[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69637-69638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28197]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0974]
Development of Prioritized Therapeutic Area Data Standards;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
intent to prioritize and develop therapeutic area data standards to
facilitate the conduct of clinical research and the regulatory review
of medical products. Therapeutic area disease and domain specific data
standards should enable and enhance the ability to integrate, analyze,
report, and share regulatory information. FDA has developed a roadmap
that provides its current thinking on therapeutic area priorities and
has posted it on the FDA Web site. FDA is actively participating with
regulated industry, the Clinical Data Interchange Standards Consortium
(CDISC), the Critical Path Institute, Health Level 7's (HL7) Clinical
Interoperability Council, and other stakeholders to support the
development of these therapeutic area standards. The therapeutic area
standards will be developed collaboratively based on open, consensus-
based data standards development methodology.
DATES: To ensure that the Agency considers your comments, submit either
electronic or written comments by January 22, 2013.
ADDRESSES: Submit written requests for a copy of the roadmap 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, Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448. Send one self-addressed adhesive label to assist that
office in processing your requests.
Submit electronic comments on FDA's objective to develop
prioritized therapeutic area data standards or on the roadmap 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. See the SUPPLEMENTARY
INFORMATION section for electronic access to the roadmap.
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 20993-0002, [email protected]; or
Amy Malla, Center for Biologics Evaluation and Research (HFM-25), 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6085.
SUPPLEMENTARY INFORMATION:
I. Background
Traditionally, clinical study data submitted to FDA is in a format
that is unique to each individual sponsor; furthermore the data quality
varies. This has created inefficiencies in the review process and
impeded efforts to analyze the data across applications when such
analyses could be beneficial to detect trends in safety or efficacy or
for other reasons. Sponsor adoption of available clinical trial data
standards (CDISC/SDTM) for the submission of product applications have
helped to improve the quality and standardization of submitted data.
However, such a voluntary approach has proved insufficient to support
both the current business requirements as well as efforts to modernize
the review environment.
In 2011, the Center for Drug Evaluation and Research (CDER)
identified a set of disease and therapeutic areas that could benefit
from further standardization. These content area standards are
primarily intended to support the efficient evaluation of medical
products as noted previously in this document. Several factors were
considered in the identification of these areas: (1) Areas of
particular need, (2) areas with existing data standardization projects
underway, and (3) areas with greater drug development pipeline
activity. The initial prioritization was based on the number of active
investigational new drug applications (or INDs) and input from review
divisions, as well as from industry. The three tiers of priority were
assembled into a roadmap and posted on the FDA Web site at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm287408.htm. The
roadmap sets out a sequence of standardization efforts to achieve
significant results by December 2017. CDER established a small grants
program to fund projects that develop
[[Page 69638]]
disease and domain-specific therapeutic area data standards.
On July 9, 2012, President Obama signed into law the Food and Drug
Administration Safety and Innovation Act of 2012, which includes the
reauthorization of the Prescription Drug User Fee Act (PDUFA V). Under
section XII of the PDUFA V performance goals, FDA agreed to create a
plan for distinct therapeutic area data standards and to prioritize and
develop the data standards in collaboration with CDISC and other open
standards organizations. FDA is seeking public comment on the roadmap
and will consider the comments as the Agency develops its proposed
project plan which is due to be issued for review and comment by June
30, 2013. In addition, FDA will publish notices soliciting input on,
and engagement in, standards development activities, and will
periodically issue guidances specifying the completed data standards,
formats, and terminologies that sponsors should use to submit data in
applications.
II. Comments
Interested persons may submit either written comments regarding the
roadmap, as well as recommendations on how the therapeutic area data
standards development effort could be accomplished more rapidly, to the
Division of Dockets Management (see ADDRESSES) or electronic comments
to http://www.regulations.gov. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the roadmap at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm287408.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.
Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28197 Filed 11-19-12; 8:45 am]
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