
[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Rules and Regulations]
[Pages 58602-58603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24685]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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


Veterinary Feed Directive Regulation Questions and Answers; Small 
Entity Compliance Guide; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a small entity compliance guide and guidance for 
industry #120 entitled ``Veterinary Feed Directive Regulation Questions 
and Answers.'' This guidance aids industry in complying with the 
requirements of the Veterinary Feed Directive (VFD) final rule that 
published in the Federal Register on June 3, 2015. The purpose of this 
document is to describe the Veterinary Feed Directive requirements for 
veterinarians, feed manufacturers and other distributors, animal 
producers, and other parties involved in the distribution or use of 
medicated feed containing a Veterinary Feed Directive drug (VFD feed).

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-2010-N-0155 for ``Veterinary Feed Directive Regulation Questions 
and Answers; Small Entity Compliance Guide; Guidance for Industry; 
Availability.'' 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

[[Page 58603]]

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: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5944, 
dragan.momcilovic@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 3, 2015 (80 FR 31520), FDA 
published a notice of availability for a draft guidance entitled 
``Veterinary Feed Directive Regulation Questions and Answers'' giving 
interested persons until August 3, 2015, to comment on the draft 
guidance. FDA received several comments on the draft guidance and those 
comments were considered as the guidance was finalized. The guidance 
announced in this notice finalizes the draft guidance dated June 2015. 
This guidance also serves as a Small Entity Compliance Guide (SECG) to 
aid industry in complying with the requirements of the VFD final rule 
that published in the Federal Register on June 3, 2015 (80 FR 31708). 
FDA has prepared this SECG in accordance with section 212 of the Small 
Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). This 
document is intended to provide guidance to small businesses on the 
requirements of the final rule.
    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 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 implementing the 
VFD-related provisions of the ADAA in 2000. On June 3, 2015, FDA 
published a VFD final rule that revised those VFD regulations and 
introduced clarifying changes to specified definitions, and published 
the draft revised guidance for comment.

II. Significance of Guidance

    This 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 VFD regulation 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 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 558.6 have been approved under OMB 
control number 0910-0363.

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: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24685 Filed 9-29-15; 8:45 am]
 BILLING CODE 4164-01-P


