Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the information technology (IT) Plan entitled “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan” to achieve the objectives defined in the 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 review process of human drug applications.
Submit written or electronic comments on the plan at any time. These comments will be considered as the agency makes annual adjustments to the plan each fiscal year.
Submit written requests for single copies of the IT plan 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 plan 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 plan.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Suzanne Mitri, Office of the Chief Information Officer, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-255-6700.End Further Info End Preamble Start Supplemental Information
FDA is announcing the availability of the IT plan entitled “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan.” 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, Information Technology Goals, of the PDUFA Performance Goals (http://www.fda.gov/oc/pdufa4/pdufa4goals.html).
On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007, which includes the reauthorization and expansion of PDUFA. The reauthorization of PDUFA will significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public. The reauthorization also includes IT Goals that are divided into four subsections: Objectives, Communications and Technical Interactions, Standards and IT Plan, and Metrics and Measures. In addition, there are IT Goals associated with the upgrade of the agency's drug safety program in section VIII, Enhancement and Modernization of the FDA Drug Safety System 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. As part of this process, FDA has developed and will periodically update the 5-year IT plan.
II. Electronic Access
Persons with access to the Internet may obtain the document at http://www.regulations.gov.
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic Start Printed Page 36881comments 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.Start Signature
Dated: June 23, 2008.
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14744 Filed 6-27-08; 8:45 am]
BILLING CODE 4160-01-S