Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Reopening of the Comment Period, 70953 [2013-28392]

Download as PDF Federal Register / Vol. 78, No. 229 / Wednesday, November 27, 2013 / Notices Dated: November 18, 2013. Leslie Kux, Assistant Commissioner for Policy. 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. [FR Doc. 2013–28438 Filed 11–26–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ‘‘Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate’’, published in the Federal Register of September 10, 2013 (78 FR 55263). In that notice, FDA requested public comment on the draft guidance.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 https:// 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: Bhawana Saluja, Center for Drug Evaluation and Research (HFD–643), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 276–8465. SUPPLEMENTARY INFORMATION: SUMMARY: emcdonald on DSK67QTVN1PROD with NOTICES I. Background In the Federal Register of September 10, 2013 (78 FR 55263), FDA announced the notice of availability for the draft guidance entitled ‘‘Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate.’’ Interested persons were given until VerDate Mar<15>2010 17:02 Nov 26, 2013 Jkt 232001 II. Request 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 https://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 https:// www.regulations.gov. Dated: November 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–28394 Filed 11–26–13; 8:45 am] BILLING CODE 4160–01–P 70953 November 13, 2013, due to technical difficulties. Submit either electronic or written comments to the docket by December 11, 2013. ADDRESSES: Submit electronic comments to https:// 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: DATES: 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 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. Notice; reopening of the comment period. ACTION: 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 SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 9990 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 https://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 https:// 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 E:\FR\FM\27NON1.SGM 27NON1

Agencies

[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.

-----------------------------------------------------------------------

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 https://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 https://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 https://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

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