DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Food and Drug Administration 

CFR Part 17 

[Docket No. 91N-90447] 

Civil Money Penalties: Biologics, Drugs, and Medical Devices 

AGENCY: Food and Drug Administration, HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug Administration (FDA) is proposing regulations to establish hearing procedures when a hearing is requested concerning the administrative imposition of civil money penalties by FDA. The proposed rule would implement the civil money penalty provisions of several recent statutes: The National Childhood Vaccine Injury Act of 1986, the Prescription Drug Marketing Act of 1988, the Safe Medical Devices Act of 1990, and the Generic Drug Enforcement Act of 1992. 

DATES: Written comments by July 26, 1993. The agency is proposing that any final rule that may be issued based upon this proposal become effective 30 days following its publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: 
	Alicia Abbott, 
	Regulations Policy and Management Staff (HF-26), 
	Food and Drug Administration, 
	5600 Fishers Lane, 
	Rockville, MD 20857, 
	301-443-3480. 

SUPPLEMENTARY INFORMATION: 

                              I. THE STATUTES 
FDA is proposing regulations governing hearing procedures when a hearing is requested concerning FDA's administrative imposition of civil money penalties under four recently enacted statutes. 
  
    A. The National Childhood Vaccine Injury Act (the NCVIA) 
  On November 14, 1986, the President signed into law the NCVIA (Pub. L. 99-660), which added section 351(d)(2)(B) to the Public Health Service Act (42 U.S.C. 262(d)(2)(B)) (the PHS Act). Section 351(d)(2)(B) of the PHS Act authorizes FDA to impose civil money penalties for violations of biologic recall orders. 
  The NCVIA also added section 2128 to the PHS Act (42 U.S.C. 300aa-28) authorizing the imposition of civil money penalties on vaccine manufacturers that intentionally violate certain recordkeeping and reporting requirements. Authority under this section was redelegated to FDA in the Federal Register of September 16, 1988 (53 FR 36127). 

      B. The Prescription Drug Marketing Act (the PDMA) 
  On April 22, 1988, the President signed into law the PDMA (Pub. L. 100-293), which amended the Federal Food, Drug, and Cosmetic Act (the act). Section 7 of the PDMA added section 303 (b)(2) through (b)(5) of the act (21 U.S.C. 333(b)(2) through (b)(5)), which provide for civil money penalties. The civil money penalties authorized in the PDMA are tied to the conviction of an employee of a manufacturer or distributor for violation of Federal or State law prohibiting the sale, purchase, trade, or the offer to sell, purchase or trade drug samples. 

           C. The Safe Medical Devices Act (the SMDA) 
  On November 28, 1990, the President signed into law the SMDA (Pub. L. 101-629), which amended the act. Section 17 of the SMDA added section 303(f) to the act (21 U.S.C. 333(f)), which authorizes FDA to impose civil money penalties for most violations of the act which relate to medical devices. 

     D. The Generic Drug Enforcement Act of 1992 (the GDEA) 
  On May 13, 1992, the President signed into law the GDEA (Pub. L. 102-282), which also amended the act. Section 3 of the GDEA added section 307(b) to the act (21 U.S.C. 337(b)) which authorizes FDA to impose civil money penalties for certain actions, such as bribing or attempting to bribe any Department of Health and Human Services (DHHS) employee in connection with an abbreviated drug application or knowingly obstructing a DHHS investigation into any drug subject to an application. 
  FDA expects that civil money penalties will be sought where other available remedies of seizure, injunction, or prosecution do not reach the violations in question, do not provide a sufficient deterrent, or are otherwise not the appropriate remedy in a particular case. FDA recognizes that administrative civil money penalties are a new authority for FDA. The agency intends to proceed responsibly in using this authority while at the same time using it effectively to achieve greater compliance with the statutes in question. 
  These proposed procedural regulations are an important step in FDA's efforts to ensure that fair and efficient procedures for civil penalties are in place. The SMDA and the GDEA provide considerable detail as to the procedures for administrative 
imposition of civil money penalties. For these statutes, procedural rules are not a prerequisite to FDA's use of the civil money penalty authority, but are desirable nonetheless. Although the NCVIA and the PDMA do not explicitly describe FDA's role in assessing civil money penalties, FDA interprets these acts as giving FDA the authority to impose these penalties administratively subject to judicial review. Alternatively, the agency may elect to seek judicial imposition of civil money penalties, as is appropriate in a particular case. Under both of these acts, FDA is proposing to provide persons against whom FDA initiates a proceeding to assess civil money penalties an opportunity for a hearing as is explicitly provided for in the SMDA and the GDEA. A regulation establishing procedures for the conduct of these hearings is appropriate. 

