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HHS/FDA RIN: 0910-AF11 Publication ID: Spring 2006 
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 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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2006    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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 Avenue, Bldg. 51, Room 6316,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: christine.rogers@fda.hhs.gov