Other Fields
Agency Scheme: 
Hearing Level: Basic Structure
Name of Hearing Office (local name): 
Center for Veterinary Biologics
Name of Hearing Office (global name): 
Department of Agriculture: Center for Veterinary Biologics
Policy, Evaluation, and Licensing (APHIS/PEL)
Hearing Officer #1 (Title): 
Under Secretary for Marketing & Reg. Programs
Hearing Officer #2 (Title): 
Presiding Officer
Are administrative appeals permitted from final decisions at the hearing-level stage?: 
Comments/Notes on Adjudication Structure: 

Joint adjudication scheme (along with Department of Commerce's Patent and Trademark Office (PTO)) relating to requests for extension of patent terms for veterinary biological products under the Virus-Serum Toxin Act. APHIS's role is to determine length of a product's regulatory review period and, if a due diligence petition is filed by an interested party, to hold an informal hearing on the petition. (9 CFR Part 124). APHIS determinations on regulatory review period are designed to used be in conjunctions with PTO regulations concerning patent term extensions. (PTO rules: 37 CFR 1.1710 - 1.791).

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?: 
Is the agency permitted to have representation at hearings?: 
Regulations/rules of practice for hearings (please include CFR citations): 
7 CFR Part 124
PROCESS & PROCEDURE - Pre-Hearing Procedure
Is discovery permitted by either party at the hearing-level stage?: 
Does the hearing officer have subpoena authority?: 
Are ex parte contacts prohibited?: 
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?: 
How is the type of hearing selected: 
Required by Rule
How many hearing officers preside at each hearing?: 
Is witness testimony permitted at hearings?: 
Can parties cross-examine witnesses?: 
Can third-parties submit amicus briefs and/or evidence?: 
Are hearings recorded and/or transcribed?: 
Discretion of Adjudication Officer(s)
PROCESS & PROCEDURE - Post-Hearing Procedure
Who typically drafts the decision at the hearing-level stage?: 
Adjudication Officer
Who has authority to issue final decisions?: 
If "Other," please specify: 
The Under Secretary for Marketing and Regulatory Programs issues the final decision on the due diligence redetermination. At the conclusion of the hearing, the Presiding Officer prepares a written report and attaches the hearing record. The Under Secretary reviews these documents, and then issues his/her final decision. The Under Secretary's final decision is published in the Federal Register, and copies are provided to PTO and the hearing parties. (7 CFR 124.42(e), 124.43)
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): 
Within 30 days of the due diligence hearing, the Under Secretary issues his/her written decision.
Is judicial review available after issuance of a final decision?: 
PROCESS & PROCEDURE - Case Management
How are claims/cases processed at the hearing-level stage?: 
First-In/First-Out Basis
Does the agency permit web-based electronic filing of hearing-related briefs or other documents?: 
Are final decisions published and/or posted on the agency website?: 
Yes (All Decisions)
Do agency regulations/rules of practice specify the contents of the administrative record at the hearing-level stage?: 
Do agency regulations/rules of practice provide for closure of the record at the hearing-level stage (subject to applicable exce: 
Comments/Notes on Hearing-Level Adjudicators (Optional): 
USDA regulations do not specify who serves as the "Presiding Officer" for due diligence petition hearings, other than to note that such person (a) is appointed by the APHIS Administrator from among USDA officers or employees, and (b) must not have participated previously in matters related to the petition. (7 CFR 124.42(a))
ADR: General Information
Is ADR available at one or more points during the hearing process?: 
Verified by Agency: 
Not verified