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HHS/FDA RIN: 0910-AB91 Publication ID: Spring 2002 
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 proposal 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: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
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
Action Date FR Cite
NPRM  05/00/2002    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Virginia G. Beakes
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone:301 594-2041
Fax:301 827-5562

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