                           II. Background 
       A. The National Childhood Vaccine Injury Act of 1986 
  The NCVIA simply states that any violation of a biologic recall order ``shall subject the violator to a civil penalty of up to $100,000 per day of violation * * *'' (42 U.S.C. 262(d)(2)(B)). Civil money penalties are the only type of penalties provided for violations of biologic recall orders. There is no maximum penalty that may be imposed. The civil money penalty provision became effective 90 days after the date of enactment.   Similar language on civil money penalties appears in the provisions of the NCVIA for vaccine manufacturers who intentionally destroy, alter, falsify, or conceal a required record or report: such a manufacturer is ``subject to a civil penalty of up to $100,000 per occurrence,'' or to a criminal 
penalty (42 U.S.C. 300aa-28).   The statute does not state the manner in which these civil money penalties are to be imposed, but FDA interprets this statute as enabling the penalties to be administratively imposed.   Because the NCVIA is silent on whether Congress intended civil money penalties to be judicially or administratively imposed, FDA believes that it has the authority to choose which 
it believes best. No court has found that, where Congress is silent on procedures, an agency is prohibited from administratively imposing civil money penalties after according a right to a hearing. See United States v. International Harvester, 387 F. Supp. 1338 (D.D.C. 1979). FDA's interpretation of its authority under the NCVIA, where delegation is implicit rather than explicit, is entitled to judicial deference. Chevron v. NRDC, 467 U.S. 837 (1984). The agency believes that the NCVIA gives FDA the option to pursue either administrative imposition of civil money penalties, followed by a right to seek judicial review of the administrative record, or judicial imposition of the penalties, depending upon which means of imposition of civil money penalties is the most fair and efficient in a particular case. 
  In contrast to the laws FDA is implementing in this proposal, some civil money penalty statutes clearly call only for judicial imposition of penalties. For example, the electronic product radiation provisions in section 539 of the act (21 U.S.C. 360pp) specify that enforcement actions are to be brought in the U.S. district courts. These provisions have been in place since enactment of the Radiation Control for Health and Safety Act of 1968 and are representative of older civil money penalty laws. 

           B. The Prescription Drug Marketing Act of 1987 
  The PDMA provides for civil money penalties upon the conviction of an employee of a manufacturer or distributor for violating Federal or State law prohibiting the sale, purchase, or trade, or the offer to sell, purchase, or trade drug samples. 
  The manufacturer or distributor may also be subject to civil money penalties for failing to report these convictions to the Secretary of Health and Human Services. Upon conviction of its employee(s) the manufacturer or distributor is subject to a civil money penalty of up to $50,000 for each violation for each of the first 2 convictions in any 10-year period and up to $1,000,000 for the third violation in the same 10-year period. In addition, the failure of the manufacturer or distributor to report such convictions to the Secretary of Health and Human Services may subject that manufacturer or distributor to a civil money penalty of up to $100,000.    There are three exceptions to the civil liability of drug manufacturers or distributors whose representatives are convicted of violating the PDMA. First, if the manufacturer or distributor provides information leading to the arrest and conviction of its representative who has violated the PDMA, the manufacturer will not be subject to the civil money penalties authorized. Secondly, the manufacturer or distributor will not be liable for civil money penalties if it can demonstrate by clear and convincing evidence that it was conducting a good faith investigation of the events or transactions which resulted in the arrest and conviction of its employee(s). Finally, in extraordinary circumstances where the drug manufacturer or distributor is making a maximum effort to detect abuses of its sample distribution system and could not reasonably be expected to have detected a violation, it will not be liable for civil money penalties. 
  As with the NCVIA, FDA interprets the PDMA as implicitly authorizing FDA to impose civil money penalties administratively, subject to procedural safeguards as provided in this proposed rule, or to seek judicial imposition of these penalties, as appropriate in the particular case. 

