81 FR 92834 - Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 244 (December 20, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #234 entitled ``Question- Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.'' To improve the process for submission and review of chemistry, manufacturing, and controls (CMC) information for animal drugs, the Center for Veterinary Medicine has developed a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. Termed Question-based Review, these questions provide a general framework for original CMC submissions to investigational new animal drug files, generic investigational new animal drug files, new animal drug applications, abbreviated new animal drug applications, conditional approval of applications for conditional approval, and veterinary master files.

[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92834-92835]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30613]



[[Page 92834]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0620]


Question-Based Review for the Chemistry, Manufacturing, and 
Controls Technical Section of Animal Drug Applications; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry #234 entitled ``Question-
Based Review for the Chemistry, Manufacturing, and Controls Technical 
Section of Animal Drug Applications.'' To improve the process for 
submission and review of chemistry, manufacturing, and controls (CMC) 
information for animal drugs, the Center for Veterinary Medicine has 
developed a series of questions that focus on the critical scientific 
and regulatory issues and pharmaceutical attributes essential for 
ensuring the quality of new animal drug substances and products. Termed 
Question-based Review, these questions provide a general framework for 
original CMC submissions to investigational new animal drug files, 
generic investigational new animal drug files, new animal drug 
applications, abbreviated new animal drug applications, conditional 
approval of applications for conditional approval, and veterinary 
master files.

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://
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-0620 for ``Question-Based Review for the Chemistry, 
Manufacturing, and Controls Technical Section of Animal Drug 
Applications.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://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 https://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 https://
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: Julie Bailey, Center for Veterinary 
Medicine (HFV-145), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0700, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 18, 2016 (81 FR 14859), FDA 
published the notice of availability for a draft guidance entitled 
``Question-Based Review for the Chemistry, Manufacturing, and Controls 
Technical Section of Animal Drug Applications'' giving interested 
persons until May 17, 2016, to comment on the draft guidance. FDA 
received no comments on the draft guidance. The guidance announced in 
this notice finalizes the draft guidance dated March 2016.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``Question-Based Review for the 
Chemistry, Manufacturing, and Controls Technical Section of Animal Drug 
Applications.'' 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

[[Page 92835]]

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(n)(1)) 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 
https://www.regulations.gov.

    Dated: December 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30613 Filed 12-19-16; 8:45 am]
 BILLING CODE 4164-01-P