CFR > Title 9 - Animals and Animal Products > CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE > SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS (parts 101 to 124) > PART 124—PATENT TERM RESTORATION > SUBPART C—Regulatory Review Period (§124.20 to §124.23) > 124.21—Regulatory review period determination.

124.21—Regulatory review period determination.

(a) 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.
(b) APHIS will also publish a notice of the regulatory review period determination in the Federal Register. The notice will include the following:
(1) The name of the applicant;
(2) The trade name and true name of the product;
(3) The number of the patent for which an extension of the term is sought;
(4) The approved indications or uses for the product;
(5) 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.