[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Notices]
[Pages 73851-73852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0481]


Draft Prescription Drug User Fee Act IV Information Technology 
Plan; Availability for Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of the draft information technology 
(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 the 
PDUFA Performance Goals.

DATES: Submit written or electronic comments on the draft IT plan by 
February 22, 2008.

ADDRESSES: Submit written requests for single copies of the draft 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 draft 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 either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the document.

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 for public comment the availability of the draft 
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 
Information Technology Goals that are divided into four subsections: 
Objectives, Communications and Technical Interactions, Standards and IT 
Plan, and Metrics and Measures. In addition, there are information 
technology goals associated with the upgrade of the agency's drug 
safety program in section VIII, Enhancement and Modernization of the 
FDA Drug Safety System.
    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,

[[Page 73852]]

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 will develop and periodically update a 5-year IT plan 
and will solicit and consider comments from the public on the draft IT 
plan. At the end of the comment period, FDA will review the comments, 
update the IT plan, and publish the final version no later than May 30, 
2008.

II. 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 in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: December 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-25310 Filed 12-27-07; 8:45 am]
BILLING CODE 4160-01-S