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HHS/FDA RIN: 0910-AI29 Publication ID: Fall 2023 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 60   
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Beverly Friedman
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 51, Room 6250,
Silver Spring, MD 20993
Phone:301 796-3468