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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 60 - Patent Term Restoration |
| 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. |