Title 21, Part 60 — Patent Term Restoration
17 sections
Section 60.1
Scope.
Section 60.2
Purpose.
Section 60.3
Definitions.
Section 60.10
FDA assistance on eligibility.
Section 60.20
FDA action on regulatory review period determinations.
Section 60.22
Regulatory review period determinations.
Section 60.24
Revision of regulatory review period determinations.
Section 60.26
Final action on regulatory review period determinations.
Section 60.28
Time frame for determining regulatory review periods.
Section 60.30
Filing, format, and content of petitions.
Section 60.32
Applicant response to petition.
Section 60.34
FDA action on petitions.
Section 60.36
Standard of due diligence.
Section 60.40
Request for hearing.
Section 60.42
Notice of hearing.
Section 60.44
Hearing procedures.
Section 60.46
Administrative decision.