0910-AG05 200804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Biological Products; Reporting of Biological Product Deviations in Manufacturing Info./Admin./Other First Time Published in The Unified Agenda Prerule Stage No No Section 610 Review 21 CFR 600.14 21 CFR 606.170 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 353 21 USC 355 21 USC 360 21 USC 360i 21 USC 360j 21 USC 371 21 USC 374 42 USC 216 42 USC 262 42 USC 263 42 USC 263a 42 USC 264 42 USC 300aa-25 No Begin Review 05/00/2008 End Review 04/00/2009 No None No Yes Not Collected Stephen Ripley M. 0910 Food and Drug Administration FDA 301 827-6210 Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville MD 20852-1448