[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55261-55262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21891]


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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Draft Guidance for Industry on Generic Drug User Fee Amendments 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 (Revision 1); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Generic Drug 
User Fee Amendments of 2012: Questions and Answers (Revision 1).'' 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 
updated 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 12, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

[[Page 55262]]


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, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    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 are 
incurred for ANDAs and PASs submitted on or after October 1, 2012. An 
application fee is also incurred the first time a DMF is referenced in 
an ANDA or PAS submitted on or after October 1, 2012. FDA previously 
announced GDUFA fees for fiscal year 2013 in the Federal Register. 
ANDA, PAS, and DMF fees were published on October 25, 2012 (77 FR 
65198); the backlog fee was published on October 25, 2012 (77 FR 
65199); and facility fees were published on January 17, 2013 (78 FR 
3900). GDUFA fees for fiscal year 2014 were announced in the Federal 
Register of August 2, 2013 (78 FR 46977).
    On August 27, 2012, FDA announced the availability of a draft 
guidance for industry entitled ``Generic Drug User Fee Amendments of 
2012: Questions and Answers'' (77 FR 51814). The comment period on the 
draft guidance closed on October 26, 2012. In response to comments 
received in the docket and to address additional questions that have 
arisen since the launch of the GDUFA program, FDA has revised the draft 
guidance and is issuing it again in draft to solicit public comment. 
Revision 1 clarifies some of the questions and answers in the first 
version and adds several new questions and answers. The questions and 
answers address four key categories: Fees; self-identification of 
facilities, sites, and organizations; review of generic drug 
submissions; and inspections and compliance.
    This revised 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: Questions and Answers 
(Revision 1).'' 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 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21891 Filed 9-9-13; 8:45 am]
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