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Electronic Code of Federal Regulations

e-CFR data is current as of February 21, 2020

Title 21Chapter ISubchapter APart 60


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

rule

Subpart A—GENERAL PROVISIONS

§60.1
Scope.
§60.2
Purpose.
§60.3
Definitions.
rule

Subpart B—ELIGIBILITY ASSISTANCE

§60.10
FDA assistance on eligibility.
rule

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.
rule

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.
rule

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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