21 CFR Part 60
PART 60—PATENT TERM RESTORATION
- PART 60—PATENT TERM RESTORATION
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- Subpart A—General Provisions
- § 60.1 Scope.
- § 60.2 Purpose.
- § 60.3 Definitions.
- Subpart B—Eligibility Assistance
- § 60.10 FDA assistance on eligibility.
- Subpart C—Regulatory Review Period Determinations
- § 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.
- Subpart D—Due Diligence Petitions
- § 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.
- Subpart E—Due Diligence Hearings
- § 60.40 Request for hearing.
- § 60.42 Notice of hearing.
- § 60.44 Hearing procedures.
- § 60.46 Administrative decision.
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