[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78367-78368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30818]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 ``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
pharmaceuticals.
DATES: Submit either electronic or written comments by February 24,
2014.
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.
FOR FURTHER INFORMATION CONTACT: Cheryl Ford, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6737,
[email protected].
SUPPLEMENTARY INFORMATION:
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]
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