[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)]
[Notices]
[Pages 75119-75120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0155]


Veterinary Feed Directive Common Format Questions and Answers; 
Draft Guidance for Industry; Availability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 or Agency) is announcing 
the availability of a draft guidance for industry #233 entitled 
``Veterinary Feed Directive Common Format Questions and Answers.'' On 
June 3, 2015, FDA published a final rule that revised the Agency's 
veterinary feed directive (VFD) regulations. During the rulemaking 
process, FDA received a few comments requesting that we require a 
uniform VFD form. Although we declined this request because we think 
that requiring a specific VFD form would be too prescriptive, we 
acknowledge that a common VFD format would help clients, veterinarians, 
and distributors (including feed mills) quickly identify relevant 
information on the VFD and are issuing this draft guidance to recommend 
a common VFD format.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 1, 2016.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-2010-N-0155 for ``Veterinary Feed Directive Common Format Questions 
and Answers.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at

[[Page 75120]]

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 draft 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: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5944, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#233 entitled ``Veterinary Feed Directive Common Format Questions and 
Answers.''
    In 1996, Congress enacted the Animal Drug Availability Act (ADAA) 
to facilitate the approval and marketing of new animal drugs and 
medicated feeds. In passing the ADAA, Congress created a new regulatory 
category for certain animal drugs used in or on animal feed called VFD 
drugs. VFD drugs are new animal drugs intended for use in or on animal 
feed which are limited to use under the professional supervision of a 
licensed veterinarian. FDA published final regulations at Sec.  558.6 
(21 CFR 558.6) implementing the VFD-related provisions of the ADAA in 
2000. On June 3, 2015 (80 FR 31707), FDA published a VFD final rule 
that revised those VFD regulations and introduced clarifying changes to 
specified definitions.
    During the latest rulemaking process, FDA received a few comments 
requesting the Agency to require a uniform VFD format. We declined this 
request because we thought that requiring a specific format would be 
too prescriptive. However, we acknowledge that a common VFD format 
would help clients, veterinarians, and distributors (including feed 
mills) quickly identify relevant information on the VFD.
    We are issuing this draft guidance to recommend a common VFD 
format. In the draft guidance, we use the term ``VFD'' to refer to the 
form used to convey the VFD order. This draft guidance describes the 
requirements in Sec.  514.1(b)(9) (21 CFR 514.1(b)(9)) for sponsor 
submission of a VFD to FDA as part of the application process for 
approval of a new animal drug for use in or on animal feed as a VFD 
drug, as well as the required and optional information to be included 
on the VFD. This draft guidance provides examples that illustrate how a 
common VFD format might appear and how some of the information on the 
VFD may be prepopulated by a sponsor.

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 
``Veterinary Feed Directive Common Format Questions and Answers.'' 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 Sec.  514.1 have been approved under OMB 
control number 0910-0032. The collections of information in Sec.  558.6 
have been approved under OMB control number 0910-0363.

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: November 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-30411 Filed 11-30-15; 8:45 am]
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