[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Page 78366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-31008]



Food and Drug Administration

[Docket No. FDA-2013-N-1615]

Draft Generic Drug User Fee Act 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 ``GDUFA 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 Generic Drug User Fee Act (GDUFA) 
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, 

ADDRESSES: Submit written requests for single copies of the draft 
``GDUFA 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 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, 
[email protected].


I. Background

    Signed into law on July 9, 2012, GDUFA is designed to speed the 
delivery of safe and effective generic drugs to the public. GDUFA 
increases FDA's authorities and responsibilities to address issues such 
as drug shortages, drug supply chain, safety, security, and drug 
innovation. As generic drugs account for more than three-quarters of 
all prescriptions dispensed in the United States, GDUFA authorizes FDA 
to collect user fees from industry that will provide funding to expand 
and modernize FDA's generic drug regulatory process.
    The draft GDUFA 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 abbreviated new drug 
applications under the GDUFA program as well as investigational new 
drug applications, biologics license applications, and new drug 
applications under the Prescription 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 GDUFA IT plan describes key activities for 
enabling progress toward achieving GDUFA 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. 2013-31008 Filed 12-24-13; 8:45 am]