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HHS/FDA RIN: 0910-AC52 Publication ID: Spring 2005 
Title: Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics 
Abstract: The Food and Drug Administration (FDA) is proposing to amend the regulations governing the format in which clinical study data (CSD) are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that CSD submitted for NDAs, ANDAs, BLAs, and their supplements and amendments be provided in electronic format and require the use of standard data structure, terminology, and code sets. The proposal would improve the efficiency of the exchange of information from clinical studies through the adoption of standards for study data submitted in an electronic form that FDA can process, review, and archive. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94 
Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/00/2005   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
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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