View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AI29 Publication ID: Spring 2019 
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, including 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 60   
Legal Authority: Pub. L. 114-89 sec. 2    Pub. L. 12-29 sec. 37   
Legal Deadline:  None
Action Date FR Cite
NPRM  02/00/2020 
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