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HHS/FDA | RIN: 0910-AF97 | Publication ID: Fall 2015 |
Title: Abbreviated New Drug Applications and 505(b)(2) | |
Abstract:
This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications and related applications to patent certifications, notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements, and the types of bioavailability and bioequivalence data that can be used to support these applications. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 314.3 21 CFR 314.50 21 CFR 314.52 21 CFR 314.53 21 CFR 314.54 21 CFR 314.60 21 CFR 314.70 21 CFR 314.90 21 CFR 314.93 to 314.97 21 CFR 314.99 21 CFR 314.101 21 CFR 314.105 21 CFR 314.107 21 CFR 314.108 21 CFR 314.125 21 CFR 314.127 21 CFR 320.1 21 CFR 320.23 | |
Legal Authority: Pub. L. 108-173, title XI 21 U.S.C. 355 21 U.S.C. 371 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Janice L. Weiner Principal Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring, MD 20993-0002 Phone:301 796-3475 Fax:301 847-8440 Email: janice.weiner@fda.hhs.gov |