[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Pages 78367-78368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30818]



Food and Drug Administration

[Docket No. FDA-2013-N-1618]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of the draft information technology 
(IT) plan entitled ``PDUFA V Information Technology Plan.'' This plan 
is intended to provide FDA's approach for enhancing business processes, 
data quality and consistency, supporting technologies, and IT 
operations as described in the Prescription Drug User Fee Act (PDUFA) 
Reauthorization Performance Goals and Procedures for Fiscal Years 2013 
through 2017. FDA is publishing a draft version of the IT plan for 
comment to allow industry and other interested stakeholders to provide 
feedback as FDA moves towards a fully automated standards-based 
environment that enhances the regulatory review process for human 

DATES: Submit either electronic or written comments by February 24, 

ADDRESSES: Submit written requests for single copies of the draft 
``PDUFA V Information Technology Plan'' to the Division of Drug 
Information, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your

[[Page 78368]]

requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft plan.
    Submit electronic comments on the draft plan to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6737, 


I. Background

    The draft PDUFA V IT plan considers assumptions, available 
resources, and statutory requirements that conform to the Food and Drug 
Administration Safety and Innovation Act (FDASIA), signed into law on 
July 9, 2012. Section 1136 of FDASIA, Electronic Submission of 
Applications, gives FDA the authority to require a standardized 
electronic format for the submission of information and data in 
standardized formats. Section 1136 addresses investigational new drug 
applications, biologics license applications, and new drug applications 
under the PDUFA program as well as abbreviated new drug applications 
under the Generic Drug User Fee Act program and describes new standards 
and processes affecting drug and biologics approvals, drug supply 
chain, and other topics related to human pharmaceuticals. The draft 
PDUFA V IT plan describes key activities for enabling progress toward 
achieving PDUFA IT goals.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/ForIndustry/UserFees/default.htm or http://www.regulations.gov.

    Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30818 Filed 12-24-13; 8:45 am]