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HHS/FDA RIN: 0910-AG62 Publication ID: Spring 2011 
Title: ●General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification (Section 610 Review) 
Abstract: FDA is undertaking a review of 21 CFR sections 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR sections 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: None     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 and 352    21 USC 355    21 USC 360 and 360j    21 USC 371    21 USC 374    42 USC 216    42 USC 262    42 USC 263a    42 USC 264    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Begin Review  06/00/2011    
End Review  12/00/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Melissa Reisman
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852
Phone:301 827-6210