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HHS/FDA RIN: 0910-AI29 Publication ID: Spring 2022 
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 beginning of the 60-day review period occurs for an application to extend the patent term, to define the term business day, and to explain how approvals after 4:30 p.m. fit in this definition. The proposed amendments will make existing FDA regulations consistent with 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 Part 60     (To search for a specific CFR, visit the Code of Federal Regulations.)
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  02/00/2023 
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