[Federal Register Volume 74, Number 161 (Friday, August 21, 2009)]
[Notices]
[Pages 42316-42317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20083]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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[rdquo,] 
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.

[[Page 42317]]


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.
[FR Doc. E9-20083 Filed 8-20-09; 8:45 am]
BILLING CODE 4160-01-S