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HHS/FDA

RIN: 0910-AC52

Publication ID: Fall 2003

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 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	07/00/2004

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Undetermined
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 Email: darren.eicken@fda.hhs.gov