. A review of final summary decisions on all issues may be had through the pro cedure set forth in § 17.47. § 17.18 Interlocutory appeal from rul ing of presiding officer. (a) Except as provided in paragraph (b) of this section, rulings of the pre siding officer may not be appealed be fore consideration on appeal of the en tire 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 cer tifies on the record or in writing that immediate review is necessary to pre vent exceptional delay, expense, or prejudice to any participant, or sub stantial harm to the public interest. (c) When an interlocutory appeal is made, a participant may file a brief on the appeal only if specifically author ized by the presiding officer or the en tity 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 opposi tion, within the period allowed by the entity deciding the appeal (currently the DAB). The deadline for filing an in terlocutory appeal is subject to the dis cretion of the presiding officer. § 17.19 Authority of the presiding offi cer. (a) The presiding officer shall con duct a fair and impartial hearing, avoid delay, maintain order, and assure that a record of the proceeding is made. (b) The presiding officer has the au thority 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 con ferences for settlement, to identify or simplify the issues, or to consider other matters that may aid in the ex peditious disposition of the proceeding; (4) Administer oaths and affirma tions; (5) Issue subpoenas requiring the at tendance and testimony of witnesses and the production of evidence that re lates to the matter under investiga tion; (6) Rule on motions and other proce dural matters; (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; VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00249 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 240 21 CFR Ch. I (4–1–16 Edition) § 17.20 (9) Examine witnesses; (10) Upon motion of a party for good cause shown, the presiding officer may allow a witness to be recalled for addi tional testimony; (11) Receive, rule on, exclude, or limit evidence; (12) Upon motion of a party or on the presiding officer’s own motion, take of ficial 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, argu ment, 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 preju diced, 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 respon sibilities of the presiding officer under this part. (c) The presiding officer does not have the authority to find Federal statutes or regulations invalid. § 17.20 Ex parte contacts. No party or person (except employees of the presiding officer’s office) shall communicate in any way with the pre siding officer on any matter at issue in a case, unless on notice and oppor tunity for all parties to participate. This provision does not prohibit a per son or party from inquiring about the status of a case or asking routine ques tions concerning administrative func tions or procedures. § 17.21 Prehearing conferences. (a) The presiding officer may sched ule prehearing conferences as appro priate. (b) Upon the motion of any party, the presiding officer shall schedule at least one prehearing conference at a reason able time in advance of the hearing. (c) The presiding officer may use a prehearing conference to discuss the following: (1) Simplification of the issues; (2) The necessity or desirability of amendments to the pleadings, includ ing the need for a more definite state ment; (3) Stipulations and admissions of fact as to the contents and authen ticity of documents; (4) Whether the parties can agree to submission of the case on a stipulated record; (5) Whether a party chooses to waive appearance at an oral hearing and to submit only documentary evidence (subject to the objection of the other party) and written argument; (6) Limitation of the number of wit nesses; (7) Scheduling dates for the exchange of witness lists and of proposed exhib its; (8) Discovery and scheduling dates for completion of discovery; (9) The date, time, and place for the hearing; and (10) Such other matters as may tend to expedite the fair and just disposition of the proceedings. (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 con ference. § 17.23 Discovery. (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. Doc uments 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, pa pers 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 re questing party. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00250 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 241 Food and Drug Administration, HHS § 17.27 (c) Requests for documents, requests for admissions, written interrogatories, depositions, and any forms of dis covery, other than those permitted under paragraphs (a) and (e) of this sec tion, 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 protec tive 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 (iii) Seeks privileged information. (3) The burden of showing that a pro tective order is necessary shall be on the party seeking the order. (4) The burden of showing that docu ments 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 evi dence may otherwise not be preserved for presentation by a witness at the hearing. § 17.25 Exchange of witness lists, wit ness statements, and exhibits. (a) At least 30 days before the hear ing, or by such other time as is speci fied by the presiding officer, the par ties shall exchange witness lists, copies