§ 124.22 Revision of regulatory review period determination.

(a) Any interested person may request a revision of the regulatory review period determination within the 30 day period beginning on its publication in the Federal Register. The request must be sent to the Director, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010. The request must specify the following: (1) The identity of the product; (2) The identity of the applicant for patent term restoration; (3) The docket number of the Federal Register notice announcing the regulatory review period determination; and (4) The basis for the request for revision, including any documentary evidence. (b) If APHIS decides to revise its prior determination, APHIS will notify PTO of the decision, and will send a copy of notification to the applicant and the person requesting the revision (if different from the applicant) with a request for comments within 10 days of notification. If no comment on the proposed revision is received, APHIS will publish the revision in the Federal Register, and include a statement giving the reasons for the revision. If comment is received, APHIS will make a final determination regarding the revision based on such comment and will then publish the revision in the Federal Register, giving reasons for its determination.