Determination of Regulatory Review Period for Purposes of Patent Extension; SupprelinRegister; Correction

概要

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 2, 1992 (57 FR 23237), that announced its determination of the regulatory review period for purposes of patent extension for Supprelin (histrelin acetate). The document was published with some mathematical errors. The document incorrectly stated, ``FDA has determined that the applicable regulatory review period for Supprelin is 2,876 days. Of this time, 1,930 days occurred during the testing phase of the regulatory review period, while 946 days occurred during the approval phase.'' It should have stated, ``FDA has determined that the applicable regulatory review period for Supprelin is 2,878 days. Of this time, 1,931 days occurred during the testing phase of the regulatory review period, while 947 days occurred during the approval phase.'' This document corrects those errors.