[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.26]

[Page 327]
 
                        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. 60.26  Final action on regulatory review period determinations.

    (a) FDA will consider a regulatory review period determination to be 
final upon expiration of the 180-day period for filing a due diligence 
petition under Sec. 60.30 unless FDA receives:
    (1) New information from PTO records, FDA records, or FDA centers 
that affects the regulatory review period determination;
    (2) A request under Sec. 60.24 for revision of the regulatory review 
period determination;
    (3) A due diligence petition filed under Sec. 60.30; or
    (4) A request for a hearing filed under Sec. 60.40.
    (b) FDA will notify PTO that the regulatory review period 
determination is final upon:
    (1) The expiration of the 180-day period for filing a due diligence 
petition; or
    (2) If FDA has received a request for a revision, a due diligence 
petition, or a request for a hearing, upon resolution of the request for 
a revision, the petition, or the hearing, whichever is later. FDA will 
send a copy of the notification to the applicant and file a copy of the 
notification in the docket established for the application in FDA's 
Dockets Management Branch (HFA-305), rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]