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HHS/FDA | RIN: 0910-AG93 | Publication ID: Fall 2013 |
Title: Pediatric Study Plan Requirements for New Drug and Biologics License Applications | |
Abstract: FDA is proposing regulations to establish requirements for pediatric study plans. The proposed rule would implement section 506 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which is designed to facilitate pediatric product development. The proposed rule would require the submission of pediatric study plans earlier in the drug development process than currently occurs in many cases. FDA is also proposing requirements for the content of initial pediatric study plans, a process for reaching agreement with FDA on initial plans, and a process for amending pediatric study plans. | |
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: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 314.56 21 CFR 314.101 21 CFR 601.23 21 CFR 312.42 | |
Legal Authority: 21 USC 355B |
Legal Deadline:
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Overall Description of Deadline: Under section 506 of FDASIA, the proposed rule must be promulgated by July 9, 2013. |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Jane Inglese Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 51, Room 6210, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-3229 Fax:301 847-8752 Email: jane.inglese@fda.hhs.gov |