21 CFR 60.32 - Applicant response to petition.
(a) The applicant shall file with FDA a written response to the petition no later than 30 days after the applicant's receipt of a copy of the petition.
(b) The applicant's response may present additional facts and circumstances to address the assertions in the petition, but shall be limited to the issue of whether the applicant acted with due diligence during the regulatory review period. The applicant's response may include documents that were not in the original patent extension application.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.