
[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Notices]               
[Page 34452-34453]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn10-71]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0279]

 
Center for Drug Evaluation and Research Data Standards Plan; 
Availability for Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of the draft document entitled ``CDER 
Data Standards Plan Version 1.0'' (draft plan). The draft plan outlines 
the general approach proposed for development of a comprehensive data 
standards program in the Center for Drug Evaluation and Research 
(CDER). The draft plan identifies key objectives for a data standards 
program at CDER, processes to be developed to ensure successful use of 
those standardized data, and a set of recommended projects to begin in 
calendar year (CY) 2010.

DATES: Submit either electronic or written comments on the draft plan 
by September 15, 2010.

ADDRESSES: Submit written requests for single copies of the draft plan 
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. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft plan.
    Submit electronic comments on the draft plan 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.

FOR FURTHER INFORMATION CONTACT: Ranjit Thomas, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 1166, Silver Spring, MD 20993-0002, e-
mail: Ranjit.Thomas@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA receives an enormous and growing amount of data in regulatory 
submissions in a variety of formats from many sources. This wealth of 
data holds great potential to advance CDER's regulatory and scientific 
work, but the present lack of standardized data creates significant 
challenges to realizing that potential. A data standards plan would 
enhance CDER's ability to efficiently and effectively perform its 
critical public health mission.
    At present, the lack of standardized data affects CDER's review 
processes by curtailing a reviewer's ability to perform integral tasks 
such as rapid acquisition, analysis, storage, and reporting of 
regulatory data. Standardized data will allow reviewers to increase 
review consistency and perform evaluations across the drug lifecycle. 
Improved data quality, accessibility, and predictability will give 
reviewers more time to carry out complex analyses, ask in-depth 
questions, and address late-emerging issues.
    Standardization of data submissions, a requirement for electronic 
submissions, and a robust computational infrastructure would make 
significant improvements possible. Facilitating improvements requires 
careful analysis, advanced planning, project management, expert input, 
and effective communication among all key stakeholders. To be 
successful, a plan is required to identify, develop, adopt, and 
maintain data standards that meet CDER ``end user'' needs.
    FDA is making available for public comment the draft plan entitled 
``CDER

[[Page 34453]]

Data Standards Plan Version 1.0.'' The draft plan is intended to 
communicate FDA's approach for establishing a comprehensive data 
standards program at CDER and ensuring the development and successful 
use of data standards for all key data needed to make regulatory 
decisions. FDA will consider comments received in developing future 
versions of the plan.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.regulations.gov or http://www.fda.gov/downloads/Drugs/
DevelopmentApprovalProcess/FormsSubmissionRequirements/
ElectronicSubmissions/UCM214120.pdf.

    Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14637 Filed 6-16-10; 8:45 am]
BILLING CODE 4160-01-S