of prior written statements of proposed witnesses, and copies of proposed hear ing exhibits, including written testi mony. (b)(1) If a party objects to the pro posed admission of evidence not ex changed 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. (2) Unless the presiding officer finds that extraordinary circumstances jus tified the failure to make a timely ex change of witness lists under paragraph (a) of this section, he or she must ex clude from the party’s hearing evidence the testimony of any witness whose name does not appear on the witness list. (3) If the presiding officer finds that extraordinary circumstances existed, the presiding officer must then deter mine whether the admission of the tes timony of any witness whose name does not appear on the witness lists ex changed under paragraph (a) of this section would cause substantial preju dice to the objecting party. If the pre siding officer finds that there is not substantial prejudice, the evidence may be admitted. If the presiding offi cer finds that there is substantial prej udice, the presiding officer may ex clude the evidence, or at his or her dis cretion, may postpone the hearing for such time as is necessary for the ob jecting party to prepare and respond to the evidence. (c) Unless a party objects within 5 days prior to the hearing, documents exchanged in accordance with para graph (a) of this section will be deemed to be authentic for the purpose of ad missibility at the hearing. § 17.27 Hearing subpoenas. (a) A party wishing to procure the appearance and testimony of any indi vidual at the hearing may, when au thorized by law, request that the pre siding officer issue a subpoena. (b) A subpoena requiring the attend ance and testimony of an individual may also require the individual to produce documents at the hearing. (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 show ing 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 par ticularity to permit such witnesses to be found. (d) The subpoena shall specify the time and place at which the witness is to appear and any documents the wit ness is to produce. (e) The party seeking the subpoena shall serve it in the manner prescribed for service of a complaint in § 17.7. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00251 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 242 21 CFR Ch. I (4–1–16 Edition) § 17.28 (f) If a party or the individual to whom the subpoena is directed believes a subpoena to be unreasonable, oppres sive, excessive in scope, or unduly bur densome, 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 com pliance if it is less than 10 days after service. Such a filing will state the basis for the motion to quash. The pre siding officer may quash or modify the subpoena or order it implemented, as justice may require. § 17.28 Protective order. (a) A party or a prospective witness may file a motion for a protective order with respect to discovery sought by a party or with respect to the hear ing, seeking to limit the availability or disclosure of evidence. (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 commer cial information, as defined in § 20.61 of this chapter, information the disclo sure of which would constitute a clear ly unwarranted invasion of personal privacy, or other information that would be withheld from public disclo sure under 21 CFR part 20. Such orders may include, but are not limited to, one or more of the following: (1) That the discovery not be had; (2) That the discovery may be had only on specified terms and conditions, including a designation of the time or place; (3) That the discovery may be had only through a method of discovery provided for by this part other than that requested; (4) That certain matters not be in quired into, or that the scope of dis covery be limited to certain matters; (5) That the contents of discovery or evidence be sealed; (6) That the information not be dis closed to the public or be disclosed only in a designated way; or (7) That the parties simultaneously file specified documents or information enclosed in sealed envelopes to be opened as directed by the presiding of ficer. § 17.29 Fees. The party requesting a subpoena shall pay the cost of the fees and mile age 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 wit ness fees and mileage shall accompany the subpoena when served. § 17.30 Computation of time. (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 in cludes 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 Satur days, Sundays, and Federal holidays shall be excluded from the computa tion. (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. § 17.31 Form, filing, and service of pa pers. (a) Form. (1) Documents filed with the Division of Dockets Management (HFA–305), Food and Drug Administra tion, 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852, shall include an origi nal 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 as signed by the Office of the Chief Coun sel, and designation of the pleading or paper (e.g., ‘‘motion to quash sub poena’’). (3) Every pleading shall be signed by, and shall contain the address and tele phone number of, the party or the per son 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 Di vision of Dockets Management. (b) Service. A party filing a document with the Division of Dockets Manage ment under this part shall, no later VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00252 