0910-AG16 201210 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 Amendments to Sterility Testing Requirements for Biological Products The Food and Drug Administration (FDA) is issuing a rule to amend the sterility testing requirements for biological products. This rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art methodologies to ensure the safety of biological products. Other Significant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 600 21 CFR 610 21 CFR 680 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 371 21 USC 374 42 USC 262 42 USC 264 No NPRM 06/21/2011 76 FR 36019 NPRM Comment Period End 09/19/2011 Final Action 05/03/2012 77 FR 26167 Final Action Effective 06/04/2012 Includes Retrospective Review under E.O.13563. No None No No Paul Levine E. 0910 Food and Drug Administration FDA 301 827-6210 Suite 200N (HFM-17), Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville MD 20852