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Section 60.1
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Purpose |
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Section 60.2
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Definitions |
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Section 60.3
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FDA assistance on eligibility |
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Section 60.10
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FDA action on regulatory review period determinations |
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Section 60.20
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Regulatory review period determinations |
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Section 60.22
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Revision of regulatory review period determinations |
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Section 60.24
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Final action on regulatory review period determinations |
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Section 60.26
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Time frame for determining regulatory review periods |
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Section 60.28
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Filing, format, and content of petitions |
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Section 60.30
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Applicant response to petition |
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Section 60.32
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FDA action on petitions |
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Section 60.34
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Standard of due diligence |
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Section 60.36
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Request for hearing |
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Section 60.40
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Notice of hearing |
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Section 60.42
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Hearing procedures |
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Section 60.44
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Administrative decision |
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Section 60.46
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Definitions |