Title 21

PART 60

Part 60 - Patent Term Restoration

PART 60 - PATENT TERM RESTORATION 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.

21:1.0.1.1.25.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.25.1.63.1SECTION 60.1
   60.1 Scope.
21:1.0.1.1.25.1.63.2SECTION 60.2
   60.2 Purpose.
21:1.0.1.1.25.1.63.3SECTION 60.3
   60.3 Definitions.
21:1.0.1.1.25.2SUBPART B
Subpart B - Eligibility Assistance
21:1.0.1.1.25.2.63.1SECTION 60.10
   60.10 FDA assistance on eligibility.
21:1.0.1.1.25.3SUBPART C
Subpart C - Regulatory Review Period Determinations
21:1.0.1.1.25.3.63.1SECTION 60.20
   60.20 FDA action on regulatory review period determinations.
21:1.0.1.1.25.3.63.2SECTION 60.22
   60.22 Regulatory review period determinations.
21:1.0.1.1.25.3.63.3SECTION 60.24
   60.24 Revision of regulatory review period determinations.
21:1.0.1.1.25.3.63.4SECTION 60.26
   60.26 Final action on regulatory review period determinations.
21:1.0.1.1.25.3.63.5SECTION 60.28
   60.28 Time frame for determining regulatory review periods.
21:1.0.1.1.25.4SUBPART D
Subpart D - Due Diligence Petitions
21:1.0.1.1.25.4.63.1SECTION 60.30
   60.30 Filing, format, and content of petitions.
21:1.0.1.1.25.4.63.2SECTION 60.32
   60.32 Applicant response to petition.
21:1.0.1.1.25.4.63.3SECTION 60.34
   60.34 FDA action on petitions.
21:1.0.1.1.25.4.63.4SECTION 60.36
   60.36 Standard of due diligence.
21:1.0.1.1.25.5SUBPART E
Subpart E - Due Diligence Hearings
21:1.0.1.1.25.5.63.1SECTION 60.40
   60.40 Request for hearing.
21:1.0.1.1.25.5.63.2SECTION 60.42
   60.42 Notice of hearing.
21:1.0.1.1.25.5.63.3SECTION 60.44
   60.44 Hearing procedures.
21:1.0.1.1.25.5.63.4SECTION 60.46
   60.46 Administrative decision.