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HHS/FDA | RIN: 0910-AI29 | Publication ID: Fall 2021 |
Title: Amendments to Patent Term Restoration | |
Abstract:
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. |
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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 Pub. L. 114-89 sec. 2 Pub. L. 112-29 sec. 37 |
Legal Deadline:
None |
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Timetable:
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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 Email: beverly.friedman@fda.hhs.gov |