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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
 
PART 60PATENT 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.

Authority: 21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 42 U.S.C. 262.
Source: 53 FR 7305, Mar. 7, 1988, unless otherwise noted.

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