Regulatory Counsel

0910-AI29 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amendments to Patent Term Restoration

FDA is proposing to amend its Patent Term Restoration regulations to identify the effective date of approval for scheduled drugs, to define when the 60-day period referred to in 35 U.S.C. 156(d)(1) begins, to define the term business day for purposes of patent term extension, and to explain how approvals transmitted after 4:30 p.m. fit in this definition. The proposed amendments will update FDA regulations to incorporate the statutory amendments. Other proposed changes to the regulations will make them conform with existing practices.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 60 35 U.S.C. 156, including subsection 156(d)(1) as amended by Pub. L. 112-29 sec. 37 Pub. L. 114-89 sec. 2 and subsection 156(i) as added by Pub. L. 114-89 sec. 2 secs. 505(x), 512(q), 572(k), and 573(c)(3) of the FD&C Act sec. 351 of the PHS Act, as added by Pub. L. 114-89 sec. 2 No NPRM 02/00/2024 No No Undetermined Undetermined No No No Beverly Friedman Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3468 beverly.friedman@fda.hhs.gov 10903 New Hampshire Avenue, WO 51, Room 6250, Silver Spring MD 20993