[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.26]
[Page 321]
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
Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]
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