0910-AG94 201304 Update to the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 314.70 21 CFR 314.97 21 CFR 314.150 21 CFR 601.12 21 USC 321 21 USC 331 21 USC 352 21 USC 353 21 USC 355 21 USC 371 42 USC 262 ... No NPRM 09/00/2013 Yes Businesses Undetermined No Yes Yes Janice Weiner L. 0910 Food and Drug Administration FDA 301 796-3475 301 847-8440 janice.weiner@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring MD 20993-0002