Document ID: FDA-2014-D-1492-0003
Agency: fda
Document Type: Notice
Title: Two-Phased Chemistry, Manufacturing, and Controls Technical 
Sections; Draft Guidance for Industry; Extension of Comment Period
Posted Date: 2014-12-09T05:00Z

[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73080-73081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28713]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1492]

Two-Phased Chemistry, Manufacturing, and Controls Technical 
Sections; Draft Guidance for Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for a notice of availability of draft guidance for 
industry (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and 
Controls Technical Sections'' that appeared in the Federal Register of 
October 20, 2014. In that notice, FDA made available for comment the 
draft guidance, which provides recommendations to sponsors submitting 
chemistry, manufacturing, and controls (CMC) data submissions. The 
Agency is taking this action in response to a request for an extension 
to allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the draft guidance. 
Submit either electronic or written comments on the draft guidance by 
February 17, 2015.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Identify comments with the docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Heather Longstaff, Center for 
Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0651, email: 
heather.longstaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 20, 2014 (79 FR 62635) FDA 
published a notice announcing the availability of draft guidance for 
industry (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and 
Controls (CMC) Technical Sections.'' It is intended to provide 
recommendations to industry regarding CMC data submitted to the Center 
for Veterinary Medicine to support approval of a new animal drug or 
abbreviated new animal drug. The notice invited comments on the draft 
guidance by December 19, 2014.
    The Agency received a request for a 60-day extension of the comment 
period for the draft guidance. The request conveyed concern that the 
current 60-day comment period does not allow sufficient time to 
respond.
    FDA has considered the request and is extending the comment period 
for the draft guidance for 60 days, until February 17, 2015. The Agency 
believes that a 60-day extension allows adequate time for interested 
persons to submit comments without significantly delaying further FDA 
action on this guidance document.

II. Request for 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.

[[Page 73081]]

    Dated: December 2, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28713 Filed 12-8-14; 8:45 am]
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