Document ID: FDA-2013-N-0391-0001
Agency: fda
Document Type: Notice
Title: Generic Drug Facilities, Sites, and Organizations
Posted Date: 2013-04-16T04:00Z

[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Pages 22553-22554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08806]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0391]

Generic Drug Facilities, Sites, and Organizations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
generic drug facility self-identification reporting period for fiscal 
year (FY) 2014 will begin on May 1, 2013, and close on June 1, 2013. 
Generic drug facilities, certain sites, and organizations identified in 
a generic drug submission are required by the Generic Drug User Fee 
Amendments of 2012 (GDUFA) to submit, update, or reconfirm 
identification information to FDA annually.

DATES: For FY 2014, identification information must be submitted, 
updated, or reconfirmed between May 1, 2013, and June 1, 2013.

ADDRESSES: Electronic tools for submitting the required information may 
be found on FDA's Web site at the following addresses:
     eSubmitter tool: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm108165.htm.
     Structured Product Labeling (SPL) Xforms: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm.

Other applications are available commercially.

FOR FURTHER INFORMATION CONTACT: Jaewon Hong, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Rm. 4145, Silver Spring, MD 20993, 301-796-6707, 
AskGDUFA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: GDUFA (Pub. L. 112-144, Title III) was 
signed into law by the President on July 9, 2012, as part of the Food 
and Drug Administration Safety and Innovation Act. GDUFA is designed to 
speed the delivery of safe and effective generic drugs to the public 
and reduce costs to industry. GDUFA enables FDA to assess user fees to 
fund critical and measurable enhancements to FDA's generic drugs 
program. GDUFA will also significantly

[[Page 22554]]

improve global supply chain transparency by requiring owners of 
facilities producing generic drug products and active pharmaceutical 
ingredients and certain other sites and organizations that support the 
manufacture or approval of these products to electronically self-
identify with FDA and update that information annually.
    Annual self-identification is required for two purposes. First, it 
is necessary to determine the universe of facilities required to pay 
user fees. Second, self-identification is a central component of an 
effort to promote global supply chain transparency. The information 
provided through self-identification enables quick, accurate, and 
reliable surveillance of generic drugs and facilitates inspections and 
compliance.
    Persons who self-identified for FY 2013 must self-identify again 
for FY 2014 between May 1, 2013, and June 1, 2013. Additional 
information including who is required to self-identify, how the 
information is submitted to FDA, the penalty for failure to self-
identify, and the technical specifications are available on http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm.
    Please note that registration and listing under section 510 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is a different 
process than self-identification under GDUFA. Many persons will thus be 
required to submit information separately to the respective systems. 
Each system populates its own database to meet unique requirements and 
deadlines. Both, however, are built on the same platform and based on 
the same technical standards.

    Dated: April 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08806 Filed 4-15-13; 8:45 am]
BILLING CODE 4160-01-P