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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 FDA’s review of critical safety information, advancing worldwide consistency in the collection and submission of safety information, and strengthening the agency’s 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
Timetable:
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