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 243 Food and Drug Administration, HHS § 17.35 than the time of filing, serve a copy of such document on every other party. Service upon any party of any docu ment, other than service of a com plaint, 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, post age prepaid and addressed, to the par ty’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. § 17.32 Motions. (a) Any application to the presiding officer for an order or ruling shall be by motion. Motions shall state the re lief sought, the authority relied upon, and the facts alleged, and shall be filed with the Division of Dockets Manage ment (HFA–305), Food and Drug Ad ministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, delivered to the presiding officer, and served on all other parties. (b) Except for motions made during a prehearing conference or at the hear ing, all motions shall be in writing. The presiding officer may require that oral motions be reduced to writing. (c) Within 15 days after a written mo tion is served, or such other time as may be fixed by the presiding officer, any party may file a response to such motion. (d) The presiding officer may not grant a written motion before the time for filing responses thereto has expired, except upon consent of the parties or following a hearing on the motion, but may overrule or deny such motion without awaiting a response. § 17.33 The hearing and burden of proof. (a) The presiding officer shall con duct a hearing on the record to deter mine whether the respondent is liable for a civil money penalty and, if so, the appropriate amount of any such civil money penalty considering any aggra vating or mitigating factors. (b) In order to prevail, the Center must prove respondent’s liability and the appropriateness of the penalty under the applicable statute by a pre ponderance of the evidence. (c) The respondent must prove any affirmative defenses and any miti gating factors by a preponderance of the evidence. (d) The hearing shall be open to the public unless otherwise ordered by the presiding officer, who may order clo sure only to protect trade secrets or confidential commercial information, as defined in § 20.61 of this chapter, in formation 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. § 17.34 Determining the amount of penalties and assessments. (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 viola tion and shall articulate in their opin ions the reasons that support the pen alties and assessments imposed. (b) The presiding officer and the enti ty deciding the appeal shall refer to the factors identified in the statute under which the penalty is assessed for pur poses 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 aggra vate the offense for which penalties and assessments are imposed. § 17.35 Sanctions. (a) The presiding officer may sanc tion a person, including any party or counsel for: (1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding; (2) Failing to prosecute or defend an action; or VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00253 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 244 21 CFR Ch. I (4–1–16 Edition) § 17.37 (3) Engaging in other misconduct that interferes with the speedy, or derly, or fair conduct of the hearing. (b) Any such sanction, including, but not limited to, those listed in para graphs (c), (d), and (e) of this section, shall reasonably relate to the severity and nature of the failure or mis conduct. (c) When a party fails to comply with a discovery order, including discovery and subpoena provisions of this part, the presiding officer may: (1) Draw an inference in favor of the requesting party with regard to the in formation sought; (2) Prohibit the party failing to com ply with such order from introducing evidence concerning, or otherwise rely ing upon, testimony relating to the in formation sought; and (3) Strike any part of the pleadings or other submissions of the party fail ing to comply with such request. (d) The presiding officer may exclude from participation in the hearing any legal counsel, party, or witness who re fuses to obey an order of the presiding officer. In the case of repeated refusal, the presiding officer may grant judg ment to the opposing party. (e) If a party fails to prosecute or de fend an action under this part after service of a notice of hearing, the pre siding 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, re sponse, brief, or other document that is not filed in a timely fashion or in com pliance with the rules of this part. (g) Sanctions imposed under this sec tion may be the subject of an inter locutory appeal as allowed in § 17.18(b), provided that no such appeal will stay or delay a proceeding. § 17.37 Witnesses. (a) Except as provided in paragraph (b) of this section, testimony at the hearing shall be given orally by wit nesses under oath or affirmation. (b) Direct testimony shall be admit ted 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 wit nesses proposed to testify at the hear ing shall be exchanged as provided in § 17.25(a). (c) The presiding officer shall exer cise reasonable control over the man ner and order of questioning witnesses and presenting evidence so as to: (1) Make the examination and presen tation effective for the ascertainment of the truth; (2) Avoid undue consumption of time; and (3) Protect witnesses from harass ment or undue embarrassment. (d) The