0910-AA94 200604 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products This regulation is one component of the Secretary's initiative to reduce medical errors. The regulation would amend the regulations governing the format and content of professional labeling for human prescription drugs (including biological products that are regulated as drugs), 21 CFR 201.56 and 201.57. The regulation would require that such labeling include highlights of prescribing information and a table of contents for prescribing information. It would reorder currently required information, make minor changes to its content, and establish minimum graphical requirements. Other Significant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 201 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 371 42 USC 262 Yes NPRM 12/22/2000 65 FR 81082 NPRM Comment Period End 03/22/2001 NPRM Comment Period Reopened 03/30/2001 66 FR 17375 NPRM Comment Period Reopening End 06/22/2001 Final Action 01/24/2006 71 FR 3922 Yes Businesses None NA Not Collected Elizabeth Sadove J. 0910 Food and Drug Administration FDA 301 796-3522 301 847-8440 elizabeth.sadove@fda.hhs.gov Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Avenue, Bldg. 51, Room 6368, Silver Spring MD 20993-0002