0910-AG54 201210 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 General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined Private Sector 21 CFR 880.5725 21 USC 351 21 USC 360 21 USC 360c 21 USC 360e 21 USC 360j 21 USC 371 No NPRM 03/00/2013 Includes Retrospective Review under E.O. 13563. Yes Businesses State Yes No Yes No Karen Fikes 0910 Food and Drug Administration FDA 240 402-7911 karen.fikes@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring MD 20993