2011-23923. Prescription Drug User Fee Act IV Information Technology Plan

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of an updated information technology (IT) plan entitled “PDUFA IV Information Technology Plan” (updated plan) to achieve the objectives defined in the Prescription Drug User Fee Act (PDUFA) Performance Goals. This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications. The FDA is publishing the updated plan for comment to allow the public to provide feedback as the Agency moves towards a fully electronic standards-based submission and review environment.

DATES:

Submit electronic or written comments on the updated plan by November 3, 2011.

ADDRESSES:

You may submit comments, identified by Docket No. FDA-2008-N-0352, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

• Fax: [phone].
• Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the Agency name and Docket No. FDA-2008-N-0352. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Alfred Kempski, Office of the PDUFA Business Program Manager, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1127, Silver Spring, MD 20993-0002, 301-796-1999.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of an updated IT plan entitled “PDUFA IV Information Technology Plan.” This plan will meet one of the performance goals agreed to under the 2007 reauthorization of PDUFA IV (Title I of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85)). Under section XIV of the PDUFA Performance Goals, FDA agreed to develop, periodically update, and publish for comment an IT plan for achieving the objectives defined in section XIV, Information Technology Goals, of the PDUFA Performance Goals (see http://www.fda.gov/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​ucm119243.htm). This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications, to achieve the objectives defined in section XIV of the PDUFA Performance Goals. The objectives of the PDUFA IV IT Goals are to move FDA towards the long-term goal of an automated standards-based information technology environment for the exchange, review, and management of information supporting the process for the review of human drug applications throughout the product life cycle.

In the Federal Register of June 30, 2008 (73 FR 36880), FDA issued a notice announcing the availability of an earlier version of the IT plan entitled “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan” (June 2008 plan). This updated plan revises the June 2008 plan; it communicates the progress and strategic changes for key initiatives that illustrate the accomplishment of near-term objectives and describes FDA's strategy for meeting the long-term goal of a fully electronic submission and review environment. The sections that have been revised are identified in the Revision Index (after the Table of Contents) in the updated plan.

FDA conducts an annual IT assessment to measure performance against the IT plan. The 2010 Annual IT Assessment is available at http://www.fda.gov/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​ucm183308.htm.

II. Electronic Access

Persons with access to the Internet may obtain the updated plan at http://www.regulations.gov.

III. 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.

Dated: September 12, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.