Not later than 30 days after the receipt of an application from PTO, APHIS shall determine the regulatory review period. Once the regulatory review period for a product has been determined, APHIS will notify PTO in writing of the determination, send a copy of the determination to the applicant, and make a copy available for public inspection in room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.
APHIS will also publish a notice of the regulatory review period determination in the Federal Register. The notice will include the following:
The name of the applicant;
The trade name and true name of the product;
The number of the patent for which an extension of the term is sought;
The approved indications or uses for the product;
The regulatory review period determination, including a statement of the length of each phase of the review period and the dates used in calculating each phase.
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