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HHS/FDA

RIN: 0910-AA94

Publication ID: Spring 2004

Title: Labeling for Human Prescription Drugs; Revised Format
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 drug and biologic products, 21 C.F.R. 201.56 and 201.57. The regulation would require that professional labeling include a section containing highlights of prescribing information, and a section containing an index to prescribing information; reorder currently required information and make minor changes to its content, and establish minimum graphical requirements for professional labeling.
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: Undetermined	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 358 21 USC 360 21 USC 360b 21 USC 360gg to 360ss 21 USC 371 21 USC 374 21 USC 379e 42 USC 216 42 USC 241 42 USC 262 42 USC 264

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	10/00/2004

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Undetermined
Small Entities Affected: Businesses	Federalism: Undetermined
Included in the Regulatory Plan: Yes
Agency Contact: Audrey A. Thomas Regulatory Policy Analyst Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6364, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 Email: audrey.thomas@fda.hhs.gov