[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Draft Guidance for Industry on Generic Drug User Fee Amendments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availability of a draft guidance for industry entitled ``Generic Drug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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 12, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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