Determination of Regulatory Review Period for Purposes of Patent Extension; Neuro Cybernetic Prosthesis (NCP®) System; Amendment

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The Food and Drug Administration (FDA) is amending a previous determination regarding the regulatory review period for the Neuro Cybernetic Prosthesis (NCP ) System that appeared in the Federal Register of November 10, 1998 (63 FR 63066). FDA is amending the notice because the agency agrees with the information provided in a request from the applicant for revision of the regulatory review period (Request) (Docket No. 98E-022 8/PRC 1, dated and received on January 8, 1999).