[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62635-62636]
From the Federal Register Online via the Government Publishing 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Sections; Draft Guidance for Industry; Availability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availability of a draft guidance for industry (GFI #227) entitled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submit either electronic or written comments on the draft guidance by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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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:
[email protected].
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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