What deadlines are set in the Federal Register Notice regarding regulatory review period determinations?
This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.
The Federal Register Notice sets two important deadlines:
- A deadline 180 days after publication for filing written comments or petitions regarding the marketing applicant’s due diligence during the regulatory review period.
- A deadline 60 days after publication for requesting redetermination if anyone believes the published dates are incorrect.
MPEP 2757 states: “The Federal Register Notice also sets a date, 180 days after publication of the notice, as a deadline for filing written comments concerning any of the information set forth in the notice or a petition for a determination regarding whether the marketing applicant has acted with due diligence during the regulatory review period. The Federal Register Notice also sets a date, which is 60 days after publication of the notice, for anyone with information that the published dates are incorrect to request redetermination.“