2010-14637. 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: [e-mail].

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 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.