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HHS/FDA | RIN: 0910-AG71 | Publication ID: 2012 |
Title: Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products | |
Abstract: FDA is finalizing a rule to amend its human subject protection regulations and institutional review board regulations. FDA is taking this action to provide additional safeguards for children enrolled in FDA-regulated clinical trials. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 50 21 CFR 56 | |
Legal Authority: 21 USC 343 21 USC 350a 21 USC 350b 21 USC 352 to 353 21 USC 355 21 USC 360j 21 USC 371 42 USC 262 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Robert "Skip" Nelson Lead Medical Officer Department of Health and Human Services Food and Drug Administration WO 32, Room 5126, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-8665 Email: robert.nelson@fda.hhs.gov |