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HHS/FDA RIN: 0910-AF11 Publication ID: Spring 2015 
Title: Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling 
Abstract: This final rule will amend the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of regulations regarding the labeling for human prescription drug and biological products to better communicate risks. 
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 201.56 and 201.57    21 CFR 201.80   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 358    21 U.S.C. 360    21 U.S.C. 360b    21 U.S.C. 360gg to 360ss    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 379e    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 262    42 U.S.C. 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/29/2008  73 FR 30831   
NPRM Comment Period End  08/27/2008    
Final Action  12/04/2014  79 FR 72064   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Kathy Schreier
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Ave, WO51, RM. 6246,
Silver Spring, MD 20993
Phone:301 796-3432
Email: kathy.schreier@fda.hhs.gov