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HHS/FDA

RIN: 0910-AG72

Publication ID: Spring 2011

Title: ●Orphan Drug Regulations
Abstract: FDA is proposing to amend the orphan drug regulations (21 CFR Part 316) to clarify issues that have arisen since those regulations were first issued in 1992. These proposed revisions are intended to assist sponsors who are seeking or who have obtained orphan-drug designation for their drugs. The 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 request for designations.
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
CFR Citation: 21 CFR 316
Legal Authority: 21 USC 360aa    21 USC 360bb    21 USC 360cc    21 USC 360dd    21 USC 371

Legal Deadline:  None

Timetable: Action Date FR Cite NPRM  12/00/2011

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