Notice2024-09137
Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry (Revised); Availability
Primary source
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Published
April 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #120 entitled "Veterinary Feed Directive Regulation Questions and Answers." This revised guidance document will aid industry in complying with the requirements of the veterinary feed directive (VFD) regulation.
Full Text
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<title>Federal Register, Volume 89 Issue 83 (Monday, April 29, 2024)</title>
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[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Notices]
[Pages 33366-33367]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09137]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0155]
Veterinary Feed Directive Regulation Questions and Answers; Small
Entity Compliance Guide; Guidance for Industry (Revised); 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 guidance for industry (GFI) #120 entitled
``Veterinary Feed Directive Regulation Questions and Answers.'' This
revised guidance document will aid industry in complying with the
requirements of the veterinary feed directive (VFD) regulation.
DATES: The announcement of the guidance is published in the Federal
Register on April 29, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, 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.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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, 7500 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-241), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5944,
<a href="/cdn-cgi/l/email-protection#07437566606669294a686a646e6b68716e6447616366296f6f7429606871"><span class="__cf_email__" data-cfemail="eeaa9c8f898f80c0a381838d87828198878dae888a8fc086869dc0898198">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 30, 2015 (80 FR 58602), FDA
announced the availability of GFI #120 entitled ``Veterinary Feed
Directive Regulation Questions and Answers'' to assist industry in
complying with the VFD regulation in 21 CFR part 558. This guidance
also serves as a Small Entities 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 prepared
this SECG in accordance with section 212 of the Small Business
Regulatory Enforcement Fairness Act (Pub. L. 104-121). In the Federal
Register of March 28, 2019 (84 FR 11804), FDA announced the
availability of a draft revised GFI #120 to provide additional
information in response to questions that have been submitted by
interested parties since 2015. FDA reviewed comments submitted in
response to that notice by stakeholders, including animal producer
organizations, the animal feed industry, veterinarians, and producers
of electronic VFD software.
The Agency is now announcing the availability of revised GFI #120
which refines and clarifies language in the draft guidance based on
stakeholder feedback. Specifically, stakeholders asked FDA to clarify
and change language related to the amount of VFD drug in feed, the
issuance and effective dates of VFDs, definitions of and requirements
for individuals who
[[Page 33367]]
distribute VFD feeds, and the expiration of medicated feeds. In
response to stakeholder comments, FDA clarified language in the
respective sections and provided examples to better distinguish roles
and responsibilities of involved parties.
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 ``Veterinary Feed Directive 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR 558.6 have been approved under OMB control number 0910-0363.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: April 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09137 Filed 4-26-24; 8:45 am]
BILLING CODE 4164-01-P
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