[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Page 5816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01641]
[[Page 5816]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0710]
Electronic Study Data Submission; Data Standard Support End Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Center for Biologics Evaluation and Research (CBER), the
Center for Drug Evaluation and Research (CDER), and the Center for
Devices and Radiological Health (CDRH) are announcing the end of
support for the 3.1.1. version of Clinical Data Interchange Standards
Consortium (CDISC) Study Data Tabulation Model (SDTM) Implementation
Guide (SDTM IG 3.1.1.). SDTM IG 3.1.2, which has been available since
October 2009, is the newer standard supported by FDA. Support for SDTM
IG 3.1.1 will end on January 28, 2015.
FOR FURTHER INFORMATION CONTACT: Virginia Hussong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1161, Silver Spring, MD 20993, Phone:
301-796-1016, EDATA@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA encourages sponsors to submit
standardized study data using Agency-supported data standards (see
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm).\1\ An Agency-supported data standard means that FDA has
established processes and technology infrastructure to support the
receipt, processing, review, and archiving of study data using the
standard. As data standards evolve, FDA will periodically end support
for old standards in favor of newer standards that are better suited to
meet FDA data management and review needs. FDA maintains a catalog of
the supported data standards for study data submissions at http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM292505.xls.
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\1\ Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), added by section 1136 of the Food and Drug
Administration Safety and Innovation Act (FDASIA) (Public Law 112-
144), requires electronic submission of drug and biologic
applications beginning no earlier than 24 months after issuance of a
final guidance. The final guidance, to be issued under section 745A
of the FD&C Act following public notice and opportunity for comment,
will specify the format required for such electronic submissions.
The action announced in this notice, although applicable to
electronic submission of standardized study data, is not being taken
under section 745A of the FD&C Act and is not intended to trigger
the mandatory submission requirements under that section.
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To facilitate the transition to newer standards, FDA is committed
to providing a transition period of 24 months during which both older
and newer standards are supported. FDA first began supporting SDTM IG
3.1.2 on October 30, 2009, over 2 years ago.
This notice establishes that CBER, CDER, and CDRH are ending
support for SDTM IG 3.1.1. effective January 28, 2015. Effective
immediately, submitters are strongly encouraged to use SDTM IG 3.1.2
instead. The support end date is the date past which study data using
the standard may not be submitted, unless special arrangements have
been made in advance with the Agency.
FDA recognizes the challenges associated with adopting a new
standard, particularly because studies are often conducted and study
data are standardized months to years before submission to the Agency.
Submitters seeking a special arrangement to provide data using SDTM IG
3.1.1 beyond the established support end date should submit a waiver
request. A waiver request process will be posted at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm249979.htm for CDER and http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm209137.htm for
CBER by November 1, 2012. The waiver process will be put into place to
support the transition and allow for submission of clinical data in
SDTM IG 3.1.1 format data in cases where SDTM IG 3.1.2 is otherwise not
feasible and/or when such submission has been determined as having no
negative impact to the review process.
Dated: January 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01641 Filed 1-25-13; 8:45 am]
BILLING CODE 4160-01-P