[Federal Register Volume 73, Number 126 (Monday, June 30, 2008)]
[Notices]
[Pages 36880-36881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0352]


Prescription Drug User Fee Act IV Information Technology Plan

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

DATES: 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.

ADDRESSES: 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.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    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.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic

[[Page 36881]]

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: June 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14744 Filed 6-27-08; 8:45 am]
BILLING CODE 4160-01-S