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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whether the regulations in parts 600 and 606 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities.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
Timetable:
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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