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HHS/FDA

RIN: 0910-AF84

Publication ID: Spring 2007

Title: Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma
Abstract: 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and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements.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.
Agency: Department of Health and Human Services(HHS)	Priority: Routine and Frequent
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 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
Legal Authority: 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

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM--Companion to Direct Final Rule	06/00/2007
Direct Final Rule	06/00/2007

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Stephen M. Ripley Team Leader Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville, MD 20852-1448 Phone:301 827-6210