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                              Guidelines: Review of ALJ Decisions in FDA Tobacco Products Cases
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Guidelines -- Appellate Review of Decisions of Administrative Law Judges in Food and Drug Administration Tobacco Products Cases








  
  
    

  
      





**Topics on This Page**: Introduction | Filing Documents With the Board; Serving Documents | Additional Rules Applicable to Both Electronic and Non-Electronic Filing | Starting the Review Process | Development of the Record on Appeal | Procedures for Interlocutory Appeals | Completion of the Review Process
Introduction
The Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 *et seq*., as amended by the Family Smoking Prevention and Tobacco Control Act, Public Law 111-31, authorizes the Food and Drug Administration to impose civil money penalties and no-tobacco-sale orders based on a determination that an individual or entity has violated a requirement of the Act that relates to tobacco products. An individual or entity affected by such a determination is entitled to a hearing by an Administrative Law Judge (ALJ) under the procedures at 21 C.F.R. Part 17. (Part 17 does not expressly refer to no-tobacco-sale orders, but Food and Drug Administration guidance indicates that those procedures apply to appeals of no-tobacco-sale orders as well as civil money penalties. Civil Money Penalties and No-Tobacco-Sale Orders to Tobacco Retailers (revised December 2016), available at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm447308.htm.) A dissatisfied party may request review of the ALJ decision by the Departmental Appeals Board (Board) in accordance with the procedures in 21 C.F.R. § 17.47. These guidelines have been designed to assist the parties in understanding and following the procedures relating to Board review.
If you have any questions about these guidelines, you may call the Appellate Division at (202) 565-0208 or call the Appellate Division Director directly at the number listed under Contact DAB on the DAB website (https://www.hhs.gov/about/agencies/dab/about-dab/contact-dab/index.html#appellate).
Filing Documents with the Board; Serving Documents
A party may file any document with the Board – including a notice of appeal, a brief, or a request for an extension of time – using either of two methods:  (1) by sending the document, by postal or commercial delivery service (or, in limited circumstances, by fax), to the Board at its Washington, D.C. address; or (2) by submitting the document electronically using the Board’s electronic filing system, called “DAB E-File.”  (For general instructions on how to access and use DAB E-File, please review the Board’s electronic filing instructions, which can be found at https://dab.efile.hhs.gov.)
Rules and requirements for each filing method, as well as the rules for serving a document on a party, are outlined below.
Filing and Service by Postal or Commercial Delivery (or by Fax in Certain Circumstances)
	(a)  A non-electronic submission is considered "filed" with the Board on the postmark date, the date sent by registered or certified mail, the date deposited with a commercial delivery service, or the date a fax (where permitted) is sent.
(b)  All non-electronic submissions to the Board should be addressed to:
Department of Health and Human Services
	Departmental Appeals Board, MS 6127
	Appellate Division
	330 Independence Ave., S.W.
	Cohen Building, Room G-644
	Washington, D.C. 20201
Faxes should be sent to (202) 565-0238.  Please do not fax a submission if it is over 10 pages.
(c)  When filing a document with the Board by non-electronic means, you should also send the document to the opposing party and to FDA’s Division of Dockets Management and include in your submission to the Board a statement that you have done so.  The address for the Division of Docket Management is:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061, HFA-305
Rockville, MD  20852
Electronic Filing and Service Using DAB E-File
	(a)  Any document, including a notice of appeal, will be deemed to have been filed with the Board on a given day if it is uploaded to DAB E-File on or before 11:59 p.m. eastern time of that day.
(b)  If the non-federal party files a notice of appeal electronically via DAB E-File, then both parties should make all future submissions by that method and will be deemed to have consented to accept electronic service of appeal-related documents via DAB E-File (including documents from the Board).
(c)  Even when the non-federal party has elected to file a notice of appeal by postal or commercial delivery service, FDA may file its response brief and other appeal-related documents electronically via DAB E-File but should also serve paper copies of its filings upon the non-federal party on or before the applicable filing due dates.  In that situation, the Board will issue documents to the non-federal party by postal or commercial delivery service and to FDA via DAB E-File.
