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.

• 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.

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

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