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HHS/FDA | RIN: 0910-AA94 | Publication ID: Fall 1996 |
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: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: Undetermined |
CFR Citation: 1 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:
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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 |