Document ID: FDA-2012-D-0880-0009
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Reopening of the Comment Period
Posted Date: 2013-11-27T05:00Z

[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Page 70953]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28392]

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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Draft Guidance for Industry on Generic Drug User Fee Amendments 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); Reopening of the Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice of availability entitled ``Draft Guidance 
for Industry on Generic Drug User Fee Amendments of 2012: Questions and 
Answers (Revision 1)'', published in the Federal Register of September 
10, 2013 (78 FR 55261). In that notice, FDA requested public comment on 
the draft guidance. FDA is reopening the comment period due to the 
inability of some commenters to submit comments through the 
www.regulations.gov Web site from November 4, 2013, through November 
13, 2013, due to technical difficulties.

DATES: Submit either electronic or written comments to the docket by 
December 11, 2013.

ADDRESSES: Submit electronic comments 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, 10001 New 
Hampshire Ave., rm. 4145, Silver Spring, MD 20993-0002, 301-796-6707, 
email: askGDUFA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 10, 2013 (78 FR 55261), FDA 
announced the notice of availability for the draft guidance entitled 
``Draft Guidance for Industry on Generic Drug User Fee Amendments of 
2012: Questions and Answers (Revision 1).'' Interested persons were 
given until November 12, 2013, to provide comments. The Agency is 
reopening the comment period until December 11, 2013 to allow 
interested persons additional time to submit comments.

II. Requests for Comments

    Following publication of the September 10, 2013, notice of 
availability, there were technical difficulties with the 
www.regulations.gov Web site from November 4, 2013, through November 
13, 2013, which would have prevented comments from being submitted.

III. How To Submit 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.

    Dated: November 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28392 Filed 11-26-13; 8:45 am]
BILLING CODE 4160-01-P