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HHS/FDA | RIN: 0910-AF11 | Publication ID: Spring 2009 |
Title: Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling | |
Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). | |
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 201.56 and 201.57 21 CFR 201.80 | |
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 |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Rachel S. Bressler Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-4288 Fax:301 847-8440 Email: rachel.bressler@fda.hhs.gov |