[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14859-14860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06119]


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

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Controls Technical Section of Animal Drug Applications; Draft Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (GFI) #234 entitled 
``Question-Based Review for the Chemistry, Manufacturing, and Controls 
Technical Section of Animal Drug Applications.'' In order to improve 
the process for submission and review of chemistry, manufacturing, and 
controls (CMC) information for animal drugs, the Center for Veterinary 
Medicine (CVM) 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 (QbR), these questions provide a 
general framework for original CMC submissions to investigational new 
animal drug (INAD) files, generic investigational new animal drug 
(JINAD) files, new animal drug applications (NADAs), abbreviated new 
animal drug applications (ANADAs), conditional approval of applications 
for conditional approval (CNADAs), and veterinary master files (VMFs).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 17, 2016.

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-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 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 draft 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

    Under sections 512(c)(2)(A)(i) and (d)(1)(C), and 571(c)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(A)(i) and 
(d)(1)(C), and 360ccc(c)(1)), applicants must submit information on CMC 
to support the approval of NADAs and ANADAs or the conditional approval 
of CNADAs. CVM reviews the CMC information for new animal drugs to 
ensure that applicants have methods and controls in place for 
manufacturing, processing, and packaging that are adequate for assuring

[[Page 14860]]

and preserving the identity, strength, quality, and purity of the new 
animal drug and, in the case of a generic drug, to ensure that it is 
equivalent to the reference listed new animal drug (RLNAD).
    In order to improve the process for submission and review of CMC 
information for animal drugs, CVM has developed draft GFI #234 entitled 
``Question-Based Review for the Chemistry, Manufacturing, and Controls 
Technical Section of Animal Drug Applications.'' This guidance contains 
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 QbR, 
these questions provide a general framework for original CMC 
submissions to INAD and JINAD files, NADAs, ANADAs, CNADAs, and VMFs.

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

    Dated: March 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06119 Filed 3-17-16; 8:45 am]
 BILLING CODE 4164-01-P