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HHS/FDA

RIN: 0910-AG72

Publication ID: Spring 2015

Title: Orphan Drug Regulations
Abstract: The final rule is intended to assist sponsors who are seeking or who have obtained orphan-drug designation for their drugs. These revisions would clarify agency policy regarding, for example, eligibility for orphan-drug designations, eligibility for multiple orphan-drug exclusive approvals, the requirement for demonstrating clinical superiority, and the timing of requests for designations. The rule published in June 2013.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 316
Legal Authority: 21 U.S.C. 360aa 21 U.S.C. 360bb 21 U.S.C. 360cc 21 U.S.C. 360dd 21 U.S.C. 371

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	10/19/2011	76 FR 64868
NPRM Comment Period End	01/17/2012
Final Action	06/12/2013	78 FR 35117

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Erica McNeilly Health Science Administrator Department of Health and Human Services Food and Drug Administration WO 32, Room 5286, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-8679 Email: erica.mcneilly@fda.hhs.gov