                     C. The Safe Medical Devices Act of 1990 
  While section 303(f) of the act authorizes the imposition of civil money penalties for most violations of the act that concern devices, civil money penalties are not authorized against persons who violate section 519(a) of the act (21 U.S.C. 360i(a)), with respect to recordkeeping and reporting, or section 520(f) of the act (21 U.S.C. 360j(f)), with respect to current good manufacturing practice (CGMP) requirements, unless the violation constitutes a significant and knowing departure from such requirements or a risk to the public health. Civil money penalties also do not apply to any person who commits minor violations of section 519(e) of the act with respect to tracking requirements or section 519(f) of the act with respect to reports of corrections only, if the person demonstrates substantial compliance with these sections. Finally, civil money penalties do not apply to violations of section 501(a)(2)(A) of the act (21 U.S.C. 351(a)(2)(A)) which involve one or more devices that are not defective. Section 501(a)(2)(A) of the act provides that a device, or drug, shall be deemed to be adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health. 
  The civil penalty may not exceed $15,000 for each violation and may not exceed $1,000,000 for all violations adjudicated in a single proceeding. The civil money penalty provisions were effective upon enactment. 
  Section 303(f) of the act provides that FDA may impose a civil money penalty by order issued after the person against whom the penalty is to be assessed has been given an opportunity for a hearing in accordance with 5 U.S.C. 554. Section 303(f) of the act further provides that, in the course of an investigation regarding the imposition of civil money penalties, FDA may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation. 
  In determining the amount of a civil money penalty, the SMDA directs FDA to take into account the nature, circumstances, extent, and gravity of the violations, the violator's ability to pay, the effect on its ability to continue to do business, any history of prior violations, the degree of culpability, and any other matter that justice may require. FDA will develop guidelines on how it will determine the amount of a civil money penalty. 
  FDA may compromise, modify, or remit, with or without conditions, any civil money penalty which is assessed. The amount of any penalty, when finally determined, may be deducted from any sums owed by the United States to the person charged.
  Any person who requests a hearing regarding the assessment of a civil money penalty and is aggrieved by an order assessing a civil money penalty may file a petition for judicial review with the United States Court of Appeals for the District of Columbia Circuit or any other circuit in which the person resides or transacts business. Any such petition must be filed within 60 days after the order making the assessment is issued. 
  If a person fails to pay an assessment of a civil money penalty, after the order making the assessment becomes final and the person affected does not file for judicial review, or after a court has entered a final action in favor of FDA, the Attorney General on behalf of FDA may recover the amount assessed with interest at the prevailing rates in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of the penalty is not subject to review. 
  Although the SMDA, unlike the GDEA discussed below, is not explicit on this point, FDA interprets section 303(f) of the act as authorizing FDA, in lieu of initiating a proceeding for administrative civil penalties, to request the Attorney General to seek a civil penalty in court. 
  Section 17(b) of the SMDA requires FDA to conduct a study to determine whether there has been substantial compliance by device user facilities with the adverse experience reporting requirements imposed by section 2 of the SMDA. FDA is directed to issue a report to Congress 45 months after the date of enactment of the SMDA. If the report is not made within 48 months after enactment, civil penalties will automatically become applicable to violations by device user facilities of the adverse experience reporting requirements. If the report is made and concludes that there has been substantial compliance by a type of device user facility or if FDA does not determine that there has not been substantial compliance by a type of device user facility, civil money penalties will not be applied to that type of device user facility. If the report concludes that there has not been substantial compliance by a type of device user facility, or if FDA reaches that conclusion after making the report, civil money penalties will be applied to that type of device user facility upon issuance of the report. 


               D. The Generic Drug Enforcement Act of 1992 
  The GDEA provides for civil money penalties for a number of actions concerning generic drugs, most of which actions would constitute felonies under the criminal law as well. In addition, it provides for civil money penalties for employers who use the services of a debarred person within the meaning of the GDEA and for debarred persons who provide such services. Maximum penalties for each violation are not to exceed $250,000 in the case of an individual and $1,000,000 in the case of any other person. 
  As with the SMDA, the GDEA provides for civil money penalties to be administratively imposed. After an opportunity for an agency hearing on disputed issues of material fact and the amount of the penalty, the Secretary shall assess a civil penalty. In lieu of this approach, the Secretary may request that the Attorney General seek a civil penalty. In addition, the Attorney General may sue to recover any uncollected civil money penalty (plus interest) assessed administratively by FDA.


    III. DISCUSSTION OF THE PROPOSED REGULATORY PROVISIONS

                           A. Scope (Proposed  17.1) 
  The procedures proposed in new part 17 are written in general terms because they could be applied whenever a person has a right to an opportunity for a hearing on the administrative imposition of civil money penalties by FDA. Regulations are useful to the public and the agency in outlining the procedure to be used and are more suited to civil penalties proceedings than any existing FDA hearing procedures. 

                        B. Definitions (Proposed  17.3) 
  As a general rule, the substantive criteria for imposing civil money penalties are specified in the statutes and do not require implementing regulations. In the proposal, the term, ``significant departure,'' as used in section 303(f)(1)(B)(i) of the act, for violations of section 519(a) of the act (medical device reporting) and section 520(f) of the act (CGMP), is defined as a departure from requirements which is neither isolated nor inconsequential. For example, ``significant departures'' from the CGMP regulations would include, among other things: failure to establish and document a formal quality assurance program; failure to validate significant operations, e.g., sterilization; failure to establish and implement an adequate complaint handling program; failure to establish a failure-investigation program or adequate recordkeeping procedures; and failure to ensure that devices meet finished specifications before distribution. Minor recordkeeping omissions would not be considered a ``significant departure.'' Proposed definitions of other terms, including ``defective'' and ``knowing departure'' as used in section 303(f)(1)(B)(i)(I) of the act, are also contained in proposed  17.3. 

