21 CFR § 60.46 - Administrative decision.

---
identifier: "/us/cfr/t21/s60.46"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 60.46 - Administrative decision."
title_number: 21
title_name: "Food and Drugs"
section_number: "60.46"
section_name: "Administrative decision."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "60"
part_name: "PATENT TERM RESTORATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 42 U.S.C. 262."
regulatory_source: "53 FR 7305, Mar. 7, 1988, unless otherwise noted."
cfr_part: "60"
---


# 60.46 Administrative decision.

Within 30 days after the completion of the due diligence hearing, the Commissioner will affirm or revise the determination made under § 60.34(a) and will publish the due diligence redetermination in the *Federal Register,* notify PTO of the redetermination, and send copies of the notice to PTO and to the requesting party, the applicant, and the petitioner.