21 CFR 60.28 - Time frame for determining regulatory review periods.
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(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.
(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.
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.