[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: 21CFR60.28]
[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
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
[[Page 322]]
(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(c) This section does not apply to applications withdrawn by the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.
Back to Top
© 2007 Betterchem Corp.
|
