Electronic Study Data Submission; Data Standard Support End Date, 5816 [2013-01641]

Download as PDF 5816 Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Notices 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. 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 Agencysupported data standards (see http:// www.fda.gov/ForIndustry/Data Standards/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/Data tkelley on DSK3SPTVN1PROD with SUMMARY: 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. VerDate Mar<15>2010 17:13 Jan 25, 2013 Jkt 229001 Standards/StudyDataStandards/ UCM292505.xls. 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/Development ApprovalProcess/FormsSubmission Requirements/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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0082] Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00046 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling.’’ This guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect a drug’s pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The guidance provides recommendations on when and how genomic principles should be considered and applied in early-phase clinical studies to address questions arising during drug development and regulatory review. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Issam Zineh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3178, Silver Spring, MD 20993–0002, 301–796–4756; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background FDA is announcing the availability of a guidance entitled ‘‘Clinical Pharmacogenomics: Premarket E:\FR\FM\28JAN1.SGM 28JAN1

Agencies

[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Page 5816]
From the Federal Register Online via the Government Printing 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.
---------------------------------------------------------------------------

    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