[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.1]

[Page 344]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 60_PATENT TERM RESTORATION--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 60.1  Scope.




                      Subpart A_General Provisions

Sec.
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.

    Editorial Note: Nomenclature changes to part 60 appear at 68 FR 
24879, May 9, 2003.



    (a) This part sets forth procedures and requirements for the Food 
and Drug Administration's review of applications for the extension of 
the term of certain patents under 35 U.S.C. 156. Patent term restoration 
is available for certain patents related to drug products (as defined in 
35 U.S.C. 156(f)(2)), and to medical devices, food additives, or color 
additives subject to regulation under the Federal Food, Drug, and 
Cosmetic Act or the Public Health Service Act. Food and Drug 
Administration actions in this area include:
    (1) Assisting the United States Patent and Trademark Office in 
determining eligibility for patent term restoration;
    (2) Determining the length of a product's regulatory review period;
    (3) If petitioned, reviewing and ruling on due diligence challenges 
to the Food and Drug Administration's regulatory review period 
determinations; and
    (4) Conducting hearings to review initial Food and Drug 
Administration findings on due diligence challenges.
    (b) References in this part to the Code of Federal Regulations are 
to chapter I of title 21, unless otherwise noted.

[53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992]