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, 1979-1981 [2021-00189]
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1979
Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Estimated total
number of
respondents
Number of
responses per
respondent
3,000
1,500
1,125
1
1
1
Semi-Structured Discussions and Focus Groups ............................................
Interviews .........................................................................................................
Questionnaires/Surveys ...................................................................................
Estimated Total Annual Burden
Hours: 8,063
Authority: Social Security Act, Sec. 1110
[42 U.S.C. 1310].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–00209 Filed 1–8–21; 8:45 am]
BILLING CODE 4184–79–P
Electronic Submissions
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.
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 foodproducing 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 foodproducing 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,
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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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.
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.’’
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Average
burden hours
per response
2
1
.5
Annual burden
hours
6,000
1,500
563
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.
• 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-201509-18/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
E:\FR\FM\11JAN1.SGM
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1980
Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices
‘‘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 selfaddressed 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,
john.mussman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
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.
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
1 See GFI #213, ‘‘New Animal Drugs and New
Animal Drug Combination Products Administered
in or on Medicated Feed or Drinking Water of FoodProducing 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-newanimal-drugs-and-new-animal-drug-combinationproducts-administered-or-medicated-feed)
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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
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 foodproducing 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.
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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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 foodproducing 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 foodproducing 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
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Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
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552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel HHS–NIH–CDC–SBIR PHS
2021–1 Phase I: Reagents for Immunologic
Analysis of Non-Mammalian and
Underrepresented Mammalian Models (Topic
094) (For SBIRs Phase I)
Date: January 28, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20892 (Virtual Meeting),
Contact Person: Kelly L. Hudspeth, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G41, Rockville, MD
20852, 240–669–5067, kelly.hudspeth@
nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel HHS–NIH–CDC–SBIR PHS
2021–1 Phase II: Reagents for Immunologic
Analysis of Non-Mammalian and
Underrepresented Mammalian Models (Topic
094) (For SBIRs Phase II).
Date: January 29, 2021.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Kelly L. Hudspeth, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G41, Rockville, MD
20852, 240–669–5067, kelly.hudspeth@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: January 5, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–00219 Filed 1–8–21; 8:45 am]
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1981
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods Communities of Practice
Webinar on Non-Animal Approaches
for Mixtures Assessment; Notice of
Public Webinar; Registration
Information
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM)
announces a public webinar ‘‘Nonanimal Approaches for Mixtures
Assessment.’’ The webinar is organized
on behalf of ICCVAM by the National
Toxicology Program Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM).
Interested persons may participate via
WebEx. Time will be allotted for
questions from the audience.
Information about the webinar and
registration are available at https://
ntp.niehs.nih.gov/go/commprac-2021.
DATES:
Webinar: January 26, 2021, 9:00 a.m.
to approximately 11:00 a.m. EST.
Registration for Webinar: January 4,
2021, until 11:00 a.m. EST January 26,
2021.
Registration to view the webinar is
required.
SUMMARY:
Webinar web page https://
ntp.niehs.nih.gov/go/commprac-2021.
FOR FURTHER INFORMATION CONTACT: Dr.
Nicole Kleinstreuer, Acting Director,
NICEATM, Division of NTP, NIEHS,
P.O. Box 12233, K2–16 Research
Triangle Park, NC 27709. Phone: 984–
287–3150, Email: Nicole.kleinstreuer@
nih.gov. Hand Deliver/Courier address:
530 Davis Drive, Room K2032,
Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background: ICCVAM promotes the
development and validation of toxicity
testing methods that protect human
health and the environment while
replacing, reducing, or refining animal
use. ICCVAM also provides guidance to
test method developers and facilitates
collaborations that promote the
development of new test methods. To
address these goals, ICCVAM will hold
a Communities of Practice webinar on
‘‘Non-animal Approaches for Mixtures
Assessment.’’
While most available toxicity data are
for single chemicals, humans are often
ADDRESSES:
E:\FR\FM\11JAN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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-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.
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, [email protected].
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.
---------------------------------------------------------------------------
\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)
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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
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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]
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