21 CFR 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
(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.