21 C.F.R. PART 60--PATENT TERM RESTORATION
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 60--PATENT TERM RESTORATION
Subpart A--GENERAL PROVISIONS
Subpart B--ELIGIBILITY ASSISTANCE
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| FDA assistance on eligibility.
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Subpart C--REGULATORY REVIEW PERIOD DETERMINATIONS
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| FDA action on regulatory review period determinations.
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| Regulatory review period determinations.
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| Revision of regulatory review period determinations.
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| Final action on regulatory review period determinations.
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| Time frame for determining regulatory review periods.
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Subpart D--DUE DILIGENCE PETITIONS
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| Filing, format, and content of petitions.
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| Applicant response to petition.
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| Standard of due diligence.
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Subpart E--DUE DILIGENCE HEARINGS
