Other Fields
Agency Scheme: 
HHSOFDVA0007
Level: 
Appeal Level One
ADJUDICATION STRUCTURE
Appeals: Basic Structure
Appeal Office (local name): 
Office of the Commissioner
Appeal Office (global name): 
Department of Health and Human Services: Office of the Commissioner
Appeal Officer #1 (Title): 
HHS Departmental Appeals Board Judges
Appeal Officer #2 (Title): 
Commissioner of Food and Drugs, and certain FDA officials with delegated authority
Are administrative appeals permitted from final decisions issued by this appellate office?: 
Yes (Some Types of Cases)
Comments/Notes on Adjudication Structure: 
21 CFR 12.125 provides that a participant may appeal an initial decision to the Commissioner. Under 21 CFR 12.139, a participant may petition the Commissioner for reconsideration of any part or all of the final decision under 21 CFR 10.33. Under 21 CFR 16.119, any party may petition the Commissioner for reconsideration of any part or all of the decision under 21 CFR 10.33. 21 CFR 17.47 provides that either the Center or any respondent may appeal an initial decision to the Commissioner of Food and Drugs or other entity the Commissioner designates to decide the appeal. The Commissioner has currently designated the Department of Health and Human Services (HHS) Departmental Appeals Board (DAB) to decide appeals under this part.
PROCESS & PROCEDURE - General Information
Which party (or parties) is/are permitted to file appeals with this office?: 
Either
Are private parties permitted to have representation at appeal hearings?: 
Yes (All Types of Cases)
Who may serve as a private party representative?: 
Either
Is the agency permitted to have representation at appeal hearings?: 
Yes (All Types of Cases)
Who may serve as an agency representative?: 
Either
Are ex parte contacts prohibited?: 
Yes (Some Types of Cases)
Regulations/rules of practice for appeal hearings (please include CFR citations): 
21 CFR 10.3321 CFR 12.125, 12.130 and 12.13921 CFR 16.11921 CFR 17.47 and 17.48
PROCESS & PROCEDURE - Hearing Procedure
What types of hearings are permitted on appeals adjudicated by this office?: 
Written (Document-Only) Hearing
In-Person
Video
Phone
How is the type of hearing selected for appeals heard by this office?: 
Required by Rule
Depends on Nature of Case/Claim
If "Depends on Nature of Case/Claim", please describe: 
21 CFR 12.120 provides that there may be oral argument on appeal. 21 CFR 16.119 provides for a party to petition the Commissioner for reconsideration of any part or all of the decision or action under 21 CFR 10.33. Under 21 CFR 17.47, parties may file briefs on appeal; however, 21 CFR 17.47(f) indicates that there is no right to appear personally before the Commissioner of Food and Drugs or the Departmental Appeals Board. The Departmental Appeals Board website indicates that hearings may be conducted by telephone or video conference. http://www.hhs.gov/dab/divisions/appellate/practicemanual/manual.html
How many appeal officers preside at each hearing?: 
Varies by Case
If "Varies by Case," please describe: 
Under 21 CFR parts 12 and 16, appeals are to the Commissioner of Food and Drugs. Under 21 CFR part 17, appeals are to the HHS Departmental Appeals Board, and, according to the HHS Departmental Appeals Board website, are decided by a panel of three judges. http://www.hhs.gov/dab/divisions/appellate/practicemanual/manual.html#40
Is factual development permitted at the appellate hearing as a means of supplementing the record from below?: 
Yes (Some Types of Cases)
Can third-parties submit amicus briefs and/or evidence?: 
Yes
No
Are appeal hearings recorded and/or transcribed?: 
Yes
Discretion of Adjudication Officer(s)
N/A (Document-Only Hearings)
Are appeal hearings open to the public?: 
Varies by Case
If "Varies by Case," please describe: 
According to the HHS Departmental Appeals Board website, hearings are ordinarily open to all who wish to be present. http://www.hhs.gov/dab/divisions/appellate/practicemanual/manual.html This question is not applicable to document-only hearings.
