[Federal Register Volume 77, Number 157 (Tuesday, August 14, 2012)]
[Proposed Rules]
[Pages 48491-48492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2012-N-0780]


Regulatory New Drug Review: Solutions for Study Data Exchange 
Standards; Notice of Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS

ACTION: Announcement of meeting, request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a meeting 
entitled ``Regulatory New Drug Review: Solutions for Study Data 
Exchange Standards'' the purpose of which is 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 
also seeks input from stakeholders and other members of the public on 
this topic and a set of premeeting questions discussed below.

DATES: The meeting will be held on November 5, 2012, from 10 a.m. to 4 
p.m.

ADDRESSES: The meeting will be held at FDA White Oak Campus, 10903 New 
Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 
1503), Silver Spring, MD 20993-0002. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Office of Planning & 
Informatics, 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, FAX: 301-847-8443, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Comments: Regardless of attendance at the public workshop, 
interested persons may submit either electronic or written comments 
regarding this document. Given that time will be limited at the public 
meeting, FDA encourages all interested persons to comment in writing to 
ensure that their comments are considered. The deadline for submitting 
responses regarding the premeeting questions is October 5, 2012.
    Submit electronic responses to the premeeting questions 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. Identify comments with the docket number 
found in brackets in the heading of this document.
    Registration: Registration is required in advance and participation 
will be limited. Send registration information (including name, title, 
firm name, country of citizenship, address, telephone and fax number, 
and email address) to Fatima Elnigoumi, Center for Drug Evaluation and 
Research, 10903 New Hampshire Ave., Bldg. 51, rm. 1195, Silver Spring, 
MD 20993, 301-796- 4863, email: [email protected]. 
Registrations will be accepted in the order that they are received with 
a limit of 300. If you need special accommodations due to a disability, 
please contact Fatima Elnigoumi at least 7 days in advance.

I. Background

    The current study data exchange format supported by FDA is the 
ASCII-based SAS Transport (XPORT) version 5 file format. Although XPORT 
has been an exchange format for many years, it is not an extensible 
modern technology. Moreover, it is not supported and maintained by an 
open, consensus-based standards development organization.
    FDA would like to discuss the current and emerging open study data 
exchange standards that will support interoperability. Currently, the 
use of XPORT can be described as an example of the exchange of study 
data between two or more systems using a specified file format (e.g., 
XML, SQL, ASCII). However, the desired path forward is to achieve 
interoperability with other systems where the exchange of data between 
systems can be reviewed, analyzed, and reported with minimal need for 
data integration.
    Based on feedback from this meeting and other information, an 
evaluation of the cost-benefit of a migration to a new study data 
exchange standard--on both FDA and regulated industry--will be 
conducted to inform next steps, which will include an action plan.

II. Premeeting Questions to Stakeholders

    FDA seeks input from stakeholders and other members of the public 
on the following premeeting questions:
    1. What are the most pressing challenges that industry faces with 
regard to study data management? Please address each of the following 
areas: (a) Study design/set-up, (b) capture, (c) integration, (d) 
analysis, (e) reporting, and (f) regulatory submission. What 
opportunities/solutions exist to meet each challenge?
    2. How could FDA's regulatory requirements make the study data 
management process more efficient?
    3. What does industry need to make clinical trials data management 
more effective and efficient? Please describe the tools, techniques, 
and processes that would help as well as the regulatory guidance 
documents that would be useful in this area.
    4. What data standards are you currently using for the conduct of 
regulated research studies?
    5. Would Health Level Seven v3 \1\ (e.g., messages, structured 
documents and Clinical Data Architecture) be a viable study data 
exchange standard? Please explain advantages and disadvantages. What 
would be the impact (e.g., financial, technical, or in terms of 
implementation or change in business processes)?
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    \1\ See http://www.hl7.org for system description.
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    6. Would CDISC Operational Data Model \2\ be a viable study data 
exchange standard? Please explain advantages and disadvantages. What 
would be the impact (e.g., financial, technical, or in terms of 
implementation or change in business processes)?
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    \2\ See http://www.cdisc.org for system description.
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    7. Are there other open data exchange standards that should be 
evaluated? Please explain advantages and disadvantages. What would be 
the impact (e.g., financial, technical, or in terms of implementation 
or change in business processes)?
    8. What would be a reasonable phased implementation period for each 
recommended exchange standard? And should supporting multiple, 
concurrent study data exchange standards be evaluated (please explain 
advantages and disadvantages of this approach)? What can FDA do to help 
industry to be more prepared for, or reduce burden of, a migration to a 
new study data exchange standard?
    9. FDA encourages sponsors to design study data collection systems 
so that

[[Page 48492]]

relationships between data elements, as well as relationships across 
data domains, can be captured at the point of data entry. Describe the 
challenges, to and opportunities for, accomplishing this goal.
    10. What other comments would you care to share with FDA concerning 
the general topic of data exchange standards?

    Dated: August 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19748 Filed 8-13-12; 8:45 am]
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