                                    C. The Hearing 
  FDA has existing procedures for hearings before a presiding officer in part 12 (21 CFR part 12) (formal evidentiary public hearing). FDA has developed these new proposed procedures, however, for civil money penalties proceedings, because FDA believes that a complaint and answer procedure is more appropriate than a published notice of hearing procedure. FDA believes that the complaint and answer process is a quicker and more efficient method of joining issues for this type of hearing. The proposed procedures have been modeled largely on the procedures of the Environmental Protection Agency for review of program fraud civil money penalties (40 CFR part 27) because they embody an efficient complaint-and-answer procedure that is readily adaptable to the kind of administrative litigation that FDA anticipates. 

                  D. Discovery (Proposed  17.23 and 17.25) 
  Prior to the hearing, a party may make a request to another party for production of relevant documents for inspection and copying, in accordance with the time period specified by the presiding officer under  17.19 and 17.23. Within 10 days after service of a request for production of documents, a party may file a motion for a protective order (proposed  17.28), on which the presiding officer will rule. This process differs from the process for disclosure of data in  12.85, which requires: (1) FDA to put certain information on file in the Dockets Management Branch before publication of the notice of hearing; and (2) the parties to submit certain information within 60 days after publication of the notice of hearing. FDA believes that the process in the proposed rule is more appropriate for a civil money penalties hearing because it allows a speedier result consistent with due process. Also, the proposed procedure is, FDA believes, more suitable to the narrower and more manageable issues likely to be the focus of a civil money penalties hearing. 
  Documents subject to discovery under the proposed rule include information, reports, answers, records, accounts, papers and other data and documentary evidence. The discoverable information is broader than the data required to be disclosed under  12.85. FDA believes that the approach in the proposed rule is appropriate, given the fact-finding nature of civil money penalty proceedings. 

                                   E. Location of Hearing 
  The presiding officer is to set the time and place of the hearing. The hearing may be held in the Washington, DC area, in any judicial district in which the defendant resides or transacts business, in any judicial district in which the violation occurred, or in any place agreed upon by the parties. Usually hearings would be held at FDA headquarters in Rockville, Maryland. However, the presiding officer may set a different place upon application based on hardship. 

                       F. Initial Decision (Proposed  17.45) 
  Under the proposal, after an opportunity for submission of posthearing briefs (proposed  17.43), the presiding officer is to issue an initial decision based only on the administrative record. The presiding officer would be required to serve the initial decision on all parties within 90 days after the time for submitting posthearing briefs and responsive briefs has expired. If the presiding officer fails to meet this deadline, he or she shall notify the parties of the reason for the delay and set a new deadline. Unless the initial decision is appealed in a timely manner to the Commissioner of Food and Drugs (the Commissioner), the initial decision would become the final decision of FDA 30 days after it is issued by the presiding officer. The proposal to impose time limits on the decision makers is a departure from other FDA hearing procedures, such as those in part 12. FDA is proposing these deadlines in an effort to achieve a speedier process. 

              G. Appeal to the Commissioner (Proposed  17.47) 
  Under the proposal, the Center, or any person who has filed an answer in a timely manner and who is determined in an initial decision to be liable for a civil money penalty, may appeal the decision to the Commissioner by filing a notice of appeal with the Dockets Management Branch within 30 days after the presiding officer issues an initial decision. The party requesting an appeal may obtain a 30-day extension for filing an appeal by filing a request with the Commissioner that shows good cause. A notice of appeal is to be accompanied by a written brief. The opposing party may file a brief in opposition. There is no right to appear personally before the Commissioner or his designee. 
  The Commissioner is to issue a decision on the appeal within 60 days after submission of the appellee's brief. The decision may be a summary affirmance of the initial decision. 

                                IV. ENVIRONMENTAL IMPACT 
  
  The agency has determined under 21 CFR 25.24(e)(2) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

                                     V. ECONOMIC IMPACT

  The agency concludes that the proposed rule is not a major rule as defined in Executive Order 12291. Further, the agency certifies that the proposed rule, if implemented, will not have a significant economic impact on a substantial number of small entities, as defined in the Regulatory Flexibility Act (Pub. L. 96-353).
  The final rule specifies the procedures to be followed by persons who have the right to a hearing on the administrative imposition of civil money penalties by the agency. As such, the rule does not impose any burden on regulated industry. Procedures themselves are protections and do not impose significant costs beyond what the underlying statute imposes.

