0910-AF97 200704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Proposed Revisions to 21 CFR Parts 314 and 320 To Implement Portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Other Changes Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 314.3 21 CFR 314.50 21 CFR 314.52 21 CFR 314.53 21 CFR 314.60 21 CFR 314.70 21 CFR 314.94 21 CFR 314.95 21 CFR 314.96 21 CFR 314.97 21 CFR 314.101 21 CFR 314.105 21 CFR 314.107 21 CFR 314.108 21 CFR 320.1 21 CFR 320.23 PL 108-173, title XI 21 USC 355 21 USC 371 No NPRM 03/00/2008 Undetermined None No NA Not Collected Janice Weiner L. 0910 Food and Drug Administration FDA 301 796-3475 301 847-8440 janice.weiner@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring MD 20993-0002