
[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58020-58021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23923]


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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 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: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions):

[[Page 58021]]

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.
[FR Doc. 2011-23923 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P


