[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66009-66010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for 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the availability of a draft guidance for industry (GFI) #273 entitled 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 This draft 
guidance document, when finalized, will provide recommendations on how 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DATES: Submit either electronic or written comments on the draft 
guidance by December 26, 2023, to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 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, [email protected].

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. (https://www.fda.gov/media/83488/download)
    \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. (https://www.fda.gov/media/130610/download)
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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.'' (https://www.fda.gov/media/115776/download)
    \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 https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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