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HHS/FDA RIN: 0910-AB91 Publication ID: Spring 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 is required to be submitted. The rule would require that certain labeing content described under section 201.160(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: No 
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; ... 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/03/2002  67 FR 22367 
Final Action  09/00/2003   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Nicole K. Mueller
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Room 3037, (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6312, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3507
Fax:301 827-8440
Email: nicole.mueller@fda.hhs.gov

 
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