81 FR 19195 - Comparability Protocols-Chemistry, Manufacturing, and Controls Information for New Animal Drugs; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 64 (April 4, 2016)

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (#156) entitled ``Comparability Protocols--Chemistry, Manufacturing, and Controls Information for New Animal Drugs.'' This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations to industry regarding comparability protocols that would be submitted in new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or supplements to these applications. This guidance also applies to comparability protocols submitted in investigational new animal drug (INAD), generic investigational new animal drug (JINAD), and veterinary master file (VMF) submissions that are referenced in applications. FDA is providing this guidance in response to requests from those interested in using comparability protocols.

[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19195-19196]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0938 (formerly FDA-2003-D-0034 and 2003D-0061)]


Comparability Protocols--Chemistry, Manufacturing, and Controls 
Information for New Animal Drugs; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry (#156) entitled 
``Comparability Protocols--Chemistry, Manufacturing, and Controls 
Information for New Animal Drugs.'' This document provides 
recommendations to applicants on preparing and using comparability 
protocols for postapproval changes in chemistry, manufacturing, and 
controls (CMC) information. It is intended to provide recommendations 
to industry regarding comparability protocols that would be submitted 
in new animal drug applications (NADAs), abbreviated new animal drug 
applications (ANADAs), or supplements to these applications. This 
guidance also applies to comparability protocols submitted in 
investigational new animal drug (INAD), generic investigational new 
animal drug (JINAD), and veterinary master file (VMF) submissions that 
are referenced in applications. FDA is providing this guidance in 
response to requests from those interested in using comparability 
protocols.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-0938 for ``Comparability

[[Page 19196]]

Protocols--Chemistry, Manufacturing, and Controls Information for New 
Animal Drugs.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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.

FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary 
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0696, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 25, 2003 (68 FR 8772), FDA 
published the notice of availability for a draft guidance for industry 
entitled ``Comparability Protocols--Chemistry, Manufacturing, and 
Controls Information,'' giving interested persons until June 25, 2003, 
to comment on the draft guidance and those comments were considered as 
the guidance was finalized. A summary of changes include describing 
comparability protocols submitted in CMC (J)INAD technical data 
submissions or (J)INAD protocols without substantial data. In 
accordance with the performance goals and procedures for the ADUFA and 
AGDUFA reauthorizations for fiscal years 2014 through 2018, 
comparability protocols may be submitted as comparability protocols 
without substantial data in a (J)INAD file. In addition, editorial 
changes were made to improve clarity. The guidance announced in this 
notice finalizes the draft guidance dated February 2003 only as it 
applies to the preparation and submission to the Center for Veterinary 
Medicine of comparability protocols for postapproval changes in CMC 
information for new animal drugs.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This guidance represents 
the current thinking of FDA on Comparability Protocols--Chemistry, 
Manufacturing, and Controls Information for New Animal Drugs. 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 have been approved under 
OMB control number 0910-0032; the collections of information in section 
512(n)(1) of the FD&C Act (21 U.S.C. 360b) have been approved under OMB 
control number 0910-0669.

IV. 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: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07573 Filed 4-1-16; 8:45 am]
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