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HHS/FDA RIN: 0910-AA94 Publication ID: Spring 1998 
Title: Labeling for Human Prescription Drugs; Revised Format 
Abstract: The proposed rule would revise existing regulations governing the format of prescription drug labeling directed toward prescribers and other health care professionals to increase the usefulness of this labeling. The revisions to part 201.57 would reorder the content areas of the labeling; add an introductory section of highlights and an index; and institute an identification system to enhance accessibility to detailed information. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 201   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 356    21 USC 357    21 USC 358    21 USC 360    21 USC 360b    21 USC 360gg to 360ss    21 USC 371    21 USC 374    21 USC 379e   
Timetable:
Action Date FR Cite
NPRM  09/00/1998    
NPRM Comment Period End  12/00/1998    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Nancy M. Ostrove
Division of Drug Marketing, Advertising, and Communications
Department of Health and Human Services
Food and Drug Administration
(HFD-42), Center for Drug Evaluation and Research, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-2828