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| HHS/FDA | RIN: 0910-AF11 | Publication ID: Spring 2008 |
| 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 part 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: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 201.56; 21 CFR 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 | |
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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: Yes | |
| RIN Data Printed in the FR: Yes | |
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Agency Contact: Christine F. Rogers Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 6316, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301-847-8440 Email: christine.rogers@fda.hhs.gov |
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