Other Fields
Agency Scheme: 
HHSOFDVA0007
ADJUDICATION STRUCTURE
Hearing Level: Basic Structure
Name of Hearing Office (local name): 
Office of Hearings and Inquiries
Name of Hearing Office (global name): 
Department of Health and Human Services: Office of Hearings and Inquiries
Sub-Agency/Bureau/Division:: 
Office of the Commissioner, Center for Tobacco Products, Center for Food Safety and Applied Nutrition, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of Regulatory Affairs
Hearing Officer #1 (Title): 
Administrative Law Judge (HHS Departmental Appeals Board ALJ)
Hearing Officer #2 (Title): 
Various employees are delegated authority to serve as presiding officers.
Are administrative appeals permitted from final decisions at the hearing-level stage?: 
Yes (All Types of Cases)
Comments/Notes on Adjudication Structure: 

Multiple FDA regulations provide for hearings. FDA has focused its responses on 21 CFR Part 12 (Formal Evidentiary Public Hearing); 21 CFR Part 16 (Regulatory Hearing before the Food and Drug Administration), and 21 CFR Part 17 (Civil Money Penalties Hearing).

21 CFR 12.60 provides that the presiding officer in a hearing will be the Commissioner, a member of the Commissioner's office to whom the responsibility for the matter involved has been delegated, or an administrative law judge qualified under 5 U.S.C. 3105. 21 CFR 16.42 provides that the presiding officer may be an FDA employee to whom the Commissioner delegates authority, or any other agency employee to whom such authority is delegated, or an administrative law judge (ALJ) may serve as the presiding officer for a Part 16 hearing, provided that individual meets the other criteria in 21 CFR 16.42. The delegations for Part 16 hearings are found in FDA Staff Manual Guide 1410.29 and the officials who may serve as a presiding officer under part 16, and who are authorized to designate other officials to serve as the presiding officer, currently include Ombudsman, Office of Scientific Integrity, Office of the Chief Scientist, Office of the Commissioner (OC); Director and Deputy Directors, CFSAN, OF; Director and Deputy Directors, CDER, OMPT; Directors, OND and OPS, CDER, OMPT; Associate Director for Policy and Associate Director for Medical Policy, CDER, OMPT; Directors, ODE I, II, III, and IV; OAP and OHOP, OND, CDER, OMPT; and Director and Deputy Director, OC, CDER, OMPT; Director and Deputy Directors, CDRH, OMPT; Director and Deputy Director, CTP, OMPT; Director, Deputy Director, and Senior Advisor for Science Policy, CVM, OF; Director and Deputy Director, CBER, OMPT; Directors and Deputy Directors, OBRR, OVRR, OCTGT; and OCBQ, CBER, OMPT; Director, OE, ORA, OGROP; and Director of Compliance, OE, ORA, OGROP; Regional Food and Drug Directors, ORA, OGROP; District Directors, ORA, OGROP; Regional Laboratory Directors, ORA, OGROP; Director, Office of Good Clinical Practice, Office of Special Medical Programs, OMPT; such other FDA Official as is designated by the Commissioner by memorandum in the proceeding. If an ALJ serves as the presiding officer over an FDA matter under part 12 or part 16 and for civil money penalties under part 17, FDA has an interagency agreement under which ALJs from the Departmental Appeals Board of the Department of Health and Human Services serve as the presiding officer.

PROCESS & PROCEDURE - General Information
Are private parties permitted to have representation at hearings?: 
Yes (All Types of Cases)
Who may serve as a private party representative?: 
Either
Is the agency permitted to have representation at hearings?: 
Yes (All Types of Cases)
Who may serve as an agency representative?: 
Either
Regulations/rules of practice for hearings (please include CFR citations): 
21 C.F.R. Parts 12, 16, and 17.
Other published guidance for hearings (if any): 
FDA has also published Guidances on certain matters that may be subject to a hearing. Examples include: "Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Clinical Investigator Administrative Actions – Disqualification"; "Guidance for FDA and Tobacco Retailers Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers"; and "Civil Monetary Penalties for Tobacco Retailers: Responses to Frequently Asked Questions," "Guidance for Industry What You Need to Know About Administrative Detention of Foods: Small Entity Compliance Guide." FDA also has Staff Manual Guides (SMGs) for certain matters that may be subject to a hearing. Examples include: SMG 7712 "Compliance Activities: Debarment Proceedings," SMG 7711 "Clinical Investigator Disqualifications," and SMG 7714 Disqualification of an Institutional Review Board (IRB), Parent Institution, or Component of Parent Institution."
