0910-AB91 200404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format The Food and Drug Administration (FDA) amended its regulations governing the format in which certain labeling in new drug applications, abbreviated new drug applications, certain biological license applications, supplements, and annual reports are required to be submitted. The rule requires that certain labeling content described under section 201.100(d)(3) be submitted to FDA in an electronic format that FDA can process, review, and achieve. Other Significant Previously Published in The Unified Agenda Completed Actions No Private Sector 21 CFR 314 21 CFR 601 21 USC 321 21 USC 331 21 USC 351 21 USC 353 21 USC 355 21 USC 360 21 USC 371 21 USC 374 21 USC 379e 42 USC 262 ... No NPRM 05/03/2002 67 FR 22367 Final Action 12/11/2003 68 FR 69009 No Businesses Federal NA Not Collected Nicole Mueller K. 0910 Food and Drug Administration FDA 301 796-3507 301 827-8440 nicole.mueller@fda.hhs.gov Room 3037, (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6312, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002