Document ID: FDA-2014-D-1492-0006
Agency: fda
Document Type: Notice
Title: Two-Phased Chemistry, Manufacturing, and Controls Technical
Sections; Guidance for Industry; Availability
Posted Date: 2015-09-01T04:00Z

[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52766-52767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21583]

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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; 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 guidance for industry (GFI) #227 entitled ``Two-
Phased Chemistry, Manufacturing, and Controls (CMC) Technical 
Sections.'' The guidance provides recommendations to sponsors 
submitting chemistry, manufacturing, and controls (CMC) data 
submissions to the Center of Veterinary Medicine (CVM) to support 
approval of a new animal drug or abbreviated new animal drug.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Policy and Regulations Staff (HFV-6), 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 guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance 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, 
heather.longstaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of October 20, 2014 (79 FR 62635) FDA 
published the notice of availability for a draft guidance for industry 
#227 entitled ``Two-Phased Chemistry, Manufacturing, and Controls (CMC) 
Technical Sections'' giving interested persons until December 19, 2014, 
to comment on the draft guidance. FDA received one comment on the draft 
guidance and that comment was considered as the guidance was finalized. 
The guidance announced in this notice finalizes the draft guidance 
dated October 2014.
    GFI #227 provides recommendations to sponsors submitting CMC data 
submissions to CVM to support approval of a new animal drug or 
abbreviated new animal drug. 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 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.

[[Page 52767]]

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulations (21 CFR 10.115). This guidance 
represents the current thinking of FDA on two-phased CMC technical 
sections. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This 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 21 CFR part 514 and section 512(n)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(n)(1)) have 
been approved under OMB control numbers 0910-0032 and 0910-0669, 
respectively.

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 guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: August 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21583 Filed 8-31-15; 8:45 am]
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