0910-AC05 200110 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 Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human Studies Are Unethical Other Significant Previously Published in The Unified Agenda Final Rule Stage Undetermined No 21 CFR 314 21 CFR 601 15 USC 1451 to 1561 21 USC 331 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 374 21 USC 379e 21 USC 381 42 USC 216 42 USC 241 42 USC 262 42 USC 263b 21 USC 321 PL 105-115, sec 122, 111 stat 2322 (21 USC 355 note) Yes NPRM 10/05/1999 64 FR 53960 Final Action 04/00/2002 No None No NA Not Collected Wayne Mitchell H. 0910 Food and Drug Administration FDA 301 594-2041 301 827-0951 wayne.mitchell@fda.hhs.gov Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-7, Rockville MD 20857 Not Procurement Related No