(d)  FDA may file a notice of appeal electronically via DAB E-File.  If it does so, FDA must also send a copy of the notice of appeal to the non-federal party by postal or commercial delivery service.  If the non-federal party files its response to FDA’s notice of appeal via DAB E-File, then both parties should make all future filings by that method and will be deemed to have consented to electronic service via DAB E-File.
(e)  Sending a document to the Board as an e-mail attachment (or in the body of an e-mail) is not a permitted method of electronic filing.  Electronic filing in Board cases must be done using DAB E-File.
Additional Rules Applicable to Both Electronic and Non-Electronic Filing
(a)  If the last day of the period for filing a submission falls on a federal nonworkday (a Saturday, Sunday, legal holiday, or a day which by statute or Executive Order is declared to be a nonworkday for federal employees), the submission may be filed on the next federal workday.
(b)  The parties should not submit to the Board materials already submitted to the ALJ since those materials will be transferred to the Board by the ALJ or will be available to the Board via DAB E-File, as appropriate.
(c)  A submission (including the notice of appeal) may not incorporate by reference a brief or parts of a brief previously submitted to the ALJ.
Starting the Review Process
(a) Under 21 C.F.R. §§ 17.17 and 17.47(a), either party dissatisfied with an ALJ's initial decision or a decision granting summary decision on all issues may appeal that decision to the Board. The Board may hear an interlocutory appeal of a ruling by the ALJ only if the ALJ certifies that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest. *See* 21 C.F.R. § 17.18(b). An initial decision in a default case is not appealable if a motion to reopen is pending before the ALJ. *See* 21 C.F.R. § 17.11(c).
(b) An affected individual or entity has a right to be represented before the Board, at the individual's or entity's own expense, by an attorney or someone else. A representative should file with the Board a signed statement that he or she has been authorized to represent the affected individual or entity, unless the same representative appeared in the proceedings before the ALJ.
(c) Your notice of appeal must be filed within 30 days of the date that the ALJ issues a decision unless you make a written request for an extension which the Board grants for good cause shown. Any request for an extension must be filed within the initial 30-day period and should explain why there is good cause for the requested extension, which may not exceed 30 days. If an ALJ decision is served by mail, it is deemed to be issued five days after it is placed in the mail. *See* 21 C.F.R. §§ 17.47(b)(1) and 17.30(c).
(d) Your notice of appeal must be accompanied by a written brief specifying each finding of fact and conclusion of law with which you disagree, and your basis for contending that each such finding or conclusion is unsupported or incorrect. The Board expects that the basis for each challenge to a finding or conclusion in the ALJ decision will be set forth in a separate paragraph or section, and that the accompanying arguments will be concisely stated. In addition, where appropriate, each argument should be supported by precise citations to the record and/or by precise citations to statutes, regulations or other relevant authorities upon which you are relying. The written brief should not exceed 30 pages or any greater length allowed by the ALJ for the posthearing brief pursuant to 21 C.F.R. § 17.47(c).
Development of the Record on Appeal
(a) The notice of appeal is referred to a panel of three Board members, one of whom presides over the development of the record on appeal. The Presiding Board Member is assisted by a staff attorney whom the parties may contact if they have questions about case status or procedures.
(b) When the Board receives a notice of appeal, it will obtain the administrative record of the ALJ proceeding.
(c) The opponent of the party that filed the notice of appeal may submit a response, which may also raise any relevant issue not addressed in the notice of appeal. The response should not exceed 30 pages or any greater length allowed by the ALJ for the posthearing brief, and must be filed within 30 days after the opposing party receives a copy of the notice of appeal.  *See* 21 C.F.R. § 17.47(d).
(d) The party that filed the notice of appeal may file a reply brief not more than 10 pages in length within 10 days of the date of service of the opposing party's brief. If the opposing party's brief is mailed to you, the date of service is deemed to be five days from the date of mailing.
