0910-AF21 200410 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 Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and Condoms with Spermicidal Lubricant The classification regulations for male condoms would be amended to specify a labeling guidance document as a special control for condoms made from NR latex. The new special control guidance document would identify issues requiring special controls and provide detailed recommendations for labeling to address these issues that together with the general controls, provides a reasonable assurance of the safety and effectiveness of these devices. These labeling recommendations are also consistent with the labeling requirements of 21 CFR 801. The rule will demonstrate how the agency is moving forward to meet the congressional directive of Public Law 106-554 that FDA review condom labeling to assure that the information regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases is medically accurate. Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 884.5300 21 CFR 884.5310 21 USC 360c No NPRM 12/00/2004 Undetermined Businesses None No NA Not Collected Joseph Sheehan M. 0910 Food and Drug Administration FDA 301 827-2974 301 594-4765 joseph.sheehan@fda.hhs.gov HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville MD 20850