[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77619-77620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Concern; Revised Draft Guidance for Industry; Availability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the availability of a draft guidance for industry #152 entitled 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This draft guidance informs stakeholders about FDA's current method for 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DATES: Submit either electronic or written comments on the draft 
guidance by March 20, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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: Ruby Singh, Center for Veterinary 
Medicine (HFV-150), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0794, [email protected].

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 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: 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


