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HHS/FDA RIN: 0910-AB91 Publication ID: Fall 2003 
Title: Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format 
Abstract: The Food and Drug Administration (FDA) is proposing to amend its regulations governing the format in which certain labeling in new drug applications, abbreviated new drug applications, certain biological license applications, supplements, and annual reports are required to be submitted. The rule would require that certain labeling content described under section 201.100(d)(3) be submitted to FDA in electronic format. 
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: Private Sector 
CFR Citation: 21 CFR 314    21 CFR 601   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 353    21 USC 355    21 USC 360    21 USC 371    21 USC 374    21 USC 379e    42 USC 262    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/03/2002  67 FR 22367   
Final Action  12/00/2003    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Darren Eicken
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Room 3037, (HFD-7), Center for Drug Evaluation and Research, Building 51, Room 6206, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-0978
Fax:301 827-8440

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