[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Pages 70954-70955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28391]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1424]


Transport Format for the Submission of Regulatory Study Data; 
Notice of Pilot Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER) in the Food and 
Drug Administration (FDA) are announcing a pilot project to evaluate 
the Clinical Data Interchange Standard Consortium (CDISC) Submission 
Data Standards (SDS) Extensible Markup Language (XML) transport format 
for the submission of regulatory study data. The current study data 
transport format supported by FDA is the SAS Transport (XPORT) version 
5 file format. Although XPORT has been a reliable exchange format for 
many years, it is not an extensible modern technology. SDS XML is an 
extension of the CDISC Operational Data Model, which is a vendor 
neutral, platform-independent format for the exchange and archive of 
study data. FDA is announcing an invitation to sponsors to participate 
in this pilot project to evaluate the SDS XML transport format.

[[Page 70955]]


DATES: Submit either electric or written requests for participation in 
the pilot project by January 27, 2014.

ADDRESSES: Submit electronic requests to participate in the pilot and 
comments regarding this pilot project to http://www.regulations.gov. 
Summit written requests and comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1062, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 1160, Silver Spring, MD 20993, 301-796-
5333, [email protected]; or Stephen Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N Rockville, MD 20852, 
301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the 1999 ``Guidance to Industry: Providing Regulatory 
Submissions in Electronic Format'' FDA recommended that regulatory 
submissions of clinical data to FDA utilize SAS Institute's open 
transport called XPORT version 5 format (XPORT). The XPORT format was 
developed in the late 1980s and there have been no version updates 
since 1999. XPORT is now considered by many to be an outdated transport 
technology for transferring data across different hardware and 
operating systems.
    Following a Federal Register Notice, FDA held a public meeting on 
November 5, 2012, entitled ``Regulatory New Drug Review: Solutions for 
Study Data Exchange Standards.'' The purpose of the public meeting was 
to solicit input from industry, technology vendors, and other members 
of the public regarding the advantages and disadvantages of current and 
emerging open, consensus-based standards for the exchange of regulated 
study data. FDA indicated, in the Notice and at the meeting, based on 
feedback received at the public meeting and other information sources, 
it would undertake further requirements analysis in support of expected 
evaluation projects.

II. Project Participation

    FDA envisions several pilot projects conducted to evaluate new 
transport formats. The purpose of this pilot project is to obtain 
additional experience with CDISC SDS XML format. A successful pilot may 
allow CDER and CBER to routinely receive study data that employ CDISC 
SDS XML format as the transport format once an alternatives analysis is 
completed. As part of this pilot, FDA would like to have sponsors 
participate in the preparation and submission of previously submitted 
study datasets using the SDS XML transport format. Participation in 
this evaluation will be outside of the regulatory pathway and, as such, 
will not be used to make regulatory decisions.
    FDA expects that the pilot will assess the technical capability of 
SDS XML to exchange and archive regulatory study data in 
investigational new drug applications, new drug applications, and 
biologics licensing applications.

III. Requests for Participation

    Requests to participate in the SDS XML pilot project are to be 
identified with the docket number found in brackets in the heading of 
this document. Interested persons should include the following 
information in the request: Contact name, contact phone number, email 
address, name of the sponsor, address, and license number. Once 
requests for participation are received, FDA will contact interested 
sponsors to discuss the pilot project. FDA is seeking a limited number 
of sponsors (approximately three to five, but no more than six) to 
participate in this project. The elapsed time duration of the pilot is 
expected to be approximately 12 months but may be extended as needed. 
Participants should be willing to provide previously submitted study 
data using both the SAS XPORT version 5 format and the CDISC SDS XML 
format.

    Dated: November 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28391 Filed 11-26-13; 8:45 am]
BILLING CODE 4160-01-P