[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]
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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.
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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