eCFR Reference Browser

---

title: "21 CFR §60.44"

source: "https://www.ecfr.gov/current/title-21/section-60.44"

title_number: "21"

volume_number: "1"

chapter_number: "Unknown"

subchapter_code: "A"

subchapter_subject: "GENERAL"

part_code: "60"

part_subject: "PATENT TERM RESTORATION"

subpart_code: "E"

subpart_subject: "Due Diligence Hearings"

section_number: "60.44"

section_subject: "Hearing procedures."

cfr_reference: "21 CFR 60.44"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 1 to 99"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§60.44 - Hearing procedures.