PROCESS & PROCEDURE - Pre-Hearing Procedure
Is discovery permitted by either party at the hearing-level stage?: 
Yes (All Types of Cases)
Briefly describe the scope and type(s) of discovery available (e.g., depositions, interrogatories, etc.): 
Part 12 does not directly address discovery; however, 12.92(b)(2) indicates that, in developing evidence on issues in controversy, the presiding officer may consider the exchange of written interrogatories directed to particular witnesses. 21 CFR 16.24(g) provides that FDA and the party requesting the hearing will, if feasible, at least 1 day before the hearing provide to each other written notice of any published articles or written information to be presented at or relied on at the hearing. A copy will also be provided in advance if the other participant could not reasonably be expected to have or be able to obtain a copy. If written notice or a copy is not provided, the presiding officer may, if time permits, allow the party who did not receive the notice or copy additional time after the close of the hearing to make a submission concerning the article or information. 21 CFR 17.23 provides that no later than 60 days prior to the hearing, unless otherwise ordered by the presiding officer, a party may make a request to another party for production, inspection, and copying of documents that are relevant to the issues before the presiding officer. Documents must be provided no later than 30 days after the request has been made. The term "documents" is defined to include information, reports, answers, records, accounts, papers and other data and documentary evidence. The regulation also provides a party the opportunity to file a motion for a protective order. The presiding officer may order depositions only when the showings in 21 CFR 17.23(e) are met.
Does the hearing officer have subpoena authority?: 
Yes (Some Types of Cases)
Are ex parte contacts prohibited?: 
Yes (Some Types of Cases)
Are parties provided notice of hearing?: 
Yes (All Types of Cases)
PROCESS & PROCEDURE - Hearing Procedure
What types of hearings are permitted at the hearing-level stage?: 
Written (Document-Only) Hearing
In-Person
Video
Phone
How is the type of hearing selected: 
Depends on Nature of Case/Claim
Please describe: 
21 CFR 12.87 provides generally for written direct testimony, except on a showing that written direct testimony is insufficient for a full and true disclosure of relevant facts and the participant will be prejudiced if unable to present direct oral testimony. Oral cross-examination of witnesses will be permitted if the conditions in 12.87(b)(1)(ii) are met. 21 CFR 16.60(a) provides that a regulatory hearing is public, except when the Commissioner determines that all or part of a hearing should be closed to prevent a clearly unwarranted invasion of personal privacy; to prevent the disclosure of a trade secret or confidential commercial or financial information that is not available for public disclosure under § 20.61; or to protect investigatory records compiled for law enforcement purposes that are not available for public disclosure under § 20.64. 21 CFR 17.37 provides for both written and oral testimony.
How many hearing officers preside at each hearing?: 
One
Is witness testimony permitted at hearings?: 
Varies by Case
If "Varies by Case," please describe: 
Witness testimony is permitted at hearings in-person, phone, or video hearings. This question is not applicable to document-only hearings.
Can parties cross-examine witnesses?: 
Varies by Case
If "Varies by Case," please describe: 
21 CFR 12.87(b)(1)(ii) provides that oral cross-examination of witnesses will be permitted if it appears that alternative means of developing the evidence are insufficient for a full and true disclosure of the facts and that the party requesting oral cross-examination will be prejudiced by denial of the request or that oral cross-examination is the most effective and efficient means to clarify the matters at issue. Under 21 CFR 16.60(b), all parties may confront and conduct reasonable cross-examination of any person (except for the presiding officer and counsel for the parties) who makes any statement on the matter at the hearing. 21 CFR 17.37(d) states that the presiding officer shall permit the parties to conduct cross examination as may be required for a full disclosure of facts. This question is not applicable to document-only hearings.
Can third-parties submit amicus briefs and/or evidence?: 
Yes
No
Are hearings recorded and/or transcribed?: 
Yes
Discretion of Adjudication Officer(s)
Are hearings open to the public?: 
Varies by Case
If "Varies by Case," please describe: 
Part 12 does not directly address whether a hearing will be public. 21 CFR 16.60(a) states that a regulatory hearing is public, except when the Commissioner determines that all or part of a hearing should be closed to prevent a clearly unwarranted invasion of personal privacy; to prevent the disclosure of a trade secret or confidential commercial or financial information that is not available for public disclosure under § 20.61; or to protect investigatory records compiled for law enforcement purposes that are not available for public disclosure under § 20.64. 17.15(a) does not directly address whether a hearing is public but provides that the parties to the hearing shall be the respondent and the Center(s) with jurisdiction over the matter at issue and that no other person may participate. This question is not applicable to document-only hearings.