presiding officer shall permit the parties to conduct such cross-ex amination as may be required for a full disclosure of the facts. (e) At the discretion of the presiding officer, a witness may be cross-exam ined on relevant matters without re gard to the scope of his or her direct examination. To the extent permitted by the presiding officer, a witness may be cross-examined on relevant matters with regard to the scope of his or her direct examination. To the extent per mitted by the presiding officer, cross examination on matters outside the scope of direct examination shall be conducted in the manner of direct ex amination and may proceed by leading questions only if the witness is a hos tile witness, an adverse party, or a wit ness identified with an adverse party. (f) Upon motion of any party, the presiding officer may order witnesses excluded so that they cannot hear the testimony of the other witnesses. This rule does not authorize exclusion of: (1) A party who is an individual; (2) In the case of a party that is not an individual, an officer or employee of the party designated to be the party’s sole representative for purposes of the hearing; or (3) An individual whose presence is shown by a party to be essential to the presentation of its case, including an individual employed by a party en gaged in assisting counsel for the party. (g) If a witness’ testimony is sub mitted in writing prior to cross-exam ination, the cross-examining party need not subpoena the witness or pay for his or her travel to the hearing. The VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00254 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 245 Food and Drug Administration, HHS § 17.43 sponsoring party is responsible for pro ducing the witness at its own expense, and failure to do so shall result in the striking of the witness’ testimony. § 17.39 Evidence. (a) The presiding officer shall deter mine the admissibility of evidence. (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 unre liable evidence. (c) The presiding officer shall exclude evidence that is not relevant or mate rial. (d) Relevant evidence may be ex cluded if its probative value is substan tially outweighed by the danger of un fair prejudice, confusion of the issues, or by considerations of undue delay or needless presentation of cumulative evidence. (e) Relevant evidence may be ex cluded if it is privileged under Federal law. (f) Evidence of furnishing or offering or promising to furnish, or accepting or offering or promising to accept, a valu able consideration in settling or at tempting to settle a civil money pen alty assessment which was disputed as to either validity or amount, is not ad missible to prove liability for or inva lidity of the civil money penalty or its amount. Evidence of conduct or state ments 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 evi dence. (h) All documents and other evidence offered or taken for the record shall be open to examination by all parties, un less otherwise ordered by the presiding officer pursuant to § 17.28. § 17.41 The administrative record. (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 per mitted only for transcription errors. The presiding officer shall promptly order justified corrections. Transcripts may be obtained following the hearing from the Division of Dockets Manage ment at a cost not to exceed the actual cost of duplication. (b) The transcript of testimony, ex hibits, 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 oth erwise ordered by the presiding officer, who shall upon motion of any party order otherwise when necessary to pro tect trade secrets or confidential com mercial information, as defined in § 20.61 of this chapter, information the disclosure of which would constitute a clearly unwarranted invasion of per sonal privacy, or other information that would be withheld from public dis closure under part 20. § 17.43 Posthearing briefs. Any party may file a posthearing brief. The presiding officer shall fix the time for filing such briefs (which shall be filed simultaneously), which shall not exceed 60 days from the date the parties received the transcript of the hearing or, if applicable, the stipulated record. Such briefs may be accom panied by proposed findings of fact and conclusions of law. The presiding offi cer may permit the parties to file re sponsive briefs. No brief may exceed 30 pages (exclusive of proposed findings and conclusions) unless the presiding officer has previously found that the issues in the proceeding are so com plex, or the administrative record is so voluminous, as to justify longer briefs, in which case the presiding officer may VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00255 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 246 21 CFR Ch. I (4–1–16 Edition) § 17.45 set a longer page limit. Proposed find ings of fact and conclusions of law shall not exceed 30 pages unless the presiding officer has previously found that the issues in the proceeding are so complex, or the administrative record is so voluminous, as to justify longer proposed findings and conclusions, in which case the presiding officer may set a longer page limit. § 17.45 Initial decision. (a) The presiding officer shall issue an initial decision based only on the administrative record. The decision shall contain findings of fact, conclu sions of law, and the amount of any penalties and assessments imposed. (b) The