0910-AF15 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 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined 21 CFR 312.120 21 USC 355(d)(5) 21 USC 355(i) 21 USC 371(a) 42 USC 262(a)(2)(A) 42 USC 262(a)(2)(B)(i)(l) No NPRM 05/00/2004 No Businesses None No No NA Not Collected Brian Pendleton L. 0910 Food and Drug Administration FDA 301 796-4614 301 847-3541 brian.pendleton@fda.hhs.gov Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002