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HHS/FDA RIN: 0910-AG05 Publication ID: Spring 2008 
Title: ●Biological Products; Reporting of Biological Product Deviations in Manufacturing (Section 610 Review) 
Abstract: Section 600.14 (21 CFR 600.14) requires licensed manufacturers of biological products to report to FDA biological product deviations in manufacturing. Section 606.170 requires licensed manufacturers of blood and blood components including Source Plasma, unlicensed registered establishments, and transfusion services to report to FDA biological product deviations in manufacturing. Under section 610 of the Regulatory Flexibility Act, FDA is initiating a review of these regulations in parts 600 and 606 under section 610. The purpose of this review is to determine whether the regulations in parts 600 and 606 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities.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 regulations; 2) the nature of complaints or comments received concerning the regulations; 3) the complexity of the regulations; 4) the extent to which a regulation in parts 600 or 606 overlaps, duplicates, or conflicts with other Federal rules, and to the extent feasible, with State and local government rules; and 5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations. 
Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
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: 21 CFR 600.14    21 CFR 606.170   
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 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   
Legal Deadline:  None
Action Date FR Cite
Begin Review  05/00/2008    
End Review  04/00/2009    
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:
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

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