PROCESS & PROCEDURE - Post-Hearing Procedure
Who typically drafts the decision at the hearing-level stage?: 
Adjudication Officer
Staff Attorney
Who has authority to issue final decisions?: 
Adjudication Officer
Other
If "Other," please specify: 
Under 21 CFR 12.120, the presiding officer shall issue the initial decision. The initial decision becomes the final decision of the Commissioner by operation of law unless a participant files exceptions or the Commissioner files a notice of review under 12.125(f). 21 CFR 16.95(b)(2) provides that the Commissioner shall issue a final decision with respect to a regulatory hearing at the Commissioner's initiative under 21 CFR 16.1(b). Under 21 CFR 17.45, the presiding officer shall issue the initial decision.
Do agency regulations or guidance provide time limits for issuance of final decisions?: 
Yes (Some Types of Cases)
If "Yes," please specify these time limit(s): 
21 CFR part 12 and part 16 are silent on a time limit for issuance of an initial decision. However, other regulations may provide for a time limit. For example, 21 CFR 1.403 provides that hearings on appeals of detention orders are conducted in accordance with 21 CFR part 16. Under 21 CFR 1.405, the presiding officer must issue a report that includes a proposed decision confirming or revoking the detention by noon on the fifth calendar day after the appeal is filed. 21 CFR 17.45(c) provides that the presiding officer shall issue an initial decision within 90 days and that the Commissioner may set a new deadline if the presiding officer believes he or she cannot meet the 90-day deadline. Some FDA Staff Manual Guides provide target time frames for issuance of decisions on particular matters. For example, FDA has developed SMG 7714 for the disqualification of an Institutional Review Board, which proceeds under part 16. This SMG provides a target time frame for issuance of a decision by the Commissioner within 90 days of receipt of the presiding officer's report.
Is judicial review available after issuance of a final decision?: 
Yes (All Types of Cases)
PROCESS & PROCEDURE - Case Management
How are claims/cases processed at the hearing-level stage?: 
Other
Please briefly describe your case management practice(s) at the hearing level stage: 
For some types of cases, there are internal documents with target time frames for processing. 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.
Does the agency permit web-based electronic filing of hearing-related briefs or other documents?: 
Yes
Are final decisions 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: 
21 CFR 12.120(f) provides that notice that the initial decision has become the decision of the Commissioner without appeal to or review by the Commissioner will be published in the Federal Register and that the Commissioner may publish the decision when it is of widespread interest. 21 CFR Part 16 is silent on publication of decisions. Information relevant to decisions may be available on FDA's website. For example, the list of disqualified Clinical Investigators disqualified under 21 CFR 312.70, 21 CFR 511(c)(2), or 21 CFR 812.119(b) and copies of the Commissioner's decisions are available at http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm For matters in which an HHS ALJ serves as the presiding officer, HHS posts all decisions on its website. http://www.hhs.gov/dab/decisions/
Do agency regulations/rules of practice specify the contents of the administrative record at the hearing-level stage?: 
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 at the hearing-level stage (subject to applicable exce: 
Yes (Some Types of Cases)
If "Yes," please provide citation(s): 
21 CFR 12.100(b) and 21 CFR 16.80(b) address closure of the record. 21 CFR 17.41(b) addresses the content of the record and provides a deadline for corrections to the hearing transcript but does not directly address closure of the record. 21 CFR 17.43 addresses and sets a timeline for the submission of posthearing briefs.
ADR: General Information
Is ADR available at one or more points during the hearing process?: 
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
Settlement Conference
Who conducts the ADR?: 
Third-Party Neutral
Agency Program Official
Agency ADR Official
Agency Counsel
Regulations/rules of practice governing ADR process (please include CFR citations): 
Under 21 CFR 12.70(d) the presiding officer has all powers necessary to conduct a fair, expeditious, and orderly hearing, including the power to hold conferences to settle, simplify, or determine the issues in a hearing or to consider other matters that may expedite the hearing. 21 CFR 17.15(b) provides that the parties may at any time prior to a final decision agree to a settlement of all or part of the matter.
Comments/Notes on ADR Process (Optional): 
Parts 12, 16 and 17 do not provide for a formal ADR program. However, FDA and the parties may have a settlement conference in the course of such proceedings. Parties to FDA matters that are heard by HHS ALJs may participate in mediation, as described on the HHS departmental appeals board website.
CASELOAD STATISTICS - Supplementary Statistics
Does your agency maintain annual caseload statistics for this hearing office by case type (e.g., discrimination complaint, licen: 
No
If "Yes," please indicate preferred format below.: 
By providing case type statistics on this form
Web address: 
For CTP, http://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm
WRAP-UP
Do you have any additional comments about your agency's responses on this form? If so, please provide comments below.: 
Information was not received from all of the Centers and Offices within FDA regarding caseload statistics.
Verified by Agency: 
Verified