PROCESS & PROCEDURE - Post-Hearing Procedure
Who typically drafts final decisions on appellate cases adjudicated by this office?: 
Adjudication Officer
Staff Attorney
Program Official
Who has authority to issue final decisions on appellate cases adjudicated by this office?: 
Adjudication Officer
Program Official
Other
If "Other/Varies by Case," please specify: 
Certain FDA officials have been delegated authority to perform all delegable functions of the Commissioner. FDA Staff Manual Guide 1410.21 at paragraph 1.B.
Do agency regulations or guidance provide time limits for issuance of final decisions on appellate cases?: 
Yes (All Types of Cases)
If "Yes," please specify these time limit(s): 
21 CFR 12.130(c) states that the final decision shall be issued as soon as possible after the briefs have been filed or any oral argument held. Under 21 CFR 16.119, a party may petition the Commissioner for reconsideration of the decision under 21 CFR 10.33. Under 21 CFR 10.33(i), if the Commissioner grants the petition for reconsideration, the 180-day time frame in 21 CFR 10.30(e)(2) for responding applies. 21 CFR 17.47(j) provides that a decision shall be issued, if practicable, within 60 days of the due date for submission of the appellee's brief.
Is judicial review available after issuance of a final decision on appellate cases adjudicated by this office?: 
Yes (All Types of Cases)
PROCESS & PROCEDURE - Case Management
How are claims/cases processed at this appellate office?: 
Differentiated Case Management
Please briefly describe your case management practice(s) at this office: 
For appeals handled by FDA officials, while cases are often processed in the order received, FDA, in some cases, may consider, e.g., the public health issues raised by a particular case or the availability of needed experts, in deciding the order in which cases are processed. For appeals handled by the HHS Departmental Appeals Board, please see the Departmental Appeals Board response to this question.
Does the agency permit web-based electronic filing of briefs or other documents in cases adjudicated by this appellate office?: 
Yes
Are final decisions issued by this appellate office published and/or posted on the agency website?: 
Yes (Some Decisions)
If "Yes (Some Decisions)," how does the agency determine which final decisions to publish/post? Please briefly describe: 
Under 21 CFR 12.130(e), notice of the Commissioner's decision shall be published in the Federal Register or the Commissioner may publish the decision when it is of widespread interest. Under 21 CFR 16.119, a party may petition the Commissioner for reconsideration of the decision under 21 CFR 10.33 by filing a petition with the Division of Dockets Management. 21 CFR 10.20(j) addresses the public availability of submissions to the docket. For appeals under 21 CFR part 17, the HHS Departmental Appeals Board publishes its decisions on its website. http://www.hhs.gov/dab/decisions/
Do agency regulations/rules of practice specify the contents of the administrative record on appeals heard by this office?: 
Yes (All Types of Cases)
If "Yes," please provide citation(s): 
21 CFR 12.100 21 CFR 16.80 21 CFR 17.41
Do agency regulations/rules of practice provide for closure of the record on appeals heard by this office?: 
Yes (All Types of Cases)
If "Yes," please provide citation(s): 
21 CFR 12.125. 21 CFR 10.33(b) for appeals under 21 CFR part 16. 21 CFR 17.47(b)-(e).
ADR: General Information
Is ADR available at one or more points for appellate cases heard by this office?: 
Yes
If "Yes," when is ADR available?: 
Pre-Hearing
Post-Hearing
Is ADR a mandatory or voluntary process?: 
Voluntary
What type(s) of ADR are available?: 
Mediation
Arbitration
If "Other," please specify:: 
FDA regulations do not explicitly address settlement or ADR at the appellate level. However, for appeals under 21 CFR part 17, the HHS Departmental Appeals Board provides ADR services, as described on its website: http://www.hhs.gov/dab/divisions/adr/index.html.
Who conducts the ADR?: 
Agency Program Official
Agency ADR Official
Agency Counsel
CASELOAD STATISTICS - Supplementary Statistics
Does your agency maintain annual caseload statistics for this hearing office by case type (e.g., discrimination complaint, licen: 
No
Verified by Agency: 
Verified