0910-AF84 200804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma FDA is issuing this rulemaking to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. Some examples of the amendments include revisions to the dating period for Platelets, Red Blood Cells Deglycerolized, and Red Blood Cells Frozen; storage temperatures for blood; and pooling and pH level of Platelets. FDA is also removing two obsolete provisions. Routine and Frequent Previously Published in The Unified Agenda Completed Actions No No 21 CFR 606.3 21 CFR 607.65 21 CFR 610.53 21 CFR 640.4 21 CFR 640.21 21 CFR 640.22 21 CFR 640.24 21 CFR 640.25 21 CFR 640.30 21 CFR 640.32 21 CFR 640.34 21 CFR 640.64 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 353 21 USC 355 21 USC 360 21 USC 360c 21 USC 360d 21 USC 360h 21 USC 360i 21 USC 360j 21 USC 371 21 USC 372 21 USC 374 21 USC 381 21 USC 393 42 USC 216 42 USC 262 42 USC 263 42 USC 263a 42 USC 264 42 USC 271 No NPRM--Companion to Direct Final Rule 08/16/2007 72 FR 45903 Direct Final Rule 08/16/2007 72 FR 45883 Comment Period End 10/30/2007 Final Action; Confirmation and Technical Amendment 02/08/2008 73 FR 7463 No No None No 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