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?:
No
Regulations/rules of practice for hearings (please include CFR citations):
21 CFR 1404, Subparts F, G, and H
Is discovery permitted by either party at the hearing-level stage?:
No
Are ex parte contacts prohibited?:
No
Are parties provided notice of hearing?:
Yes (All Types of Cases)
What types of hearings are permitted at the hearing-level stage?:
Written (Document-Only) Hearing
In-Person
How is the type of hearing selected:
Required by Rule
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 may be permitted at in-person hearings. For document-only hearings, this question is N/A.
Can parties cross-examine witnesses?:
Varies by Case
If "Varies by Case," please describe:
Cross-examination may be permitted at in-person hearings. For document-only hearings, this question is N/A.
Can third-parties submit amicus briefs and/or evidence?:
No
Are hearings recorded and/or transcribed?:
Yes
N/A (Document-Only Hearings)
Who typically drafts the decision at the hearing-level stage?:
Adjudication Officer
Do agency regulations or guidance provide time limits for issuance of final decisions?:
Yes (All Types of Cases)
If "Yes," please specify these time limit(s):
The suspending or debarring official must issue a written decision within 45 days of closing the official record. See 21 CFR 1404.755, 1404.870.
Is judicial review available after issuance of a final decision?:
No
Does the agency permit web-based electronic filing of hearing-related briefs or other documents?:
No
Are final decisions published and/or posted on the agency website?:
No
If "Yes (Some Decisions)," how does the agency determine which final decisions to publish/post? Please briefly describe:
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 1404.750(a), 1404.845(b).
Do agency regulations/rules of practice provide for closure of the record at the hearing-level stage (subject to applicable exce:
Yes (All Types of Cases)
If "Yes," please provide citation(s):
21 CFR 1404.755, 1404.870(a).
Comments/Notes on Hearing-Level Process & Procedures (Optional):
Is ADR available at one or more points during the hearing process?:
No
Verified by Agency:
Not verified