(a) Any interested person may request, within 60 days beginning on the date of publication of a due diligence determination by APHIS in accordance with §124.32, that APHIS conduct an informal hearing on the due diligence determination.

(b) The request for a hearing must:

(1) Be in writing;

(2) Contain the docket number of the Federal Register notice of APHIS's regulatory review period determination;

(3) Be delivered to the Director, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010.

(4) Contain a full statement of facts upon which the request for hearing is based;

(5) Contain the name, the address, and the principal place of business of the person requesting the hearing; and

(6) Contain a certification that the person requesting the hearing has served a true and complete copy of the request upon the petitioner of the due diligence determination and the applicant for patent term extension by certified or registered mail (return receipt requested) or by personal service.

(c) The request must state whether the requesting party seeks a hearing not later than 30 days after the date APHIS receives the request, or, at the request of the person making the request, not later than 60 days after such date.

[58 FR 11369, Feb. 25, 1993, as amended at 59 FR 67617, Dec. 30, 1994; 64 FR 43045, Aug. 9, 1999; 75 FR 20773, Apr. 21, 2010]