[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Notices]
[Page 51814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0880]


Draft Guidance for Industry on Generic Drug User Fee Amendments 
of 2012: Questions and Answers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Generic 
Drug User Fee Amendments of 2012: Questions and Answers.'' The Generic 
Drug User Fee Amendments of 2012 (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 support 
critical and measurable enhancements to FDA's generic drugs program. 
GDUFA also requires that generic drug facilities, sites, and 
organizations located around the world provide identification 
information annually to FDA. This guidance is intended to provide 
answers to common questions from the generic drug industry and other 
interested parties involved in the development and/or testing of 
generic drug products regarding the requirements and commitments of 
GDUFA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 26, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Jaewon Hong, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 866-405-5367 or 301-796-6707.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Generic Drug User Fee Amendments of 2012: Questions and 
Answers.'' GDUFA (Pub. L. 112-144, Title III) was signed into law by 
the President on July 9, 2012. 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 support critical and 
measurable enhancements to FDA's generic drugs program.
    GDUFA establishes fees for abbreviated new drug applications 
(ANDAs), prior approval supplements (PASs) to ANDAs, and drug master 
files (DMFs), annual facility fees, and a one-time fee for original 
ANDAs pending with FDA on October 1, 2012 (backlog fees). Fees will be 
incurred for ANDAs and PASs submitted on or after October 1, 2012. An 
application fee will also be incurred the first time a DMF is 
referenced in an ANDA or PAS submitted on or after October 1, 2012. FDA 
plans to publish the fee amounts for ANDAs, PASs, DMFs, and the backlog 
fee in the Federal Register on or before October 31, 2012.
    The amount of the annual user fees for generic drug facilities will 
be determined after GDUFA program launch. Under GDUFA, facilities, 
sites, and organizations are first required to self-identify. Fees will 
be determined after the self-identification process has been completed, 
providing FDA information about the number of facilities that will be 
required to pay user fees. These include facilities manufacturing, or 
intending to manufacture, active pharmaceutical ingredients of human 
generic drugs and/or finished dosage form human generic drugs.
    This draft guidance is intended to provide answers to common 
questions from generic drug industry participants and other interested 
parties involved in the development and/or testing of generic drug 
products regarding FDA's plans for implementing GDUFA. This draft 
guidance is being issued consistent with FDA's good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent the Agency's current thinking on generic drug user fee 
amendments of 2012. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20944 Filed 8-22-12; 11:15 am]
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