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HHS/FDA RIN: 0910-AB83 Publication ID: Spring 2001 
Title: Postmarketing Studies for Human Drugs and Licensed Biological Products: Status Reports 
Abstract: Section 130(a) of the Food and Drug Administration Modernization Act of 1997 adds a new section 506B to the Federal Food, Drug, and Cosmetic Act requiring a drug sponsor that has agreed to conduct a postmarketing study to submit within one year after the drug's approval and annually thereafter until the study's conclusion, a progress report, or an explanation of why the sponsor has not conducted the study. Any information pertaining to postmarketing study reports will be considered public to identify the sponsor or explain the status of the study, including why it has not been carried out. FDA is required to publish annually in the Federal Register a report concerning the status of postmarketing studies that sponsors have agreements to conduct. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 314.81    21 CFR 601.37    21 CFR 601.70   
Legal Authority: PL 105-115   
Legal Deadline:
Action Source Description Date
Other  Statutory  Section 130(b) requires the FDA to report by October 1, 2001 to the House and Senate committees summarizing postmarketing study reports submitted by sponsors to FDA.  10/01/2001 
Timetable:
Action Date FR Cite
NPRM  12/01/1999  64 FR 67207   
NPRM Comment Period End  02/14/2000    
Final Action  10/30/2000  65 FR 64607   
60-Day Delay of Effective Date  02/21/2001  66 FR 10815   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Nathaniel L. Geary
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852-1448
Phone:301 827-6210
Fax:301 827-9434
Email: nathaniel.geary@fda.hhs.gov