(e) The Board expects any party needing an extension for filing the response or the reply (or any additional submission required by the Board) to file a request for an extension before the original due date, to include a statement about whether the opposing party objects to the requested extension, and to state the reasons for the request. The Board will grant an extension only for good cause shown.
(f) The Board may ask for additional briefing if it considers issues not adequately briefed by the parties. Additional briefs will not, however, be considered unless the Board requests them. *See* 21 C.F.R. § 17.47(h).
(g) There is no right to appear personally before the Board.  *See* 21 C.F.R. § 17.47(f).  The Board may schedule oral argument, on its own motion or at the request of a party, only if it determines that oral argument would facilitate its decisionmaking.
Procedures for Interlocutory Appeals
(a) A party wishing to file an interlocutory appeal must obtain a certification from the ALJ that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest. The ALJ's certification must be made on the record or in writing. The certification must specify the deadline for filing an interlocutory appeal. The certification may also authorize the party filing the interlocutory appeal to submit a brief in support of the appeal at a time set by the ALJ or to be set by the Board.
(b) The interlocutory appeal must be filed with the Board by the deadline specified in the ALJ's certification and must include a copy of the ALJ's certification. The appeal must specifically identify the determination made by the ALJ that is being appealed and should include a copy of the ALJ's partial summary decision, ruling, order or other document setting out this determination. The interlocutory appeal may not exceed three pages (not including the copy of the ALJ's determination).
(c) If the certification does not authorize the party filing the interlocutory appeal to submit a brief in support of the appeal, that party may request that the Board authorize the submission of such a brief. Upon receipt of an interlocutory appeal, the Board will rule on any request to submit a brief in support of the appeal and set a time for the submission of any brief authorized by it, or set a time for the submission of any brief authorized by the ALJ for which no such time has been specified. In setting such a time, the Board will consider any estimate by the filing party of the time needed to prepare the brief and the impact of any delay in the proceedings before the ALJ.
(d) The opposing party may submit a brief in response to any brief in support of the interlocutory appeal. Unless otherwise specified by the Board, the opposing party's brief must be filed within 30 days of its receipt of the brief in support of the interlocutory appeal. No further briefs may be filed except at the request of the Board.
(e) The Board will, where appropriate, rule on the interlocutory appeal without reviewing the administrative record of the ALJ proceeding.  If the ALJ does not stay the proceedings pending the interlocutory appeal, the Board may ask the parties to enter into a stipulation as to what documents in the administrative record are necessary for the Board's review and to provide a copy of those documents.
Completion of the Review Process
(a) The Board will review only those parts of the record before the ALJ which are cited by the parties or which the Board considers necessary to decide the appeal.
(b) If a party demonstrates to the satisfaction of the Board that evidence not presented to the ALJ is relevant and material and that there were reasonable grounds for the failure to present it to the ALJ, the Board may remand the case to the ALJ for consideration of such additional evidence.
(c) The standard of review on a disputed factual issue is whether the initial decision is supported by substantial evidence on the whole record. The standard of review on a disputed issue of law is whether the initial decision is erroneous. *See* 21 C.F.R. § 17.47(k).
(d) The Board may decline review of the case, affirm or reverse the ALJ decision, or may affirm, increase, reduce, reverse or remand any penalty or assessment determined by the ALJ.
(e) If practicable, the Board will complete its review and issue a decision within 60 days after the time for the last submission permitted by the Board has expired. *See* 21 C.F.R. § 17.47(j).
(f) If the affected individual or entity files a petition for judicial review of the Board’s decision pursuant to 21 U.S.C. § 333(f)(6), a copy of the filed petition must be sent by certified mail, return receipt requested, to the Chief Counsel of FDA. The administrative record is certified by the Board Chair and is filed with the court by the Chief Counsel of FDA.  *See* 21 C.F.R. § 17.51.
Dated: March 26, 2013

                    
  


Content created by Departmental Appeals Board (DAB) Content last reviewed August 24, 2017 Back to top
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