Part 60 — Patent Term Restoration
Current through Sep 8, 2026
Authority: 21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 42 U.S.C. 262.
Source: 53 FR 7305, Mar. 7, 1988, unless otherwise noted.
Editorial Note: Nomenclature changes to part 60 appear at 68 FR 24879, May 9, 2003, and at 88 FR 45065, July 14, 2023.
Sections
- § 60.1 Scope.
- § 60.2 Purpose.
- § 60.3 Definitions.
- § 60.10 FDA assistance on eligibility.
- § 60.20 FDA action on regulatory review period determinations.
- § 60.22 Regulatory review period determinations.
- § 60.24 Revision of regulatory review period determinations.
- § 60.26 Final action on regulatory review period determinations.
- § 60.28 Time frame for determining regulatory review periods.
- § 60.30 Filing, format, and content of petitions.
- § 60.32 Applicant response to petition.
- § 60.34 FDA action on petitions.
- § 60.36 Standard of due diligence.
- § 60.40 Request for hearing.
- § 60.42 Notice of hearing.
- § 60.44 Hearing procedures.
- § 60.46 Administrative decision.