Document ID: FDA-1998-D-0038-0150
Agency: fda
Document Type: Notice
Title: 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Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability; Extension of  Comment Period
Posted Date: 2023-03-07T05:00Z

[Federal Register Volume 88, Number 44 (Tuesday, March 7, 2023)]
[Notices]
[Pages 14170-14171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04562]

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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Concern; Revised Draft Guidance for Industry; Availability; Extension 
of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice announcing the availability 
of a draft guidance for industry that appeared in the Federal Register 
of December 19, 2022. In that notice, FDA requested comments on draft 
guidance for industry (GFI) #152 entitled ``Evaluating the Safety of 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.'' The Agency is taking 
this action in response to a request for an extension to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice published 
December 19, 2022 (87 FR 77619). Submit either electronic or written 
comments by May 19, 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comment on this draft guidance before it begins work on the final 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

[[Page 14171]]

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: 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: In the Federal Register of December 19, 
2022, FDA published a notice announcing the availability of a draft 
guidance for industry entitled ``Evaluating the Safety of Antimicrobial 
New Animal Drugs with Regard to their Microbiological Effects on 
Bacteria of Human Health Concern,'' and requesting comments on the 
proposed GFI.
    Interested persons were originally given until March 20, 2023, to 
comment on the document. The Agency has received a request for an 
extension of the comment period. The request stated that an additional 
90 days would allow interested parties to thoroughly consider the 
request for input. FDA has considered the request and is extending the 
comment period for the request for comments for 60 days, until May 19, 
2023. The Agency believes that a 60-day extension allows adequate time 
for interested persons to submit comments.

    Dated: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04562 Filed 3-6-23; 8:45 am]
BILLING CODE 4164-01-P