[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Notices]
[Pages 1979-1981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2635]


Potential Approach for Defining Durations of Use for Medically 
Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept 
Paper; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
requesting comments on a document entitled ``Potential Approach for 
Defining Durations of Use for Medically Important Antimicrobial Drugs 
Intended for Use In or On Feed: A Concept Paper.'' The concept paper 
outlines a potential framework for how sponsors of new animal drug 
products containing medically important antimicrobial drugs approved 
for use in or on animal feed might voluntarily establish appropriately 
defined durations of therapeutic administration to food-producing 
animals where none currently exist. Establishing appropriately defined 
durations of use to mitigate development of antimicrobial resistance 
would be consistent with previous efforts by FDA to protect public 
health by promoting the judicious use of these drugs in food-producing 
animals.

DATES: Submit either electronic or written comments by April 12, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 12, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 12, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <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-2016-D-2635 for ``Potential Approach for Defining Durations of Use 
for Medically Important Antimicrobial Drugs Intended for Use In or On 
Feed: A Concept Paper.'' Received comments, those filed in a timely 
manner (see ADDRESSES), 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.
    <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 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

[[Page 1980]]

``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.
    Submit written requests for single copies of the concept paper 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 concept paper.

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#9ff5f0f7f1b1f2eaececf2fef1dff9fbfeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="294346414707445c5a5a444847694f4d480741415a074e465f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    In response to recommendations made by FDA in Guidance for Industry 
(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 new animal drugs containing 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 assuring animal health (production 
indications) and to voluntarily change the marketing status of all 
remaining approved uses of such new animal drugs from ``over the 
counter'' to either by veterinary prescription 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/regulatory-information/search-fda-guidance-documents/cvm-gfi-213-new-animal-drugs-and-new-animal-drug-combination-products-administered-or-medicated-feed)
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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 antimicrobial drugs 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 on 
September 14, 2016 (81 FR 63187), the Agency requested information from 
the public about how to establish appropriately targeted durations of 
use for therapeutic products affected by GFI #213 with no defined 
duration of use. Public feedback received in response to that request 
for information was taken into consideration during development of this 
concept paper.
    On September 14, 2018, FDA released a 5-year action plan for 
supporting antimicrobial stewardship in veterinary settings.\2\ This 
plan includes an action item intended to ensure that all medically 
important antimicrobial drugs used in or on the feed or drinking water 
of food-producing animals have an appropriately targeted duration of 
use.\3\
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    \2\ 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)
    \3\ See Action item 1.1.2 of the 5-year plan.
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II. Request for Comments

    We are requesting early input and comments from the public on a 
concept paper that outlines a potential framework for how sponsors of 
approved new animal drug applications and abbreviated new animal drug 
applications for products containing medically important antimicrobial 
drugs for use in or on the feed of food-producing animals could 
voluntarily 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. A copy of the concept 
paper may be obtained as described in section III below.
    For the purpose of this potential framework, the term ``undefined 
duration of use'' means that for one or more of the indications for 
which the drug is approved, the product's labeling either includes no 
information regarding the duration of administration or otherwise does 
not provide an appropriately targeted duration of use. Although FDA's 
5-year action plan for supporting antimicrobial stewardship that issued 
in September 2018 included an action item calling for the Agency to 
develop a strategy for establishing appropriately defined durations of 
use for medically important antimicrobial drugs used in or on the feed 
or drinking water of food-producing animals, the Center for Veterinary 
Medicine later determined that all of the approved uses of medically 
important antimicrobial drugs in dosage forms other than feed already 
have appropriately defined durations of use. For this reason, the scope 
of the concept paper is limited to those drugs that are approved for 
use in or on medicated feed.
    The concept paper is intended to outline for sponsors and other 
stakeholders a potential process framework for how to make voluntary 
changes to the approved conditions of use of their medically important 
antimicrobial drugs administered in or on the medicated feed of food-
producing animals to establish appropriately defined durations of use 
where none currently exist. Establishing appropriately defined 
durations of use to mitigate the development of antimicrobial 
resistance would be consistent with previous efforts by FDA to protect 
public health by promoting the judicious use of these drugs in food-
producing animals.
    Under the potential framework described in the concept paper, the 
process for revising the conditions of use would include making changes 
to the approved labeling for the product to appropriately define 
duration of use and, when appropriate, providing additional information 
to be included on the product's labeling that would be relevant to the 
veterinarian in determining when drug administration should be 
initiated or stopped in accordance with the approved labeling and 
consistent with the principles of judicious use of antimicrobials. In 
addition, were the potential framework later to be adopted through 
guidance, sponsors who choose to voluntarily establish appropriately 
defined durations of use for their products would be expected to submit 
data or other information supporting effectiveness at the shortest 
duration of use proposed for the labeling.
    The potential framework includes a possible timeline for sponsors, 
with two phases: Phase 1, reassessing the existing data used to support 
the original approval of the affected product indications, considering 
what additional data or information might be needed, and formulating 
plans to obtain such data or information; and Phase 2, taking steps to 
obtain approval of revisions to conditions of use for their affected 
products. The potential framework also includes possible timelines for 
making labeling changes to combination proprietary free-choice 
medicated feeds and generic products, as well as a possible timeline 
for sponsors who intend to voluntarily withdraw the approval of an 
indication or an entire application rather than submit data or other 
information to define a duration of use.
    We do not intend for the concept paper described in this notice to 
produce any decisions or new positions on specific regulatory issues or 
processes. Rather, the intent is to gather

[[Page 1981]]

information and obtain early input from the public on a potential 
framework for how sponsors may voluntarily change the approved 
conditions of use of medically important antimicrobial drugs used in or 
on the medicated feed of food-producing animals to establish an 
appropriately defined duration of use for those indications that 
currently have an undefined duration of use. The concept paper does not 
contain recommendations and does not constitute draft or final guidance 
by FDA. It should not be used for any purpose other than to facilitate 
public comment. FDA intends to consider all information and comments 
received on the concept paper before issuing draft guidance for 
additional comment.
    We are specifically interested in receiving public comments on the 
following questions:
    1. Are the potential timeframes outlined in the concept paper 
reasonable to achieve the goals described in the concept paper? If not, 
are there specific scientific or administrative barriers that would 
prevent sponsors from meeting these timeframes?
    2. Are the potential processes for revising the applications 
described in the concept paper reasonable? If not, what specific 
adjustments could be made to improve these processes?
    3. Are there other factors we should consider regarding this 
potential framework? If so, what are they?

III. Electronic Access

    Persons with access to the internet may obtain the concept paper at 
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00189 Filed 1-8-21; 8:45 am]
BILLING CODE 4164-01-P


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