Document ID: FDA-2021-N-0318-0001
Agency: fda
Document Type: Notice
Title: Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea; Public Workshop; 
Request for Comments
Posted Date: 2021-04-13T04:00Z

[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19271-19272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07548]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0318]

Development Considerations of Antimicrobial Drugs for the 
Treatment of Gonorrhea; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, National Institute of Allergy and 
Infectious Diseases, Centers for Disease Control and Prevention, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we), the 
National Institute of Allergy and Infectious Diseases (NIAID), and the 
Centers for Disease Control and Prevention (CDC) are announcing the 
following public workshop entitled ``Development Considerations of 
Antimicrobial Drugs for the Treatment of Gonorrhea.'' The purpose of 
the public workshop is to discuss the nonclinical and clinical 
pharmacology data and clinical trial design considerations regarding 
developing antimicrobial drugs for the treatment of gonorrhea.

DATES: The public workshop will be held virtually on April 23, 2021, 
from 9 a.m. to 5 p.m., Eastern Time. Submit either electronic or 
written comments on this public workshop by June 1, 2021. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held in virtual format only.
    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 June 1, 2021. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of June 1, 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-2021-N-0318 for ``Development Considerations of Antimicrobial Drugs 
for the Treatment of Gonorrhea.'' 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: Lori Benner and/or Antoinette 
Ziolkowski, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver 
Spring, MD 20993-0002, 301-796-1300.

I. Background

    FDA, NIAID, and CDC are announcing a public workshop regarding the 
development considerations of antimicrobial drugs for the treatment of 
gonorrhea. As such, discussions will focus on the current state of 
diagnosis and treatment of gonorrhea and nonclinical and clinical trial 
design considerations for drug development.

II. Topics for Discussion at the Public Workshop

    The workshop will focus on discussing challenges and clinical trial

[[Page 19272]]

considerations regarding antimicrobial drug development for gonorrhea.
    Discussions are planned around the following topic areas:
     Animal models;
     Clinical pharmacology considerations; and
     Trial design considerations for gonorrhea, such as 
enrollment strategies, choice of comparators, and site of infection.
    The Agency encourages healthcare providers, other U.S. Government 
Agencies, academic experts, industry, and other stakeholders to attend 
this public workshop.

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online, using the internet link noted in the Transcripts 
section below, by April 21, 2021, 11:59 p.m. Eastern Time. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Registrants will receive confirmation when 
they have been accepted.
    If you need special accommodations due to a disability, please 
contact Antoinette Ziolkowski or Lori Benner (see FOR FURTHER 
INFORMATION CONTACT) no later than April 20, 2021.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during the virtual public comment 
session and which topic(s) you wish to address. All requests to make 
oral presentations must be received by April 15, 2021. We will do our 
best to accommodate requests to make public comments. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate their presentations and request time for a joint 
presentation. We will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin 
and will select and notify participants by April 16, 2021. If selected 
for presentation, any presentation materials must be emailed to 
ONDPublicMTGSupport@fda.hhs.gov no later than April 19, 2021. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast at the following site: https://collaboration.fda.gov/cderond042321/.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/drugs/news-events-human-drugs/development-considerations-antimicrobial-drugs-treatment-gonorrhea-04232021-04232021.

    Dated: April 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07548 Filed 4-12-21; 8:45 am]
BILLING CODE 4164-01-P