TITLE 21--FOOD AND DRUGS 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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