0910-AF97 201404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Abbreviated New Drug Applications and 505(b)(2) Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 314.3 21 CFR 314.50 21 CFR 314.52 21 CFR 314.53 21 CFR 314.54 21 CFR 314.60 21 CFR 314.70 21 CFR 314.90 21 CFR 314.93 to 314.97 21 CFR 314.99 21 CFR 314.101 21 CFR 314.105 21 CFR 314.107 21 CFR 314.108 21 CFR 314.125 21 CFR 314.127 21 CFR 320.1 21 CFR 320.23 PL 108-173, title XI 21 USC 355 21 USC 371 No NPRM 05/00/2014 Yes Businesses None No Yes No 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