                               VI. REQUEST FOR COMMENTS

  Interested persons may, on or before July 26, 1993, submit to the Dockets Management Branch (address above) written comments regarding this proposal. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

                            List of Subjects in 21 CFR Part 17
  Administrative practice and procedure, Animal drugs, Biologics, Civil money penalties hearings, Drugs, Generic drugs, Prescription drug samples, Medical devices.
  Therefore, under the Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that new 21 CFR part 17 be added to read as follows:

                     PART 17 -- CIVIL MONEY PENALTIES HEARINGS

Sec. 
17.1 Scope.
17.3 Definitions.
17.5 Complaint.
17.7 Service of complaint.
17.9 Answer.
17.11 Default upon failure to file an answer.
17.12 Initiation of hearing, the presiding officer.
17.13 Notice of hearing.
17.15 Parties to the hearing.
17.17 Summary decisions.
17.19 Authority of the presiding officer.
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 Appeal to the Commissioner.
17.48 Harmless error.
17.49 Delegated functions.
17.51 Judicial review.
17.54 Deposit in the Treasury of United States.

   AUTHORITY: Secs. 301, 303, 307, 501, 502, 505, 510, 513, 516, 519, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c, 360f, 360i, 360j, 371); secs. 351, 2128 of the Public Health Service Act (42 U.S.C. 262, 300aa-28); 5 U.S.C. 555, 556.

 17.1 Scope.
  This part sets forth practices and procedures for hearings concerning the administrative imposition of civil money penalties by FDA. The procedures will apply to civil money penalties authority statutes, that Congress enacts in the future as well as to those which it has already enacted. Listed below are the statutory provisions that currently authorize civil money penalties that are to be imposed under these procedures.
    (a) Section 303(b)(2) through (b)(5) of the Federal Food, Drug, and Cosmetic Act (the act) authorizing civil money penalties for certain violations of the act which relate to prescription drug marketing practices.
    (b) Section 303(f) of the act authorizing civil money penalties for certain violations of the act which relate to medical devices.
    (c) Section 307 of the act authorizing civil money penalties for certain actions in connection with an abbreviated new drug application or the investigation of a drug subject to an abbreviated new drug application.
    (d) Section 351(d)(2)(B) of the Public Health Service Act authorizing civil money penalties for violations of biologic recall orders.
    (e) Section 2128 of the Public Health Service 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 pursuant to that section of the Public Health Service Act. 

17.3 Definitions.
    (a)   Defective includes any defect in performance, manufacture, construction, components, materials, specifications, design, installation, maintenance, service, or any defect in mechanical, physical and chemical properties in a device.
    (b) Knowing departure means actual knowledge of departure from requirements, or acting in deliberate ignorance of such departure, or acting in reckless disregard of such departure.
    (c) Significant departure means a departure from requirements which is neither isolated nor inconsequential.
    (d) Minor violations means violations which are isolated and inconsequential.
    (e) Person or respondent includes an individual, partnership, corporation, association, or other legal entity.
    (f) A term that is defined in section 201 of the Federal Food, Drug, and Cosmetic Act has the same definition in this part.

 17.5 Complaint.
    (a) The Center with jurisdiction over the matter involved shall begin all administrative civil money penalty actions by serving a complaint signed by the Office of the General Counsel attorney for the Center on the respondent and by filing a copy with the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    (b) The complaint shall state:
    (1) The allegations of liability against the respondent including the statutory basis for liability, the identification of violations that are the basis for the alleged liability, and the reasons why liability allegedly arises from such claims or statements;
    (2) The amount of penalties and assessments which the Center is seeking;
    (3) Instructions for filing an answer to request a hearing, including a specific statement of the respondent's right to request a hearing by filing an answer and to retain counsel to represent the respondent; and
    (4) That failure to file an answer within 30 days of service of the complaint will result in the imposition of the proposed amount of penalties and assessments without right to appeal, as provided in  17.11.

 17.7 Service of complaint.
    (a) Service of a complaint may be made by:
    (1) Certified or registered mail or similar express delivery service; 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 delivery;
    (2) A United States Postal Service return receipt card acknowledging receipt; or
    (3) Written acknowledgment of receipt by the respondent or by the respondent's counsel or authorized representative or agent.

 17.9 Answer.
    (a) The respondent may request a hearing by filing an answer with the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, within 30 days of service of the complaint. 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;
    (2) Shall state any defense on which the respondent intends to rely;
    (3) May state any 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 may, 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.

