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HHS/FDA RIN: 0910-AA94 Publication ID: Spring 2005 
Title: Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products 
Abstract: This regulation is one component of the Secretary's initiative to reduce medical errors. The regulation would amend the regulations governing the format and content of professional labeling for human prescription drugs (including biological products that are regulated as drugs), 21 CFR 201.56 and 201.57. The regulation would require that such labeling include highlights of prescribing information and a table of contents for prescribing information. It would reorder currently required information, make minor changes to its content, and establish minimum graphical requirements. 
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 201 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 42 USC 262 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/22/2000  65 FR 81082 
NPRM Comment Period End  03/22/2001   
NPRM Comment Period Reopened  03/30/2001   
NPRM Comment Period Reopening End  06/22/2001   
Final Action  05/00/2005   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Elizabeth J. Sadove
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Avenue, Bldg. 51, Room 6368,
Silver Spring, MD 20993-0002
Phone:301 796-3522
Fax:301 847-8440
Email: elizabeth.sadove@fda.hhs.gov

 
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