Notice2022-27415
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability
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Published
December 19, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #152 entitled "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern." This draft guidance informs stakeholders about FDA's current method for evaluating potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process.
Full Text
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<title>Federal Register, Volume 87 Issue 242 (Monday, December 19, 2022)</title>
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[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77619-77620]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27415]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1998-D-0038]
Evaluating the Safety of Antimicrobial New Animal Drugs With
Regard to Their Microbiological Effects on Bacteria of Human Health
Concern; Revised Draft Guidance for Industry; Availability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the availability of a draft guidance for industry #152 entitled
``Evaluating the Safety of Antimicrobial New Animal Drugs with Regard
to Their Microbiological Effects on Bacteria of Human Health Concern.''
This draft guidance informs stakeholders about FDA's current method for
evaluating potential microbiological effects of antimicrobial new
animal drugs on bacteria of human health concern as part of the new
animal drug application process.
DATES: Submit either electronic or written comments on the draft
guidance by March 20, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-1998-D-0038 for ``Evaluating the Safety of Antimicrobial New Animal
Drugs with Regard to Their Microbiological Effects on Bacteria of Human
Health Concern.'' 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: Ruby Singh, Center for Veterinary
Medicine (HFV-150), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0794, <a href="/cdn-cgi/l/email-protection#4a383f2833643923242d220a2c2e2b64222239642d253c"><span class="__cf_email__" data-cfemail="453730273c6b362c2b222d052321246b2d2d366b222a33">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
#152 entitled ``Evaluating the Safety of Antimicrobial New Animal Drugs
with Regard to their Microbiological Effects on Bacteria of Human
Health Concern.'' Antimicrobial drugs have been used since the mid-20th
century to control and cure infectious diseases in humans. Since their
discovery, these drugs have prevented millions of human deaths
worldwide, they have helped to promote animal health, and they have
helped to provide an abundant and affordable supply of meat, milk, and
eggs. Soon after antimicrobial drugs became widely available,
scientists noted that their use could contribute to the emergence and
selection of antimicrobial resistance in bacteria, thereby reducing the
effectiveness of the
[[Page 77620]]
antimicrobial drugs. To address the human health risks surrounding the
use of antimicrobial new animal drugs, in 2003, FDA issued Guidance for
Industry (GFI) #152, entitled ``Evaluating the Safety of Antimicrobial
New Animal Drugs with Regard to their Microbiological Effects on
Bacteria of Human Health Concern.''
GFI #152 outlines a qualitative risk assessment methodology as a
process for evaluating foodborne antimicrobial resistance concerns
related to the use of antimicrobial drugs in food-producing animals.
GFI #152 also contains an appendix, commonly referred to as ``Appendix
A,'' in which FDA ranks antimicrobial drugs according to their relative
importance to human medicine: ``critically important,'' ``highly
important,'' or ``important.''
The current list of medically important antimicrobial drugs in
Appendix A reflects FDA's thinking at the time of publication, in 2003.
It was envisioned at the time of publication of GFI #152 that the
Agency would reassess the rankings provided in Appendix A periodically
to confirm that the rankings are consistent with contemporary practices
and needs. As noted in GFI #152, the development of new antimicrobial
drugs for human therapy, the emergence or re-emergence of diseases in
humans, and changes in prescribing practices, are some factors that may
cause the human medical importance rankings to change over time.
Given the considerable advances in science that have taken place
since 2003, new relevant information has become available. In light of
those advances and the new information now available, FDA published a
notice in the Federal Register of October 13, 2020 (85 FR 64481),
announcing a public meeting and requesting comments on a concept paper
entitled ``Potential Approach for Ranking of Antimicrobial Drugs
According to Their Importance in Human Medicine: A Risk Management Tool
for Antimicrobial New Animal Drugs.''
FDA received more than 60 comment submissions from pharmaceutical
companies, academia, organizations, and private citizens on this
concept paper. FDA has considered all comments and is issuing this
draft guidance document, which contains revised sections in the risk
assessment framework, including updated tables and figures, and a
revised Appendix A based on new ranking criteria of antimicrobials
according to their importance in human medicine.
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
``Evaluating the Safety of Antimicrobial New Animal Drugs with Regard
to their Microbiological Effects on Bacteria of Human Health Concern.''
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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. 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: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27415 Filed 12-16-22; 8:45 am]
BILLING CODE 4164-01-P
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