findings of fact shall include a finding on each of the following issues: (1) Whether the allegations in the complaint are true, and, if so, whether respondent’s actions identified in the complaint violated the law; (2) Whether any affirmative defenses are meritorious; and (3) If the respondent is liable for pen alties or assessments, the appropriate amount of any such penalties or assess ments, considering any mitigating or aggravating factors that he or she finds in the case. (c) The presiding officer shall serve the initial decision or the decision granting summary decision on all par ties within 90 days after the time for submission of posthearing briefs and responsive briefs (if permitted) has ex pired. If the presiding officer believes that he or she cannot meet the 90-day deadline, he or she shall notify the Commissioner of Food and Drugs or other entity designated by the Com missioner to decide the appeal of the reason(s) therefor, and the Commis sioner or that entity may then set a new deadline. (d) Unless the initial decision or the decision granting summary decision of the presiding officer is timely ap pealed, the initial decision or the deci sion granting summary decision shall constitute the final decision of FDA and shall be final and binding on the parties 30 days after it is issued by the presiding officer. § 17.47 Appeals. (a) Either the Center or any respond ent may appeal an initial decision, in cluding a decision not to withdraw a default judgment, or a decision grant ing summary decision to the Commis sioner of Food and Drugs or other enti ty the Commissioner designates to de cide the appeal. The Commissioner has currently designated the Departmental Appeals Board (DAB) to decide appeals under this part. Parties may appeal to the DAB by filing a notice of appeal with the DAB, Appellate Division MS6127, Departmental Appeals Board, United States Department of Health and Human Services, 330 Independence Ave. SW., Cohen Bldg., rm. G–644, Washington, DC 20201, and the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, in accordance with this section. (b)(1) A notice of appeal may be filed at any time within 30 days after the presiding officer issues an initial deci sion or decision granting summary de cision. (2) The Commissioner or the entity designated by the Commissioner to hear appeals may, within his or her dis cretion, extend the initial 30-day period for an additional period of time if the Center or any respondent files a re quest for an extension within the ini tial 30-day period and shows good cause. (c) A notice of appeal shall be accom panied by a written brief of no greater length than that allowed for the posthearing brief. The notice must identify specific exceptions to the ini tial decision, must support each excep tion with citations to the record, and must explain the basis for each excep tion. (d) The opposing party may file a brief of no greater length than that al lowed for the posthearing brief in oppo sition to exceptions within 30 days of receiving the notice of appeal and ac companying brief, unless such time pe riod is extended by the Commissioner or the entity designated by the Com missioner to hear appeals on request of the opposing party for good cause VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00256 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 247 Food and Drug Administration, HHS § 17.51 shown. Any brief in opposition to ex ceptions shall be filed with the Divi sion of Dockets Management and the DAB (addresses above). (e) The appellant may file a reply brief not more than 10 pages in length within 10 days of being served with ap pellee’s brief. (f) There is no right to appear person ally before the Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB). (g) The entity deciding the appeal will consider only those issues raised before the presiding officer, except that the appellee may make any argument based on the record in support of the initial decision or decision granting summary decision. (h) If on appeal the entity deciding the appeal considers issues not ade quately briefed by the parties, the enti ty may ask for additional briefing. However, no such additional briefs will be considered unless so requested. (i) If any party demonstrates to the satisfaction of the entity deciding the appeal (currently the DAB) that addi tional evidence not presented at the hearing is relevant and material and that there were reasonable grounds for the failure to adduce such evidence at the hearing, the entity deciding the ap peal may remand the matter to the presiding officer for consideration of the additional evidence. (j) The Commissioner of Food and Drugs or other entity deciding the ap peal (currently the DAB) will issue a decision on the appeal within 60 days, if practicable, of the due date for sub mission of the appellee’s brief. In the decision, the entity deciding the appeal may decline to review the case, affirm the initial decision or decision grant ing summary decision (with or without an opinion), or reverse the initial deci sion or decision granting summary de cision, or increase, reduce, reverse, or remand any civil money penalty deter mined by the presiding officer in the initial decision. If the entity deciding the appeal declines to review the case, the initial decision or the decision granting summary decision shall con stitute the final decision of FDA and shall be final and binding on the par ties 30 days after the declination by the entity deciding the appeal. (k) The standard of review on a dis puted issue of fact is whether the ini tial decision is supported by substan tial evidence on the whole record. The standard of review on a disputed issue of law is whether the initial decision is erroneous. [60 FR 38626, July 27, 1995, as amended at 71 FR 5979, Feb. 6, 2006] § 17.48 Harmless error. 