
[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Proposed Rules]
[Pages 31520-31521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13394]


=======================================================================
-----------------------------------------------------------------------

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Veterinary Feed Directive Regulation Questions and Answers; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Draft revised guidance; availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft revised guidance for industry (GIF) #120 
entitled ``Veterinary Feed Directive Regulation Questions and 
Answers.'' The purpose of this document is to describe the current 
Veterinary Feed Directive (VFD) 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). This draft 
revised guidance reflects changes to the VFD requirements under the VFD 
final rule.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 3, 2015.

ADDRESSES: 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for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6856, 
dragan.momcilovic@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

[[Page 31521]]

I. Background

    FDA is announcing the availability of a draft revised GFI #120 
entitled ``Veterinary Feed Directive Regulation Questions and 
Answers.'' The audience for this draft guidance is comprised of 
veterinarians issuing VFD orders, feed mills manufacturing VFD feeds 
and other distributors, animal producers who obtain VFD feeds for use 
in treating their animals, and others. This draft revised guidance 
reflects changes to the VFD requirements under the VFD final rule 
published elsewhere in this edition of the Federal Register.
    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 veterinary 
feed directive (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.
    Elsewhere in this edition of the Federal Register, FDA is 
publishing a VFD final rule that revises those VFD regulations and 
introduces clarifying changes to specified definitions. This draft 
revised guidance includes revisions that are consistent with the 
requirements in that final rule.

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 Agency's current thinking on this 
topic. It does not establish any rights for or on any person and does 
is not binding on FDA or the public. An alternative approach may be 
used if such approach 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 558.6 have been approved under OMB 
control number 0910-0363.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

V. 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: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13394 Filed 6-2-15; 8:45 am]
 BILLING CODE 4164-01-P