 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, the Commissioner will assume the facts alleged in the complaint to be true, and, if such facts establish liability under the relevant statute, the Commissioner shall issue a decision within 30 days imposing: 
    (1) The maximum amount of penalties provided for by law for the violations complained of; 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 further review of the penalties and assessments imposed under paragraph (a) of this section, and the 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 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 Commissioner 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) and shall remand the case to the presiding officer with instructions to grant the respondent an opportunity to answer. 
    (e) If the Commissioner 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, which shall become final and binding upon the parties on the date when the Commissioner issues the decision on the respondent's motion under paragraph (c) of this section. 

 17.12 Initiation of hearing; the presiding officer. 
  If the respondent files an answer in accordance with  17.9, determination of liability for a civil money penalty and assessment thereof will be assigned to a presiding officer, who shall be an administrative law judge qualified under 5 U.S.C. 3105. If the respondent does not file an answer in accordance with  17.9, determination of liability for a civil money penalty and whether to assess a penalty will be made by the Commissioner, based on the record of the proceeding. 

 17.13 Notice of hearing. 
  Along with the complaint, 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) The matters of fact and law to be asserted; 
    (d) A description of the procedures for the conduct of the hearing; 
    (e) The name, address, and telephone number of the representative of the Government and of the respondent, if any; 
and 
    (f) Such other matters as the Center or the presiding officer deems appropriate. 
 17.15 Parties to the hearing. 
    (a) The parties to the hearing shall be the respondent and the Center 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 Commissioner, agree to a settlement of all or a part of the matter. 

 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 declarations under penalty of perjury), for a summary decision on any issue in the hearing. 
The other party may, within 10 days after service of the motion, which may be extended for an additional 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 will grant the motion if the pleadings, affidavits, and other material filed in connection with the hearing, or matters officially noticed, show that there is no genuine issue as to any material fact and that the party is 
entitled to summary decision as a matter of law.     
    (c) Affidavits should set forth facts that would be admissible in evidence and show affirmatively that the affiant is competent to testify to the matters stated. When a properly supported motion for summary decision is made, a party opposing the motion may not rest on mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses 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 evidentiary facts need to be developed, the presiding officer will issue an order specifying the facts that appear without substantial controversy and directing further evidentiary proceedings on facts still at issue. The facts specified not to be at issue will be deemed established. 
    (e) A party may obtain interlocutory review by the Commissioner of a partial summary decision of the presiding officer. Failure to seek interlocutory review of a decision granting partial summary judgment shall constitute a waiver of all appeal rights on the issues decided in the order granting partial summary judgment. A review of final summary judgment decisions on all issues may be had through the procedure set forth in 17.47. 

 17.19 Authority of the presiding officer. 
    (a) The presiding officer shall conduct 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 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) Hold conference to identify or simplify the issues or to consider other matters that may aid in the expeditious disposition of the proceeding; 
    (4) Administer oaths and affirmations; 
    (5) Issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation; 
    (6) Rule on motions and other procedural 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; 
    (9) Examine witnesses; 
    (10) Receive, rule on, exclude, or limit evidence; 
    (11) Upon motion of a party or on the presiding officer's own motion, take official notice of facts; 
    (12) Upon motion of a party, decide cases, in whole or in part, by summary judgment where there is no disputed issue of material fact; 
    (13) Conduct any conference, argument, or hearing on motions in person or by telephone; 
    (14) Consolidate related or similar proceedings or sever unrelated matters; and 
    (15) Limit the length of pleadings; 
    (16) 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; and 
    (17) 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. 

17.21 Prehearing conferences. 
    (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: 
    (1) Simplification of the issues; 
    (2) The necessity or desirability of amendments to the pleadings, including the need for a more definite statement; 
    (3) Stipulations and admissions of fact as to the contents and authenticity 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 other parties) and written argument; 
    (6) Limitation of the number of witnesses; 
    (7) Scheduling dates for the exchange of witness lists and of proposed exhibits;      (8) 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 may issue an order containing all matters agreed upon by the parties or ordered by the presiding officer at a prehearing conference. 

 17.23 Discovery. 
    (a) Prior to the hearing, and in accordance with the time period specified by the presiding officer, a party may make a request to another party for production of documents, for inspection and copying, which are relevant to the issues before the presiding officer. 
    (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 will be interpreted to require the creation of a document, except that requested data stored in an electronic data storage system will be produced in a form 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 paragraph (a) 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 
    (iii) Seeks privileged information. 
    (3) The burden of showing that documents should be produced is on the party seeking their production. 

