[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]


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

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.

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

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]
BILLING CODE 4160-01-P