0910-AC07 200310 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 Investigations of FDA-Regulated Products The final rule will finalize the interim rule that published in April 2001, providing additional protections for children involved as subjects in clinical investigations of FDA-regulated products, as required by the Children's Health Act of 2000. Other Significant Previously Published in The Unified Agenda Final Rule Stage Undetermined Undetermined 21 CFR 50 21 CFR 56 21 USC 321 21 USC 343 21 USC 346 21 USC 346a 21 USC 348 21 USC 350a 21 USC 350b 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360c to 360f 21 USC 360h to 360j 21 USC 371 21 USC 379e 21 USC 381 41 USC 216 41 USC 241 41 USC 262 41 USC 263b to 263n Statutory Other 04/17/2001 The Children's Health Act of 2000 requires that, within six months of the date of its enactment on October 17, 2000, FDA adopt existing HHS regulations providing additional protections for children in No Interim Rule 04/24/2001 66 FR 20589 Final Rule 03/00/2004 Undetermined No None NA Not Collected Carol Drew 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6306, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002