0910-AG48 201004 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; Acceptance of Clinical Studies Conducted Outside the United States Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 812.2(e) 21 CFR 812.3(t) 21 CFR 812.27(b)(4) 21 CFR 812.28 21 CFR 814.15 21 CFR 814.20(b)(6)(ii)(C) 21 CFR 814.45(a)(5) 21 CFR 814.46(a)(4) 21 CFR 807.87(j) ... 21 USC 331 21 USC 351 to 352 21 USC 360 21 USC 360c 21 USC 360e to 360h 21 USC 360j No NPRM 12/00/2010 NPRM Comment Period End 03/00/2011 No Businesses None No No Yes Aaliyah Eaves K. 0910 Food and Drug Administration FDA 301 796-2948 301 847-8120 aaliyah.eaves-leanos@fda.hhs.gov Center for Devices and Radiological Health, WO 66, Room 5422, 10903 New Hampshire Avenue, Silver Spring MD 20993