Source: https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/fda-tobacco-decision-review/index.html
Timestamp: 2017-05-01 04:22:54
Document Index: 558993803

Matched Legal Cases: ['§ 301', 'art 17', '§ 17', '§ 17', '§ 17', '§ 333', '§ 17']

Home > About > Agencies > DAB > Different Appeals At DAB > Appeals To Board > Guidelines > Guidelines: Review of ALJ Decisions in FDA Tobacco Products Cases Text Resize A
Guidelines -- Appellate Review of Decisions of Administrative Law Judges in Food and Drug Administration Tobacco Products CasesTopics 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
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 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. 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.
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.)
(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:
(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.
(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).
(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.
Content created by Departmental Appeals Board (DAB)Content last reviewed on March 26, 2013