- (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.
- (c) This section does not apply to applications withdrawn by the applicant or applications that PTO determines are ineligible for patent term restoration.