View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AA94 | Publication ID: Spring 2006 |
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: Completed Actions |
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:
|
Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: Yes | |
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 |