[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Page 42084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16861]

[[Page 42084]]



Food and Drug Administration

[Docket No. FDA-2013-N-0812]

Electronic Study Data Submission; Data Standard Support; 
Availability of the Center for Drug Evaluation and Research Data 
Standards Program Documents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Center for Drug Evaluation and Research (CDER) of the Food 
and Drug Administration (FDA) is announcing the availability of the 
CDER Data Standards Strategy (version 1.0) and the CDER Data Standards 
Strategy--Action Plan (version 1.0). This action is being taken to 
ensure that all interested stakeholders are aware that the data 
standards program documents are available and is intended to increase 
awareness of CDER's data standards plans, ongoing projects, and avenues 
of communication. Comments may be submitted to the email address listed 

FOR FURTHER INFORMATION CONTACT: Office of Strategic Programs, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 1100, Silver Spring, MD 20993, 301-
796-3800; email: CDERDataStandards@fda.hhs.gov.

    On December 5, 2012, the CDER Data Standards Strategy (version 1.0) 
was released. Its purpose is to reinforce FDA's ongoing commitment to 
the development, implementation, and maintenance of a comprehensive 
data standards program to facilitate the efficient and effective review 
of regulatory submissions so that safe and effective products can get 
to market sooner. It is aligned with the objectives of FDA's Strategic 
Plan and the performance goals of the Prescription Drug User Fee Act V 
Reauthorization as captured in the FDA Safety and Innovation Act. The 
CDER Data Standards Strategy supersedes version 1.1 of the CDER Data 
Standards Plan, which was issued in December 2010.
    The first release of the companion document to the Data Standards 
Strategy, the CDER Data Standards Strategy--Action Plan, was issued on 
March 20, 2013. The Action Plan provides internal and external 
stakeholders with an overview and progress of current relevant data 
standards initiatives. The plan will be updated quarterly to indicate 
progress of current projects as well as initiation of new projects.
    These documents are available from the CDER Data Standards Program 
Web site at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm249979.htm.

    Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16861 Filed 7-12-13; 8:45 am]