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HHS/FDA RIN: 0910-AA97 Publication ID: Spring 2018 
Title: Postmarketing Safety Reporting Requirements for Human Drug and Biological Products 

The final rule would amend the postmarketing safety reporting regulations for human drugs and biological products including blood and blood products in order to better align FDA requirements with guidelines of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH);  and to update reporting requirements in light of current pharmacovigilance practice and safety information sources and enhance the quality of safety reports received by FDA. 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. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 310    21 CFR 314    21 CFR 600    21 CFR 601    21 CFR 606   
Legal Authority: 42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 242a    42 U.S.C. 262 and 263    42 U.S.C. 263a to 263n    42 U.S.C. 264    42 U.S.C. 300aa    21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360b to 360j    21 U.S.C. 361a    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 375    21 U.S.C. 379e    21 U.S.C. 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 Extension End  10/14/2003    
Final Rule  12/00/2018 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Jane E. Baluss
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3469
Fax:301 847-8440