17.25 Exchange of witness lists, witness statements, and exhibits. 
    (a) At least 15 days before the hearing, or by such other time as is specified by the presiding officer, the parties shall exchange witness lists, copies of prior written statements of proposed witnesses, and copies of proposed hearing exhibits, including written testimony. 
    (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 it 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 justified the failure to make a timely exchange of information under paragraph (a) of this section, he or she must exclude 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 determine whether the admission of such evidence would cause substantial prejudice to the objecting party. If the presiding officer finds that there is not substantial prejudice, the evidence may be admitted. If the presiding officer finds that there is substantial prejudice, the presiding officer may exclude the evidence, or at his or her discretion, may postpone the hearing for such time as is necessary for the objecting party to prepare and respond to the evidence. 
    (c) Unless another party objects within a reasonable time prior to the hearing, documents exchanged in accordance with paragraph (a) of this section will be deemed to be authentic for the purpose of admissibility at the hearing. 

 17.27 Hearing subpoenas. 
    (a) A party wishing to procure the appearance and testimony of any individual at the hearing may request that the presiding officer issue a subpoena. 
    (b) A subpoena requiring the attendance 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, upon a showing by the party of good cause, by the presiding officer. 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. 
    (d) The subpoena shall specify the time and place at which the witness is to appear and any documents the witness is to produce. 
    (e) The party seeking the subpoena shall serve it in the manner prescribed in
 17.7. A subpoena on a party or an individual under the control of a party may be served by first class mail. 
    (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. 

 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 hearing, seeking to limit the availability or disclosure of evidence. 
    (b) In 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, including but 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 inquired into, or that the scope of discovery be limited to certain matters; 
    (5) That the contents of discovery or evidence be sealed; 
    (6) That a trade secret or other confidential research, development, or commercial information or fact pertaining to any criminal investigation, proceeding, or other administrative investigation not be disclosed 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 officer. 

 17.29 Fees. 
    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. 

 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 includes the last day of the period, unless either such day is a Saturday, Sunday, or Federal legal holiday, in which event it includes the next business day. 
    (b) When the period of time allowed is less than 7 days, intermediate Saturdays, Sundays, and legal holidays observed by the Federal Government 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. 

17.31 Form, filing, and service of papers. 
    (a) Form. (1) Documents filed with the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, 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 General 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 Dockets Management Branch. 
    (b) Service. A party filing a document with the Dockets Management Branch under this part shall, at 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 similar 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 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 relief sought, the authority relied upon, and the facts alleged, and shall be filed with the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and served on all other parties. 
    (b) Except for motions made during a prehearing conference or at the hearing, 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 motion 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 conduct a hearing on the record in order to determine whether the respondent is liable for a civil money penalty and, if so, the appropriate amount of any such civil money penalty considering any aggravating or mitigating factors. 
    (b) In order to prevail, the Center is to prove respondent's liability and any aggravating factors by a preponderance of the evidence. 
    (c) The respondent is to prove any affirmative defenses and any mitigating 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 closure only to protect patient privacy, trade secrets, confidential commercial information, or sensitive enforcement information. 

 17.34 Determining the amount of penalties and assessments. 
    (a) In determining an appropriate amount of civil money penalties and assessments, the presiding officer and the Commissioner will evaluate any circumstances that mitigate or aggravate the violation and should articulate in their opinions the reasons that support the penalties and assessments imposed. 
    (b) Among the factors to be considered are the nature, circumstances, extent, and gravity of the act subject to penalty, the person's ability to pay, the effect on the person's ability to do business, and history of prior, similar acts, and such other matters as justice may require. 
    (c) Nothing in this section shall be construed to limit the presiding officer or the Commissioner from considering any other factors that in any given case may mitigate or aggravate the offense for which penalties and assessments are imposed. 

17.35 Sanctions. 
    (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; 
    (2) Failing to prosecute or defend an action; or 
    (3) Engaging in other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing. 
    (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: 
    (1) Draw an inference in favor of the requesting party with regard to the information sought; 
    (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 the presiding officer's orders. 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 which is not filed in a timely fashion. 
    (g) The presiding officer may order the party or legal counsel to pay reasonable expenses incurred because of any failure or misconduct described in this section. 

