Are private parties permitted to have representation at hearings?:
Yes (All Types of Cases)
Who may serve as a private party representative?:
Either
Regulations/rules of practice for hearings (please include CFR citations):
21 CFR 1316.31-1316.34
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:
By Private Party
How many hearing officers preside at each hearing?:
One
Can third-parties submit amicus briefs and/or evidence?:
No
Are hearings recorded and/or transcribed?:
Discretion of Adjudication Officer(s)
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?:
No
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
Do agency regulations/rules of practice specify the contents of the administrative record at the hearing-level stage?:
No
Do agency regulations/rules of practice provide for closure of the record at the hearing-level stage (subject to applicable exce:
No
Is ADR available at one or more points during the hearing process?:
No
Verified by Agency:
Not verified