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Part 60
FEDERAL · 21 CFR
Part 60 — Patent Term Restoration
17 sections · Title 21: Food and Drugs
§ 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.