0910-AF11 200904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 201.56 and 201.57 21 CFR 201.80 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 358 21 USC 360 21 USC 360b 21 USC 360gg to 360ss 21 USC 371 21 USC 374 21 USC 379e 42 USC 216 42 USC 241 42 USC 262 42 USC 264 No NPRM 05/29/2008 73 FR 30831 NPRM Comment Period End 08/27/2008 Final Action 03/00/2010 Yes Businesses State Yes No Yes No Rachel Bressler S. 0910 Food and Drug Administration FDA 301 796-4288 301 847-8440 rachel.bressler@fda.hhs.gov Center for Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002