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HHS/FDA RIN: 0910-AG13 Publication ID: Spring 2010 
Title: Premarketing Safety Reporting Requirements for Human Drug and Biological Products 
Abstract: The Food and Drug Administration (FDA) has undertaken revisions to 21 CFR 312.32, 312.64, and 320.31 to better protect public health and improve safety reporting by increasing the quality of safety reports, expediting FDAs review of critical safety information, advancing worldwide consistency in the collection and submission of safety information, and strengthening the agencys ability to monitor the safety of certain human drugs and biological products. The final rule amends the premarketing safety reporting requirements for human drugs and biological products to codify the Agency's expectations for timely acquisition, evaluation, and submission of relevant and useful safety information, to improve the overall quality of safety reporting, to implement internationally consistent definitions, to subject bioavailability and bioequivalence studies to safety reporting requirements, and to make other minor revisions. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. FDA plans to finalize the premarket and postmarket safety reporting requirements in separate final rules. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 312; 21 CFR 320 
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and 263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 
Legal Deadline:  None
Action Date FR Cite
NPRM  03/14/2003  68 FR 12406 
NPRM Comment Period Extended  06/18/2003   
NPRM Comment Period End  07/14/2003   
NPRM Comment Period Extended End  10/14/2003   
Final Action  09/00/2010   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Carol Drew
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6306, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440

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