0910-AF11 200310 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 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation The proposed rule would amend FDA regulations concerning the format and content of the "Pregnancy," "Labor and Delivery," and "Nursing Mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drugs. The proposal would require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined 21 CFR 201.57 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 358 21 USC 360 21 USC 360(b) 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 07/00/2004 Undetermined Businesses Undetermined Undetermined NA Not Collected Christine Rogers F. 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 christine.rogers@fda.hhs.gov Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6316, Silver Spring MD 20993-0002