• The New Drug Application (NDA) holder must submit patent information to its NDA using the appropriate form (see 21 CFR 314.53(d)). An applicant described in paragraph (a) of this section must submit to its NDA the required information, on the required FDA declaration form.Patent information for listing in the orange book must be submitted on form 3542 within 30 days following the approval of an NDA or supplement. The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information. The FTC filed an amicus brief in the Teva v. The provisional patent application cover sheet is a form that you file with the specification and drawings of your patent application. Patent foramen ovale (PFO) is a hole between your heart's upper chambers. You can fill out the provisional patent application cover sheet yourself but it is often helpful to hire a patent attorney to do it for you. Pharmaceutical manufacturers are increasingly finding themselves defending decisions to list in the US Food and Drug Administration's (FDA) Orange Book patents. Patent foramen ovale, a congenital defect, was identified after service. 2.