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 pre siding officer or by any of the parties is grounds for vacating, modifying, or otherwise disturbing an otherwise ap propriate ruling or order or act, unless refusal to take such action appears to the presiding officer or the Commis sioner of Food and Drugs or other enti ty deciding the appeal (currently the DAB) to be inconsistent with substan tial 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. § 17.51 Judicial review. (a) The final decision of the Commis sioner of Food and Drugs or other enti ty 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. Al though the filing of a petition for judi cial 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 offi cer on whom copies of petitions for ju dicial review are to be served. This offi cer is responsible for filing the record on which the final decision is based. The record of the proceeding is cer tified by the entity deciding the appeal (currently the DAB). (c) Exhaustion of an appeal to the en tity deciding the appeal (currently the DAB) is a jurisdictional prerequisite to judicial review. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00257 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 248 21 CFR Ch. I (4–1–16 Edition) § 17.54 § 17.54 Deposit in the Treasury of the United States. All amounts assessed pursuant to this part shall be delivered to the Di rector, Division of Financial Manage ment (HFA–100), Food and Drug Ad ministration, rm. 11–61, 5600 Fishers Lane, Rockville, MD 20857, and shall be deposited as miscellaneous receipts in the Treasury of the United States. PART 19—STANDARDS OF CON DUCT AND CONFLICTS OF INTER EST Subpart A—General Provisions Sec. 19.1 Scope. 19.5 Reference to Department regulations. 19.6 Code of ethics for government service. 19.10 Food and Drug Administration Con flict of Interest Review Board. Subpart B—Reporting of Violations 19.21 Duty to report violations. Subpart C—Disqualification Conditions 19.45 Temporary disqualification of former employees. 19.55 Permanent disqualification of former employees. AUTHORITY: 21 U.S.C. 371. SOURCE: 42 FR 15615, Mar. 22, 1977, unless otherwise noted. Subpart A—General Provisions § 19.1 Scope. This part governs the standards of conduct for, and establishes regula tions to prevent conflicts of interest by, all Food and Drug Administration employees. § 19.5 Reference to Department regula tions. (a) The provisions of 45 CFR part 73, establishing standards of conduct for all Department employees, are fully applicable to all Food and Drug Admin istration employees, except that such regulations shall be applicable to spe cial government employees, i.e., con sultants to the Food and Drug Admin istration, only to the extent stated in subpart L of 45 CFR part 73. (b) The provisions of 45 CFR part 73a supplement the Department standards of conduct and apply only to Food and Drug Administration employees except special government employees. § 19.6 Code of ethics for government service. The following code of ethics, adopted by Congress on July 11, 1958, shall apply to all Food and Drug Administra tion employees: CODE OF ETHICS FOR GOVERNMENT SERVICE Any person in Government service should: 1. Put loyalty to the highest moral prin ciples and to country above loyalty to per sons, party, or Government department. 2. Uphold the Constitution, laws, and legal regulations of the United States and of all governments therein and never be a party to their evasion. 3. Give a full day’s labor for a full day’s pay; giving to the performance of his duties his earnest effort and best thought. 4. Seek to find and employ more efficient and economical ways of getting tasks accom plished. 5. Never discriminate unfairly by the dis pensing of special favors or privileges to any one, whether for remuneration or not; and never accept, for himself or his family, fa vors or benefits under circumstances which might be construed by reasonable persons as influencing the performance of his govern mental duties. 6. Make no private promises of any kind binding upon the duties of office, since a Government employee has no private word which can be binding on public duty. 7. Engage in no business with the Govern ment, either directly or indirectly, which is inconsistent with the conscientious perform ance of his governmental duties. 8. Never use any information coming to him confidentially in the performance of governmental duties as a means for making private profit. 9. Expose corruption wherever discovered. 10. Uphold these principles, ever conscious that public office is a public trust. § 19.10 Food and Drug Administration Conflict of Interest Review Board. (a) The Commissioner shall establish a permanent five-member Conflict of Interest Review Board, which shall re view and make recommendations to the Commissioner on all specific or policy matters relating to conflicts of interest arising within the Food and VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00258 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B