Document ID: FDA-2020-N-1736-0065
Agency: fda
Document Type: Notice
Title: Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: 
A Risk Management Tool for Antimicrobial New Animal Drugs; Reopening of the Comment Period
Posted Date: 2021-04-12T04:00Z

[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18988-18989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07452]

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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; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and request for comments; reopening of 
the comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notice announcing a public meeting 
and requesting comments that appeared in the Federal Register of 
October 13, 2020. In that notice, FDA announced a public meeting, which 
was held on November 16, 2020, and requested public input 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. Specifically, the Agency requested comments on the 
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. 
We are taking this action in response to technical difficulties 
submitting comments to the Federal eRulemaking portal.

DATES: Submit either electronic or written comments by April 22, 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 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 22, 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

[[Page 18989]]

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 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,'' 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.

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, Kelly.Covington@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 13, 2020, 
FDA published a notice 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,'' giving 
interested persons until January 15, 2021, to comment on the public 
meeting and request for comments. In a notice published in the Federal 
Register on November 27, 2020 (85 FR 76081), the Agency extended the 
comment period to March 16, 2021. The Agency has received several 
comments from stakeholders of technical difficulties submitting 
comments to the Federal eRulemaking portal. In consideration of these 
difficulties, FDA is reopening the comment period for 10 days to allow 
these stakeholders the opportunity to submit comments. All comments 
previously submitted, do not need to be resubmitted.

    Dated: April 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07452 Filed 4-9-21; 8:45 am]
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