
[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62635-62636]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24796]


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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Sections; Draft Guidance for Industry; Availability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availability of a draft guidance for industry (GFI #227) entitled 
``Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical 
Sections.'' The purpose of this document is to provide recommendations 
to sponsors submitting CMC data submissions. For review efficiency, the 
Center for Veterinary Medicine (CVM) prefers that CMC information be 
submitted in a single technical section. However, there may be 
instances when a two-phased technical submission process is more 
beneficial to improve the overall time to drug approval. Sponsors may 
submit the phased CMC technical section as a single technical section 
or a two-phased technical section. This guidance describes the use of 
the two-phased technical section submission process.

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

[[Page 62636]]

guidance before it begins work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
December 19, 2014.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

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

    FDA is announcing the availability of a 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 CVM to support approval of 
a new animal drug or abbreviated new animal drug. As specified in the 
Animal Drug User Fee Amendments of 2013 (ADUFA III) and Animal Generic 
Drug User Fee Amendments of 2013 (AGDUFA II) respective goals letters, 
the Agency agreed to develop guidance for a two-phased CMC technical 
section submission and review process by the end of fiscal year 2014.
    The two-phased process allows for two separate CMC submissions, 
each with its own review clock, and each including complete appropriate 
CMC information that is available for review at the time of submission. 
The draft guidance specifies the technical details of how the process 
works, the review clocks, the information that is appropriate for each 
technical section submission, and the possible review outcomes. The 
guidance also includes CVM's recommendations for meetings between the 
Division of Manufacturing Technologies and the sponsor during this 
process to ensure concurrence with the approach used for the CMC 
technical section.

II. Significance of Guidance

    This level 1 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 this 
topic. 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.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance have been approved under 
0910-0032 and 0910-0669.

IV. 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.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24796 Filed 10-17-14; 8:45 am]
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