[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Pages 64481-64483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1736]


Potential Approach for Ranking of Antimicrobial Drugs According 
to Their Importance in Human Medicine: A Risk Management Tool for 
Antimicrobial New Animal Drugs; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
hosting a virtual public meeting entitled ``Potential Approach for 
Ranking of Antimicrobial Drugs According to Their Importance in Human 
Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.'' 
The purpose of the meeting is to obtain early input from the public on 
a potential revised approach for considering the human medical 
importance of antimicrobial new animal drugs when assessing and 
managing the antimicrobial resistance risks associated with the use of 
antimicrobial drugs in animals. The Agency is seeking public input on a 
potential revised process for ranking antimicrobials according to their 
relative importance in human medicine, on the potential criteria for 
their ranking, and on the resulting ranked list of antimicrobial drugs. 
A concept paper describing this potential revised process will be made 
available for discussion at the public meeting and can be obtained at 
the website listed in section II of this notice.

DATES: The public meeting will be held on November 16, 2020. Submit 
either electronic or written comments on this topic by January 15, 
2021. Further information regarding the meeting, including the time the 
meeting will start, the agenda, and how to register to attend the 
meeting, can be found at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/fda-public-meeting-potential-approach-ranking-antimicrobial-drugs-according-their-importance-human. See the 
SUPPLEMENTARY INFORMATION section for registration dates and 
information.

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 January 15, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 15, 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-2020-N-1736 for ``Potential Approach for Ranking of Antimicrobial 
Drugs of According to Their Importance in Human Medicine: A Risk 
Management Tool for Antimicrobial New Animal Drugs.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' be 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

[[Page 64482]]

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.
    Transcripts of the meeting will be available on the FDA website at: 
https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/fda-public-meeting-potential-approach-ranking-antimicrobial-drugs-according-their-importance-human approximately 30 days after the 
meeting.

FOR FURTHER INFORMATION CONTACT: Kelly Covington, Center for Veterinary 
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-5661, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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 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.'' \1\ 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. One component 
of the risk assessment is the consequence assessment, which considers 
the medical importance of an antimicrobial drug or drug class used in 
human medicine.
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    \1\ https://www.fda.gov/media/69949/download.
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    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.'' In GFI #152, FDA recommends 
that sponsors of antimicrobial new animal drugs refer to Appendix A to 
initially assess the importance of the antimicrobial drug or drug class 
in question to human medicine and base their consequence assessment 
conclusion on this human medical importance ranking.
    The current list of medically important antimicrobial drugs in 
Appendix A reflects FDA's thinking at the time of publication, in 2003.
    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. 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.
    Given the considerable advances in science that have taken place 
since 2003, new relevant information has become available. The purpose 
of the public meeting is to obtain early input on a potential revised 
process for ranking antimicrobial drugs according to their relative 
importance in human medicine, as well as potential criteria for their 
ranking.

II. Topics for Discussion at the Public Meeting

    We will publish the public meeting agenda and related information, 
including a concept paper describing a potential revised ranking 
process, at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/fda-public-meeting-potential-approach-ranking-antimicrobial-drugs-according-their-importance-human. We do not intend 
for this meeting to produce any decisions or new positions on specific 
regulatory questions. However, we expect this meeting to be an 
important step in our efforts to gather information and public feedback 
on a potential revised process for ranking antimicrobial drugs 
according to their relative importance in human medicine, on the 
criteria for their ranking, and on a ranked list of antimicrobial 
drugs.
    We are specifically interested in receiving public comments on the 
following questions:
    1. Are the criteria and the tier-based framework described in the 
potential revised process for ranking antimicrobial drugs according to 
their relative human medical importance clear, complete, and 
consistent?
    2. What changes do you think are needed to the criteria or tiers, 
if any?
    3. Have the potential criteria been applied correctly to the 
antimicrobial classes as reflected in the resulting rankings?
    4. Are there other issues we should consider regarding these 
criteria and the tier-based framework?
    5. How often and by what process should FDA update the ranking of 
medically important antimicrobials?

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register no later than 11:59 p.m. Eastern Time on November 12, 
2020, by emailing complete contact information for each attendee, 
including name, title, affiliation, address, email, telephone number, 
and if you need reasonable accommodations due to a disability (e.g., 
Closed Captioning) to Kelly Covington at [email protected]. 
Early registration is recommended. Registrants will receive 
confirmation when their registration has been received and will be 
provided the webcast link.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to make an oral presentation during the public 
meeting. To facilitate agenda development,

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registrants requesting to present will be contacted to provide 
information regarding which topics they intend to address and the title 
of their presentation. We will do our best to accommodate requests to 
make an oral presentation. Individuals and organizations with common 
interests are urged to consolidate or coordinate their presentations, 
and request time for a joint presentation, or submit requests for 
designated representatives to participate. All requests to make oral 
presentations must be received by October 23, 2020.
    We will determine the amount of time allotted to each presenter and 
the approximate time each oral presentation is to begin, and we will 
notify participants by October 27, 2020. Selected presenters planning 
to use an electronic slide deck must submit an electronic copy of their 
PowerPoint presentation to Kelly Covington (see FOR FURTHER INFORMATION 
CONTACT) with the subject line ``Potential Approach for Ranking of 
Antimicrobial Drugs According to Their Importance in Human Medicine: A 
Risk Management Tool for Antimicrobial New Animal Drugs'' on or before 
November 9, 2020. If presenters choose not to use a slide deck, they 
are requested to submit a single slide with their name, affiliation, 
title of their presentation, and contact information. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public meeting.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management 
Staff (see ADDRESSES). A link to the transcript will also be available 
on the Agency's website at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/fda-public-meeting-potential-approach-ranking-antimicrobial-drugs-according-their-importance-human.

    Dated: October 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22581 Filed 10-9-20; 8:45 am]
BILLING CODE 4164-01-P