Notice2023-20920
Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Availability
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Published
September 26, 2023
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #273 entitled "Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals." This draft guidance document, when finalized, will provide recommendations on how sponsors may voluntarily establish defined durations of use for certain antimicrobial new animal drugs used in or on the medicated feed of food-producing animals that are currently approved with one or more indications that lack a defined duration of use. Establishing defined durations of use within the approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) is intended to mitigate development of antimicrobial resistance for these antimicrobial drugs, which are important to human medicine. It also, when finalized, will propose timelines for stakeholders wishing to voluntarily align their affected applications with this guidance.
Full Text
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<title>Federal Register, Volume 88 Issue 185 (Tuesday, September 26, 2023)</title>
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[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66009-66010]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20920]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-2925]
Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for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the availability of a draft guidance for industry (GFI) #273 entitled
``Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals.'' This draft
guidance document, when finalized, will provide recommendations on how
sponsors may voluntarily establish defined durations of use for certain
antimicrobial new animal drugs used in or on the medicated feed of
food-producing animals that are currently approved with one or more
indications that lack a defined duration of use. Establishing defined
durations of use within the approved new animal drug applications
(NADAs) and abbreviated new animal drug applications (ANADAs) is
intended to mitigate development of antimicrobial resistance for these
antimicrobial drugs, which are important to human medicine. It also,
when finalized, will propose timelines for stakeholders wishing to
voluntarily align their affected applications with this guidance.
DATES: Submit either electronic or written comments on the draft
guidance by December 26, 2023, to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2023-D-2925 for ``Defining Durations of Use for Approved Medically
Important Antimicrobial Drugs Fed to Food-Producing Animals.'' 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: John Mussman, Center for Veterinary
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0589, <a href="/cdn-cgi/l/email-protection#256f4a4d4b0b6850565648444b654341440b4d4d560b424a53"><span class="__cf_email__" data-cfemail="367c595e58187b4345455b575876505257185e5e4518515940">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft GFI #273 entitled
``Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals.'' This draft
guidance, when finalized, will provide information to sponsors of
certain antimicrobial animal drug products who are interested in
establishing appropriately defined durations of therapeutic
administration to food-producing animals where none currently exist.
The draft guidance, when finalized, will also propose timelines for
stakeholders wishing to comply voluntarily with this guidance.
[[Page 66010]]
In response to recommendations made by FDA in GFI #213,\1\ as part
of a strategy to address antimicrobial resistance associated with the
use of antimicrobial drugs in animal agriculture, sponsors of all NADAs
and ANADAs for antimicrobial drugs important to human medicine
(medically important antimicrobial drugs) approved for use in or on the
feed or in the drinking water of food-producing animals worked with FDA
over a 3-year period from 2013 to 2016 to voluntarily withdraw approval
of indications that were not considered necessary for ensuring animal
health (production indications). In response to FDA recommendations
made in GFI #263,\2\ sponsors also voluntarily worked with FDA to
change the marketing status of all remaining approved uses of such new
animal drugs from over-the-counter (OTC) to either by veterinary
prescription (Rx) or by veterinary feed directive, as applicable.
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\1\ See GFI #213, ``New Animal Drugs and New Animal Drug
Combination Products Administered in or on Medicated Feed or
Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions with GFI
#209,'' December 2013. (<a href="https://www.fda.gov/media/83488/download">https://www.fda.gov/media/83488/download</a>)
\2\ See GFI #263, ``Recommendations for Sponsors of Medically
Important Antimicrobial Drugs Approved for Use in Animals to
Voluntarily Bring Under Veterinary Oversight All Products That
Continue to be Available Over-the-Counter,'' June 2021. (<a href="https://www.fda.gov/media/130610/download">https://www.fda.gov/media/130610/download</a>)
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In September 2016, FDA announced that it intended to enter the next
phase of its efforts to mitigate antimicrobial resistance by focusing
on medically important antimicrobials used in animal feed or water that
have at least one therapeutic indication without a defined duration of
use. In a notice published in the Federal Register of September 14,
2016 (81 FR 63187), the Agency requested comments from the public about
how to establish appropriately targeted durations of use for
therapeutic products within the scope of GFI #213 with no currently
defined duration of use. Public feedback received in response to that
request for information was taken into consideration during subsequent
development of a concept paper released in 2021.
On September 14, 2018, FDA released a 5-year action plan for
supporting antimicrobial stewardship in veterinary settings.\3\ This
plan includes an action item intended ``to ensure that all medically
important antimicrobial drugs used in the feed or drinking water of
food-producing animals have an appropriately targeted duration of
use.'' \4\
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\3\ See FDA's 5-year action plan entitled ``Supporting
Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal
Years 2019-2023.'' (<a href="https://www.fda.gov/media/115776/download">https://www.fda.gov/media/115776/download</a>)
\4\ See Action item 1.1.2 of the 5-year plan.
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In a notice published in the Federal Register of January 11, 2021
(86 FR 1979), FDA requested comments from the public on a concept paper
that outlined a potential framework for how sponsors of NADAs and
ANADAs for products containing medically important antimicrobial drugs
approved for use in or on the feed of food-producing animals could
voluntarily work with FDA to change the approved conditions of use of
these drugs to establish appropriately defined durations of use for
those indications that currently have an undefined duration of use. The
concept paper generated invaluable public comment; FDA considered all
information and feedback received on the concept paper as it developed
this draft 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
``Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals.'' 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 section 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-
0669. The collections of information in 21 CFR part 514 have been
approved under OMB control number 0910-0032.
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: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20920 Filed 9-25-23; 8:45 am]
BILLING CODE 4164-01-P
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