§60.36. Standard of due diligence. — Inbound Citations

(a) Within 90 days after FDA receives a petition filed under § 60.30(a), the agency will either deny the petition under paragraph (b) or (c) of this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal Register, notify PTO of the due diligence determination in writing, and send copies of the notice to PTO, the applicant, and the petitioner.

The due diligence hearing shall be conducted in accordance with this part, supplemented by the nonconflicting procedures in part 16. During the due diligence hearing, the applicant and the petitioner shall enjoy all the rights and privileges accorded a person requesting a hearing under part 16. The standard of due diligence set forth in § 60.36 will apply in the due diligence hearing. The party requesting the due diligence hearing shall have the burden of proof at the hearing.