17.37 Witnesses. 
    (a) Except as provided in paragraph (b) of this section, testimony at the hearing shall be given orally by witnesses under oath or affirmation. 
    (b) At the discretion of the presiding officer, testimony may be admitted in the form of a written declaration under penalty of perjury. Any such written declaration must be provided to all other parties along with the last known address of the witness in a manner which allows sufficient time for other parties to subpoena such witness for cross-examination at the hearing. Failure of such a witness to submit to cross-examination shall result in the striking of his or her written testimony. Prior written statements of witnesses proposed to testify at the hearing shall be exchanged as provided in  17.23(a). 
    (c) The presiding officer shall exercise reasonable control over the mode and order of interrogating witnesses and presenting evidence so as to:
    (1) Make the interrogation and presentation effective for the ascertainment of the truth; 
    (2) Avoid needless consumption of time; and 
    (3) Protect witnesses from harassment or undue embarrassment. 
    (d) The presiding officer shall permit the parties to conduct such cross-examination as may be required for a full and true disclosure of the facts. 
    (e) At the discretion of the presiding officer, a witness may be cross-examined on matters relevant to the proceeding without regard to the scope of his or her direct examination. To the extent permitted by the presiding officer, cross-examination on matters outside the scope of direct examination shall be conducted in the manner of direct examination and may proceed by leading questions only if the witness is a hostile witness, an adverse party, or a witness 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 appearing for the entity per se or designated by the party's representative; 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 the Government engaged in assisting counsel for the Center. 

 17.39 Evidence. 
    (a) The presiding officer shall determine 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 unreliable evidence.       (c) The presiding officer shall exclude irrelevant and immaterial evidence. 
    (d) Although 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. 
    (e) Although relevant, evidence may be excluded if it is privileged under Federal law. 
    (f) Evidence concerning offers of compromise or settlement shall be inadmissible to the extent provided in Rule 408 of the Federal Rules of Evidence. 
    (g) The presiding officer may 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. 

 17.41 The administrative record. 
    (a) The hearing will be recorded and transcribed. Transcripts may be obtained following the hearing from the Dockets Management Branch 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 Commissioner. 
    (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 may otherwise order only to protect trade secrets, confidential commercial information, or patient privacy. 

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), not to exceed 60 days from the date the parties received the transcript of the hearing or, if applicable, 
the stipulated record. Such briefs may be accompanied by proposed findings of fact and conclusions of law. The presiding officer may permit the parties to file responsive 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 complex, or the administrative record is so voluminous, as to justify longer briefs, 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, conclusions 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 penalties or assessments, the appropriate amount of any such penalties or assessments 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 judgment on all parties within 90 days after the time for submission of posthearing briefs and responsive briefs (if permitted) has expired. If the presiding 
officer believes that he or she cannot meet the 90-day deadline, he or she shall notify the Commissioner of the reason therefor, and the Commissioner may then set a new deadline. 
    (d) Unless the initial decision of the presiding officer is timely appealed to the Commissioner, the initial 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 Appeal to the Commissioner. 
    (a) Either the Center or any respondent who is determined in an initial decision or a decision granting summary judgment liable for a civil money penalty or assessment may appeal such decision to the Commissioner by filing a notice of appeal with the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, 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 decision or decision granting summary judgment. 
    (2) The Commissioner may extend the initial 30-day period for an additional 30 days if the respondent files a request for an extension within the initial 30-day period and shows good cause. 
    (c) A notice of appeal shall be accompanied by a written brief specifying exceptions to the initial decision and reasons supporting the exceptions. 
    (d) The opposing party may file a brief in opposition to exceptions within 30 days of receiving the notice of appeal and accompanying brief. Any brief in opposition to exceptions is to be filed with the Dockets Management Branch (address above). There is no right to file an appellant's reply brief. 
    (e) There is no right to appear personally before the Commissioner or his designee. 
    (f) The Commissioner 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 judgment. 
    (g) If any party demonstrates to the satisfaction of the Commissioner that additional 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 Commissioner may remand the matter to the presiding officer 
for consideration of the additional evidence. 
    (h) The standard of review on a disputed issue of fact is whether the initial decision is supported by substantial evidence on the whole record. 
    (i) The Commissioner will issue a decision on the appeal within 60 days of the due date for submission of the appellee's brief. In the decision, the Commissioner may decline to review the case, affirm the initial decision or decision granting 
summary judgment (with or without an opinion), or increase, reduce, reverse, or remand any penalty determined by the presiding officer in the initial decision. 

 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 presiding officer or by any of the parties is ground 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 inconsistent with substantial justice. The presiding officer and the Commissioner 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. 

 17.49 Delegated functions. 
  The Commissioner may delegate to another FDA official not assigned to advise the Center all or part of the Commissioner's authority to act in a given proceeding. 
 17.51 Judicial review. 
    (a) The Commissioner's final decision constitutes final agency action from which a party 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 party 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 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 Commissioner. 

 17.54 Deposit in Treasury of the United States. 
  All amounts collected pursuant to this part shall be deposited as miscellaneous receipts in the Treasury of the United States. 

Dated: May 18, 1993. 



					Michael R. Taylor, 
					Deputy Commissioner for Policy. 

[FR Doc. 93-12314 Filed 5-25-93; 8:45 am] 
BILLING CODE 4160-01-P