E9-20083. Prescription Drug User Fee Act IV Information Technology Assessment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

In the last decade, the Food and Drug Adminstration (FDA) has achieved great success in reforming and modernizing its regulatory processes and responsibilities as a result of changes and improvements driven by the requirements of the Prescription Drug User Fee Act (PDUFA), the 1997 FDA Modernization Act (FDAMA), and other legislation. PDUFA was reauthorized by the Food and Drug Administration Amendments Act of 2007, Title I, Prescription Drug User Fee Amendments of 2007 (PDUFA IV). FDA plans to make even greater progress during the PDUFA IV timeframe (Fiscal Years 2008 through 2012), building on the foundation established in previous years. The additional resources provided by user fees, when combined with appropriations, have enabled the FDA to modernize its information technology infrastructure and begin a monumental transformation from a paper-based to an electronic work environment.

As part of the PDUFA IV commitment, FDA published the PDUFA IV Information Technology (IT) Plan for comment to allow the public to provide feedback as FDA moves towards a fully electronic standards-based submission and review environment. FDA reviewed the comments, updated the plan, and published the updated version in June 2008 (73 FR 36880; June 30, 2008).

Under the PDUFA IV IT Plan an assessment of progress against the plan is conducted on an annual basis. The most recent report, which is available at http://www.fda.gov/​oc/​pdufa/​, reflects the current assessment of the PDUFA IV IT Plan. The report contains four columns. The first three columns were previously published as part of the original plan. The last column, labeled “Current Status” provides details of the activities for each project assessed. The next assessment will be published in November 2009.

More information on the PDUFA program is available at http://www.fda.gov/​oc/​pdufa/​.

DATES:

Submit written or electronic comments on the assessment at any time. These comments will be considered as the agency makes annual updates to the plan each fiscal year.

ADDRESSES:

Submit written requests for single copies of the IT Assessment to the Office of the Chief Information Officer (HFA-080), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the IT Assessment to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the assessment.

FOR FURTHER INFORMATION CONTACT:

Gina Kiang, Office of the Chief Information Officer, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-255-6702

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of the IT Assessment entitled “Prescription Drug User Fee Act (PDUFA) IV Information Technology Assessment.” This Assessment is intended to provide regulated industry and other stakeholders with information on FDA's progress toward the goals set out in the PDUFA IV IT Plan. As referenced in that plan published in May 2008, Section 7.2, B. Communications and Technical Interactions, 3.b., “FDA will conduct an annual assessment of progress against the IT plan and publish on the FDA Web site a summary of the assessment within 2 months after the close of each fiscal year.”

II. Electronic Access

Persons with access to the Internet may obtain the document at http://www.regulations.gov and at http://www.fda.gov/​oc/​pdufa.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov

Dated: August 12, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.