[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.28]

[Page 321-322]
 
                        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 C--Regulatory Review Period Determinations
 
Sec. 60.28  Time frame for determining regulatory review periods.

    (a) FDA will determine the regulatory review period for a product

[[Page 322]]

within 30 days of the receipt of a written request from PTO for such a 
determination and a copy of the patent term restoration application.
    (b) FDA may extend the 30-day period if:
    (1) A related FDA action that may affect the regulatory review 
period determination is pending; or
    (2) PTO requests that FDA temporarily suspend the determination 
process; or
    (3) PTO or FDA receives new information about the product that 
warrants an extension of the time required for the determination of the 
regulatory review period.
    (c) This section does not apply to applications withdrawn by the 
applicant or applications that PTO determines are ineligible for patent 
term restoration.