0910-AG71 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products 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. Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 50 21 CFR 56 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 No Interim Final Rule 04/24/2001 66 FR 20589 Final Action 12/00/2012 No No Federal No No Robert "Skip" Nelson 0910 Food and Drug Administration FDA 301 796-8665 robert.nelson@fda.hhs.gov WO 32, Room 5126, 10903 New Hampshire Avenue, Silver Spring MD 20993